J Clin Pharm Ther [JOURNAL]
Sun
200 papers
Liver failure caused by intravenous amiodarone and effective intervention measures: A case report.
Jiang Z, Zhao C, Li X … +2 more , Yi W, Yan R
J Clin Pharm Ther · 2022 Aug · PMID 35322453 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: We present a case of intravenous amiodarone-induced liver injury, pharmacy monitoring and its therapy. CASE SUMMARY: A 76-year-old male patient developed acute liver injury 24 h after startin...
WHAT IS KNOWN AND OBJECTIVE: We present a case of intravenous amiodarone-induced liver injury, pharmacy monitoring and its therapy. CASE SUMMARY: A 76-year-old male patient developed acute liver injury 24 h after starting intravenous amiodarone. His liver enzymes improved after discontinuing amiodarone and anti-inflammatory liver therapy, which used reduced glutathione, magnesium isoglycyrrhizinate and ademetionine1,4-butanedisulfonate for injection. WHAT IS NEW AND CONCLUSION: Amiodarone is a highly effective antiarrhythmic agent for the treatment and prevention of atrial and ventricular arrhythmias. Acute liver damage after intravenous amiodarone is rare but potentially harmful. Amiodarone loading should be adapted to the necessity of an immediate effect of the drug, and liver function should be monitored closely in critically ill patients. Timely stopped suspected drug and anti-inflammatory liver therapy may reduce the occurrence of drug-induced diseases.
Repositioning of Cannabis sativa: A topic under construction.
Foletto VS, Serafin MB, Bottega A … +4 more , da Rosa TF, Marion SL, da Mota AD, Hörner R
J Clin Pharm Ther · 2022 Aug · PMID 35322448 · Publisher ↗
Abstract loading — click title to view on PubMed.
Comprehensive analysis of everolimus-induced adverse events using the Japanese real-world database.
Uchida M, Nakano K, Fujiwara M … +2 more , Uesawa Y, Shimizu T
J Clin Pharm Ther · 2022 Aug · PMID 35316861 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVES: As for adverse events (AEs) caused by everolimus, findings from clinical trials and post-marketing surveillance have reported interstitial lung disease, hyperglycaemia, cardiovascular diseas...
WHAT IS KNOWN AND OBJECTIVES: As for adverse events (AEs) caused by everolimus, findings from clinical trials and post-marketing surveillance have reported interstitial lung disease, hyperglycaemia, cardiovascular disease, etc. However, these reports are limited to incidence, and detailed studies on the risk of occurrence, time to onset and post-event clinical outcomes are only related to hyperglycaemia. The purpose of this study was to perform a comprehensive analysis of adverse events during everolimus therapy in patients with renal cell carcinoma (RCC) using the Japanese Adverse Event Report database. METHODS: Data reported between April 2004 and June 2021 in the Japanese Adverse Drug Event Report database were extracted for use. The reported odds ratio, time to onset and post-event course were analysed for the top 30 adverse events reported. RESULTS AND DISCUSSION: Among the top 30 adverse events, 23 adverse event signals were detected and classified into seven categories: lung-related AEs, haematological-related AEs, cancer progression, blood glucose-related AEs, hepatic-related AEs, renal-related AEs and others. The lung-related adverse events category was the most common, and the proportion of fatal outcomes after the occurrence of two adverse events related to infectious pneumonia was more than 10%. WHAT IS NEW AND CONCLUSION: A comprehensive survey of adverse events associated with everolimus administration using the pharmacovigilance database revealed that pulmonary and haematological AEs are frequently reported. The results suggest that attention should be paid to the occurrence of lung disorders because they may lead to fatal outcomes.
Comment on "Persistent remission of acromegaly in a patient with GH-secreting pituitary adenoma: Effect of treatment with pasireotide long-acting release and consequence of treatment withdrawal".
Daly AF
J Clin Pharm Ther · 2022 Sep · PMID 35313386 · Publisher ↗
Abstract loading — click title to view on PubMed.
Incidence and risk factors for hyperkalaemia in patients treated for COVID-19 with nafamostat mesylate.
Kodama K, Imai T, Asai Y … +5 more , Kozu Y, Hayashi K, Shimizu T, Gon Y, Ootsuka S
J Clin Pharm Ther · 2022 Jul · PMID 35313385 · Full text
WHAT IS KNOWN AND OBJECTIVE: Nafamostat mesylate (NM) is used clinically in combination with antiviral drugs to treat coronavirus disease (COVID-19). One of the adverse events of NM is hyperkalaemia due to inhibition of...
