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针刺治疗剖宫产术后子宫收缩痛的临床疗效:一项随机对照试验方案

Clinical Efficacy of Acupuncture in the Treatment of Uterine Contraction Pain Post-Cesarean Section: Protocol of a Randomized Controlled Trial.

作者信息

Deng Yuanzheng, Li Zhengping, Zhang Tiankui, Tang Xin, Luo Yan, Li Qifu, Zhang Shumin, Liu Zili, Tang Diwei, Ai Zhenghai, Guo Taipin, Liang Fanrong

机构信息

School of Second Clinical Medicine/The Second Affiliated Hospital, Yunnan University of Chinese Medicine, Kunming, People's Republic of China.

Traditional Chinese Medicine Department of Preventive Care, Ludian County Hospital of Traditional Chinese Medicine, Zhaotong, People's Republic of China.

出版信息

J Pain Res. 2025 Jun 28;18:3263-3274. doi: 10.2147/JPR.S531188. eCollection 2025.

Abstract

PURPOSE

Uterine contraction pain post-cesarean section (UCPCS) is one of the main complaints for mothers in the early stages of the puerperium. Acupuncture, a non-pharmacological therapy, has shown sound analgesic effects with almost no toxic side effects. This study uses acupuncture as an intervention and aimed to provide strong evidence for the clinical efficacy of acupuncture in treating UCPCS.

PATIENTS AND METHODS

This single-blind, randomized controlled trial (RCT) was conducted at the Ludian County Hospital of Traditional Chinese Medicine, China. Participants (138) are randomly assigned in a 1:1 ratio to either an observation or control group following cesarean section. Both groups receive routine postpartum care, the control group with sham acupuncture and the observation group with conventional acupuncture for 3 days. The primary outcome is the mean Visual Analogue Scale (VAS) score of the UCPCS. Secondary outcomes include the mean of UCPCS intensity, frequency, total duration, number of days to disappear, amount of vaginal bleeding and lactation, time to first lactation, and the Edinburgh Postnatal Depression Scale (EPDS) score. The final results will be analyzed in accordance with the intention-to-treat (ITT) principle using SPSS V.28.0.

DISCUSSION

This is the first RCT using non-penetrating sham acupuncture as a control to validate the clinical efficacy of acupuncture for UCPCS. The results of this study are expected to provide an effective therapeutic option for UCPCS, as well as offer clinicians and researchers strong evidence regarding non-pharmacological interventions.

摘要

目的

剖宫产术后子宫收缩痛(UCPCS)是产褥期早期母亲的主要主诉之一。针灸作为一种非药物疗法,已显示出良好的镇痛效果,且几乎无毒性副作用。本研究采用针灸作为干预措施,旨在为针灸治疗UCPCS的临床疗效提供有力证据。

患者与方法

本单盲随机对照试验(RCT)在中国鲁甸县中医医院进行。138名参与者在剖宫产术后按1:1比例随机分为观察组和对照组。两组均接受常规产后护理,对照组采用假针刺,观察组采用传统针刺,为期3天。主要结局是UCPCS的平均视觉模拟量表(VAS)评分。次要结局包括UCPCS的强度、频率、总持续时间、消失天数、阴道出血量和泌乳量的平均值、首次泌乳时间以及爱丁堡产后抑郁量表(EPDS)评分。最终结果将根据意向性分析(ITT)原则,使用SPSS V.28.0进行分析。

讨论

这是第一项使用非穿透性假针刺作为对照来验证针灸治疗UCPCS临床疗效的RCT。本研究结果有望为UCPCS提供一种有效的治疗选择,并为临床医生和研究人员提供关于非药物干预的有力证据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54b7/12222625/a43f6f712417/JPR-18-3263-g0001.jpg

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