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“十二五”国家科技支持计划课题成果论文在全球影响力妇产科杂志成功发表

2017-06-16 17:36 来源:光明网 
2017-06-16 17:36:46来源:光明网作者:责任编辑:孙鹏宇

    2017年6月5日,“十二五”国家科技支撑计划课题成果论文通过了审核。发表在了全球最有影响力的妇产科学杂志之一《英国妇产科杂志》6月刊。

“十二五”国家科技支持计划课题成果论文在全球影响力妇产科杂志成功发表

    “十二五”国家科技支撑计划成果论文杂志截图

    附成果论文摘要(中英文对照): BJOG. 2017 Apr 19. doi: 10.1111/1471-0528.14689. Evaluation of HIFU Ablation for Uterine Fibroids: an IDEAL Prospective Exploration Study. HIFU消融治疗子宫肌瘤的评价:IDEAL前瞻性探索研究 Chen J1, Li Y2, Wang Z1, McCulloch P3, Hu L1, Chen W4, Liu G2, Li J2, Lang J5; Committee of the Clinical Trial of HIFU versus Surgical Treatment for Fibroids.

    陈锦云、李幼平、王智彪、麦库洛、胡亮、陈文直、刘关键、李静、郎景和和HIFU与手术治疗子宫肌瘤临床试验委员会

    Abstract 摘要 OBJECTIVE: 目标: To evaluate the clinical outcomes of High intensity focused ultrasound (HIFU) and surgery in treating uterine fibroids, and prepare for a definitive randomised trial. 评估高强度聚焦超声与外科手术治疗子宫肌瘤的临床结果,并为随机临床试验提供依据。

    DESIGN: 研究设计 Prospective multicentre patient choice cohort study (IDEAL Exploratory study) of HIFU, myomectomy or hysterectomy for treating symptomatic uterine fibroids. 前瞻性、多中心队列研究(IDEAL Exploratory study),HIFU、子宫肌瘤切除术或子宫全切术治疗有症状的子宫肌瘤的比较。

    SETTING: 研究开展地点 20 Chinese hospitals. 中国20家医院。

    POPULATION OR SAMPLE: 研究人群 2411 Chinese women with symptomatic fibroids. 2411例患有症状性子宫肌瘤的中国女性。

    METHODS: 研究方法: Prospective non-randomised cohort study with learning curve analysis (IDEAL Stage 2b Prospective Exploration Study) MAIN OUTCOME MEASURES: Complications, hospital stay, return to normal activities, and quality of life (measured with UFS-Qol and SF-36 at baseline, 6 and 12 months), and need for further treatment. Quality of life outcomes were adjusted using regression modelling. HIFU treatment quality was evaluated using LC-CUSUM to identify operator learning curves. A health economic analysis of costs was performed. 有学习曲线分析的前瞻性非随机队列研究(IDEAL2b阶段前瞻性探索性研究)。主要评价指标:并发症、住院时间、恢复正常活动的时间,生活质量(采用UFS-Qol和SF-36健康调查问卷评测,收集基线、术后第6个月与第12个月随访的数据)以及需要再干预治疗情况。使用回归模型对生活质量的结果进行校正分析。采用LC-CUSUM确定操作者的学习曲线,用于评估HIFU治疗质量。进一步进行卫生经济学评价。

    RESULTS: 研究结果 1353 women received HIFU, 472 hysterectomy and 586 myomectomy. HIFU patients were significantly younger (p<0.001), slimmer (p<0.001), better educated (p<0.001) and wealthier (p=0.002) than surgery patients. Both UFS and QoL improved more rapidly after HIFU than after surgery (p = 0.002 and p = 0.001 respectively at 6 months), but absolute differences were small. Major adverse events occurred in 3 (0.2%) of HIFU and in 133 (12.6%) of surgical cases (p<0.001). Hospital stay was 4 Days (+/-3.2, 95% CI), 10 Days (3.2 CI) and 8 Days (3.1 CI) respectively (p<0.001). 2411例患者纳入了本研究,其中1353例患者接受了HIFU治疗,472例接受子宫全切术,586例接受子宫肌瘤剔除术。接受HIFU治疗的患者远比接受手术治疗的患者年轻(p<0.001)、体瘦 (p<0.001)、文化程度高(p<0.001)、经济条件好 (p=0.002)。与手术相比,HIFU治疗后,UFS与QoL均提升得更快(治疗后第6个月与治疗前相比分别为p=0.002和p=0,001),但绝对分差很小。重要并发症HIFU组发生3例(0.2%),而手术组为133例(12.6%)(p<0.001)。三种手术方式住院期分别为4天(+/- 3.2天,95%CI)、10天(3.2CI)与8天(3.1CI)。

    CONCLUSIONS: 结论: HIFU caused substantially less morbidity than surgery, with similar longer term QoL. Despite group baseline differences and lack of blinding, these findings support the need for an RCT of HIFU treatment for fibroids. The IDEAL Exploratory design facilitated RCT protocol development. This article is protected by copyright. All rights reserved. 高强度聚焦超声与手术治疗子宫肌瘤比较术后长期的生活质量类似,而副反应远小于手术。由于缺少盲法,三个研究组存在基线差异。“IDEAL”模式的探索性设计加快了随机对照试验的进程。本研究为开展子宫肌瘤治疗的临床随机对照试验提供了依据。本文受版权保护。保留所有权利。

[责任编辑:孙鹏宇]

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