摘要
目的分析阿托伐他汀仿制药与原研药治疗2型糖尿病(type 2 diabetes mellitus,T2DM)合并血脂异常患者的临床疗效。方法选取2020年7月至2022年7月贺州市人民医院收治的88例初诊为T2DM合并血脂异常患者作为研究对象,根据使用的药物分为对照组(n=33)与观察组(n=55)。对照组给予20 mg原研药阿托伐他汀钙片治疗,观察组给予20 mg仿制药阿托伐他汀片治疗,同时维持原有糖尿病治疗方案,比较两组血脂指标[总胆固醇(total cholesterol,TC)、甘油三酯(triglyceride,TG)、高密度脂蛋白胆固醇(high-density lipoprotein cholesterol,HDL-C)、低密度脂蛋白胆固醇(low-density lipoprotein cholesterol,LDL-C)]、肝功能指标[丙氨酸氨基转移酶(alanine aminotransferase,ALT)、天冬氨酸氨基转移酶(aspartate aminotransferase,AST)]、血糖控制情况[空腹血糖(fasting blood glucose,FBG)、糖化血红蛋白A1c(hemoglobin A1c,HbA1c)]、临床疗效、成本-效果分析及敏感性分析。结果治疗后,两组TC、LDL-C、TG水平均低于治疗前,差异有统计学意义(P<0.05),但两组HDL-C水平治疗前后比较差异无统计学意义,两组TC、LDL-C、TG、HDL-C水平比较差异无统计学意义。对照组中ALT升高2例,AST升高1例,AST降低3例;观察组中ALT升高2例,AST升高1例,AST降低1例。其余两组ALT、AST水平比较差异无统计学意义。治疗后,两组FBG、HbA1c水平比较差异无统计学意义。两组治疗总有效率比较差异无统计学意义。观察组方案的成本(cost,C)、成本-效果比(cost-effectiveness ratio,C/E)均显著低于对照组;以观察组作为参照,进行增量成本-效果分析,对照组的增量成本-效果比(incremental cost-effectiveness ratio,ΔC/ΔE)为负数。在成本均降低10%的情况下,观察组C、C/E依然明显低于对照组;以观察组作为参考,对照组ΔC/ΔE为负。结论阿托伐他汀仿制药在主要降脂疗效及短期肝脏安全性方面与原研药相当,结合仿制药的经济学优势,其可作为原研药的有效替代用于T2DM合并血脂异常患者的临床降脂治疗,有助于减轻患者负担并提高治疗可及性。
Objective To analyze the clinical efficacy of atorvastatin generic drugs and originator drugs in patients with type 2 diabetes mellitus(T2DM)complicated with dyslipidemia.Methods A total of 88 patients with newly diagnosed T2DM complicated with dyslipidemia admitted to Hezhou People's Hospital from July 2020 to July 2022 were selected as the research subjects,and they were divided into the control group(n=33)and the observation group(n=55)according to the drugs used.The control group was treated with 20 mg of the original drug atorvastatin calcium tablets,while the observation group was treated with 20 mg of the generic drug atorvastatin tablets,while maintaining the original diabetes treatment plan.The lipid indicators(total cholesterol[TC],triglyceride[TG],high-density lipoprotein cholesterol[HDL-C],low-density lipoprotein cholesterol[LDL-C]),liver function indicators(alanine aminotransferase[ALT],aspartate aminotransferase[AST]),blood glucose control(fasting blood glucose[FBG],hemoglobin A1c[HbA1c]),clinical efficacy,cost-effectiveness analysis and sensitivity analysis were compared between the two groups.Results After treatment,the levels of TC,LDL-C and TG of the two groups were lower than those before treatment,and the differences were statistically significant(P<0.05),however,there were no statistically significant differences in HDL-C levels before and after treatment of the two groups,and there were no statistically significant differences in TC,LDL-C,TG and HDL-C levels between the two groups.In the control group,2 cases of ALT elevation,1 case of AST elevation and 3 cases of AST reduction were observed;in the observation group,2 cases of ALT elevation,1 case of AST elevation and 1 case of AST reduction were observed.There were no statistically significant differences in ALT and AST levels between the two groups.After treatment,there were no statistically significant differences in FBG and HbA1c levels between the two groups.There was no statistically significant difference in the total effective rate of treatment between the two groups.The cost(C),cost-effectiveness ratio(C/E)in the observation group were significantly lower than those in the control group.When the observation group was used as a reference,the incremental cost-effectiveness ratio(ΔC/ΔE)in the control group was negative.When the costs of both groups were reduced by 10%,the C and C/E in the observation group were still significantly lower than those in the control group.When the observation group was used as a reference,the in the control group was negative.Conclusion Atorvastatin generic drugs are comparable to originator drugs in terms of main lipid-lowering efficacy and short-term liver safety,combined with the economic advantages of generic drugs,they can be used as an effective alternative to originator drugs for lipid-lowering treatment in patients with T2DM complicated with dyslipidemia,which helps to reduce the burden on patients and improve treatment accessibility.
作者
易文燕
罗青锚
蒋周倩
欧荣清
李乐
严汝庆
YI Wenyin;LUO Qingmao;JIANG Zhouqian;OU Rongqing;LI Le;YAN Ruqing(Department of Pharmacy,Hezhou People's Hospital,Hezhou,Guangxi,542899,China)
出处
《当代医学》
2025年第2期71-75,共5页
Contemporary Medicine
基金
广西壮族自治区卫生健康委员会自筹经费科研课题(No.Z20200588)。
