Vypro Ⅱ补片在腹股沟疝修补术后疗效的系统评价
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摘要
目的比较VyproⅡ片与普通聚丙烯补片在腹股沟疝修补术后的临床疗效。
简要背景在腹股沟疝手术中,假体补片的应用变得越来越普遍,以前的许多RCT已经比较了VYPROⅡ补片与普通聚丙烯补片的相对优缺点,现在需要一个系统评价来综合过去的研究成果。
方法检索PubMed (1966-2009.05), Cochrane library(2009年第2期),EMBASE (1974-2009.05), SCI(1974-2009.05),中国生物医学文献数据库(CBM)(1978-2009.05)等数据库收录的公开发表的关于VyproⅡ补片的临床随机和半随机对照试验。由两名研究者独立对符合标准的研究进行资料提取。采用Cochrane系统评价手册简单评分法评价纳入文献质量和Cochrane协作网提供的RevMan 5.0.1统计软件进行Meta分析。计量资料采用加权均数差(WMD)或标准化均数差(SMD)计算统计量,计数资料用相对危险度(RR)或优势比(OR)计算统计量,各效应量均以95%可信区间(CI)表示。评价指标包括：术后疝复发、术后慢性疼痛、异物感、尿道感染、血清肿和睾丸萎缩。
结果10个RCTs,2027例患者纳入分析。Meta分析显示：与普通聚丙烯补片比较,VyproⅡ补片在术后疝复发[OR=1.53,95%CI(0.73,3.19)],术后慢性疼痛[OR=0.87,95%CI(0.55,1.37)],尿道感染[OR=0.71,95%CI(0.14,3.63)],血清肿[OR=0.80,95%CI(0.26,2.48)]和睾丸萎缩[OR=1.94,95%CI(0.58,6.49)]方面均无统计学差异,但异物感发生率明显较低[OR=0.58,95%CI(0.42,0.80)]。
结论目前证据显示,除VyproⅡ补片在异物感方面占优外,VyproⅡ补片与普通聚丙烯补片在腹股沟疝修补术后的短期临床疗效无明显差别,期待更多高质量、随访期长的相关随机对照试验进一步验证。
Objective:The aim of this Meta Analysis was to compare the effectiveness between Vypro II mesh and polypropylene mesh after inguinal hernia repair.
Summary Background Data:The use of prosthetic meshes had become increasingly popular performing inguinal hernia surgery. Previous RCTS had shown their relative merits and risks between the VYPROⅡmesh and the standard polypropylene mesh. A Meta Analysis was needed to estimate the real effectiveness.
Methods:PubMed (1966-2009.05), Cochrane library (2 issue,2009), EMBASE (1974-2009.05), SCI (1974-2009.05) and Chinese Biomedical Literature Database (1978-2009.05) were used to search the published clinical randomized controlled trials about VyproⅡmesh. Two independent reviewers assessed trials for eligibility and quality, all the related data matched our standards were abstracted for Meta-analysis by RevMan 5.0.1. Weighted mean difference (WMD) or standard mean difference (SMD) between continuous variables was calculated. For dichotomous data, relative risk (RR) or odds radio (OR) was determined. All effect values were expressed by 95% confidence intervals (CI). The evaluation criteria included recurrence, pain, feeling of foreign body, urinary tract infection, seroma and testicular atrophy.
Result:2027 patients of 10 RCTs were included. Compared with polypropylene Mesh, VyproⅡMesh had no significant difference in recurrence [OR=1.53,95%CI (0.73,3.19)], pain [OR=0.87,95%CI (0.55,1.37)], urinary tract infection [OR=0.71, 95%CI (0.14,3.63)], seroma [OR=0.80,95%CI (0.26,2.48)] and testicular atrophy [OR=1.94,95%CI (0.58,6.49)], but feeling of foreign body was significantly lower [OR=0.58,95%CI (0.42,0.80)].
Conclusion:Current evidence suggests that there is no significant difference between VyproⅡand polypropylene mesh in the short term effectiveness. However, use of VyproⅡmesh was associated with less feeling of foreign body. Further high-quality, long follow-up period RCTs should be carried out to provide more reliable evidence.
