Health Outcome Research Department, Pharmacia Italia SpA, Milan, Italy.
Clin Drug Investig. 2003;23(11):751-60. doi: 10.2165/00044011-200323110-00008.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are prescribed widely in Italy. They include nonspecific NSAIDs (NS-NSAIDs) and the newly marketed cyclo-oxygenase (COX)-2 specific inhibitors (COXIBs) celecoxib and rofecoxib. The objective of this study was to describe the prescribing patterns for NS-NSAIDs and COXIBs in a local Italian area, analysing an administrative database.
We extracted from the database information on subjects who had received at least one reimbursed prescription of an NSAID during the period between 1 January 2001 and 31 December 2001, including age, sex, patient identification code, Anatomical Therapeutic Chemical (ATC) classification system code, strength, formulation, number of packs prescribed, prescription date, and prescription of gastroprotective agents (GPAs) on the same day as the prescription of the NSAID. On the basis of the type of NSAID received, we divided the patients into five cohorts: oral NS-NSAIDs only during the observed year, injectable NS-NSAIDs only, celecoxib only, rofecoxib only, and a combination. For descriptive purposes, we defined three age groups: <40 years, 40-64 years, and >64 years. The duration of exposure to NSAID therapy was calculated using the most commonly prescribed dose for the different drugs. Subjects receiving >/=30 doses per year were defined as "regular users". Analyses included mean age, mean duration of exposure, percentage of regular users, and percentage of GPAs co-prescribed in the different cohorts.
NSAIDs were prescribed to 62 059 subjects from a resident population of 365 321 inhabitants; 43.8% received oral NS-NSAIDs only, 22.6% injectable NS-NSAIDs only, 7.2% celecoxib only, 5.2% rofecoxib only, and 22% different regimens of different types of NSAIDs. The mean duration of treatment increased with age in all cohorts; the mean age was 56 years in the NS-NSAID cohort, 61 years in the celecoxib cohort, and 62 years in the rofecoxib cohort (p = 0.01, COXIBs vs NS-NSAIDs). The mean duration of therapy was 11.4 days/year for injectable NS-NSAIDs, 43.8 days/year for rofecoxib, 50.5 days/year for oral NS-NSAIDs, and 53.7 days/year for celecoxib. Fifty-four percent of subjects in the oral NS-NSAID cohort were regular users versus 64% in the rofecoxib and 70% in the celecoxib groups (p = 0.001, COXIBs vs NS-NSAIDs). Co-prescription with GPAs was 9.5% for NS-NSAIDs, 8.4% for rofecoxib, and 7.7% for celecoxib.
Analysis of an administrative database in Italy showed a trend suggesting that COXIBs are prescribed to an older population and for a longer period of time than NS-NSAIDs, and that their use is less frequently associated with GPAs.
非甾体抗炎药（NSAIDs）在意大利广泛应用。其中包括非特异性 NSAIDs（NS-NSAIDs）和新上市的环氧化酶（COX）-2 特异性抑制剂（COXIBs）塞来昔布和罗非昔布。本研究旨在通过分析一个意大利地方的行政数据库，描述 NSAIDs 和 COXIBs 的处方模式。
我们从数据库中提取了 2001 年 1 月 1 日至 12 月 31 日期间至少接受一次 NSAID 报销处方的患者信息，包括年龄、性别、患者识别码、解剖治疗化学（ATC）分类系统代码、强度、配方、开处方的 NSAID 数量、处方日期以及与 NSAID 同日开具的胃保护剂（GPA）。根据 NSAID 的类型，我们将患者分为五组：仅在观察年内口服 NS-NSAIDs、仅注射用 NS-NSAIDs、仅塞来昔布、仅罗非昔布和联合用药。出于描述性目的，我们将三个年龄组定义为：<40 岁、40-64 岁和>64 岁。使用不同药物最常开的剂量计算 NSAID 治疗的暴露时间。每年接受> = 30 剂的患者被定义为“常规使用者”。分析包括平均年龄、平均暴露时间、常规使用者的百分比和不同组中同时开具 GPA 的百分比。
从 365321 名居民中，向 62059 名患者开具了 NSAIDs；43.8%的患者仅接受口服 NS-NSAIDs，22.6%仅接受注射用 NS-NSAIDs，7.2%仅接受塞来昔布，5.2%仅接受罗非昔布，22%接受不同类型 NSAIDs 的不同方案。所有组中，治疗时间随年龄的增长而增加；NS-NSAIDs 组的平均年龄为 56 岁，塞来昔布组为 61 岁，罗非昔布组为 62 岁（p = 0.01，COXIBs 与 NS-NSAIDs 相比）。注射用 NS-NSAIDs 的平均治疗时间为 11.4 天/年，罗非昔布为 43.8 天/年，口服 NS-NSAIDs 为 50.5 天/年，塞来昔布为 53.7 天/年。口服 NS-NSAIDs 组中 54%的患者为常规使用者，而罗非昔布组和塞来昔布组分别为 64%和 70%（p = 0.001，COXIBs 与 NS-NSAIDs 相比）。NS-NSAIDs 组的 GPA 联合用药率为 9.5%，罗非昔布组为 8.4%，塞来昔布组为 7.7%。
对意大利一个行政数据库的分析表明，COXIBs 用于年龄较大的人群，且治疗时间较长，而与 NSAIDs 相比，其使用与 GPA 的关联较少。
