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The Effect And Safety Of Allisartan On The Primary Hypertension Patients With Low Or Moderate Risks-a Double Blind, Placebo-controlled Clinical Trial

Posted on:2011-05-23Degree:MasterType:Thesis
Country:ChinaCandidate:L DuFull Text:PDF
GTID:2144360305955076Subject:Internal Medicine
Abstract/Summary:PDF Full Text Request
Hypertension is one of the most common cardiovascular diseases, Anti-hypertensive therapy from the traditional step-down as an indicator to be extended to slow down or reverse the hypertension induced target organ damage, to reduce the incidence and mortality rate of cardiovascular diseases. Since 1994, the first angiotensinⅡ(AngⅡ) receptor antagonist (ARB) losartan has been used, the knowledge of the ARB is constantly updated. ARB class antihypertensive drugs is a long-lasting, stable, powerful drugs, By selective blocking AngⅡand combining with angiotensinⅡ1 receptor (AT1R) ,ARB play a big role in blood pressure lowering and protecting the target organ .The use of it is becoming more and more widespread in the treatment of hypertension,it meets the requirements of the morden treatment of hypertension ,and it has received increasing attention in clinical.The current treatment of hypertension are mainly five types of antihypertensive drugs, Are as follows: diuretics,βblockers, angiotensin- converting enzyme inhibitors (ACEI), angiotensin receptor blocker (ARB), calcium channel blocker. As the ARB class of drugs can block the renin - angiotensin system (RAS), so been wildly used in clinical.In the area of treatment of hypertension the goal is to develop a new drug, which can smooth blood pressure lowering, reversing target organ damage. ARB represent the innovative progress of the area of treatment of angiocardiopathy. ARB treatment of cardiovascular diseases represent a ground-breaking progress in the field of clinical applications are increasingly common. At the same time, in order to benefit patients with cardiovascular disease , the time of administration, dosage, and other antihypertensive drugs in combination and interaction, and how will the outcome of medical sonsultantion timely used in clinical practice need further study. Purpose:After taking 8 weeks measur the sitting diastolic blood pressur realtive baseline change. Comparison of the effect of Allisartan Isoproxil and placebo in treatment low risk hypertension patients.Materials and methods:40 Low-risk primary hypertension patients, divided into two groups. Inclusion criteria: age 18 to 70 (including 18,70) years old, male or female; 18.5kg/m2≤BMI≤26kg/m2 (BMI = weight / height 2). According to the Chinese Hypertension Prevention Guide 2005 revised edition of the diagnostic criteria, Diagnosis of low-risk patients with essential hypertension; afte take 2 weeks the average sitting blood pressure is 140mmHg≤SBP<180mmHg and 90≤DBP<110mmHg。All selected subjects are recorded age , heart rate (HR), measurement of blood pressure, including systolic and diastolic blood pressure, recorded BMI, routine blood indicators (the total number of red blood cells, WBC count, neutrophil percentage, the total number of platelets, hemoglobin), liver function (alanine aminotransferase, aspartate aminotransferase, bilirubin), renal function (urea nitrogen does, creatinine, uric acid ), fasting blood glucose, blood lipids (triglycerides, total cholesterol, high density lipoprotein, low density lipoprotein), serum electrolytes (potassium, sodium, chlorine), urine routine.After take 2 weeks placebo, one group give Aillisartan Isoproxil 240mg and the other group give placebo-240mg, once a day for half an hour before breakfast. Respectively, At the 2nd week, 4th week and 8th week measurement of sitting blood pressure and heart rate, and record the end of the event. At the 4th week,8th week routine examination of the blood and urine, liver function, renal function and blood electrolyte testing. At the 8th week examination of the blood lipids and fasting blood glucose.Method of measuring blood pressure: before blood pressure measure 15 minutes not to smoke, back sit 5 minutes, the first 2 weeks are the selected period during the two weeks measure blood pressure three times in the different day, takeing the average of three times, after the treatment is started, measure the blood pressure three times in the following day, take the average of the three times under the atandard state to measure, namely the same time each day, the same side arm, with the same blood pressure, measured by the same person to complete.Results: 1. Effect of systolic blood pressure : after taking medicin two weeks, each group`s systolic blood pressure dropping , after 4 weeks of treatment up to the maximum effection , after 8 weeks the antihypertensive effect of sustained , between the two groups were statistically significant.2. Effect of diastolic blood pressure: in the medication process, two groups of subjects` diastolic blood pressure decrease is not obvious, and little difference between the two groups.3. Safety: A combination of B group the incidence of major adverse events were 5% (1 / 20) and 10% (2 / 20), no significant difference among the groups, no serious adverse events. Various laboratory tests, vital signs and physical examination found no abnormalities. After treatment, sitting resting heart rate before treatment did not change.The results suggesting:The study showed that compared with the baseline, after 8 weeks A, B group sitting diastolic blood pressure decreased 2.05mmHg and 5.5mmHg. Sitting systolic blood pressure decreased 11.15mmHg and 8.8mmHg group and between the two groups were statistically significant. And treatment of 2 weeks, 4 weeks after the sitting blood pressure drop comparison and found that two groups of subjects after 2 weeks of treatment could significantly reduce the diastolic and systolic blood pressure, and as the treatment continues, diastolic blood pressure continued to drop, treatment 8 week up to the maximum antihypertensive effect; systolic blood pressure up to the maximum antihypertensive effect at 4 weeks, after 8 weeks antihypertensive effect sustained, stable hypotensive effect, the two groups decreased the value of the difference between the systolic blood pressure continued to increase with the treatment, statistically significant difference between the two groups were compared.Safety results showed that,A, B group of adverse reaction rates were 5% (1 / 20) and 20% (2 / 20), A group of mainly as in increased urine white blood cells, B group mainly as headache, dizziness, no significant difference between the two groups. Adverse reactions in each group are mostly mild, some moderate, can tolerate and do not affect the continued to use the drug.Conclusions:1. Effect: Allisartan Isoproxil and Allisartan Isoproxil placebo orally once a day, able to reduce low-risk patients with primary hypertension in systolic and diastolic blood pressure, the effect of antihypertensive is sustained and steady.2. Security: Allisartan Isoproxil and Allisartan Isoproxil placebo orally adverse reaction rate is low, well tolerated.
Keywords/Search Tags:Hypertension, Allisartan Isoproxil, Clinical Research
PDF Full Text Request
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