补片在食管裂孔疝修补中的临床价值与安全性：系统评价与Meta分析

doi:10.3877/cma.j.issn.1674-0793.2026.05.011

目的

系统评价与比较食管裂孔疝（HH）修补术中应用补片（合成、生物或可吸收）与单纯缝合修补的疗效与安全性。

方法

计算机系统检索PubMed、Embase、Cochrane Library、Web of Science、中国知网（CNKI）、中国生物医学文献服务系统、万方数据知识服务平台、维普中文期刊服务平台。检索时限均从建库至2025年12月10日，搜集比较补片修补与单纯缝合修补治疗HH的随机对照试验（RCT）。对符合纳入标准的资料提取数据并采用Cochrane偏倚风险与质量评估工具（RoB 2）评估后，使用RevMan 5.4.1软件进行Meta分析。主要结局指标为影像学或内镜证实的解剖复发率，次要结局包括吞咽困难发生率、再手术率、术中并发症等。采用随机效应模型或固定效应模型合并效应量，并按照补片材质（可吸收/不可吸收）进行亚组分析。

结果

共纳入10篇文献汇报8项RCTs的近远期随访结果，共768例患者，其中补片组421例，单纯缝合组347例。在降低术后解剖复发率方面，共8项RCTs报告了术后近期（<1年）的解剖学复发率，各研究间存在中度异质性（I²=57%，P=0.02）。在随机效应模型下，补片组的近期复发风险显著降低（合并OR=0.41，95% CI：0.18~0.92，P=0.03），共3项RCTs报告了HH修补术后远期（随访时间>3年）的解剖学复发率，其中补片组215例，缝合组211例。各研究间无异质性（I²=0，P=0.77）。基于补片可吸收性的亚组分析显示，可吸收补片与不可吸收补片在降低近期复发率的效果上差异无统计学意义（P=0.45），住院时间组间差异无统计学意义（P=0.485）。由于数据报告形式异质性大，未进行定量合并分析。

结论

HH修补术中应用补片的益处具有明显的材料依赖性和时间依赖性。不可吸收合成补片能显著降低近期复发风险，而可吸收生物补片的疗效未获证实，补片的长期耐久性证据不足。未来需要更多高质量、长期随访的RCT进一步验证不同补片的远期效果。

关键词: 疝，食管裂孔, 疝修补术, 外科补片, 随机对照试验, Meta分析

Objective

To systematically evaluate the efficacy and safety of mesh (synthetic, biological or absorbable) reinforcement versus suture-only repair in the surgical treatment of hiatal hernia (HH).

Methods

A comprehensive literature search was conducted in PubMed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang Data, CBMdisc and VIP Chinese Journal Service Platform from inception to September 10, 2025 for randomized controlled trials (RCTs) comparing mesh-augmented HH repair with suture-only repair. After screened studies, data were extracted and assessed the risk of bias using the Cochrane RoB 2 tool. Meta-analysis was performed using RevMan 5.4.1 software. The primary outcome was radiologically or endoscopically confirmed anatomical recurrence. Secondary outcomes included incidence of dysphagia, reoperation rate, intraoperative complications, et al. Pooled risk ratios (RR) or mean differences (MD) with 95% confidence intervals (CI) were calculated using fixed-effect or random-effects models. Pre-specified subgroup analyses were conducted based on mesh material (absorbable or non-absorbable).

Results

A total of 10 publications reporting outcomes from 8 RCTs follow-up were included, involving 768 patients. The mesh group consisted of 421 patients, while the suture group 347 patients. Regarding the reduction of postoperative anatomical recurrence rates, eight RCTs reported short-term (<1 year) recurrence. The initial meta-analysis indicated moderate heterogeneity among studies (I²=57%, P=0.02). Under a random-effects model, the mesh group demonstrated significant reduction in short-term recurrence risk (pooled OR=0.41, 95% CI: 0.18-0.92, P=0.03). Three RCTs reported mid- to long-term anatomical recurrence rates (follow-up >3 years), involving 215 patients in the mesh group and 211 in the suture group. No heterogeneity was observed among these studies (I²=0, P=0.77). A subgroup analysis based on mesh absorbability showed no significant difference between absorbable and non-absorbable meshes in the effect of reducing short-term recurrence (P=0.45). There was no statistically significant difference in hospital stay length between the two groups (P=0.485). Due to significant heterogeneity in data reporting formats, no quantitative pooled analysis was performed for this outcome.

