虎贞清风胶囊治疗湿热蕴结证急性痛风性关节炎多中心随机双盲对照研究  

Huzhen Qingfeng Capsule for Treatment of Acute Gouty Arthritis: a Multicenter, Randomized, Double-blind, Controlled Trial

作　　者：刘宏潇[1] 姜泉[1] 黄清春[2] 王义军[3] 雷鹏[4] 张建新[5] 张永红[6] 金泽[7] 吴洋[8] 于世家[9] 王济华[10] 付滨[11] 许东云[12] 李小群 乌力吉巴特尔 陈平雁[15] 连凤梅[1] LIU Hong-xiao;JIANG Quan;HUANG Qing-chun;WANG Yi-jun;LEI Peng;ZHANG Jian-xin;ZHANG Yong-hong;JIN Ze;WU Yang;YU Shi-ja;WANG Ji-hua;FU Bin;XU Dong-yun;LI Xiao-qun;WU Lj-ba-te-er;CHEN Ping-yan;LIAN Feng-mei(Department of Rheumatology and Immunology,Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing,100053;Department of Rheumatology,Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou,510006;Department of Rheumatism,Wangjing Hospital,China Academy of Chinese Medical Sciences,Beijing,100102;Department of Traditional Chinese Medicine,Shaanxi Provincial People's Hospital,Xi'an,710068;Department of Orthopedics,Xiamen Hospital of Traditional Chinese Medicine,Fujian,361009;Department of Rheumatism,Luoyang Orthopedic Traumatological Hospital of Henan Province,Henan,471002;Department of Acupuncture,Second Affiliated Hospital,Heilongjiang University of Traditional Chinese Medicine,Harbin,150001;Department of Rheumatism,Yunnan Hospital of Traditional Chinese Medicine,Kunming,650021;Department of Endocrine,First Affiliated Hospital,Liaoning University of Traditional Chinese Medicine,Shenyang,110032;Department of Rheumatism,First Affiliated Hospital,Henan University of Traditional Chinese Medicine,Zhengzhou,450000;Department of Nephropathy and Rheumatology,Second Affiliated Hospital,Tianjin University of Traditional Chinese Medicine,Tianjin,300150;Department of Traditional Chinese Medicine,First Affiliated Hospital,Kunming Medical University,Kunming,650032;Department of Orthopedics,The Affiliated Hospital of Shaanxi University of Chinese Medicine,Shaanxi,712000;Department of Rheumatism and Immunology,Affiliated Hospital of Inner Mongolia University for the Nationalities,Huhehaote,028007;Department of Biostatistics,Southern Medical University,Guangzhou,510515)

机构地区：[1]中国中医科学院广安门医院风湿病科,北京100053 [2]广东省中医院风湿科,广州510006 [3]中国中医科学院望京医院风湿病科,北京100102 [4]陕西省人民医院中医科,西安710068 [5]厦门市中医院骨科,福建361009 [6]河南省洛阳正骨医院风湿病科,河南471002 [7]黑龙江中医药大学附属第二医院针灸科,哈尔滨150001 [8]云南省中医医院风湿病科,昆明650021 [9]辽宁中医药大学附属医院内分泌科,沈阳110032 [10]河南中医药大学第一附属医院风湿病科,郑州450000 [11]天津中医药大学第二附属医院肾病风湿科,天津300150 [12]昆明医科大学第一附属医院中医科,昆明650032 [13]陕西中医药大学附属医院骨科,陕西712000 [14]内蒙古民族大学附属医院风湿免疫科,呼和浩特028007 [15]南方医科大学生物统计学系,广州510515

出　　处：《中国中西医结合杂志》2023年第3期274-280,共7页Chinese Journal of Integrated Traditional and Western Medicine