简要背景在腹股沟疝手术中,假体补片的应用变得越来越普遍,以前的许多RCT已经比较了VYPROⅡ补片与普通聚丙烯补片的相对优缺点,现在需要一个系统评价来综合过去的研究成果。
方法检索PubMed (1966-2009.05), Cochrane library(2009年第2期),EMBASE (1974-2009.05), SCI(1974-2009.05),中国生物医学文献数据库(CBM)(1978-2009.05)等数据库收录的公开发表的关于VyproⅡ补片的临床随机和半随机对照试验。由两名研究者独立对符合标准的研究进行资料提取。采用Cochrane系统评价手册简单评分法评价纳入文献质量和Cochrane协作网提供的RevMan 5.0.1统计软件进行Meta分析。计量资料采用加权均数差(WMD)或标准化均数差(SMD)计算统计量,计数资料用相对危险度(RR)或优势比(OR)计算统计量,各效应量均以95%可信区间(CI)表示。评价指标包括：术后疝复发、术后慢性疼痛、异物感、尿道感染、血清肿和睾丸萎缩。
结果10个RCTs,2027例患者纳入分析。Meta分析显示：与普通聚丙烯补片比较,VyproⅡ补片在术后疝复发[OR=1.53,95%CI(0.73,3.19)],术后慢性疼痛[OR=0.87,95%CI(0.55,1.37)],尿道感染[OR=0.71,95%CI(0.14,3.63)],血清肿[OR=0.80,95%CI(0.26,2.48)]和睾丸萎缩[OR=1.94,95%CI(0.58,6.49)]方面均无统计学差异,但异物感发生率明显较低[OR=0.58,95%CI(0.42,0.80)]。
结论目前证据显示,除VyproⅡ补片在异物感方面占优外,VyproⅡ补片与普通聚丙烯补片在腹股沟疝修补术后的短期临床疗效无明显差别,期待更多高质量、随访期长的相关随机对照试验进一步验证。
Objective:The aim of this Meta Analysis was to compare the effectiveness between Vypro II mesh and polypropylene mesh after inguinal hernia repair.
Summary Background Data:The use of prosthetic meshes had become increasingly popular performing inguinal hernia surgery. Previous RCTS had shown their relative merits and risks between the VYPROⅡmesh and the standard polypropylene mesh. A Meta Analysis was needed to estimate the real effectiveness.
Methods:PubMed (1966-2009.05), Cochrane library (2 issue,2009), EMBASE (1974-2009.05), SCI (1974-2009.05) and Chinese Biomedical Literature Database (1978-2009.05) were used to search the published clinical randomized controlled trials about VyproⅡmesh. Two independent reviewers assessed trials for eligibility and quality, all the related data matched our standards were abstracted for Meta-analysis by RevMan 5.0.1. Weighted mean difference (WMD) or standard mean difference (SMD) between continuous variables was calculated. For dichotomous data, relative risk (RR) or odds radio (OR) was determined. All effect values were expressed by 95% confidence intervals (CI). The evaluation criteria included recurrence, pain, feeling of foreign body, urinary tract infection, seroma and testicular atrophy.
Result:2027 patients of 10 RCTs were included. Compared with polypropylene Mesh, VyproⅡMesh had no significant difference in recurrence [OR=1.53,95%CI (0.73,3.19)], pain [OR=0.87,95%CI (0.55,1.37)], urinary tract infection [OR=0.71, 95%CI (0.14,3.63)], seroma [OR=0.80,95%CI (0.26,2.48)] and testicular atrophy [OR=1.94,95%CI (0.58,6.49)], but feeling of foreign body was significantly lower [OR=0.58,95%CI (0.42,0.80)].
Conclusion:Current evidence suggests that there is no significant difference between VyproⅡand polypropylene mesh in the short term effectiveness. However, use of VyproⅡmesh was associated with less feeling of foreign body. Further high-quality, long follow-up period RCTs should be carried out to provide more reliable evidence.
引文
1. Rutkow IM, Robbins AW. Demographic, classificatory, and socioeconomic aspects of hernia repair in the United States [J]. Surg Clin North Am.1993,73(3):413-426.
