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关节镜手术治疗退行性膝关节疾病(骨关节炎,包括退行性半月板撕裂)。

Arthroscopic surgery for degenerative knee disease (osteoarthritis including degenerative meniscal tears).

机构信息

Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University; Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology, Cabrini Health, Melbourne, Australia.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.

出版信息

Cochrane Database Syst Rev. 2022 Mar 3;3(3):CD014328. doi: 10.1002/14651858.CD014328.

Abstract

BACKGROUND

Arthroscopic knee surgery remains a common treatment for symptomatic knee osteoarthritis, including for degenerative meniscal tears, despite guidelines strongly recommending against its use. This Cochrane Review is an update of a non-Cochrane systematic review published in 2017.

OBJECTIVES

To assess the benefits and harms of arthroscopic surgery, including debridement, partial menisectomy or both, compared with placebo surgery or non-surgical treatment in people with degenerative knee disease (osteoarthritis, degenerative meniscal tears, or both).

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and two trials registers up to 16 April 2021, unrestricted by language.

SELECTION CRITERIA

We included randomised controlled trials (RCTs), or trials using quasi-randomised methods of participant allocation, comparing arthroscopic surgery with placebo surgery or non-surgical interventions (e.g. exercise, injections, non-arthroscopic lavage/irrigation, drug therapy, and supplements and complementary therapies) in people with symptomatic degenerative knee disease (osteoarthritis or degenerative meniscal tears or both). Major outcomes were pain, function, participant-reported treatment success, knee-specific quality of life, serious adverse events, total adverse events and knee surgery (replacement or osteotomy).

DATA COLLECTION AND ANALYSIS

Two review authors independently selected studies for inclusion, extracted data, and assessed risk of bias and the certainty of evidence using GRADE. The primary comparison was arthroscopic surgery compared to placebo surgery for outcomes that measured benefits of surgery, but we combined data from all control groups to assess harms and knee surgery (replacement or osteotomy).

MAIN RESULTS

Sixteen trials (2105 participants) met our inclusion criteria. The average age of participants ranged from 46 to 65 years, and 56% of participants were women. Four trials (380 participants) compared arthroscopic surgery to placebo surgery. For the remaining trials, arthroscopic surgery was compared to exercise (eight trials, 1371 participants), a single intra-articular glucocorticoid injection (one trial, 120 participants), non-arthroscopic lavage (one trial, 34 participants), non-steroidal anti-inflammatory drugs (one trial, 80 participants) and weekly hyaluronic acid injections for five weeks (one trial, 120 participants). The majority of trials without a placebo control were susceptible to bias: in particular, selection (56%), performance (75%), detection (75%), attrition (44%) and selective reporting (75%) biases. The placebo-controlled trials were less susceptible to bias and none were at risk of performance or detection bias. Here we limit reporting to the main comparison, arthroscopic surgery versus placebo surgery. High-certainty evidence indicates arthroscopic surgery leads to little or no difference in pain or function at three months after surgery, moderate-certainty evidence indicates there is probably little or no improvement in knee-specific quality of life three months after surgery, and low-certainty evidence indicates arthroscopic surgery may lead to little or no difference in participant-reported success at up to five years, compared with placebo surgery. Mean post-operative pain in the placebo group was 40.1 points on a 0 to 100 scale (where lower score indicates less pain) compared to 35.5 points in the arthroscopic surgery group, a difference of 4.6 points better (95% confidence interval (CI) 0.02 better to 9 better; I = 0%; 4 trials, 309 participants). Mean post-operative function in the placebo group was 75.9 points on a 0 to 100 rating scale (where higher score indicates better function) compared to 76 points in the arthroscopic surgery group, a difference of 0.1 points better (95% CI 3.2 worse to 3.4 better; I = 0%; 3 trials, 302 participants). Mean post-operative knee-specific health-related quality of life in the placebo group was 69.7 points on a 0 to 100 rating scale (where higher score indicates better quality of life) compared with 75.3 points in the arthroscopic surgery group, a difference of 5.6 points better (95% CI 0.36 better to 10.68 better; I = 0%; 2 trials, 188 participants). We downgraded this evidence to moderate certainty as the 95% confidence interval does not rule in or rule out a clinically important change. After surgery, 74 out of 100 people reported treatment success with placebo and 82 out of 100 people reported treatment success with arthroscopic surgery at up to five years (risk ratio (RR) 1.11, 95% CI 0.66 to 1.86; I = 53%; 3 trials, 189 participants). We downgraded this evidence to low certainty due to serious indirectness (diversity in definition and timing of outcome measurement) and serious imprecision (small number of events). We are less certain if the risk of serious or total adverse events increased with arthroscopic surgery compared to placebo or non-surgical interventions. Serious adverse events were reported in 6 out of 100 people in the control groups and 8 out of 100 people in the arthroscopy groups from eight trials (RR 1.35, 95% CI 0.64 to 2.83; I = 47%; 8 trials, 1206 participants). Fifteen out of 100 people reported adverse events with control interventions, and 17 out of 100 people with surgery at up to five years (RR 1.15, 95% CI 0.78 to 1.70; I = 48%; 9 trials, 1326 participants). The certainty of the evidence was low, downgraded twice due to serious imprecision (small number of events) and possible reporting bias (incomplete reporting of outcome across studies). Serious adverse events included death, pulmonary embolism, acute myocardial infarction, deep vein thrombosis and deep infection. Subsequent knee surgery (replacement or high tibial osteotomy) was reported in 2 out of 100 people in the control groups and 4 out of 100 people in the arthroscopy surgery groups at up to five years in four trials (RR 2.63, 95% CI 0.94 to 7.34; I = 11%; 4 trials, 864 participants). The certainty of the evidence was low, downgraded twice due to the small number of events.

