肩袖补片的治疗现状及研究进展：Meta分析与文献综述

doi:10.3877/cma.j.issn.2095-5790.2023.03.010

目的

分析近年针对肩袖损伤行肩袖补片或非补片修复手术的对照试验，对治疗效果进行Meta分析，为选择恰当的手术方式提供参考；回顾近五年（2018~2022年）有关肩袖补片的研究，并比较不同补片类型之间的差异，探究不同补片的临床应用场景，揭示未来的研究方向。

方法

在文献数据库PubMed、Web of Science、中国知网中筛选相关文献，提取数据，采用Revman5.4进行Meta分析，比较肩袖补片手术与常规修复手术的临床结局，进行系统评价。

结果

共筛选出9篇文献进行Meta分析。与对照组相比，肩袖补片组的再撕裂率显著降低[OR=0.18, 95% CI （0.09, 0.35）, P<0.00001]；术后0~12个月、24个月及以上的随访中视觉模拟评分均无显著差异[MD= -0.28, 95% CI（-1.00, 0.44）, P=0.45]、[MD=-1.72, 95% CI（-3.82, 0.37）, P=0.11]；术后6个月、24个月及以上随访的Constant-Murley肩关节评分均有显著提高[MD=2.68, 95% CI（1.23, 4.13）, P=0.0003]、[MD=1.38, 95% CI（0.22, 2.54）, P=0.02]，但术后12个月随访的Constant-Murley肩关节评分无显著差异[MD=1.53, 95% CI（-1.74, 4.81）, P=0.36]；术后0~12个月、24个月及以上美国肩肘协会评分均无显著差异[MD=1.84, 95% CI （-1.60, 5.29）, P=0.29]、[MD=6.83, 95% CI （-0.10, 13.77）, P=0.05]；术后0~12个月西安大略肩袖疾病评分指数无显著差异[MD=3.25, 95% CI （-15.45, 21.94）, P=0.73]，但术后24个月及以上西安大略肩袖疾病评分指数显著提高[MD=15.45, 95% CI （1.50, 29.34）, P=0.03]；术后肩关节前屈及外旋均无显著差异[MD=6.26, 95% CI（-9.52, 22.03）, P=0.44]、[MD=-5.29, 95% CI（-10.66, 0.08）, P=0.05]。

结论

补片修复能够提高肩袖撕裂修复的临床结局，降低再撕裂率。补片类型和手术技术的选择还有待进一步的临床研究。

关键词: 肩袖补片, Meta分析, 肩袖撕裂, 肌腱-骨界面

Background

Rotator cuff tears are a common cause of shoulder dysfunction, and their prevalence is difficult to quantify, ranging from 20.7% in a study of 683 subjects to 22% in 104 subjects aged 65 years and older. The main symptoms of rotator cuff tears are pain and limited mobility, and risk factors include advanced age and certain occupations. The treatment of rotator cuff tears includes non-surgical treatment and surgical treatment. Currently, surgical treatment is the primary treatment, and the repair technique is determined by the thickness, size, and shape of the tear, but the retear rate of conventional repair surgery is very high. In recent years, research on rotator cuff patches has led to new solutions, especially for patients with large rotator cuff tears, which promote healing of the tendon-bone interface and provide higher biomechanical stability. There are generally three types of mesh materials: heterogeneous mesh, allograft (allogeneic, autograft) , and synthetic mesh. Several studies have shown that these types of rotator cuff patches can improve clinical outcomes. There are still some controversies regarding the clinical efficacy of the rotator cuff patch and the possible inflammatory reaction. The research of rotator cuff patches is still a new technique in the repair of rotator cuff tears.

Objective

To investigate the controlled trials of rotator cuff patch or non-patch repair for rotator cuff injury in recent years and to perform a Meta-analysis of the therapeutic effect to provide a reference for selecting the appropriate surgical method; to review the research on rotator cuff patch in the past five years (2018-2022) , and to compare the differences between different patch types, to explore the clinical application scenarios of different patches, and to reveal the future research direction.

Methods

The relevant literature was screened in PubMed, Web of Science, and CNKI, the data were extracted, and a meta-analysis was performed with Revman 5.4 to compare the clinical outcomes of rotator cuff patch surgery and conventional repair surgery for systematic review.