2. Kingsnorth AN, Gray MR, Nott DM. Prospective randomized trial comparing the Shouldice technique and plication dam for inguinal hernia [J]. Br J Surg.1992,79(10):1068-1070.
3. Schumpelick V, Treutner KH, Arlt G. Inguinal hernia repair in adults [J]. Lancet.1994, 344(8919):375-379.
4.唐健雄,华蕾,张逖,等.成人腹股沟疝患病情况的多中心研究[J].外科理论与实践.2002,7(6)：421-422.
5.陈双.腹股沟疝外科学[M].广州：中山大学出版社.2005,24-26.
6.陈双.谈腹股沟疝成因学说的新认识[J].外科理论与实践.2005,10(2)：115-116.
7. Smigielski J, Kolomecki K, Ziemniak P, et al. Degradation of collagen by metalloproteinase 2 in patients with abdominal hernias [J]. Eur Surg Res.2009,42(2):118-121.
8. Friedman DW, Boyd CD, Norton P, et al. Increases in type III collagen gene expression and protein synthesis in patients with inguinal hernias [J]. Ann Surg.1993,218(6):754-760.
9. Lichtenstein IL, Shulman AG, Amid PK, et al, The tension-free hernioplasty [J]. Am J Surg. 1989,157(2):188-193.
10. Schultz L, Graber J, Pietrafitta J, et al. Laser laparoscopic herniorraphy:a clinical trial preliminary results [J]. J Laparoendosc Surg.1990,1(1):41-45.
11.李健文,郑民华.腹腔镜治疗腹股沟疝的合理选择[J].中国实用外科杂志.2006,26(11)：824-826.
12. Fitzgibbons RJ, Salerno GM, Filipi CJ, et al. A laparoscopic intraperitoneal onlay mesh technique for the repair of an indirect inguinal hernia [J]. Ann Surg.1994,219(2):144-156.
13. Mckernan JB, Laws HL. Laparoscopic repair of inguinal hernias using a totally extraperitoneal prosthetic approach [J]. Surg Endosc.1993,7(1):26-28.
14. Felix EL, Michas CA, Gonzalez MH. Laparoscopic hernioplasty. TAPP vs TEP [J]. Surg Endosc.1995,9(9):984-989.
15.臧潞,李健文,毛志海,等.腹腔镜完全腹膜外与经腹腹膜前疝修补术临床对照分析[J].中国实用外科杂志.2005,25(10)：611-613.
16. Bay-Nielsen M, Kehlet H, Strand L, et al. Quality assessment of 26,304 herniorrhaphies in Denmark:a prospective nationwide study [J]. Lancet.2001,358(9288):1124-1128.
17. EU Hernia Trialists Collaboration. Mesh compared with non-mesh methods of open groin hernia repair:systematic review of randomized controlled trials [J]. Br J Surg.2000,87(7): 854-859.
18. Klinge U, Klosterhalfen B, Muller M, et al. Foreign body reaction to meshes used for the repair of abdominal wall hernias [J]. Eur J Surg.1999,165(7):665-673.
19. Junge K, Klinge U, Rosch R, et al. Functional and morphologic properties of a modified mesh for inguinal hernia repair [J]. World J Surg.2002,26(12):1472-1480.
20. Klinge U, Klosterhalfen B, Muller M, et al. Shrinking of polypropylene mesh in vivo:an experimental study in dogs [J]. Eur J Surg.1998,164(12):965-969.
21. Greca FH, de Paula JB, Biondo-Simoes ML, et al. The influence of differing pore sizes on the biocompatibility of two polypropylene meshes in the repair of abdominal defects. Experimental study in dogs [J]. Hernia.2001,5(2):59-64.
22. Klosterhalfen B, Klinge U, Hermanns B, et al. Pathology of traditional surgical nets for hernia repair after long-term implantation in humans [J]. Chirurg.2000,71(1):43-51.
23. Bellon JM, Bujan J, Contreras LA, et al. Comparison of a new type of polytetrafluoroethylene patch (Mycro Mesh) and polypropylene prosthesis (Marlex) for repair of abdominal wall defects [J]. J Am Coll Surg.1996,183(1):11-18.
