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子宫动脉栓塞术与手术方法治疗有症状的子宫平滑肌瘤:一项间接治疗比较后的系统评价与荟萃分析

Uterine Artery Embolization and Surgical Methods for the Treatment of Symptomatic Uterine Leiomyomas: A Systemic Review and Meta-analysis Followed by Indirect Treatment Comparison.

作者信息

Fonseca Marcelo C M, Castro Rodrigo, Machado Marcio, Conte Tania, Girao Manoel J B C

机构信息

Department of Gynecology, Federal University of Sao Paulo, São Paulo, Brazil.

Department of Gynecology, Federal University of Sao Paulo, São Paulo, Brazil.

出版信息

Clin Ther. 2017 Jul;39(7):1438-1455.e2. doi: 10.1016/j.clinthera.2017.05.346. Epub 2017 Jun 20.

Abstract

PURPOSE

There is significant discussion and uncertainty about the optimal management of symptomatic uterine leiomyomas (SULs). Nonsurgical procedures such as uterine artery embolization (UAE) have been developed. The goal of this study was to conduct a meta-analysis and an indirect treatment comparison to examine the comparative efficacy and safety of the surgical procedures to treat SULs compared with UAE.

METHODS

MEDLINE, EMBASE, Lilacs, and the Cochrane Central Register of Controlled Trials databases were searched from inception to February 2016. Ten randomized controlled trials comparing UAE versus hysterectomy, myomectomy, and laparoscopic occlusion of the uterine arteries in patients with SUL published in a peer-reviewed journal were included. Two reviewers independently selected studies, assessed quality, and extracted data. Discrepancies were resolved through consensus.

FINDINGS

Data from 986 patients submitted to UEA (n = 527) or surgery (n = 459) were analyzed. UAE had a lower risk of major complications (risk ratio [RR], 0.45 [95% CI, 0.22-0.95]; P = 0.04)and a higher risk of minor complications (RR, 1.65 [95% CI, 1.32-2.06]; P < 0.00001); UAE had a higher risk of re-intervention up to 2 years (RR, 3.74 [95% CI, 1.76-7.96]; P = 0.0006) and up to 5 years (RR, 5.01 [95% CI, 1.37-18.39]; P = 0.02); UAE had a similar risk of follicle-stimulating hormone levels >40 IU/L after 6 months (RR, 1.76 [95% CI, 0.24-12.95]; P = 0.58)and of recommending the procedure to another patient up to 5 years after treatment (RR, 1.00 [95% CI, 0.87-1.14]; P = 0.94). The indirect comparison between myomectomy and hysterectomy found that the 2 procedures were similar in the studied outcomes.

IMPLICATIONS

Compared with surgery, UAE had lower rates of major complications with an increased risk of re-intervention up to 2 and 5 years after the first procedure. UAE compared with surgery had a similar risk of ovarian failure and similar recommendation of the procedure to another patient. However, the number of trials was limited, and there was a high risk of bias in at least 2 domains. None of the trials blinded the participants and personnel or the outcome assessment. PROSPERO identifier: CRD42015026319.

摘要

目的

对于有症状的子宫平滑肌瘤(SULs)的最佳管理存在大量讨论和不确定性。诸如子宫动脉栓塞术(UAE)等非手术方法已被开发出来。本研究的目的是进行一项荟萃分析和间接治疗比较,以检验与UAE相比,治疗SULs的手术方法的相对疗效和安全性。

方法

检索MEDLINE、EMBASE、Lilacs以及Cochrane对照试验中央注册库数据库,检索时间从建库至2016年2月。纳入10项在同行评审期刊上发表的比较UAE与子宫切除术、肌瘤切除术以及腹腔镜下子宫动脉闭塞术治疗SULs患者的随机对照试验。两名评审员独立选择研究、评估质量并提取数据。分歧通过协商解决。

结果

分析了986例接受UAE(n = 527)或手术(n = 459)患者的数据。UAE发生严重并发症的风险较低(风险比[RR],0.45 [95% CI,0.22 - 0.95];P = 0.04),发生轻微并发症的风险较高(RR,1.65 [95% CI,1.32 - 2.06];P < 0.00001);UAE在2年(RR,3.74 [95% CI,1.76 - 7.96];P = 0.0006)和5年(RR,5.01 [95% CI,1.37 - 18.39];P = 0.02)内再次干预的风险较高;UAE在6个月后促卵泡生成素水平>40 IU/L的风险(RR,1.76 [95% CI,0.24 - 12.95];P = 0.58)以及在治疗后5年内向另一名患者推荐该手术的风险(RR,1.00 [95% CI,0.87 - 1.14];P = 0.94)与手术相似。肌瘤切除术和子宫切除术之间的间接比较发现,这两种手术在所研究的结果方面相似。

启示

与手术相比,UAE严重并发症发生率较低,但在首次手术后2年和5年内再次干预的风险增加。与手术相比,UAE发生卵巢功能衰竭的风险以及向另一名患者推荐该手术的风险相似。然而,试验数量有限,并且至少在2个领域存在高偏倚风险。没有一项试验对参与者、人员或结果评估进行了盲法处理。PROSPERO标识符:CRD42015026319。

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