目的 探讨湘A1颗粒改善脾虚湿盛证人类免疫缺陷病毒（human immunodeficiency virus，HIV）/获得性免疫缺陷综合征（acquired immunodeficiency syndrome，AIDS）患者免疫功能的临床疗效及其作用机制。方法 采用随机数字表法将符合要求的54例HIV/AIDS脾虚湿盛证患者分为治疗组28例，对照组26例。治疗组采用高效抗反转录病毒疗法（highly activeantiretroviral therapy，HAART）联合湘A1颗粒进行治疗，对照组采用HAART联合湘A1颗粒模拟剂治疗。两组均连续治疗6个月，分别于治疗前后评估两组患者临床疗效、症状体征积分、生存质量分值，比较CD4⁺T细胞计数以及血清转化生长因子-β1（transforming growth factor-β1，TGF-β1）、白细胞介素-10（interleukin-10，IL-10）、γ干扰素（interferon-γ，IFN-γ）、肿瘤坏死因子-α（tumor necrosis factor-α，TNF-α）水平，并对安全性指标进行评价。结果 治疗后，治疗组总有效率（92.86%）明显高于对照组（69.23%）（P＜0.05）；治疗后，两组患者症状体征积分、TGF-β1、IL-10水平均较治疗前均明显下降（P＜0.05），且治疗组较对照组下降更为明显（P＜0.05）；两组治疗后生存质量分值、CD4⁺T细胞计数、IFN-γ水平均较治疗前明显提高（P＜0.05），且治疗组明显高于对照组（P＜0.05）。两组均未出现明显不良反应。结论 湘A1颗粒治疗脾虚湿盛证HIV/AID患者临床疗效显著，可以有效改善艾滋病患者症状、提高生存质量、促进免疫功能。其作用机制可能与调节血清细胞因子TGF-β1、IL-10、IFN-γ水平相关。

Objective To explore the clinical efficacy and mechanism of Xiang A1 Granules (湘A1颗粒) in promoting immune function in human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) patients with spleen deficiency and dampness excess syndrome. Methods A total of 54 cases of HIV/AID patients with spleen deficiency and damp excess syndrome were randomly divided into treatment group (28 cases) and control group (26 cases). The treatment group was treated with highly active antiretroviral therapy (HAART) combined with oral Xiang A1 Granules, while the control group was treated with HAART combined with Xiang A1 Granules mimicking agent. Both groups were treated continuously for six months. The clinical efficacy, the scores of symptoms and signs, the scores of quality of life, the CD4⁺T cell count, and the expression levels of transforming growth factor-β1 (TGF-β1), interleukin-10 (IL-10), interferon-γ (IFN-γ), tumor necrosis factor-α (TNF-α) of the patients in two groups were evaluated before and after treatment. And the safety indicators were evaluated. Results After treatment, the total effective rate of the treatment group (92.86%) was significantly higher than that of the control group (69.23%) (P < 0.05). The symptoms and signs scores, TGF-β1 and IL-10 levels of the patients in two groups after treatment were significantly decreased compared with those before treatment (P < 0.05), and the decrease was more significant in the treatment group compared with the control group (P < 0.05). The scores of quality of life, CD4⁺T cell count, and IFN-γ levels were significantly increased (P < 0.05), and the treatment group was significantly higher than the control group (P < 0.05). There were no obvious adverse reactions in both groups. Conclusion Xiang A1 Granules have significant clinical efficacy in the treatment of HIV/AID patients with spleen deficiency and dampness excess, which can effectively improve the symptoms of HIV/AID patients, improve the quality of life, and promote immune function. Its mechanism of action may be related to the regulation of serum TGF-β1, IL-10 and IFN-γ cytokines.

R285.64

湖南省自然科学基金项目（2022JJ30442）；湖南省中医药科研计划项目（202011）；湖南省教育厅研究项目（20A382）；湖南中医药大学研究生科研创新课题（2021CX300）