鼻胆管引流对内镜逆行胰胆管造影术相关并发症防治效应的系统评价

发布时间：2018-05-15 10:15

本文选题：鼻胆管引流 + 胰胆管造影　；参考：《南昌大学》2015年硕士论文

【摘要】：研究背景:内镜逆行胰胆管造影术(endoscopic retrograde cholangiopancreatography,ERCP)已成为诊治胰胆管疾病不可或缺的手段之一,但其作为一项有创性操作,与其相关的并发症一直居高不下。研究显示行鼻胆管引流术(endoscopic nasobiliary drainage,ENBD)置入、取出简单,且方便观察引流液的性状及量,防治并发症具有较好的的效应,但由于多为单中心研究,样本量小,结论不一致。故行预防性ENBD防治ERCP相关并发症的效应尚存争议、缺乏循证学依据。目的:系统评价预防性ENBD防治ERCP相关并发症的效应及其安全性。具体包括高淀粉酶血症、急性胰腺炎(post-ERCP pancreatitis,PEP)、重度胰腺炎(severe post-ERCP pancreatitis,SPEP)、急性胆管炎、重症胆管炎(acute cholangitis of severe type,ACST)、消化道出血、肠穿孔等ERCP相关并发症发生率,病死率,术后并发症需外科急诊干预率,ERCP术后住院时间,临床症状和体征缓解时间,住院费用等指标。方法:计算机检索PubMed、Medline、Web of SCI、Cochrane Library、CBM、CNKI、WanFang Data及CQVIP,并进一步追查相关会议纪要、学位论文,及纳入研究的参考文献,检索时限从建库至2015年3月5日,语种限定为英文或中文,全面收集公开报道的ENBD防治ERCP相关并发症的随机对照试验(random control trial,RCT)和临床对照试验;依照预定的文献纳入和排除标准筛选文献;参考NOS评分标准进行质量评价;应用系统评价的方法对纳入的研究进行统计分析。定量分析应用Review Manager 5.3软件,有统计学意义的Meta分析结果计算需治疗的患者数(Number needed to be treated,NNT)。结果:⑴共纳入18项研究(RCT 11项,临床对照试验7项),包含行预防性ENBD患者1952例(ENBD组)、未行预防性ENBD患者1577例(no-ENBD组)。⑵ENBD对高淀粉酶血症发生率的影响:Meta分析P0.00001,OR=0.50(95%ci=0.37~0.67),nnt=10;敏感性分析与原meta分析结果一致,p0.00001,or=0.55(95%ci=0.39~0.76);漏斗图大致对称,begg’s检验z=1.07,p=0.283。⑶enbd对pep发生率的影响:meta分析p0.00001,or=0.27(95%ci=0.19~0.38),nnt=11;敏感性分析与原meta分析结果一致,p0.00001,or=0.28(95%ci=0.19~0.39);漏斗图存在一定的不对称性,主要为右下角缺失,然而各研究结果均位于95%可信区间内,且begg’s检验z=1.71,p=0.086。⑷enbd对spep发生率的影响:meta分析p=0.03,or=0.19(95%ci=0.04~0.88),敏感性分析结果失去统计学意义,p=0.09,or=0.22(95%ci=0.04~1.30),但纳入的研究enbd组spep发生率为0.3%,明显低于no-enbd组的3.4%。⑸enbd对急性胆管炎发生率的影响:meta分析p0.00001,or=0.50(95%ci=0.37~0.67),nnt=20;敏感性分析与原meta分析结果一致,p0.00001,or=0.25(95%ci=0.14~0.45);漏斗图大致对称,begg’s检验p=1.000。⑹enbd对acst发生率的影响:meta分析p=0.009,or=0.10(95%ci=0.02~0.57),nnt=33。⑺enbd对消化道出血发生率的影响:meta分析p=0.89,or=0.92(95%ci=0.32~2.68);敏感性分析与原meta分析结果一致,p=0.89,or=1.09(95%ci=0.33~3.64)。⑻enbd对病死率的影响:meta分析p=0.08,or=0.20(95%ci=0.03~1.20),enbd组病死率为0.1%,明显低于no-enbd组的1.1%。⑼enbd对并发症需外科急诊干预率的影响:meta分析p=0.001,or=0.09(95%ci=0.02~0.40);敏感性分析结果失去统计学意义,p=0.08,or=0.15(95%ci=0.02~1.24),但纳入的研究enbd组并发症需外科急诊干预率为0.1%,明显低于no-enbd组的2.6%。⑽enbd对ercp术后住院时间的影响:meta分析p=0.21,wmd=-0.81d(95%ci=-2.09d~0.46d)。⑾enbd对ercp术后疗效的影响:纳入的部分研究报道enbd不能有效缩短血清c反应蛋白、丙氨酸转氨酶、胆红素等实验室指标恢复正常时间,但可以有效缩短pep患者临床症状和体征缓解时间,淀粉酶、中性粒细胞百分比等实验室指标恢复正常时间和平均住院时间。⑿enbd的安全性:纳入的部分研究报道了enbd的安全性,均未发生enbd导致的严重后果。结论:预防性enbd可有效预防ercp相关的高淀粉酶血症、pep和急性胆管炎的发生,并且可降低pep和急性胆管炎的重症化趋势,从而减少spep和acst的发生;另外,enbd可缩短pep患者的治愈时间,尤其是可以提高对spep和ASCT的内科治愈率;除此之外,预防性ENBD本身并不引起不良后果。故预防性ENBD防治ERCP相关并发症是一种安全有效的的办法,值得临床推广应用。
[Abstract]:Background: endoscopic retrograde cholangiopancreatography (endoscopic retrograde cholangiopancreatography, ERCP) has become one of the indispensable means for the diagnosis and treatment of cholangiopancreatopancreatography, but as a invasive operation, the complications associated with it have remained high. The study showed nasobiliary drainage (endoscopic nasobiliary drainage, EN). BD) it is simple to take out, and it is convenient to observe the characters and quantities of the drainage fluid, and the effect of preventing complications is better. But because of the single center study, the sample size is small and the conclusion is not consistent. Therefore, the effect of preventive ENBD prevention and control of ERCP related complications is still controversial and lack of evidence-based basis. Objective: to systematically evaluate the prevention of the prevention of ERCP related to the prevention of ERCP. The effects and safety of complications included hyperamylacemia, acute pancreatitis (post-ERCP pancreatitis, PEP), severe pancreatitis (severe post-ERCP pancreatitis, SPEP), acute cholangitis, severe cholangitis (acute cholangitis of severe type, acute), gastrointestinal bleeding, intestinal perforation and other related complications, fatality rate, Postoperative complications required emergency surgical intervention rate, hospitalization time after ERCP, clinical symptoms and signs remission time, and