国产西尼地平治疗原发性高血压的多中心随机双盲双模拟临床研究

目的 对西尼地平治疗原发性高血压患者的疗效与安全性进行临床评价。方法 用多中心双盲双摸拟随机平行对照的试验方法,研究国产西尼地平与对照药苯磺酸氨氯地平对233例轻中度原发性高血压患者的降压疗效及药物不良反应。结果 治疗8周后,西尼地平组平均坐位收缩压(SBP)及舒张压(DBP)下降幅度分别为16.2,1 2.7 mmHg,苯磺酸氨氯地平组分别下降23.1,15.1 mmHg;两药总有效率分别为76.6％和87.7％,与治疗前比较有显著性差异(P<0.01);两药对心率无明显影响;两组药物不良反应的发生率分别为16.7％和12.9％。长期服用西尼地平疗效能持续,并有良好的耐受性。结论 西尼地平治疗轻中度原发性高血压具有明确的降压疗效与良好的安全性。     

西尼地平胶囊治疗轻中度原发性高血压的多中心临床研究

目的:评价西尼地平胶囊治疗轻中度原发性高血压的临床疗效和安全性。方法:采用随机、双盲、平行对照的多中心研究。227例轻中度原发性高血压患者经2周安慰剂洗脱后,随机分入试验组(n=114)或对照组(n=113),分别服用西尼地平胶囊或西尼地平片5mg·d~(-1),治疗2周末坐位舒张压≥90 mmHg者剂量加倍至10 mg·d~(-1)治疗至8周末。于安慰剂洗脱末及治疗2,4,6,8周末测量诊室血压、心率、体征及记录不良反应,试验开始前及结束时进行实验室及心电图检查。结果:203例完成试验,其中西尼地平胶囊组101例,西尼地平片组102例。服药8周后试验组和对照组总有效率分别为78．22%和80．39%,组间比较无统计学差异(P＞0．05)。两组服药后2,4,6,8周坐位收缩压和舒张压与服药前比较均有统计学意义的明显降低(P＜0．05);服药后血压下降幅度组间比较无统计学差异(P＞0．05)。两组血压达标率及剂量加倍情况无统计学差异。两组不良反应轻微,组间比较无显著差异。结论:西尼地平胶囊5～10mg每日一次治疗轻、中度原发性高血压安全有效。     

贝尼地平与非洛地平治疗高血压的疗效比较

目的:应用动态血压监测(ABPM)的方法比较两种钙拮抗剂(盐酸贝尼地平与非洛地平缓释片)治疗原发性高血压的疗效。方法:选择原发性高血压患者83例,随机分为两组,贝尼地平组41例,晨起口服贝尼地平1次/d,初始剂量4 mg;非洛地平缓释片(波依定)组42例,晨起口服波依定1次/d,初始剂量5 mg。两组1周后血压未达显效者,剂量增加1倍。结果:治疗4周后,两组血压均有明显下降,用药前后相比均有显著差异(P(0.01)。贝尼地平组为总有效率82.93%,降压谷/峰(T/P)值SBP为65.00%,DBP为62.50%;非洛地平缓释片组总有效率为83.33%,降压T/P值SBP为66.45%,DBP为67.63%。两组间比较差异无统计学意义(P(0.05)。药物不良反应两组间无统计学差异。结论:盐酸贝尼地平或非洛地平缓释片治疗原发性高血压疗效肯定,未见明显不良反应,适合临床使用。     

西尼地平与尼群地平治疗高血压病的疗效比较

目的:比较西尼地平与尼群地平治疗高血压病的疗效及安全性。方法:86例原发性高血压病患者随机均分为西尼地平组和尼群地平组,西尼地平组给予西尼地平,起始剂量为5mg,qd,根据血压可调整至10mg,qd;尼群地平组给予尼群地平,起始剂量为10mg,qd,根据血压可调整至20mg,bid。比较2组的降压疗效及药品不良反应。结果:西尼地平组与尼群地平组的总有效率分别为90.7%和88.4%,2组比较差异无统计学意义(P>0.05);西尼地平组和尼群地平组收缩压的最大降幅分别为(34.2±3.8)和(29.2±2.2)mmHg,舒张压最大降幅分别为(23.8±2.6)和(19.4±2.3)mmHg,差异有统计学意义(P<0.05)。尼群地平组治疗后心率明显快于治疗前及西尼地平组治疗后(P<0.05),但西尼地平组患者心率治疗前、后无显著变化(P>0.05)。治疗过程中2组均未见明显不良反应发生。结论:西尼地平用于治疗高血压疗效与尼群地平相近,但其对患者的心率影响较小。     

