机构地区：[1]Institute of Spleen-Stomach Diseases,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing(100091),China [2]Department of Gastroenterology,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing(100010),China [3]Department of Gastroenterology,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan(430022),China [4]Department of Traditional Chinese Medicine,Shengjing Hospital,China Medical University,Shenyang(110004),China [5]Department of Gastroenterology,Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu(610075),China [6]Department of Integrated Traditional Chinese and Western Medicine,West China Hospital of Sichuan University,Chengdu(610041),China [7]Department of Gastroenterology,the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin(300250),China [8]Department of Gastroenterology,the Second Affiliated Hospital of Shaanxi College of Traditional Chinese Medicine,Xianyang(712000),Shaanxi Province,China [9]Department of Gastroenterology,the Second Affiliated Hospital of Shandong Traditional Chinese Medicine University,Jinan(250001),China [10]Department of Gastroenterology,Chongqing Traditional Chinese Medicine Hospital,Chongqing(400021),China [11]Department of Gastroenterology,Harbin Traditional Chinese Medicine Hospital,Harbin(150076),China [12]Department of Gastroenterology,Yuncheng Central Hospital,Yuncheng(044031)Shanxi Province,China [13]Department of Gastroenterology,The First Hospital of Yichang,Yichang(443000),Hubei Province,China [14]Harbin Concise Pharmaceutical Technology Development Co.,Ltd.,Harbin(150001),China
出 处：《Chinese Journal of Integrative Medicine》2019年第12期887-894,共8页中国结合医学杂志（英文版）
摘 要：Objective: To evaluate the efficacy and safety of Tongxiening Granules(痛泻宁颗粒, TXNG) in the treatment of irritable bowel syndrome with predominant diarrhea(IBS-D). Methods: A randomized, double-blind, double-dummy, and positive paral el control ed clinical trial was conducted from October 2014 to March 2016. Total y 342 patients from 13 clinical centers were enrolled and randomly assigned(at the ratio of 1:1) to a treatment group(171 cases) and a control group(171 cases) by a random coding table. The patients in the treatment group were administered oral y with TXNG(5 g per time) combined with pinaverium bromide Tablet simulator(50 mg per time), 3 times per day. The patients in the control group were given TXNG simulator(5 g per time) combined with pinaverium bromide Tablets(50 mg per time), 3 times per day. The treatment course lasted for 6 weeks. The improvement of Irritable Bowel Syndrome Symptom Severity Score(IBS-SSS) was used to evaluate the primary outcome. Secondary outcomes included adequate relief(AR) rate, Irritable Bowel Syndrome-Quality of Life Questionnaire(IBS-QOL), Hamilton Anxiety Scale(HAMA), Hamilton Depression Scale(HAMD), and the recurrence rate at fol ow-ups. Safety indices including the adverse events(AEs) and related laboratory tests were evaluated. Results: Primary outcome: IBS-SSS at baseline, weeks 2, 4, 6 showed no statistical significance in both full analysis set(FAS) and per protocol set(PPS, P>0.05). After 6 weeks of treatment, the total effective rate of IBS-SSS scores in the treatment group(147/171, 86.0%) was higher than the control group(143/171, 83.6%) by FAS(P>0.05). In regard to secondary outcomes, after 6-week treatment, there was no significant difference in AR rate, total score of IBS-QOL, improvement of HAMD and HAMA total scores between the two groups(P>0.05). The recurrence rate at 8-week fol ow-up was 12.35%(10/18) in treatment group and 15.79%(12/76) in control group, respectivery(P>0.05). A total of 21 AEs occurred in 15 cases, of which 11 occurred in 8 casObjective: To evaluate the efficacy and safety of Tongxiening Granules(痛泻宁颗粒, TXNG) in the treatment of irritable bowel syndrome with predominant diarrhea(IBS-D). Methods: A randomized, double-blind, double-dummy, and positive paral el control ed clinical trial was conducted from October 2014 to March 2016. Total y 342 patients from 13 clinical centers were enrolled and randomly assigned(at the ratio of 1:1) to a treatment group(171 cases) and a control group(171 cases) by a random coding table. The patients in the treatment group were administered oral y with TXNG(5 g per time) combined with pinaverium bromide Tablet simulator(50 mg per time), 3 times per day. The patients in the control group were given TXNG simulator(5 g per time) combined with pinaverium bromide Tablets(50 mg per time), 3 times per day. The treatment course lasted for 6 weeks. The improvement of Irritable Bowel Syndrome Symptom Severity Score(IBS-SSS) was used to evaluate the primary outcome. Secondary outcomes included adequate relief(AR) rate, Irritable Bowel Syndrome-Quality of Life Questionnaire(IBS-QOL), Hamilton Anxiety Scale(HAMA), Hamilton Depression Scale(HAMD), and the recurrence rate at fol ow-ups. Safety indices including the adverse events(AEs) and related laboratory tests were evaluated. Results: Primary outcome: IBS-SSS at baseline, weeks 2, 4, 6 showed no statistical significance in both full analysis set(FAS) and per protocol set(PPS, P>0.05). After 6 weeks of treatment, the total effective rate of IBS-SSS scores in the treatment group(147/171, 86.0%) was higher than the control group(143/171, 83.6%) by FAS(P>0.05). In regard to secondary outcomes, after 6-week treatment, there was no significant difference in AR rate, total score of IBS-QOL, improvement of HAMD and HAMA total scores between the two groups(P>0.05). The recurrence rate at 8-week fol ow-up was 12.35%(10/18) in treatment group and 15.79%(12/76) in control group, respectivery(P>0.05). A total of 21 AEs occurred in 15 cases, of which 11 occurred in 8 cas
关 键 词：Tongxiening GRANULES IRRITABLE bowel syndrome with predominant diarrhea POST-MARKETING evaluation RANDOMIZED controlled TRIAL
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