萆薢分清丸联合别嘌醇治疗痛风患者高尿酸血症的临床疗效和安全性

目的 观察萆薢分清丸联合别嘌醇治疗痛风患者高尿酸血症的临床疗效和安全性。方法 纳入2016年11月至2017年9月在3个中心就诊的痛风患者72例，区组随机分为实验组和对照组，每组36例，总疗程12周。两组别嘌醇剂量：第1周100 mg/d，第2周起调整至200 mg/d并维持。试验组和对照组分别同步使用萆薢分清丸和安慰剂，一天2次，每次9 g。结果 治疗12周后，对照组和试验组分别有3例和10例患者血尿酸<6.0 mg/dL，试验组的达标率高于对照组。两组之间不良事件、重要不良事件、严重不良事件及不良反应发生率的差异均无统计学意义。结论 萆薢分清丸可提高别嘌醇降尿酸治疗的达标率，且安全性良好。

Clinical efficacy and safety of Bixie Fenqing Pills combined with allopurinol in the treatment of hyperuricemia in patients with gouty

Objective To observe the clinical efficacy and safety of Bixie Fenqing Pills combined with allopurinol in the treatment of hyperuricemia in patients with gout. Methods Seventy-two patients with gout were randomly divided into experimental group (n=36) and control group (n=36) for a total course of 12 weeks. The initialdose of allopurinol in both groups was 100 mg/day in the first week,and was adjusted to 200 mg/day from the second week.The experimental group and the control group took Bixie Fenqing Pills and placebo,simultaneously and respectively (9 g/time,twice a day). Results After 12 weeks of treatment,serum uric acid levels were <6.0 mg/dL in 3 and 10 patients in the control and experimental group,respectively.The standard-reaching rate of the experimental group was higher than that of the control group.There were no significant difference in adverse events,major adverse events,serious adverse events,and adverse reactions between the two groups. Conclusion Bixie Fenqing Pills improved the standard-reaching rate of allopurinol in uric acid lowering therapy and showed good safety.