中华普通外科杂志
中華普通外科雜誌
중화보통외과잡지
CHINESE JOURNAL OF GENERAL SURGERY
2015年
5期
361-364
,共4页
七叶素%外科手术%多中心研究
七葉素%外科手術%多中心研究
칠협소%외과수술%다중심연구
Escin%Surgical procedures,operative%Multicenter study
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.
目的 評估註射用七葉皂苷鈉對腹部術後患者腸道蠕動恢複的促進及對手術切口水腫的緩解作用.方法 採用多中心、隨機、前瞻性臨床研究.觀察兩組腸道蠕動的恢複情況:首次腸鳴音、首次排氣、首次排便的齣現時間;觀察手術切口水腫情況及藥物不良反應.結果 註射用七葉皂苷鈉組手術後首次腸鳴音、首次排氣時間及排便時間齣現均早于常規組,兩組間比較均P＜0.01,差異有統計學意義.註射用七葉皂苷鈉組術後手術切口水腫程度明顯輕于對照組,各時間觀察點差異均有統計學意義(均P＜0.01).研究中註射用七葉皂苷鈉組偶見靜脈炎、靜脈刺激、皮疹、皮膚過敏、輸液部位疼痛、胃腸道反應等不良事件,靜脈炎髮生最多,但髮生率僅為0.66％.無嚴重不良反應髮生.結論 註射用七葉皂苷鈉可以促進普外科腹部手術後患者胃腸功能的恢複,併明顯減輕手術切口的水腫.
목적 평고주사용칠협조감납대복부술후환자장도연동회복적촉진급대수술절구수종적완해작용.방법 채용다중심、수궤、전첨성림상연구.관찰량조장도연동적회복정황:수차장명음、수차배기、수차배편적출현시간;관찰수술절구수종정황급약물불량반응.결과 주사용칠협조감납조수술후수차장명음、수차배기시간급배편시간출현균조우상규조,량조간비교균P＜0.01,차이유통계학의의.주사용칠협조감납조술후수술절구수종정도명현경우대조조,각시간관찰점차이균유통계학의의(균P＜0.01).연구중주사용칠협조감납조우견정맥염、정맥자격、피진、피부과민、수액부위동통、위장도반응등불량사건,정맥염발생최다,단발생솔부위0.66％.무엄중불량반응발생.결론 주사용칠협조감납가이촉진보외과복부수술후환자위장공능적회복,병명현감경수술절구적수종.
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.
