利多卡因贴剂联合塞来昔布胶囊预防开胸术后慢性疼痛的疗效分析

Clinical study and safety analysis of lidocaine patch for prevention of chronic pain after open heart surgery

摘要:

目的：观察利多卡因凝胶贴剂联合塞来昔布胶囊预防开胸术后慢性切口痛的疗效及安全性。方法：筛选于南京市第一医院、南京大学医学院附属金陵医院、南京中医药大学附属南京医院、扬州大学附属泰州市第二人民医院进行开胸手术切口愈合后存在中、重度切口痛且疼痛持续≥1周的患者160例，按随机数字表法分为对照组和试验组，每组80例。试验组采用口服塞来昔布胶囊0.2g、Q12 h联合利多卡因凝胶贴剂治疗；对照组患者仅口服塞来昔布胶囊0.2g、Q12h。两组患者治疗周期均为2周。观察并记录患者用药后1天、7天、14天、1个月、3个月的疼痛数字评定量表（numerical rating scale, NRS）评分和不良反应，以及治疗前和治疗后3个月时杜勒神经病理性疼痛评估量表（Douleur Neuropathique 4 questions, DN4）、疼痛干扰睡眠评分（Daily sleep interference score，SIS）。结果：试验组各个时间点NRS评分均低于治疗前和同期对照组，差异有统计学意义（P<0.05）；试验组治疗后3个月时DN4评分＞4分患者数较对照组明显减少（P <0.001），患者睡眠质量较对照组改善。两组均未有严重不良反应 。结论：利多卡因凝胶贴剂联合塞来昔布胶囊能够安全有效的控制开胸术后的慢性疼痛，减少慢性胸科术后疼痛的发生率。

Abstract:

Objective: Observation of the efficacy and safety of lidocaine patch combined with celecoxib capsule in the prevention of chronic incisional pain after open heart surgery. Method: 160 patients with moderate to severe incision pain 1 week after thoracic surgery were selected and randomly divided into a control group and an experimental group, with 80 patients in each group. Control group was treated with oral Celecoxib capsules of 0.2g, Q12h. Experimental group was treated with oral celecoxib capsule 0.2g, Q12h combined with lidocaine patch for external application of pain site. The treatment cycle for both groups of patients is 2 weeks. Observe and record the numerical rating scale (NRS) and adverse reactions of patients at 1 day, 7 days, 14 days, 1 month, and 3 months after medication, as well as the Douleur neuropathique 4 questions (DN4) scores and Daily sleep interference score(SIS) scores before and 3 months after treatment. Results: The NRS scores of experimental group in each period after the use of lidocaine plaster were lower than those of control group before and during the same period, with a statistically significant difference (P<0.05); The number of patients with neuropathic pain in experimental group after 3 months of treatment is lower than that in control group, and the sleep quality of patients is improved compared to control group. There were no serious adverse reactions in either group . Conclusion: Lidocaine patch combined with celecoxib capsules safely and effectively controls chronic pain after open-heart surgery and reduces the incidence of chronic postoperative thoracic pain.