24. Evidence-Based Medicine Working Group. Evidence-based medicine:a new approach to teaching the practice of medicine [J]. JAMA.1992,268(17):2420-2427.
25.王家良.临床流行病学[M].第二版,上海：上海科学技术出版社.2001,47-59.
26. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated September 2008]. The Cochrane Collaboration,2008. Available at: http://www.cochrane-handbook.org.
27. Langenbach MR, Schmidt J, Ubrig B, et al. Sixty-month follow-up after endoscopic inguinal hernia repair with three types of mesh:a prospective randomized trial [J]. Surg Endosc.2008, 22(8):1790-1797.
28. Paajanen H. A single-surgeon randomized trial comparing three composite meshes on chronic pain after Lichtenstein hernia repair in local anesthesia [J]. Hernia.2007,11(4):335-339.
29. Horstmann R, Hellwig M, Classen C, et al. Impact of polypropylene amount on functional outcome and quality of life after inguinal hernia repair by the TAPP procedure using pure, mixed, and titanium-coated meshes [J]. World J Surg.2006,30(9):1742-1749.
30. Heikkinen T, Wollert S, Osterberg J, et al. Early results of a randomised trial comparing Prolene and VyproII-mesh in endoscopic extraperitoneal inguinal hernia repair (TEP) of recurrent unilateral hernias [J]. Hernia.2006,10(1):34-40.
31. Bringman S, Wollert S, Osterberg J, et al. Three-year results of a randomized clinical trial of lightweight or standard polypropylene mesh in Lichtenstein repair of primary inguinal hernia [J]. Br J Surg.2006,93(9):1056-1059.
32. O'Dwyer PJ, Kingsnorth AN, Molloy RG, et al. Randomized clinical trial assessing impact of a lightweight or heavyweight mesh on chronic pain after inguinal hernia repair [J]. Br J Surg. 2005,92(2):166-170.
33. Bringman S, Wollert S, Osterberg J, et al. One year results of a randomised controlled multi-centre study comparing Prolene and Vypro Ⅱ-mesh in Lichtenstein hernioplasty [J]. Hernia.2005,9(3):223-227.
34. Bringman S, Wollert S, Osterberg J, et al. Early results of a randomized multicenter trial comparing Prolene and VyproⅡ mesh in bilateral endoscopic extraperitoneal hernioplasty (TEP) [J]. Surg Endosc.2005,19(4):536-540.
35. Post S, Weiss B, Willer M, et al. Randomized clinical trial of lightweight composite mesh for Lichtenstein inguinal hernia repair [J]. Br J Surg.2004,91(1):44-48.
36. Bringman S, Heikkinen TJ, Wollert S, et al. Early results of a single-blinded, randomized, controlled, Internet-based multicenter trial comparing Prolene and Vypro Ⅱ mesh in Lichtenstein hernioplasty [J]. Hernia.2004,8(2):127-134.
37. Klinge U, Junge K, Stumpf M, et al. Functional and morphological evaluation of a low-weight, monofilament polypropylene mesh for hernia repair [J]. J Biomed Mater Res.2002,63(2): 129-136.
38.张亚男主编.疝与腹壁外科学[M].西安：第四军医大学出版社.2008,47.
39. Bellon JM, Rodriguez M, Garcia-Honduvilla N, et al. Partially absorbable meshes for hernia repair offer advantages over nonabsorbable meshes [J]. Am J Surg,2007.194(1):68-74.
40. Langenbach MR, Schmidt J, Zirngibl H. Comparison of biomaterials:three meshes and TAPP for inguinal hernia [J]. Surg Endosc.2006,20(10):1511-1517.
41. Champault G, Bernard C, Rizk N, et al. Inguinal hernia repair:the choice of prosthesis outweighs that of technique [J]. Hernia.2007,11(2):125-128.
1 Schumpelick V, Treutner KH, Arlt G. Inguinal hernia repair in adults [J]. Lancet.1994, 344(8919):375-379.
2唐健雄,华蕾,等.成人腹股沟疝患病情况的多中心研究[J].外科理论与实践.2002,7(6)：421-422.
