甘露清血散治疗查培病的临床疗效评价和安全性研究

Clinical efficacy evaluation and safety research on treating chronic high altitude polycythemia with Ganlu Qingxue San

目的:通过完全随机、双盲对照临床试验,评价甘露清血散治疗查培病(慢性高原红细胞增多症)的临床疗效及安全性。方法:选择100例慢性高原红细胞增多症患者,随机分为对照组和试验组,每组50例,进行为期2个月的治疗和观察。试验组服用甘露清血散,对照组服用二十五味余甘子,以慢性高原病计分标准(国际标准)、藏医症状评分标准、血氧饱和度、血红蛋白、红细胞压积为指标评价临床疗效;观测治疗前后血常规、空腹血糖、肝功能(ALT)、肾功能(BUN、Cr)及不良反应,评价安全性。结果:治疗0天和60天比较,试验组和对照组患者血红蛋白数量、血氧饱和度均显著降低(P<0.01);试验组红细胞压积指数明显降低(P<0.05);对照组红细胞压积指数无显著性差异(P>0.05)。两组治疗前后血常规、空腹血糖、肾功能(BUN、Cr)比较无显著性差异(P>0.05),肝功能(ALT)治疗前后比较,指数降低明显(P<0.05);两组治疗期间均无不良反应和严重不良事件发生。结论:甘露清血散及二十五味余甘子治疗查培病均有效,并能改善查培病的临床症状,改善患者生活质量,甘露清血散较二十五味余甘子在降低患者红细胞压积方面更显效,且两组药均符合安全性的要求。

Objective:The clinical efficacy and safety of Ganlu Qingxue San on chronic altitude erythrocytosis were evaluatedby completely randomized,double-blind control clinical trials.Methods:100cases were randomly assigned to the control group andexperimental group,50cases in each group.The experimental group took Ganlu Qingxue San and the control group took ErshiwuweiYuganzi.Results:In0day and60days,amount of hemoglobin,blood oxygen saturation in the experimental group and control group weredecreased significantly(P<0.01);hematocrit in the experimental group was decreased significantly(P<0.05);but hematocrit in the controlgroup showed no significant difference(P>0.05).The blood routine,fasting blood glucose,BUN,Cr in two groups showed no significantdifference(P>0.05);ALT was decreased significantly(P<0.05)after treatment.Conclusion:Ganlu Qingxue San was effective on chronicaltitude erythrocytosis,and can improve clinical symptoms,reduce hematocrit,with the requirements of safety.