国产西尼地平治疗原发性轻中度高血压的疗效和安全性

目的:评价西尼地平治疗原发性轻中度高血压的疗效和安全性.方法:采用随机、双盲、前瞻性平行对照试验,64例原发性轻中度高血压患者分为试验组和对照组各32例,两组分别口服西尼地平和氨氯地平5mg·d -1 ,4周时如血压未达到有效标准则两组都增加剂量至10mg·d -1 至8周结束.检测两组治疗前后的血压、心率、心电图和血、尿实验室检查的变化.结果:63例完成全部试验,治疗8周末,经ITT分析,试验组平均坐位收缩压和舒张压降低程度与对照组比较差异无显著性[收缩压降低(17.63±12.06)mmHg vs(21.18±13.67)mmHg,P=0.1695;舒张压降低(13.06±6.73)mmHg vs(15.67±6.80)mmHg,P=0.1564];对照组降压的总有效率为90.63%,试验组为90.63%,两组差异无显著性(P=0.427);两组患者不良事件发生率也差异无显著性.结论:国产西尼地平治疗轻中度高血压安全有效.     

西尼地平治疗轻中度原发性高血压的有效性和安全性

目的:评价西尼地平治疗轻中度原发性高血压的有效性和安全性。方法:采用随机对照、双盲双模拟研究设计。48例患者分为试验组和对照组各24例。试验组患者口服西尼地平片和苯磺酸氨氯地平模拟片,西尼地平起始剂量为5 mg,qd,4周后若舒张压≥90 mmHg,则增加至10 mg,qd,直至试验结束。对照组口服苯磺酸氨氯地平片和西尼地平模拟片,给药方法及剂量调整与试验组相同。结果:8周后试验组和对照组的收缩压降低幅度分别为(11.13±7.31)和(16.10±7.68)mmHg,最大舒张压降低幅度分别为(11.01±4.17)和(13.27±4.57)mmHg,治疗前后组内比较均有统计学意义。8周末两组间收缩压降低幅度有显著差异(P<0.05)。两组均无严重不良反应发生,每组各有5例发生药物不良反应,无统计学差异(P>0.05)。结论:西尼地平每日服用1次降压安全有效。     

国产左旋氨氯地平与非洛地平治疗原发性高血压的比较

目的比较左旋氨氯地平与非洛地平治疗原发性轻、中度高血压的疗效和安全性。方法选取126例轻、中度原发性高血压患者,采用随机、单盲和平行对照的方法分成两组,分别每日口服1次左旋氨氯地平5mg或非洛地平5mg,治疗4周,并用24h动态血压监测评价用药前后24h血压变化情况,观察两组的不良反应。结果两组治疗4周后血压明显下降(P<0.01),两组间无显著性差异(P>0.05)。两药均能降低24h平均、白天平均及夜间平均血压。两组不良反应发生率均较低。结论左旋氨氯地平、非洛地平均能有效降低轻、中度高血压患者的血压,作用平稳、有效、安全。     

西尼地平胶囊治疗原发性高血压双盲双模拟随机对照多中心研究

目的:评价国产西尼地平胶囊治疗轻度至中度高血压的临床疗效及安全性。方法:以国产西尼地平片为对照药,在252例轻度至中度高血压病人中进行多中心、随机、双盲、平行、活性药物对照的临床试验。结果:治疗8wk后,西尼地平胶囊组平均坐位收缩压和舒张压分别下降(18±s 11)mmHg (11．9％)和(12±8)mmHg(12．6％),西尼地平片组平均坐位收缩压和舒张压分别下降(19±13)mmHg (12．5％)和(12±8)mmHg(12．9％),2药的总有效率分别为80．3％和82．9％。西尼地平胶囊和西尼地平片对心率无明显影响,与药物有关的不良反应分别为6例和4例,主要表现为轻到中度的头晕、头痛、面红、心悸等。2药的疗效和不良反应比较无统计学差异(P＞0．05)。结论:国产西尼地平胶囊与国产西尼地平片相似,治疗轻中度原发性高血压具有明确的降压疗效与良好的安全性。     

