基于非核苷类逆转录酶抑制剂的抗逆转录病毒疗法的药物不良反应：一项为期24周的前瞻性研究。

Adverse drug reactions to nonnucleoside reverse transcriptase inhibitor-based antiretroviral regimen: a 24-week prospective study.

作者信息

Jena Anupam, Sachdeva Ravinder K, Sharma Aman, Wanchu Ajay

机构信息

Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

J Int Assoc Physicians AIDS Care (Chic). 2009 Sep-Oct;8(5):318-22. doi: 10.1177/1545109709343967. Epub 2009 Aug 31.

DOI:10.1177/1545109709343967

PMID:19721097

Abstract

BACKGROUND

Few studies have addressed the issue of adverse drug reactions with non-protease inhibitor (PI)-based antiretroviral therapy (ART) in resource-constrained settings. We studied prospectively the incidence of adverse drug reactions with generic ART among our patients.

METHODOLOGY

A total of 100 HIV-infected individuals were recruited. Patients received nevirapine (NVP) or efavirenz (EFV) with lamivudine (3TC) and zidovudine (ZDV)/stavudine (d4T). They were followed for 6 months for evidence of adverse drug reactions.

RESULTS

The mean CD4 count was 114.09 +/- 60.07 cells/mm(3) (range, 12-232 cells/mm(3)). Transient gastrointestinal symptoms were most frequent. Fourteen individuals (12 receiving ZDV/d4T, 3TC, NVP and 2 receiving ZDV/d4T, 3TC, EFV) developed skin rash. Among patients receiving NVP, 25.7% developed grade 1 hepatotoxicity. Three patients had numbness in both lower limbs. Among those individuals who received EFV, 32.3% individuals had central nervous system (CNS) symptoms in the form of insomnia, vivid dreams, dizziness, and drowsiness.

CONCLUSION

As the developing world increasingly uses generic ART, the clinician must be constantly vigilant for treatment-related adverse events.

摘要

背景

在资源有限的环境中，很少有研究探讨基于非蛋白酶抑制剂（PI）的抗逆转录病毒疗法（ART）的药物不良反应问题。我们前瞻性地研究了我们患者中使用通用ART的药物不良反应发生率。

方法

共招募了100名HIV感染者。患者接受奈韦拉平（NVP）或依非韦伦（EFV）联合拉米夫定（3TC）和齐多夫定（ZDV）/司他夫定（d4T）治疗。对他们进行了6个月的随访，以寻找药物不良反应的证据。

结果

平均CD4细胞计数为114.09±60.07个细胞/mm³（范围为12 - 232个细胞/mm³）。短暂的胃肠道症状最为常见。14名患者（12名接受ZDV/d4T、3TC、NVP，2名接受ZDV/d4T、3TC、EFV）出现皮疹。在接受NVP的患者中，25.7%出现1级肝毒性。3名患者双下肢麻木。在接受EFV的患者中，32.3%的患者出现以失眠、多梦、头晕和嗜睡形式表现的中枢神经系统（CNS）症状。