坎地沙坦与厄贝沙坦联合二甲双胍治疗非糖尿病肥胖型高血压患者临床疗效及对血管内皮功能影响的多中心联合随机对照研究

Clinical Effect on Non-diabetic Obesity-related Hypertension and Impact on Vascular Endothelial Function between Candesartan and Irbesartan Based on Metformin:a Multi-center Randomized Controlled Study

目的比较坎地沙坦与厄贝沙坦联合二甲双胍治疗非糖尿病肥胖型高血压患者的临床疗效及对血管内皮功能的影响。方法选取2016年1月—2017年1月成都医学院第一附属医院心血管内科、中国人民解放军西部战区总医院心血管内科、广东省中医院心脏中心、重庆市第三人民医院收治的非糖尿病肥胖型高血压患者500例,采用随机数字表法分为C+M组和I+M组,每组250例,其中C+M组患者脱落6例,I+M组患者脱落7例。在常规干预基础上,C+M组患者给予坎地沙坦联合二甲双胍治疗,I+M组患者给予厄贝沙坦联合二甲双胍治疗;两组患者均连续治疗24周。比较两组患者治疗后血压达标率,治疗前后血压、心率、体质指数(BMI)、腰围、血脂指标[包括总胆固醇(TC)、三酰甘油(TG)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)]、胰岛素抵抗指数(HOMA-IR)及血管内皮功能指标[包括内皮依赖性血流介导的舒张反应(FMD)及非内皮依赖性硝酸甘油介导的舒张反应(NID)],并观察两组患者治疗期间不良反应发生情况。结果 (1)治疗后两组患者血压达标率比较,差异无统计学意义(P>0.05)。(2)两组患者治疗前收缩压(SBP)、舒张压(DBP)、心率、BMI、腰围及治疗后心率、腰围比较,差异无统计学意义(P>0.05);治疗后C+M组患者SBP、DBP、BMI低于I+M组(P<0.05)。(3)两组患者治疗前TC、TG、LDL-C、HDL-C、HOMA-IR及治疗后LDL-C、HDL-C比较,差异无统计学意义(P>0.05);治疗后C+M组患者TC、TG、HOMA-IR低于I+M组(P<0.05)。(4)治疗前两组患者FMD、NID及治疗后NID比较,差异无统计学意义(P>0.05),治疗后C+M组患者FMD高于I+M组(P<0.05)。(5)两组患者治疗期间均未出现严重不良反应。结论坎地沙坦联合二甲双胍与厄贝沙坦联合二甲双胍对非糖尿病肥胖型高血压患者的血压控制效果相当,但与厄贝沙坦联合二甲双胍相比,坎地沙坦联合二甲双胍可更有效地降低患者血压,改善患者体脂分布、血脂代谢、血管内皮功能,减轻患者胰岛素抵抗,且安全性较高。

Objective To compare the clinical effect on non-diabetic obesity-related hypertension and impact on vascular endothelial function between candesartan and irbesartan based on metformin. Methods From January 2016 to January 2017,a total of 500 patients with non-diabetic obesity-related hypertension were selected in the Department of Cardiovascular Medicine,the First Affiliated Hospital of Chengdu Medical College,the Department of Cardiovascular Medicine,Chinese PLA General Hospital of the Western Theater Command,Heart Center of Guangdong Provincial Traditional Chinese Medicine Hospital,and the Third People’s Hospital of Chongqing,and they were divided into C+M group and I+M group according to random number table,each of 250 cases,thereinto 6 cases in C+M group and 7 cases in I+M group quit midway. Based on conventional intervention,patients in C+M group received candesartan combined with metformin,while patients in I+M group received irbesartan combined with metformin;both groups continuously treated for 24 weeks. Blood pressure control rate after treatment,blood pressure,heart rate,BMI,waistline,blood lipid index(including TC,TG,LDL-C and HDL-C),HOMA-IR and index of vascular endothelial function(including FMD and NID)before and after treatment were compared between the two groups,and incidence of adverse reactions was observed during treatment. Results(1)NO statistically significant differences of blood pressure control rate was found between the two groups(P>0.05).(2)No statistically significant differences of SBP,DBP,heart rate,BMI or waistline was found between the two groups before treatment,nor was heart rate or waistline after treatment(P>0.05),while SBP,DBP and BMI in C+M group were statistically significantly lower than those in I+M group after treatment(P<0.05).(3)No statistically significant differences of TC,TG,LDL-C,HDL-C or HOMA-IR was found between the two groups before treatment,nor was LDL-C or HDL-C after treatment(P>0.05),while TC,TG,HOMA-IR in C+M group was statistically significantly lower than that in I+M group(P<0.05).(4)No statistically significant differences of FMD or NID was found between the two groups before treatment,nor was NID after treatment(P>0.05),while FMD in C+M group was statistically significantly higher than that in I+M group(P<0.05).(5)No one in the two groups occurred any serious adverse reactions. Conclusion Candesartan combined with metformin has similar blood pressure control effect and anti-hyperlipidemic effect,but compared with irbesartan combined with metformin,candesartan combined with metformin can more effectively reduce the blood pressure and insulin resistance,is more helpful to improve the body fat distribution,blood lipid metabolism and vascular endothelial function,with relatively high safety.