WHAT IS KNOWN AND OBJECTIVE: Nafamostat mesylate (NM) is used clinically in combination with antiviral drugs to treat coronavirus disease (COVID-19). One of the adverse events of NM is hyperkalaemia due to inhibition of the amiloride-sensitive sodium channels (ENaC). The incidence and risk factors for hyperkalaemia due to NM have been studied in patients with pancreatitis but not in COVID-19. COVID-19 can be associated with hypokalaemia or hyperkalaemia, and SARS-CoV-2 is thought to inhibit ENaC. Therefore, frequency and risk factors for hyperkalaemia due to NM may differ between COVID-19 and pancreatitis. Hyperkalaemia may worsen the respiratory condition of patients. The objective of this study was to determine the incidence and risk factors for hyperkalaemia in COVID-19 patients treated with favipiravir, dexamethasone and NM. METHODS: This retrospective study reviewed the records of hospitalized COVID-19 patients treated with favipiravir and dexamethasone, with or without NM, between March 2020 and January 2021. Multivariable logistic regression analysis was performed to identify the risk factors for hyperkalaemia. RESULTS AND DISCUSSION: Of 45 patients who received favipiravir and dexamethasone with NM for the treatment of COVID-19, 21 (47%) experienced hyperkalaemia. The duration of NM administration was a significant predictor of hyperkalaemia (odds ratio: 1.55, 95% confidence interval: 1.04-2.31, p = 0.031). The receiver-operating characteristic curve analysis determined that the cut-off value for predicting the number of days until the onset of hyperkalaemia was 6 days and the area under the curve was 0.707. WHAT IS NEW AND CONCLUSION: This study revealed that the incidence of hyperkalaemia is high in patients treated for COVID-19 with NM, and that the duration of NM administration is a key risk factor. When NM is administered for the treatment of COVID-19, it should be discontinued within 6 days to minimize the risk of hyperkalaemia.
Effects of linezolid on the haematological system in very low birth weight infants: A single-centre retrospective study.
Bu X, Zhou J
J Clin Pharm Ther · 2022 Aug · PMID 35312093 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Linezolid, as a substitute for vancomycin, has been used in treating methicillin-resistant Gram-positive bacterial infections in very low birth weight (VLBW) infants. However, when linezolid...
WHAT IS KNOWN AND OBJECTIVE: Linezolid, as a substitute for vancomycin, has been used in treating methicillin-resistant Gram-positive bacterial infections in very low birth weight (VLBW) infants. However, when linezolid induces thrombocytopenia in adults, its side effects in VLBW infants are concerning. This study aimed to investigate the effect of linezolid on haematologic profiles in this specific vulnerable population. METHODS: VLBW infants treated with linezolid from January, 2017, to July, 2021, were retrospectively analysed compared with vancomycin as controls. The effects of medications on haematologic parameters were compared on Days 1, 3, 5, 7, 10, 14 and 21 after medication initiation. RESULT AND DISCUSSION: Totally 40 VLBW infants treated with linezolid were recruited in the study, using 45 VLBW treated with vancomycin as controls. Baseline clinical characteristics, such as gestational age and birth weight, were not significantly different between the two groups. After medication initiation, the white blood cell counts on the Days 5 and 7 in the linezolid group were significantly lower than that in the vancomycin group (D5: 11.6 ± 6.2*10⁹/L vs. 14.5 ± 6.4*10⁹/L, p = 0.013; D7: 10.8 ± 5.9*10⁹/L vs. 14.1 ± 8.0*10⁹/L, p = 0.01), while the platelet counts were significantly lower in the linezolid group on Days 10 and 14 (D10: 219.2 ± 90.5*10⁹/L vs. 287.5 ± 100.4*10⁹/L, p = 0.049; D14: 263.0 ± 110.9*10⁹/L vs. 325.0 ± 155.1*10⁹/L, p = 0.036). For substantial haematologic abnormalities, there were no significant differences in leukopenia, neutropenia, agranulocytosis and thrombocytopenia between the two groups. WHAT IS NEW AND CONCLUSIONS: In VLBW infants, compared with vancomycin, linezolid tends to induce lower white blood cell and platelet counts transiently, but does not increase the severe forms of haematologic side effects.
An open-label, phase 1, randomized, three treatments, three-period, crossover, relative bioavailability study of CC-292, a potent and orally available inhibitor of bruton tyrosine kinase.
Cheng Y, Liu L, Xue Y … +2 more , Zhou S, Li Y
J Clin Pharm Ther · 2022 Aug · PMID 35307850 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: CC-292 is a potent, selective, orally administered small molecule inhibitor of bruton tyrosine kinase (BTK). The aim of this study was to evaluate the relative bioavailability of newly develo...
