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口服普瑞巴林对电视辅助胸腔镜手术后患者术后睡眠的影响:一项随机双盲对照试验。

Effects of oral pregabalin on postoperative sleep of patients after video-assisted thoracoscopic surgery: a randomized double-blind controlled trial.

机构信息

Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, China.

Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.

出版信息

Minerva Anestesiol. 2024 Oct;90(10):872-881. doi: 10.23736/S0375-9393.24.18195-3.

DOI:10.23736/S0375-9393.24.18195-3
PMID:39381868
Abstract

BACKGROUND

The aim of this study was to explore the effect of oral pregabalin at varying concentrations on postoperative sleep of patients undergoing video-assisted thoracic surgery (VATS), and to identify the optimal dosage.

METHODS

A total of 120 VATS-treated patients admitted from June 2023 to October 2023 were randomly assigned to be orally administered with 75 mg pregabalin, 150 mg pregabalin and starch capsules (control group) at a 1:1:1 ratio. One capsule of pregabalin (75 mg) and one capsule of placebo with the same shape and odor, two capsules of pregabalin (150 mg), and two capsules of placebo with the same shape and odor were administered orally to patients in the three groups on the night of surgery, and in the morning and evening of postoperative days 2 and 3. The primary outcome was the incidence of postoperative sleep disturbance (PSD) on postoperative day 1 (POD1). The secondary outcomes included the St.Mary's Hospital Sleep Questionnaire (SMH), the Pittsburg Sleep Quality Index (PSQI) and pain intensity measured with a Numerical Rating Scale (NRS). Multivariate logistic regression analysis was performed to identify risk factors for PSD in VATS-treated patients.

RESULTS

The incidence of PSD on POD1 in the 75 mg pregabalin group and 150 mg pregabalin group was significantly lower than that of the control group (45.0% vs. 42.5% vs. 72.5%; P<0.0167 for two-by-two comparisons of groups A and B with group C, respectively). The SMH scores at night on POD1-3 were significantly higher in the 75 mg pregabalin group and 150 mg pregabalin group than those of the control group (P<0.05). Since there was definitive lower incidence of pain in the experimental groups,the median NRS scores of the incisional pain on POD2-3 were significantly lower in the 75 mg pregabalin group and 150 mg pregabalin group (P<0.05). The incidence of dizziness in the 150 mg pregabalin group was significantly higher than that of the 75 mg pregabalin group and control group (55.0% vs. 25.0% vs. 32.5%; P<0.0167 for two-by-two comparisons of groups A and C with group B, respectively). NRS score on POD1, preoperative PSQI and Self-Rating Depression Scale scores were risk factors for PSD in VATS-treated patients.

CONCLUSIONS

Oral administration of 75 mg or 150mg pregabalin for consecutive three days after VATS effectively reduces the incidence of PSD and improves the quality of sleep.

摘要

背景

本研究旨在探讨不同浓度的口服普瑞巴林对接受电视辅助胸腔镜手术(VATS)患者术后睡眠的影响,并确定最佳剂量。

方法

2023 年 6 月至 2023 年 10 月期间,共有 120 例接受 VATS 治疗的患者被随机分为三组,分别给予 75mg 普瑞巴林、150mg 普瑞巴林和淀粉胶囊(对照组),每组各 40 例。三组患者均于手术当晚、术后第 2 天和第 3 天早晚各口服 1 粒普瑞巴林(75mg)和 1 粒安慰剂(形状和气味相同),2 粒普瑞巴林(150mg)和 2 粒安慰剂(形状和气味相同)。主要结局指标为术后第 1 天(POD1)的术后睡眠障碍(PSD)发生率。次要结局指标包括圣玛丽医院睡眠问卷(SMH)、匹兹堡睡眠质量指数(PSQI)和数字评分量表(NRS)测量的疼痛强度。采用多变量逻辑回归分析 VATS 治疗患者 PSD 的危险因素。

结果

75mg 普瑞巴林组和 150mg 普瑞巴林组 POD1 的 PSD 发生率明显低于对照组(45.0%比 42.5%比 72.5%;A、B 两组分别与 C 组两两比较,P<0.0167)。75mg 普瑞巴林组和 150mg 普瑞巴林组 POD1-3 夜间 SMH 评分明显高于对照组(P<0.05)。由于实验组疼痛发生率明显降低,75mg 普瑞巴林组和 150mg 普瑞巴林组 POD2-3 的切口疼痛 NRS 评分中位数明显低于对照组(P<0.05)。150mg 普瑞巴林组头晕发生率明显高于 75mg 普瑞巴林组和对照组(55.0%比 25.0%比 32.5%;A、C 两组分别与 B 组两两比较,P<0.0167)。VATS 治疗患者 POD1 的 NRS 评分、术前 PSQI 和自评抑郁量表评分是 PSD 的危险因素。

结论

连续 3 天口服 75mg 或 150mg 普瑞巴林可有效降低 VATS 后 PSD 的发生率,改善睡眠质量。

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