培哚普利与卡托普利对高血压的疗效比较

评价培哚普利治疗中度原发性高血压的有效性和安全性并与卡托普利比较。１２０例患者随机分为培哚普利组和卡托普利组，每组中４４例行偶测血压监测，１６例行动态血压监测；培为利４－６ｍｇ，１／ｄ，卡托普利１２．５－１８．７５ｍｇ，３／ｄ，疗程４周。降压总有效率培哚普利组为９１．７％，卡托普利组为７８．３％；副作用发生率培哚普利组为１１．７％，且均较轻微。     

培哚普利治疗原发性高血压的临床观察

目的观察培哚普利对原发性高血压的降压作用及副反应。方法３７例轻中度原发性高血压患者予培哚普利共８周，评价对随诊血压及２４ｈ动态血压的影响。结果治疗４周收缩压（ＳＢＰ）无明显降低（Ｐ＞０．０５），舒张压（ＤＢＰ）明显降低（Ｐ＜０．００１），８周ＳＢＰ、ＤＢＰ均明显降低（Ｐ＜０．００１），随诊血压降压有效率分别为５４．１％（４周）及６７．６％（８周），２４ｈ动态血压曲线８周时呈明显下降，除咳嗽外未发现其他严重副反应。结论培哚普利对轻中度原发性高血压是安全有效的降压药物。     

苯那普利与依那普利降压效果的对比研究

目的：以进口依那普利进行临床对比研究,评价国产盐酸苯那普利的降压疗效和安全性。方法：盐酸苯那普利和依那普利随机、单盲治疗轻、中度Ⅰ、Ⅱ期原发性高血压患者４０ 例,剂量均为１０ ｍ ｇ／ｄ,治疗２ 周后必要时均加氢氯噻嗪２５ ｍ ｇ／ｄ。观察苯那普利短期（４ 周）及长期（６ 个月）治疗的效果、动态血压变化及不良反应。结果：①苯那普利和依那普利治疗４ 周末的显效率及总有效率分别为６０．０％ 、５０．０％ 及７５．０％ 、７０．０％ ,组间无显著性差异;②苯那普利服用６ 个月的患者降压疗效与服药４ 周时相同,无耐药性出现;③１０ ｍ ｇ／ｄ 苯那普利组治疗４ 周后２４ ｈ 血压监测收缩压和舒张压的谷－峰比值分别为７１．９％ 和５５．１％ ,均＞ ５０％ ;④苯那普利组出现不良反应的发生率为１５．０％ （３／２０）,依那普利组２０．０％ （４／２０）。结论：国产苯那普利治疗轻、中度原发性高血压的近期及长期疗效显著,每日１ 次给药效果持久、稳定,不良反应轻。     

厄贝沙坦治疗原发性轻、中度高血压的有效性和安全性

目的评价厄贝沙坦治疗轻、中度原发性高血压的有效性和安全性，并与缬沙坦进行比较。方法120例轻、中度高血压患者随机分成2组，分别每日口服1片厄贝沙坦及1片缬沙坦治疗，治疗周期为8周，用24h动态血压检测评价用药前及8周治疗后24h血压变化情况。结果厄贝沙坦组有58例完成治疗随访，降压总有效率达86．2％，缬沙坦组56例完成治疗随访，降压总有效率达85．7％。与用药前相比，两组治疗后的收缩压与舒张压均显著降低。两组降压疗效相近，谷／峰比值〉50％。结论厄贝沙坦能降低轻中度高血压患者的血压，降压疗效确切、安全。     

尼索地平降压疗效的临床观察

尼索地平（Nisoldipine）为新一代的二氢吡啶类钙拮抗剂[1]，我们应用尼索地平治疗高血压病患者，观察了该药的降压疗效和不良反应，现将其临床观察结果报告如下。病例选择符合WHO高血压诊断标准的75例轻、中度高内压（舒张压95～114mmHg）患者随机分为两组。A组为尼索地平治疗组，共50（男26、女24）例，平均年龄53．9±9．14岁；B组为尼群地平对照组，共25（男15、女10）例，平均年龄56．4±10．34岁。伴有严重心、肝、肾功能损害、不稳定性糖尿病、恶性肿瘤患者及妊娠期妇女不列人本观察。羌1两组患者服药前后血压及心率的变化。。表…     

