摘要
目的通过动态临床试验分析,对广西地区目前常用的AZT、d4T及TDF为主的3组抗反转录病毒治疗方案进行临床疗效比较。方法收治HIV/AIDS患者76例,分为3组,AZT组接受AZT+3TC+EFV治疗,d4T组接受d4T+3TC+EFV治疗,TDF组接受TDF+3TC+EFV治疗。对3组30个月内新发机会性感染率、免疫重建效果、病毒学应答效果、主要生化指标变化、换药及耐药情况进行动态分析比较。结果 3组患者经治疗满6个月时HIV RNA载量显著下降(P均<0.05),CD4+T淋巴细胞计数显著上升(P均<0.05),但是3组间差异无统计学意义;6个月以后各组CD4+T淋巴细胞计数上升缓慢,12个月和18个月时,d4T组CD4+T淋巴细胞计数上升幅度均大于AZT组和TDF组(P均<0.05);3组患者治疗满6个月ALB显著升高(P均<0.05),而后各阶段变化不大;AZT组、d4T组、TDF组随访期间新发机会性感染发生率分别为15.62%、11.53%、27.77%,不良反应换药率分别为12.50%、30.80%、16.67%,但差异均无统计学意义。结论广西地区3组常用一线抗HIV药物方案的治疗效果显著且相似,但d4T方案因药物不良反应和耐药而换药的发生率较高,应考虑停用。
Objective To compare clinical curative effect of 3 ART regimens in Guangxi region through a dynamic clinical trial analysis. Methods Seventy-six HIV/AIDS patients were included in this study and randomly divided into 3 groups. AZT group was treated with AZT＋3TC＋EFV. The d4T group received d4T＋3TC＋EFV treatment. TDF group received TDF＋3TC＋EFV treatment. The incidence of opportunistic infections, immune reconstitution, virological response, changes of major biochemical indexes, dressing change and drug resistance were dynamically analyzed and compared in 3 groups within 30 months. Results The HIV-RNA loading was significantly decreased in 3 groups at 6 months of treatment （P 〈 0.05）, while the levels of CD4~ T lymphocytes increased significantly （P 〈 0.05）, but there was no significant difference among 3 groups. After 6 months of treatment, CD4＋ T lymphocytes increased gradually in 3 groups. At 12 and 18 months, the increment of CD4＋ T lymphocytes in d4T group was more significant than that in AZT group and TDF group （P 〈 0.05）. The ALB level in 3 groups increased significantly at 6 months of treatment （P 〈 0.05）, and then the change was not obvious at subsequent time points. The incidence of opportunistic infections was 15.62% in AZT group, 11.53% in d4T group, 27.77% in TDF group. The dressing change rate was 12.50% in AZT group, 30.80% in d4T group and 16.67% in TDF group, respectively, however no significant difference was observed. Conclusions Three first-line anti-HIV drug regimens commonly used in Guangxi area have significant and similar effects, but the rate of dressing change for d4T regimen is higher due to adverse drug reactions and drug resistance, so this regimen is recommended to withdraw.
出处
《传染病信息》
2017年第6期342-345,383,共5页
Infectious Disease Information
基金
南宁市兴宁区科学研究与技术开发项目(2015A15)
十三五国家重大新药创制课题(2017ZX09009070-001-008)
