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一线抗逆转录病毒治疗中使用依非韦伦的比较安全性及神经精神不良事件:一项随机试验的系统评价和荟萃分析

Comparative Safety and Neuropsychiatric Adverse Events Associated With Efavirenz Use in First-Line Antiretroviral Therapy: A Systematic Review and Meta-Analysis of Randomized Trials.

作者信息

Ford Nathan, Shubber Zara, Pozniak Anton, Vitoria Marco, Doherty Meg, Kirby Catherine, Calmy Alexandra

机构信息

*Department of HIV/AIDS, World Health Organization, Geneva, Switzerland; †Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom; ‡Chelsea and Westminster NHS Hospital Foundation Trust and St Stephens AIDS Trust, London, United Kingdom; §Lawson Unit, Royal Sussex County Hospital, Brighton, United Kingdom; and ‖HIV/AIDS Unit, Infectious Disease Service, Geneva University Hospital, Geneva, Switzerland.

出版信息

J Acquir Immune Defic Syndr. 2015 Aug 1;69(4):422-9. doi: 10.1097/QAI.0000000000000606.

DOI:10.1097/QAI.0000000000000606
PMID:25850607
Abstract

INTRODUCTION

Efavirenz (EFV) is widely used for the treatment of antiretroviral-naive HIV-positive individuals, but there are concerns about the risk of adverse neuropsychiatric events. We systematically reviewed the safety of EFV in first-line therapy.

METHODS

Four databases were searched until October 2014 for randomized trials comparing EFV against non-EFV-based regimens for the treatment of antiretroviral-naive HIV-positive adults and children. The primary outcome was drug discontinuation as a result of any adverse event. Relative risks and proportions were pooled using random-effects meta-analysis.

RESULTS

Forty-two trials were included for review. A lower relative and absolute risk of discontinuations due to adverse drug reactions was seen with EFV compared to nevirapine. The relative and absolute risk of discontinuation was greater for EFV compared with low-dose EFV, rilpivirine, tenofovir, atazanavir, and maraviroc. The relative risk of discontinuation was greater for EFV compared with dolutegravir and raltegravir, but absolute risks were not significantly different. There was no difference in the risk of any severe clinical adverse events for any comparison. With the exception of dizziness, fewer than 10% of patients exposed to EFV experienced any other specific type of neuropsychiatric event. No suicides were reported.

CONCLUSIONS

This review found that over 90% of patients remained on an EFV-based first-line regimen after an average follow-up time of 78 weeks. The relative risk of discontinuations due to adverse events was higher for EFV compared with most other first-line options, but absolute differences were less than 5% for all comparisons.

摘要

引言

依非韦伦(EFV)广泛用于治疗初治的HIV阳性个体,但人们担心其存在不良神经精神事件风险。我们系统回顾了EFV在一线治疗中的安全性。

方法

检索了四个数据库直至2014年10月,以查找比较EFV与非EFV方案治疗初治HIV阳性成人和儿童的随机试验。主要结局是因任何不良事件导致停药。使用随机效应荟萃分析汇总相对风险和比例。

结果

纳入42项试验进行综述。与奈韦拉平相比,EFV因药物不良反应导致停药的相对风险和绝对风险更低。与低剂量EFV、利匹韦林、替诺福韦、阿扎那韦和马拉维罗相比,EFV停药的相对风险和绝对风险更高。与多替拉韦和拉替拉韦相比,EFV停药的相对风险更高,但绝对风险无显著差异。任何比较中,严重临床不良事件风险均无差异。除头晕外,接触EFV的患者中不到10%经历任何其他特定类型的神经精神事件。未报告自杀事件。

结论

本综述发现,平均随访78周后,超过90%的患者仍采用基于EFV的一线治疗方案。与大多数其他一线治疗方案相比,EFV因不良事件导致停药的相对风险更高,但所有比较中的绝对差异均小于5%。

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