AUTHORS' CONCLUSIONS: Arthroscopic surgery provides little or no clinically important benefit in pain or function, probably does not provide clinically important benefits in knee-specific quality of life, and may not improve treatment success compared with a placebo procedure. It may lead to little or no difference, or a slight increase, in serious and total adverse events compared to control, but the evidence is of low certainty. Whether or not arthroscopic surgery results in slightly more subsequent knee surgery (replacement or osteotomy) compared to control remains unresolved.

摘要

背景

尽管指南强烈建议避免使用,但关节镜膝关节手术仍然是治疗有症状的膝关节骨关节炎(包括退行性半月板撕裂)的常见方法。本 Cochrane 综述是对 2017 年发表的非 Cochrane 系统综述的更新。

目的

评估关节镜手术(包括清创术、部分半月板切除术或两者)与安慰剂手术或非手术治疗相比,在退行性膝关节疾病(骨关节炎、退行性半月板撕裂或两者兼有)患者中的获益和危害。

检索方法

我们检索了 Cochrane 中心对照试验注册库(CENTRAL)、MEDLINE、Embase 和两个试验注册库,截至 2021 年 4 月 16 日,未对语言进行限制。

选择标准

我们纳入了随机对照试验(RCT)或使用准随机方法分配参与者的试验,将关节镜手术与安慰剂手术或非手术干预(如运动、注射、非关节镜灌洗/冲洗、药物治疗和补充剂和补充疗法)进行比较,以治疗有症状的退行性膝关节疾病(骨关节炎或退行性半月板撕裂或两者兼有)患者。主要结局是疼痛、功能、参与者报告的治疗成功率、膝关节特异性生活质量、严重不良事件、总不良事件和膝关节手术(置换或截骨术)。

数据收集和分析

两名综述作者独立选择纳入研究,提取数据,并使用 GRADE 评估偏倚风险和证据确定性。主要比较是关节镜手术与安慰剂手术比较,以衡量手术益处的结局,但我们结合了所有对照组的数据来评估危害和膝关节手术(置换或截骨术)。

