莫沙必利联合聚乙二醇预防全髋关节置换术后便秘的有效性和安全性

Efficacy and safety of mosapride combined with polyethylene glycol in the prevention of constipation after total hip arthroplasty:a randomized controlled trial

背景:全髋关节置换(THA)术后便秘是普遍存在的问题,目前针对这一问题的高质量研究极少。目的:评估莫沙必利联合聚乙二醇预防THA术后便秘的有效性和安全性。方法:前瞻性纳入2017年7月至2017年12月收治的70例THA患者并随机分为对照组和干预组各35例。对照组患者给予预防便秘的术前教育;干预组患者给予相同的术前教育的同时,从手术当天起至术后3 d给予口服枸橼酸莫沙必利及聚乙二醇4000散。有效性指标为术后住院期间及术后15 d、30 d的便秘率,术后补救药物使用率,术后30 d再住院率。安全性指标为术后胃肠道相关不良事件发生率。结果:住院期间,对照组20例(57.1%)发生术后便秘,干预组8例(22.9%)发生术后便秘,两组比较有统计学差异(P=0.003)。对照组15例(42.9%)和干预组6例(17.1%)需肥皂水灌肠作为补救措施,两组比较有统计学差异(P=0.019)。两组患者术后15 d及30 d随访的便秘率无统计学差异。对照组2例和干预组1例于术后30 d内再住院,两组比较无统计学差异。两组患者术后胃肠道相关不良事件的发生率无统计学差异。结论:莫沙必利联合聚乙二醇可有效降低THA术后的便秘率,减少补救药物使用率,并不增加术后胃肠道系统相关不良事件发生风险。

Background:Constipation is common in patients undergoing total hip arthroplasty(THA).However,there are few high quality studies on the prevention of constipation after THA.Objective:To evaluate the efficacy and safety of mosapride combined with polyethylene glycol(PEG)on preventing constipation in patients after THA.Methods:A total of 70 patients undergoing THA were randomized into two groups as the intervention group receiving a preventive protocol including preoperative education for lifestyle and mosapride and polyethylene glycol 4000(PEG 4000)from the operation day to 3 days after the operation and lhe control group only receiving the same preoperalive education,with 35 patients in each group.The efficacy outcomes included the postoperative constipation rate during the hospitalization period and at 15 and 30 days after the operation,the rescue measure of enema rate,and the readmissions within 30 days.The safety outcome was the incidence of postoperative adverse events.Results:Patients in the intervention group has a significant lower rate of postoperative constipation during hospitalization than patients in the control group(22.9%vs 57.1%,P=0.007).The rescue measure of enema rate was 17.1%in the in tervention group versus 42.9%in the control group,and the difference was also statistically significant(P=0.036).The differences of constipation rate at postoperative 15 days and 30 days,the readmissions within 30 days,and the postoperative adverse events rates were not statistically significant between the two groups.Conclusions:Mosapride combined with PEG is effective to relieve THA postoperative constipation and reduce rescue measure rate without sacrificing the safety.