中药加HAART降低HIV/AIDS病人HIV耐药发生的临床研究

Clinical research of reducing HIV drug resistance among 600 HIV/AIDS patients with HAART combined with Chinese traditional medicine

目的评价中药降低高效抗反转录病毒治疗(HAART)初治病人耐药的有效性,为中国抗病毒治疗提供新的思路和证据。方法采用多中心、随机、双盲、安慰剂对照的临床研究方法,治疗组与安慰剂对照组按1∶1比例随机分配。根据入组辨证结果,治疗组给予HAART+艾可清胶囊(脾肾阳虚证)或艾复康胶囊(热毒蕴结证),对照组给予HAART+艾可清胶囊或艾复康胶囊模拟剂,疗程72周,记录抗病毒治疗耐药发生情况、病毒载量及免疫学指标。结果共有536例受试者完成试验,治疗组(266例)耐药率为6.35%,对照组(270例)为10.58%,治疗组的耐药率比对照组降低了4.23%。核苷类耐药位点M184V、K65R和非核苷类耐药位点V108I的出现率治疗组显著低于对照组;48周治疗组病毒学抑制率为68.42%,对照组为61.48%,治疗组的病毒学抑制率比对照组提高了6.94%(P=0.049)。分层分析显示,CD4+T淋巴细胞计数≥350个/μL时中医药降低耐药效果更显著。结论中西医结合治疗,可提高HAART病毒学抑制率,降低耐药率,免疫学指标较高时干预效果更好。

Objective To evaluate the effect of reducing HIV drug resistance for those receiving HAART with Chinese medicine.Method The clinical research was conducted with the methods of multicenter,random grouping,double-blind,for placebo-controlled group and treatment group with 1∶1proportion.Treatment group was treated with HAART and Aikeqing capsule（for spleen-kidney yang deficiency syndrome）or Aifukang capsule（for heattoxin stagnation syndrome）.Control group was treated with HAART and simulation agent of Aikeqing or Aifukang.Then drug-resistance,viral load and immune function were recorded during 72 weeks of the treatment.Results A total number of 536 cases completed the test,and drug resistance rates of treatment group and control group were 6.35%（266cases）,and 10.58%（270cases）respectively.Moreover,M184 V,K65Rand V108 Ioccurred in treatment group was significantly lower than those in control group.The virology inhibition rate of treatment group was 68.42%,while that of control group was 61.48%,increasing by 6.94%（P=0.049）at the timepoint of 48 weeks.CD4 stratification analysis showed that the drug resistance rate was much lower in treatment group when CD4 cell counts above 350perμl of blood.Conclusion HAART combined with TCM can improve the virology inhibition rate,and reduce drug resistance rate.The curative effect will be better when the immune function is maintained.