静脉注射尼卡地平对重度高血压患者血压和心功能的影响

目的研究静脉注射尼卡地平对重度高血压患者血压和左心功能的影响。方法用尼卡地平持续２４ｈ静脉滴注（１．５～３ｍｇ／ｈ）治疗２０例重度高血压患者，观察给药前后血压、心率、左心功能以及自觉症状变化。结果降压显效率１００％，５ｍｉｎ起效，０．５～１ｈ血压降至理想水平，同时全部病例脑循环障碍症状消失，２４ｈ降压效果平稳，心率轻度增快（＜１０ｍｉｎ－１），左心收缩功能明显改善，而舒张功能未见变化。结论静脉注射尼卡地平可迅速、显著而平稳降低重度高血压患者的血压，改善左心收缩功能。     

尼莫地平、尼群地平及硝苯啶对高血压患者疗效的比较

本试验结果表明钙拮抗剂尼莫地平、尼群地平及硝苯啶均显著降低轻、中度原发性高血压患者(n=199)的血压,降压效力尼群地平>硝苯啶>尼莫地平,副作用均较轻。尼群地平似有一定降血胆固醇作用。根据此结果与以往资料,我们初步认为,尼莫地平对轻、中度高血压尤其是伴有脑血管疾患患者的防治应是有益的;尼群地平对高血压或伴有高胆固醇血症患者的治疗可能是较好的;硝苯啶对高血压或伴有冠心病患者的治疗是合适的。     

几种降压药物综合疗效随机双盲研究—511例报告

背景有据医学的新模式提出随机双盲对照是评价药物效果的金标准，许多新一代降压药物国内外均少随机双盲研究，本研究采用随机双盲法对常用三类药物的降压效果，安全性，副作用进行评价，为临床医师提供重要参考资料。方法采用随机双盲并行研究，经二周安慰剂洗脱后，５１１例高血压患者分入三组：尼群地平组１７２例，２０ｍｇ／ｄ～３０ｍｇ／ｄ；氨酰心安组１６８例，２５ｍｇ／ｄ～５０ｍｇ／ｄ；卡托普利组１７１例，５０ｍｇ／ｄ～７５ｍｇ／ｄ，观察６月。结果各组３月时降压达峰值，六月时收缩压均有轻微回升，而舒张压持续降低。尼组降压达标率（＜１４０ｍｍＨｇ／９０ｍｍＨｇ）为６５．２％，氨及卡组为５０．８％，４８．４％。撤药率卡组达９．１％，尼、氨组均为５．６％。各组副作用累计发生率相似，卡组咳嗽高达３６．２％，尼组面红２６．１％，氨组乏力２６．３％。氨组生活质量改善最佳。卡组对认知有轻度负面影响，尼组对生活质量总体有轻微负面影响。结论三种药物均可有效降压，尼群地平的综合降压效果优于氨酰心安、卡托普利。氨组生活质量最佳。     

静脉注射尼卡地平对生度高血压患者血压和心功能的影响

研究静脉注射尼卡地平对重度高血压患者血压和左心功能的影响。方法 用尼卡地平持续２４ｈ静脉滴注（１．５－３ｍｇ／ｇ）治疗２０例重度高血压患者、观察给药前后血压、心率、左心功能以及自觉症状变化。结果 降压显效率１００％，５ｍｉｎ起效，０．５－１ｈ血压降对理想水平，同时全中病例脑循环障碍症状消失，２４ｈ降压效果平稳，心率轻度增快（Ｐ〈１０ｍｉｎ＾－１），左心收缩功能明显改善，而舒张功能未见变化。结果 静     

卡维地洛治疗轻,中度原发性高血压的疗效和安全性

目的：评价新药卡维地洛片治疗轻、中度原发性高血压的降压疗效和安全性。方法：２５例轻、中度高血压病患者经过２表洗期后，服卡维地洛片１０ｍｇ．ｂｉｄ，，治疗２ 一其中血压下降不满意者９例（舒张压〉９０ｍｍＨｇ）啬剂量为２０ｍｇ．ｂｉｄ，共观察４周。结果：服药后第周末舒张压即明显下降，治疗第３周后收缩人压也显著下降。４周降压治疗总有效率为８８％，服卡维地洛２０／ｄ、４０ｍｇ／ｄ的总效率分别为５６％、３２     

Dose titration study of isradipine in Chinese patients with mild to moderate essential hypertension

