ICS 11.020 CCS C 30 T/GDMDMA 0046—2025团 体 标 准 经阴道网片植入盆底重建术治疗盆腔 脏器脱垂的中国临床应用标准 Chinese clinical application standard of r econstructive pelvic surgery using transvaginal mesh implantation in the tr eatment of pelvic organ pr olapse 2025-06-23 发布          2025 -06-23 实施 广东省医疗器械管理学会 发 布T/GDMDMA 全国团体标准信息平台 全国团体标准信息平台 T/GDMDMA 0046—2025 Ⅰ目 次T/GDMDMA0046—2025 前言 ···························································································································· Ⅲ 引言 ···························································································································· Ⅳ 1 范围 ························································································································· 1 2 规范性引用文件 ········· ································································································· 1 3 术语和定义 ················································································································ 1 4 总则 ························································································································· 2 5 适应证及禁忌证 ············································ ······························································ 2 5.1 通用 ···················································································································· 2 5.2 适应证 ················································································································· 2 5.3 禁忌证 ··················································································· ······························ 2 6 术前评估和准备 ·········································································································· 2 6.1 了解病史 ·············································································································· 2 6.2 全面查体 ·············································································································· 2 6.3 术前检查 ·············································································································· 2 6.4 术前沟通 ·············································································································· 3 7 合成网片的选择、手术步骤和注意事项 ············································································ 3 7.1 合成网片的选择及结构 ···························································· ································ 3 7.2 手术步骤 ·············································································································· 3 8 手术并发症的随访及评估 ······························································································ 5 8.1 围手术期管理 ········································································································ 5 8.2 术后随访及评估 ·········· ··························································································· 5 参考文献 ························································································································ 8 全国团体标准信息平台 T/GDMDMA 0046—2025 Ⅱ全国团体标准信息平台 T/GDMDMA 0046—2025 Ⅲ前   言 本文件按照GB/T 1.1—2020《标准化工作导则 第1部分：标准化文件的结构和起草规则》的规定 起草。 请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。 本文件由中国医学科学院北京协和医院提出。 本文件由广东省医疗器械管理学会归口。本文件起草单位：中国医学科学院北京协和医院、复旦大学附属妇产科医院、上海市第六人民医 院、武汉大学人民医院、江西省妇幼保健院、重庆市妇幼保健院、同济大学附属同济医院、宁夏医科 大学总医院、北京大学人民医院、哈尔滨医科大学附属第二医院、南京市第一医院、昆明医科大学附 属延安医院、无锡市妇幼保健院、新疆医科大学第一附属医院、国家药品监督管理局药品评价中心 （国家药品不良反应监测中心 ）。 本文件主要起草人：朱兰、梁硕、史宏晖、张志博、周莹、夏志军、吴氢凯、洪莉、汪利群、刘 禄斌、李怀芳、哈春芳、杨欣、李佩玲、谢静燕、韩雪松、陈艳琴、祖菲娅、赵燕、赵一飞、 李栋。 全国团体标准信息平台 6T/GDMDMA 0046—2025 Ⅳ引   言 与其他治疗盆腔脏器脱垂的手术方式相比，经阴道网片植入的盆底重建术治愈率高、复发率低、 操作简单、微创、无需另外获取自体组织，自2002年上市后的二十年里得到了全球各国医生的广泛应 用。Ⅰ级证据表明经阴道网片植入术疗效确切、降低解剖学复发率。但随着经阴道网片植入术在临床 上迅速推广应用，不良事件不断增多，尤其网片暴露、疼痛等并发症给患者造成的危害，引发了美国 食品药品监督管理局（Food and Drug Administration， FDA）对阴道网片使用安全性的多次警示，并于 2019年4月下令停止经阴道网片套盒在美国本土销售。随后，澳洲、新西兰、加拿大、英国等也相继 颁布了禁令。但我国、日本和韩国为主的亚洲国家、德国及南美洲国家仍在开展经阴道网片植入盆底 重建术。采用经阴道网片开展经阴道网片植入的盆底重建术是妇科泌尿领域争议最大的术式。 鉴于经阴道网片植入术在全球女性盆底重建手术实践不同发展时期作用的特殊性，以及该术式确 切的长期疗效及不容忽视的术后并发症，本着病人利益最大化的医疗