经皮尼古丁与褪黑素对腹腔镜胆囊切除术术后疼痛缓解的比较研究，一项双盲、安慰剂对照试验

经皮尼古丁与褪黑素对腹腔镜胆囊切除术术后疼痛缓解的比较研究，一项双盲、安慰剂对照试验
Comparative study between transdermal nicotine and melatonin patches on postoperative pain relief after laparoscopic cholecystectomy, a double-blind, placebo-controlled trial

                               
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Abstract
摘要
Background
背景
This study evaluated the efficacy of transdermal nicotine (TDN) delivery system (15 mg/16 h) or transdermal melatonin (TDM) delivery system (7 mg) 2 h preoperatively for acute postoperative pain after laparoscopic cholecystectomy compared to placebo group (C).
这项研究评估了经皮尼古丁的功效（TDN）输送系统（15毫克/ 16小时）或术前2 h经皮给药褪黑素（TDM）输送系统（7 mg），与腹腔镜胆囊切除术后安慰剂组在急性术后疼痛的比较（C）。

Methods
方法
Sixty female non-smoker patients, aged 18–50 years and ASA I and II undergoing elective laparoscopic cholecystectomy under general anesthesia were included in this randomized controlled double-blind study. Patients were randomly divided into 3 groups 20 each, and C group patients received transdermal placebo patch, TDN group (15 mg/16 h) and TDM group (7 mg/8 h). Assessment of postoperative pain, sedation, hemodynamic variables such as HR and MAP, postoperative monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritus, respiratory depression and hemodynamic instability) were done 30 min, 1, 2, 6 and 12 h postoperatively. Postoperative Patient’s and Surgeons’ satisfaction, Intraoperative bleeding and plasma cortisol (μg/dl) 2 h postoperatively were also assessed.
六十名女性非吸烟者患者，年龄18岁-50岁，ASA I和II接受择期腹腔镜胆囊切除术在全身麻醉下被纳入这项随机对照的双盲研究。患者被随机分为3组，每组20例，C组患者接受经皮吸收的安慰剂，TDN组（15 mg／16 h）和TDM组（7 mg／8 h）。术后疼痛、镇静等血流动力学评估，HR、MAP、SpO2、动脉的副作用，术后监测（如恶心、呕吐、皮肤瘙痒、呼吸抑制和血流动力学不稳定）进行了30分钟，1、2、6和12 h后。术后患者和外科医生的满意度，术中出血和血浆皮质醇（μg）2小时术后也进行了评估。

Results
结果
There was a significant reduction in the VAS score, total pethidine requirements (mg) and significantly higher patient’s satisfaction in TDN and TDM groups when compared with the C group postoperatively. The sedation score and surgeons’ satisfaction were significantly higher associated with a significant decrease in MAP and Intraoperative bleeding in TDM group compared to C and TDN groups postoperatively. Significant nausea and vomiting in TDN group and significant sedation in TDM group were recorded.
在VAS评分显著下降，哌替啶总需求（MG）和病人的满意度明显高于TDN和TDM组与C组术后。该镇静评分和外科医生的满意度相比于C和TDN组在术后TDM组MAP和术中出血一个显著下跌均显著增加有关。明显的恶心和TDN组、TDM组显著镇静呕吐的记录。

Conclusion
结论
The use of preoperative TDN (15 mg/16 h) or TDM (7 mg/8 h) was an effective and a safe adjuvant for acute pain after surgery.
术前使用TDN（15毫克/ 16小时）或TDM（7 mg／8 h）用于术后急性疼痛是一种有效的、安全的辅助治疗。

Keywords
关键词
Transdermal nicotine; Transdermal melatonin; Postoperative pain; Laparoscopic cholecystectomy
经皮尼古丁；经皮褪黑激素；术后疼痛；腹腔镜胆囊切除术

原文：
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经皮尼古丁与褪黑素对腹腔镜胆囊切除术术后疼痛缓解的比较研究，一项双盲、安慰剂对照试验