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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。
Objective: To evaluate the efficacy and safety of domestic bezafibrate in the treatment of hypertriglyceridemia. METHODS: From May 2006 to July 2007, 132 patients with hypertriglyceridemia included in the study were randomized into 3 groups: Bezafib (59), Fenofibrate (55) and Control group (18 cases). Bezafib group of 45 males and 14 females, mean age (51.4 ± 15.4) years; fenofibrate group of 42 males and 13 females, mean age (51.5 ± 15.5) years old; control group of 13 males, Female 5 cases, the average age (52.7 ± 16.0) years old. The bezafibrate group was given bezafibrate 200 mg orally three times a day. The fenofibrate group was given fenofibrate 100 mg orally three times per day. The control group was non-drug-treated for 3 months. The triglyceride (TG), total cholesterol (TC), low density lipoprotein cholesterol (LDL-C) and high density lipoprotein cholesterol (HDL-C) levels were compared between the three groups before and after treatment. . Results: The levels of TG, TC and LDL-C in bezafibrate group and fenofibrate group before treatment were (3.16 ± 0.60), (5.25 ± 0.56), (2.76 ± 0.45) and (3.13 ± 0.55), (2.42 ± 0.43), (4.93 ± 0.47), (2.55 ± 0.44) and (2.43 ± 0.43), (4.97 ± 0.47), (2.82 ± 0.41) mmol / L and (1.09 ± 0.18) and (1.10 ± 0.16) mmol / L, respectively, before treatment, respectively (2.48 ± 0.45 mmol / L, all P <0.01) 1.23 ± 0.13) and (1.22 ± 0.18) mmol / L, respectively (all P <0.01). The levels of TG, TC and LDL-C in the control group were (3.10 ± 0.40), (5.22 ± 0.42) and (2.81 ± 0.57) mmol / L respectively, which were significantly higher than those in the bezafibrate group (P <0.05). The level of HDL-C was (1.10 ± 0.13) mmol / L, which was significantly lower than that of bezafibrate Group and fenofibrate group (all P <0.05). There was no significant difference between the two drug treatment groups (all P> 0.05). There were 11 cases (18.6%) and 9 cases (16.4%) of gastrointestinal symptoms in bezafibrate group and fenofibrate group, respectively, with no significant difference (P> 0.05) Transaminase (ALT) and aspartate aminotransferase (AST) and creatine phosphokinase (CK) showed a transient increase. Rash and other adverse reactions between groups, the difference was not statistically significant (P> 0.05). Conclusion: Domestic bezafibrate is a safe and effective lipid-lowering drug.