WHAT IS KNOWN AND OBJECTIVE: CC-292 is a potent, selective, orally administered small molecule inhibitor of bruton tyrosine kinase (BTK). The aim of this study was to evaluate the relative bioavailability of newly developed CC-292 tablet formulation (P22 tablet (P22-TAB) and CC-292 capsule formulation (P22 capsule [P22-CAP]) compared to the current CC-292 capsule formulation (P1 capsule [P01-CAP]). METHODS: This was an open-label, randomized, three-period, crossover study in healthy subjects (N = 12). Blood samples for pharmacokinetics (PK) assessment were collected up to 48 h postdose during each treatment period. Safety was evaluated throughout the study. RESULTS AND DISCUSSION: For all three formulations, following administration of CC-292 at a dose level of 250 mg under fasted conditions, CC-292 was rapidly absorbed with maximum plasma concentrations (Cmax) occurring at a median of 1.5-1.75 h (Tmax). P22-CAP formulation showed a similar range of Tmax compared to P01-CAP and P22-TAB showed a wider range of Tmax compared to P01-CAP. Comparable or higher Cmax and AUC0-∞ were noted for P22-TAB and P22-CAP formulations as compared to P01-CAP formulation. The relative bioavailability (Frel) of the CC-292 P22-TAB compared to the P01-CAP reference formulation was 1.02, and the relative bioavailability (Frel) of the CC-292 P22-CAP compared to the P01-CAP reference formulation was 1.23. In conclusion, CC-292 was well tolerated when administered as single 250-mg oral doses of P22-TAB, P22-CAP or P01-CAP in the fasted state in this group of healthy subjects. Given that CC-292 has shown favourable safety profiles in the current clinical settings, the new formulations (P22-TAB and P22-CAP) are similar as the reference formulation (P01-CAP).
Implementation of a pharmacist-led transitional pharmaceutical care programme: Process evaluation of Medication Actions to Reduce hospital admissions through a collaboration between Community and Hospital pharmacists (MARCH).
En-Nasery-de Heer S, Uitvlugt EB, Bet PM … +6 more , van den Bemt BJF, Alai A, van den Bemt PMLA, Swart EL, Karapinar-Çarkit F, Hugtenburg JG
J Clin Pharm Ther · 2022 Jul · PMID 35306683 · Full text
WHAT IS KNOWN AND OBJECTIVE: The recently conducted Medication Actions to Reduce hospital admissions through a collaboration between Community and Hospital pharmacists (MARCH) transitional care programme, which aimed to...
WHAT IS KNOWN AND OBJECTIVE: The recently conducted Medication Actions to Reduce hospital admissions through a collaboration between Community and Hospital pharmacists (MARCH) transitional care programme, which aimed to test the effectiveness of a transitional care programme on the occurrence of ADEs post-discharge, did not show a significant effect. To clarify whether this non-significant effect was due to poor implementation or due to ineffectiveness of the intervention as such, a process evaluation was conducted. The aim of the study was to gain more insight into the implementation fidelity of MARCH. METHODS: A mixed methods design and the modified Conceptual Framework for Implementation Fidelity was used. For evaluation, the implementation fidelity and moderating factors of four key MARCH intervention components (teach-back, the pharmaceutical discharge letter, the post-discharge home-visit and the transitional medication review) were assessed. Quantitative data were collected during and after the intervention. Qualitative data were collected using semi-structured interviews with MARCH healthcare professionals (community pharmacists, clinical pharmacists, pharmacy assistants and pharmaceutical consultants) and analysed using thematic analysis. RESULTS AND DISCUSSION: Not all key intervention components were implemented as intended. Teach-back was not always performed. Moreover, 63% of the pharmaceutical discharge letters, 35% of the post-discharge home-visits and 44% of the transitional medication reviews were not conducted within their planned time frames. Training sessions, structured manuals and protocols with detailed descriptions facilitated implementation. Intervention complexity, time constraints and the multidisciplinary coordination were identified as barriers for the implementation. WHAT IS NEW AND CONCLUSION: Overall, the implementation fidelity was considered to be moderate. Not all key intervention components were carried out as planned. Therefore, the non-significant results of the MARCH programme on ADEs may at least partly be explained by poor implementation of the programme. To successfully implement transitional care programmes, healthcare professionals require full integration of these programmes in the standard work-flow including IT improvements as well as compensation for the time investment.
Treatment and economic burden of mucormycosis in China: Case report review and burden estimation.
Jian Y, Wang M, Yu Y … +4 more , Zhuo Y, Xiao D, Lin S, Xuan J
J Clin Pharm Ther · 2022 Jul · PMID 35304764 · Full text
WHAT IS KNOWN AND OBJECTIVE: Mucormycosis is an opportunistic fungal infection associated with low incidence but high mortality. Few studies have shown the treatment and disease burden of mucormycosis in China. This stud...
WHAT IS KNOWN AND OBJECTIVE: Mucormycosis is an opportunistic fungal infection associated with low incidence but high mortality. Few studies have shown the treatment and disease burden of mucormycosis in China. This study aims at collecting all the reported cases to describe the characteristics and treatment patterns and to assess the economic burden of mucormycosis in China. METHODS: We conducted a literature review of mucormycosis case reports in Chinese patients to summarize the characteristics and treatment patterns of the disease in China. An economic model was built to evaluate the total cost of mucormycosis per person, including direct medical cost, direct non-medical cost and indirect cost. RESULTS AND DISCUSSION: A total of 676 case reports showed that the most common type of mucormycosis was pulmonary mucormycosis (299/676, 44.2%), and rhinocerebral mucormycosis had the highest case fatality rate (122/185, 68.5%). Among those who used empiric therapies, 48.8% (231/473) did not include anti-mucor drugs; 79.8% (336/421) of the therapies include amphotericin B (AMB) or AMB-lipo after detection of mucormycetes; 98.6% (69/70) of the reported adverse events were associated with AMB and AMB-lipo. The duration of treatment ranged from 90 to 180 days; the length of stay ranged from 22 to 95 days. The average total cost per patient was 166 thousand Chinese Yuan (CNY), of which 93.1% was the direct medical cost (155 thousand CNY). WHAT IS NEW AND CONCLUSION: There are a limited number of antifungal treatment options for mucormycosis in China. This study highlights the critical need to introduce innovative and broader spectrum antifungal drugs with improved safety, better clinical efficacy, easier administration and reduced economic burden to Chinese mucormycosis patients.
