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阿扎司琼对肺手术后慢性术后疼痛的疗效:一项随机、三盲、对照试验。

Efficacy of azasetron on postoperative chronic pain after pulmonary surgery: a randomized triple-blind controlled trial.

机构信息

Institute of Neuroscience and Brain Disease, Department of Pain, Xiangyang Central Hospital, Hubei University of Arts and Science, Hubei, China.

Institute of Neuroscience and Brain Disease, Department of Anesthesiology, Xiangyang Central Hospital, Hubei University of Arts and Science, No.136. Jinzhou Street, Xiangcheng District, Xiangyang, 441000, China.

出版信息

BMC Anesthesiol. 2024 Jul 30;24(1):261. doi: 10.1186/s12871-024-02653-z.

Abstract

BACKGROUND

Inhibition of 5-HT3 (5-Hydroxyl Tryptamine) receptors is known to enhance morphine analgesia in animal models. We tested the efficacy of azasetron, a 5-HT3 receptor antagonist, on postoperative chronic pain after pulmonary surgery in a randomized triple-blind controlled study.

METHODS

A total of 250 patients who were scheduled to receive pulmonary surgery were randomized to patient-controlled analgesia (PCA) using 200 µg sufentanil with normal saline or 200 µg sufentanil with 20 mg azasetron. The numerical rating scale of pain (NRS) was recorded at baseline, postoperative day (POD) 1, 2, 3, 90, and 180. Negative binomial regression was used to identify associated factors for postoperative NRS six months after surgery.

RESULTS

The results showed that azasetron did not affect the primary outcomes: the incidence of postoperative chronic pain on POD90 and 180. However, azasetron decreased postoperative NRS at rest and activity on POD1, 2, and 3. Furthermore, azasetron decreased postoperative nausea and vomiting on POD1 and 2. Univariate and multivariate negative binomial regression analysis identified preoperative pain, smoking, drinking and open surgery are risk factors of chronic pain six months after surgery.

CONCLUSIONS

Azasetron did not affect the incidence of chronic pain after pulmonary surgery. The presence of preoperative pain, smoking, drinking, and open surgery were found to be associated with chronic pain six months after surgery.

CLINICAL TRIAL REGISTRATION

The trial was registered prior to patient enrollment at the Chinese Clinical Trial Registry (ChiCTR2200060139), 20/05/2022; the site url is https://www.chictr.org.cn/ .

摘要

背景

抑制 5-HT3(5-羟色胺)受体已知可增强动物模型中的吗啡镇痛作用。我们在一项随机、三盲、对照研究中测试了 5-HT3 受体拮抗剂阿扎司琼对肺手术后慢性术后疼痛的疗效。

方法

共有 250 名计划接受肺手术的患者被随机分配至使用生理盐水或 200µg 阿扎司琼的患者自控镇痛(PCA),用 200µg 舒芬太尼。疼痛的数字评分量表(NRS)在基线、术后第 1、2、3、90 和 180 天记录。使用负二项回归分析确定术后 6 个月与 NRS 相关的因素。

结果

结果显示,阿扎司琼对术后慢性疼痛的发生率(POD90 和 180)没有影响。然而,阿扎司琼在术后第 1、2 和 3 天降低了静息和活动时的 NRS。此外,阿扎司琼还降低了术后第 1 和 2 天的恶心和呕吐。单因素和多因素负二项回归分析发现术前疼痛、吸烟、饮酒和开放性手术是术后 6 个月慢性疼痛的危险因素。

结论

阿扎司琼对肺手术后慢性疼痛的发生率没有影响。术前疼痛、吸烟、饮酒和开放性手术与术后 6 个月慢性疼痛相关。

临床试验注册

该试验在患者入组前在中国临床试验注册中心(ChiCTR2200060139)注册,2022 年 5 月 20 日;网址为 https://www.chictr.org.cn/。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/16c1/11290065/55d8e764b3b2/12871_2024_2653_Fig1_HTML.jpg

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