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施沛特预防术后腹腔粘连的疗效与安全性:系统评价与荟萃分析

Efficacy and safety of Seprafilm for preventing postoperative abdominal adhesion: systematic review and meta-analysis.

作者信息

Zeng Qiqiang, Yu Zhengping, You Jie, Zhang Qiyu

机构信息

Department of General Surgery, the First Affiliated Hospital, Wenzhou Medical College, Wenzhou 325003 Zhejiang Province, China.

出版信息

World J Surg. 2007 Nov;31(11):2125-31; discussion 2132. doi: 10.1007/s00268-007-9242-9.

Abstract

BACKGROUND

There is no clear consensus on the efficacy and safety of hyaluronate-carboxymethylcellulose membrane (Seprafilm) for preventing postoperative abdominal adhesion. This study is a meta-analysis of the available evidence.

METHODS

A search of the MEDLINE, EMBASE, and the Cochrane Library identified eight studies that met the inclusion criteria for data extraction. Estimates of effectiveness were performed using fixed- and random-effects models. The effect was calculated as an odds ratio (OR) with 95% confidence intervals (CI) using the statistical software Review Manager Version 4.2. Level of significance was set at p < 0.05.

RESULTS

Outcomes of 4203 patients were studied. The incidence of grade 0 adhesions among Seprafilm-treated patients was statistically significantly more than that observed among control group patients (OR 95%CI, 3.74-20.34; p < 0.01). There was no significant difference in the incidence of grade 1 adhesions between Seprafilm and control groups (OR 95%CI, 0.58-2.71; p = 0.56). The severity of grade 2 and grade 3 adhesions among Seprafilm-treated patients was significantly less than that observed among control group patients (OR 95%CI, 0.22-0.93; p = 0.03; OR 95%CI, 0.09-0.63; p < 0.01, respectively). The incidence of intestinal obstruction after abdominal surgery was not different between Seprafilm and control groups (OR 95%CI, 0.78-1.23; p = 0.84). Using Seprafilm significantly increased the incidence of abdominal abscesses (OR 95%CI, 1.06-2.54; p = 0.03) and anastomotic leaks (OR 95%CI, 1.18-3.50; p = 0.01).

CONCLUSIONS

Our systematic review and meta-analysis showed that Seprafilm could decrease abdominal adhesions after general surgery, which may benefit patients, but could not reduce postoperative intestinal obstruction. At the same time, Seprafilm did increase abdominal abscesses and anastomotic leaks.

摘要

背景

对于透明质酸-羧甲基纤维素膜(Seprafilm)预防术后腹腔粘连的有效性和安全性尚无明确共识。本研究是对现有证据的荟萃分析。

方法

检索MEDLINE、EMBASE和Cochrane图书馆,确定了八项符合数据提取纳入标准的研究。使用固定效应模型和随机效应模型进行有效性评估。使用统计软件Review Manager版本4.2计算效应值,以比值比(OR)和95%置信区间(CI)表示。显著性水平设定为p<0.05。

结果

对4203例患者的结果进行了研究。Seprafilm治疗组0级粘连的发生率在统计学上显著高于对照组患者(OR 95%CI,3.74 - 20.34;p<0.01)。Seprafilm组和对照组1级粘连的发生率无显著差异(OR 95%CI,0.58 - 2.71;p = 0.56)。Seprafilm治疗组2级和3级粘连的严重程度显著低于对照组患者(OR 95%CI,0.22 - 0.93;p = 0.03;OR 95%CI,0.09 - 0.63;p<0.01)。Seprafilm组和对照组腹部手术后肠梗阻的发生率无差异(OR 95%CI,0.78 - 1.23;p = 0.84)。使用Seprafilm显著增加了腹腔脓肿的发生率(OR 95%CI,1.06 - 2.54;p = 0.03)和吻合口漏的发生率(OR 95%CI,1.18 - 3.50;p = 0.01)。

结论

我们的系统评价和荟萃分析表明,Seprafilm可减少普通外科手术后的腹腔粘连,这可能使患者受益,但不能降低术后肠梗阻的发生率。同时,Seprafilm确实增加了腹腔脓肿和吻合口漏的发生率。

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