Ravulizumab 100 mg/mL formulation reduces infusion time and frequency, improving the patient and caregiver experience in the treatment of atypical haemolytic uraemic syndrome.
Dixon BP, Sabus A
J Clin Pharm Ther · 2022 Jul · PMID 35304755 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: The C5 inhibitor eculizumab is the standard of care for treatment of atypical haemolytic uraemic syndrome (aHUS). Ravulizumab, a next-generation C5 inhibitor, was engineered to have a longer...
WHAT IS KNOWN AND OBJECTIVE: The C5 inhibitor eculizumab is the standard of care for treatment of atypical haemolytic uraemic syndrome (aHUS). Ravulizumab, a next-generation C5 inhibitor, was engineered to have a longer terminal half-life than eculizumab. We describe practical benefits of the advanced ravulizumab 100 mg/mL formulation. COMMENT: Use of ravulizumab results in fewer maintenance infusions per year (25%-50%) compared with eculizumab. Maintenance infusion time of ravulizumab 100 mg/mL is 2-4 times shorter than ravulizumab 10 mg/mL in all weight cohorts and approximately half that of eculizumab for patients weighing <40 kg. Ravulizumab 100 mg/mL requires fewer vials annually than eculizumab in most weight cohorts. WHAT IS NEW AND CONCLUSION: With ravulizumab 100 mg/mL, patients and caregivers experience fewer infusions per year and decreased annual infusion times, improving infusion experience. Infusion centres can expect corresponding decreases in resource utilization.
Rapid infusion of fish oil-based lipid emulsions: Is there a risk of fat overload syndrome? A case report of rapid administration.
Burdine J, Franco-Fuenmayor ME, Huff ML … +1 more , Shattuck KE
J Clin Pharm Ther · 2022 Jul · PMID 35304749 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVES: Errors involving the delivery of IVFE containing soybean oil have known significant complications, including fat overload syndrome. However, little is known regarding the risks of fat overlo...
WHAT IS KNOWN AND OBJECTIVES: Errors involving the delivery of IVFE containing soybean oil have known significant complications, including fat overload syndrome. However, little is known regarding the risks of fat overload syndrome with other types of lipid emulsions. CASE SUMMARY: We describe a medication administration error that resulted in rapid fish oil-base lipid emulsion (Omegaven) infusion in a five-month-old infant with parenteral nutrition associated liver disease (PNALD). The medication administration error resulted in bolus infusion of Omegaven over 12 min (5 g/kg/h) instead of 12 h (0.083 g/kg/h). WHAT IS NEW AND CONCLUSION: No adverse reactions were notes because of the rapid infusion, supporting conclusion that rapid infusion of fish oil will not result in fat overload syndrome.
Four kinds of tocolytic therapy for preterm delivery: Systematic review and network meta-analysis.
Xiong Z, Pei S, Zhu Z
J Clin Pharm Ther · 2022 Jul · PMID 35304748 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Premature birth affects more than 15 million infants, as well as mothers and families around the world. With the relaxation of the two-child policy, the problem of premature birth has become...
WHAT IS KNOWN AND OBJECTIVE: Premature birth affects more than 15 million infants, as well as mothers and families around the world. With the relaxation of the two-child policy, the problem of premature birth has become relatively prominent in China. According to statistics, China had a birth population of 15.23 million in 2018, with a considerably large number of premature births. This study aims to evaluate the efficacy and safety of tocolysis in the treatment of preterm delivery, provide clinical evidence for medical staff and promote the self-management of patients with premature births. METHODS: Four English databases (PubMed, Embase, Cochrane Library and Web of Science) were retrieved by computer, the retrieval time was from the establishment of each database to November 2021, and the randomized controlled trials for the treatment of preterm delivery were screened according to the pre-set natriuretic exclusion criteria. After literature screening, data selection and risk of bias evaluation were independently conducted by two researchers. R 4.1.1 and Stata 17.0 software were used for statistical analysis. RESULTS AND DISCUSSION: A total of 44 RCTs were included, including 6939 patients. The results of network meta-analysis reveal that in terms of effectiveness, indomethacin was the most effective intervention measure, followed by nifedipine, and the difference was statistically significant; regarding safety, nifedipine was the safest intervention measure, followed by indomethacin, and the difference was statistically significant; and in respect of adverse reactions, ritodrine had the highest probability, and the difference was statistically significant. WHAT IS NEW AND CONCLUSION: Nifedipine may be better for delayed delivery and less likely to produce adverse pregnancy outcomes, followed by indomethacin. Limited by the number and quality of recipient studies, the aforementioned conclusions need to be verified through more high-quality studies. At the same time, the focus should be on patients with twin pregnancy and patients with clinical manifestations of extreme preterm delivery.
