International journal of clinical pharmacology and therapeutics最新文献_第2页

Dosing strategy of tacrolimus when co-administered with Wuzhi tablet in renal transplant recipients. 肾移植受者与五味子片合用时他克莫司的剂量策略。

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2024-08-19 DOI: 10.5414/CP204561

Rui Dai, Yiting Cai, Jun Li, Xiaoman Liu, Qian Fu, Min Huang, Changxi Wang, Pan Chen

{"title":"Dosing strategy of tacrolimus when co-administered with Wuzhi tablet in renal transplant recipients.","authors":"Rui Dai, Yiting Cai, Jun Li, Xiaoman Liu, Qian Fu, Min Huang, Changxi Wang, Pan Chen","doi":"10.5414/CP204561","DOIUrl":"10.5414/CP204561","url":null,"abstract":"Objective: Tacrolimus (TAC) is a first-line immunosuppressant to prevent allograft rejection. Wuzhi tablet is widely used as a TAC-sparing agent in China that could significantly elevate TAC exposure. However, insufficient data support the dose recommendation of TAC when co-administered with Wuzhi.Materials and methods: A total of 305 adult renal transplant patients with 2,541 TAC trough concentrations (C0) were enrolled for population pharmacokinetic (PPK) modeling. CYP3A5 polymorphism was genotyped, and corresponding clinical factors were recorded. Nonlinear mixed-effects modeling and Monte Carlo simulation were used for dose recommendation. PK parameters were calculated based on one-compartment model with first-order absorption and elimination.Results: The estimated total clearance (CL/F) and volume of distribution (Vd/F) of TAC were 23.84 L/h and 1,075.96 L, respectively. Wuzhi, CYP3A5 genotype, hematocrit (HCT), and weight were found to have a significant influence on CL/F. CL/F was significantly lower in the individuals who were CYP3A5 non-expressers and received TAC together with Wuzhi. CYP3A5 genotype (expressers or non-expressers), body weight (40 - 80 kg), and hematocrit (20 - 40%) were selected as the specific clinical scenarios, and the starting dose of TAC ranged from 1.5 to 4.5 mg when co-administered with Wuzhi.Conclusion: We establish a TAC PPK model comprising Wuzhi as a covariate in renal transplant recipients and recommend an initial dose of TAC when co-administered with Wuzhi, which could provide reference for the individualized regimens of TAC.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Early acute kidney injury after tacrolimus administration in heart transplant recipients receiving basiliximab induction therapy. 接受巴利昔单抗诱导治疗的心脏移植受者在服用他克莫司后出现早期急性肾损伤。

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2024-08-09 DOI: 10.5414/CP204586

Megumi Ikura, Tsutomu Nakamura, Kyoichi Wada, Rikako Nagata, Tomoko Ueno, Kazuyoshi Kawabata, Fumiki Yoshihara, Takuya Watanabe, Yasumasa Tsukamoto

{"title":"Early acute kidney injury after tacrolimus administration in heart transplant recipients receiving basiliximab induction therapy.","authors":"Megumi Ikura, Tsutomu Nakamura, Kyoichi Wada, Rikako Nagata, Tomoko Ueno, Kazuyoshi Kawabata, Fumiki Yoshihara, Takuya Watanabe, Yasumasa Tsukamoto","doi":"10.5414/CP204586","DOIUrl":"10.5414/CP204586","url":null,"abstract":"Objective: In this study, we aimed to analyze the association among the timing of tacrolimus initiation, time required to reach the target blood concentration, and early acute kidney injury (AKI) after tacrolimus administration in heart transplant recipients who received basiliximab induction therapy.Materials and methods: 88 patients treated with tacrolimus-based immunosuppressive therapy were retrospectively reviewed. Induction therapy was administered to 52 patients. AKI was evaluated within 7 days of tacrolimus administration.Results: The rate of increase in tacrolimus trough concentration to the target trough concentration of 10 µg/mL early after its administration was set to be similar in the basiliximab induction and non-induction group; 8 and 2 patients developed AKI in the induction and non-induction group, respectively. In the induction group, there was no significant difference in the timing of tacrolimus initiation and the time required to reach the target concentration between patients who developed and did not develop AKI. In contrast, the cumulative incidence of AKI was significantly different between patients with an estimated glomerular filtration rate below and those with an estimated glomerular filtration rate above 43 mL/min/1.73m2 at the start of tacrolimus administration (37.5% and 11.4%, respectively; p = 0.045).Conclusion: In patients receiving basiliximab induction therapy, the timing of tacrolimus initiation and the time to reach the target concentration are unlikely to be associated with early AKI after tacrolimus administration. However, the recovery of sufficient renal function after heart transplantation is important for determining the start time of tacrolimus.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141906608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Evaluation of metronidazole oral monotherapy in anaerobic oral infections. 评估甲硝唑口服单药治疗口腔厌氧菌感染的效果。