Summary In order to assess the effective dose, tolerability, and safety of isradipine as a monotherapeutic antihypertensive agent for Chinese patients in Taiwan, an open trial was carried out. This study consisted of a 2-week, placebo, run-in period and an 8-week active treatment period, starting with isradipine 1.25 mg twice daily (bid) for the first 4 weeks, followed by 2.5 mg bid if the blood pressure was not normalized (diastole <90 mmHg). One hundred and one patients (M/F=48:53) were valid for efficacy analysis. Their age ranged from 30 to 64 years (mean±SD, 52±8). The blood pressure before active treatment was 160±2/104±1 mmHg. At the end of treatment period I (week 4), 12–14 hours after the last dose, 38 (37.6%) patients were normalized and 47 (46.5%) subjects responded (diastolic blood pressure reduction 10 mmHg). At week 8, 68 (67.3%) patients were normalized and 79 (78.2%) subjects responded. Isradipine reduced both systolic and diastolic blood pressures within 2 weeks of treatment. There were no significant differences in blood pressure reduction between both genders and among age groups. Safety analysis showed two subjects with severe flushing, dizziness, and palpitation who used the dose of 1.25 mg bid. They withdrew from the study. The adverse reactions of other patients were transient, mild, and tolerable. Most of the side effects were related to vasodilatation, but edema was not found. There was no change in body weight or heart rate, nor any atrioventricular conduction disturbances. In conclusion, isradipine in a dose of 1.25 or 2.5 mg bid proved to be an effective and well-tolerated antihypertensive agent for Chinese subjects in Taiwan with mild to moderate essential hypertension. This finding is similar to those reported in Caucasian patients.     

Isradipine-SRO: antihypertensive efficacy,central and peripheral hemodynamic effects in patients with hypertensive disease

AIM: To assess antihypertensive efficacy of isradipine, to study its effects on central and peripheral hemodynamics, and to investigate relationships between state of microcirculation and response to treatment. MATERIAL AND METHODS: Isradipine was given for 12 weeks to 30 patients (16 men, 14 women, mean age 50.2+/-9.8 years) with I-II stage mild and moderate hypertension. Twenty four hour blood pressure monitoring, assessment of parameters of central hemodynamics and state of microcirculation were carried out before and after 12 weeks of isradipine administration. RESULTS: Administration of isradipine was associated with improved sense of well-being and significant lowering of 24-hour, diurnal and nocturnal systolic/diastolic blood pressure (by 6.4/12.7, 7.6/9.4, 10.5/13.4%, respectively). Average 24-hour heart rate increased mainly during daytime (by 10.6%). Mean hemodynamic blood pressure was lowered by 16.3% due to reduction of total peripheral vascular resistance. There occurred redistribution of types of microcirculation with increase of proportion of normocirculatory and decrease - of spastic types. Changes of parameters of microcirculation at rest and during functional tests evidenced for resolution of baseline arteriolar spasm, stasis and venous congestion in microcirculatory vascular bed. Patients who responded to isradipine more often had spastic (50%) and congestive (35%) types of microcirculation. Patients with hyperemic type did not respond to isradipine. Most frequent side effect was flushing (23.3%) because of which 2 patients stopped taking the drug.     

MIS (Multicentric Isradipine Study of antihypertensive therapy).

One-year open Multicentric Isradipine Study (MIS) performed in 7 centres in Czechoslovakia included 144 patients with mild and moderate hypertension. Isradipine was given at a dose of 2.5 mg daily. If normalization of diastolic blood pressure (BP) had not been reached, the dosage was increased to 5 mg. Monotherapy with isradipine normalized diastolic BP in 44% of patients. Isradipine (5 mg daily) was combined with bopindolol in patients in whom isradipine alone failed to normalize diastolic BP. These had higher mean systolic and diastolic BP, body weight, erythrocyte and platelet counts at the beginning of the study. The combination of isradipine with bopindolol normalized diastolic BP in 87% of the group at the end of 48 weeks' treatment. Tolerance was excellent in 82% of patients. Treatment was discontinued in 8% patients, undesirable effects being the reason in 2%, ineffective therapy in 2% and poor adherence to therapy in 4%. Isradipine in monotherapy or in combination with bopindolol did not exert an adverse effect on the metabolic risk factors of ischaemic heart disease (cholesterol, glycaemia).     

The effect of isradipine,a new calcium-channel antagonist,in patients with primary Raynaud's phenomenon: A single-blind dose-response study

Summary Isradipine is a new potent calcium-channel blocking agent with highly selective action on peripheral vessels. In this single-blind study, its dose-related effect on cold-induced changes in finger systolic pressure (FSP) was investigated in ten female patients with primary Raynaud's phenomenon, and the side effects of isradipine treatment were evaluated. The patients were studied during 9 weeks of treatment. After 3 weeks of placebo, isradipine was given in doses of 1.25 mg b. i. d. and 2.5 mg b. i. d. for 3 weeks each. FSP was measured on local finger cooling to 10°C. FSP at 10°C expressed in percent of the value of 30°C increased from 21±16% (M±SD) after placebo to 42±28% (p<0.05) and 62±25% (p<0.001) after treatment with isradipine 1.25 mg and 2.5 mg b. i. d., respectively. The subjective efficacy of the treatment was assessed with a visual analogue scale (VAS). The VAS rating increased from 17 (range 0–66) after placebo to 39 (range 12–88) (NS) and 68 (range 25–99) (p<0.001) after isradipine treatment with 1.25 mg and 2.5 mg b.i.d., respectively. Adverse effects of isradipine therapy were few and did not differ from those reported after the placebo period. This single-blind dose-response study showed that isradipine in doses of 1.25 mg and 2.5 mg b.i.d had favorable objective and subjective effects in patients with primary Raynaud's phenomenon and had no serious side effects.     