Synthetic and natural coumarins as potent anticonvulsant agents: A review with structure-activity relationship.
Keri RS, Budagumpi S, Balappa Somappa S
J Clin Pharm Ther · 2022 Jul · PMID 35288962 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: The main objective of this review is to highlight the most relevant studies since 1990 (to date) in the area of medicinal chemistry aspects to provide a panoramic view to the biologists/medic...
WHAT IS KNOWN AND OBJECTIVE: The main objective of this review is to highlight the most relevant studies since 1990 (to date) in the area of medicinal chemistry aspects to provide a panoramic view to the biologists/medicinal chemists working in this area and would assist them in their efforts to design, synthesize and extract (from natural source) coumarin-based anticonvulsant agents. Also, the structure-activity relationship (SAR) studies are also discussed for further rational design of this kind of derivatives. It is hoped that this review will be helpful for new thoughts in the quest for rational designs of more active and less toxic coumarin-based antiepileptic agents. METHODS: A literature review emphasizing the application of coumarin core as antiepileptic agents identify articles related to the topic; we performed a standardized search from 1990 to November 2021, using search engines like Scifinder, web of Science, Pubmed and Scopus. RESULTS AND DISCUSSION: This review gives an overview of attempts to shed light and compile published reports on coumarin derivatives along with some opinions on different approaches to help the medicinal chemists in designing future generation potent yet safer anticonvulsant agents. The possible structure-activity relationships (SARs) will also be discussed to indicate the direction for the rational design of more effective candidates. WHAT IS NEW AND CONCLUSION: The findings from this review provide new indications or directions for the discovery of new and better drugs from synthetic and naturally occurring coumarins as antiepileptic agents. In our review, we have tried to depict the recent researches which made in the design and development of novel anticonvulsant compounds with coumarin nucleus. Also, SAR of expressed derivatives indicated that the choice of a fitting substitution containing electron-withdrawing/donating groups to coumarin or with some heterocyclic moieties joined to parent coumarin skeleton assumes an essential role in changing the anticonvulsant activity of synthesized derivatives. These findings encourage the scientific community towards the optimization of the pharmacological profile of this structural moiety as an important scaffold for the treatment of epilepsy.
Observation of clinical efficacy of the cefoperazone/sulbactam anti-infective regimen in the treatment of multidrug-resistant Acinetobacter baumannii lung infection.
Wang Q, Huang M, Zhou S
J Clin Pharm Ther · 2022 Jul · PMID 35285526 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Sulbactam and sulbactam-containing β-lactam antibiotics are often used in the treatment of Acinetobacter baumannii. We aimed to further examine the clinical efficacy of a cefoperazone/sulbact...
WHAT IS KNOWN AND OBJECTIVE: Sulbactam and sulbactam-containing β-lactam antibiotics are often used in the treatment of Acinetobacter baumannii. We aimed to further examine the clinical efficacy of a cefoperazone/sulbactam anti-infective regimen in multidrug-resistant A. baumannii (MDRAB) lung infections. METHODS: We conducted a retrospective analysis among patients with MDRAB lung infection and complete data who were treated at the geriatric intensive care unit of Jiangsu Province Hospital from January 2018 to December 2020. We collected general information, including age, sex, APACHE II score, anti-infective course, comorbid infections in other sites, other pathogens, cefoperazone/sulbactam regimen and concomitant medications, and adverse reactions. We used microbiological changes before and after treatment to assess microbiological efficacy, defined as microbial eradication and reduction. RESULTS AND DISCUSSION: 121 patients were included, among which 96 (79.34%) were men and 25 (20.66%) were women. The median age was 76 (interquartile range [IQR] 62.5-83) years, median APACHE II score was 22 (IQR 19-26), and median treatment course was 8 (IQR 5-12.5) days. Among these patients, tigecycline was concomitantly used in 52 patients and the sulbactam dose was increased to 4 g and above in 27 patients. The microbiological efficacy of conventional cefoperazone/sulbactam with/without tigecycline in MDRAB decreased with each consecutive year and a reduction in efficacy was linearly correlated with year, which was both statistically significant (p = 0.039, 0.030, respectively). In 2020, the microbiological efficacy of a higher sulbactam dose combined with tigecycline was 75%, which was a significant improvement over the conventional dose (p = 0.028). The 3-year data showed that the microbiological efficacy of conventional cefoperazone/sulbactam 3 g eight hourly (q8h) without tigecycline was 32% and efficacy increased to 57.9% when the sulbactam dose was increased. Hence, the increased sulbactam dose significantly improved efficacy in MDRAB lung infection (p = 0.049). Different doses of sulbactam combined with tigecycline increased the microbiological efficacy of MDRAB but the differences were not statistically significant. WHAT IS NEW AND CONCLUSION: A cefoperazone/sulbactam-based anti-infective regimen showed some efficacy in MDRAB lung infection, but the microbiological efficacy of a cefoperazone/sulbactam 3 g q8h regimen decreased over time. Increasing the sulbactam dose to 4 g or more can improve efficacy. Minimum inhibitory concentration (MIC)-guided personalized medicine may be a future research direction.
