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芬太尼 HCl 离子电渗经皮贴剂与吗啡静脉患者自控镇痛用于术后疼痛管理的疗效和安全性:患者亚组比较。

Efficacy and safety of fentanyl HCl iontophoretic transdermal system compared with morphine intravenous patient-controlled analgesia for postoperative pain management for patient subgroups.

机构信息

I.C.O.T.-Polo Pontino, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University of Rome La Sapienza, Rome, Italy.

出版信息

Eur J Anaesthesiol. 2010 May;27(5):433-40. doi: 10.1097/EJA.0b013e3283349d82.

DOI:10.1097/EJA.0b013e3283349d82
PMID:20186064
Abstract

BACKGROUND AND OBJECTIVE

Inadequate postoperative pain control remains a problem for many patients undergoing surgery. This study presents subgroup analyses from a large, randomized, multicentre, European study comparing the efficacy and safety of the fentanyl HCl iontophoretic transdermal system and morphine intravenous patient-controlled analgesia for postoperative pain management.

METHODS

The efficacy and safety of the fentanyl iontophoretic transdermal system and morphine intravenous patient-controlled analgesia were evaluated for patients divided by surgery type, sex, American Society of Anesthesiologists physical status and type of anaesthesia used during surgery. Efficacy measures included a patient global assessment of the method of pain control (a rating of 'good' or 'excellent' was considered as a success rating) and mean last pain intensity scores in the first 24 h. Discontinuation rates and the incidence of adverse events were also evaluated.

RESULTS

Numerically similar percentages of patients in most subgroups reported success on the last patient global assessment in the first 24 h for both the fentanyl iontophoretic transdermal system and morphine intravenous patient-controlled analgesia. Similar percentages of investigators reported success ratings on the investigator global assessment at the last assessment for both treatment groups regardless of surgery type, except for the knee surgery subgroup (fentanyl iontophoretic transdermal system, 75%; morphine intravenous patient-controlled analgesia, 95%). Mean last pain intensity scores in the first 24 h after surgery were similar in all subgroups. Rates of patient withdrawals and the incidence of adverse events were generally similar between treatment groups in the patient subgroups.

CONCLUSION

The fentanyl iontophoretic transdermal system and morphine intravenous patient-controlled analgesia are comparably well tolerated and effective methods of pain control, regardless of sex, American Society of Anesthesiologists physical status or the type of anaesthesia used for surgery, and following most surgery types.

摘要

背景与目的

许多接受手术的患者术后仍存在疼痛控制不足的问题。本研究报告了一项大型、随机、多中心、欧洲研究的亚组分析结果,该研究比较了芬太尼 HCl 离子电渗经皮贴剂和吗啡静脉患者自控镇痛用于术后疼痛管理的疗效和安全性。

方法

根据手术类型、性别、美国麻醉医师协会身体状况和手术期间使用的麻醉类型对芬太尼离子电渗经皮贴剂和吗啡静脉患者自控镇痛的疗效和安全性进行评估。疗效评估指标包括患者对疼痛控制方法的总体评估(“良好”或“优秀”的评分被认为是成功评分)和前 24 小时内的平均末次疼痛强度评分。还评估了停药率和不良事件的发生率。

结果

在大多数亚组中,接受芬太尼离子电渗经皮贴剂和吗啡静脉患者自控镇痛治疗的患者在前 24 小时内最后一次患者总体评估中报告成功的比例数值上相似。无论手术类型如何,大多数治疗组的研究者在最后一次评估时报告的成功率都相似,只有膝关节手术亚组(芬太尼离子电渗经皮贴剂,75%;吗啡静脉患者自控镇痛,95%)除外。术后前 24 小时内的平均末次疼痛强度评分在所有亚组中相似。在患者亚组中,两组之间的患者退出率和不良事件发生率通常相似。

结论

无论性别、美国麻醉医师协会身体状况或手术中使用的麻醉类型如何,以及在大多数手术类型后,芬太尼离子电渗经皮贴剂和吗啡静脉患者自控镇痛都是可耐受且有效的疼痛控制方法。

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