3陈明,陈念平,缪辉米,等.腹腔镜下改良腹腔内置网法治疗成人腹股沟斜疝[J].中国微创外科杂志.2006,6(6)：441-442.
4 McConnack K, Scott NW, Go PM, et al. Laparoscopic techniques versus open techniques for inguinal hernia repair [J]. Cochrane Database Syst Rev.2003. (1):CD001785.
5 Lau H, Patil NG. Selective non-stapling of mesh during unilateral endoscopic total extraperitoneal inguinal hernioplasty:a case-control study [J]. Arch Surg.2003,138(12): 1352-1355.
6 Higgins JPT, Green S(editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated September 2008]. The Cochrane Collaboration,2008. Available from: www.cochrane-handbook.org.
7戎祯祥,陆光生,陈小伍,等.腹腔镜完全腹膜外补片植入钉合固定与小固定术治疗腹股沟疝前瞻性随机临床对比研究[J].南方医科大学学报.2008,28(12)：2277-2278.
8 李健文,郑民华,李华青,等.腹腔镜全腹膜外补片植入术中补片固定与不固定的随机对照试验[J].中华普通外科杂志.2007,22(6)：440-442.
9 Koch CA, Greenlee SM, Larson DR, et al. Randomized prospective study of totally extraperitoneal inguinal hernia repair:fixation versus no fixation of mesh [J]. JSLS.2006, 10(4):457-460.
10 Parshad R, Kumar R, Hazrah P, et al. A randomized comparison of the early outcome of stapled and unstapled techniques of laparoscopic total extraperitoneal inguinal hernia repair [J]. JSLS.2005,9(4):403-407.
11 Moreno-Egea A, Torralba Martinez J△, Morales Cuenca G, et al. Randomized clinical trial of fixation vs nonfixation of mesh in total extraperitoneal inguinal hernioplasty [J]. Arch Surg. 2004,139(12):1376-1379.
12 Ferzli GS, Frezza EE, Pecoraro AM, et al. Prospective randomized study of stapled versus unstapled mesh in a laparoscopic preperitoneal inguinal hernia repair [J]. J Am Coll Surg. 1999,188(5):461-465.
13陆朝阳,姜洪池.微创化—现代外科学发展的基石[J].中国微创外科杂志.2006,6(2)：91-92.
14 Taylor C, Layani L, Liew V, et al. Laparoscopic inguinal hernia repair without mesh fixation, early results of a large randomised clinical trial [J]. Surg Endosc.2008,22(3):757-762.
15 Moher D, Pham B, Jones A, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analysis [J]? Lancet.1998,352(9128):609-613.
2. Kingsnorth AN, Gray MR, Nott DM. Prospective randomized trial comparing the Shouldice technique and plication dam for inguinal hernia [J]. Br J Surg.1992,79(10):1068-1070.
3. Schumpelick V, Treutner KH, Arlt G. Inguinal hernia repair in adults [J]. Lancet.1994, 344(8919):375-379.
4.唐健雄,华蕾,张逖,等.成人腹股沟疝患病情况的多中心研究[J].外科理论与实践.2002,7(6)：421-422.
5.陈双.腹股沟疝外科学[M].广州：中山大学出版社.2005,24-26.
6.陈双.谈腹股沟疝成因学说的新认识[J].外科理论与实践.2005,10(2)：115-116.
7. Smigielski J, Kolomecki K, Ziemniak P, et al. Degradation of collagen by metalloproteinase 2 in patients with abdominal hernias [J]. Eur Surg Res.2009,42(2):118-121.
8. Friedman DW, Boyd CD, Norton P, et al. Increases in type III collagen gene expression and protein synthesis in patients with inguinal hernias [J]. Ann Surg.1993,218(6):754-760.
9. Lichtenstein IL, Shulman AG, Amid PK, et al, The tension-free hernioplasty [J]. Am J Surg. 1989,157(2):188-193.
10. Schultz L, Graber J, Pietrafitta J, et al. Laser laparoscopic herniorraphy:a clinical trial preliminary results [J]. J Laparoendosc Surg.1990,1(1):41-45.
11.李健文,郑民华.腹腔镜治疗腹股沟疝的合理选择[J].中国实用外科杂志.2006,26(11)：824-826.
