奥替溴铵和匹维溴铵治疗腹泻型肠易激综合征的疗效和安全性对比研究

发布时间：2017-12-27 04:02

本文关键词：奥替溴铵和匹维溴铵治疗腹泻型肠易激综合征的疗效和安全性对比研究　出处：《福建医科大学》2015年硕士论文　论文类型：学位论文

【摘要】：目的:评估奥替溴铵(OB)和匹维溴铵(PB)治疗腹泻型肠易激综合征(IBS-D)的临床疗效和安全性。方法:采用前瞻性、开放标签、单中心、随机平行对照、二阶段交叉设计的临床试验。将符合研究标准的IBS-D患者根据随机数字表法随机分为OB组和PB组。OB组为OB 40mg,3次/d,;PB组为PB 50mg,3次/d;此外2组都加用整肠生(0.5,3次/d)和谷参肠铵(2粒,3次/d)。第14天时,若症状总评分减少超过50%则继续用药2周,若未达标则切换成另一种药物(OB或PB)再治疗2周,总疗程为4周。治疗前、后分别评估消化道症状评分,并记录不良事件。首要结局指标是腹痛、次要结局指标是腹胀、腹泻和患者满意度。结果:1、纳入IBS-D 84例,男/女为38/46,平均年龄(41.15±10.54)岁,中位病程4年,其中OB组43例、PB组41例。第14天时,OB组的腹痛减分率是43.45±28.28、PB组是45.53±28.48,差异无统计学意义(P=0.757);2组的腹痛频率减少值也无统计学差异(1.68±1.25 vs 2.13±1.21,P=0.144)。第28天时,OB组和PB组的腹痛减分率(68.82±27.59 vs63.33±22.22,P=0.520)、腹痛频率减少值(2.41±1.48 vs 2.75±1.44,P=0.350)差异无统计学意义。2、第14天时,OB组和PB组的腹胀减分率(40.30±34.31 vs 33.53±25.12,P=0.478)、腹泻减分率(39.04±31.31 vs 43.93±30.54,P=0.471)之间差异无统计学意义。第28天时,两组的腹胀减分率(57.50±29.16 vs 50.00±27.84,P=0.596)、腹泻减分率(58.18±28.72 vs 70.95±22.34,P=0.112),两组间差异无统计学意义。第28天时,OB组和PB组的总疗效分别是70.00%、71.05%,差异无统计学意义(P0.05)。第14天无效者,切换用药后腹胀、腹痛、腹泻减分率和腹痛频率减少值均高于切换前(P0.05)。3、OB组和PB组的不良反应率是16.28%、14.63%;整体满意度是82.50%、84.21%,两组间差异无统计学意义(P0.05)。结论:短程使用奥替溴铵或匹维溴铵都有效缓解IBS-D患者的腹痛、腹胀、腹泻等症状,两者疗效基本一致,安全性好,都可以作为IBS-D症状发作时的“紧急”用药选择,并且可以切换使用。
[Abstract]:Objective: To evaluate the otilonium bromide (OB) and pinaverium bromide (PB) in treatment of diarrhea type irritable bowel syndrome (IBS-D) clinical efficacy and safety. Methods: the clinical trials of prospective, open label, single center, random parallel control and two stage cross design were used. The IBS-D patients were randomly divided into group OB and group PB according to the random digital table method. The OB group is OB 40mg, 3 /d, PB; group PB 50mg, 3 /d; in addition to the 2 group with Zhengchangsheng (0.5,3 /d) and entero ammonium (2 capsules, 3 times /d). At fourteenth days, if the total score of the symptoms was reduced by more than 50%, the drug was continued for 2 weeks. If the score was not reached, it was switched to another drug (OB or PB) for 2 weeks, and the total course was 4 weeks. The scores of digestive tract symptoms were evaluated before and after treatment, and adverse events were recorded. The primary outcome index is abdominal pain and secondary outcome indicators are abdominal distention, diarrhea, and patient satisfaction. Results: 1. 84 cases were included in IBS-D. The male / female was 38/46, the average age was (41.15 + 10.54) years, and the median course of disease was 4 years, of which 43 cases in group OB and 41 cases in group PB. On the fourteenth day, the abdominal pain reduction rate of group OB was 43.45 + 28.28, group PB was 45.53 + 28.48, the difference was not statistically significant (P=0.757), and there was no significant difference between the 2 groups in the frequency of abdominal pain reduction (1.68 + 1.25 vs 2.13, 1.21, P=0.144). On the twenty-eighth day, the abdominal pain reduction rate in group OB and group PB (68.82 + 27.59 vs63.33 + 22.22, P=0.520) and the frequency of abdominal pain reduction (2.41 + 1.48 vs 2.75 + 1.44, P=0.350) were not statistically significant. On days 2 and fourteenth, there was no significant difference in abdominal distension reduction rate between group OB and group PB (40.30 + 34.31 vs, 33.53 + 25.12, P=0.478) and diarrhea reduction rate (39.04 + 31.31 vs 43.93, 30.54, P=0.471). On the twenty-eighth day, the abdominal distension reduction rate of the two groups (57.50 + 29.16 vs, 50 + 27.84, P=0.596) and the diarrhea reduction rate (58.18 + 28.72 vs 70.95, 22.34, P=0.112) were not significantly different between the two groups. At twenty-eighth days, the total curative effect of group OB and PB group was 70% and 71.05% respectively, and the difference was not statistically significant (P0.05). After fourteenth days, the reduction rate of abdominal distention, abdominal pain, diarrhea and the frequency of abdominal pain were all higher than that before switching (P0.05). The adverse reaction rates of group 3, OB and PB were 16.28% and 14.63%, and the overall satisfaction was 82.50% and 84.21%, and there was no statistical difference between the two groups (P0.05). Conclusion: the short-term use of otilonium bromide or ammonium pinaverium bromide are effective to alleviate IBS-D patients with abdominal pain, abdominal distension, diarrhea and other symptoms, the two effects are basically the same, good safety, can be used as IBS-D symptoms at the onset of the "emergency" drug selection, and can be used to switch.
【学位授予单位】：福建医科大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R574

【共引文献】