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目的评估高强度聚焦超声(high-intensity focused ultrasound,HIFU)治疗子宫肌瘤的安全性,为临床实践与防治并发症提供参考。方法计算机检索PubMed、The Cochrane Library(2016年2期)、EMbase、CBM、CNKI和VIP数据库,搜集所有HIFU治疗子宫肌瘤的随机对照试验(randomized controlled trial,RCT)和自身对照试验,检索时限均从2005年3月1日至2016年2月15日。由2名评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用R软件进行Meta分析。结果最终纳入20个研究,包括2 405例患者。经单组率的Meta分析结果显示:HIFU治疗子宫肌瘤妇科并发症总发生率为6.63%[95%CI(3.58%,12.28%)];其中阴道出血发生率为5.82%[95%CI(3.22%,10.53%)],腹痛发生率为10.02%[95%CI(4.77%,21.05%)]。结论当前证据显示HIFU治疗子宫肌瘤存在一定妇科并发症。受纳入研究的数量和质量的限制,上述结论仍需要更多研究予以证实。
Objective To evaluate the safety of high-intensity focused ultrasound (HIFU) in the treatment of uterine fibroids and provide references for clinical practice and prevention and treatment of uterine fibroids. Methods PubMed, The Cochrane Library (2016 Issue 2), EMbase, CBM, CNKI and VIP databases were searched. All randomized controlled trials (RCTs) and self-controlled trials of HIFU in the treatment of uterine myoma were collected. From March 1, 2005 to February 15, 2016. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias included in the study, using the R software for meta-analysis. The results eventually included 20 studies, including 2,405 patients. The single-group meta-analysis showed that the overall incidence of gynecological complications was 6.63% [95% CI (3.58%, 12.28%]] in HIFU patients. The incidence of vaginal bleeding was 5.82% [95% CI 3.22%, 10.53%)]. The incidence of abdominal pain was 10.02% [95% CI (4.77%, 21.05%)]. Conclusions Current evidence suggests that there are certain gynecological complications associated with HIFU in the treatment of uterine fibroids. Due to the limited number and quality of studies included, the above conclusion still needs further study to be confirmed.