100例HIV／AIDS患者接受AZT＋3TC＋EFV治疗不良事件的分析

Analysis of adverse events happened in 100 HIV/AIDS cases receiving AZT+3TC+EFV treatment

目的评价联合抗逆转录病毒药物治疗方案(AZT+3TC+EFV),治疗中国农村艾滋病病毒Ⅰ型(HIV-1)感染者的安全性。方法采取开放的、前瞻性的单组临床试验,观察100例受试者在52周抗病毒治疗过程中发生的不良事件(Adverse events,AE)。结果100例患者均出现至少1例次的AE,总共发生700例次,其中实验室检查异常、消化系统和神经系统AEs的发生率分别是42.15%、19.29%和14.14%,占所有AE的一半以上。最常见的是头昏,其次分别是血钾降低、丙氨酸转氨酶(ALT)增高,恶心和天冬氨酸转氨酶(AST)增高。在所有AE中,达到3级或4级的共有53例次,占7.57%(53/700)。其中血红蛋白降低和ALT/AST增高是最常见的AE。因发生严重不良事件(Serious adverse events,SAE)而退出研究的有13例(13%),其中有9例评定为与4级SAE很可能相关,其他可能无关。在研究结束时,约77.43%的AE痊愈,4.71%的好转,但有17.86%的患者AE还持续存在,无死亡病例。在所有的700例次AE中,27例次(3.86%)、207例次(29.57%)和281例次(40.14%)分别被判定为肯定有关、很可能有关和可能有关。结论AZT+3TC+EFV治疗方案对中国农村HIV-1感染者治疗是安全的,在治疗过程中尤其要注意肝功能和血红蛋白的变化。

Objective To assess the safety of a potent combined antiretroviral therapy regimen, 3TC/ZDV ＋ EFV, for the treatment of HIV-1 infected persons in a rural area of China. Method An open-labeled prospective single-arm clinical study was conducted to observe the adverse events in HIV-infected subjects who received 50 week long ART therapy and whose CD4 ＋ count was〈350 cells/mm3. Result Of the 100 subjects,everyone experienced at least one episode of adverse event（AE）, and a total of 700 adverse events occurred among them during the span of 52 weeks. The rates of adverse events related to laboratory abnormal parameters, gastrointestinal disorders and nervous system were 42. 15 % （295）, 19. 290//00 （135）and 14.14% （99）, respectively, accounting for more than half of the overall cases/episodes of AEs. The most frequent symptoms were dizziness, followed by hypokalemia,increased ALT,nausea and raised AST. Of the total AEs 53 events/cases were assessed as grade 3 or 4 accounting for 7.57% （53/700） ,among which decreased hemoglobin and increased ALT/AST were the commonest manifestations. Thir- teen cases（13 %）withdrew from the study because of severe adverse events, of whom 9 cases were certainly due to 4 grade adverse events. At the end of the study, of the total AE cases 77.43% recovered, 4.71% improved, but 17.86% remained abnormal, None of the subjects died in the period of the study. Among all the 700 cases/episodes of AEs,27（3.86%） ,207（29.57%）and 281（40.14%）were assessed as definitely related,most likely related and likely related with the therapy, respectively. Conclusion The combined ART regimen was safe for the treatment of HIV-1 infected persons in a rural area of China. Monitoring the liver functions and hemoglobin during the therapeu- tic process should be given special attention.