穿虎痛风合剂治疗急性痛风性关节炎的临床研究  

A CLINICAL STUDY OF CHUANHU ANTI-GOUT MIXTURE IN THE TREATMENT OF ACUTE GOUTY ARTHRITIS

作　　者：李杨[1] 余宵龙[1] 李恩泽[1] 王颜刚[1] 

机构地区：[1]青岛大学医学院附属医院内分泌科,山东青岛266003

出　　处：《青岛大学医学院学报》2013年第3期260-262,共3页Acta Academiae Medicinae Qingdao Universitatis

摘　　要：目的评价穿虎痛风合剂治疗急性痛风性关节炎的临床效果和安全性。方法采用随机、双盲双模拟、阳性药物平行对照、非劣效试验设计方法,选择2011年9月—2012年9月就诊于我院内分泌科及痛风病门诊,病程在48h以内且新诊断的急性痛风性关节炎病人112例,以1∶1随机分入穿虎痛风合剂组及秋水仙碱组。在应用小苏打碱化尿液治疗的基础上,穿虎痛风合剂组给予中药水煎剂和秋水仙碱模拟片,秋水仙碱组给予秋水仙碱及穿虎痛风合剂模拟剂。观察两组病人治疗前后的关节疼痛、肿胀、活动受限积分,并计算两组病人的总有效率及不良反应发生率。结果穿虎痛风合剂组和秋水仙碱组总有效率分别为94.64%和87.50%,差值95%CI下限值为-1.09%,大于预设的非劣性界值-15%,非劣性检验合格。但不良反应发生率秋水仙碱组明显高于穿虎痛风合剂组(χ2=19.72,P<0.01)。结论穿虎痛风合剂治疗急性痛风性关节炎的临床效果不劣于秋水仙碱,且安全性高。Objective To assess the efficacy and safety of ChuanHu gout mixture in the treatment of acute gouty arthri- tis （AGA）. Methods From September 2011 to September 2012, 112 cases with AGA were selected for a randomized, double- blind, double-dummy, parallel-controlled clinical trial. They were evenly randomized to Chuanhu anti-gout mixture （mixture group） and colehicine group. All the patients were given bicarbonate to alkaiify the urine. For patients in mixture group, ChuanHu mixture and colchicinc mock were offered; those in the eolchicine group received colchicine and ChuanHu mixture mock. Joint pain, swelling and limitation of motion were observed before and after treatment, the total effective rate and adverse reactions calculated. Results The total effective rate was 94.64% for mixture group and 87.50% for eolchicine group, the lower limit was --1.09% （95 % confidence interval）. Non-inferiority result with the criterion of 15 % showed statistically significant. The rate of adverse re- actions was higher in colchicine group than mixture group （X2=19.72,P〈0.01）. Conclusion It is safe to use ChuanHu anti- gout mixture in the treatment of AGA, its clinical efficacy is not lower than that of colchicine.

关 键 词：中草药 关节炎 痛风性 治疗结果 

分 类 号：R259[医药卫生—中西医结合]