米氮平联合选择性钙通道拮抗剂治疗肠易激综合征有效性与安全性的Meta分析

目的:系统评价米氮平联合选择性钙通道拮抗剂(SCCB)治疗肠易激综合征(IBS)的疗效和安全性,为临床用药提供循证参考。方法:计算机检索Cochrane图书馆、PubMed、Embase、Medline、中国知网数据库、维普数据库、万方数据库,收集米氮平联合SCCB(试验组)对比SCCB(对照组)治疗IBS的随机对照试验(RCT)。筛选文献、资料提取后采用Cochrane系统评价员手册5.1.0推荐的偏倚风险评估工具评价文献质量,采用Stata 14.0软件进行Meta分析。结果:共纳入14项RCT,共计1 005例患者。Meta分析结果显示,试验组患者总有效率RR=1.34,95%CI(1.25,1.44),P<0.001]、治疗后神经肽Y水平SMD=0.77,95%CI(0.49,1.05),P<0.001]、腹痛治疗有效率RR=1.32,95%CI(1.06,1.66),P=0.014]、大便性状异常治疗有效率RR=1.75,95%CI(1.36,2.27),P<0.001]均显著高于对照组,治疗后抑郁量表评分SMD=-1.87,95%CI(-2.35,-1.39),P<0.001]、治疗后焦虑量表评分SMD=-2.25,95%CI(-3.35,-1.15),P<0.001]、治疗后腹痛症状评分SMD=-7.41,95%CI(-8.30,-6.51),P<0.001]、治疗后腹泻症状评分SMD=-6.39,95%CI(-7.96,-4.81),P<0.001]均显著低于对照组;两组患者腹胀治疗有效率RR=1.07,95%CI(0.90,1.28),P=0.421]、排便异常治疗有效率RR=1.05,95%CI(0.88,1.26),P=0.588]、腹痛发生率RR=0.45,95%CI(0.11,1.97),P=0.291]、乏力发生率RR=5.00,95%CI(0.60,41.79),P=0.137]比较差异均无统计学意义。结论:米氮平联合SCCB能够显著提高IBS患者的疗效,改善其临床症状,且不增加腹痛、乏力等不良反应的发生。

Meta-analysis of Therapeutic Efficacy and Safety of Mirtazapine Combined with Selective Calcium Channel Blocker in the Treatment of Irritable Bowel Syndrome

OBJECTIVE:To systematically review therapeutic efficacy and safety of mirtazapine combined with selective calcium channel blocker(SCCB) in the treatment of irritable bowel syndrome(IBS),and provide evidence-based reference for clinical medication. METHODS:Retrieved from the Cochrane Library,PubMed,Embase,Medline,CNKI,VIP and Wanfang database,randomized controlled trials(RCTs)about mirtazapine combined with SCCB(trial group)versus SCCB(control group)for IBS were collected. After literature screening and data extraction,quality evaluation was performed by using Cochrane system evaluator manual 5.1.0 recommend bias risk evaluation tool. Meta-analysis was performed by using Stata 14.0 software. RESULTS:A total of 14 RCTs involving 1 005 patients were included. The results of Meta-analysis showed that the total response rate RR=1.34,95%CI(1.25,1.44),P<0.001],neuropeptide-Y level after treatment SMD=0.77,95%CI(0.49,1.05),P<0.001],response rate of abdominal pain therapy RR=1.32,95% CI(1.06,1.66),P=0.014] and response rate of treatment for abnormal stool characteristics RR=1.75,95%CI(1.36,2.27),P<0.001] were significantly higher than control group;the scores of depression scale after treatment SMD=-1.87,95%CI(-2.35,-1.39),P<0.001],anxiety scale after treatment SMD=-2.25,95%CI(-3.35,-1.15),P<0.001],abdominal pain symptom score after treatment SMD=-7.41,95% CI(-8.30,-6.51),P<0.001],diarrhea symptom score after treatment SMD=-6.39,95%CI(-7.96,-4.81),P<0.001] were significantly lower than those of the control group. There were no statistical significance in response rate of abdominal distension therapyRR=1.07,95%CI(0.90,1.28),P=0.421] and response rate of abnormal defecation therapy RR=1.05,95% CI(0.88,1.26),P=0.588],the incidence of abdominal pain RR=0.45,95%CI(0.11,1.97),P=0.291] and exhaustion RR=5.00,95% CI(0.60,41.79),P=0.137] between 2 groups. CONCLUSIONS:Mirtazapine combined with SCCB can significantly improve therapeutic efficacy of IBS patients,promote clinical symptoms,but do not increase the occurrence of ADR as abdominal pain and exhaustion.