摘　　要：目的评价虎贞清风胶囊治疗湿热蕴结证急性痛风性关节炎的临床疗效和安全性。方法采用随机、双盲、安慰剂平行对照、多中心、优效性检验临床试验设计。由全国14家医院共收集480例中医辨证为湿热蕴结证急性痛风性关节炎患者,采用分层区组随机化方法,使用SAS软件按3:1随机分为治疗组(360例)和对照组(120例)。治疗组口服虎贞清风胶囊,对照组口服虎贞清风胶囊模拟剂,两组均每次4粒、每日3次给药,共治疗3天。在治疗第3天进行疼痛视觉模拟评分(VAS),观察治疗前后关节疼痛VAS评分、中医证候积分、各单项症状消失率、血沉(ESR)、C反应蛋白(CRP)、白细胞(WBC)计数及不良事件发生率。结果480例患者中438例纳入全分析集(FAS)进行疗效分析,其中治疗组325例,脱落35例(不良事件2例,失访29例,违背方案2例,缺乏疗效退出试验2例);对照组113例,脱落7例(失访2例,违背方案5例)。治疗组第3天疼痛VAS评分及差值下降程度均优于对照组,差异均有统计学意义(t=7.241,t=6.452,P<0.01)。治疗组中医证候总有效率91.4%(297/325),优于对照组[68.1%(77/113)],差异亦有统计学意义(χ2=7.184,P<0.01);治疗组治疗第3天中医证候评分及差值均少于对照组,差异均有统计学意义(t=7.126,t=6.417,P<0.01)。关节疼痛、关节肿胀、关节发热、关节肌肤颜色、活动不便、关节压痛、发热、口渴、烦躁不安9项症状消失率,除发热症状外,治疗组均高于对照组(P<0.01)。两组ESR、CRP、WBC计数比较,差异无统计学意义(P>0.05)。治疗期间不良事件发生率治疗组24.4%(87/357),对照组24.8%(30/121),差异无统计学意义(χ2=0.009,P>0.05)。结论虎贞清风胶囊可有效缓解急性痛风性关节炎(湿热蕴结证)关节疼痛,起效时间短,但安全性与安慰剂相当,临床应用较安全。Objective To evaluate the clinical efficacy and safety of Huzhen Qingfeng Capsule(HZQFC) in the treatment of acute gouty arthritis patients with damp-heat accumulation syndrome(DHAS).Methods A randomized, double-blind, placebo-controlled, multicenter, superiority testing clinical trial was performed. A total of 480 acute gouty arthritis patients with DHAS were collected from 14 hospitals across China.They were randomly assigned to the treatment group(360 cases) and the control group(120 cases) using SAS Software at 3 :1 by stratified block randomization. Patients in the treatment group took HZQFC, while those in the control group took HZQFC simulators. All patients took 4 capsules each time, 3 times a day, for a total of 3days. The visual analogue scale(VAS) of pain, TCM syndrome score, the disappearance rate of each symptom, erythrocyte sedimentation rate(ESR), C-reactive protein(CRP), blood routines(white blood cell count), and the incidence of adverse events were observed before and after treatment. Results Of 480 subjects, 438were included in the full analysis set(FAS) for efficacy analysis. There were 325 cases in the treatment group with 35 cases dropped off(including 2 cases with adverse events, 29 lost to follow-ups, 2 cases violating the protocols, and 2 cases withdrawn from the trial due to lack of efficacy). There were 113 cases in the control group with 7 cases dropped off(including 2 cases lost to follow-ups and 5 cases violating the protocols). The VAS score and difference of pain in the treatment group on the third day were better than those in the control group, and the differences were statistically significant(t =7.241, t =6.452, P<0.01). The total effective rate of TCM syndrome in the treatment group was 91.4%(297/325), better than that [68.1%(77/113)] in the control group with statistical difference(χ~2=7.184, P<0.01). The TCM syndrome scores and differences of the treatment group on the third day were better than those of the control group, and the differences were statistically significant(

关 键 词：虎贞清风胶囊 急性痛风性关节炎 湿热蕴结证 有效性 安全性 

分 类 号：R259[医药卫生—中西医结合]