一线方案耐药HIV/AIDS患儿更换二线方案的长期疗效和安全性

Long term efficacy and safety of the second-line regimen on treatment for HIV/AIDS children with antiretroviral drug resistance to first-line regimen

目的研究一线方案发生耐药的HIV/AIDS患儿服用含ABC+LPV/r方案的长期疗效与安全性。方法对更换为二线方案的26例患儿进行观察性队列研究,分析服用ABC+3TC+LPV/r或ABC+3TC+AZT+LPV/r 8年的病毒学和免疫学疗效及安全性。结果在治疗第6个月病毒载量<200拷贝/mL患儿的比例达96.15%,前3年分别达88.46%、96.15%和88.46%,第5年和第8年分别达79.17%、75.00%。CD4细胞计数在第3个月和第6个月时从换药时的(128.73±109.54)个/μL显著上升至(231.16±143.22)和(329.35±193.29)个/μL(P<0.05),第5年时达(700.29±380.38)个/μL,第8年降至(572.63±224.76)个/μL,但仍显著高于换药时水平(P<0.05)。在前3个月,有11例(42.31%)出现恶心,4例(15.38%)出现腹泻,4例(15.38%)出现皮疹,3例(11.54%)出现骨髓抑制。另外,治疗8年时甘油三酯、总胆固醇、血糖升高发生率分别为87.50%、12.50%和30.00%。随访期间,无1例患儿停用ABC及LPV/r或退出研究。结论在密切督促患儿依从性的情况下,含ABC+LPV/r的二线方案在HIV/AIDS耐药患儿中近期疗效良好,安全性较高,但在长期临床应用中应注意密切监测病毒载量、免疫学反应以及血糖和血脂异常。

Objective To study the long-term efficacy and safety of abacavir(ABC)+lopinavir/ritonavir(LPV/r)regimen in children with HIV/AIDS resistant to the first-line regimen.Methods An observational cohort study was conducted in 26 children who were switched to the second line regimen according to the drug resistance report for analyzing the virological and immunological efficacy and safety of taking ABC+lamivudine(3TC)+LPV/r or ABC+3TC+zidovudine(AZT)+LPV/r for eight years.Results We noticed that 96.15%of the children were with viral load<200 copies/mLin the sixth month,88.46%,96.15%,and 88.46%in the first three years,as well as 79.17%and 75.00%in the fifth and eighth years,respectively.The number of CD4 T cells increased significantly from 128.73±109.54 cell/uL to 231.16±143.22 cell/uL and 329.35±193.29 cell/uL at the third and sixth month(P<0.05),reaching 700.29±380.38 cell/uL in the fifth year,and decreased to 572.63±224.76 cell/uL in the eighth year(P<0.05).In the first three months,11 cases(42.31%)had nausea,4 cases(15.38%)had diarrhea,4 cases(15.38%)had a rash,and 3 cases(11.54%)had myelosuppression.In addition,the Incidence rates of triglyceride,total cholesterol,and blood glucose were 87.50%,12.50%,and 30.00%,respectively.During the follow-up period,none of the children stopped ABC and LPV/r or withdrew from the study.Conclusion The second-line regimen containing ABC+LPV/r has good short-term efficacy and high safety seen in those HIV/AIDS drug-resistant children.However,in the long-term clinical application,the viral load,immune response,blood glucose,and dyslipidemia should be closely monitored.