目的 探讨参苓白术散联合抗逆转录病毒治疗(highly active anti-retroviral therapy，HAART)干预对免疫重建不良肺脾气虚证HIV/AIDS患者的临床疗效。方法 本次研究采用前瞻性单中心随机对照的研究方法，受试对象为60例艾滋病病毒感染者/艾滋病患者(HIV/AIDS)，入选患者均于本院沿用基线抗病毒治疗方案HAART治疗4年以上并达到病毒学抑制，且经纳入标准和排除标准筛选入组。研究时间为2021年1月至2022年1月，60例受试患者分组方法为随机数字表法，共分为2组，每组均30例。对照组给予西医抗病毒治疗方案，试验组在对照组治疗基础上服用参苓白术散。连续服药6个月，随访12个月，比较两组患者免疫重建临床疗效、两组治疗前后症状体征积分变化情况。分别于治疗后3个月、6个月检测并对比两组CD4+T淋巴细胞计数、CD4+/CD8+比值和病毒载量，观察两组患者治疗期间不良反应发生情况。结果 治疗后，试验组咳嗽、乏力、纳呆、呕吐、卡波氏肉瘤、淋巴结肿大等各项症状体征评分相较于对照组更低(P＜0。05);治疗后6个月，试验组CD4+T淋巴细胞计数、CD4+/CD8+比值显著高于对照组(P＜0。05);试验组治疗前至治疗后3个月以及治疗前至治疗后6个月的CD4+T淋巴细胞计数上升差值均显著高于对照组(P＜0。05);治疗期间两组均出现1例病毒载量高于检测线并均于随访第12个月时再行病毒载量检测结果显示低于检测限。本次研究无严重不良反应事件。结论 参苓白术散联合HAART干预对免疫重建不良HIV/AIDS患者免疫重建疗效较好，有助于提高患者CD4+T淋巴细胞水平，且治疗安全性良好。
Evaluation of therapeutic effect of Shenling Baizhu Powder combined with HAART intervention on HIV/AIDS patients with poor immune reconstitution
Objective To investigate the clinical effect of ShenlingBaizhu powder combined with HAART intervention on HIV/AIDS patients with lung Qi deficiency syndrome of poor immune reconstitution.Methods This study adopted a pro-spective single-center randomized controlled study.The subjects included 60 patients with HIV/AIDS who had been trea-ted with HAART for more than 4 years in our hospital and had achieved virological inhibition,and were screened by inclu-sion and exclusion criteria.The study period was from January 2021 to January 2022.Sixty patients were divided into 2 groups with 30 cases in each group by random number table method.The control group was given Western antiviral treat-ment,and the experimental group was given Shenling Baizhu powder based on the treatment of the control group.After 6 months of continuous medication and 12 months of follow-up,the clinical efficacy of immune reestablishment and the changes of symptom and sign scores before and after treatment were compared between the two groups.CD4+T lymphocyte count,CD4+/CD8+ratio and viral load were detected and compared between the two groups at 3 and 6 months after treat-ment,respectively,to observe the occurrence of adverse reac-tions during treatment in the two groups.Results After treatment,the scores of symptoms and signs such as cough,fa-tigue,natrium,vomiting,Kapo's sarcoma and lymph node enlargement in test group were lower than those in control group(P＜0.05).At 6 months after treatment,CD4+T lymphocyte count and CD4+/CD8+ratio in experimental group were significantly higher than those in control group(P＜0.05).The increase difference of CD4+T lymphocyte count from be-fore treatment to 3 months after treatment and from before treatment to 6 months after treatment in experimental group was significantly higher than that in control group(P＜0.05).During the treatment period,there was 1 case of viral load above the detection line in both groups,and the viral load detection results were below the detection limit at the 12th month of follow-up in both groups.There were no serious adverse events in this study.Conclusion ShenlingBaizhu Powder com-bined with HAART intervention has a good effect on immune reestablishment in HIV/AIDS patients with poor immune re-establishment,helps to improve the level of CD4+T lymphocytes in patients with HIV/AIDS,and the treatment is safe.
AIDS virus infected persons/AIDS patientsShen Ling Bai Zhu SanPoor immune reconstitutionAnti retro-viral therapy
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