四磨汤口服液治疗腹部手术后促进胃肠功能恢复的随机、双盲、安慰剂对照、多中心临床试验

Randomized,Double-Blind,Placebo-Controlled,Multi-Center Clinical Trial of Simo Decoction Oral Liquid(四磨汤口服液)for Recovery of Gastrointestinal Function after Abdominal Surgery

目的评价四磨汤口服液治疗腹部手术后促进胃肠功能恢复的有效性和安全性。方法采用随机、双盲、安慰剂对照、多中心临床试验设计。共纳入患者140例,按3∶1的比例分为试验组105例和对照组35例。试验组口服四磨汤口服液,对照组口服四磨汤口服液模拟剂,疗程3 d。比较两组患者首次肛门排气时间、肠鸣音恢复时间和24、36、48 h排气率及用药安全性。结果有效性评价采用全分析(FAS)集及符合方案(PPS)集分析,安全性指标以安全性(SS)集进行分析。结果140例患者均进入FAS集和SS集(试验组105例,对照组35例),125例进入FAS集(试验组96例,对照组29例)。试验组首次肛门排气中位时间FAS(PPS)为27.5 h(24.0 h),对照组为34.0 h(34.0 h);肠鸣音恢复中位时间FAS(PPS)为8.0 h(8.0 h),对照组为11.0 h(11.0 h),试验组均早于对照组(P<0.05)。PPS分析显示,试验组36 h排气率与48 h排气率分别为72.92%(70/96)、87.50%(84/96),均高于对照组的51.72%(15/29)和68.97%(20/29)(P<0.05)。试验期间,两组均未出现不良反应。结论四磨汤口服液可明显促进腹部手术后胃肠功能恢复,且安全性好。

Objective To evaluate the efficacy and safety of Simo Decoction Oral Liquid(四磨汤口服液)for the recovery of gastrointestinal function after abdominal surgery.Methods A randomized,double-blind,placebo-controlled,multi-center clinical trial was designed.A total of 140 cases were divided into treatment group(105 cases)and control group(35 cases)at a ratio of 3∶1.The treatment group was treated with Simo Decoction Oral Liquid,while the control group was given Simo Decoction Oral Liquid simulation agent.The treatment course was 3 days.The first anal exhaust median time,bowel sound recovery median time,24,36,48 h exhaust rate and safety were compared.Full analysis set(FAS)and per protocol set(PPS)were used for effectiveness analysis,while safety set(SS)was used for safety analysis.Results All 140 cases were included in the FAS and SS(with 105 cases in treatment group and 35 cases in control group),and 125 cases in the PPS(with 96 cases in treatment group and 29 cases in control group).PPS and FAS analyses showed that the first anal exhaust median time of FAS(PPS)in the treatment group was 27.5 h(24.0 h)and 34.0 h(34.0 h)in the control group,bowel sound recovery median time of FAS(PPS)in the treatment group was 8.0 h(8.0 h)and 11.0 h(11.0 h)in the control group.Both were earlier than those in control group(P<0.05).PPS showed that in the treatment group,36 h and 48 h exhaust rates were 72.92%(70/96)and 87.50%(84/96),respectively.Both were higher than those in control group(51.72%,15/29 and 68.97%,15/29)(P<0.05).No adverse reactions were occurred in either group during the trial.Conclusion Simo Decoction Oral Liquid is effective and safe in promoting gastrointestinal function recovery after abdominal surgery.