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不同穴位电针对化疗所致恶心呕吐的疗效及安全性:一项随机对照试验的研究方案

Efficacy and safety of electroacupuncture with different acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial.

作者信息

Chen Bo, Hu Shu-xiang, Liu Bao-hu, Zhao Tian-yi, Li Bo, Liu Yan, Li Ming-yue, Pan Xing-fang, Guo Yong-ming, Chen Ze-lin, Guo Yi

机构信息

Acu-moxibustion and Tuina Department of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.

Acupuncture Research Center of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.

出版信息

Trials. 2015 May 12;16:212. doi: 10.1186/s13063-015-0734-x.

Abstract

BACKGROUND

Many patients experience nausea and vomiting during chemotherapy treatment. Evidence demonstrates that electroacupuncture is beneficial for controlling chemotherapy-induced nausea and vomiting (CINV). However, the acupoint or matching acupoint with the best efficacy for controlling CINV still remains unidentified.

METHODS/DESIGN: This study consists of a randomized controlled trial (RCT) with four parallel arms: a control group and three electroacupuncture groups (one with Neiguan (PC6), one with Zhongwan (CV12), and one with both PC6 and CV12). The control group received standard antiemetic only, while the other three groups received electroacupuncture stimulation with different acupoints besides the standard antiemetic. The intervention is done once daily from the first day (day 1) to the fourth day (day 4) during chemotherapy treatment. The primary outcome measures include frequency of nausea, vomiting and retching. The secondary outcome measures are the grade of constipation and diarrhea, electrogastrogram, assessment of quality of life, assessment of anxiety and depression, and other adverse effects during the chemotherapy. Assessments are scheduled from one day pre-chemotherapy (day 0) to the fifth day of chemotherapy (day 5). Follow-ups are done from day 6 to day 21.

DISCUSSION

The aim of this study is to evaluate the efficacy and safety of electro-acupuncture with different acupoints in the management of CINV.

TRIAL REGISTRATION

The register number of randomized controlled trial is NCT02195908 . The date of registration was 21 July 2014.

摘要

背景

许多患者在化疗期间会出现恶心和呕吐。有证据表明,电针疗法有助于控制化疗引起的恶心和呕吐(CINV)。然而,对于控制CINV疗效最佳的穴位或配对穴位仍未明确。

方法/设计:本研究包括一项随机对照试验(RCT),有四个平行组:一个对照组和三个电针组(一个针刺内关穴(PC6),一个针刺中脘穴(CV12),一个同时针刺PC6和CV12)。对照组仅接受标准的止吐治疗,而其他三组除标准止吐治疗外,还接受不同穴位的电针刺激。干预从化疗治疗的第一天(第1天)至第四天(第4天)每天进行一次。主要结局指标包括恶心、呕吐和干呕的频率。次要结局指标为便秘和腹泻的分级、胃电图、生活质量评估、焦虑和抑郁评估以及化疗期间的其他不良反应。评估安排在化疗前一天(第0天)至化疗第五天(第5天)进行。随访从第6天至第21天。

讨论

本研究的目的是评估不同穴位电针治疗CINV的疗效和安全性。

试验注册

随机对照试验的注册号为NCT02195908。注册日期为2014年7月21日。

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