纾肠方治疗肝郁脾虚证腹泻型肠易激综合征
多中心随机双盲安慰剂对照研究

思璎桀;温红珠;卞慧;卢璐;火龙;费晓燕;林江;何文姬;王勇军;章谙鸣;田芸;葛毅骏;魏智祥;黄烨;张伟;卢月婷;丁燕;程芳;苏海;王炜妮;马璐璐;江雯雯;盛颖辉;杨滢;崔龙泉.纾肠方治疗肝郁脾虚证腹泻型肠易激综合征多中心随机双盲安慰剂对照研究[J].中国中西医结合杂志,2023,43(11):1304-1313

纾肠方治疗肝郁脾虚证腹泻型肠易激综合征多中心随机双盲安慰剂对照研究

Shuchang Decoction for Treatment of Diarrhea Predominant Irritable Bowel Syndrome with Gan Depression and Pi Deficiency： A Multicenter， Randomized， Double-Blind， Placebo Controlled Trial

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DOI：10.7661/j.cjim.20230726. 052

中文关键词: 纾肠方疏肝饮腹泻型肠易激综合征肝郁脾虚型临床研究

英文关键词:Shuchang Decoction Shugan Decoction diarrhea-predominant irritable bowel syndrome Gan depression and Pi deficiency sydrome clinical study

基金项目:上海市中医专科（专病）联盟建设项目 [No.ZY（2018-2020）-FWTX-4018]

作者

单位

思璎桀;温红珠;卞慧;卢璐;火龙;费晓燕;林江;何文姬;王勇军;章谙鸣;田芸;葛毅骏;魏智祥;黄烨;张伟;卢月婷;丁燕;程芳;苏海;王炜妮;马璐璐;江雯雯;盛颖辉;杨滢;崔龙泉

1.上海中医药大学附属龙华医院脾胃病科（上海 200032）,2.上海普陀区人民医院中医科（上海 200060）,3.上海市杨浦区中医医院脾胃病科（上海 200090）,4.上海普陀区中医医院中医内科（上海 200063）,5.上海长宁区天山中医院中医内科（上海 200051）,6.上海普陀区长征镇社区卫生服务中心中医科（上海 200333）,7.上海普陀区长风街道白玉社区卫生服务中心中医科（上海 200063）,8.上海普陀区桃浦镇社区卫生服务中心中医科（上海 200331）,9.上海杨浦区延吉社区卫生服务中心中医科（上海 200093）,10.上海浦东新区上钢社区卫生服务中心中医科（上海 200120）,11.上海浦东新区金杨社区卫生服务中心中医科（上海 200136）,12.上海徐汇区漕河泾街道社区卫生服务中心中医科（上海 200235）

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中文摘要:

目的观察纾肠方治疗肝郁脾虚证腹泻型肠易激综合征（IBS-D）的临床疗效和安全性。方法采用多中心、随机、双盲、安慰剂平行对照、优效性检验临床试验设计，收集12家上海市脾胃病专科联盟加盟单位就诊的IBS-D患者179例，最终入组受试者120例，采用中心分层区组化随机方法分为试验组（42例，给予纾肠方）、对照组（43例，给予疏肝饮）和安慰剂组（35例，给予十分之一剂量药物）。3组同时给予低可发酵的低聚糖、二糖、单糖和多元醇（FODMAP）饮食指导。治疗周期为8周。采用符合方案集（PPS）为主要数据集进行疗效评价，依据意向性分析原则进行安全性分析。主要疗效评价指标为肠道严重程度评分（IBS-SSS）及中医证候评分；次要疗效指标为腹痛/腹部不适视觉模拟（VAS）评分、腹泻评分、临床症状痊愈率和肠易激综合征生活质量量表（IBS-QOL）。结果 PPS集纳入110例，其中试验组39例，对照组39例，安慰剂组32例。与本组治疗前比较，试验组与对照组治疗14~56天时IBS-SSS评分均降低（P＜0.05），56天时多梦易醒、急躁易怒、善思多虑症状评分及脾虚次症均降低（P＜0.05），治疗后IBS-QOL评分亦降低（P＜0.05）。与安慰剂组比较，试验组与对照组IBS-SSS、腹痛、腹泻总有效率及临床痊愈率升高，中医证候总有效率及显效率亦升高（P＜0.05），试验组中医证候痊愈率及临床痊愈率升高（P＜0.05）；试验组与对照组治疗后IBS-SSS评分、多梦易醒、急躁易怒、善思多虑、食欲不振、精神疲乏、四肢无力次症评分及IBS-QOL评分均降低（P＜0.05）。与对照组比较，试验组IBS-SSS总有效率、痊愈率，中医证候评分显效率，腹痛痊愈率，腹泻痊愈率和总有效率，临床症状痊愈率均升高（P＜0.05）；试验组治疗42~56天时IBS-SSS评分、56天时善思多虑、精神疲乏、四肢无力评分均降低（P＜0.05）。治疗前后未发现试验组安全性指标异常。结论纾肠方可改善肝郁脾虚证IBS-D患者腹痛腹泻症状和中医证候，疗效优于疏肝饮，短期应用安全性好。

