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一项探讨针灸在减轻乳腺癌后淋巴水肿症状中作用的可行性研究:一项随机对照试验。

A feasibility study to examine the role of acupuncture to reduce symptoms of lymphoedema after breast cancer: a randomised controlled trial.

作者信息

Smith Caroline A, Pirotta Marie, Kilbreath Sharon

机构信息

National Institute for Complementary Medicine, University of Western Sydney, Penrith, Australia.

Department of General Practice, University of Melbourne, Melbourne, Australia.

出版信息

Acupunct Med. 2014 Oct;32(5):387-93. doi: 10.1136/acupmed-2014-010593. Epub 2014 Jul 2.

DOI:10.1136/acupmed-2014-010593
PMID:24990160
Abstract

OBJECTIVE

To determine the feasibility, acceptability and safety of using acupuncture to treat arm lymphoedema in women following treatment for breast cancer.

METHODS

We conducted a randomised controlled trial of acupuncture compared with treatment as usual. Twenty women with stable unilateral intransient lymphoedema present for at least 6 months were recruited from Sydney, Australia. The women received 12 acupuncture treatments administered to body and arm points on the non-lymphoedematous limb over 8 weeks, twice weekly for 4 weeks then once weekly for 4 weeks. Outcome measures included an assessment of interest to participate in the trial, identification of successful recruitment strategies, the appropriateness of eligibility criteria and compliance with treatment attendance. Clinical outcomes were assessed at baseline and 8 weeks and included extracellular fluid, lymphoedema symptoms, well-being and safety.

RESULTS

Acupuncture was an acceptable intervention in women with upper limb lymphoedema. Compliance with the treatment protocol was high, with nine women completing all 12 treatments. Outcome forms were completed by 17 women at 8 weeks. No major adverse occurrences, as defined by the study protocol, were reported from the acupuncture group although one woman found the needling uncomfortable, and no study participant experienced an increase in swelling of >10%. There was no change in extracellular fluid or any patient-reported outcome measurement.

CONCLUSIONS

Lymphoedema is a persistent symptom experienced by women recovering from breast cancer. Our study suggests that acupuncture may stabilise symptoms and no major safety concerns were identified, so further research is needed.

TRIAL REGISTRATION NUMBER

Australian New Zealand Clinical Trials Registry, http://www.anzctr.org.au ACTRN12612000607875.

摘要

目的

确定针刺疗法治疗乳腺癌术后女性手臂淋巴水肿的可行性、可接受性及安全性。

方法

我们开展了一项针刺疗法与常规治疗对比的随机对照试验。从澳大利亚悉尼招募了20名单侧持续性淋巴水肿稳定至少6个月的女性。这些女性在8周内接受了12次针刺治疗,针刺部位为非淋巴水肿肢体的身体和手臂穴位,前4周每周两次,后4周每周一次。观察指标包括对参与试验的兴趣评估、成功招募策略的确定、纳入标准的合理性以及治疗依从性。在基线和8周时评估临床结局,包括细胞外液、淋巴水肿症状、健康状况和安全性。

结果

针刺疗法对于上肢淋巴水肿女性是一种可接受的干预措施。治疗方案依从性高,9名女性完成了全部12次治疗。17名女性在8周时完成了结局表格。针刺组未报告研究方案定义的重大不良事件,尽管有一名女性觉得针刺不舒服,且没有研究参与者出现肿胀增加超过10%的情况。细胞外液及任何患者报告的结局指标均无变化。

结论

淋巴水肿是乳腺癌康复女性持续存在的症状。我们的研究表明针刺疗法可能使症状稳定,且未发现重大安全问题,因此需要进一步研究。

试验注册号

澳大利亚新西兰临床试验注册中心,http://www.anzctr.org.au ,ACTRN12

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