Efficacy and safety of fenofibrate or gemfibrozil on serum lipid profiles in Chinese patients with type IIb hyperlipidemia: a single-blind, randomized, and cross-over study.
Efficacy and safety of fenofibrate or gemfibrozil on serum lipid profiles in Chinese patients with type IIb hyperlipidemia: a single-blind, randomized, and cross-over study.
复制标题
非诺贝特或吉非贝齐对中国 IIb 型高脂血症患者血脂谱的疗效和安全性：单盲、随机、交叉研究。
DOI：
--
复制
发表时间：
1997
期刊：
影响因子：
--
通讯作者：
S. P. Wang
中科院分区：
文献类型：
--
作者：
S. Jen;J. Chen;W. L. Lee;S. P. Wang
背景
本研究的目的是评价非诺贝特或吉非贝齐对中国IIb型高脂血症患者血脂谱的影响和安全性。
方法
在这项单盲、随机、交叉研究中，对既往诊断为IIb型高脂血症的患者进行了初步评价。只有那些在两个月的饮食控制期后患有持续高脂血症的人被纳入。患者随机接受非诺贝特100 mg tid或吉非贝齐600 mg bid治疗3个月，然后在两个月的洗脱期后换用替代药物治疗3个月。在整个10个月期间，保持谨慎的饮食。每例患者定期在门诊随访饮食访谈、依从性和可能的不良事件。
结果
共有12名患者（11名男性和1名女性）完成了整个研究。非诺贝特治疗3个月后，血浆总胆固醇（22.7%，p < 0.001）、总甘油三酯（43.2%，p < 0.001）和低密度脂蛋白（LDL）-胆固醇（25.7%，p = 0.001）显著降低。血清高密度脂蛋白（HDL）胆固醇也增加了30.2%（p = 0.055）。另一方面，吉非罗齐治疗仅使总甘油三酯显著降低36.5%（p = 0.005）。吉非罗齐治疗3个月后，血清总胆固醇、高密度脂蛋白胆固醇和低密度脂蛋白胆固醇无显著变化。此外，血清尿酸和碱性磷酸酶显着降低与非诺贝特，但没有与吉非贝齐治疗。两种药物在每个治疗阶段均未观察到明显的不良事件。
结论
结果表明，在中国IIb型高脂血症患者中，非诺贝特和吉非贝齐均能安全且显著地降低血清甘油三酯。非诺贝特也能降低血清总胆固醇、低密度脂蛋白和尿酸，而吉非贝齐不能。这一结果与以前在西方高脂血症患者中的研究结果一致。
BACKGROUND
The purpose of the study was to evaluate the effects and safety of fenofibrate or gemfibrozil on plasma lipid profiles in Chinese patients with type IIb hyperlipidemia.
METHODS
Patients with previously diagnosed type IIb hyperlipidemia were initially evaluated in this single-blind, randomized, cross-over study. Only those who had persistent hyperlipidemia after a two-month diet control period were included. The patients were randomized to either fenofibrate 100 mg tid or gemfibrozil 600 mg bid for three months, then shifted to alternate drug for another three months after a two-month washout period. During the whole 10-month period, a prudent diet was maintained. Each patient was followed up at Out-patient Clinic regularly for diet interview, compliance and possible adverse events.
RESULTS
A total of 12 patients, 11 males and 1 female, completed the whole study. After a three-month treatment of fenofibrate, there was significant reduction in plasma total cholesterol (22.7%, p < 0.001), total triglycerides (43.2%, p < 0.001), and low-density lipoprotein (LDL)-cholesterol (25.7%, p = 0.001). Serum high density lipoprotein (HDL) cholesterol was also increased by 30.2% (p = 0.055). On the other hand, only total triglyceride was significantly reduced by 36.5% (p = 0.005) with gemfibrozil treatment. There was no significant change of serum total, HDL- and LDL-cholesterol after the three-month treatment of gemfibrozil. Besides, serum uric acid and alkaline phosphatase were significantly reduced with fenofibrate but not with gemfibrozil treatment. There was no obvious adverse event noted during each treatment period with either drug.
CONCLUSIONS
The findings suggest that in Chinese patients with type IIb hyperlipidemia, both fenofibrate and gemfibrozil can safely and significantly reduce serum triglyceride. Fenofibrate, but not gemfibrozil, could also reduce serum total cholesterol, LDL and uric acid. The results were compatible with the findings of previous studies in western patients with hyperlipidemia.