摘要目的 了解接受含奈韦拉平(NVP)的联合抗逆转录病毒治疗(cART)后获得性免疫缺陷综合征(AIDS)患者肝毒性的发生率,评估相关的危险因素.方法 回顾性研究本地区2003年3月2008年6月开始接受cART的AIDS患者的人口学和临床资料.单因素和多因素Logistic回归分析各变量与肝损害发生的相关性;Kaplan-Meier方法分析合并HCV感染和未合并HCV感染者肝损害的危险性.结果 330例患者中267例接受了基于NVP的cART,63例接受了基于依非韦仑(EFV)的cART,两组患者肝毒性发生率差异有统计学意义(49.8%比31.7%,x2=6.691,P-0.01).267例接受基于NVP的cART的患者,随访期间有133例(49.8%)出现了至少1次1级以上ALT升高,百人年发生率为28.5.基线期ALT升高(OR=14.368,P=0.017)、合并HCV感染(OR=3.009,P=0.000)与NVP相关肝毒性的发生显著相关.与未合并HCV感染者相比,合并HCV感染者发生肝毒性的可能性更大(x2=16.764,P=0.000).133例发生肝毒性反应的患者中,1例合并NVP相关重度皮疹死亡,尚未发现死于急性肝衰竭的病例,23例(17.3%)曾暂时停止cART或将NVP替换为EFV.结论 本队列接受含NVP的cART患者肝毒性较常见,基线期ALT水平升高、合开HCV感染是发生肝毒性反应的危险因素.

abstractsObjective To investigate the incidence of hepatotoxicity in acquired immunodeficiency syndrome (AIDS) patients on combined anti-retroviral therapy (cART) containing nevirapine (NVP) and to assess the risk factors and its impact on cART. Methods 330 AIDS patients from March 2003 to June 2008at local county were enrolled and a retrospective study using Kaplan-meier survival and Multivariate logistic regression modeling was conducted. Results 267 out of 330 patients received NVP based cART and 63 cases received EFV-based cART. The deference of prevalences of hepatotoxicity between the two groups is statistically significant (x2 = 6.691, P = 0.01). 133 out of 267 (49.8%) patients on NVP based cART had at least one episode of ALT elevation during a median 21 months (interquartile ranges, IQR 6, 37) follow-up time,acounts for 28.5 cases per 100 person-years. Baseline ALT elevation (OR = 14.368, P = 0.017)and HCV coinfection (OR = 3.009, P = 0.000) were risk factors for cART related hepatotoxicity, while greatly increased CD4+T(CD4) cell count was protective against hepatotoxicity development (OR = 0.996, P = 0.000). Patients co-infected with HCV received NVP-based cART had the higher probability of hepatotoxicity than those without HCV co-infection (Log rank: x2 = 16.764, P = 0.000). 23 out of the 133 subjects (17.3%) with NVP related hepatotoxicity discontinued cART temporarily or shifted NVP to efavirenz. Conclusions NVP related hepatotoxicity was common among ARV naive HIV infected subjects in our cohort. Baseline ALT elevation and HCV co-infection were associated statistically with the development of hepatotoxicity. Hepatotoxicity led to discontinuing cART temporarily or switching to other regimens in some subjects. It suggested that NVP should be used with caution in patients co-infected with HCV among whom anti-HCV therapy before cART initiation may contribute to minimizing the probability of NVP associated hepatotoxicity.