依那普利与非洛地平缓释片治疗原发性高血压的临床疗效观察

目的探讨依那普利与非洛地平缓释片治疗高血压的临床疗效。方法原发性高血压患者192例,均给予依那普利与非洛地平缓释片治疗;其中96例给予依那普利与非洛地平缓释片作为治疗组,96例给予非洛地平缓释片作为观察组。结果与观察组相比,治疗组血压达标率有统计学意义。结论原发性高血压依那普利与非洛地平缓释片联合应用比单用非洛地平缓释片降压治疗临床效果更好。     

西尼地平治疗原发性高血压伴2型糖尿病合并肾脏损伤的疗效分析

目的 观察应用西尼地平对原发性高血压合并2型糖尿病伴肾脏损伤患者尿蛋白及血清肌酐水平的影响.方法 人选31例患者,基线背景治疗为依那普利,随机加用西尼地平,或非洛地平,分析治疗6及12个月时血清肌酐以及24 h尿蛋白定量的变化.结果 两组患者基线值各项指标以及治疗过程中血压、心率差异均无统计学意义,24 h尿蛋白随访值西尼地平组低于非洛地平组（P＜0.01）,治疗6个月时西尼地平组血清肌酐高于非洛地平组[分别为（142.5±26.0）μmol/L与（129.9±29.0）μmol/L]（P＞0.05）,治疗12个月时低于非洛地平组[分别为（134.1±35.3）μmol/L与（159.7±33.2）μmol/L]（P＜0.05）.结论 与非洛地平相比,西尼地平对原发性高血压伴发2型糖尿病患者具有明显肾脏保护作用.     

Effect of morning and bedtime dosing with cilnidipine on blood pressure, heart rate, and sympathetic nervous activity in essential hypertensive patients

Cilnidipine has a blocking action against N-type calcium channels as well as L-type calcium channels. We studied the effect of morning and bedtime dosing on circadian variation of blood pressure (BP), heart rate (HR), and activity of the autonomic nervous system, using an open randomized crossover study in 13 essential hypertensive patients. An automated device allowed 24-hour monitoring of ambulatory BP and HR and the power spectrum of the R-R interval, at the observation period, the morning dosing regimen, and the bedtime dosing regimen. Morning dosing and bedtime dosing with cilnidipine reduced the average systolic BP over 24 hours, during daytime, and during nighttime. The average HR and the average LF/HF ratio over 24 hours, during daytime, and during nighttime, were similar for the three periods. Both morning and bedtime dosing reduced the maximum systolic BP in the early morning and suppressed the morning rise of BP, which were accompanied by partial inhibition of the increase in LF/HF ratio. Our results show that cilnidipine administered once daily is an efficient antihypertensive drug regardless of the time of dosing, without reflex tachycardia and increase in sympathetic nervous activity, and with partial inhibition of the morning activation of the sympathetic nervous system.     

西尼地平治疗轻、中度原发性高血压病人的疗效和安全性

目的 :观察西尼地平治疗轻、中度原发性高血压病人的降压疗效和安全性。方法 :采用随机、双盲、平行对照试验设计。经过 2wk安慰剂洗脱后 ,筛选轻、中度高血压病病人 4 8例。分为A组 2 4例 ,给西尼地平 5mg加苯磺酸氨氯地平模拟片 ,po ,qd ;B组 2 4例 ,为苯磺酸氨氯地平 5mg加西尼地平模拟片 ,po ,qd。 4wk末如达目标血压 (坐位舒张压≤ 12kPa) ,继续服用至 8wk末 ,否则剂量加倍服用至 8wk末。结果 :2组总有效率分别为 75 %和 83% ,2组收缩压降低幅度分别为 (0 .2 6±s 0 .16 )kPa和 (0 .31± 0 .16 )kPa ,舒张压降低幅度分别为 (0 .2 1± 0 .11)kPa和 (0 .2 4± 0 .0 8)kPa(均P <0 .0 1)。不良反应 2组无显著差异。结论 :西尼地平治疗对轻、中度原发性高血压病人有效、安全     

Effects of cilnidipine, a novel dihydropyridine calcium antagonist, on autonomic function, ambulatory blood pressure and heart rate in patients with essential hypertension

