Efficacy And Safety Of Manidipine Hydrochloride Tablets In The Treatment Of Essential Hypertension

BackgroundIn recent years,with the improvement of living standard of people in our country and the modern work pressure increases,the incidence rate of essential hypertension had been iccreased year by year,and more and more young people had hypertension.It was one of the key projects of clinical study of medical workers to discovery and intervention for hypertension occurrence development process and prevent the complication.Manidipine hydrochloride,two dihydropyridine calcium antagonist,on 1990 in the Japanese market,had a blocking effect on L type and T type calcium channel two long-acting dihydropyridine calcium antagonists.Shu Pingxi,the commodity name of manidipine hydrochloride generic drugs in China,was produced and sold by Xuchang Aosen Pharmaceutical Company Limited in 2012.In clinic,the therapeutic effect of Shu Pingxi was not expected to a part of patients with essential hypertension disease.Based on these,we conducted the study of manidipine hydrochloride on primary hypertension efficacy and safety in clinic,and at present,the reported in the literature was rare.ObjectiveTo observe the efficacy and safety of manidipine hydrochloride(Shu Pingxi)in the treatment of essential hypertension,and to provide reference for clinical treatment of hypertension.Methods264 patients with hypertension from January 2014 to June 2015 in Xuchang Central hospital were involved in this research and randomly divided into the group A and B.The disease diagnosis criteria was the Guidelines for prevention and treatment of hypertension in China in 2010.All patients were primary hypertension,and the classification of hypertension was grade 1,grade 2 and grade 3.The patients in group A were treated with manidipine hydrochloride tablets(Shu Pingxi).The patients in group B were treated with Amlodipine besylate tablets.The starting dosage of manidipine hydrochloride tablets(Shu Pingxi)in group A was 5mg/day,and based on the patient’s treatment,the dosage could be appropriate to increase to 20 mg.The starting dosage of Amlodipine besylate tablets in group B was 5mg/day,and based on the patient’s treatment,the dosage could be appropriate to increase to 10 mg.The reduction degree of SBP and DBP of two group were used to evaluate the therapeutic effectiveness in 0,3,7,10,14 days of treatment.The adverse reactions of two group during treatment was recorder and used to evaluate the therapeutic safety.SPSS19.0 statistical software was used to analysis of the research data.The measurement data were carried out by normal test,and the data of normal distribution were compared with the standard±deviation(±s).The independent sample t test was used for the comparison between the two groups.Chi square test was used for count data,and the significance level was 0.05.Results1.Effectiveness evaluation results:(1)After seven days of treatment,the SBP and DBP of A group was higher than those in B group,and the difference was statistically significant(P<0.05);(2)After ten days of treatment,the SBP and DBP of A group was higher than those in B group,and the difference with SBP in two groups had statistically significant(P<0.05);(3)After fourteen days of treatment,the SBP and DBP of A group was higher than those in B group,and the difference in two groups had no statistically significant(P>0.05);(4)The effective rate was 82.8% in A group,88.9% in B group,the difference in the two groups was no statistically significant(P>0.05).2.safety evaluation results: there was no obvious abnormalities of laboratory indexes of two groups of patients during treatment,and the adverse reactions were nausea,dry mouth,dizziness,palpitations,abdominal distension,constipation,edema,abnormal liver function,and so on.The difference of two groups in the incidence of adverse reaction was not statistically significant(P>0.05).ConclusionThe action of manidipine in the treatment of essential hypertension required a long time,but the antihypertensive effect was safe and effective.It had the characteristics of good tolerance and no serious adverse reactions,which was worthy of clinical application.