中药清湿热解毒配方颗粒治疗高尿酸血症的临床疗效及安全性评价

Clinical efficacy of traditional Chinese medicine formula granules of clear heat evil and detoxification in treating hyperuricemia and its safety evaluation

目的通过随机、对照、盲法临床试验,评价中药清湿热解毒配方颗粒治疗高尿酸血症的临床疗效及安全性。方法选择120例证属湿毒热阻型的高尿酸血症患者,随机分为对照组和治疗组,每组各60例,进行为期4周的治疗和观察。两组均予基础治疗(饮食、运动等),治疗组服用中药清湿热解毒配方颗粒,对照组服用安慰剂,通过对比两组治疗前后中医临床症状、血清尿酸、血脂(TC、TG、LDL-C)、空腹血糖指标,评价本品的临床疗效;观测两组治疗前后血常规、肝功能(ALT、AST)、肾功能(BUN、Cr)、心电图及不良反应,评价其安全性。结果治疗组4周后中医症候总有效率84%,对照组总有效率25%(P<0.001);治疗组患者血清尿酸水平降低,与治疗前比较,P<0.01,与对照组治疗后比较,P<0.05;治疗组患者LDLC水平降低,与治疗前比较,P<0.05,;两组治疗前后血常规、肝功能(ALT、AST)、肾功能(BUN、Cr)、心电图比较,差异无统计学意义(P>0.05);两组观察期间均无不良反应和严重不良事件发生。结论用中药清湿热解毒配方颗粒治疗高尿酸血症疗效确切,并能明显改善湿毒热阻型高尿酸血症的中医临床症状,是安全有效的降尿酸组方。

Objective To evaluate traditional Chinese medicine （TCM） formula granules of clear heat evil and detoxifica- tion treating hyperurieemia clinical efficacy and safety through randomized, placebo controlled, blinded clinical trial. Methods 120 patients with hyperuricemia syndrome of damp heat and blood stasis were selected, randomly divided into control and treat- ment groups, 60 cases in each group, in a period of 4 weeks of treatment and observation. The basic treatment was given to both two groups （diet, exercise etc） ; in addition, the control group had placebo while treatment group was given TCM clean heat evil and detoxifying formula granules. The clinical efficacy of the products was evaluated by compariment of TCM clinical symptoms before and after treatment as well as serum uric acid, lipids （TC, TG, LDL-C）, fasting blood sugar; meanwhile ob- serving complete blood counts （CBC）,liver function （ALT, AST）, kidney function （BUN, Cr）, electrocardiogram （ECG） and adverse reactions to evaluate its safety. Results After 4 weeks of treatment with TCM clear heat evil and detoxifying formula granules, the treatment group symptom total efficiency was 84 % ,while the placebo control group symptom total efficiency was 25 %,the difference is significant statisticly （P〈0. 001） ; the treatment group of TCM clean heat evil and detoxifying formula granules significantly reduced in the blood uric acid,compared with before treatment （P〈0.01）,as well as compared with the placebo control group （P〈0.05）; after treatment the TCM clear heat evil and detoxifying formula granules significantly re- duced in the LDL-C level （P〈0.05） compared with before treatment. Comparing before treatment with after treatment,there was no significant difference between the two groups, in routine blood tests, liver and kidney functions, or ECG （P〉0.05）. There were no side effects or adverse events in either groups in period of treatment and observation. Conclusion TCM clear heat evil and detoxifying formula granules is curative for the hyperuricemia and obviously improve the clinical symptoms for hy- peruricemia in patients with damp heat and blood stasis. It is a safe and efficient formulation to reduce uric acid.