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胃内球囊用于减重的临床研究进展

康军仁 徐强 李海龙 魏薇

康军仁, 徐强, 李海龙, 魏薇. 胃内球囊用于减重的临床研究进展[J]. 协和医学杂志, 2023, 14(3): 591-597. doi: 10.12290/xhyxzz.2022-0486
引用本文: 康军仁, 徐强, 李海龙, 魏薇. 胃内球囊用于减重的临床研究进展[J]. 协和医学杂志, 2023, 14(3): 591-597. doi: 10.12290/xhyxzz.2022-0486
KANG Junren, XU Qiang, LI Hailong, WEI Wei. Clinical Research Progress of the Intragastric Balloon for Weight Loss[J]. Medical Journal of Peking Union Medical College Hospital, 2023, 14(3): 591-597. doi: 10.12290/xhyxzz.2022-0486
Citation: KANG Junren, XU Qiang, LI Hailong, WEI Wei. Clinical Research Progress of the Intragastric Balloon for Weight Loss[J]. Medical Journal of Peking Union Medical College Hospital, 2023, 14(3): 591-597. doi: 10.12290/xhyxzz.2022-0486

胃内球囊用于减重的临床研究进展

doi: 10.12290/xhyxzz.2022-0486
基金项目: 

中央高水平医院临床科研业务费项目 2022-PUMCH-A-061

详细信息
    通讯作者:

    康军仁, E-mail: kangjunren@pumch.cn

  • 中图分类号: R459.3;R589

Clinical Research Progress of the Intragastric Balloon for Weight Loss

Funds: 

National High Level Hospital Clinical Research Funding 2022-PUMCH-A-061

More Information
  • 摘要: 胃内球囊是一种无创的肥胖症治疗策略。通过在胃内放置球囊,限制容量和延缓胃排空可实现减重目的,临床上适用于单纯通过饮食和运动未能减重成功,或不愿意接受减重手术的肥胖症患者,也可用于减重手术术前先期减重的过渡性治疗。胃内球囊留置期内减重效果良好,严重并发症发生率低,但长期减重及改善代谢效果尚需更多临床研究加以验证。目前胃内球囊在我国尚未获批应用于临床。本文对胃内球囊的适应证、禁忌证、减重效果及相关并发症进行综述,以期指导临床实践。
    作者贡献:康军仁负责构思、起草、修订论文;徐强、李海龙负责查阅、整理文献资料,修订初稿和写作指导;魏薇负责查阅、整理文献资料及论文修订。
    利益冲突:所有作者均声明不存在利益冲突
  • 表  1  常见胃内球囊及其特征

    球囊种类 放置/移除 材质 球囊体积(mL) 球囊数目(个) 内容物 可调节 留置时间 批准上市机构
    Orbera 胃镜/胃镜 硅胶 400~700 1 盐水+10 mL亚甲蓝 6个月 美国FDA
    Orbera365 胃镜/胃镜 硅胶 400~700 1 盐水+10 mL亚甲蓝 12个月 美国FDA
    ReShape Duo 胃镜/胃镜 硅胶 450/个 2 盐水 6个月 美国FDA
    Obalon 吞咽/胃镜 聚乙烯混合物 250/个 3 氮气 6个月 美国FDA
    Spatz3 胃镜/胃镜 硅胶 400~550 1 盐水 12个月 欧盟
    Elipse 吞咽/自行排出 高分子聚合物 450~550 1 盐水 4个月 欧盟
    FDA:食品药品监督管理局
    下载: 导出CSV

    表  2  常见胃内球囊减重效果及其并发症发生率(%)

    球囊种类 取出时减重 恶心呕吐 不耐受提前移除 器械并发症 胰腺炎 胃溃疡 胃肠穿孔 肠梗阻
    Orbera[27, 31-36] TWL:13.2/EWL:42.34 - 7.5~18.8 3.1 - 2 0.1 -
    Orbera365[30] TWL:16.2/EWL:54.6 - 14.4 7.2 2.1 - - -
    ReShape Duo[24, 28, 37] TWL:6.8~15.4/EWL:25.1~47.1 22.9 9 15 - 2.9~23.3 1.7 2.9
    Obalon[38-39] TWL:7.1~10.3 91.1 0.22 0.18 - 0.2 0.07 -
    Spatz3[14, 26, 40-41] TWL:19/EWL:45.7 - 17~30 4.3 - 2.9~3.33 - -
    Elipse[25, 29, 42] TWL:12.8~14.2/EWL:49.1~67 - 2.3~3.6 0.6 0.06 0.06 0.05 0.15
    TWL: 总体质量减少百分比;EWL:额外体质量减少百分比;-:文献未提及
    下载: 导出CSV

    表  3  胃内球囊与减重手术比较

    项目 胃内球囊 减重手术
    适应证 (1)BMI 30~40 kg/m2,经严格的饮食生活方式或药物干预无效的人群;(2)BMI≥40 kg/m2,拒绝手术或有手术禁忌证的人群;(3)BMI≥50 kg/m2,减重手术术前进行先期诱导性减重治疗[7, 17-18] (1)BMI≥37.5 kg/m2的单纯肥胖患者,建议积极手术;(2)BMI 32.5~37.5 kg/m2,推荐手术;BMI 27.5~32.5 kg/m2,经改变生活方式和内科治疗难以控制,且至少符合2项代谢综合征组分或存在合并症[6]
    主要并发症 胃肠道症状(91%),球囊破裂和移位(0.6%~15%),胃肠道梗阻(0.15%~2.9%),胃溃疡(2.9%~3.33%),消化道穿孔(0.05%~1.7%),胰腺炎(2.1%)[9, 24-30, 40] 早期并发症,如消化道漏(0.7%~7.0%)、胃出血(0.7%~4.4%)、静脉血栓栓塞(0.3%~1.3%)、吻合口狭窄(3%~6%)、内疝与肠梗阻(1.3%~4.4%);远期并发症,如吻合口溃疡(4.0%~7.0%)、倾倒综合征、胆管结石、营养不良、胃食管反流等[6]
    治疗糖尿病 尚需验证 标准治疗
    长期减重效果 尚需验证,球囊取出后长期随访研究较少:一项随访2年的研究显示患者减重和代谢获益并未维持[16];另一项随访5年的研究发现,额外体质量减轻13.0%[34] 长期减重效果显著, 术后长期随访研究较多:一项随访10年得随机对照研究结果显示患者仍可减重28%[4]
    BMI: 体质量指数
    下载: 导出CSV
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  • 收稿日期:  2022-08-29
  • 录用日期:  2022-11-16
  • 网络出版日期:  2023-04-26
  • 刊出日期:  2023-05-30

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