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2024-08-09 DOI: 10.5414/CP204565

Najla Dar-Odeh, Ala'a Atef, Yara Flaifl, Dilnoza Bobamuratova, Basem Akily, Rayan Meer, Osama Abu-Hammad

{"title":"Evaluation of metronidazole oral monotherapy in anaerobic oral infections.","authors":"Najla Dar-Odeh, Ala'a Atef, Yara Flaifl, Dilnoza Bobamuratova, Basem Akily, Rayan Meer, Osama Abu-Hammad","doi":"10.5414/CP204565","DOIUrl":"10.5414/CP204565","url":null,"abstract":"Objectives: To evaluate the indications and dosing regimens for oral metronidazole monotherapy (OMM) for the management of oral anaerobic infections (OAIs) other than periodontitis.Materials and methods: The study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines in literature of PubMed/Medline, Scopus, and Cochrane databases. Data were retrieved from reports published in English in the period January 1, 1980 - August 30, 2023. Joanna Briggs Institute Critical Appraisal Tools were used to assess study risk of bias.Results: A total of 228 articles were retrieved from the databases of which 16 met the inclusion criteria necessary for achieving the aims of the study. OAIs in which OMM was used or recommended included pericoronitis; necrotizing ulcerative gingivitis/periodontitis/stomatitis, osteomyelitis, acute periapical infection, and cellulitis. OMM was prescribed in dosages ranging from 200 to 500 mg t.i.d. for periods ranging from 2 to 7 days. Osteomyelitis of the jaw was the only infection for which the dosage regimen of metronidazole was not clearly described.Conclusion: Evidence from the databases searched support the view that OMM has clinical efficacy in the treatment of specific OAIs namely pericoronitis and necrotizing oral infections in immune-competent and immune-compromised patients. The evidence does not support the use of OMM in \"deep tissue\" infections such as osteomyelitis, and odontogenic infections such as acute apical infection and cellulitis. Clinical trials are warranted to determine the efficacy of OMM in comparison with other antibiotic regimens.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141906609","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Post-marketing safety concerns with montelukast: A pharmacovigilance study based on the FDA adverse event reporting system. 孟鲁司特上市后的安全问题：基于美国食品药物管理局不良事件报告系统的药物警戒研究。

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2024-08-05 DOI: 10.5414/CP204560

Zhimin Ou, Ying Han, Wei Zhuang, Yunshan Xiao, Shuying Cai, Xueqin Zhang

{"title":"Post-marketing safety concerns with montelukast: A pharmacovigilance study based on the FDA adverse event reporting system.","authors":"Zhimin Ou, Ying Han, Wei Zhuang, Yunshan Xiao, Shuying Cai, Xueqin Zhang","doi":"10.5414/CP204560","DOIUrl":"10.5414/CP204560","url":null,"abstract":"The United States Food and Drug Administration (FDA) has been warning about the psychiatric disorders associated with montelukast (MTK) for years. To study the characteristics of the presence of MTK-associated adverse events (AEs), we obtained data from the FDA Adverse Event Reporting System database and used a case (MTK) vs. non-case (all other drugs) analysis to investigate the safety signals in a disproportionality study. 27,507 reported AEs from January 2004 to December 2022 were analyzed. Disproportionality analysis shows that psychiatric, respiratory, thoracic, and mediastinal disorders as well as social circumstances are the most commonly reported AEs. In addition, our study found several unreported AEs, such as increased systolic blood pressure, diastolic dysfunction, hypothyroidism, obesity, bursitis, and polycystic ovaries. The timing of AE occurrence indicates that MTK-associated AEs are mainly acute effects. Most importantly, we found that 60.1% of patients reporting AEs in the category of psychiatric disorders were younger than 18 years. In summary, we revealed an age-preference pattern of psychiatric AEs in patients prescribed MTK. Our study is helpful for physicians and health professionals to better evaluate the value and risk of MTK and to achieve the goal of optimal patient care.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141889131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Degree of serum LDL cholesterol reduction by simvastatin and ezetimibe is dependent on baseline LDL cholesterol concentration but not on baseline values and changes in cholesterol synthesis and absorption parameters. 辛伐他汀和依折麦布降低血清低密度脂蛋白胆固醇的程度取决于低密度脂蛋白胆固醇的基线浓度，而与胆固醇合成和吸收参数的基线值和变化无关。

