李静 孙维峰 武鹏 劳贝妮 石尉宏

【摘 要】目的：觀察复方土茯苓颗粒降低痰瘀痹阻型痛风患者血尿酸的临床疗效和安全性。方法：将104例痰瘀痹阻型痛风间歇期血尿酸升高患者随机分为治疗组和对照组，每组52例。治疗组给予复方土茯苓颗粒治疗，对照组给予苯溴马隆治疗。2组疗程均为12周。观察2组中西医疗效和安全性。结果：治疗组51例、对照组50例完成试验。治疗4周后，2组血尿酸水平较治疗前均降低（P < 0.05）;治疗8周后，2组血尿酸水平均低于治疗4周（P < 0.05）;治疗12周后，2组血尿酸水平与治疗8周比较，差异无统计学意义（P > 0.05）。治疗4，8，12周后，2组血尿酸水平比较，差异均无统计学意义（P > 0.05）。治疗4，8，12周，治疗组、对照组血尿酸 < 300 μmol·L-1患者的比例分别为31.37%、36.00%，50.98%、54.00%，64.71%、68.00%，组间比较，差异均无统计学意义（P > 0.05）。治疗12周后，治疗组显效12例，有效34例，无效5例，总有效率为90.20%;对照组显效10例，有效35例，无效5例，总有效率为90.00%。2组比较，差异无统计学意义（P > 0.05）。治疗过程中，2组均无不良事件发生;治疗组急性痛风性关节炎发作患者比例低于对照组（P < 0.05）。结论：复方土茯苓颗粒降低痰瘀痹阻型痛风患者血尿酸有效、安全，可为临床治疗提供药物选择和依据。

【关键词】 痛风;复方土茯苓颗粒;痰瘀痹阻型;临床疗效

【ABSTRACT】Objective：To observe the clinical efficacy and safety of Fufang Tufuling Keli（复方土茯苓颗粒）in reducing blood uric acid in patients with gouty of phlegm stasis obstruction type.Methods：One hundred and four patients with elevated serum uric acid in the remission stage of gout of phlegm stasis obstruction type were randomly divided into a treatment group and a control group，52 cases in each group.The treatment group was treated with Fufang Tufuling Keli and the control group was treated with benzbromarone.The course of treatment for both groups was 12 weeks.The efficacy and safety of Chinese and Western medicine in the two groups were observed.Results：Fifty-one cases in the treatment group and 50 cases in the control group completed the test.After 4 weeks of treatment，the level of serum uric acid in the two groups decreased compared with that before treatment（P < 0.05）.After 8 weeks of treatment，the level of serum uric acid in the two groups was lower than that after 4 weeks of treatment（P < 0.05）.There was no significant   difference between 12 weeks of treatment and 8 weeks of treatment（P > 0.05）.After 4，8 and 12 weeks of treatment，there was no significant difference in the level of serum uric acid between the two groups（P > 0.05）.After 4，8 and 12 weeks of treatment，the proportions of patients with serum uric acid（< 300 μmol·L-1）in the treatment group and the control group were 31.37%：36.00%，50.98%：54.00%，and 64.71%：68.00% respectively.The differences between groups were statistically significant（P > 0.05）.After 12 weeks of treatment，12 cases were markedly effective，34 cases were effective and 5 cases were ineffective in the treatment group and the total effective rate was 90.20%;In the control group，10 cases were markedly effective，35 cases were effective and 5 cases were ineffective.The total effective rate was 90.00%.There was no significant difference between the two groups（P > 0.05）.During the treatment，no adverse events occurred in both groups;the incidence of acute gouty arthritis in the treatment group was lower than that in the control group（P < 0.05）.Conclusion：Fufang Tufuling Keli is effective and safe in reducing blood uric acid in patients with gouty of phlegm stasis obstruction type，and can provide reference of drug selection and lay basis for clinical treatment.

【Keywords】 gouty;Fufang Tufuling Keli（复方土茯苓颗粒）;phlegm stasis obstruction type;clinical efficacy

痛风是由于嘌呤代谢紊乱和（或）尿酸排泄减少导致持续高尿酸血症引起机体损伤的一组疾病。随着人们生活水平的提高，痛风患病率逐年升高，严重危害人们的健康。我国高尿酸血症总体患病率为13.3%，痛风患病率为1.1%[1]。苯溴马隆通过促进尿酸排泄降低血尿酸水平，为临床治疗痛风一线用药，但患者长期服用有可能出现肝损害等不良反应，应用受到一定限制。

复方土茯苓颗粒为孙维峰经验方，获得国家发明专利（专利号ZL2007100323.3）。该药以利湿泄浊、化痰祛瘀为治则，临床治疗高尿酸血症具有较好的疗效。本研究拟……