注射用七叶皂苷钠促进普外科腹部术后患者恢复的多中心随机对照前瞻性研究  

The multicenter randomized controlled prospective trail of sodium aescinate on recovery of abdominal surgery

作　　者：孟凡强[1] 李超丰[1] 王文跃[1] 

机构地区：[1]北京中日友好医院胃肠外科,100029

出　　处：《中华普通外科杂志》2015年第5期361-364,共4页Chinese Journal of General Surgery

摘　　要：目的 评估注射用七叶皂苷钠对腹部术后患者肠道蠕动恢复的促进及对手术切口水肿的缓解作用.方法 采用多中心、随机、前瞻性临床研究.观察两组肠道蠕动的恢复情况：首次肠鸣音、首次排气、首次排便的出现时间;观察手术切口水肿情况及药物不良反应.结果 注射用七叶皂苷钠组手术后首次肠鸣音、首次排气时间及排便时间出现均早于常规组,两组间比较均P＜0.01,差异有统计学意义.注射用七叶皂苷钠组术后手术切口水肿程度明显轻于对照组,各时间观察点差异均有统计学意义（均P＜0.01）.研究中注射用七叶皂苷钠组偶见静脉炎、静脉刺激、皮疹、皮肤过敏、输液部位疼痛、胃肠道反应等不良事件,静脉炎发生最多,但发生率仅为0.66％.无严重不良反应发生.结论 注射用七叶皂苷钠可以促进普外科腹部手术后患者胃肠功能的恢复,并明显减轻手术切口的水肿.Objective To evaluate the efficacy and safety of sodium aescinate for abdominal operation in general surgery.Methods A multicenter,prospective and open labeled trail was conducted.Data of 2001 patients in PPS group who had undergone either conventional treated （n =500） or sodium aescinate treated （n =1 501） for abdominal operation in general surgery were analyzed.In the sodium aescinate treated group,sodium aescinate was given by ivgtt 12 h before the surgery started,and 20 mg daily after the surgery for 6 days.Time to recovery of gastrointestinal sounds （TRGS）,time to recovery of passage of gas （TRPG）,and time to recovery of bowel movements （TRBM） were recorded to evaluate the bowl function recovery.The difference of incision edema was observed by the evaluate edema level.Results The TRGS of sodium aescinate treated group was significantly shorter than that of the conventional treated group,P 〈 0.01.The TRPG of sodium aescinate treated group was significantly shorter than that of the conventional treated group,P 〈 0.01.The TRBM of sodium aescinate treated group was significantly shorter than that of the conventional treated group,P 〈 0.01.The incision edema of sodium aescinate treated group was better than that of conventional treated group.The rate of adverse event was low in the sodium aescinate treated group,phlebitis was the most common one,accounting for 0.66%.No serious adverse event happened.Conclusion Sodium aescinate is effective and safe in accelerating patients recovery in general surgery.

关 键 词：七叶素 外科手术 多中心研究 

分 类 号：R283[医药卫生—中药学]