复方土茯苓颗粒治疗高尿酸血症40例随机对照临床观察

Clinical Observation on Fufang Tufuling Keli(复方土茯苓颗粒) Treating 40 Cases of Hyperuricemia: A Randomize-Controlled Study

目的观察复方土茯苓颗粒治疗高尿酸血症的临床疗效及安全性。方法将60例高尿酸血症患者随机分成对照组、短疗程组、长疗程组各20例。对照组仅给予健康教育、低嘌呤饮食等治疗措施12个月;短疗程组在对照组基础上口服复方土茯苓颗粒每次10 g,每日2次,20天为1个疗程,2个疗程间间隔10天,共治疗3个月,之后继续基础治疗9个月;长疗程组在短疗程组基础上,从第4个月开始10天为1个疗程,2个疗程间间隔20天,再口服9个疗程,共治疗12个月。于治疗前及治疗后3、12个月分别采集患者中医临床四诊资料进行中医症状评分,并检测患者血尿酸水平以及血常规、尿常规、肝功能、肾功能等安全性指标。结果 3组患者治疗3、12个月时血尿酸水平均较治疗前下降(P<0.01);短、长疗程组血尿酸下降程度均优于对照组(P<0.05或P<0.01),且治疗12个月时长疗程组优于短疗程组(P<0.05)。治疗3个月短、长疗程组患者痰涎、神疲乏力、四肢沉重、小便颜色积分均降低,小便量积分均增加(P<0.05或P<0.01),治疗12个月后长疗程组仍可继续改善上述症状。3组患者治疗3、12个月时血常规、尿常规、肝功能、肾功能各指标与治疗前比较差异无统计学意义(P>0.05)。结论复方土茯苓颗粒可有效降低高尿酸血症患者血尿酸水平,对与痰湿阻滞相关的中医临床症状有改善作用,远期疗效及安全性好。

Objective To observe clinical curative effects and safety of Fufang Tufuling Keli （复方土茯苓颗粒） treating hyperuricemia. Methods Randomly divided 60 cases of patients with hyperuricemia into the control group, the short-term group and the long-term group, with 20 cases each. The control group was only given treatment measures like health education and low purine diet for 12 months; The short-tel^n group took Fufang Tufuling Keli orally based on that of the control group, 10 g every time, twice per day and 20 days was a treatment course. There were 10-day intervals between two courses. The treatment was for 3 months in total, after which 9-months basic treat- ment was conducted. The long-term group took 10 days for a treatment course from the fourth month bases on treat- ment of the short-term group. There was a 20-day interval between two courses. Nine more courses were conducted,with 12 months in total. Collected clinical four diagnostic information of Chinese medicine, and scored for Chinese medicine symptoms. At baseline and at the third and 12th month during treatment, examined safety indexes （inclu- ding tests of serum uric acid, blood routine, urine routine, liver function and kidney function）. Results Serum uric level of patients in 3 groups in the third and the 12th month during treatment decreased compared with that before treatment （P 〈0. 01 ）. The degree of serum uric decreasing of the short-term group and the long-term group was both superior to that of the control group （P 〈0. 05 or P 〈0. 01 ）. And the long-term group was superior to the short-term group after 12 months treatment （P 〈 0. 05）. Integration of sputum, physically and mentally fatigued, limbs heavi- ness and urine color of patients in the short-term and long-term group all decreased in the third month during treat- ment, while that of urine volume all increased （P 〈 0. 05 or P 〈 0. 01 ）. Above symptoms of the long-term group still continued to improve after treatment for 12 months. Index including blood routine, urine routine, liver function and kidney function of patients in 3 groups in the third and 12th month had no statistical difference compared with that before treatment （P 〉 0. 05 ）. Conclusion Fufang Tufuling patients with hyperuricemia, and could improve clinical stagnation with good long-term effect and safety. Keli could effectively decreased serum urine level of symptom of Chinese medicine related to phlegm dampness