【摘要】 背景:肠易激综合征(IBS)发病机制未明,治疗上主要针对其病理生理特点,罗马Ⅲ理论认为复方制剂的疗效优于单方制剂。目的:观察复方枸橼酸阿尔维林治疗腹泻型IBS的疗效、费用和不良反应。方法:82例腹泻型IBS患者随机分入研究组和对照组,分别口服复方枸橼酸阿尔维林胶囊和匹维溴铵片8周。以分级记分法描述症状,参照症状积分的变化评价疗效,计算费用-效益比(C/E),观察药物不良反应。结果:两组治疗前各症状积分和总积分均无明显差异。治疗第8周末,研究组各症状积分和总积分均较治疗前显著下降,而对照组仅腹痛、腹泻积分和总积分显著下降(P<0.01);研究组治疗后腹胀、直肠肛门不适感积分和总积分显著低于对照组(P<0.05)。研究组腹痛、腹泻症状的疗效与对照组无明显差异,腹胀、直肠肛门不适感症状的疗效和总疗效显著优于对照组(P<0.05),两组腹胀、直肠肛门不适感和总疗效的ITT/PP分析总有效率分别为73.2%/78.9%对29.3%/30.8%、68.3%/73.7%对41.5%/43.6%和80.5%/86.8%对58.5%/61.5%。对照组C/E优于研究组(6.58对8.95),两组不良反应发生率无明显差异(10.5%对7.7%)。结论:复方枸橼酸阿尔维林治疗以腹胀、直肠肛门不适感为主要表现的腹泻型IBS,总有效率高且不良反应发生率低。更多还原

【Abstract】 Background:The pathogenesis of irritable bowel syndrome(IBS) is not clear yet,therefore therapies are mainly targeting the pathophysiologic characteristics of IBS.The efficacy of medicinal compound is better than a single preparation according to the theories of RomeⅢ.Aims:To investigate the effect,cost and adverse reactions of compound alverine citrate in treating patients with diarrhea-predominant IBS(IBS-D).Methods:Eighty-two patients with IBS-D were randomized to study group and control group,receiving compound alverine citrate capsule and pinaverium bromide tablet for 8 weeks,respectively.Symptoms were described by grading score,and the efficacy was assessed according to the changes of symptom score.The cost and effect(C/E) ratio was analyzed,and the adverse reactions were observed.Results:There were no significant differences in individual and total symptom scores prior to the treatment between study group and control group.At the end of treatment course,individual and total symptom scores of the study group were all decreased significantly compared with those prior to treatment,whereas in the control group,only abdominal pain score,diarrhea score and total score were significantly decreased(P<0.01).The distension score,rectal and anal uncomfortableness(RAUC) score and total score of the study group were markedly lower than those of the control group after treatment(P<0.05).There were no significant differences in efficacies on abdominal pain and diarrhea between study group and control group,while the efficacies on distension,RAUC and total symptoms of the study group were superior to those of the control group(P<0.05).The total effectiveness rates(ITT/PP analysis) on distension,RAUC and total symptoms of the two groups were 73.2%/78.9%vs.29.3%/30.8%,68.3%/73.7%vs.41.5%/43.6%,and 80.5%/86.8%vs. 58.5%/61.5%,respectively.The C/E ratio of control group was superior to that of study group(6.58 vs.8.95).No significant difference in adverse reactions was found between the two groups(10.5%vs.7.7%).Conclusions:Compound alverine citrate is effective in treating IBS-D patients characterized by abdominal distension and RAUC with low adverse reactions.更多还原