高效抗逆转录病毒治疗艾滋病毒感染者和艾滋病患者的6年临床疗效及安全性观察  

Therapeutic effect and safety evaluation on 6-year highly active antiretroviral therapy for Chinese HIV-1 infected patients

作　　者：周华英[1] 郑煜煌[1] 何艳[1] 龚国忠[1] 谌资[1] 刘猛[1] 尹伟[1] 刘纯[1] 

机构地区：[1]中南大学湘雅二医院传染科艾滋病研究室,长沙410011

出　　处：《中南大学学报（医学版）》2009年第8期731-737,共7页Journal of Central South University ：Medical Science

基　　金：国家"十五"科技攻关计划(204BA719A10);卫生部重点研究项目(WA2003-15)~~

摘　　要：目的:评估奈韦拉平加两种核苷类反转录酶抑制剂组合对艾滋病毒(human immunodeficien-cy virus,HIV)感染者和艾滋病(acquired immunodeficiency syndrome,AIDS)患者的长期抗病毒和免疫重建效果以及毒副作用。方法:从2002年10月至2004年5月共有57例HIV-1感染者/AIDS患者陆续接受高效抗反转录病毒治疗(highly active antiretroviral therapy,HAART),定期随访截止于2008年12月。HAART方案主要为两种核苷类反转录酶抑制剂加奈韦拉平。随访期间定期监测其病毒载量,T细胞亚群的变化,记录药物的毒副作用并适当处理,追踪血常规和主要生化指标的变化;对治疗出现病毒学失败或严重毒副作用者及时调整用药。结果:57例中,34例持续追踪了4年以上。经过5～6年治疗,63.3%(19/30)的患者病毒载量<50拷贝/mL。CD4+细胞比治疗前平均上升了329个/μL。CD8+细胞平均下降128个/μL,CD4+CD45RA+CD62L童贞细胞和CD4+CD45RO+记忆细胞逐渐上升,CD8+CD38+激活细胞逐渐下降;这些变化均以治疗2年内较明显,2年以上的长期趋势变缓,但6年时均未达到健康者的水平。56%(32/57)的患者先后出现多种可能与药物相关的毒副作用,主要为消化道症状、神经系统症状、皮疹和脱发,多发生于6月内。29.8%(17/57)的病例γ-谷氨酰转肽酶升高,26.3%(15/57)的患者血脂升高,6例出现脂肪分布异常,多见于女性患者;25例发生血象异常、肝功能受损、肾功能变化和淀粉酶升高。3例患者发生3～4级毒副作用(2例为外周神经炎,1例怀疑乳酸酸中毒),1例患者发生3级皮疹。结论:奈韦拉平加两种核苷类反转录酶抑制剂的HAART药物组合长期治疗艾滋病毒感染者和艾滋病患者可持续抑制病毒,增加CD4细胞,其毒副作用可控制,是安全有效的治疗方案。Objective To evaluate the long-term efficacy and safety of nevirapine（NVP）-based regimens for HIV-infected Chinese patients in routine clinical practice.Methods From October 2002 to May 2004,57 HIV-1-infected patients commenced highly active antiretroviral therapy（HAART）,and were followed to December 2008.They originally received 2 nucleoside reverse transcriptase inhibitors（NRTIs） and nevirapine.HIV RNA levels,T lymphocyte subsets and safety were assessed.Blood routine test and main laboratory parameter changes were traced.If apparent side effects or virological failure appeared we would,if necessary,terminate the therapy or change the regimen.Results Of the 57 subjects,34 were followed-up for more than 4 years.After 5~6 years,63.3% of the subjects（19/30） had HIV RNA levels50 copies/μL,and the median increase in CD4＋ cell count from the baseline was 329 cells/μL.The mean decrease in CD8＋ cell count was 128 cells/μL.At the same time,the CD4＋CD45RA＋CD62L cell count and CD4＋CD45RO＋ cell gradually increased,and the counts of CD8＋CD38＋ cell declined gradually.These changes are apparent 2 years after HAART.The increase rate slowed down after 2 years.But they did not recover completely as well as healthy people at year 6.About 56%（32/57） of HIV-infected patients developed various drug-related side effects.The most common was gastrointestinal side effect,followed nervous disorder,baldness,and rashes,mostly happened in 6 months.Gamma-GT increased occurred in 29.8% of patients（17/57）,and serum cholesterol and triglyceride elevated in 26.3% of the patients（15/57）.Six patients developed lipodystrophy,mainly in female patients,and 25 patients showed abnormal blood picture and liver function,renal function changes and amylase elevation.Grade 3~4 adverse events occurred in 3 cases（2 peripheral neuropathy,and 1 suspected lactic acidosis）.One subject experienced grade 3 rashes.Conclusion Antiretroviral therapy with NVP-based regimens is safe and effective by suppressing HIV vire

关 键 词：高效抗反转录病毒治疗 奈韦拉平 长期 疗效 安全性 中国 

分 类 号：R512.91[医药卫生—内科学]