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耳穴按压对乳腺癌患者化疗所致恶心呕吐的影响:一项初步的随机对照试验。

Effects of auricular acupressure on chemotherapy-induced nausea and vomiting in breast cancer patients: a preliminary randomized controlled trial.

机构信息

School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong SAR.

College of Nursing and Midwifery, Charles Darwin University, Casuarina Campus, Ellengowan Drive, Brinkin, NT, 0810, Australia.

出版信息

BMC Complement Med Ther. 2022 Mar 24;22(1):87. doi: 10.1186/s12906-022-03543-y.

DOI:10.1186/s12906-022-03543-y
PMID:35331208
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8953362/
Abstract

BACKGROUND

Auricular acupressure (AA) has been viewed as a promising approach to managing chemotherapy-induced nausea and vomiting (CINV) but relevant research evidence has been inconclusive. This study aimed to examine the effects of AA on CINV in breast cancer (BC) patients undergoing chemotherapy.

METHODS

A preliminary randomized controlled trial was conducted in 114 BC patients. Participants were randomly allocated to a true AA group (n = 38), a sham AA group (n = 38), and a standard care group (n = 38). All the participants were provided with standard antiemetic treatment and care, while the true AA group and the sham AA group received an additional 5-day true AA and a 5-day sham AA, respectively. Acute and delayed CINV were assessed by using the MASCC Antiemesis Tool (MAT), anticipatory nausea and vomiting were measured by the Index of Nausea, Vomiting, and Retching (INVR), and patients' quality of life (QoL) was evaluated by the Functional Assessment of Cancer Therapy-Breast (FACT-B).

RESULTS

Both the true and sham AA groups reported improved CINV outcomes than the standard care group, with the true AA demonstrating larger effects than the sham comparison. The true and sham AA groups had higher complete response (CR) rates of CINV when compared with the standard care group, with the difference in the CR of acute CINV achieving statistical significance (p = 0.03). Both the true and sham AA groups demonstrated lower incidence and severity of acute CINV compared with the standard care group with the among-group difference reaching statistical significance for the occurrence (p = 0.04) and severity (p = 0.001) of acute nausea. No significant differences in anticipatory CINV and QoL were found among the groups.

CONCLUSION

The use of AA plus standard antiemetic treatment and care was superior to the use of standard antiemetic treatment and care alone in managing CINV among BC patients receiving chemotherapy. The antiemetic effects of AA were identified to be more profound in improving acute CINV, particularly acute nausea. The antiemetic effects of AA were deemed to be a mixture of specific treatment effects and placebo effects, and the placebo effects were very large and even reached clinical significance.

TRIAL REGISTRATION

ClinicalTrials.gov; NCT02403037 ; Registered March 31, 2015.

摘要

背景

耳穴按压(AA)被视为管理化疗引起的恶心和呕吐(CINV)的一种有前途的方法,但相关研究证据尚无定论。本研究旨在探讨 AA 对接受化疗的乳腺癌(BC)患者 CINV 的影响。

方法

在 114 例 BC 患者中进行了初步的随机对照试验。参与者被随机分配到真 AA 组(n=38)、假 AA 组(n=38)和标准护理组(n=38)。所有参与者均接受标准止吐治疗和护理,而真 AA 组和假 AA 组分别接受为期 5 天的真 AA 和假 AA。采用 MASCC 止吐工具(MAT)评估急性和迟发性 CINV,采用恶心、呕吐和干呕指数(INVR)评估预期性恶心和呕吐,采用癌症治疗功能评估-乳房(FACT-B)评估患者的生活质量(QoL)。

结果

真 AA 组和假 AA 组报告的 CINV 结局均优于标准护理组,真 AA 组的效果大于假 AA 组。与标准护理组相比,真 AA 组和假 AA 组的完全缓解(CR)率更高,急性 CINV 的 CR 差异具有统计学意义(p=0.03)。与标准护理组相比,真 AA 组和假 AA 组的急性 CINV 发生率和严重程度均较低,组间差异在急性恶心的发生(p=0.04)和严重程度(p=0.001)方面具有统计学意义。各组间预期性 CINV 和 QoL 无显著差异。

结论

在接受化疗的 BC 患者中,AA 联合标准止吐治疗和护理优于单独使用标准止吐治疗和护理。AA 在改善急性 CINV,特别是急性恶心方面的止吐效果更为明显。AA 的止吐效果被认为是特定治疗效果和安慰剂效应的混合,且安慰剂效应非常大,甚至达到临床意义。

试验注册

ClinicalTrials.gov;NCT02403037;注册于 2015 年 3 月 31 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f0b/8953362/f5277c236b6a/12906_2022_3543_Fig5_HTML.jpg
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