12. Fitzgibbons RJ, Salerno GM, Filipi CJ, et al. A laparoscopic intraperitoneal onlay mesh technique for the repair of an indirect inguinal hernia [J]. Ann Surg.1994,219(2):144-156.
13. Mckernan JB, Laws HL. Laparoscopic repair of inguinal hernias using a totally extraperitoneal prosthetic approach [J]. Surg Endosc.1993,7(1):26-28.
14. Felix EL, Michas CA, Gonzalez MH. Laparoscopic hernioplasty. TAPP vs TEP [J]. Surg Endosc.1995,9(9):984-989.
15.臧潞,李健文,毛志海,等.腹腔镜完全腹膜外与经腹腹膜前疝修补术临床对照分析[J].中国实用外科杂志.2005,25(10)：611-613.
16. Bay-Nielsen M, Kehlet H, Strand L, et al. Quality assessment of 26,304 herniorrhaphies in Denmark:a prospective nationwide study [J]. Lancet.2001,358(9288):1124-1128.
17. EU Hernia Trialists Collaboration. Mesh compared with non-mesh methods of open groin hernia repair:systematic review of randomized controlled trials [J]. Br J Surg.2000,87(7): 854-859.
18. Klinge U, Klosterhalfen B, Muller M, et al. Foreign body reaction to meshes used for the repair of abdominal wall hernias [J]. Eur J Surg.1999,165(7):665-673.
19. Junge K, Klinge U, Rosch R, et al. Functional and morphologic properties of a modified mesh for inguinal hernia repair [J]. World J Surg.2002,26(12):1472-1480.
20. Klinge U, Klosterhalfen B, Muller M, et al. Shrinking of polypropylene mesh in vivo:an experimental study in dogs [J]. Eur J Surg.1998,164(12):965-969.
21. Greca FH, de Paula JB, Biondo-Simoes ML, et al. The influence of differing pore sizes on the biocompatibility of two polypropylene meshes in the repair of abdominal defects. Experimental study in dogs [J]. Hernia.2001,5(2):59-64.
22. Klosterhalfen B, Klinge U, Hermanns B, et al. Pathology of traditional surgical nets for hernia repair after long-term implantation in humans [J]. Chirurg.2000,71(1):43-51.
23. Bellon JM, Bujan J, Contreras LA, et al. Comparison of a new type of polytetrafluoroethylene patch (Mycro Mesh) and polypropylene prosthesis (Marlex) for repair of abdominal wall defects [J]. J Am Coll Surg.1996,183(1):11-18.
24. Evidence-Based Medicine Working Group. Evidence-based medicine:a new approach to teaching the practice of medicine [J]. JAMA.1992,268(17):2420-2427.
25.王家良.临床流行病学[M].第二版,上海：上海科学技术出版社.2001,47-59.
26. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated September 2008]. The Cochrane Collaboration,2008. Available at: http://www.cochrane-handbook.org.
27. Langenbach MR, Schmidt J, Ubrig B, et al. Sixty-month follow-up after endoscopic inguinal hernia repair with three types of mesh:a prospective randomized trial [J]. Surg Endosc.2008, 22(8):1790-1797.
28. Paajanen H. A single-surgeon randomized trial comparing three composite meshes on chronic pain after Lichtenstein hernia repair in local anesthesia [J]. Hernia.2007,11(4):335-339.
29. Horstmann R, Hellwig M, Classen C, et al. Impact of polypropylene amount on functional outcome and quality of life after inguinal hernia repair by the TAPP procedure using pure, mixed, and titanium-coated meshes [J]. World J Surg.2006,30(9):1742-1749.
30. Heikkinen T, Wollert S, Osterberg J, et al. Early results of a randomised trial comparing Prolene and VyproII-mesh in endoscopic extraperitoneal inguinal hernia repair (TEP) of recurrent unilateral hernias [J]. Hernia.2006,10(1):34-40.
31. Bringman S, Wollert S, Osterberg J, et al. Three-year results of a randomized clinical trial of lightweight or standard polypropylene mesh in Lichtenstein repair of primary inguinal hernia [J]. Br J Surg.2006,93(9):1056-1059.
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