Abstract:

Objective　To observe the clinical efficacy of eicosapentaenoic acid (EPA) soft capsules in the treatment of hyperlipidemia, and to explore its effects on serum tumor necrosis factor-α (TNF-α), adiponectin (ADPN), and homocysteine (Hcy) levels. Methods　It was a randomized controlled trial. A total of 108 patients with hyperlipidemia in Community Health Service Center of Beijing Chaoyangmen from June 2018 to December 2019 were enrolled and were divided into a study group and a control group by the random number table method. Excluding the excluded and dropped 2 cases, 106 cases finally completed the study. There were 52 cases in the study group, including 17 males and 35 females, aged (57.85±5.10) years; there were 54 cases in the control group, including 19 males and 35 females, aged (56.69±6.27) years. The study group was given EPA soft capsules orally, 2 times per day, 1 capsule each time (1.0 g per capsule); the control group was given placebos, 2 times per day, 1 capsule each time. The treatment period was 60 days. The changes of lipid metabolism indexes [triglyceride (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), and low density lipoprotein cholesterol (LDL-C)] and serum levels of TNF-α, ADPN, and Hcy before and after treatment were compared between the two groups, and the safety was evaluated. t test and χ² test were used. Results　After treatment, the levels of serum TC, TG, and LDL-C in the study group were (5.03±0.59), (1.59±0.19), and (2.95±0.53) mmol/L, respectively, which were significantly lower than those in the control group [(5.76±0.41), (1.93±0.23), and (3.68±0.39) mmol/L] (all P<0.05). After treatment, the serum levels of TNF-α and Hcy in the study group were significantly lower than those in the baseline period, and were also lower than those in the control group; the serum ADPN level was significantly higher than that in the baseline period, and was also higher than that in the control group (all P<0.05). After treatment, there was no abnormal change in the safety indexes of the two groups. Conclusion　EPA soft capsules can significantly improve the lipid metabolism in patients with primary hyperlipidemia, regulate the serum TNF-α, ADPN, and Hcy levels, and have significant clinical lipid lowering effect.

Key words:

Eicosapentaenoic acid soft capsules, Hyperlipidemia, Tumor necrosis factor-α, Adiponectin, Homocysteine

摘要：

目的　观察二十碳五烯酸软胶囊对高脂血症患者的降脂疗效，探讨其对血清肿瘤坏死因子-α（TNF-α）、脂联素（ADPN）及同型半胱氨酸（Hcy）水平的影响。方法　本研究为随机对照试验。纳入2018年6月至2019年12月北京东城区朝阳门社区卫生服务中心108例高脂血症患者，采用随机数字表法分成两组，除剔除与脱落病例2例，106例完成研究。研究组52例，其中男17例，女35例，年龄（57.85±5.10）岁；对照组54例，其中男19例，女35例，年龄（56.69±6.27）岁。研究组口服二十碳五烯酸软胶囊，每日2次，每次1粒（1.0 g/粒）；对照组服用安慰剂，每日2次，每次1粒，疗程为60 d。对比两组治疗前后脂代谢指标［三酰甘油（TG）、总胆固醇（TC）、高密度脂蛋白胆固醇（HDL-C）和低密度脂蛋白胆固醇（LDL-C）］和血清TNF-α、ADPN、Hcy水平变化，并进行安全性评估。采用t检验、χ²检验。结果　治疗后研究组血清TC、TG、LDL-C水平分别为（5.03±0.59）、（1.59±0.19）、（2.95±0.53）mmol/L，显著低于对照组的（5.76±0.41）、（1.93±0.23）、（3.68±0.39）mmol/L（均P<0.05）。治疗后研究组血清TNF-α、Hcy水平较基线期显著降低，也低于对照组；血清ADPN水平较基线期显著升高，也高于对照组（均P<0.05）。治疗后两组安全性指标检查未见异常变化。结论　二十碳五烯酸软胶囊治疗原发性高脂血症患者能明显改善脂代谢指标，调节血清TNF-α、ADPN、Hcy水平，具有明确临床降脂疗效。

关键词:

二十碳五烯酸软胶囊, 高脂血症, 肿瘤坏死因子-α, 脂联素, 同型半胱氨酸