[环丙贝特的安全性。葡萄牙人群中的开放性研究]
[Safety of ciprofibrate. Open study in a Portuguese population].
作者信息
Branco M C, de Moura J P, Pereira M, Jesus L C, Ferraz A, Silva J M, Ferreira M R, Serra e Silva P
机构信息
Centro Hospitalar de Coimbra (CHC), Serviço de Medicina Interna.
出版信息
Rev Port Cardiol. 1995 May;14(5):395-9, 360.
STUDY OBJECTIVE
To determine the safety of ciprofibrate in portuguese patients with dyslipidaemia.
DESIGN
Open-label study with 6-month therapy.
PARTICIPANTS
Sequential sample of 40 patients, 20 from each hospital, 37 patients (92.5%) completed the study.
METHODS
After at least one month of diet or washout period, all participants were given 100 mg/day of ciprofibrate, taken after the evening meal. Analysis and clinical examinations were performed at weeks (-4), (0), (+8), (+16) and (+24). Glycemia, uric acid, creatine kinase, creatinine and transaminases were determined.
MAIN RESULTS
Thirty-seven patients ended the study (92.5%), three abandoned because of gastrointestinal adverse effects, six other patients also complaint of gastrointestinal side effects. The creatinine and creatine kinase levels increased 9.7% and 19.2%, although kept in the normal range. There were no statistically significant changes in glycemia, uric acid and transaminases levels.
CONCLUSIONS
These results confirm the high safety of ciprofibrate in patients with dislipidaemia. The short term of this study does not allows taking conclusions about long term use of this drug.
研究目的
确定环丙贝特对葡萄牙血脂异常患者的安全性。
设计
为期6个月治疗的开放标签研究。
参与者
连续抽取40名患者，每家医院20名，37名患者（92.5%）完成了研究。
方法
在至少1个月的饮食期或洗脱期后，所有参与者均接受每日100毫克环丙贝特治疗，于晚餐后服用。在第（-4）、（0）、（+8）、（+16）和（+24）周进行分析和临床检查。测定血糖、尿酸、肌酸激酶、肌酐和转氨酶。
主要结果
37名患者完成了研究（92.5%），3名因胃肠道不良反应退出，另外6名患者也抱怨有胃肠道副作用。肌酐和肌酸激酶水平分别升高了9.7%和19.2%，尽管仍在正常范围内。血糖、尿酸和转氨酶水平无统计学显著变化。
结论
这些结果证实了环丙贝特对血脂异常患者具有高度安全性。本研究的短期性质不允许就该药物的长期使用得出结论。
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