Objective To observe the efficacy,adverse effects and the influence on the deprssion and anxiety scoring of combined venlafaxine sustained release table and pinaverium for treating patients with dominant-diarrhea irritable bowel syndrome (IBS-D).Methods With randomized,parallel control,multi-center and opening study method,403 IBS-D patients met the criteria were divided into combined venlafaxine and pinaverium study group and pinaverium alone control group.The symptoms of abdominal pain and diarrhea were scored.The efficacy was determined by the changes of symptom scores.The mood of the patients was scored with Hamilton depression scale and Hamilton anxiety scale system.The side effects were observed and recorded.Independent t test was performed for quantitative data and chi-square test for qualitative data.Intention to treat principle (ITT) and perprotocol set (PP) were also analyzed.Results 93.88％ (353/376) of patients with IBS-D were combined with depression or anxiety.The abdominal pain and diarrhea symptom of patients in study group significantly improved after one week treatment and the depression and anxiety significantly improved after two weeks treatment.In PP analysis,the efficacy rate of abdominal treatment,the efficacy rate and total effective rates of diarrhea treatment of study group were 74.61％ (144/193),79.79％ (154/193) and 91.19％ (176/193),all of which were higher than those of control group (45.36％ (83/183),57.92％ (106/183) and 68.85％ (126/183)).The differences were statistically significant (x2 =33.606,21.059 and 29.655,all P＜0.01).In ITT analysis,the efficacy rate of abdominal treatment,the efficacy rate and total effective rates of diarrhea treatment of study group were 69.57％ (144/207),74.40％ (154/207) and 85.02％ (176/207),all of which were higher than those of control group (42.35％ (83/196),54.08％ (106/196) and 64.29％ (126/196)).The differences were statistically significant (x2 =30.319,18.148,23.054,all P＜0.01).The side effect rate of study group (10.36％ (20/193)) was higher than that of control group (1.09％ (2/183)),the difference was statistically significant (x2 =14.652,P ＜ 0.01).Conclusions The depression,anxiety and main symptoms of patients with IBS-D were significantly improved by combined venlafaxine sustained release table and pinaverium treatment; however the rate of adverse effects was high.%目的 观察文拉法辛缓释片与匹维溴铵联用治疗腹泻型肠易激综合征(IBS-D)的疗效、不良反应和对抑郁焦虑评分的影响.方法 采用随机、开放、平行对照、多中心研究方法,将403例符合入选标准的IBS-D患者分为联用文拉法辛和匹维溴铵的试验组及单用匹维溴铵的对照组.对患者的腹痛和腹泻症状进行评分,根据症状积分变化判定疗效.应用汉密尔顿抑郁量表和汉密尔顿焦虑量表对患者情绪进行评分.观察和记录患者的不良反应.定量资料行独立t检验,定性资料行卡方检验,并行意向性治疗原则(ITT)和符合方案集(PP)分析.结果 93.88％(353/376)的IBS-D患者伴抑郁或焦虑状态.试验组患者治疗后1周腹痛和腹泻症状获明显改善,治疗后2周抑郁焦虑状态获明显改善.在PP分析中,试验组的腹痛治疗有效率、腹泻治疗有效率、总有效率[分别为74.61％(144/193)、79.79％(154/193)、91.19％(176/193)]均高于对照组[45.36％(83/183)、57.92％(106/183)、68.85％(126/183)],差异均有统计学意义(x2=33.606、21.059、29.655,P均＜0.01).在ITT分析中,试验组的腹痛治疗有效率、腹泻治疗有效率、总有效率[分别为69.57％(144/207)、74.40％(154/207)、85.02％ (176/207)]均高于对照组[42.35％ (83/196)、54.08％(106/196)、64.29％(126/196)],差异均有统计学意义(x2=30.319、18.148、23.054,P均＜0.01).试验组的不良反应发生率[10.36％(20/193)]高于对照组[1.09％(2/183)],差异有统计学意义(x2=14.652,P＜0.01).结论 文拉法辛缓释片与匹维溴铵联用治疗IBS-D可明显改善患者的抑郁焦虑状态和IBS的核心症状,但不良反应发生率较高.
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