主要结果

16 项试验(2105 名参与者)符合我们的纳入标准。参与者的平均年龄从 46 岁到 65 岁不等,56%的参与者为女性。四项试验(380 名参与者)将关节镜手术与安慰剂手术进行了比较。对于其余的试验,关节镜手术与运动(八项试验,1371 名参与者)、单次关节内糖皮质激素注射(一项试验,120 名参与者)、非关节镜灌洗(一项试验,34 名参与者)、非甾体抗炎药(一项试验,80 名参与者)和每周五次透明质酸注射(一项试验,120 名参与者)进行了比较。大多数没有安慰剂对照的试验容易受到偏倚的影响:特别是选择(56%)、实施(75%)、检测(75%)、失访(44%)和选择性报告(75%)偏倚。安慰剂对照试验受偏倚的影响较小,没有一项试验存在实施或检测偏倚的风险。在这里,我们将报告限制在主要比较,即关节镜手术与安慰剂手术。高质量证据表明,与安慰剂手术相比,关节镜手术后三个月疼痛或功能几乎没有改善,中质量证据表明,关节镜手术后三个月膝关节特异性生活质量可能没有改善,低质量证据表明,与安慰剂手术相比,关节镜手术后五年内参与者报告的成功率可能没有改善,差异为 4.6 分更好(95%置信区间(CI)为 0.02 更好到 9 更好;I = 0%;4 项试验,309 名参与者)。与关节镜手术组相比,安慰剂组术后平均疼痛为 40.1 分(0 到 100 分,分数越低疼痛越低),差异为 4.6 分更好(95%CI 0.02 更好到 9 更好;I = 0%;3 项试验,302 名参与者)。与关节镜手术组相比,安慰剂组术后平均功能为 75.9 分(0 到 100 分,分数越高功能越好),差异为 0.1 分更好(95%CI 3.2 更差到 3.4 更好;I = 0%;3 项试验,302 名参与者)。与关节镜手术组相比,安慰剂组术后平均膝关节特异性健康相关生活质量为 69.7 分(0 到 100 分,分数越高生活质量越好),差异为 5.6 分更好(95%CI 0.36 更好到 10.68 更好;I = 0%;2 项试验,188 名参与者)。我们将这一证据降级为中等确定性,因为 95%置信区间不能排除或确定临床重要的变化。手术后,安慰剂组有 74%的人报告治疗成功,关节镜手术组有 82%的人报告治疗成功,最长随访时间为五年(风险比(RR)1.11,95%置信区间(CI)为 0.66 到 1.86;I = 53%;3 项试验,189 名参与者)。由于定义和结局测量的时间存在严重的间接性和严重的不精确性,我们将这一证据降级为低确定性。与安慰剂或非手术干预相比,关节镜手术是否会增加严重或总不良事件的风险,我们还不太确定。在八项试验中,对照组有 6 人发生严重不良事件,关节镜组有 8 人发生严重不良事件(RR 1.35,95%CI 0.64 到 2.83;I = 47%;8 项试验,1206 名参与者)。在对照组中,有 15 人报告了不良反应,在手术组中,有 17 人在五年内报告了不良反应(RR 1.15,95%CI 0.78 到 1.70;I = 48%;9 项试验,1326 名参与者)。证据的确定性较低,由于严重的不精确性(事件数量少)和可能存在的报告偏倚(研究之间的结局报告不完整),两次降低了证据的确定性。严重不良事件包括死亡、肺栓塞、急性心肌梗死、深静脉血栓形成和深部感染。在四项试验中,对照组中有 2 人报告了后续膝关节手术(置换或高位胫骨截骨术),关节镜手术组中有 4 人报告了后续膝关节手术(RR 2.63,95%CI 0.94 到 7.34;I = 11%;4 项试验,864 名参与者)。由于事件数量少,我们将证据的确定性降低了两次。

作者结论

关节镜手术在疼痛或功能方面几乎没有提供临床重要的益处,可能在膝关节特异性生活质量方面没有提供临床重要的益处,与安慰剂治疗相比,可能不会改善治疗成功率。与对照组相比,它可能导致严重或总不良事件的发生率较低或略有增加,但证据质量较低。与对照组相比,关节镜手术是否会导致膝关节手术(置换或截骨术)略多,目前仍未解决。

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