Conclusions

In the surgical treatment of HH, the benefits of mesh reinforcement exhibit clear material-dependency and time-dependency. Non-absorbable synthetic mesh significantly reduces short-term recurrence risk, whereas the efficacy of absorbable biological mesh remains unconfirmed. Furthermore, evidence regarding the long-term durability of mesh is insufficient. Future high-quality RCTs with extended follow-up are required to validate the long-term outcomes of different mesh types.

Key words: Hernia, hiatal, Herniorrhaphy, Surgical mesh, Randomized controlled trial, Meta-analysis

图1 文献筛选流程

表1 纳入的随机对照试验的基本特征

第一作者（年）	补片组（421例）	单纯缝合组（347例）	随访时间点	疝囊大小(cm)
Analatos 2024^［11］	82	77	1、3、13年	>2
Carlson 1999^［15］	15	16	6个月	≥8
Frantzides 2002^［12］	36	36	6个月	>8
Granderath 2005^［16］	50	50	4周至9个月	—
Oelschlager 2006^［4］	51	57	6个月	>5
Oelschlager 2011^［7］	51	57	51个月	>5
Oor 2018^［13］	36	36	6个月	>5
Watson 2015^［10］	83	43	6个月	≥50%的胃疝入胸腔
Watson 2021^［3］	83	43	3~4年	≥50%的胃疝入胸腔
范嘉俊 2020^［14］	68	32	1年	—

表1 纳入的随机对照试验的基本特征

第一作者（年）	补片组（421例）	单纯缝合组（347例）	随访时间点	疝囊大小(cm)
Analatos 2024^［11］	82	77	1、3、13年	>2
Carlson 1999^［15］	15	16	6个月	≥8
Frantzides 2002^［12］	36	36	6个月	>8
Granderath 2005^［16］	50	50	4周至9个月	—
Oelschlager 2006^［4］	51	57	6个月	>5
Oelschlager 2011^［7］	51	57	51个月	>5
Oor 2018^［13］	36	36	6个月	>5
Watson 2015^［10］	83	43	6个月	≥50%的胃疝入胸腔
Watson 2021^［3］	83	43	3~4年	≥50%的胃疝入胸腔
范嘉俊 2020^［14］	68	32	1年	—

表2 纳入研究的临床特征与结局数据

第一作者（年）	干预组平均年龄(岁)	对照组平均年龄(岁)	干预组描述	对照组描述	结局类别	干预组事件数	对照组事件数	干预组住院时间(d)	对照组住院时间(d)	干预组手术时长（min）	对照组手术时长（min）
Analatos 2024^［11］	60.0 ± 12.7	59.5 ± 12.9	PTFE补片，环形，缝合+订仓固定	不可吸收线三线间断缝合	复发	1年:3/41，3年:4/39,13年:11/29	1年:1/45,3年:3/44,13年:11/35	2 (2~3)	2 (2~3)	—	—
Carlson 1999^［15］	—	—	PTFE补片，椭圆形，吻合器固定	不可吸收线双侧膈肌脚加固缝合	复发	0	3	—	—	—	—
Frantzides 2002^［12］	58(36~92)	63(42~81)	PTFE补片，椭圆形，吻合器固定	不可吸收线双侧膈肌脚加固缝合	复发	0	8	2	2	156 ± 30	126 ± 18
Granderath 2005^［16］	48.7(24~73)	48.3(22~71)	聚丙烯补片缝合固定	膈肌角单纯缝合	复发	4	13	—	—	56	58
Oelschlager 2006^［4］	67±11	64± 13	SIS生物补片，U型，缝合固定	单纯后瓣缝合	复发	4/45	12/50	—	—	201±69	185±66
Oelschlager 2011^［7］	64± 10	63± 10	SIS生物补片，U型，缝合固定	单纯后瓣缝合	复发	14/26	20/34			201±69	185±66
Oor 2018^［13］	67.0 ± 10.6	66.1 ± 10.1	不可吸收补片，U型，缝合固定	单纯缝合（膈肌后脚缝合必要时辅以前脚缝合）	复发	8/32	7/36	—	—	61.3(54.7~67.9)	69.3(58.2~80.4)
Watson 2015^［10］	可吸收补片: 69 (58~84)不可吸收补片: 69 (48~81)	70(52~81)	41可吸收补片, 42 不可吸收补片，缝合膈肌角	单纯缝合（膈肌后脚缝合必要时辅以前脚缝合）	复发	可吸收补片：12/39 不可吸收补片：5/39	9/39	2 (1~14)	2 (1~8)	可吸收补片: 110.3 (96.7~123.9)不可吸收补片: 111.8 (102.2~132.1)	111.8(91.0~132.7)
Watson 2021^［3］	可吸收补片:69 (58-84)不可吸收补片:69 (48-81)	70(52~81)	41可吸收补片, 42 不可吸收补片，缝合膈肌角	单纯缝合（膈肌后脚缝合必要时辅以前脚缝合）	复发	可吸收补片：17/30 不可吸收补片：12/28	11/28	2 (1~15)	2 (1~9)	可吸收补片: 110.3 (96.7~123.9)不可吸收补片: 111.8 (102.2~132.1)	111.8 (91.0~132.7)
范嘉俊 2020^［14］	68.38 ± 11.49	67.20 ± 12.66	巴德布片（聚丙烯补片）补片修补钉枪固定	不可吸收线间断缝合	复发	2/68	8/30	7.32 ± 6.33	6.13 ± 2.36	167.85 ± 72.19	117.67 ± 29.87