hospitalization expenses. Methods: computer retrieval of PubMed, Medline, Web of SCI, Cochrane Library, CBM, CNKI, WanFang Data, and further tracing related conferences, dissertations, and references to the study. The cable time limit was limited to English or Chinese in March 5, 2015. The language was limited to English or Chinese. A comprehensive collection of publicly reported randomized controlled trials (random control trial, RCT) and clinical controlled trials on the prevention and control of complications related to the prevention and treatment of ERCP related to ENBD were collected. Statistical analysis of the integrated study. Quantitative analysis applied Review Manager 5.3 software and statistically significant Meta analysis results to calculate the number of patients needed to be treated (Number needed to be treated, NNT). Results: (1) a total of 18 studies (RCT 11, clinics 7), including 1952 cases of preventive ENBD patients (EN) BD group (group BD), 1577 cases of non prophylactic ENBD patients (group no-ENBD). (2) the effect of ENBD on the incidence of hyperamylase: Meta analysis of P0.00001, OR=0.50 (95%ci=0.37~0.67), nnt=10; sensitivity analysis was consistent with the results of original meta analysis, p0.00001, or=0.55. The impact of rate: Meta analysis p0.00001, or=0.27 (95%ci=0.19~0.38), nnt=11; sensitivity analysis and the original meta analysis results, p0.00001, or=0.28 (95%ci=0.19~0.39); the funnel graph has a certain asymmetry, mainly in the right lower corner, but the results are in the 95% confidence interval, and Begg 's test z=1.71. The impact of the incidence: Meta analysis p=0.03, or=0.19 (95%ci=0.04~0.88), and the results of sensitivity analysis lost statistical significance, p=0.09, or=0.22 (95%ci=0.04~1.30), but the incidence of SPEP in ENBD group was 0.3%, which was significantly lower than that of 3.4%. ENBD in the no-enbd group. Nnt=20; the sensitivity analysis is consistent with the results of the original meta analysis, p0.00001, or=0.25 (95%ci=0.14~0.45); the funnel plot is roughly symmetrical, and the Begg 's tests the effect of p=1.000. ENBD on the incidence of ACST: Meta analysis p=0.009. The sensitivity analysis was consistent with the results of the original meta analysis, p=0.89, or=1.09 (95%ci=0.33~3.64). The effect of ENBD on the mortality was p=0.08, or=0.20 (95%ci=0.03~1.20), and the fatality rate of the ENBD group was 0.1%, which was significantly lower than that of no-enbd group. The results of sensitivity analysis lost statistical significance, p=0.08, or=0.15 (95%ci=0.02~1.24), but the incidence of complications in the group ENBD was 0.1%, which was significantly lower than the effect of 2.6%. ENBD on the time of hospitalization after ERCP: Meta analysis p=0.21, wmd= -0.81d. The part of the study reported that ENBD could not effectively shorten the serum C reactive protein, alanine aminotransferase, bilirubin and other laboratory indexes to restore normal time, but could effectively shorten the time of clinical symptoms and signs remission of PEP patients and the normal time and average time of hospitalization of the laboratory indexes such as amylase and neutrophils percentage. ENBD Safety: part of the study reported that ENBD was safe and had no serious consequences caused by ENBD. Conclusion: prophylactic ENBD can effectively prevent ERCP related hyperamylasemia, PEP and acute cholangitis, and reduce the severe trend of PEP and acute cholangitis, thus reducing the occurrence of SPEP and ACST; moreover, ENBD can Shorten the cure time of PEP patients, especially to improve the cure rate of SPEP and ASCT; in addition, preventive ENBD itself does not cause adverse consequences. Therefore, preventive ENBD prevention and control of ERCP related complications is a safe and effective method, which is worthy of clinical application.

【学位授予单位】：南昌大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R657.4

【参考文献】