Qin Lifeng, Qin Jinmei, Yang Qian, Lv Xiaoping, Huang Liyi
Department of Gastroenterology, First Affiliated Hospital of Guangxi Medical University.
Department of infectious diseases, First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Medicine (Baltimore). 2019 Jan;98(2):e14064. doi: 10.1097/MD.0000000000014064.
There are many trials on the combination of Pinaverium bromide (PB) and Flupentixol-melitracen (FM) in the treatment of diarrhea-type irritable bowel syndrome (IBS-D), but the sample sizes are small, and the research conclusions are inconsistent. Thus, a meta-analysis was performed, aiming to evaluate the efficacy and safety of this combination therapy in patients with IBS-D.
A systematic literature search was conducted in 7 databases covering the period up to July 2018 to identify randomized controlled trials (RCTs) of PB combined with FM versus PB alone for IBS-D. The primary outcome was the total symptom relief rate. The other outcomes were the adverse events rate, HAMA/SAS score, and HAMD/SDS score. The methodological quality of the RCTs was assessed independently using 6 criteria according to the Cochrane Collaboration. All data were analyzed using Review Manager 5.3.
Fifteen RCTs with 1487 participants were identified from 2005 to 2018. Compared with PB alone, 15 RCTs showed significant effects of PB plus FM in terms of improved symptom relief in patients with IBS-D (n = 1487, OR = 5.17, 95%CI, 3.79-7.07, P < .00001). Eleven RCTs reported adverse effects in both the PB plus FM and PB groups, there was no statistically significant difference in the adverse events rate between the 2 groups (n = 1207, OR = 2.91, 95%CI, 0.91-9.28, P = 0.07). Two RCTs and 3 RCTs reported HAMA and HAMD scores respectively, and 3 RCTs reported both SAS and SDS scores. After treatment, the above scores in the PB plus FM group were significantly lower than the PB group (all P < .01). However, the trials were deemed to have a medium risk of bias.
The efficacy of PB combined with FM is superior to PB alone in the treatment of IBS-D, and it is safe for clinical use. However, the conclusions still need to be verified by conducting more large-scale and high-quality RCTs.
有许多关于匹维溴铵（PB）与氟哌噻吨美利曲辛（FM）联合治疗腹泻型肠易激综合征（IBS-D）的试验，但样本量较小，研究结论不一致。因此，进行了一项荟萃分析，旨在评估这种联合治疗对IBS-D患者的疗效和安全性。
在截至2018年7月的7个数据库中进行系统的文献检索，以确定PB联合FM与单用PB治疗IBS-D的随机对照试验（RCT）。主要结局是总症状缓解率。其他结局是不良事件发生率、汉密尔顿焦虑量表（HAMA）/汉密尔顿抑郁量表（HAMD）评分以及状态焦虑量表（SAS）/抑郁自评量表（SDS）评分。根据Cochrane协作网的6条标准独立评估RCT的方法学质量。所有数据均使用Review Manager 5.3进行分析。
从2005年至2018年共纳入15项RCT，涉及1487名参与者。与单用PB相比，15项RCT显示PB加FM在改善IBS-D患者症状缓解方面有显著效果（n = 1487，比值比[OR]=5.17，95%置信区间[CI]为3.79 - 7.07，P <.00001）。11项RCT报告了PB加FM组和PB组的不良反应，两组不良事件发生率无统计学显著差异（n = 1207，OR = 2.91，95%CI为0.91 - 9.28，P = 0.07）。分别有2项RCT和3项RCT报告了HAMA和HAMD评分，3项RCT报告了SAS和SDS评分。治疗后，PB加FM组的上述评分显著低于PB组（所有P <.01）。然而，这些试验被认为存在中度偏倚风险。
PB联合FM治疗IBS-D的疗效优于单用PB，临床使用安全。然而，仍需要通过开展更多大规模、高质量的RCT来验证这些结论。