Osteoporosis or fracture risk associated with thiazolidinedione and proton pump inhibitor co-administration in patients with type 2 diabetes mellitus.
Ock M, Lee S, Kim H
J Clin Pharm Ther · 2022 Jul · PMID 35257383 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Thiazolidinedione (TZD) and proton pump inhibitor (PPI) belong to classes of drugs that affect bone metabolism; however, few studies have investigated the effects of these drugs on bone metab...
WHAT IS KNOWN AND OBJECTIVE: Thiazolidinedione (TZD) and proton pump inhibitor (PPI) belong to classes of drugs that affect bone metabolism; however, few studies have investigated the effects of these drugs on bone metabolism. The aim of this study was to assess the risk of osteoporosis or fracture in patients with type 2 diabetes mellitus (T2DM) co-administered TZD and PPIs. METHODS: This retrospective cohort study was conducted using the National Sample Cohort database from 2003 to 2013. We included adult patients with T2DM who were prescribed TZD and PPIs together for the first time. The Cox proportional hazard model was used to determine the risk ratio of fracture or osteoporosis in the co-administration cohort (TZD + PPI) compared with the TZD-only group (TZD). We adjusted for age, sex, use of other medications and other diseases that affect the bone. RESULTS AND DISCUSSION: Of 9073 patients administered TZD, the number of eligible patients was 7240 (545 TZD + PPI, 6695 TZD-only). After 1:3 propensity score matching, 545 patients remained in the TZD + PPI group and 1635 in the TZD-only group. The risk of osteoporosis or fracture was significantly higher in the TZD + PPI cohort than in the TZD-only cohort. The adjusted hazard ratio (HR) for fracture or osteoporosis was 1.47 (95% CI 1.05-2.07). TZD and PPI use in women were associated with an increased risk of skeletal outcomes. WHAT IS NEW AND CONCLUSION: TZD and PPI use were associated with an increased risk of osteoporosis or fracture in patients with T2DM.
ED and ED of propofol combined with different doses of esketamine for children undergoing upper gastrointestinal endoscopy: A prospective dose-finding study using up-and-down sequential allocation method.
Zheng XS, Shen Y, Yang YY … +5 more , He P, Wang YT, Tao YY, Zheng JJ, Sun Y
J Clin Pharm Ther · 2022 Jul · PMID 35255530 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Propofol and esketamine are routine anaesthetics used in sedation or general anaesthesia for paediatric procedures. Coadministration could reduce the dose of either propofol or esketamine req...
WHAT IS KNOWN AND OBJECTIVE: Propofol and esketamine are routine anaesthetics used in sedation or general anaesthesia for paediatric procedures. Coadministration could reduce the dose of either propofol or esketamine required and lower the incidence of drug-related adverse events. We designed a four-arm randomized controlled trial in children undergoing diagnostic upper gastrointestinal endoscopy to investigate the dose of propofol with different doses of esketamine inducing appropriate depth of anaesthesia in 50% patients (median effective dose, ED ). METHODS: After getting the approval of the research ethics committee and informed consent, 92 paediatric patients planning for upper gastrointestinal endoscopy were divided into four groups randomly: esketamine 0, 0.25, 0.5 and 1 mg/kg groups (n = 23/group). Propofol doses followed the Dixon and Massey up-and-down method with different starting and interval doses between groups. During the first attempt of endoscope insertion, if patients' reactions prevented the insertion, it would be considered as a failure. The awakening time, total propofol doses, as well as the perioperative and post-procedure adverse events were evaluated and recorded for each patient. RESULTS AND DISCUSSION: The ED (median, 95% confidence interval) of propofol was significantly greater in esketamine 0 and 0.25 mg/kg groups in comparison with the esketamine 0.5 and 1 mg/kg groups (4.1 [3.3-4.9]; 3.1 [2.5-3.8] mg/kg vs. 1.8 [1.1-2.4]; 0.8 [0.2-1.3] mg/kg, respectively, p < .05). The total doses of propofol in esketamine 0.5 and 1 mg/kg groups were statistically lower than these in esketamine 0 and 0.25 mg/kg group (p < .01). The mean blood pressure was lower in the esketamine 0 mg/kg group than that in 1 mg/kg group after administration and during the procedure (p < .01). The esketamine 1 mg/kg group showed a higher incidence of vomiting and visual disturbances than the other three groups (p < .001). WHAT IS NEW AND CONCLUSION: In children who accomplished diagnostic paediatric upper gastrointestinal endoscopy under deep sedation/anaesthesia, the total dosage of propofol needed was reduced significantly in esketamine 0.5 and 1 mg/kg groups with a corresponding reduce in propofol-related hemodynamic changes. However, a higher incidence of esketamine-related adverse effects was found in esketamine 1 mg/kg group.
