目的 观察长期服用扶正抗毒丸对接受高效抗反转录病毒治疗（highly active antiretroviral therapy，HAART）艾滋病（AIDS）患者免疫重建的影响。方法 将200例无症状期人类免疫缺陷病毒（HIV）感染者分为对照组（单纯HAART）和试验组（服用扶正抗毒丸满1年后，在扶正抗毒丸的基础上加入HAART）；分别在治疗0、6、12个月对患者症状体征总积分和卡洛夫斯基积分（生存质量）进行评分，监测CD₄⁺、CD₄⁺CD₄₅RA⁺、CD₈⁺T淋巴细胞计数，治疗12个月时，计算患者免疫重建成功率。结果 试验组的免疫重建成功率（77.53%）、在治率（89%）均高于对照组（成功率58.97%和在治率78%），不良反应发生率（4%）、失访率（3%）低于对照组（不良反应发生率8%、失访率12%）；CD₄⁺、CD₄⁺CD₄₅RA⁺T淋巴细胞计数与对照组相比明显增加（P<0.05），CD₈⁺T淋巴细胞计数呈逐渐增加的趋势；症状体征总积分较对照组显著降低（P<0.001），卡洛夫斯基积分则显著升高（P<0.001）。结论 无症状期HIV感染者在未行HAART前长期服用扶正抗毒丸可有效提高患者后期接受HAART时的免疫重建成功率及CD₄⁺、CD₄⁺CD₄₅RA⁺、CD₈⁺T淋巴细胞计数，减少不良反应发生率以及增加患者用药依从性。

Objective To investigate the effect of long-term administration of Fuzheng Anti-poisonous Pellet on the immune reconstitution in AIDS patients treated with highly active antiretroviral therapy (HAART). Methods Two hundred cases of asymptomatic HIV-infected patients were divided into the WM group (receiving HAART alone) and the TCM-WM group (administering Fuzheng Anti-poisonous Pellet for a whole year, followed by the combination with HAART based on the basis of Fuzheng Anti-poisonous Pellet treatment). The overall scores of signs and symptoms as well as the Karnovsky scores were evaluated in all patients at 0, 6, and 12 months after treatment, respectively, accompanied by monitoring the T-lymphocyte counts of CD₄⁺, CD₄⁺CD₄₅RA⁺ and CD₈⁺; The success rate of immune reconstitution was calculated at 12 months after treatment. Results In the TCM-WM group, both the success rate and in-treatment rate of immune reconstitution (77.53% and 89%) were higher than those in the WM group (58.97% and 78%), while its incidence rate of adverse reactions and rate of loss to follow-up (4% and 3%) were lower than those in the WM group (8% and 12%); Compared with the WM group, the T-lymphocyte counts of CD₄⁺ and CD₄⁺CD₄₅RA⁺ were increased significantly (P<0.05), and the T-lymphocyte count of CD₈⁺ gradually increased with the treatment; The overall scores of signs and symptoms were significantly lower than those in the WM group (P<0.001), while the Karnovsky scores were significantly elevated (P<0.001). Conclusion In asymptomatic HIV-infected patients, the long-term administration of Fuzheng Anti-poisonous Pellet before HAART can not only effectively improve the success rate of immune reconstitution as well as T-lymphocyte counts of CD₄⁺, CD₄⁺CD₄₅RA⁺ and CD₈⁺ during the subsequent HAART, but also reduce the incidence rate of the adverse reactions, and enhance patient medication compliance.

国家自然科学基金地区科学基金项目（81360583）；云南省医疗卫生单位内设研究机构科研项目（2016NS338）