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  

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

作　　者：吴健瑜[1] 孙伟鹏[2] 郭惟[3] 杨海淦 张子敬[1] 侯政昆[1] 樊冬梅[1] 温俊茂 陈育忠[1] Wu Jian-yu Sun Wei-peng Guo Weis Yang Hai-gan Zhang Zi-jing Hou Zheng-kun Fan Dong-mei Wen Jun-mao Chen Yu-zhong(Department of Gastrointestinal Surgery, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, Guangdong Province, China the First Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou 510405, Guangdong Province, China the Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen 518000, Guangdong Province, China)

机构地区：[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

出　　处：《中国组织工程研究》2017年第18期2946-2952,共7页Chinese Journal of Tissue Engineering Research

基　　金：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)~~

摘　　要：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Pub Med,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。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 Pub Med, EMbase, Cochrane Library, CBM, CNKI, and VIP databases was performed for articles published before January 15 th, 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.

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 

分 类 号：R318[医药卫生—生物医学工程]