Results

A total of 9 articles were selected for Meta-analysis. Compared with the control group, the rotator cuff patch group had a significantly lower retear rate [OR = 0.18, 95% CI (0.09, 0.35) , P < 0.00001] ; there were no significant differences in visual analogue scale scores during follow-up at 0-12 months and more than 24 months (including 24 months) after surgery [MD = -0.28, 95% CI (-1.00, 0.44) , P = 0.45] , [MD = -1.72, 95% CI (-3.82, 0.37) , P = 0.11] ; Constant-Murley scores were significantly increased at 6 months and more than 24 months (including 24 months) after surgery [MD = 2.68, 95% CI (1.23, 4.13) , P = 0.0003] , [MD = 1.38, 95% CI (0.22, 2.54) , P = 0.02] . However, there was no significant difference in Constant-Murley scores during follow-up at 12 months after surgery [MD = 1.53, 95% CI (-1.74, 4.81) , P = 0.36] ; there was no significant difference in American shoulder and elbow surgeons scores during follow-up at 0-12 months and more than 24 months (including 24 months) after surgery [MD = 1.84, 95% CI (-1.60, 5.29) , P = 0.29] , [MD = 6.83, 95% CI (-0.10, 13.77) , P = 0.05] ; there was no significant difference in western ontario rotator cuff index during follow-up at 0-12 months after surgery [MD = 3.25, 95% CI (-15.45, 21.94) , P = 0.73] , but it increased significantly during follow-up at more than 24 months (including 24 months) after surgery [MD = 15.45, 95% CI (1.50, 29.34) , P = 0.03] ; postoperative shoulder flexion and external rotation were not significantly different [MD = 6.26, 95% CI (-9.52, 22.03) , P = 0.44] , [MD = -5.29, 95% CI (10.66, 0.08) , P = 0.05] .

Conclusion

Patch repair can improve the clinical outcome of rotator cuff tear repair and reduce the retear rate. The choice of patch type and surgical technique remains to be further investigated clinically.

Key words: Rotator cuff patch, Meta-analysis, Rotator cuff tear, Tendon-bone surface

图1 文献筛选流程图

表1 纳入文献的基本特征

作者	年份	组别	例数	平均年龄（岁）	撕裂范围（cm）	失访例数	随访时间（月）	研究设计类型
Lee等^[12]	2022	同种异体材料CGDerm	30	60.2±8.4	3.46±0.56	8	68.4±12.0	随机对照试验
		常规修复手术	30	58.3±7.0	3.30±0.44	9
Avanzi等^[13]	2019	猪真皮补片	46	68±4		8	24	随机对照试验
		常规修复手术	46	66±5.5		15
Barber等^[14]	2012	GraftJacket脱细胞人真皮基质	22	56	3.1±1.4	0	24	随机对照试验
		常规修复手术	20	56	2.4±1.0	0
Bryant等^[15]	2016	小肠黏膜下层	34	55.3±11.3	3.1±1.4	0		随机对照试验
		常规修复手术	28	58.3±10.2	2.9±1.2	0
Cowling等^[16]	2020	Leeds Kuff合成补片	29	65.17±8.98	>5	1	6	非随机对照试验
		常规修复手术	39	65.38±9.44	>5	10
Flury等^[8]	2018	DX强化基质补片（猪真皮）	20	65.4±3.3		2	24	回顾性队列研究
		常规修复手术	20	67.6±3.1		0
Cai等^[17]	2018	3D I型胶原蛋白补片	54	62.9±9.7	4.6±1.6	3	28.2	随机对照试验
		常规修复手术	58	61.3±7.6	4.4±1.1	5
Wong等^[18]	2021	同种异体真皮组织GraftJacket	14	59.10±8.81		0	24	随机对照试验
		常规修复手术	15	60.86±6.67		0	24
Gilot等^[19]	2015	ArthroFlex脱细胞真皮基质	20	58.9±6.2	3.51	0	24.0±1.6	非随机对照试验
		常规修复手术	15	62±4.6	3.43	0	25.0±0.8