Cardiovascular effects of isradipine in essential hypertension

The immediate and short-term cardiovascular effects of oral isradipine therapy were evaluated in 11 patients with mild to moderate systemic hypertension. Isradipine, 5 mg administered orally, induced a significant reduction in arterial pressure from 165 +/- 6/88 +/- 3 mm Hg to 140 +/- 5/76 +/- 2 mm Hg (p less than 0.001) within 2.5 hours by a decrease in total peripheral resistance associated with an increase in heart rate and cardiac output. Contrary to the acute effect, oral therapy with isradipine for 3 months reduced arterial pressure through a decrease in total peripheral resistance but without causing an increase in heart rate or cardiac output or activation of the sympathetic nervous system. Isradipine slightly reduced left ventricular mass and improved cardiac systolic function and left ventricular filling. Renal blood flow increased, and renal vascular resistance (p less than 0.01) and total blood volume (p less than 0.002) decreased without a change in either sodium excretion or body weight. Thus, isradipine, when given for 3 months, decreased arterial pressure by reducing total peripheral resistance without activation of reflexive mechanisms. Its favorable effects on systemic hemodynamics, total blood volume, renal blood flow, and cardiac structure and function suggest isradipine to be an excellent choice for antihypertensive therapy.     

A randomized comparison of isradipine slow release given once daily with isradipine twice daily on 24 hour blood pressure in hypertensive patients.

Isradipine, a new calcium channel blocker, was given to 32 patients with mild to moderate essential hypertension. After a run-in period of three weeks, 32 patients were randomized double-blindly to six weeks' treatment with either isradipine 2.5 mg twice daily or isradipine 5.0 mg once daily in a modified release formulation. Based on conventional 'clinic' BP measurements 12 or 24 hours postdose, the two treatments resulted in clinically relevant BP reduction (16/11 and 19/15 mmHg) without reflex tachycardia. No differences were seen between the groups. Efficacy increased throughout the study period. By determination of the 24 hour BP profile with a noninvasive method, the two groups were comparable during the placebo period, and no differences were seen between the two treatments. Both treatments resulted in satisfactory BP reduction during 24 hours (daily reduction of 4/6 and 12/9 mmHg twice daily and once daily dosing respectively). One third of the patients had 'white-coat' hypertension based on ambulatory daytime mean BPs, compared with conventional measurements. No relationship was found between the initial BP lowering effect and the effect after long-term treatment with isradipine in either dose.     

Duration of effects of isradipine during twice daily therapy in angina pectoris

Summary Isradipine, a 1,4 dihydropyridine calcium channel antagonist, is a potent coronary artery dilator that increases coronary blood flow with little effect on cardiac contractility. Isradipine is an approved antihypertensive agent, but its anti-anginal effects have not been well documented. In this placebo-controlled, double-blind, parallel-group design study we evaluated the duration of effects and safety of isradipine 10 mg bid in male patients with chronic stable angina pectoris. Seventy-two patients experiencing moderately severe angina between 3 and 7.5 minutes during a standard Bruce exercise test received placebo in a single-blind manner for 8–14 days. Sixty-one of these patients had reproducible treadmill exercise test results on three consecutive occasions and underwent further exercise tests at 3, 8, and 12 hours after a placebo period. Patients were then randomized (double blind) to either placebo or isradipine 10 mg bid for 2 weeks. Symptom-limited exercise tests were repeated predose and at 3, 8, and 12 hours after the 0800 hour dose dosing. Exercise duration increased significantly from baseline (last qualifying test during the single-blind placebo therapy, i.e., 0800 hours predose at visit 4) in the isradipine group compared to the placebo group prior to the administration of the 0800 hour dose (i.e., 12 hours after the 2000 hour dose) by 51 vs. 18 seconds, p=0.04; and after the administration of the 0800 hour dose at 3 hours by 78 vs. 29 seconds, p=0.005; and at 8 hours by 54 vs. 18 seconds, p=0.04. Similarly, statistical significance was achieved when exercise data were analyzed using visit 4 (single-blind placebo therapy) corresponding time points as baseline. At 12 hours after the 0800 hour dose, exercise tolerance did not increase significantly after isradipine compared to placebo. Time to 1-mm ST-segment depression increased significantly after isradipine at 3 hours post 0800 hour dose compared to placebo (87 vs. 7 seconds, p<0.01) but not at the 0, 8, or 12-hour postdose time points, regardless of which baseline was used. Isradipine therapy did not affect the rate-pressure double product. A significant correlation between the mean increase in total exercise time and mean plasma isradipine concentration was also present (p=0.0295). During double-blind treatment, drug-related adverse events were experienced by four patients in the isradipine group and two patients in the placebo group. None of the patients experienced ischemic complications during the study. In male patients with chronic stable angina, monotherapy with isradipine 10 mg twice a day significantly increased exercise duration for 8 hours after the 0800 hour dose. Of interest is the observation that isradipine significantly increased exercise duration at 12 hours post 2000 hour dose but not after post 0800 hour dose. These findings would suggest that three-time rather than twice-daily dosing with the standard formulation of isradipine, which has been recommended for the treatment of hypertension, may be required for optimal anti-anginal therapy.Presented as an abstract at the Annual Meeting of the American Heart Association, Anaheim, California.     

