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尼美舒利栓剂用于儿童术后疼痛和炎症的药代动力学及治疗研究。

Pharmacokinetics and therapeutic study with nimesulide suppositories in children with post-operative pain and inflammation.

作者信息

Schärli A F, Brülhart K, Monti T

机构信息

Department of Paediatric Surgery, Children's Hospital, Lucerne, Switzerland.

出版信息

J Int Med Res. 1990 Jul-Aug;18(4):315-21. doi: 10.1177/030006059001800408.

DOI:10.1177/030006059001800408
PMID:2227079
Abstract

The pharmacokinetic pattern of 100 mg nimesulide administered rectally at different times prior to undergoing minor surgery was studied in 45 children. Absorption of nimesulide was relatively fast, a peak plasma concentration of 75 mg/l being reached 3 h after administration, and the elimination half-life was 3.15 h. The efficacy and tolerability of the nimesulide suppositories were assessed in a randomized, double-blind, dipyrone-controlled study of 50 children suffering from moderate to severe post-operative pain, the drugs being administered one to three times daily as required; 26 patients received nimesulide and 24 dipyrone. A consistent reduction in pain was recorded during nimesulide therapy given for a mean period of 2.5 days, with a mean consumption of 3.5 suppositories. Similar results were obtained in dipyrone-treated patients. The efficacy of both drugs was judged by the physicians to be good or very good in 70% of cases and there were no statistically significant differences between the two treatment groups in the dosage required or the pain relief. Tolerability of both drugs was excellent, with only one patient in each treatment group complaining of nausea.

摘要

对45名儿童进行了研究,观察在接受小手术前不同时间直肠给予100毫克尼美舒利后的药代动力学模式。尼美舒利吸收相对较快,给药后3小时达到血浆峰值浓度75毫克/升,消除半衰期为3.15小时。在一项随机、双盲、以安乃近为对照的研究中,对50名患有中度至重度术后疼痛的儿童评估了尼美舒利栓剂的疗效和耐受性,根据需要每天给药1至3次;26例患者接受尼美舒利治疗,24例接受安乃近治疗。在平均为期2.5天的尼美舒利治疗期间,疼痛持续减轻,平均使用3.5枚栓剂。安乃近治疗的患者也获得了类似结果。医生判定两种药物在70%的病例中疗效良好或非常好,两个治疗组在所需剂量或疼痛缓解方面无统计学显著差异。两种药物的耐受性都很好,每个治疗组只有1名患者抱怨恶心。

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