| Objective:In this study,aiming to evaluate the efficacy and safety of allisartan tablets in the treatment of patients who with mild to moderate Essential Hypertension(EH),by valsartan capsules were used as control group,simultaneously,to improve carotid artery atherosclerosis(CAS).Methods:120 patients who with mild to moderate EH(or)without CAS were randomly selected from the Department of Cardiology Affiliated Hospital of Yan'an University from July 2015 to March 2016.In the form of envelopes,all selected patients were randomly divided into two groups:test group who were treated with allisartan tablets 240mg(one tablet),additionly,patients who were treated with valsartan capsules 80mg(one grain)was control group;in the test group,patients who were CAS was group A,with the CAS in control group for group B.The test group was treated with allisartan tablets 240mg/d,however,the control group was treated with valsartan 80mg/d;fasting oral(morning 8:00 or so),the total course of 48 weeks.The CBP was monitored after 4 weeks of treatment,the drug was doubled if the CBP was not to the standard.Blood pressure was measured at 8 weeks,12 weeks,24 weeks and 48 weeks.From week 9 to week 48,pulse,breath and body temperature were recorded in detail,parallel blood,urine,liver function,renal function electrolyte,fasting blood glucose,blood lipids,electrocardiogram and other assessment of safety assessment were recorded at week 12,week 24 and week 48 evaluate security.Exploration of carotid artery plaque size,thickness and number of carotid artery and carotid intima-media thickness to evaluate the efficacy of CAS.Result:1.Treatment effectiveness results:1.1 Between the two groups,there was no significant difference in the systolic blood pressure(P=0.839).Between the two groups,the difference of systolic blood pressure was statistically significant at different time points(P<0.001);Two groups after treatment at each time point compared with before treatment,meanwhile,the 8th week,the 12 th week,the 24 th week and the 48 th week compared with the 4th week,there was a significant difference(P<0.05).In test group,the difference among the 24 th week,the 48 th week and the 8th week was statistical different(P24W=0.023,P48W=0.012);However,the difference was statistically significant(P<0.001)between the 12 th week,the 24 th week,the 48 th week and the 8th week.Between the two groups,no significantly different at other time points.No significant difference between the group and the time point(P=0.468).1.2 Between the two groups,there was no significant difference in the diastolic blood pressure(P=0.602).There was a significantly different in diastolic blood pressure at different time points(P<0.001),between the two groups.Two groups after treatment at each time point compared with previous treatment,meanwhile,the 8th week,the 12 th week,the 24 th week and the 48 th week compared with the 4th week,there was a significantly different(P<0.01);A significantly different was found between the 12 th week,the 24 th week,the 48 th week and the 8th week(P<0.01).At other time points,no significant difference between the two groups.Between the group and the time(P=0.450),no statistical difference was found.1.3 After 4weeks treatment,the test group mean clinical systolic blood pressure amplitude 14.45 mm Hg,while the control group,the average blood pressure amplitude 12.06 mm Hg,the difference was significant difference(P=0.048).There were significant differences between the two groups(P<0.05)in the treatment of 8 weeks,12 weeks,24 weeks and 48 weeks.At other time points,no statistical difference was found between the two groups.1.4 The total compliance rate of the two groups were more than 50%,the overall efficiency were greater than 70%,the difference between the two groups were not statistical.Respectively,two groups within 24 weeks,48 weeks,compared with 4weeks and 8weeks,the difference was statistical(P<0.01).2.Treatment safety results:2.1 In the test group,transaminase was normal,2 cases of ALT increased in the control group;at 12 weeks,ALT increased to about 85U/L,24 weeks down to about 60U/L,to normal 48 weeks;there were no effect on routine,other biochemical indicator and vital signs in two groups.2.2 The percentage of abnormal ECG at 12 weeks,24 weeks and 48 weeks was 10.53%,9.26% and 8.16% respectively in test group,additionally,11.86%,10.91% and 8.00% respectively in control group;they were no clinical significance.2.3 In the control group,the ADR was 8.16% in the test group and 10.0%.The main ADR was dizziness,nausea,headache and chest tightness.Mostly mild,a few moderate,could be relieved after self or symptomatic treatment.AE was mainly elevated ALT;no significant adverse events occurred in both groups.Evaluation of safety indicators were differed insignificantly among two groups.3.Results improved carotid atherosclerosis:3.1 In the changes of carotid IMT,there was no significant difference between group A and group B.Before and after IMT,significant differences between the two groups(P<0.001).Group A of 24 weeks,48 weeks compared with before therapy,12 weeks,respectively,difference was obviously statistical(P<0.01);Group B 48 weeks,respectively,compared with before therapy,12 weeks and 24 weeks were obviously statistical(P< 0.05);At other time points,no statistical difference was found between the two groups.The difference was obviously statistical(P=0.027),between the group and the time point.3.2 In plaque area,no significant difference was found between the two groups.At different time points in two groups,there was obviously different in plaque area(P< 0.001).Group A of 24 weeks,48 weeks compared with before therapy was statistical difference(P<0.01);Respectively,48 weeks compared with 12 weeks and 24 weeks,there was obviously significant difference(P<0.05).Group B of 48 weeks,respectively,compared with before therapy,12 weeks and 24 weeks,difference was statistical(P<0.05).At other time points in two groups,no statistical difference was found.No significant difference between the group and the time.3.3 Plaque thickness in two groups,there was no significant difference.In carotid plaque thickness,there were differences significantly between the two groups at different time points(P<0.001).Respectively,Group A of 48 weeks was compared with before therapy and 12 weeks,difference was statistical;Between 48 weeks and before therapy,difference was statistical(P<0.05).At other time points in two groups,difference wasn't statistical.No significant difference between the group and the time.3.4 In the number of plaque changes in two groups,there was no significant difference.The number of carotid plaques at different treatment points,difference was statistical(P<0.001).Respectively,24 weeks?48 weeks compared with before therapy,48 weeks and 12 weeks,difference was statistical in two groups(P<0.05).Conclusion:1.Allisartan tablets in the treatment of mild to moderate essential hypertension are effective and and the efficacy is comparable with that of Valsartan.2.Patients who with mild to moderate essential hypertension have long-term use of allisartan tablets for high safety.3.Allisartan tablets can improve carotid atherosclerosis and improve IMT better than valsartan. |
PDF Full Text Request