Calcium-channel blockers and sodium intake: A controlled study in patients with essential hypertension

Summary Thirteen patients with mild to moderate essential hypertension and whose average supine blood pressure with no treatment was 165/104 mmHg were studied as inpatients for 3 consecutive one-week periods on different sodium intakes. On the last day of each dietary period, they received a single, 20-mg nitrendipine tablet and blood pressure was monitored every 10 minutes for 2 hours after drug administration.Nitrendipine significantly lowered blood pressure independently of the level of sodium intake, and the maximum blood-pressure lowering effect was achieved approximately 1 hour after the dose. The blood-pressure lowering effect of nitrendipine was greater on high sodium intake as compared to low sodium intake (p<0.02), and it was also greater with higher initial blood pressures. However, the sodium-related effect on blood pressure was, at least in part, independent of the pretreatment blood pressure.These results suggest that calcium antagonists, such as nitrendipine, are effective in reducing blood pressure in patients with essential hypertension and could be drugs of choice in those who are unable to restrict their salt intake.     

Antihypertensive effect of isradipine administered once or twice daily on ambulatory blood pressure

The antihypertensive efficacy of sustained-release isradipine administered once daily compared to the immediate-release formulation administered twice daily was assessed by ambulatory blood pressure (BP) monitoring in a double-blind randomized crossover study in 76 mild-to-moderate hypertensive patients. Conventional BP and heart rate parameters were evaluated after a 4-week placebo period and patients qualified for entry if sitting diastolic BP was between 95 and 114 mm Hg. Ambulatory BP monitoring was measured at baseline and after active treatment with both formulations. The 2 regimens induced a significant and almost identical reduction (p less than 0.001) in the mean 24-hour BP without affecting heart rate. Isradipine was more effective in patients whose clinical hypertension was confirmed by ambulatory BP monitoring (35) than in patients who remained normotensive by ambulatory BP monitoring criteria (41). The isradipine-treated ambulatory hypertensive group experienced significantly greater decreases in BP during 24-hour, work, awake and sleep periods than did the ambulatory normotensive group. These data suggest that sustained-release isradipine has a sustained antihypertensive effect throughout 24 hours comparable to that of isradipine given twice daily and may improve compliance with long-term treatment. In addition, the results confirm the usefulness of ambulatory BP monitoring in determining truly hypertensive patients likely to respond to drug administration.     

Comparison of isradipine and nifedipine in chronic stable angina

Isradipine, a new dihydropyridine calcium antagonist, was compared to nifedipine in the treatment of 11 male patients with angina and coronary artery disease in a randomised, double-blind cross-over study. Patients received 5 mg nifedipine three times a day rising to 20 mg three times a day in three dosage increments over six weeks or 2.5 mg isradipine three times a day rising to 7.5 mg three times a day in three dosage increments over six weeks, and then received the alternate preparation. There were no significant differences between the drugs in terms of the frequency and severity of angina attacks or the consumption of glyceryl trinitrate. The increases in systolic blood pressure and the double product during exercise were significantly less with isradipine than with nifedipine. There was a similar trend in heart rates. There was no difference between the treatments in respect of exercise induced ST-segment depression or diastolic blood pressure. We conclude that isradipine and nifedipine have similar anti-anginal effects and that isradipine may be a useful new anti-anginal agent.