|
|||||
|
|
| 丁桂油软胶囊治疗肠易激综合征寒凝气滞证的随机双盲安慰剂对照多中心临床研究 | |
| 引用本文： | 张瑞明,王蕾,杨晓楠,夏庆,蒋明德,范宗江,张方信,张海蓉,玉珍,李廷谦. 丁桂油软胶囊治疗肠易激综合征寒凝气滞证的随机双盲安慰剂对照多中心临床研究[J]. 中西医结合学报, 2007, 5(4): 392-397 |
| 作者姓名： | 张瑞明 王蕾 杨晓楠 夏庆 蒋明德 范宗江 张方信 张海蓉 玉珍 李廷谦 |
| 作者单位： | 1. 四川大学华西医院中西医结合科,四川,成都,610041 2. 成都军区总医院消化科,四川,成都,610083 3. 成都军区昆明总医院消化科,云南,昆明,650032 4. 兰州军区总医院消化科,甘肃,兰州,730050 5. 昆明医学院附属第一医院消化科,云南,昆明,650031 |
| 摘 要： | 目的:评价丁桂油软胶囊治疗肠易激综合征(irritable bowel syndrome,IBS)的安全性及有效性。方法:采用随机双盲、安慰剂平行对照临床试验方法,共纳入198例IBS患者,随机分为低剂量组、高剂量组和安慰剂组,每组66例,疗程均为2周。结果:3组患者治疗后临床症状显效率分别为高剂量组54.1%,低剂量组28.8%,安慰剂组21.9%(P<0.05)。中医证候愈显率分别为高剂量组54.1%,低剂量组25.8%,安慰剂组23.4%(P<0.05)。丁桂油软胶囊缓解腹痛的效果优于安慰剂,差异有统计学意义(P<0.05)。研究过程中未发现明显不良反应。结论:丁桂油软胶囊可有效缓解IBS寒凝气滞证腹痛,作用安全。 |
| 关 键 词： | 软胶囊 随机对照试验 双盲法 安慰剂 多中心研究 结肠疾病 功能性 |
| 文章编号： | 1672-1977（2007）04-0392-06 |
Dinggui Oil Capsule in treating irritable bowel syndrome with stagnation of qi and cold: a prospective, multi-center, randomized, placebo-controlled, double-blind trial |
|
| Rui-ming ZHANG,Lei WANG,Xiao-nan YANG,Qing XIA,Ming-de JIANG,Zong-jiang FAN,Fang-xing ZHANG,Hai-rong ZHANG,Zheng YU,Ting-qian LI. Dinggui Oil Capsule in treating irritable bowel syndrome with stagnation of qi and cold: a prospective, multi-center, randomized, placebo-controlled, double-blind trial[J]. Journal of Chinese integrative medicine, 2007, 5(4): 392-397 | |
| Authors: | Rui-ming ZHANG Lei WANG Xiao-nan YANG Qing XIA Ming-de JIANG Zong-jiang FAN Fang-xing ZHANG Hai-rong ZHANG Zheng YU Ting-qian LI |
| Affiliation: | 1. Department of Integrated Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China;2. Department of Gastroenterology, General Hospital of Chengdu Military Region, Chengdu, Sichuan Province 610083, China;3. Department of Gastroenterology, Kunming General Hospital of Chengdu Military Region, Kunming, Yunnan Province 650032, China;4. Department of Gastroenterology, General Hospital of Lanzhou Military Region, Lanzhou, Gansu Province 730050, China;5. Department of Gastroenterology, First Affiliated Hospital, Kunming College of Medicine, Kunming, Yunnan Province 650031, China |
| Abstract: | Objective: To evaluate the efficacy and safety of Dinggui Oil Capsule in treating irritable bowel syndrome (IBS) with stagnation of qi and cold. Methods: A prospective, randomized, placebo-controlled, double-blind clinical study was undertaken. One hundred and ninty-eight patients with IBS and syndrome of stagnation of qi and cold were randomly divided into high-dose Dinggui Oil group (DGO-H, 1.2 g, 3 times daily; n=66), low-dose Dinggui Oil group (DGO-L, 0.8 g, 3 times daily, n=66), and placebo group (placebo, 5.0 g, 3 times daily, n=66). Patients in the three groups were all treated for 2 weeks. Results: The total significant effective rates for IBS were 54.1%, 28.8% and 21.9% in the DGO-H, DGO-L, and placebo groups, and the total effective rates for the syndrome of stagnation of qi and cold were 54.1%, 25.8% and 23.4% in the three groups, respectively. Dinggui Oil Capsule showed a higher efficacy than the placebo in relieving the abdominal pain (P<0.01). No adverse effects were found in this trial.Conclusion: Dinggui Oil Capsule is effective and safe in relieving abdominal pain due to IBS with stagnation of qi and cold. |
| Keywords: | soft capsules randomized controlled trials double-blinded method placebos multi-centre studies colonic diseases functional |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |