多廿烷醇联合辛伐他汀对男性高脂血症患者血脂及性激素水平的影响

Effects of policosanol combined with simvastatin on serum lipids and sex hormones in male patients with hyperlipidemia

目的评估多廿烷醇联合辛伐他汀对男性高脂血症患者血脂及性激素水平的影响，同时观察不良反应。方法选取笔者所在医院2011年9月至2012年6月收治的高脂血症患者120例随机分成两组，试验组采用辛伐他汀40mg／d联合多廿烷醇20mg／d进行治疗，对照组采用辛伐他汀40mg／d联合安慰剂进行治疗，治疗16周。观察两组患者治疗前后总胆固醇（TC）、甘油三酯（TG）、高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇（LDL．C）、睾酮（T）、雌二醇（E：）的变化及不良反应情况。结果两组各指标在基线时差异无统计学意义（P〉0．05）。经过16周的治疗，试验组TC、TG、LDL—C治疗前分别为（5．74±0．99）、（1．62±0．69）、（3．60±0．56）mmol／L，治疗后分别为（4．57±0．58）、（1．54±0．55）、（2．68±0．38）mmol／L，治疗后上述指标较治疗前差异均有统计学意义（P〈0．05）；对照组，TC、LDL—C治疗前分别为（5．99±0．93）、（3．76±0．42）mmol／L，治疗后分别为（5．03±0．59）、（2．98．4-0．28）mmol／L，治疗后上述指标较治疗前差异均有统计学意义（P〈0．05），TG在治疗前后差异无统计学意义（P〉0．05）。无论在试验组或对照组，HDL—C、T、E，治疗后较治疗前差异均无统计学意义（P〉0．05）。在降脂幅度方面，试验组在降低TC、LDL．c方面强于对照组（P〈0．01）。不良反应大都发生在治疗初期且较轻微，无需停药都能缓解，二组比较差异无统计学意义（P〉0．05）。结论辛伐他汀40mg／d联合多廿烷醇20mg／d对男性高脂血症患者的调脂效果强于辛伐他汀40mg／d与安慰剂的联合，且安全性良好，对性激素不产生影响。

Objective To evaluate the effects and safety of policosanol combined with simvastatin on serum lipids and sex hormones in male patients with hyperlipidemia. Methods This randomized, single- blinded, placebo-controlled study included 120 male patients with hyperlipidemia. Patients were devided randomly into treatment group（n = 60） and control group（ n = 60）. Patients in the treatment group were administrated with simvastatin （40 mg/d） plus policosanol （20 mg/d） ,and those in the control group were treated with simvastatin （40 rag/d） plus placebo （ 20 mg/d）. The values of total cholesterol （ TC ）, triglyceride（TG）, high density lipoprotein cholesterol （HDL-C）, low-density lipoprotein cholesterol（ LDL- C）, testosterone（T） and estradiol（ E2 ） were assessed before and after 16 weeks treatment. Drug-induced adverse effects were observed. Results Baseline characteristics were similar between groups. TC,TG, LDL- C were （ 5.74 ± 0. 99 ）, （ 1.62± 0. 69 ）, （ 3.60 ±0. 56） mmol/L in the treatment group at baseline and significantly reduced after 16 weeks treatment （4. 57 ±0. 58）, （1.54 ± 0. 55 ）, （2. 68 ± 0. 38 ）mmol/L （all P 〈 0.05）. TC, LDL-C were （5.99 ±0. 93 ）, （ 3.76 ± 0. 42 ） mmol/L in the control group at baseline and significantly reduced after 16 weeks treatment （5.03 ± 0. 59）, （ 2. 98 ± 0. 28 ） mmol/L （ all P 〈 0. 05 ） while TG remained unchanged post 16 weeks therapy in the control group. Simvastatin plus policosanol achieved a significantly greater reduction in LDL-C and TC than simvastatin plus placebo （ P 〈 0. 05 ）. HDL-C, T and E2 were similar before and after 16 weeks treatments in both groups（ P 〉 0. 05）. The adverse reactions were similar between the two groups, most of them were mild and happened at the beginning of drug therapy and could be well tolerated. Conclusion Simvastatin/policosanol produces greater decreases in TC, LDL-C than simvastatin/placebo without resulting more side effects and changes on sex hormones.