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氯诺昔康与曲马多作为头颈部手术后镇痛药的疗效和安全性比较研究。

A comparative study of efficacy and safety of lornoxicam versus tramadol as analgesics after surgery on head and neck.

作者信息

Das Sudip Kr, Banerjee Manasi, Mondal Shirsendu, Ghosh Balaram, Ghosh Bhaskar, Sen Shubhrakanti

机构信息

Department of ENT and Head & Neck Surgery, Medical College, Kolkata, India.

Department of Pharmacology, Medical College, Kolkata, India.

出版信息

Indian J Otolaryngol Head Neck Surg. 2013 Jul;65(Suppl 1):126-30. doi: 10.1007/s12070-013-0617-y. Epub 2013 Jan 22.

Abstract

To assess efficacy and safety of lornoxicam as analgesic after surgery on head and neck in comparison to tramadol. Forty five patients undergoing operations on head and neck were recruited and randomly assigned to two parallel groups-lornoxicam and tramadol, both given intramuscular on the first post-operative day followed by oral tablets for the consecutive 4 days. Treatment was given single blind. 10 cm visual analog scale (VAS) pain score and wound tenderness assessed by a 3-point ordinal scale were the primary efficacy parameters. Use of rescue medication and percentage of subjects having at least 50 % pain relief by 48 h were also compared as secondary parameters. The groups were comparable at baseline regarding age, sex and VAS score. There was steady decline in VAS pain score from baseline to study end in both the groups, indicating good analgesic efficacy with either drug. Between groups comparisons of VAS score showed no significant difference at any time point. Between groups comparisons of wound tenderness also showed no significant difference. Five patients on lornoxicam and one patient on tramadol experienced at least 50 % pain relief at 48 hours compared to baseline while five patients from the lornoxicam group and eight from the tramadol group required rescue medicine. The tolerability of lornoxicam appeared to be significantly superior to tramadol, with less number of patients experiencing adverse drug reactions. Lornoxicam is safe, effective and comparable to tramadol for relieving postoperative pain after operations on head and neck.

摘要

为了比较氯诺昔康与曲马多作为头颈部手术后镇痛药的疗效和安全性。招募了45名头颈部手术患者,并随机分为两个平行组——氯诺昔康组和曲马多组,两组均在术后第一天肌肉注射给药,随后连续4天口服片剂。治疗采用单盲法。主要疗效参数为用10厘米视觉模拟量表(VAS)评估疼痛评分,并用3分有序量表评估伤口压痛。还比较了急救药物的使用情况以及在48小时内至少有50%疼痛缓解的受试者百分比作为次要参数。两组在年龄、性别和VAS评分的基线方面具有可比性。两组从基线到研究结束时VAS疼痛评分均稳步下降,表明两种药物均具有良好的镇痛效果。两组间VAS评分比较在任何时间点均无显著差异。两组间伤口压痛比较也无显著差异。与基线相比,氯诺昔康组有5名患者、曲马多组有1名患者在48小时时疼痛缓解至少50%,而氯诺昔康组有5名患者、曲马多组有8名患者需要使用急救药物。氯诺昔康的耐受性似乎明显优于曲马多,发生药物不良反应的患者较少。氯诺昔康在缓解头颈部手术后的术后疼痛方面安全、有效,且与曲马多相当。

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