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2024-07-01 DOI: 10.5414/CP204536

Dieter Lütjohann, Frans Stellaard

{"title":"Degree of serum LDL cholesterol reduction by simvastatin and ezetimibe is dependent on baseline LDL cholesterol concentration but not on baseline values and changes in cholesterol synthesis and absorption parameters.","authors":"Dieter Lütjohann, Frans Stellaard","doi":"10.5414/CP204536","DOIUrl":"10.5414/CP204536","url":null,"abstract":"Objective: We questioned whether the baseline status of low-density lipoprotein cholesterol (LDL-C), cholesterol synthesis and absorption, and the changes in these parameters determine the change in serum LDL-C under statin or ezetimibe treatment or under combination treatment.Materials and methods: 37 mildly hypercholesterolemic healthy male subjects were studied under placebo, simvastatin (20 mg/d), ezetimibe (10 mg/d), and combination treatment. We correlated the change of LDL-C (ΔLDL-C) under treatment with the placebo end values of LDL-C (baseline), whole-body cholesterol synthesis, and hepatic cholesterol synthesis (serum lathosterol to cholesterol ratio) as well as fractional absorption rate (FAR) of cholesterol and serum campesterol to cholesterol ratio. The change in serum LDL-C was also correlated with the changes in synthesis and absorption parameters.Results: ΔLDL-C was highly negatively related to baseline LDL-C under ezetimibe (p < 0.0001), simvastatin (p < 0.0001), and combination treatment (p < 0.0001). Under combination treatment, LDL-C lowering appears possible from baseline values of 10 mg/dL upwards, while ΔLDL-C was independent of the baseline value (-50 to -60%). ΔLDL-C was positively associated with placebo FAR under ezetimibe (p = 0.0106) and combination treatment (p = 0.0457). No associations were found between ΔLDL-C and baseline values for synthesis nor between ΔLDL-C and changes in synthesis and absorption surrogate markers.Conclusion: Under ezetimibe, simvastatin, and combination treatment, ΔLDL-C is predominantly dependent on the baseline LDL-C concentration. We hypothesize that the concentration gradient between serum LDL-C and hepatic cellular cholesterol determines the efficiency of serum LDL-C lowering. Combination treatment is the preferred treatment.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140865515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Activated charcoal helps in the diagnosis of dabigatran overdose: A case study. 活性炭有助于诊断达比加群过量：病例研究。

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2024-07-01 DOI: 10.5414/CP204493

Ning Zhang, Weihua Niu, Haiqing Zhang, Songsong Lu

{"title":"Activated charcoal helps in the diagnosis of dabigatran overdose: A case study.","authors":"Ning Zhang, Weihua Niu, Haiqing Zhang, Songsong Lu","doi":"10.5414/CP204493","DOIUrl":"10.5414/CP204493","url":null,"abstract":"The direct-acting oral anticoagulant dabigatran etexilate (DE) targets thrombin and is used widely to prevent thromboembolism. A 79-year-old man was admitted to the Emergency Department due to anuria for 2 days. An urgent laboratory examination revealed a serum creatinine concentration of 888 µmol/L. He was diagnosed with acute exacerbation of chronic renal insufficiency. During continuous renal replacement therapy (CRRT), the coagulation test showed a severe reduction in the fibrinogen level as well as a significantly prolonged prothrombin time (PT) and activated partial thromboplastin time (APTT). The patient had been taking DE (110 mg twice daily) for a long time and had not suspended the medication or reduced the dose during the worsening of anuria. Therefore, it should be evaluated before considering plasma replacement therapy for the patient, whether the abnormal coagulation parameters were induced by interference of excessive DE. Tentatively, we used activated charcoal to treat the plasma and then retested the fibrinogen, PT, and APTT. Results showed that the coagulation indices nearly returned to normal. The present case indicated that activated charcoal could adsorb DE in plasma effectively and eliminate its interference with coagulation test results, thereby providing support for clinical diagnosis and treatment.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140897411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Primary and secondary prevention of stroke and cardiovascular events using evolocumab and alirocumab: Meta-analysis of randomized controlled trials. 使用 evolocumab 和 alirocumab 对中风和心血管事件进行一级和二级预防：随机对照试验的 Meta 分析。

