| Objective:To compare the clinical effects of collectively procured and imported amlodipine besylate in the treatment of patients with mild to moderate essential hypertension,and to provide a scientific basis for further comprehensive clinical promotion of collectively procured amlodipine besylate.Methods:Patients with mild,moderate essential hypertension who visited the First Affiliated Hospital of Kunming Medical University as outpatients and inpatients from Jan 2020 to Jan 2021 were selected.One hundred cases were selected as study subjects,and the sitting upper arm blood pressure after sitting for 5 minutes was measured three times daily with a validated upper arm medical sphygmomanometer,and the average was taken,and the blood pressure reached the level 1 and 2 of hypertension in the Chinese Guidelines for the Prevention and Treatment of Hypertension 2018 Revised Edition on the classification and stratification of hypertension.All patients were randomly divided into the experimental group(50 cases)and the control group(50 cases)according to the time of consultation,and the experimental group was treated with amlodipine besylate(State Drug Quantifier H20113236),and the control group was treated with imported amlodipine besylate(trade name:Norvasc,State Drug Quantifier H20093660).The blood pressure level,treatment efficiency,heart rate,adverse drug reactions,drug dose and drug economics effects were compared and analyzed before and after treatment in both groups.Results:A total of 100 cases were enrolled,and there were no statistically significant differences between the experimental group(n=50)and the control group(n=50)in the basic data of patients’ gender,age,duration of hypertension,BMI,office heart rate and office blood pressure(P>0.05).Patients in the experimental and control groups showed significant decreases in systolic and diastolic blood pressure throughout the day,early morning,and at night after 4 weeks of treatment compared with those before treatment(P<0.01).There was no significant difference in the total effective rate of treatment between patients in the experimental and control groups(88%versus 92%,2=0.444,P>0.05),and no significant difference in the magnitude of blood pressure decrease after treatment(P>0.05).The control of early morning systolic blood pressure variability(SBPV)by imported amlodipine besylate(P<0.05)was better than that by amlodipine besylate in patients(P>0.05),while there was no significant difference(P>0.05)for the control of early morning diastolic blood pressure variability(DBPV),all day and night blood pressure variability.There was no significant difference in heart rate(72.20±6.621/71.66±7.537)and HRV(0.54±2.64/-0.54±8.09)before and after treatment in the experimental group(74.56 ± 8.488/74.02 ±7.865)and in the control group(P>0.05).In terms of dose,there was no significant difference(2=1.515,P>0.05)between patients in the experimental group 5mg/10mg(42/8)and patients in the control group 5mg/10mg(46/4),and there was no significant difference(P>0.05)between the experimental group(6%)and the control group(10%)in terms of the incidence of adverse reactions during treatment.Both groups were tolerated and no patient discontinued the drug,and the average cost effect of experimental group(C/E=0.02)was better than the control group(C/E=1.15).Conclusions:There was no significant difference in the efficacy,adverse effects and safety of amlodipine besylate between collectively procured and imported amlodipine besylate in hypertension,but amlodipine besylate from collectively procured sources had better economics and reduced the economic burden on patients while ensuring efficacy.Imported amlodipine besylate is more effective in controlling patients’ early morning SBPV compared to amlodipine besylate,and is more advantageous in controlling blood pressure in patients with large fluctuations in early morning blood pressure. |
PDF Full Text Request