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一项关于针刺联合传统疗法治疗前列腺癌所致疼痛的随机对照试验:研究方案临床试验(符合SPIRIT标准)

A randomized controlled trial for acupuncture combined with conventional therapy in the treatment of pain caused by prostate cancer: Study protocol clinical trial (SPIRIT compliant).

作者信息

Lei Yi, Duan Yunyun, Wang Jisheng, Yu Xudong, Deng Sheng, Liu Ruijia, Si Hongmei, Li Jiameng, Zhang Bao

机构信息

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi.

Graduate School of Beijing University of Chinese Medicine.

出版信息

Medicine (Baltimore). 2020 Apr;99(14):e19609. doi: 10.1097/MD.0000000000019609.

Abstract

INTRODUCTION

Prostate cancer refers to an epithelial malignant tumor that occurs in the prostate area. In recent years, with the improvement of people's living standards, the incidence of prostate cancer has gradually increased, which has greatly affected people's life and health and quality of life. Acupuncture has its unique advantages in treating cancer pain. We will evaluate the efficacy and safety of acupuncture and moxibustion in the treatment of pain caused by prostate cancer using a clinical randomized parallel control method.

METHODS/DESIGN: This pragmatic randomized controlled trial will recruit 120 patients who are diagnosed with prostate cancer. Simple randomization to conventional drug treatment with a 1:1 allocation ratio will be used. Based on the patient's pain location and the primary lesion, the acupuncture needle insertion position was determined according to the principle of local selection of acupoints. All participants will continue to receive conventional drug treatment.

DISCUSSION

This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for pain caused by prostate cancer.

TRIAL REGISTRATION

ClinicalTrials.gov, ChiCTR2000029801, Registered on 14 February 2020.

摘要

引言

前列腺癌是指发生于前列腺区域的上皮性恶性肿瘤。近年来,随着人们生活水平的提高,前列腺癌的发病率逐渐上升,这极大地影响了人们的生命健康和生活质量。针刺在治疗癌痛方面具有独特优势。我们将采用临床随机平行对照方法评估针灸治疗前列腺癌所致疼痛的疗效和安全性。

方法/设计:本实用随机对照试验将招募120例被诊断为前列腺癌的患者。采用简单随机化方法,按照1:1的分配比例分为常规药物治疗组。根据患者疼痛部位和原发灶,按照局部选穴原则确定针刺穴位位置。所有参与者将继续接受常规药物治疗。

讨论

本试验可能为针灸治疗前列腺癌所致疼痛的临床有效性、安全性和成本效益提供证据。

试验注册

ClinicalTrials.gov,ChiCTR2000029801,于2020年2月14日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/677f/7440164/73259ee6be48/medi-99-e19609-g001.jpg

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