透皮芬太尼贴剂用于术后镇痛的临床研究

A clinical study on the transdermal fentanyl used for postoperative pain relief

目的 研究芬太尼透皮贴剂 (TTS)用于全麻患者术后镇痛的临床效果及安全性。方法 选择骨科择期手术的全麻病人 90例 ,随机分为A、B、C三组 ,分别于术前 2h ,在患者前胸锁骨下贴释放率为 5 0、2 5 μg/h的芬太尼透皮贴剂或安慰剂贴剂 ,常规诱导维持。于使用贴剂后 6、12、2 4、36、4 8、72h对三组患者进行随访 ,记录VAS动、静态疼痛评分 ,VAS恶心评分及其他不良反应。并于术前 2h及术后 12、2 4h采集血样 ,用放免法测定部分病人的促肾上腺皮质激素 (ACTH)、泌乳素(PRL)、β 内啡肽 (β EP)和胰岛素 (Ins)水平。 结果 手术后各时间点A、B两组的ACTH、PRL、β EP水平显著低于C组 (P <0 0 1) ,A、B两组间无明显差异 ;Ins水平A、B、C三组间差别不明显 ;手术后各时间点的动、静态VAS评分A、B两组均低于C组 ,但A、B两组的VAS恶心评分高于C组 (P <0 0 1) ;A、B两组间VAS静态评分及VAS恶心评分无显著性差异 (P >0 0 5 ) ,但在术后的 6、12、2 4h ,A、B两组间VAS动态评分差异显著 (P <0 0 1)。三组中均未出现呼吸抑制、瘙痒、尿潴留、发生率三组相似。结论 TTS用于 2h左右的骨科手术安全可靠 ,主要不良反应为恶心。

Objective The purpose of this study was to investigate the efficacy of transdermal fentanyl(TTS)for postoperative analgesia.Methods Ninety ASA Ⅰ Ⅱ patients undergoing lower limbs surgery were studied.The patients were randomly divided into three groups:50μg/kg TTS patch(group A),25μg/h TTS patch(group B),placebo patch(group C).Anesthesia was induced with fentanyl 5μg/h,midazolum 0 10mg/kg and vecuronium 0 13mg/kg,and maintained with lower concentration of isoflurane inhalation and intermittent boluses of propofol and vecuronium in all groups.Three kinds of patch were applied 2 hours before operation and left in place for 72 hours.Blood samples were withdrawn 2 hours before induction of anesthesia,12,24h after TTS used for determination of ACTH,PRL,β EP and Ins concentration.Postoperative analgesia was assessed by VAS both at rest and during movement at 6,12,24,36,48,72 hours after TTS used.Results The age,sex,weight,ASA status and hormone levels were comparable among the three groups before the operation.The ACTH,PRL and β EP level were significantly lower in group A and B than those in group C after operation,but there was not significantly different in Ins concentration among three groups during perioperative period.There was no significant difference in ACTH,PRL and β EP level between group A and B.The VAS at rest and during movement was significantly lower in group A and B than that in control group,and the incidence of vomitting was more frequenct in group A and B than that in group C.There was not significantly different between group A and B with regard to VAS at rest and the incidence of vomitting,but significantly reduced in pain score during the first postoperative day in group A.Conclusion Transdermal fentanyl patch can be effectively used for postoperative analgesia in patients underwent 2 hours orthopedic surgery.The major adverse effects are vomitting and nausa. [