Ceftolozane/tazobactam for difficult-to-treat Gram-negative infections: A real-world tertiary hospital experience.
Ronda M, Pérez-Recio S, González Laguna M … +6 more , Tubau Quintano MF, Llop Talaveron J, Soldevila-Boixader L, Carratalà J, Cuervo G, Padullés A
J Clin Pharm Ther · 2022 Jul · PMID 35255527 · Publisher ↗
OBJECTIVE: To evaluate the real-world clinical efficacy of ceftolozane/tazobactam (C/T) in difficult-to-treat infections caused by multi-drug resistant Gram-negative microorganisms, including carbapenem-resistant Pseudom...
OBJECTIVE: To evaluate the real-world clinical efficacy of ceftolozane/tazobactam (C/T) in difficult-to-treat infections caused by multi-drug resistant Gram-negative microorganisms, including carbapenem-resistant Pseudomonas aeruginosa. METHODS: Retrospective cohort study of adult patients treated with C/T for at least 48 hours for infections caused by multi-drug resistant Gram-negative bacteria in a tertiary hospital from May 2016 until August 2019. The primary outcome analysed was clinical failure, defined as a composite of symptomatology persistence after 7 days of C/T treatment, infection recurrence, and/or all-cause mortality within 30 days of follow-up. RESULTS AND DISCUSSION: 96 episodes of C/T treatment were included, mostly consisting of targeted treatments (83.9%) for the following sources of infection: intra-abdominal (22.6%), urinary tract (25.8%), skin and soft tissue (19.4%), hospital-acquired pneumonia (14%), and other (6.4%). The most frequently isolated bacteria were carbapenem-resistant (88, 94.6%). Clinical failure rate was 30.1%, due to persistent infection at day 7 (4.3%), recurrence of the initial infection (16.1%), or 30-day all-cause mortality (8.6%). Adverse events most frequently reported were Clostridium difficile infection (9%) and cholestasis (8%). WHAT IS NEW AND CONCLUSION: C/T showed a favourable clinical profile for difficult-to-treat multidrug-resistant and carbapenem-resistant Gram-negative infections, regardless of the source of infection.
Network meta-analysis on efficacy and safety of different Janus kinase inhibitors for ulcerative colitis.
Li Y, Yao C, Xiong Q … +4 more , Xie F, Luo L, Li T, Feng P
J Clin Pharm Ther · 2022 Jul · PMID 35253941 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: In the absence of head-to-head comparisons, the objective of this study was to conduct a network meta-analysis (NMA) to indirectly compare the relative efficacy and safety of Janus kinase (JA...
WHAT IS KNOWN AND OBJECTIVE: In the absence of head-to-head comparisons, the objective of this study was to conduct a network meta-analysis (NMA) to indirectly compare the relative efficacy and safety of Janus kinase (JAK) inhibitors for ulcerative colitis (UC). METHODS: We searched PubMed, EMBASE, Web of Science and Cochrane Library from the database inception until 13 August 2021. No randomized controlled trials (RCTs) that directly compared these interventions were identified. Therefore, a fixed-effects Bayesian NMA was conducted by identifying a connected (via comparison to placebo) network of RCTs. Ranking was assessed using surface under the cumulative ranking (SUCRA) probabilities. RESULTS AND DISCUSSION: Seven RCTs including 3190 patients met the inclusion criteria. Filgotinib 100 mg was ranked highest for induction of endoscopic remission (SUCRA, 0.67) whereas peficitinib 75 mg BID was ranked highest for induction of clinical response (SUCRA, 0.72). Peficitinib 75 mg was ranked highest for induction of mucosal healing (SUCRA, 0.71), whereas peficitinib 150 mg was ranked highest for clinical remission (SUCRA, 0.74). Tofacitinib 3 mg had the highest probability of being the best treatment in terms of change from baseline in Mayo score (SUCRA, 0.78). Adverse events (AEs) and treatment discontinuations or withdrawals from the study due to AEs did not differ between JAK inhibitors and placebo groups. WHAT IS NEW AND CONCLUSION: Based on indirect comparisons, peficitinib 75 mg/75 mg BID/150 mg, tofacitinib 3 mg and filgotinib 100mg were the most efficacious JAK inhibitor interventions in patients with UC. However, head-to-head trials are warranted to inform clinical decision-making with greater confidence.
Evaluation of the strategies to reduce third-generation oral cephalosporins in dentistry at a Japanese academic hospital: An interrupted time series analysis.
Yamagami A, Narumi K, Saito Y … +8 more , Furugen A, Imai S, Kitagawa Y, Ohiro Y, Takagi R, Takekuma Y, Sugawara M, Kobayashi M
J Clin Pharm Ther · 2022 Jul · PMID 35253939 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Third-generation oral cephalosporins, especially cefcapene-pivoxil (CFPN-PI), have been used frequently in the Japanese dental field. In December 2014 and April 2016, the newly published clin...
