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改良型综合消肿物理疗法预防宫颈癌根治术后下肢淋巴水肿的有效性:一项随机对照试验。

Effectiveness of modified complex decongestive physiotherapy for preventing lower extremity lymphedema after radical surgery for cervical cancer: a randomized controlled trial.

机构信息

Department of Gynecologic Oncology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.

Department of Nursing, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China

出版信息

Int J Gynecol Cancer. 2020 Jun;30(6):757-763. doi: 10.1136/ijgc-2019-000911. Epub 2020 Feb 26.

Abstract

BACKGROUND

There is a lack of evidence in support of any prophylactic measure to prevent secondary lower extremity lymphedema after radical hysterectomy among patients with cervical cancer. This study aimed to determine the effectiveness of modified complex decongestive physiotherapy in reducing the risk of secondary lower extremity lymphedema after radical surgery.

METHODS

A randomized single-blind clinical trial was conducted in 120 patients with cervical cancer who underwent laparoscopic radical hysterectomy with pelvic lymphadenectomy between January 2016 and April 2017 in the Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China. Participants were randomly assigned to a modified complex decongestive physiotherapy intervention group (n=60) or control group (n=60). The intervention group received a modified complex decongestive physiotherapy program, which included manual lymph drainage, compression hosiery, regular exercise, and health education. The control group only received a health education program. The main outcome was the incidence of secondary lower extremity lymphedema.

RESULTS

A total of 117 patients with cervical cancer completed a 1-year follow-up. Twenty-eight (23.9%) patients developed secondary lower extremity lymphedema (20 (34.5%) patients in the control group and 8 (13.6%) in the intervention group). The incidence of secondary lower extremity lymphedema was significantly higher in the control group than in the intervention group (p=0.008; OR 0.30 (95% CI 0.12 to 0.75). The median percentage of excess volume was significantly less in the intervention group (2.1%, IQR 0.5-3.4%) than in the control group (2.96%, IQR 1.1-4.98%); (p0.042). The mean (SD) onset time of lymphedema was 8 (2.00) months vs 4.6 (2.82) months in the intervention and control groups, respectively (p=0.004).

CONCLUSIONS

This randomized trial showed that modified complex decongestive physiotherapy is effective for preventing lower extremity lymphedema in patients with cervical cancer after laparoscopic radical hysterectomy with pelvic lymphadenectomy.

摘要

背景

目前尚无证据支持任何预防措施可以降低宫颈癌根治术后下肢继发淋巴水肿的风险。本研究旨在评估改良型综合消肿物理疗法对降低腹腔镜根治性子宫切除加盆腔淋巴结清扫术后下肢继发淋巴水肿风险的有效性。

方法

本研究为一项随机单盲临床试验,纳入了 2016 年 1 月至 2017 年 4 月在复旦大学妇产科医院接受腹腔镜根治性子宫切除术加盆腔淋巴结清扫术的 120 例宫颈癌患者。参与者被随机分配至改良型综合消肿物理疗法干预组(n=60)或对照组(n=60)。干预组接受改良型综合消肿物理疗法方案,包括手动淋巴引流、压力衣、常规运动和健康教育。对照组仅接受健康教育。主要结局为下肢继发淋巴水肿的发生率。

结果

共有 117 例宫颈癌患者完成了 1 年随访。28 例(23.9%)患者发生下肢继发淋巴水肿(对照组 20 例[34.5%],干预组 8 例[13.6%])。对照组下肢继发淋巴水肿的发生率显著高于干预组(p=0.008;OR 0.30(95%CI 0.12 至 0.75)。干预组的多余体积中位数明显小于对照组(2.1%,IQR 0.5-3.4% 比 2.96%,IQR 1.1-4.98%);(p=0.042)。干预组和对照组的淋巴水肿发病时间分别为 8(2.00)个月和 4.6(2.82)个月(p=0.004)。

结论

这项随机试验表明,改良型综合消肿物理疗法对预防腹腔镜根治性子宫切除加盆腔淋巴结清扫术后宫颈癌患者的下肢淋巴水肿是有效的。

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