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2024-06-01 DOI: 10.5414/CP204506

Kwang-Hee Shin, Hye Duck Choi

{"title":"Primary and secondary prevention of stroke and cardiovascular events using evolocumab and alirocumab: Meta-analysis of randomized controlled trials.","authors":"Kwang-Hee Shin, Hye Duck Choi","doi":"10.5414/CP204506","DOIUrl":"10.5414/CP204506","url":null,"abstract":"Objectives: Although the clinical role of protein convertase subtilisin kexin type 9 (PCSK9) inhibitors for cholesterol management is increasing, the post-marketing period of use is short compared to other lipid-lowering drugs, so there is still insufficient evidence for their efficacy and safety. In this meta-analysis, we evaluated preventive effects of stroke and cardiovascular (CV) events using evolocumab and alirocumab.Materials and methods: We assessed the relative risk of stroke and CV events after alirocumab or evolocumab treatment in individuals with or without clinical CV diseases compared with that in controls. In addition, we evaluated the relative risk of hemorrhagic stroke.Results: A total of 25 articles were included (median of study duration = 52 weeks). The risk of stroke was significantly decreased after treatment with alirocumab or evolocumab (primary prevention in patients without CV diseases: RR = 0.733; 95% CI, 0.618 - 0.870; secondary prevention in patients with CV diseases: RR = 0.703; 95% CI, 0.562 - 0.880). The risk of CV events also significantly decreased in patients treated with alirocumab or evolocumab (primary prevention: RR = 0.818; 95% CI, 0.777 - 0.861; secondary prevention: RR = 0.725; 95% CI, 0.578 - 0.910). The relative risk of hemorrhagic stroke was not significantly different between PCSK9 inhibitor-treated patients and controls (RR = 1.041; 95% CI, 0.690 - 1.573).Conclusion: Our findings indicate that evolocumab and alirocumab are significantly effective without increasing the risk of hemorrhagic stroke. Based on this, the PCSK9 inhibitors can be highly recommended for cholesterol management.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140287456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Balancing efficacy and adverse reactions using everolimus in a patient with metastatic malignant insulinoma: Case report. 平衡依维莫司在转移性恶性胰岛素瘤患者中的疗效和不良反应：病例报告。

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2024-06-01 DOI: 10.5414/CP204503

Siham Rouf, Khadija Boujtat, Tijani El Harroudi, Hanane Latrech

{"title":"Balancing efficacy and adverse reactions using everolimus in a patient with metastatic malignant insulinoma: Case report.","authors":"Siham Rouf, Khadija Boujtat, Tijani El Harroudi, Hanane Latrech","doi":"10.5414/CP204503","DOIUrl":"10.5414/CP204503","url":null,"abstract":"Introduction: Malignant insulinoma is a rare neuroendocrine tumor responsible for excessive insulin secretion and life-threatening hypoglycemia episodes. Computed tomography (CT) of the abdomen can identify a pancreatic tumor corresponding to insulinoma. Loco-regional metastases define the metastatic cases. The first-line therapeutic approach is surgery, while other medical treatments like diazoxide and everolimus play also a role. These treatments have shown efficacy in regulating blood glucose and, to some extent, controlling tumor progression.Case presentation: We present the case of a 48-year-old female who was admitted for severe hypoglycemia episodes. She presented neuroglycopenic symptoms without any other clinical features. High levels of C-peptide and insulin during severe hypoglycemia confirmed the presence of endogenous hyperinsulinism. The CT scan of the abdomen confirmed the existence of an insulinoma along with several hepatic metastases. Surgery was proposed as a first-line approach. However, due to the persistent occurrence of severe hypoglycemia episodes, other treatment options were necessary such as diazoxide and everolimus. Diazoxide caused a significant improvement in the patient's blood glucose levels. Nonetheless, glycemic control was unsustainable, obligating the switch to everolimus, which showed better control of blood glucose levels with challenging management due to the appearance of grade 3 stomatitis as a side effect. The patient died 1 year after the diagnosis due to tumor progression.Conclusion: Balancing the benefits of enhanced glycemic control with the difficulties posed by side effect management of everolimus underscores the need to carefully consider both efficacy and potential adverse events.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140021679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Efficacy and safety of antiplatelet therapy in COVID-19: Insights from a meta-analysis of randomized controlled trials. COVID-19中抗血小板治疗的有效性和安全性：随机对照试验荟萃分析的启示。

