中药治疗HAART相关血脂异常的临床研究

目的:评价以消脂颗粒及二陈汤和桃红四物汤为组方的中药制剂与血脂康胶囊治疗HAART致血脂异常的有效性和安全性.方法:采用多中心、随机对照的研究方法将180例HAART致血脂异常患者随机分为治疗组和对照组,观察指标为治疗前及治疗后第4,8,12周检测患者的总胆固醇(Tch)、甘油三酯(TG)、低密度脂蛋白(LDL)、高密度脂蛋白(HDL).结果:在治疗后第12周与对照组比较,治疗组患者Tch,LDL的变化有明显差异(P＜0.05),TG的变化无明显差异,对照组患者Tch,LDL下降优于治疗组;治疗组患者HDL的升高值有显著差异(P＜0.05),治疗组患者HDL的升高优于对照组.结论:血脂康胶囊和以消脂颗粒及二陈汤和桃红为组方的中药配方颗粒制剂可以作为防治我国HAART致血脂异常患者的主要中药制剂之一.

Multi-centered,randomized controlled clinical study on Chinese medicine formula particles for hyperlipidaemia associated with highly active antiretroviral therapy

Objective: To observe the effect and safety of Xiaozhi particles, integrated taohong Siwu tang and Erchen tang and Xuezhikang capsule in treating hyperlipidaemia (HLP) associated with highly active antiretroviral therapy (HAART). Method: In the multi-centered, randomized controlled clinical study,180 hyperlipidaemia associated with highly active antiretroviral therapy cases were divided into the treatment group treated by Xiaozhi particles, integrated Taohong Siwu tang and Erchen tang,and the control group treated by Xuezhikang capsule.The treatment course was 12 weeks.The total cholesterol(Tch), triglyceride(TG), low density lipoprotein(LDL) and high-density lipoprotein(HDL) were observed. Result: After 12 weeks, compared with Xuezhikang capsule, the change difference of Tch, LDL, HDL in the Chinese traditional medicine formula groups of patients is significant (P<0.05), the change of the TG has no significant difference. The effect of Tch, LDL in Xuezhikang capsule groups is better than in traditional Chinese medicine formula group,but the effect of HDL in traditional Chinese medicine formula group is better than in Xuezhikang capsule groups. Conclusion: Integrated Taohong Siwu tang and Erchen tang, Xiaozhi particles and Xuezhikang capsule can be used to control the hyperlipidaemia associated with highly active antiretroviral therapy as one of the main Chinese native medicine preparation.