The Observation Of Efficacy Of Nifedipine Controlled Release Tablets Treating Hypertension In Maintenance Hemodialysis Patients And The Analysis Of Serum Concentration Of Nifedipine

【Background and Objective】When Various types of chronic kidney diseases develop to end stage of renal disease, due to volume overload, the increased activity of renin - angiotensin - aldosterone and sympathetic nervous system,the role of endothelial derived factors and other factors, the proportion of hypertension in patients increase significantly.Furthermore,the prosess of Hemodialysis itself and the use of EPO and other Medications also make hypertension become a complication which difficult to control in hemodialysis patients. Since hypertension-induced cardiovascular and Cerebrovascular diseases in hemodialysis patients are the most common causes of death, so it is significant to control hypertension and maintain the blood pressure in a steady level to improve the quality of life and prognosis in hemodialysis patients. Besides enhancing hemodialysis and low-salt diet,the treatment of hemodialysis patients with hypertension includes antihypertensive drugs such as calcium channel blockers,βblockers and angiotensin converting enzyme inhibitors, of which the most commonly used is the calcium channel blockers.As a commonly used calcium antagonist, Nifedipine GITS has Features of reducing blood pressure continuously and stably,less adverse reactions and others. Many clinical observations indicate its good antihypertensive effect and safety in maintenance hemodialysis patients. However, many indicators of clinical observation is limited to occasionally measured has characteristics of large fluctuations, the disappearance of circadian rhythm and others,therefore they can not fully evaluate the effect and stability of Nifedipine GITS reducing the blood pressure in 24 hours in the maintenance hemodialysis patients. Meanwhile, the impact of hemodialysis itself on plasma concentrations of Nifedipine GITS in patients is directly related to the antihypertensive effect of Nifedipine GITS, but there are conflicting reports on this point.This study is to observe the curative effect and safety of Nifedipine controlled release tablets in treating hemodialysis patients with hypertension by 24-hour ambulatory blood pressure monitoring and detect the plasma concentration of Nifedipine GITS and the possible affection of hemodialysis on serum concentration and the fluctuation of blood pressure in hemodialysis.【Method】10 patients with hemodialysis and hypertension, the daily single oral dose of nifedipine GITS 60mg was taken to maintain the patients' blood pressure dropped to 140/90mmHg by following 4 weeks, the ambulatory blood pressure monitorings were performed in the hemodialysis and non-dialysis day,2mL venous blood samples which protected from light were collected in patients for determining the plasma concentration before starting hemodialysis and 1,2,3,4 hour after the period of hemodialysis.When during non-hemodialysis day at the same five time points,blood samplings were also collected. Different blood concentrations were detected by high performance liquid chromatography(HPLC), comparing the dynamic changes and the average level of blood pressure, blood pressure variability and load values, trough to peak ( T/P ) ratio, smoothness index, the average plasma concentration, concentration - time curve area, and other indicators with which on non-dialysis day. we also compare the average systolic blood pressure,the average diastolic blood pressure, the average heart rate and other indicators during hemodialysis with which between dialysis period.To get further analysis of the effect of Nifedipine controlled release tablets treating hemodialysis patients on dialysis and non-dialysis day,and the influence and safety of hemodialysis on plasma concentration of nifedipine controlled release tablets.Wheather the relationship between the average of plasma concentration and pulse pressure exgsists on dialysis and non-dialysis day were also explored.【Results】1. The average systolic pressure,the average diastolic pressure,the average pulse pressure and the average heart rates showed no significant difference between hemodialysis day and non-dialysis day (P> 0.05).2. There was no significant difference in the variability of systolic blood pressure,the variability of diastolic blood pressure, systolic blood pressure load and diastolic blood pressure load between hemodialysis day and non-dialysis day (P>0.05).3. The average systolic pressure,the average diastolic pressure,the average pulse pressure and the average heart rates of 10 patients showed no significant difference during hemodialysis and the interval of dialysis(P> 0.05).4. There were no obvious adverse reactions occurred during hemodialysis and between dialysis period by observing 10 hemodialysis cases who had taken nifedipine GITS.5. There was no significant difference in average plasma concentration and concentration - time curve area(AUC0-t) of nifedipine GITS between five corresponding time points of during hemodialysis and the interval of dialysis(P> 0.05).【Conclusion】1.Effect of oral nifedipine GITS 60mg/day for the treatment of hypertension in hemodialysis patients was obvious,and the blood pressure can be maintained at a nomal level after it was under the standard level.2. The change of average plasma concentration of nifedipine GITS was little affected by hemodialysis, wheather hemadialysis or not does not affect the antihypertensive effect of nifedipine GITS.3.Oral nifedipine GITS 60mg / day is safely tolerated by hemodialysis patients during the hemodialysis period and between hemodialysis without adverse reaction.