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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 standardreaching rate of allopurinol in uric acid lowering therapy and showed good safety. [ABSTRACT FROM AUTHOR]