国产苯扎贝特治疗高甘油三酯血症的疗效及安全性

Efficacy and safety of homemade bezafibrate in treatment of hypertriglyceridemia

目的:评估国产苯扎贝特治疗高甘油三酯血症的疗效及安全性。方法:2006年5月至2007年7月,纳入研究的高甘油三酯血症患者132例随机分为3组:苯扎贝特组(59例),非诺贝特组(55例)及对照组(18例)。苯扎贝特组男45例,女14例,平均年龄(51.4±15.4)岁;非诺贝特组男42例,女13例,平均年龄(51.5±15.5)岁;对照组男13例,女5例,平均年龄(52.7±16.0)岁。苯扎贝特组给予苯扎贝特200mg,3次/d口服;非诺贝特组给予非诺贝特100mg,3次/d口服;对照组非药物治疗,疗程均3个月。比较3组患者治疗前后血甘油三酯(TG)、总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)和高密度脂蛋白胆固醇(HDL-C)]水平,并观察出现的不良反应。结果:苯扎贝特组和非诺贝特组TG、TC、LDL-C水平治疗前分别为(3.16±0.60)、(5.25±0.56)、(2.76±0.45)和(3.13±0.55)、(5.28±0.52)、(2.82±0.41)mmol/L,治疗后分别降至(2.42±0.43)、(4.93±0.47)、(2.55±0.44)和(2.43±0.43)、(4.97±0.47)、(2.48±0.45)mmol/L,差异均有统计学意义(均P<0.01);HDL-C水平治疗前分别为(1.09±0.18)、(1.10±0.16)mmol/L,治疗后分别升至(1.23±0.13)、(1.22±0.18)mmol/L,差异有统计学意义(均P<0.01)。对照组治疗后TG、TC、LDL-C水平分别为(3.10±0.40)、(5.22±0.42)、(2.81±0.57)mmol/L,均明显高于苯扎贝特组(P<0.05,P<0.01),而TG、LDL-C水平明显高于非诺贝特组(P<0.05,P<0.01);HDL-C水平为(1.10±0.13)mmol/L,明显低于苯扎贝特组和非诺贝特组(均P<0.05)。2个药物治疗组间各项指标差异均无统计学意义(均P>0.05)。苯扎贝特组和非诺贝特组中出现胃肠道症状的患者分别有11例(18.6%)、9例(16.4%),差异无统计学意义(P>0.05);丙氨酸氨基转移酶(ALT)和天冬氨酸氨基转移酶(AST)及磷酸肌酸激酶(CK)水平呈一过性升高。皮疹等不良反应组间比较,差异均无统计学意义(均P>0.05)。结论:国产苯扎贝特为安全有效的降脂药物。

ABSTRACT Objective： To assess the efficacy and safety of homemade bezafibrate in treatment of hypertriglyceridemia. Methods： Form May 2006 to July 2007, 132 patients with hypertriglyeeridemia were enrolled in the study and randomly divided into the following three groups ： the bezafibrate group （59 cases） , the fenofibrate group （ 55 cases） , and the control group （ 18 cases）. The bezafibrate group comprised 45 male and 14 female patients with an average age of （51.4 --- 15.4 ） years. The fenofibrate group comprised 42 male and 13 female patients with an average age of （51.5 ± 15.5） years. The control group comprised 13 male and 5 female patients with an average age of （52.7 ± 16.0） years. The bezafibrate group was administered bezafibrate 200 mg orally thrice daily, the fenofibrate group was administered fenofibrate 100 mg orally thrice daily, the control group received non-drug therapy. The duration of treatment was 3 months. The blood levels of trlglyeeride, total cholesterol , low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol were measured before and after therapy and compared among the three groups. The adverse reactions were observed. Results ： In the bezafibrate and fenofibrate groups, the levels of TG, TC and LDL-C were respectively（3.16 ±0. 60）, （5.25 ±0.56）, （2.76 ^-0.45） and（3.13 ±0.55） , （5.28 ±0.52）, （2.82 ±0.41 ） mmoL/L before treatment and deceased respectively to （2.42 ± 0.43）,（4.93 ±0.47）,（2.55 ±0.44）and（2.43 ±0.43）,（4.97 ±0.47）,（2.48 ±0.45）mmo[/L after treatment, and the differences were statistically significant （ all P 〈 0.01 ） ; the levels of HDL-C were respectively （ 1.09 ± 0.18 ） and （ 1. 10 ± 0.16 ） mmol/L before treatment and increased respectively to （ 1.23 ± 0.13） and （ 1.22 ± 0.18） mmoL/L after treatment, and the differences were statistically significant （ all P 〈 0.01 ）. In the control groups, after treatment, the levels of TG, TC, and LDL-C were respcetively （3.10 ±0.40）, （5.22 ±0.42）, and （2.81 ±0.57）retool/L, which were higher than those in the bezafibrate group （P 〈0.05, P 〈 0.01 ） ; and the levels of TG and LDL-C were markedly higher than those in the fenofibrate group （ P 〈 0.05, P 〈 0.01 ） ; HDL-C leveL was （1.10 ± 0.13 ）mmol/L, which was markedly lower than that in the bezafibrate and fenofibrate groups（ all P 〈 0.05 ）. There was no statistically significant difference in the indices between the two treatment groups （ all P 〉 0.05 ）. In the bezafibrate and fenofibrate groups, gastrointestinal symptoms occurred in 11 cases （18.6%） and 9 cases （16.4%）, respectively; there was no statistically significant difference （P 〉 0.05） ; Transient elevation of ALT, AST, and CK levels .occurred. There were no statistically significant differences in rash and some other adverse reactions between the two treatment groups （ all P 〉 0. 05 ）. Conclusion： Homemade bezafibrate is a safe and effective lipid-lowering agent.