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目的:观察湘A1号颗粒治疗艾滋病的临床疗效及安全性,探讨湘A1号颗粒治疗艾滋病的相关机制。方法:采用双盲双模拟设计,将60例艾滋病脾虚湿盛型患者随机分为3组,每组20例。湘A1号组予湘A1号颗粒加抗病毒药物安慰剂;抗病毒组予抗病毒药物加湘A1号颗粒安慰剂;联合组予湘A1号颗粒加抗病毒药物;连续治疗6个月。治疗结束后通过症状体征积分、病毒载量、T细胞亚群进行疗效分析。结果:3组均能有效改善症状体征、提高生活质量(P<0.05),湘A1号组与抗病毒组无显著差异,联合组优于湘A1号组和抗病毒组(P<0.05);联合组与抗病毒组治疗前后病毒载量计数下降明显(P<0.01),且抗病毒作用优于湘A1号组(P<0.01);湘A1号组和联合组患者CD45RA+、CD45RA+CD3+、CD45RA+CD28+、CD45RA+CD4+、CD45RA+CD25+百分率及CD4/CD8比值显著上升(P<0.01),抗病毒组CD45RA+、CD45RA+CD3+、CD45RA+CD4+百分率及CD4/CD8比值显著上升(P<0.01),湘A1号组和联合组治疗后CD45RA+、CD45RA+CD3+、CD45RA+CD28+、CD45RA+CD4+、CD45RA+CD25+百分率与抗病毒组治疗后比较差异有统计学意义(P<0.01,P<0.05)。结论:湘A1号颗粒能缓解艾滋病脾虚湿盛型患者的症状体征、提高生活质量,湘A1颗粒与抗病毒疗法联用有协同作用;湘A1号颗粒抗病毒作用不明显,但具有明显免疫重建作用。
Objective: To observe the clinical efficacy and safety of Xiang A1 granule in the treatment of AIDS and to explore the related mechanism of Xiang A1 granule in treating AIDS. Methods: A double-blind, double-dummy design was adopted. Sixty AIDS patients with spleen-asthenia-dampness type were randomly divided into three groups (20 in each group). Xiang A1 group to Xiang A1 particles plus antivirals placebo; antiviral group plus antiviral drugs plus Xiang A1 particles placebo; combination group to Xiang A1 particles plus antiviral drugs; continuous treatment for 6 months. After the treatment by symptom score, viral load, T cell subsets for the efficacy analysis. Results: All the three groups were able to effectively improve symptoms and signs and improve quality of life (P <0.05). No significant difference was found between Xian A1 group and antiviral group. The combination group was better than that of Xiang A1 group and antiviral group (P <0.05). Compared with Hunan A1 group (P <0.01), the virus load count of combination group and antiviral group decreased significantly (P <0.01) before and after treatment. The expression of CD45RA +, CD45RA + CD3 + The percentage of CD45RA + CD28 +, CD45RA + CD4 + and CD45RA + CD25 + and the ratio of CD4 / CD8 were significantly increased (P <0.01) (P <0.01, P <0.05). There was significant difference in the percentage of CD45RA +, CD45RA + CD3 +, CD45RA + CD28 +, CD45RA + CD4 +, CD45RA + CD25 + between the group A1 and the combination group after treatment. Conclusion: Xiang A1 granules can alleviate the symptoms and signs of AIDS patients with wet spleen and improve the quality of life. The combination of Xiang A1 granules and anti-virus therapy has a synergistic effect. The effect of Xiang A1 granules on antivirus is not obvious, but it has obvious immune reconstitution effect.