摘要
目的前瞻性长期观察人免疫缺陷病毒感染者和获得性免疫缺陷综合征(HIV/AIDS)患者的高效抗逆转录病毒治疗(highly active antiretroviral therapy,HAART)一线药物抗HIV及免疫重建效果和主要毒副反应,探索我国艾滋病长期抗病毒治疗的规律。方法 437例HIV/AIDS患者先后启动HAART,一线方案为2个核苷类逆转录酶抑制剂(NRTI)加1个非核苷类逆转录酶抑制剂(NNRTI)。随访监测CD4+T细胞数量、HIV病毒载量,追踪血常规和主要生化指标的变化;观察发生的机会感染和药物毒副反应并及时处理,对出现病毒学失败或严重毒副反应者及时调整用药。结果对437例接受HAART的HIV/AIDS患者平均追踪了4.69年(3.15～7.34年),总病死率6.86%,大部分死亡发生在HAART启动的6个月内。启动HAART 12个月时,90.80%的患者HIV载量小于可检测下限;至治疗4、5、6、7年(±1个月)时,仍分别有63.46%、69.41%、70.00%和72.22%的患者病毒载量小于可检测下限。CD4+细胞数量在治疗的O、1、2、3、4、5、6、7年(±1个月)时分别为115、246、301、334、363、356、386和373个/μL。67.73%出现过各种可能与药物毒副作用相关的表现,主要有消化道症状、神经系统症状、肝功能损害、骨髓毒性、皮疹和血脂升高等,多发生于治疗启动12个月内;血脂分布异常和乳酸酸中毒较少见,多发生于启动2年以后;41例患者先后发生过Ⅲ/Ⅳ级毒副反应。因毒副反应而更换为其他一线药物者占19.22%,因病毒耐药或毒副反应而更换为二线药物者占11.67%。结论通过对HIV/AIDS患者HAART3～7年的多中心前瞻性观察,明确我国2个NRTI加1个NNRTI的HAART一线方案对大多数HIV/AIDS患者长期有效,病毒持续抑制,CD4+细胞增加;主要的毒副反应和死亡多发生在启动治疗12个月内。大多数HIV/AIDS患者可长期坚持一线药物治疗,少数因药物毒副反应或病毒耐药须换为二线药物治疗。
Objective To prospectively observe the efficacy, tolerance , immune reconstruction and toxicity of long-term highly active antiretroviral therapy （HAART） in HIV-infected patients in China. Methods Four hundred and thirty-seven HIV-infected patients initiated HAART and originally received two nucleoside reverse transcriptase inhibitors（NRTI） and one non-nucleoside reverse transcriptase inhibitors（NNRTI）, and were traced HIV RNA levels, T lymphocyte subsets, blood routine tests, main laboratory parameter changes and treated for active opportunistic infections. Patients with severe side effects or virological failure changed to the second line regimens. Results 437 patients from 8 hospitals received a mean of 4. 69 years （3. 15-7. 34） follow-up. Total mortality was 6. 86 %, and the majority of patients died within the first 6 months of the treatment. The proportion of subjects who had HIV-1 RNA〈500 copies/mL were 90. 80%, 63. 46%, 69. 41%, 70. 00%, and 72. 22% at 1,4,5,6 and 7 year （ ± 1 month） respectively. CD4 ＋ T cell count were 115,246,301,334, 363,356,386 and 373 cells/μL at 0, 1, 2, 3, 4, 5, 6 and 7 year （ ± 1 month） of follow-up, respectively. 67. 73% of HIV-infected patients showed various drugrelated side effects, the majoriy were digestive system symptoms , neurological system symptoms, liver dysfunction, marrow toxicity , skin rash, and hyperlipemia, et al. 19. 22% of patients changed their primary regimens into other first-line drugs for drug-related side effects, 11.67% of patients switch to second-line regimen for viral resistance. Conclusion This paper firstly reported the 3 to 7-year results from the multicenter prospective follow-up of HIV-infected patients in China taking potent antiretroviral therapy. The study demonstrated antiretroviral therapy with two NRTI and one NNRTI regimen may persistently suppress HIV and increase CD4 cell in a majority of subjects. The majority of subjects take first-line regimen effectively, minor switch to second-line regimen for drug-re- lated side effects or viral resistance .
出处
《中国感染控制杂志》
CAS
2010年第5期310-315,共6页
Chinese Journal of Infection Control
基金
卫生部艾滋病防治应用研究项目(WA2003-15)
"十五攻关"国家科技计划项目(2004BA719A10)
关键词
艾滋病
高效抗逆转录病毒治疗
不良反应
临床观察
长期治疗
acquired immunodeficiency syndrome
highly active antiretroviral therapy
side effect
clinical observation
long-term treatment
