艾复康胶囊治疗艾滋病的有效性和安全性临床观察

目的观察艾复康胶囊治疗艾滋病的有效性和安全性。方法选取198例符合诊断标准的艾滋病病人,随机分为两组,试验组给予艾复康胶囊,对照组给予艾复康胶囊模拟剂,观察治疗前及治疗后4周、12周、24周的CD4+细胞数、艾滋病病毒(HIV)病毒载量(对数)、临床症状评分、病人报告的临床结局(PRO)评分、体重、安全性指标等。结果艾复康胶囊能明显提高受试者的免疫功能;明显增加受试者体重;明显改善疲劳不适、食欲减退、头痛、皮疹、失眠等临床症状;病毒载量两组间未见明显差异。观察期间两组均未发现与治疗相关的严重不良反应。结论艾复康胶囊治疗艾滋病有效、安全。

Clinical observation of the efficacy and safety of Aifukang capsule in patients with HIV infections and AIDS

Objective To evaluate the efficacy and safety of Aifukang capsule for HIV/AIDS.Method One hundred and ninety eight participants were randomized to receive Aifukang capsule(treatment group) and placebo(control group).CD4 cell counts,viral loads,scores of clinical symptom and patient reporting outcome(PRO),body weight,laboratory tests and safety indexes were assessed before treatment and in 4,12 and 24 weeks after treatment.Results Aifukang capsule significantly improved immune function and clinical symptoms of the patients,such as fatigue,anorexia,headache,skin rash and insomnia.Body weight was increased significantly in the treatment group.There was no significant difference in viral loads between the two groups.No serious adverse events were found.Conclusion Aifukang capsule is effective and safe for treating HIV infections and AIDS.