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罗非昔布撤市后医师开具环氧化酶-2 抑制剂处方习惯的变化:台湾地区医患配对的回顾性研究。

Changes in physicians' practice of prescribing cyclooxygenase-2 inhibitor after market withdrawal of rofecoxib: a retrospective study of physician-patient pairs in Taiwan.

机构信息

Institute of Health and Welfare Policy, National Yang-Ming University, Taipei, Taiwan.

出版信息

Clin Ther. 2009 Nov;31(11):2618-27. doi: 10.1016/j.clinthera.2009.11.022.

Abstract

BACKGROUND

Safety concerns regarding severe cardiovascular events associated with the use of selective cyclooxygenase-2 (COX-2) inhibitors resulted in the market withdrawal of rofecoxib in September 2004.

OBJECTIVE

Using Taiwan's National Health Insurance 2003-;2004 claims database, this population-based retrospective cohort study assessed changes in physicians' practice of prescribing a COX-2 inhibitor after market withdrawal of rofecoxib.

METHODS

Patients with rheumatoid arthritis (RA) or osteoarthritis (OA) who were chronic users of COX-2 inhibitors before market withdrawal of rofecoxib were identified. Eligible chronic users of COX-2 inhibitors were patients who received >or=3 consecutive prescriptions for celecoxib or rofecoxib to treat RA or OA between April 1 and September 30, 2004. The main outcome evaluated in this study was the volume of celecoxib prescribing for each patient by his or her prescribing physician at the first postwithdrawal outpatient visit related to RA or OA. For each matched physician, we calculated the prescribing practice indexes before and after the withdrawal of rofecoxib to assess changes in prescribing practice. A higher value of the index represented less potential that patients with a history of cardiovascular events who were seen by a physician received a prescription for a COX-2 inhibitor. A 2-stage model analysis was used to assess changes, in physicians' prescribing practice after rofecoxib's withdrawal, in the volume of prescribing a COX-2 inhibitor for each matched patient by his or her prescribing physician.

RESULTS

Of the chronic users of COX-2 inhibitors identified, 13,101 were taking celecoxib and 8763 were taking rofecoxib before rofecoxib was withdrawn from the market. Concerns about safety after the mar- ket withdrawal of rofecoxib reduced physicians' volume of prescribing a COX-2 inhibitor, particularly in patients who had previously received rofecoxib. After rofecoxib's withdrawal, 72.50% of previous rofecoxib users (n = 6353) and 49.50% of previous celecoxib users (n = 6485) stopped taking COX-2 inhibitors. Only 27.50% of the rofecoxib users (n = 2410) were switched to celecoxib after rofecoxib's withdrawal. Overall, physicians' prescribing practice for celecoxib increased, from baseline to 3 months after rofecoxib's withdrawal, from 0.66 to 0.79 for academic medical center physicians, 0.71 to 0.82 for metropolitan hospital physicians, 0.77 to 0.88 for local community hospital physicians, and 0.86 to 0.92 for primary care clinic physicians. After controlling for patients' demographics, the linear regression analysis revealed that changes in physicians' prescribing practice after the withdrawal of rofecoxib affected the volume of prescribing a COX-2 inhibitor (P < 0.001).

CONCLUSIONS

The volume of celecoxib prescribing was greatly reduced after rofecoxib was withdrawn from the market. Physicians' prescribing practice for COX-2 inhibitors significantly changed after the withdrawal, and it had a significant impact on the postwithdrawal volume of celecoxib prescribing.

摘要

背景

与选择性环氧化酶-2(COX-2)抑制剂相关的严重心血管事件的安全问题导致罗非昔布于 2004 年 9 月撤出市场。

目的

利用台湾 2003-2004 年的全民健康保险理赔数据库,本基于人群的回顾性队列研究评估了罗非昔布撤出市场后医生开具 COX-2 抑制剂处方的做法变化。

方法

确定了在罗非昔布撤出市场之前长期使用 COX-2 抑制剂的类风湿关节炎(RA)或骨关节炎(OA)患者。合格的 COX-2 抑制剂长期使用者是指在 2004 年 4 月 1 日至 9 月 30 日期间,连续接受>或=3 次塞来昔布或罗非昔布处方治疗 RA 或 OA 的 COX-2 抑制剂慢性使用者。本研究的主要结局是每位患者的第一例与 RA 或 OA 相关的门诊就诊时其主治医生为其开具的塞来昔布处方量。对于每个匹配的医生,我们计算了罗非昔布撤出前后的处方实践指数,以评估处方实践的变化。该指数的值越高,表示有心血管事件史的患者接受 COX-2 抑制剂处方的可能性越低。采用两阶段模型分析评估罗非昔布撤出后医生为每位匹配患者开具 COX-2 抑制剂处方量的处方实践变化。

结果

在确定的 COX-2 抑制剂慢性使用者中,有 13101 名患者服用塞来昔布,8763 名患者服用罗非昔布。罗非昔布撤出市场后对安全性的担忧降低了医生开具 COX-2 抑制剂的数量,特别是在以前服用过罗非昔布的患者中。罗非昔布撤出后,6353 名(72.50%)以前服用过罗非昔布的患者和 6485 名(49.50%)以前服用过塞来昔布的患者停止服用 COX-2 抑制剂。罗非昔布撤出后,只有 2410 名(27.50%)罗非昔布使用者转换为服用塞来昔布。总体而言,罗非昔布撤出后,从基线到罗非昔布撤出后 3 个月,学术医疗中心医生开具塞来昔布的处方量从 0.66 增加到 0.79,大都市医院医生从 0.71 增加到 0.82,当地社区医院医生从 0.77 增加到 0.88,初级保健诊所医生从 0.86 增加到 0.92。在控制患者人口统计学特征后,线性回归分析显示,罗非昔布撤出后医生处方实践的变化影响了 COX-2 抑制剂的开具量(P<0.001)。

结论

罗非昔布撤出市场后,塞来昔布的开具量大大减少。罗非昔布撤出后,医生开具 COX-2 抑制剂的处方实践发生了显著变化,这对撤出后塞来昔布的开具量有显著影响。

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