中国组织工程研究

中国组织工程研究 ›› 2017, Vol. 21 ›› Issue (18): 2946-2952.doi: 10.3969/j.issn.2095-4344.2017.18.025

• 生物材料循证医学 evidence-based medicine of biomaterials • 上一篇    

镍钛记忆合金加压吻合夹在消化道吻合术中的系统评价及序贯分析

吴健瑜1，孙伟鹏2，郭  惟3，杨海淦1，张子敬1，侯政昆1，樊冬梅1，温俊茂2，陈育忠1   

  1. 1广州中医药大学第一附属医院胃肠外科，广东省广州市  510405；2广州中医药大学第一临床医学院，广东省广州市  510405；3广州中医药大学第四临床医学院，广东省深圳市 518000
  • 收稿日期:2017-04-24 出版日期:2017-06-28 发布日期:2017-07-07
  • 通讯作者: 陈育忠，硕士，主任医师，广州中医药大学第一附属医院胃肠外科，广东省广州市 510405
  • 作者简介:吴健瑜，男，1983年生，广东省人，汉族， 2006年广州中医药大学毕业，硕士，主治医师。
  • 基金资助:

    国家自然科学基金青年科学基金项目(81303148)；广东省自然科学基金(2016A030313643)

Nickel-titanium memory-shape compression anastomosis clip for gastrointestinal anastomosis:a Meta-analysis and sequential analysis

Wu Jian-yu1, Sun Wei-peng2, Guo Wei3, Yang Hai-gan1, Zhang Zi-jing1, Hou Zheng-kun1, Fan Dong-mei1, Wen Jun-mao2, Chen Yu-zhong1
  

  1. 1Department of Gastrointestinal Surgery, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, Guangdong Province, China; 2the First Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou 510405, Guangdong Province, China; 3the Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen 518000, Guangdong Province, China
  • Received:2017-04-24 Online:2017-06-28 Published:2017-07-07
  • Contact: Chen Yu-zhong, Master, Chief physician, Department of Gastrointestinal Surgery, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, Guangdong Province, China
  • About author:Wu Jian-yu, Master, Attending physician, Department of Gastrointestinal Surgery, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, Guangdong Province, China
  • Supported by:

    the Young National Natural Science Foundation of China, No. 81303148; the Natural Science Foundation of Guangdong Province, No. 2016A030313643

被引次数

1

摘要：

文章快速阅读：

 

文题释义：
镍钛记忆合金加压吻合夹：含镍钛的具有记忆金属性质的吻合夹应用于消化道创口的吻合，吻合夹通过对吻合处的胃肠道组织产生持久均匀的压力，吻合夹内的组织由于缺血坏死、脱落，吻合夹外的组织愈合并形成均一的吻合口，而镍钛记忆合金加压吻合夹与坏死的组织会脱落进入胃肠道，随粪便被排出体外。
试验序贯分析：作为累积Meta分析的一种，其主要是将序贯分析方法引入传统Meta分析，以最大限度地减少因传统Meta分析在反复更新中出现的随机误差而产生的假阳性结果，同时计算出Meta分析获得某一个确切结论所需要的样本量。


背景：镍钛记忆合金加压吻合夹已经被用于消化道吻合术，但其有效性和安全性仍存在争议。
目的：评价镍钛记忆合金加压吻合夹(Ni-Ti CAC)在消化道吻合术中的有效性及安全性。
方法：计算机检索PubMed，Embase，Cochrane Library中国期刊全文数据库(CNKI)，中国生物医学文献数据库(CBM)，万方及维普(VIP)数据库。检索时间：从建库至2017年1月15日。检索词：镍钛记忆合金、加压吻合夹、吻合术、胃、空肠、回肠、小肠、结肠、直肠及大肠等。纳入消化道吻合术中应用镍钛记忆合金加压吻合夹对比常用消化道吻合方法的随机对照试验文献，对其吻合时间、术后排气时间以及术后住院时间进行Meta分析，并采用 TSA v0.9 软件进行序贯分析。
结果与结论：共纳入18篇随机对照试验文献，共1 860例行消化道吻合术患者。Meta分析结果显示，镍钛记忆合金加压吻合夹的使用能缩短术中吻合时间(MD=-3.83，95%CI：-6.48至-1.19，P=0.004)、术后排气时间(MD=-0.14，95% CI：-0.22至-0.05，P=0.002)，但对于术后住院时间改变无明显差异(MD=-0.83，95% CI：-1.82至0.16，P=0.10)。GRADE质量评价表明所述指标证据质量为中低级。序贯分析提示Meta分析在术后排气时间方面，镍钛记忆合金加压吻合夹组优于对照组获得证实。在不良反应上，除死亡1例外，最常见的是切口感染，其他还可见肺栓塞及腹痛等。结果证实，镍钛记忆合金加压吻合夹可以在消化道吻合术减少吻合时间，加快术后排气，在消化道吻合术中具有较好的安全性。由于目测纳入试验的设计缺陷，今后研究仍需多中心、高质量的随机对照试验支持。

ORCID: 0000-0003-3108-4086(陈育忠)

关键词: 生物材料, 材料相容性, 镍钛记忆合金, 加压吻合夹, 消化道吻合术, 系统评价, 序贯分析, GRADE质量评价, 术中吻合时间, 术后排气时间, 术后住院时间, 不良反应, 国家自然科学基金

Abstract:

BACKGROUND: Nickel-titanium memory-shape compression anastomosis clip (Ni-Ti CAC) has been used in gastrointestinal anastomosis, but its efficacy and safety still remain controversial.
OBJECTIVE: To evaluate the efficacy and safety of Ni-Ti CAC in gastrointestinal anastomosis.
METHODS: A computer-based online research of PubMed, EMbase, Cochrane Library, CBM, CNKI, and VIP databases was performed for articles published before January 15th, 2017 using the keywords of “nickel-titanium, compression anastomosis clip, anastomosis, gastric, jejunum, ileum, small intestine, colon, rectum, and large intestine” in English and Chinese, respectively. The randomized controlled trials about Ni-Ti CAC versus conventional methods for gastrointestinal anastomosis were included. Meta-analysis of the anastomosis time, time of exsufflation, and hospitalization time was performed, and sequential analysis was conducted on TSA v0.9 software.
RESULTS AND CONCLUSION: A total of 18 eligible randomized controlled trials were enrolled, involving 1 860 patients. Ni-Ti CAC could reduce the anastomosis time [MD=-3.83, 95% CI(-6.48, -1.19), P=0.004] and time of exsufflation [MD=-0.14, 95% CI(-0.22,-0.05), P=0.002], but there was no significant difference in the hospitalization time [MD=-0.83, 95% CI(-1.82, 0.16), P=0.10]. The quality was ranked as low level based on GRADE system. The time of exsufflation of Ni-Ti CAC was superior to that of conventional method, which was confirmed by sequential analysis. One case of death was reported and incision infection was the most common adverse effects; additionally, pulmonary embolism and abdominal pain occurred. To conclude, Ni-Ti CAC can facilitate gastrointestinal anastomosis, accelerate the time of exsufflation, and holds a good safety. However, more multicenter and high-quality randomized controlled trials are needed. 

Key words: Tissue Engineering, Alloys, Nickel, Titanium, Anastomosis, Surgical

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