Department of Anaesthesiology and Intensive Care, Orebro Medical Centre Hospital, Orebro, Sweden.
Clin Drug Investig. 2010;30(10):687-97. doi: 10.2165/11538860-000000000-00000.
Post-marketing surveillance studies can provide supplemental data on the safety of medications in the general population.
This study aimed to evaluate the safety of analgesic regimens including the NSAID lornoxicam in the short-term treatment of postoperative pain in a clinically relevant population.
Randomized, open-label, multicentre, multinational, observational cohort study of 4 days' duration.
In-hospital postoperative setting, with discharge to home treatment within 24 hours of surgery.
Adults aged > or =18 years expected to be in need of analgesic treatment after day-case surgery.
Analgesic regimens containing lornoxicam were compared with a standard analgesic treatment, which was defined as the treatment that the patient would normally receive at the centre.
Following day-case surgery, patients were provided with appropriate analgesic medication, and adverse events (AEs; defined as all recorded events with symptoms) were recorded by the investigator during the in-hospital stay and by the patient for the next 3 days using entries recorded morning and evening in a patient diary. Statistical analyses tested for between-treatment differences in AEs, adverse drug reactions (ADRs; defined as events probably, possibly or unlikely to be related to treatment) and gastrointestinal AEs (GI-AEs).
A total of 4152 patients were randomized to treatment. Since 400 patients did not take any analgesic, the safety population consisted of 1838 patients for lornoxicam and 1914 patients for standard analgesic treatment. Demographic and disease characteristics were similar between the two treatment groups, as were the type of surgery and the anaesthesia used in surgery. In the safety population, 16.9% of patients received no analgesic in hospital, and when analgesics were provided they were often administered in combination. Similarly, approximately 17% of patients did not take any analgesics at home. AEs were reported in 27.1% and 29.4% of patients in the lornoxicam and standard analgesic treatment groups, respectively, and ADRs constituted the majority of these events. No significant differences were demonstrated with regard to the incidence of AEs between the two groups. Most events were of mild or moderate intensity. Consistent with what may be expected for an NSAID, most AEs with lornoxicam were related to the GI system. GI-AEs were reported in 19.5% and 21.3% of patients in the lornoxicam and standard analgesic treatment groups, respectively, and most of these were considered ADRs. Most patients were satisfied with their pain treatment both in hospital and at home.
Lornoxicam-containing regimens are as well tolerated as other analgesic regimens over 4 days in the treatment of postoperative pain.
上市后监测研究可以提供药物在普通人群中的安全性补充数据。
本研究旨在评估包括 NSAID 洛索洛芬在内的镇痛方案在临床相关人群中短期治疗术后疼痛的安全性。
为期 4 天的随机、开放标签、多中心、多国、观察性队列研究。
住院术后环境，术后 24 小时内出院回家治疗。
预计在日间手术后需要镇痛治疗的年龄≥18 岁的成年人。
洛索洛芬联合镇痛方案与标准镇痛治疗进行比较，标准镇痛治疗定义为患者在中心通常接受的治疗。
在日间手术后，为患者提供了适当的镇痛药物，研究者在住院期间和患者在接下来的 3 天内通过患者日记记录的早晨和晚上的条目记录了不良事件（AE；定义为有症状的所有记录事件）。统计分析测试了治疗之间 AE、药物不良反应（ADR；定义为可能、可能或不太可能与治疗相关的事件）和胃肠道不良事件（GI-AE）的差异。
共 4152 名患者被随机分配至治疗组。由于 400 名患者未服用任何镇痛药，因此安全性人群包括洛索洛芬组 1838 名患者和标准镇痛治疗组 1914 名患者。两组患者的人口统计学和疾病特征相似，手术类型和手术中使用的麻醉也相似。在安全性人群中，16.9%的患者在住院期间未接受任何镇痛治疗，而当给予镇痛治疗时，通常会联合使用。同样，大约 17%的患者在家中未服用任何镇痛药。洛索洛芬组和标准镇痛治疗组分别有 27.1%和 29.4%的患者报告发生 AE，其中大多数 ADR 构成了这些事件的主要部分。两组间 AE 的发生率无显著差异。大多数事件为轻度或中度强度。与 NSAID 可能预期的情况一致，大多数与洛索洛芬相关的 AE 与胃肠道系统有关。洛索洛芬组和标准镇痛治疗组分别有 19.5%和 21.3%的患者报告发生 GI-AE，其中大多数被认为是 ADR。大多数患者对住院和在家中的疼痛治疗均满意。
洛索洛芬联合镇痛方案在治疗术后疼痛的 4 天内与其他镇痛方案一样耐受良好。
