虎地肠溶胶囊联合美沙拉秦肠溶片治疗活动期溃疡性结肠炎多中心、随机对照、双盲双模拟的临床研究  

Hudi Enteric-coated Capsule Combined with Mesalazine Enteric-coated Tablet for Active Ulcerative Colitis:a Multi-centre,Randomized, Double-blinded and Double-simulated Clinical Study

作　　者：沈洪[1] 朱磊[1] 胡乃中[2] 孙宏普 王韶峰 孟宪梅[5] 冯培民[6] 张素云[7] 任顺平[8] 吴洁琼[9] 胡阳黔 赵百岁[11] 陈文习[12] 张苏闽[13] 王敏[14] 田耀洲[15] 肖建国[16] 王琦[17] 杨小军[18] SHEN Hong;ZHU Lei;HU Nai-zhong;SUN Hong-pu;WANG Shao-feng;MENG Xian-mei;FENG Pei-min;ZHANG Su-yun;REN Shun-ping;WU Jie-qiong;HU Yang-qian;ZHAO Bai-sui;CHEN Wen-xi;ZHANG Su-min;WANG Min;TIAN Yao-zhou;XIAO Jian-guo;WANG Qi;YANG Xiao-Jun(Department of Gastroenterology,Jiangsu Provincial Hospital of Chinese Medicine,Nanjing,210000;Department of Gastroenterology,First Hospital of Anhui Medical University,Hefei,230000;Department of Anorectal Surgery,Luoyang Second People's Hospital,Henan,471000;Department of Gastroenterology,Shanxi Province Changzhi People's Hospital,Shanxi,046000;Department of Gastroenterology,Second Affiliated Hospital,Baotou Medical College,Inner Mongolia,014000;Department of Gastroenterology,Affiliated Hospital,Chengdu University of Traditional Chinese Medicine,Chengdu,610000;Department of Anorectal Surgery,Chifeng Municipal Hospital,Inner Mongolia,024000;Department of Gastroenterology,Affiliated Hospital of Shanxi college of TCM,Taiyuan,030009;Department of Integrative Medicine,Second Affiliated Hospital of Shaanxi University of Chinese Medicine,Shaanxi,712000;Department of Gastroenterology,Dongfeng Motor Corporation General Hospital,Hubei,442000;Department of Gastroenterology,Affiliated Hospital of Inner Mongolia University for the Nationalities,Inner Mongolia,028000;Department of Gastroenterology,Ezhou Central Hospital,Hubei,436000;Department of Anorectal Surgery,Nanjing Hospital of Traditional Chinese Medicine,Nanjing,210000;Department of Gastroenterology,Second People's Hospital of Yunnan Province,Kunming,650000;Department of Gastroenterology,Jiangsu Provincial Hospital of Integration of Chinese and Western Medicine,Nanjing,210000;Department of Gastroenterology,Taizhou Hospital of Traditional Chinese Medicine,Jiangsu,225300;Department of Gastroenterology,Second Hospital of Shanxi Medical University,Taiyuan,030000;Department of Gastroenterology,Chongqing Municipal Hospital of Traditional Chinese Medicine,Chongqing,400000)

机构地区：[1]江苏省中医院消化科,南京210000 [2]安徽医科大学第一附属医院消化科,合肥230000 [3]洛阳市第二人民医院肛肠科,河南471000 [4]山西省长治市人民医院消化科,山西046000 [5]包头医学院第二附属医院消化科,内蒙古014000 [6]成都中医药大学附属医院消化科,成都610000 [7]赤峰市医院肛肠科,内蒙古024000 [8]山西中医学院附属医院消化科,太原030009 [9]陕西中医药大学第二附属医院中西医结合科,陕西712000 [10]湖北省医学院附属东风医院消化科,湖北442000 [11]内蒙古民族大学附属医院消化科,内蒙古028000 [12]鄂州市中心医院消化科,湖北436000 [13]南京市中医院肛肠科,南京210000 [14]云南省第二人民医院消化科,昆明650000 [15]江苏省中西医结合医院消化科,南京210000 [16]泰州市中医院消化科,江苏225300 [17]山西医科大学第二医院消化科,太原030000 [18]重庆市中医院消化科,重庆400000

出　　处：《中国中西医结合杂志》2019年第11期1326-1331,共6页Chinese Journal of Integrated Traditional and Western Medicine

摘　　要：目的评价虎地肠溶胶囊联合美沙拉秦肠溶片对轻、中度活动期溃疡性结肠炎的临床疗效。方法按照区组随机、双盲双模拟对照临床试验研究设计,将18个临床中心的355例溃疡性结肠炎患者随机分为试验组(118例)、阳性对照组(118例)、联合用药组(119例),试验组予以虎地肠溶胶囊口服,阳性对照组口服美沙拉嗪肠溶片口服,联合用药组予以虎地肠溶胶囊+美沙拉秦肠溶片口服,疗程6周。记录治疗前及治疗后2、4和6周的症状积分,比较两组患者症状积分变化及临床疗效。结果355例患者中,符合方案有效病例318例,试验组101例,阳性对照组104例,联合用药组113例。治疗结束时,试验组中医证候疗效为91.09%(92/101),阳性对照组为84.62%(88/104),联合用药组为95.58%(108/113),联合用药组优于阳性药对照组(P<0.05);用药6周后,试验组和联合用药组在改善脓血便方面优于阳性药对照组(P<0.05);联合用药组对于里急后重、肛门灼热、小便短赤的改善优于阳性药对照组(P<0.05)。结论虎地肠溶胶囊能够对轻、中度活动期溃疡性结肠炎患者的症状有改善作用,和美沙拉嗪联用效果更佳。Objective To evaluate the clinical efficacy of Hudi Enteric-coated Capsule(HEC)combined with Mesalazine Enteric-coated Tablet(MET)on mild to moderate active ulcerative colitis(UC).Methods According to randomized,double-blinded,double-dummy,controlled clinical trial design,355 UC patients in 18 clinical centers were randomly assigned to the experimental group(118 cases),the positive control group(118 cases),and the combination group(119 cases).Patients in the experimental group took HEC.Patients in the positive control group took MET.Patients in the combination group took HEC and HEC.The treatment course for all was 6 weeks.The symptom scores were recorded before treatment,and 2,4,and 6 weeks after treatment.Changes in symptom scores were compared between the two groups,and the clinical efficacy was evaluated.Results Of the 355 patients,318 were eligible for the trial,101 in the experimental group,104 in the positive control group,and 113 in the combination group.At the end of treatment,the TCM syndrome efficacy was 91.09%(92/101)in the experimental group,84.62%(88/104)in the positive control group,and 95.58%(108/113)in the combination group.The combination group was superior to the positive control group(P<0.05).After 6 weeks of treatment,the experiment group and the combination group were superior to the positive control group in improving pus and bloody stools(P<0.05).The combination group was better than the positive control group in improving urgency,anal burning and short urine(P<0.05).Conclusion HEC improved symptoms of patients with mild to moderate active UC,and the effect of combination with mesalazine was better.

关 键 词：溃疡性结肠炎 随机对照 双盲双模拟 虎地肠溶胶囊 

分 类 号：R[医药卫生]