国产抗逆转录病毒药物联合中药新血片治疗HIV/AIDS患者24周临床研究  

A 24 week chinical observation on the officaoy and safety of a domestic generic ARV drug combined with the Chinese treating medicine in the treatment of HIV/AIDS patients

作　　者：赵红心[1] 张福杰[2] 郜桂菊[1] 于兰[2] 卢联合[1] 文毅[2] 韩宁[1] 赵燕[1] 李鑫[1] 

机构地区：[1]北京地坛医院,北京100011 [2]中国疾病预防控制中心性病艾滋病预防控制中心,北京100050

出　　处：《中国艾滋病性病》2006年第4期297-299,316,共4页Chinese Journal of Aids & STD

基　　金：卫生部应用性研究(课题编号:WA2002-01-02)

摘　　要：目的试图通过联合应用中药来改善西药的毒副作用,提高患者的免疫功能,探讨国产药物抗病毒治疗的效果及安全性。方法采用随机、开放、对照的临床观察方法,在艾滋病病毒/艾滋病(HIV/AIDS)患者进行治疗的半年中,每8周进行一次随诊和检查,包括记录用药情况、副反应发生情况、临床症状改善情况,测定病毒载量、T细胞亚群等,对检测的结果进行统计学分析。结果选择的受试者49例,中西医组(治疗组)25例,西医组(对照组)24例,比较两组治疗前后的效果。治疗后在免疫学方面,两组的CD4细胞计数均有不同程度的上升,治疗组平均上升38个/μl,对照组平均上升70个/μl,但没有统计学意义;治疗组在治疗2个月和6个月后,病毒学反应的成功率分别为60%和28%,对照组均为70.83%;两组在治疗2个月后,对病毒的抑制程度没有明显差异,而在治疗6个月后比较,对病毒的抑制程度对照组要优于治疗组,有显著性差异,P<0.05。两组在治疗过程中未发生严重的毒副作用,患者的临床症状得到改善。结论国产抗病毒药物是安全的,单纯西药组抗病毒治疗效果不论是从病毒学还是免疫学都优于中西医结合组。但在临床表现方面,两组机会性感染的发生下降,两组患者在体力、食欲、体重、腹泻及脱发等方面,都有不同程度的改善,两组差异无显著统计学意义(P>0.05)。Objective To investigate the efficacy and safety of a domestic generic ARV drug and try to combine it with the traditional Chinese medicine for the purpose of reducing its side effects and toxicity and improve patients＇ immune system. Method The present study was an open controlled clinical observation involving 49 subjects and lasting for 24 weeks. All the subjects were divided into two groups： control group （n-24, receiving ARV drug only） and treatment group （n-25, receiving both ARV drug and traditional Chinese medicine, TCM）, and were followed up on the 8th week after the study. The patients＇ compliance, and response, improvement of clinical manifestations, side effects of the drug, viral loads and T cell counts were all recorded and statistical analysis was provided accordingly. Results CD4 cell counts increased in both groups after the treatment in certain degrees. In the treatment group CD4 cell counts were elevated by 38 cells/μl, while in the control groups they were elovated on average by 70 cells/μl,but without statistical significance. The viral responses in the treatment group in 2 and 6 months after the treatment were 60 96 and 28 96 respectively while such responses in the control group were 70.83 % on average. In regards with viral suppression, there was no significant dttorence between the two groups in 2 mouths after the traatment, but significant differences were pasent in 6 months after the treatment, that is to say, more obvious vial supppression was observed in the control group. No severe side effects was seen in either groups and clinical symptoms of the pationts were improved in both groups. Conclusion The domestic ARV drug is safe and single use of ARV drug is better than its combination with TCM in terms of virological and immuno- logical responses. Opportunistic infections were decreased in both groups and patients in both groups folt better in their physical strength, appetite, hair loss, body weight, diarrhea and other conditions （P 〉 0.05 ）.

关 键 词：艾滋病病毒/艾滋病 中西医联合 疗效 

分 类 号：R373.9[医药卫生—病原生物学] R512.91[医药卫生—基础医学]