中国中西医结合杂志2025，Vol.45Issue(9)：1059-1064,6.DOI:10.7661/j.cjim.20250303.112
五妙丸联合秋水仙碱治疗急性痛风关节炎患者(湿热蕴结证)随机对照试验
Wumiao Pill Combined with Colchicine for Treatment of Acute Gouty Arthritis Patients with Damp-Heat Accumulation Syndrome:A Randomized Controlled Trial
摘要
Abstract
Objective To evaluate the clinical efficacy and safety of Wumiao Pill combined with colchicine for treating acute gouty arthritis patients with damp-heat accumulation syndrome.Methods Of the 102 acute gouty arthritis patients at the outpatient clinic and wards of Guanghua Hospital affiliated to Shanghai University of Traditional Chinese Medicine from May 2023 to August 2024,100 patients met the inclusion criteria and were randomly assigned to the experimental group(50 cases)and the control group(50 cases)on a 1∶1 basis using SPSS 27.0 software.Patients in the experimental group took Wumiao Pill decoction combined with colchicine tablets,while those in the control group took colchicine tablets.Seven days consisted of one course,and patients in the two groups were treated for a total of one course.The joint pain score[VAS(0-100mm)]was observed,and blood sedimentation rate(ESR),hypersensitive C-reactive protein(hs-CRP),blood white blood cell count(WBC),and blood uric acid(SUA)levels were measured.The CM pattern score and the efficacy of Chinese Medicine(CM)syndrome were compared,and the adverse reactions were recorded.Results A total of 93 cases were finally observed,including 46 cases in the experimental group[4 cases dropped out(2 cases lost to follow-up,1 case with missing data,and 1 case with discontinuation of medication due to aggravated symptoms)],and 47 cases in the control group[3 cases dropped out(2 case lost to follow-up and 1 case with missing data)].Compared with before treatment in the same group,the VAS of both groups decreased significantly(P＜0.01).The ESR,hs-CRP,blood WBC and CM syndrome score in the experimental group significantly decreased,and the reductions were better than those in the control group(P＜0.05).The CM syndrome efficacy in experimental group was better than the control group(x2=4.287,P＜0.05).After treatment,the hs-CRP and CM syndrome scores in the control group also decreased compared with those before treatment(P＜0.05).The reduction in SUA was similar in both groups.The incidence of adverse reactions during the treatment period was 31.9％.Conclusion The anti-inflammatory effect of Wumiao Pill combined with colchicine in the treatment of acute gouty arthritis patients with damp-heat accumulation syndrome was better than that of using colchicine alone,and the safety was good.关键词
五妙丸/急性痛风关节炎/湿热蕴结证/秋水仙碱/中药复方/中西医结合/随机对照试验Key words
Wumiao Pill/acute gouty arthritis/damp-heat accumulation syndrome/colchicine/Chinese herbal compound/integrative medicine/randomized controlled trial引用本文复制引用
高维琴,何东仪,龚学忠,杨晓凌,刘佳,张冬钰,郭梦如,沈逸,郑新春,汪荣盛..五妙丸联合秋水仙碱治疗急性痛风关节炎患者(湿热蕴结证)随机对照试验[J].中国中西医结合杂志,2025,45(9):1059-1064,6.基金项目
2023年度长宁区卫生健康委员会科研项目(No.20234Z007) （No.20234Z007）
上海市卫生健康委员会科研项目-青年(No.20224Y0330) （No.20224Y0330）