AIMS: The aim of the present study was to evaluate the effects of cilnidipine, a novel dihydropyridine calcium antagonist, on autonomic function, ambulatory blood pressure and heart rate in patients with essential hypertension. METHODS: Ten inpatients with mild to moderate essential hypertension (four men and six women; age: 44-64 years) underwent a drug-free period for 7 days and a treatment period with cilnidipine 10 mg orally for another 7 days, in a randomized crossover study. On the sixth day of each period, they underwent autonomic function tests including a mental arithmetic test, a cold pressor test and a Valsalva manoeuvre. After these tests, 24 h ambulatory blood pressure, heart rate, and the electrocardiogram R-R intervals were monitored every 30 min. A power spectral analysis of R-R intervals was performed to obtain the low-and high-frequency components. RESULTS: Cilnidipine significantly decreased the 24 h blood pressure by 6.5 +/- 1.7 mm Hg systolic (mean +/- s.e.mean; P < 0.01) and 5.0 +/- 1.1 mmHg diastolic (P < 0.01), whereas cilnidipine did not change heart rate or any indices of power spectral components. During the cold pressor test, the maximum change in systolic blood pressure and percentage changes in both systolic and diastolic blood pressures were significantly lower during the treatment period with cilnidipine than during the drug-free period. The baroreflex sensitivity measured from the overshoot phase of the Valsalva manoeuvre did not differ significantly between the two periods. CONCLUSIONS: Cilnidipine is effective as a once-daily antihypertensive agent and causes little influence on heart rate and the autonomic nervous system in patients with mild to moderate essential hypertension. Moreover, it is suggested that cilnidipine has an additional clinical benefit in the inhibition of the pressor response induced by acute cold stress.     

Treatment of essential hypertension with felodipine in combination with a diuretic

Summary In a double-blind cross-over study, the effect on blood pressure (BP), heart rate (HR) and plasma noradrenaline concentration (pNA) of placebo or felodipine given in addition to hydrochlorothiazide was studied in 12 male patients with essential hypertension, not satisfactorily controlled with the diuretic alone. The first dose of felodipine decreased BP and increased HR for about 6 h. After 4 weeks of treatment with felodipine, BP was reduced for 24 h, whereas HR was only transiently increased. The elimination half-life of felodipine was about 23 h. The plasma noradrenaline concentration increased after felodipine and serum uric acid decreased. Side-effects were few and usually mild.     

西尼地平治疗轻、中度原发性高血压临床疗效的观察

目的：评价Ⅱ类新药西尼地平治疗轻、中度原发性高血压的疗效和安全性。方法：采用随机、双盲、平行对照法，将43例轻、中度高血压患者分为西尼地平组和氨氯地平组，检测2组治疗前后血压、心率及血液生化值变化。同时，在开放组患者中进行动态血压的监测。结果：西尼地平组血压控制显效率为63．64％，有效率为13．64％，总有效率为77．28％；氨氯地平组血压控制显效率为66．67％，有效率为11．11％，总有效率为77．78％。两组比较无显著性差异。与治疗前基线情况相比，治疗8周末两组受试者的坐、立位血压都有明显下降，两组间比较无显著性差异。用药前后血糖、血脂、血电解质及肾功能无显著变化。开放组显示T／P比值均已达到美国FDA提出的对长效降压药物的要求，即50％以上。结论：国产西尼地平治疗轻、中度高血压降压平稳，对心率影响小，副作用少。     

Catecholamines, renin-angiotensin-aldosterone, and cardiovascular response during exercise following acute and long-term calcium antagonism with felodipine in essential hypertension

Studies were performed in nine patients with essential hypertension to explore the effect of the calcium antagonist felodipine on the exercise-induced responses of the sympathetic and renin-angiotensin-aldosterone systems as well as of blood pressure and heart rate. The patients were subjected to an individually graded submaximal work test (bicycling) after administration of placebo and a single dose of felodipine (10 mg) in a double-blind design and following long-term (8 weeks) felodipine treatment (10 mg twice daily). After a single dose of felodipine sitting preexercise blood pressure was decreased, whereas heart rate, plasma noradrenaline, adrenaline, renin activity, and angiotensin II increased. After long-term felodipine treatment blood pressure was reduced, heart rate was unchanged, and plasma noradrenaline and renin activity increased. The exercise-induced increases in plasma catecholamines, renin activity, angiotensin II, aldosterone, blood pressure, and heart rate were similar after acute and long-term felodipine administration as compared with placebo. In conclusion, acute and long-term felodipine treatment influences neither reflex activation of the sympathetic nervous system and the renin-angiotensin-aldosterone system nor the cardiovascular responses to physical exercise in patients with essential hypertension.