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口服降糖药罗格列酮在临床应用中的危险因素分析

奚宝晨, 丁庆明, 史录文*
  

  1. 1. 北京大学 药学院 药事管理与临床药学系, 北京 100191;
    2. 中日友好医院 药学部, 北京 100029
  • 收稿日期:2008-04-15 修回日期:2008-11-10 出版日期:2008-12-15 发布日期:2008-12-15
  • 通讯作者: 史录文

Risk factors analysis of rosiglitazone in patients with diabetes mellitus

Bao-Chen Xi, Qing-Ming Ding, Lu-Wen Shi*
  

  1. 1. Department of Pharmacy Administration and Clinical Pharmacy, Peking University, Beijing 100191, China;
    2. Department of Pharmacy, China-Japan Friendship Hospital, Beijing 100029, China
  • Received:2008-04-15 Revised:2008-11-10 Online:2008-12-15 Published:2008-12-15
  • Contact: Lu-Wen Shi

摘要:

根据最新药品说明书中的相关用药风险内容, 对中日友好医院目前使用口服降糖药罗格列酮的过程中可能存在的危险因素进行分析与讨论。收集近两年在中日友好医院住院患者中使用罗格列酮的病例, 通过查阅病历分析与罗格列酮可能相关的不良反应、用药禁忌症及联合用药相关问题的发生情况, 并针对这些问题进行进一步讨论。本次所调查的398例患者中, 1型糖尿病患者3(0.75%), 2型糖尿病患者395(99.25%)9例患者(2.26%)在用药过程中存在外周水肿; 1例患者(0.25%)在用药前存在黄斑水肿; 1.51%(6)患者在住院过程中存在心功能异常, 其中心功能2, 心功能3, 心功能1; 住院过程中存在肝功能异常(ALT异常)患者占19.85%(79), 其中ALT高于正常上限1 - 2.5倍的患者70, ALT高于正常上限2.5 - 3倍的患者3, ALT高于正常上限3倍以上的患者6例。使用罗格列酮的同时联合使用胰岛素、二甲双胍、硝酸酯类药物、吉非罗齐和利福平的患者分别占30.90%(123)41.46%(165)26.13%(104)0.75%(3)0.25%(1)。对罗格列酮使用过程中可能存在的各种危险因素的发生情况进行分析, 发现了目前罗格列酮临床应用中存在的潜在风险, 提出了相应的建议, 以促进临床合理用药。

关键词: 罗格列酮, 罗格列酮, 罗格列酮, 住院患者, 住院患者, 住院患者, 危险因素, 危险因素, 危险因素, 说明书, 说明书, 说明书, , ,

Abstract:

According to the drug-related risk factors indicated in the latest product monograph, we made this research to analyze and discuss the risk factors associated with rosiglitazone in clinical application in China-Japan Friendship Hospital. We collected and reviewed all cases involving inpatients who had used rosiglitazone in the hospital over the past two years. The focus of our study is on the identification and discussion of the incidence of adverse reactions, contraindications and drug induced problems associated with monotherapy or combined therapy of rosiglitazone. Three hundred and ninety eight cases were reviewed in the study including 3 patients with type 1 DM (0.75%) and 395 patients with type 2 diabetes mellitus (99.25%). Peripheral edema developed in 9 patients (2.26%) in the course of rosiglitazone therapy; one patient (0.25%) was found to have macula edema before rosiglitazone therapy; Cardiac abnormalities were identified in 6 patients (1.51%) in the course of treatment, of which 2 patients were NYHA class I, 3 patients were NYHA class II and 1 patient was NYHA class IV. Abnormal hepatic function (elevated ALT) was found in 79 patients (19.85%) during their stay in hospital. In these patients, ALT levels of 1 - 2.5 times, 2.5 - 3 times over the upper limit were identified in 70 patients, 3 patients and 6 patients, respectively. Of the 398 patients on rosiglitazone, 123 patients (30.90%), 165 patients (41.46%), 104 patients (26.13%), 3 patients (0.75%) and 1 patient (0.25%) were found to use concurrently insulin, metformin, organic nitrate, gemfibrozil and rifampin, respectively. We analyzed the risk factors associated with the clinical use of rosiglitazone, and identified the potential risks, and put forward suggestions to improve the effectiveness and safety of rosiglitazone therapy.

Key words: Rosiglitazone, Rosiglitazone, Inpatient, Inpatient, Risk factors, Risk factors, Product monograph, Product monograph, ,

Supporting: *Corresponding author. Tel.: 86-10-82801711;