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普瑞巴林在乳腺癌根治术后疼痛综合征中的可能预防作用:一项双盲随机对照试验。

The Possible Preventive Role of Pregabalin in Postmastectomy Pain Syndrome: A Double-Blinded Randomized Controlled Trial.

机构信息

Department of Anesthesia and Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.

Department of Anesthesia and Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.

出版信息

J Pain Symptom Manage. 2019 Jan;57(1):1-9. doi: 10.1016/j.jpainsymman.2018.10.496. Epub 2018 Oct 22.

DOI:10.1016/j.jpainsymman.2018.10.496
PMID:30359684
Abstract

CONTEXT

Chronic postmastectomy pain syndrome (PMPS) has a considerable negative impact on the quality of life of breast cancer patients.

OBJECTIVE

The objective of this study was to assess the possible preventive role of perioperative pregabalin in PMPS.

METHODS

This randomized controlled study included 200 patients with breast cancer scheduled for elective breast cancer surgery. They were randomly assigned to one of two treatment groups. The pregabalin group received 75 mg of pregabalin twice daily for seven days and the control group received oral equivalent placebo capsules. The primary outcome was development of neuropathic PMPS. Neuropathic pain was assessed using the Grading System for Neuropathic Pain. Secondary outcome measures were safety and Visual Analogue Scale scores.

RESULTS

Neuropathic pain was significantly less frequent in the pregabalin group compared to the control group at four weeks (P = 0.005), 12 weeks (P = 0.002), and 24 weeks (P < 0.001) postoperatively. PMPS was diagnosed in 11 patients (11%) of the pregabalin group and 29 patients (29%) of the control group (P < 0.001, relative risk: 0.26, 95% CI: 0.12-0.56). At the three follow-up time points, Visual Analogue Scale scores during the first three postoperative weeks were comparable in both groups while they were significantly lower in the pregabalin group at 4, 12, and 24 weeks. These two groups were comparable in the frequency of adverse events (P = 0.552).

CONCLUSION

Perioperative oral pregabalin 75 mg twice daily, starting at the morning of surgery and continued for one week, could reduce the frequency of postmastectomy pain syndrome.

摘要

背景

慢性乳腺癌术后疼痛综合征(PMPS)对乳腺癌患者的生活质量有很大的负面影响。

目的

本研究旨在评估围手术期普瑞巴林预防 PMPS 的可能性。

方法

这是一项随机对照研究,纳入了 200 名计划接受择期乳腺癌手术的乳腺癌患者。他们被随机分配到两个治疗组之一。普瑞巴林组每天两次口服 75 毫克普瑞巴林,共 7 天,对照组则给予口服等效安慰剂胶囊。主要结局是出现神经性 PMPS。神经性疼痛采用神经性疼痛分级系统进行评估。次要结局指标为安全性和视觉模拟评分。

结果

与对照组相比,普瑞巴林组在术后 4 周(P=0.005)、12 周(P=0.002)和 24 周(P<0.001)时神经性疼痛的发生率明显较低。普瑞巴林组有 11 例(11%)患者诊断为 PMPS,对照组有 29 例(29%)患者诊断为 PMPS(P<0.001,相对风险:0.26,95%CI:0.12-0.56)。在三个随访时间点,两组在前 3 周的术后视觉模拟评分相似,但普瑞巴林组在第 4、12 和 24 周时的评分明显较低。两组的不良事件发生率相当(P=0.552)。

结论

术前一天早晨开始口服普瑞巴林 75 毫克,每天两次,持续一周,可降低乳腺癌术后疼痛综合征的发生率。

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