表2 纳入研究的临床特征与结局数据

第一作者（年）	干预组平均年龄(岁)	对照组平均年龄(岁)	干预组描述	对照组描述	结局类别	干预组事件数	对照组事件数	干预组住院时间(d)	对照组住院时间(d)	干预组手术时长（min）	对照组手术时长（min）
Analatos 2024^［11］	60.0 ± 12.7	59.5 ± 12.9	PTFE补片，环形，缝合+订仓固定	不可吸收线三线间断缝合	复发	1年:3/41，3年:4/39,13年:11/29	1年:1/45,3年:3/44,13年:11/35	2 (2~3)	2 (2~3)	—	—
Carlson 1999^［15］	—	—	PTFE补片，椭圆形，吻合器固定	不可吸收线双侧膈肌脚加固缝合	复发	0	3	—	—	—	—
Frantzides 2002^［12］	58(36~92)	63(42~81)	PTFE补片，椭圆形，吻合器固定	不可吸收线双侧膈肌脚加固缝合	复发	0	8	2	2	156 ± 30	126 ± 18
Granderath 2005^［16］	48.7(24~73)	48.3(22~71)	聚丙烯补片缝合固定	膈肌角单纯缝合	复发	4	13	—	—	56	58
Oelschlager 2006^［4］	67±11	64± 13	SIS生物补片，U型，缝合固定	单纯后瓣缝合	复发	4/45	12/50	—	—	201±69	185±66
Oelschlager 2011^［7］	64± 10	63± 10	SIS生物补片，U型，缝合固定	单纯后瓣缝合	复发	14/26	20/34			201±69	185±66
Oor 2018^［13］	67.0 ± 10.6	66.1 ± 10.1	不可吸收补片，U型，缝合固定	单纯缝合（膈肌后脚缝合必要时辅以前脚缝合）	复发	8/32	7/36	—	—	61.3(54.7~67.9)	69.3(58.2~80.4)
Watson 2015^［10］	可吸收补片: 69 (58~84)不可吸收补片: 69 (48~81)	70(52~81)	41可吸收补片, 42 不可吸收补片，缝合膈肌角	单纯缝合（膈肌后脚缝合必要时辅以前脚缝合）	复发	可吸收补片：12/39 不可吸收补片：5/39	9/39	2 (1~14)	2 (1~8)	可吸收补片: 110.3 (96.7~123.9)不可吸收补片: 111.8 (102.2~132.1)	111.8(91.0~132.7)
Watson 2021^［3］	可吸收补片:69 (58-84)不可吸收补片:69 (48-81)	70(52~81)	41可吸收补片, 42 不可吸收补片，缝合膈肌角	单纯缝合（膈肌后脚缝合必要时辅以前脚缝合）	复发	可吸收补片：17/30 不可吸收补片：12/28	11/28	2 (1~15)	2 (1~9)	可吸收补片: 110.3 (96.7~123.9)不可吸收补片: 111.8 (102.2~132.1)	111.8 (91.0~132.7)
范嘉俊 2020^［14］	68.38 ± 11.49	67.20 ± 12.66	巴德布片（聚丙烯补片）补片修补钉枪固定	不可吸收线间断缝合	复发	2/68	8/30	7.32 ± 6.33	6.13 ± 2.36	167.85 ± 72.19	117.67 ± 29.87

图2 偏倚风险与质量评估

图3 术后1年内的解剖学复发率分析

图4 近期复发率敏感性分析

图5 可吸收补片与不可吸收补片的近期复发率亚组分析

图6 可吸收补片与不可吸收补片的近期复发率亚组敏感性分析

图7 补片组和单纯缝合组远期复发率分析

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Clinical value and safety of mesh in hiatal hernia repair: A systematic review and meta-analysis

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Clinical value and safety of mesh in hiatal hernia repair: A systematic review and meta-analysis