Médecins Sans Frontières, Geneva, Switzerland.
AIDS. 2013 Apr 24;27(7):1135-43. doi: 10.1097/QAD.0b013e32835e0752.
The risk of adverse drug events associated with nevirapine (NVP) is suggested to be greater in pregnant women. We conducted a systematic review and meta-analysis of severe adverse events in HIV-positive women who initiated NVP while pregnant.
We searched six databases for studies reporting adverse events among HIV-positive pregnant women who had received NVP-based antiretroviral therapy for at least 7 days. Data were pooled by the fixed-effects method.
Twenty studies (3582 pregnant women) from 14 countries were included in the final review. The pooled proportion of patients experiencing a severe hepatotoxic event was 3.2% [95% confidence interval (CI) 2.1-4.3%], severe rash was experienced by 3.3% of patients (95% CI 2.1-4.5%) and 6.1% (95% CI 3.9-8.3%) of patients discontinued NVP due to an adverse event. These results were comparable to frequencies observed in the general adult patient population, and to frequencies reported in non-pregnant women within the same cohort. For pregnant women with a CD4 cell count above 250 cells/μl there was a non-significant tendency towards an increased likelihood of severe cutaneous adverse events (OR 1.4, 95% CI 0.8-2.4) and severe hepatotoxic events (OR 1.5, 95%CI 0.9-2.3) and consequently an increased risk of toxicity-driven regimen substitution (OR 1.7, 95% CI 1.1-2.6).
These results suggest that the frequency of adverse events associated with NVP use in pregnant women, although high, is no higher than reported for NVP in the general adult population. Pregnant women with a high CD4 cell count may be at increased risk of adverse events, but evidence supporting this association is weak.
与奈韦拉平（NVP）相关的不良药物事件风险在孕妇中被认为更高。我们对接受基于 NVP 的抗逆转录病毒治疗至少 7 天的 HIV 阳性孕妇中发生严重不良事件进行了系统评价和荟萃分析。
我们在六个数据库中搜索了报告在接受基于 NVP 的抗逆转录病毒治疗至少 7 天的 HIV 阳性孕妇中发生不良事件的研究。数据通过固定效应方法进行汇总。
来自 14 个国家的 20 项研究（3582 名孕妇）纳入最终综述。发生严重肝毒性事件的患者比例为 3.2%[95%置信区间（CI）2.1-4.3%]，严重皮疹的患者比例为 3.3%（95%CI 2.1-4.5%），6.1%（95%CI 3.9-8.3%）的患者因不良事件停用 NVP。这些结果与一般成年患者人群中观察到的频率相当，也与同一队列中的非孕妇中报告的频率相当。对于 CD4 细胞计数高于 250 个/μl 的孕妇，发生严重皮肤不良事件（OR 1.4，95%CI 0.8-2.4）和严重肝毒性事件（OR 1.5，95%CI 0.9-2.3）的可能性增加具有非显著性趋势，因此毒性驱动的治疗方案替换的风险增加（OR 1.7，95%CI 1.1-2.6）。
这些结果表明，与 NVP 相关的不良事件的频率在孕妇中虽然较高，但并不高于一般成年人群中报告的 NVP 频率。CD4 细胞计数较高的孕妇发生不良事件的风险可能增加，但支持这种关联的证据较弱。