IF 0.9 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2024-05-01 DOI: 10.5414/CP204497

Guoying Kao, Yunlin Chen, Jinqi Fan

{"title":"Efficacy and safety of antiplatelet therapy in COVID-19: Insights from a meta-analysis of randomized controlled trials.","authors":"Guoying Kao, Yunlin Chen, Jinqi Fan","doi":"10.5414/CP204497","DOIUrl":"10.5414/CP204497","url":null,"abstract":"Background: COVID-19 induces a pro-coagulant state with thrombotic events. This meta-analysis explores the efficacy and safety of antiplatelet-based therapy in COVID-19 patients through randomized controlled trials (RCTs).Materials and methods: A systematic literature search until March 10, 2023, identified 7 RCTs involving 23,415 inpatients. Of these, 11,891 received antiplatelet-based treatment, and 11,524 received placebo/other drugs. Statistical analysis was performed using Review Manager 5.4.Results: The included trials involved patients with a mean age ranging from 54.3 to 62.0 years and a prevalence of hypertension ranging from 10.9 to 65.0% and coronary artery disease ranging from 3.2 to 32.7%. The pooled analysis showed no significant difference in overall mortality between groups (RR 1.0, 95% CI 0.99 - 1.01, p = 0.76). However, antiplatelet therapy significantly reduced major thrombotic events (RR 0.86, 95% CI 0.75 - 0.99, p = 0.04). Conversely, it increased major bleeding risks (RR 1.62, 95% CI 1.24 - 2.12, p = 0.0005). There was no significant difference in the incidence of invasive mechanical ventilation and respiratory death.Conclusion: Antiplatelet therapy does not confer mortality benefit in COVID-19 patients but lowers major thrombotic events while increasing major bleeding risks. Ongoing large RCTs will provide more information on the therapeutic value of this therapy.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140101475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Low albumin combined with low-molecular-weight heparin as risk factors for liver injury using azvudine: Evidence from an analysis of COVID-19 patients in a national prospective pharmacovigilance database. 低白蛋白合并低分子量肝素是阿兹夫定导致肝损伤的风险因素：来自国家前瞻性药物警戒数据库中 COVID-19 患者分析的证据。

IF 0.8 4区医学

International journal of clinical pharmacology and therapeutics Pub Date : 2024-05-01 DOI: 10.5414/CP204544

Hong Lu, Ying Zeng, Qun-Zhi Shi, Lin Liu, Yong-Qing Gong, Sen Li, Pan Yan

{"title":"Low albumin combined with low-molecular-weight heparin as risk factors for liver injury using azvudine: Evidence from an analysis of COVID-19 patients in a national prospective pharmacovigilance database.","authors":"Hong Lu, Ying Zeng, Qun-Zhi Shi, Lin Liu, Yong-Qing Gong, Sen Li, Pan Yan","doi":"10.5414/CP204544","DOIUrl":"10.5414/CP204544","url":null,"abstract":"Objective: Azvudine is an effective treatment for patients infected with common COVID-19. However, physicians have reported a series of adverse reactions, including multiple cases of liver injury, caused by azvudine in clinical practice. This study assessed the incidence, clinical features, and associated risk factors of liver injury induced by azvudine in real-world settings, offering guidance for safe clinical use.Materials and methods: This study utilized the Chinese Hospital Pharmacovigilance System (CHPS) to retrospectively analyze the treatment of COVID-19 patients with azvudine at Changsha Central Hospital from December 19, 2022, to June 6, 2023. A case-control study was conducted to analyze the occurrence of azvudine-induced liver injury in COVID-19 patients who triggered a CHPS alert compared to normal COVID-19 patients.Results: Among the total of 2,141 COVID-19 patients, 31 (1.45%) developed azvudine-induced liver injury, which is classified as an occasional adverse reaction. Liver injury was observed in 93.55% of patients between days 4 and 12 of the azvudine treatment, with elevated transaminases as the primary clinical manifestation. Univariate and binary logistic regression analyses indicated that low albumin levels and co-administration of low-molecular-weight heparin were statistically significant risk factors (p < 0.05).Conclusion: This study represents the first investigation of azvudine-induced liver injury and high-risk patients using the CHPS. The findings provide valuable insights to promote the safety of anti-COVID-19 drugs, serving as an important reference for future drug safety measures.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140021682","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0