摘要
目的观察依折麦布片联合瑞舒伐他汀钙片治疗2型糖尿病合并血脂代谢紊乱患者的临床疗效及安全性。方法将78例2型糖尿病合并血脂代谢紊乱患者随机分为对照组和试验组,每组39例。对照组给予瑞舒伐他汀钙片每次10 mg,bid,口服;试验组在对照组治疗的基础上,给予依折麦布片每次10 mg,qd,口服。2组患者均治疗8周。比较2组患者的临床疗效,总胆固醇(TC)、脂联素(APN)和视黄醛结合蛋白-4(RBP-4)的水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为94.87%(37例/39例)和79.49%(31例/39例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的TC分别为(4.93±0.48)和(5.30±0.52)mmol·L^-1,APN分别为(7.13±2.81)和(5.47±2.76)mg·L^-1,RBP-4分别为(25.12±3.81)和(27.63±3.90)mg·L^-1,差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应有恶心呕吐、腹泻和白细胞降低,对照组发生的药物不良反应有恶心呕吐、谷丙转氨酶轻微升高和白细胞降低。试验组和对照组的总药物不良反应发生率分别为15.38%和12.82%,差异无统计学意义(P>0.05)。结论依折麦布片联合瑞舒伐他汀钙片治疗2型糖尿病合并血脂代谢紊乱患者的临床疗效确切,且不增加药物不良反应的发生率。
Objective To observe the clinical efficacy and safety of ezetimibe tablets combined with rosuvastatin calcium tablets in the treatment of patients with type 2 diabetes mellitus complicated with dyslipidemia.Methods A total of 78 patients with type 2 diabetes mellitus complicated with dyslipidemia were randomly divided into control and treatment groups with 39 cases per group.Control group was treated with rosuvastatin calcium tablets 10 mg per time,bid,orally.Treatment group was given ezetimibe tablets 10 mg per time,qd,orally,on the basis of control group.Two groups were treated for 8 weeks.The clinical efficacy,levels of total cholesterol(TC),adiponectin(APN)and retinal binding protein-4(RBP-4),and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 94.87%(37 cases/39 cases)and 79.49%(31 cases/39 cases)with significant difference(P<0.05).After treatment,the main indexes of treatment and control groups were compared:TC were(4.93±0.48)and(5.30±0.52)mmol·L^-1,APN were(7.13±2.81)and(5.47±2.76)mg·L^-1,RBP-4 were(25.12±3.81)and(27.63±3.90)mg·L^-1,the differences were statistically significant(all P<0.05).The adverse drug reactions of treatment group were nausea and vomiting,diarrhea and leukopenia,while those in control group were nausea and vomiting,slight increase of alanine aminotransferase and leukopenia.The incidences of total adverse drug reactions in the treatment and control groups were 15.38%and 12.82%without significant difference(P>0.05).Conclusion Ezetimibe tablets combined with rosuvastatin calcium tablets have a definitive clinical efficacy in the treatment of patients with type 2 diabetes mellitus complicated with dyslipidemia,without increasing the incidence of adverse drug reactions.
作者
陈秋
秦得营
李爱敏
李丽丽
CHEN Qiu;QIN De-ying;LI Ai-min;LI Li-li(Department of Pharmacy,Medical College,Pingdingshan University,Pingdingshan 467000,Henan Province,China;Department of Neurology,First People’s Hospital of Pingdingshan City,Pingdingshan 467000,Henan Province,China;Pingdingshan Food and Drug Inspection Institute,Pingdingshan 467000,Henan Province,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2020年第11期1457-1459,共3页
The Chinese Journal of Clinical Pharmacology
基金
河南省社科联调研课题资助项目(SKL-2019-575)。