英文摘要:

Objective To observe the clinical efficacy and safety of Shuchang Decoction（SCD） in the treatment of diarrhea-predominant irritable bowel syndrome（IBS-D）with Gan depression and Pi deficiency syndrome. Methods This was a multicenter， randomized， double-blind， placebo-controlled， superiority testing clinical trial. A total of 179 patients with IBS-D were recruited from 12 hospitals of Shanghai TCM Gastroenterology Federation. Finally 120 patients who met the inclusion criteria were randomly assigned to the test group（42 cases）， the control group（43 cases）， and the placebo group （35 cases）. Patients in the test group took SCD， patients in the control group took Shugan Decoction（SGD）， while those in the placebo group took 1/10 dose of SCD. The treatment period was 8 weeks. All subjects accepted low-FODMAP food instruction. The efficacy was evaluated with Per Protocol set（PPS）and the safety evaluation was analyzed according to the principle of intention-to-treat analysis. The main efficacy indexes were irritable bowel syndrome intestinal severity score （IBS-SSS）and Chinese medicine（CM）symptom score. The secondary efficacy indexes were abdominal pain/discomfort Visual Analogue Scale（VAS）score， diarrhea score， clinical cure rate and IBS-QOL. Results Totally 110 patients were included in PPS set， 39 cases in the test group， 39 cases in the control group， and 32 cases in the placebo group. Compared with the baseline， IBS-SSS scores of the test group and the control group decreased at 14-56 days（P＜0.05），and CM symptom scores of dreaminess， irritability， anxiety and all CM symptom scores of Pi deficiency decreased at 56 days（P＜0.05），IBS-QOL scores of the test group and the control group decreased after the treatment（P＜0.05）.Compared with the placebo group，IBS-SSS total effective rate， the cure rate and the total effective rate of abdominal pain and diarrhea， CM symptom total effective rate and the remarkable effective rate increased in the test and the control group（P＜0.05）， CM symptom cure rate and clinical cure rate increased in the test group（P＜0.05）. Compared with the placebo group，IBS-SSS score， dreaminess score， irritability score， anxiety score， poor appetite score， fatigue score， limb weakness score and IBS-QOL score decreased in both groups after treatment（P＜0.05）. Compared with the control group， IBS-SSS total effective rate and the cure rate， CM symptom remarkable effective rate， abdominal pain cure rate， diarrhea cure rate and total effective rate， as well as clinical cure rate increased in the test group（P＜0.05）. Compared with the control group，IBS-SSS score decreased at 42-56 days， the scores of anxiety， fatigue and limb weakness score decreased at 56 days after treatment in the test group（P＜0.05）.There were no abnormal safety indexes in the test group. Conclusions SCD can relieved the symptoms of abdominal pain， diarrhea and CM syndrome in IBS-D patients with Gan depression and Pi deficiency syndrome. Short-term application is safe.

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