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一项比较普理灵和Vypro II补片用于李金斯坦疝修补术的随机对照多中心研究的一年结果

One year results of a randomised controlled multi-centre study comparing Prolene and Vypro II-mesh in Lichtenstein hernioplasty.

作者信息

Bringman S, Wollert S, Osterberg J, Smedberg S, Granlund H, Felländer G, Heikkinen T

机构信息

Center for Surgical Sciences, Karolinska Institutet, Department of Surgery, Södertälje Hospital, 15286 Södertälje, Sweden.

出版信息

Hernia. 2005 Oct;9(3):223-7. doi: 10.1007/s10029-005-0324-z. Epub 2005 Oct 22.

Abstract

A standard polypropylene mesh used in Lichtenstein's operation induces a strong foreign tissue reaction with potential harmful effects. A mesh with less polypropylene could possibly be beneficial. Six hundred men with primary unilateral inguinal hernias were randomised to Lichtenstein's operation using a Prolene- or Vypro II-mesh in six centres. The patients were blinded to which mesh they received. A validated questionnaire assessing recurrence and pain along with SF-36 Health Survey was sent after 1 year to all patients and a selected group was clinically examined. Of the 591 operated patients, 526 (89.0%) returned the questionnaire. 188 patients had some complaints or sensations of which 111 patients were clinically examined. The mean follow-up time was 13.6 (SD. 4.0) months. The incidence of hernia recurrence (four vs. four patients) and neuralgia (three vs. four patients) did not differ between Prolene and Vypro II-groups, respectively. One Vypro II-patient was re-operated due to neuralgia. There was no difference in the SF-36 scores. The results of Lichtenstein's operation with either Prolene or Vypro II do not seem to differ significantly.

摘要

用于李金斯坦手术的标准聚丙烯补片会引发强烈的异物组织反应,并可能产生有害影响。聚丙烯含量较低的补片可能会有益处。600例原发性单侧腹股沟疝男性患者在6个中心被随机分为接受使用普理灵补片或Vypro II补片的李金斯坦手术。患者对自己所接受的补片类型不知情。术后1年,向所有患者发送一份经过验证的评估复发和疼痛情况的问卷以及SF-36健康调查,并且对一组选定的患者进行临床检查。在591例接受手术的患者中,526例(89.0%)回复了问卷。188例患者有一些不适或感觉,其中111例患者接受了临床检查。平均随访时间为13.6(标准差4.0)个月。普理灵组和Vypro II组的疝复发率(分别为4例对4例患者)和神经痛发生率(分别为3例对4例患者)并无差异。1例Vypro II补片患者因神经痛接受了再次手术。SF-36评分没有差异。使用普理灵或Vypro II进行李金斯坦手术的结果似乎没有显著差异。

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