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
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 clin-ical 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 effec-tiveness 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 11.0h(11.0h)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),re-spectively.Both were higher than those in control group(51.72％,15/29 and 68.97％,15/29)(P＜0.05).No adverse reac-tions were occurred in either group during the trial.Conclusion Simo Decoction Oral Liquid is effective and safe in promoting gas-trointestinal function recovery after abdominal surgery.
Simo Decoction Oral Liquid(四磨汤口服液)gastrointestinal function recoveryplacebo-controlledclinical trial
万方数据
维普