表1 纳入文献的基本特征

作者	年份	组别	例数	平均年龄（岁）	撕裂范围（cm）	失访例数	随访时间（月）	研究设计类型
Lee等^[12]	2022	同种异体材料CGDerm	30	60.2±8.4	3.46±0.56	8	68.4±12.0	随机对照试验
		常规修复手术	30	58.3±7.0	3.30±0.44	9
Avanzi等^[13]	2019	猪真皮补片	46	68±4		8	24	随机对照试验
		常规修复手术	46	66±5.5		15
Barber等^[14]	2012	GraftJacket脱细胞人真皮基质	22	56	3.1±1.4	0	24	随机对照试验
		常规修复手术	20	56	2.4±1.0	0
Bryant等^[15]	2016	小肠黏膜下层	34	55.3±11.3	3.1±1.4	0		随机对照试验
		常规修复手术	28	58.3±10.2	2.9±1.2	0
Cowling等^[16]	2020	Leeds Kuff合成补片	29	65.17±8.98	>5	1	6	非随机对照试验
		常规修复手术	39	65.38±9.44	>5	10
Flury等^[8]	2018	DX强化基质补片（猪真皮）	20	65.4±3.3		2	24	回顾性队列研究
		常规修复手术	20	67.6±3.1		0
Cai等^[17]	2018	3D I型胶原蛋白补片	54	62.9±9.7	4.6±1.6	3	28.2	随机对照试验
		常规修复手术	58	61.3±7.6	4.4±1.1	5
Wong等^[18]	2021	同种异体真皮组织GraftJacket	14	59.10±8.81		0	24	随机对照试验
		常规修复手术	15	60.86±6.67		0	24
Gilot等^[19]	2015	ArthroFlex脱细胞真皮基质	20	58.9±6.2	3.51	0	24.0±1.6	非随机对照试验
		常规修复手术	15	62±4.6	3.43	0	25.0±0.8

图2 偏倚风险图

图3 总结性偏倚风险图

表2 非随机干预研究风险偏倚评价工具（ROBINS-1）

作者	年份	混杂偏倚	受试者选择偏倚	干预分类偏倚	暴露偏差偏倚	数据缺失偏倚	结局测量偏倚	选择性报道偏倚
Cowling等^[16]	2020	低偏倚	低偏倚	低偏倚	低偏倚	中偏倚	低偏倚	低偏倚
Flury等^[8]	2018	低偏倚	低偏倚	低偏倚	低偏倚	低偏倚	低偏倚	低偏倚
Gilot等^[19]	2015	低偏倚	低偏倚	低偏倚	低偏倚	低偏倚	低偏倚	低偏倚

表2 非随机干预研究风险偏倚评价工具（ROBINS-1）

作者	年份	混杂偏倚	受试者选择偏倚	干预分类偏倚	暴露偏差偏倚	数据缺失偏倚	结局测量偏倚	选择性报道偏倚
Cowling等^[16]	2020	低偏倚	低偏倚	低偏倚	低偏倚	中偏倚	低偏倚	低偏倚
Flury等^[8]	2018	低偏倚	低偏倚	低偏倚	低偏倚	低偏倚	低偏倚	低偏倚
Gilot等^[19]	2015	低偏倚	低偏倚	低偏倚	低偏倚	低偏倚	低偏倚	低偏倚

图4 肩袖补片与常规修复手术术后再撕裂率比较的Meta分析

图5 肩袖补片与常规修复手术术后VAS比较的Meta分析　图A：术后0~12个月；图B：术后24个月及以上注：VAS为视觉模拟量表

图6 肩袖补片与常规修复手术术后CMS比较的Meta分析　图A：术后6个月；图B：术后12个月；图C：术后24个月及以上注：CMS为Constant-Murley肩关节评分

图7 肩袖补片与常规修复手术术后ASES比较的Meta分析　图A：术后0~12个月；图B：术后24个月及以上注：ASES为美国肩肘外科协会评分

图8 肩袖补片与常规修复手术术后WORC比较的Meta分析　图A：术后0~12个月；图B：术后24个月及以上注:WORC为西安大略肩袖疾病评分指数

图9 肩袖补片与常规修复手术术后肩关节活动度比较的Meta分析　图A：前屈；图B：外旋

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Treatment and research progress of rotator cuff patch: a systematic review and meta-analysis

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Treatment and research progress of rotator cuff patch: a systematic review and meta-analysis