Clinical efficacy and safety of amlodipine besylate and benazepril hydrochloride tablets(Ⅱ)in the treatment of primary hypertension
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目的 观察氨氯地平贝那普利片(Ⅱ)治疗原发性高血压的临床疗效和安全性.方法 选择2022年6月至2023年6月在首钢水钢医院接受诊治的原发性高血压患者280例为研究对象,采用临床病例对照研究方法,按照返回随机数(RAND)函数法随机分为四组,并接受不同治疗方法,分别是氨氯地平组(A组,70例)、贝那普利组(B组,70例)、单片复方制剂氨氯地平贝那普利片(Ⅱ)组(C组,71例)、氨氯地平+贝那普利组(D组,69例).观察相关疗效指标(血压达标率、血压值变化)和安全性指标(不良反应、服药依从性).结果 C组和D组血压达标率分别为91.5％(65/71)和89.9％(62/69),两组差异无统计学意义(x2=1.24,P=0.143),但均高于A组和B组的77.1％(54/70)和74.3％(52/70)(x2=5.68、4.86,P=0.004、0.012).治疗前,四组患者的收缩压和舒张压差异均无统计学意义(均P＞0.05);治疗后,四组患者的收缩压和舒张压较治疗前均明显下降(均P＜0.05),且以C组和D组的治疗后血压降低幅度较大(t=4.35、5.12、7.25、5.86,均P＜0.05).同时,C组治疗后收缩压与D组比较,差异无统计学意义(P＞0.05),治疗后舒张压低于D组(t=6.01,P＜0.05).四组患者治疗后总胆固醇、三酰甘油和低密度脂蛋白胆固醇均呈现降低趋势(均P＜0.05)o B组和D组治疗后分别出现15例和10例干咳患者,较A组和C组(1例和3例)显著增加(x2=4.25、5.04,均P＜0.05).A组、B组和C组的治疗依从性分别是 72.9％(51/70)、71.4％(50/70)、74.6％(53/71),均高于 D 组的 46.4％(32/69)(x2=4.68、5.24、4.98,均P＜0.05).结论 复方制剂氨氯地平贝那普利(Ⅱ)治疗原发性高血压的临床疗效和安全性优于单片药物及两药联用.
Objective To investigate the clinical efficacy and safety of amlodipine besylate and benazepril hydrochloride tablets(Ⅱ)in the treatment of primary hypertension.Methods A total of 280 patients with primary hypertension who were treated at Shougang Shuigang Hospital between June 2022 and June 2023 were selected as study subjects.A clinical case-control study was conducted,and the RAND function method was utilized to randomly allocate the subjects into four groups,each receiving a different treatment:amlodipine besylate group(Group A,n=70),benazepril hydrochloride group(Group B,n=70),compound formulation amlodipine besylate and benazepril hydrochloride tablets group(Group C,n=71),and amlodipine besylate plus benazepril hydrochloride group(Group D,n=69).Relevant therapeutic indicators(blood pressure compliance rate,changes in blood pressure values)and safety indicators(adverse reactions,medication adherence)were observed.Results The blood pressure compliance rates of Group C and Group D were 91.5％(65/71)and 89.9％(62/69),respectively.There was no statistically significant difference between the two groups(x2=1.24,P=0.143),but both were higher than the rates of 77.1％(54/70)and 74.3％(52/70)in Group A and Group B,respectively(x2=5.68,4.86,P=0.004,0.012).Before treatment,there was no statistically significant difference in systolic and diastolic blood pressure among the four groups of patients(all P＞0.05).After treatment,there was a statistically signifiicant decrease in both systolic and diastolic blood pressure among the four groups compared with their pre-treatment levels(all P＜0.05).Specifically,Group C and Group D exhibited significant reductions in blood pressure following treatment(t=4.35,5.12,7.25,5.86,all P＜0.05).Meanwhile,there was no statistically significant difference in systolic blood pressure between Group C and Group D after treatment(P＞0.05),while diastolic blood pressure was lower in Group C than Group D after treatment(t=6.01,P＜0.05).There was a significant downward trend observed in total cholesterol,triglycerides,and low-density lipoprotein cholesterol levels(all P＜0.05).Notably,Group B and Group D reported higher incidences of dry cough,with 15 and 10 cases,respectively,compared with Group A and Group C,which had 1 and 3 cases,respectively.These differences were statistically significant(x2=4.25,5.04,both P＜0.05).Furthermore,the treatment compliance rates for Group A,Group B,and Group C were 72.9％(51/70),71.4％(50/70),and 74.6％(53/71),respectively,all exceeding the 46.4％(32/69)compliance rate of Group D.These differences were also statistically significant(x2=4.68,5.24,4.98,all P＜0.05).Conclusion The clinical efficacy and safety of the compound formulation amlodipine besylate and benazepril hydrochloride tablets(Ⅱ)in the treatment of primary hypertension are superior to those of single tablets and combination therapy.
HypertensionBlood pressure determinationDrug-related side effects and adverse reactionsMedication adherenceAmlodipineComparative effectiveness research
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