康爱保生丸治疗艾滋病402例临床观察

Clinical Efficacy of Kang′ai Baosheng Pill(康爱保生丸)in Treatment on 402 Cases of HIV/AIDS

目的观察国医大师张震研究员验方康爱保生丸治疗艾滋病的临床疗效及安全性。方法选取530例ⅡA期HIV/AIDS病例,按4∶1比例随机分为治疗组和对照组,对照组未给予治疗,治疗组给予康爱保生丸口服,3 g/次,4次/d。两组观察24个月。观察两组的临床症状体征评分、CD^(+)_(4)T淋巴细胞计数、疾病进展等指标变化。结果506例完成研究,其中治疗组402例,对照组104例,治疗组临床症状体征积分、HIV病载、临床结局评价量表(PRO)评分均较治疗前明显降低(P<0.05或P<0.01)。治疗组临床症状体征积分、HIV病载、PRO评分均明显低于对照组(P<0.05)。治疗组CD^(+)_(4)T淋巴细胞数均高于对照组;疾病进展:治疗组ⅡA期进入ⅡB期时间较对照组延长3.163月。结论康爱保生丸治疗ⅡA期艾滋病患者,能明显改善临床症状,可升高或稳定CD^(+)_(4)T淋巴细胞数,改善或稳定患者免疫功能;明显提高患者生存质量,延缓艾滋病病程进展。

Objective The purpose of this paper is to examine the efficacy and safety of Kang′ai Baosheng Pill(康爱保生丸)created by ZHANG Zhen who is a sophisticated researcher in traditional Chinese medicine in the treatment of AIDS.Method A total of 530 HIV/AIDS patients at stage IIA were randomly divided into treatment group and control group with the ratio of 4 to 1.The patients of treatment group were asked to take the drug orally,4 times a day with 3 g for each time,but the patients of control group were left without treatment.Then the two groups were examined for 24 months to see if there were any changes in symptom and signs score,CD^(+)_(4) T lymphocyte counts,disease progression or other indicators.Results The result showed that among the 506 participants,symptom and signs score,HIV viral load and clinical reported outcome(PRO)of 402 patients in the treatment group were much lower than those before treatment(P<0.05 or P<0.01)and also lower than those of 104 patients in the control group(P<0.05).The CD^(+)_(4) T lymphocyte counts in the treatment group were higher than those in the control group.The disease progression of the patients at stage IIA progressing into stage IIB in the treatment group was 3.163 months,longer than that in the control group.Conclusion Finally,we came to the conclusion that Kang′ai Baosheng Pill can relieve the symptoms of HIV/AIDS patientsat stage IIA,increase or stabilize the CD^(+)_(4) T lymphocyte counts and immune function,significantly improve the quality of life of pa-tients,and delay the progress of AIDS.