摘要
目的 评价3种基于奈韦拉平（NVP）的高效联合抗逆转录病毒治疗（HAART）对中国成人初治HIV/AIDS患者的安全性.方法 从我国13个研究中心的初治HIV/AIDS患者筛选出198例,随机分配至3个HAART组：A组：AZT＋DDl＋NVP;B组：D4T＋3TC＋NVP;C组：AZT＋3TC＋NVP,分别在基线及用药后第4、8、12、24、36、52周随访观察,比较3组方案的不良事件（AE）发生及影响因素.结果 198例患者在52周随访期共有188例发生968例次AE（发生率95.0%）,第3/4级AE发生率37.4%,37例因HAART相关AE退出（18.7%）.AE以肝功能异常、骨髓抑制、胃肠道反应、皮疹等最常见,多发牛在用药12周内.含AZT方案更容易出现骨髓抑制,AZT合用DDI时更容易出现胃肠道反应,含D4T或DDI方案更容易发生外周神经炎、血脂异常.第3/4级肝毒性发生率20.7%（41例）,基线CD4〉250个/mm3是引起肝毒性的危险因素（OR=2.08,95%CI：1.114～3.882,P=0.021）.结论 HAART导致停药的毒副作用是肝脏毒性、胃肠道反应、骨髓抑制、皮疹,治疗期间尤其是前3个月要严密监测AE.基线CIM＞250＋/mm3的患者应避免使用NVP.
objeefive To evaluate the safety profiles of three nevirapine-based theranies for antiretmviral-naive Chinese adults infected with HIV-1（human immunodeficiency virus-1）.Methods For this prospective multicentric randomized trial.a total of 198 antiretroviral-naive HIV-1 positive patients were recruited from 13 research centers in China.They were randomly assigned to receive three NVP-based antiretroviral therapies for 52 weeks：Group A,AZT（zidovudine）＋DDI（didanosine）＋NVP（nevirapifie）;Group B,D4T（stavudine）＋3TC（lamivudine）＋NVP;Group C,AZT＋3TC＋NVP.Their clinical events and laboratory examinations were monitored at baseline and the end of weeks 4,8,12,24,36 ＆ 52 post-HAART（highly active antiretroviral therapy）to evaluate the occurrence of advelse events（AEs）.The chi-square or Fisher＇s exact test was employed to compare the rates of AEs among three treatment groups.Multivariate logistic regression analyses were used to identify the factors associated with hepatotoxicity.For all tests,P＜0.05 was considered as statistically significant.Results During the 52-week HAART,968 cases of AEs occurred in 188 patients（95.0%）.Only 37.4%experienced grade 3/4 AE.And 37 patients withdrew because of HA ART-related AEs （18.7%）.The common AEs were hepatotoxicity,bone morrow suppression,gastreintestinal disordels,rash and hyperlipidemia.etc.Most instances of AEs occurred during the early 12 weeks.The total count of AEs for each group had no statistic significant difference（P=0.403）.Bone marrow suppression was more strongly associated with an AZT.containing HAART and it was especially prone to gastrointestinal disorders when combined with DDI.The introduction of D4T or DDI led more frequently to peripheral neuropathy and hyperlipidemia.Logistic regression analysis indicated that presence of hepatotoxicity was associated with a higher baseline level of CD4（CD4 count＞250/μl）（OR=2.08,95%CI：1.114-3.882,P=0.021）.Conclusion The common reasons of discontinuing HAART are hepatotoxicity,gastrointestinal disorders,bone marrow suppression and rash.The occurrence of AEs should be vigorously monitored especially during the early 3 months of HAART.The HIV/AIDS patients with a CD4 cotmt of＞250/μl shall avoid any NVP-containing regimen.
出处
《中华医学杂志》
CAS
CSCD
北大核心
2011年第19期1318-1322,共5页
National Medical Journal of China
基金
国家＂十一五＂科技重大专项（2008ZX10001-006）
2010-2012年度卫生部临床重点学科项目＂中国艾滋病患者抗病毒治疗失败的影响因素与应对策略研究＂
志谢特别感谢以下机构共同参与：北京佑安医院、北京地坛医院、郑州大学医学院第一附院、第四军医大学唐都医院、中南大学湘雅二医院、上海市公共卫生临床中心、深圳市疾病预防控制中心、广州市第八人民医院、云南省艾滋病关爱中心、浙江大学传染病研究所