WHAT IS KNOWN AND OBJECTIVE: Third-generation oral cephalosporins, especially cefcapene-pivoxil (CFPN-PI), have been used frequently in the Japanese dental field. In December 2014 and April 2016, the newly published clinical guidelines recommended the use of amoxicillin (AMPC). Thus, it is important to evaluate the impact of these guidelines on the prescription profiles of prophylactic antibiotics, clinical outcomes and cost-effectiveness of antibiotics. METHODS: We conducted a retrospective study to analyse an interrupted time series analysis from April 2013 to March 2020 at the Department of Dentistry of Hokkaido University Hospital. A segmented regression model was used to estimate the changes in the incidence of infectious complications following tooth extraction. Prescribed antibiotic data were evaluated via days of therapy (DOT). Antibiotic costs were calculated in terms of the Japanese yen (JPY). RESULTS AND DISCUSSION: We identified 17,825 eligible patients. The incidence rates of infectious complications (SSI + dry socket) and SSI after tooth extraction were 3.2% and 2.2%, respectively, during the entire period. The extraction of impacted third molars corresponded to 5.0% and 3.4%, respectively. However, their incidence rates were not significantly different during this period. The use of prophylactic antibiotics and antibiotic cost showed consistent trends following the implementation of guidelines. The mean DOT of CFPN-PI decreased (ranging from 4893.6 DOTs/1000 patients [March 2013 to November 2014] to 3856.4 DOTs/1000 patients [December 2014 to March 2016]; p < 0.001, and from 3856.4 DOTs/1000 patients [December 2014 to March 2016] to 2293.9 DOTs/1000 patients [April 2016 to March 2020]; p < 0.001). In contrast, the mean DOT of AMPC was found to be increased (ranging from 1379.7 DOTs/1000 patients [March 2013 to November 2014] to 3236.3 DOTs/1000 patients [December 2014 to March 2016]; p < 0.001, and from 3236.3 DOTs/1000 patients [December 2014 to March 2016] to 4597.8 DOTs/1000 patients [April 2016 to March 2020]; p < 0.001). The mean monthly cost was decreased (ranging from 905.3 JPY [March 2013 to November 2014] to 788.7 JPY [December 2014 to March 2016]; p = 0.003, and from 788.7 JPY [December 2014 to March 2016] to 614.0 JPY [April 2016 to March 2020]; p < 0.001). WHAT IS NEW AND CONCLUSION: After December 2014, prophylactic antibiotics were switched from CFPN-PI to AMPC, and the incidence rate of infectious complications was not significantly different over time. However, changing antibiotics is useful from a cost-effectiveness perspective.
Oral immunosuppressants improve pregnancy outcomes in women with idiopathic recurrent miscarriage: A meta-analysis.
Ma N, Qin R, Qin W … +4 more , Liao M, Zhao Y, Hang F, Qin A
J Clin Pharm Ther · 2022 Jul · PMID 35249235 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Reports said immunotherapy is effective for the treatment of idiopathic recurrent miscarriage (RM). Immunotherapy is invasive, and lymphocyte therapy carries some risk of infection. Oral immu...
WHAT IS KNOWN AND OBJECTIVE: Reports said immunotherapy is effective for the treatment of idiopathic recurrent miscarriage (RM). Immunotherapy is invasive, and lymphocyte therapy carries some risk of infection. Oral immunosuppressants have the advantages of simple administration and convenience; however, there is no statistical analysis of whether they can improve pregnancy outcomes in patients with idiopathic RM. METHODS: Six databases were searched for studies on oral immunosuppressants and RM; 374 articles were identified. There were two oral immunosuppressants, cyclosporine A and prednisone; two studies were on cyclosporine A and three studies were on prednisone for RM. RESULTS AND DISCUSSION: In total, 554 RM patients were included in this analysis, including 357 patients who received oral immunosuppressive agents and 197 patients who received basic treatment, placebo, or no treatment. Oral administration of cyclosporine A or prednisolone increases live birth rate (OR = 3.6, 95% CI: 2.1-6.15, p < 0.00001) and ongoing pregnancy rate (OR = 8.82, 95% CI: 2.91-26.75, p = 0.0001) in patients with idiopathic RM. Drug use reduced miscarriage rate (OR = 0.21, 95% CI: 0.08-0.52, p = 0.0007); however, there was significant heterogeneity (I = 73%) and a moderate-to-severe risk of bias. There was no effect on premature birth rate (OR = 2.26, 95% CI: 0.96-5.31, p = 0.06). This meta-analysis cannot provide a reference for the duration of medication treatment because the selected studies had inconsistent durations. WHAT IS NEW AND CONCLUSION: We did a statistical analysis and found that oral immunosuppressants (including cyclosporine A or prednisolone) can improve pregnancy outcomes in patients with idiopathic RM, increase live birth rate and ongoing pregnancy rate, and reduce miscarriage rate.
About
- Frequency
- Sun
- Papers found
- 200
- RSS feed
- Subscribe