扶正抗艾颗粒联合HAART疗法对HIV/AIDS患者临床疗效和不良反应的临床研究

Fuzhengkangai Particle Combination HAART Therapy in Patients with HIV/AIDS Clinical Curative Effect and Adverse Reactions of Clinical Research

目的:应用扶正抗艾颗粒联合高效抗逆转录疗法(HAART)治疗HIV/AIDS(人类免疫缺陷病毒/获得性免疫缺陷综合征,human immunodeficiency virus/acquired immunodeficiency syndrome)初治患者,观察其临床疗效和改善相关不良反应的作用。方法:采用多中心、随机、双盲和安慰剂对照的临床研究方法,分为试验组和对照组各57例,试验组予"扶正抗艾颗粒"联合高效抗逆转录疗法(HAART)抗病毒治疗,对照组予"扶正抗艾颗粒"安慰剂(5%低剂量)联合高效抗逆转录疗法(HAART)抗病毒治疗,疗程3个月。两组患者同时进行肝肾功能、血常规、CD4+T淋巴细胞计数、中医症状体征积分、生存质量积分的观察。结果:经过12周的临床治疗,对照组与试验组比较,实验组能明显升高外周血RBC水平、降低CR水平,降低症状体征(总积分、乏力、纳呆、自汗)积分、升高CD4+T淋巴细胞计数水平和生存质量积分,经检验差异均有统计学意义(P<0.05)。结论:扶正抗艾颗粒联合高效抗逆转录疗法(HAART)抗病毒治疗,能够改善HAART初始治疗后的患者临床症状、血液毒副作用、生存质量,减轻抗病毒治疗不良反应,联合用药较单独用药能显著升高CD4+T淋巴细胞,从而提高临床疗效。

Objective：to apply Fuzhengkangai AIDS particles combined therapy with effective antiretroviral therapy （HAART） at the beginning of the HIV/AIDS （human immunodeficiency virus/acquired immunodeficiency syndrome）patients, observe its clinical curative effect and improve the related adverse reactions.Methods： a multicenter, randomized, double-blind, placebo-controlled clinical research method, divided into experimental group and the control group （n = 57）, experimental group to ＂Fuzhengkangai particles＂ joint efficient antiretroviral therapy （HAART） antiviral treatment, control group to ＂Fuzhengkangai particles＂ placebo （5% low dose） joint efficient antiretroviral therapy （HAART） antiviral treatment, treatment for 3 months. Two groups of patients with simultaneous liver and kidney function, blood routine, CD4 ＋ T lymphocyte count, the observation of TCM symptoms and signs, survival quality of integral. Results： after 12 weeks of treatment, the control group and experimental group, the experimental group significantly elevated levels of peripheral blood RBC, lower levels of CR, reduce the signs and symptoms （total score, fatigue, stay, and spontaneous perspiration） integral, higher levels of CD4 ＋ T lymphocyte count and survival quality score, the difference had statistical significance （P 〈 0.05）. Conclusion： Fuzhengkangai particles joint efficient antiretroviral therapy （HAART） antiviral treatment, can improve HAART after initial treatment of the patient＇s clinical symptoms, blood toxicity, the quality of survival, reduce the antiviral treatment of adverse reactions, combination drug alone can significantly increase the CD4 ＋ T lymphocytes, so as to improve clinical curative effect.