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The Random, Double-blind, Parallel Controlled,Multi Center Phase Iii Clinical Drug Trial For The Sulfate Sustained Release Capsule Of Carvedilol In The Treatment Of Mild And Moderate Primary Hypertension

Posted on:2017-05-14Degree:MasterType:Thesis
Country:ChinaCandidate:R H ZhangFull Text:PDF
GTID:2334330503490711Subject:Department of Cardiology
Abstract/Summary:PDF Full Text Request
Background|:Hypertension is divided into primary and secondary, in which essential hypertension accounted for 90%. Sympathetic nerve activity increased leads to hypertension, so early blockade of the sympathetic activity, to reduce the release of norepinephrine is one of the major mechanisms to treat hypertension. Controlling of blood pressure timely and effective can reduce complications,the economic burden of the society and improve the quality of life of patients with high blood pressure. ?- blockers can inhibit sympathetic activity and have a certain effect on the treatment of hypertension. Carvedilol is a new product of a third generation beta blockers,which pharmacological effects more widely than the 1st and 2nd generation blockers and have block effect to ?1??1??2 receptors.It has regulating catecholamine on cardiac,peripheral vascular and renal adverse effects,which can reverse thevascular tension of hormone and receptor changes in joint regulation, and there is no simple vasodilator and beta blockers bring side effects,as the antihypertensive effect and side effects less for patients with hypertension is undoubtedly a valuable and ideal drug for the hypertension,it has good prospects for clinical applicationObjective: Assessing the effectiveness and safety of the sulfate carvedilol capsule in the treatment of mild and moderate primary hypertension by comparing with metoprolol succinate. Observing sulfate carvedilol capsules of 24 hour blood pressure control effect by ambulatory blood pressure research.Method: The patients who are diagnosed with mild or moderate hypertension after strict screening are parted in the clinical trial of carvedilol in the treatment of mild and moderate primary hypertension, randomized, double blind, positive drug parallel controlled, multi center. The are divided into two groups : a multi center, randomized, double blind, double dummy, positive drug parallel controlled clinical study; the other a single arm, open, multi center, dynamic blood pressure, clinical study. We will examine blood biochemistry, blood routine, urine routine, 12 lead electrocardiogram and measure of blood pressure before and after administration,and the efficacy and safety evaluation will be at the end of the complete and effective cases.Results: Carvedilol and metoprolol groups showed the same good clinical curative effect in the primary and secondary outcome, namely to the eighth week in control group diastolic blood pressure dropped by 12.96 ±6.55 mm Hg before and after treatment,difference was statistically significant; diastolic blood pressure dropped by 12.24±5.82 mm Hg in the experimental group before and after treatment, the difference has statistical significance. Systolic blood pressure decreased by 17.13±11.22 mm Hg in the control group to the eighth week before and after treatment, the difference has statistically significant; systolic blood pressure decreased by 16.92±11.07 mm Hg in the experimental group before and after treatment, the difference was statistically significant. The difference in the statistics of the two groups is statistically significant(P < 0.05), but there is no statistical significance(P < 0.05) between the carvedilol group and metoprolol group of treatment efficacy. We failed to find the two groups of drugs on liver function, renal function, uric acid, blood glucose, blood lipids, white blood cells and neutrophils have a significant impact after statistical analysis of the safety in all selected patients.Conclusion: Carvedilol has the same effect in the treatment of mild and moderate hypertension compared to metoprolol, but its adverse reaction was significantly reduced, and the treatment of mild and moderate hypertension is an effective and safe...
Keywords/Search Tags:sulfate Carvedilol, metoprolol, mild and moderate hypertension, drug test
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