国产伊贝沙坦治疗轻、中度原发性高血压疗效和安全性评价

目的 :评价国产伊贝沙坦 (Irbesartan)治疗轻、中度原发性高血压疗效和安全性。方法 :43例轻、中度原发性高血压患者(坐位舒张压在95～110mmHg及收缩压<180mmHg) ,性别不限 ,采用随机、双盲双模拟、平行对照研究的方法 ,经口服安慰剂2周后 ,平均坐位舒张压95～110mmHg,收缩压<180mmHg进入治疗期 ,给予伊贝沙坦150mg/天或缬沙坦80mg/天口服。两周后降压若未达有效 ,加量至伊贝沙坦300mg/日或缬沙坦160mg/天 ,继续服药2周。4周后开盲 ,服用伊贝沙坦患者继续服用原剂量8周 ,8周结束时测量血压。每次随访均记录不良反应 ,包括程度、与试验药物的关系和处理办法及试验开始前、治疗4周、12周进行体格检查 ,心电图 ,血常规 ,尿常规 ,生化等指标检查。结果:伊贝沙坦组与缬沙坦组治疗前与治疗后2周及4周收缩压 (SBP)与舒张压 (DBP)均有下降 ,差异有统计学显著性意义 (P<0.01)。伊贝沙坦组降压总有效率63.6 % ,缬沙坦组降压总有效率57.1% ,两组比较差异无统计学显著性意义 (P>0.05)。伊贝沙坦组有效者服300mg占50 % ,缬沙坦组有效者服160mg占83.3 % ,两组比较差异有统计学显著性意义 (P<0.01)。用药前后血、尿常规 ,生化指标 (肝、肾功能 ,电解质 ,血糖 ,血脂 ,尿酸 ) ,ECG比较 ,两组间差异无统计学显著性意义 (P>     

Dual blockade of the renin-angiotensin system in type 1 patients with diabetic nephropathy.

BACKGROUND: Albuminuria and hypertension are predictors of poor renal and cardiovascular outcome in patients with diabetes. Approximately 30% of type 1 patients with diabetic nephropathy (DN) have albuminuria >1 g/day, and blood pressure >135 and/or >85 mmHg despite antihypertensive therapy with recommended doses of ACE inhibitor (ACEI) and diuretics. We tested the effect of dual blockade of the renin-angiotensin system (RAS) in these patients. METHODS: We performed a randomised double blind crossover trial with 2 months treatment with Irbesartan 300 mg o.d. and placebo added on top of previous antihypertensive treatment. We included 21 type 1 patients with DN responding insufficiently to ACEI and diuretics, as defined above. At the end of each treatment period, albuminuria, 24-h blood pressure and glomerular filtration rate (GFR) were measured. RESULTS: Addition of 300 mg Irbesartan to the patients' usual antihypertensive therapy induced a mean reduction in albuminuria of 37% (95% CI 20-49, P<0.001); from 1574 mg/24 h (95% CI 1162-2132) to 996 mg/24 h (95% CI 699-1419), a reduction in 24-h blood pressure of 8 mmHg systolic (95% CI -2 to 18) and 5 mmHg diastolic (95% CI 1-9) (P=0.11 and 0.01, respectively) (from placebo, mean (SE) 146 (4)/80 (2) mmHg). GFR remained unchanged. Serum potassium increased (mean 4.3 to 4.6 mmol/l, P=0.02). Intervention to reduce serum potassium was needed in two patients with GFR <35 ml/min/1.73 m(2). Otherwise the dual blockade with Irbesartan was safe and well tolerated. CONCLUSIONS: Dual blockade of the RAS may offer additional renal and cardiovascular protection in type 1 patients with DN responding insufficiently to conventional antihypertensive therapy, including recommended doses of ACEI and diuretics.     

厄贝沙坦单甩和与吲达帕胺联用治疗轻-中度老年高血压病的临床评价

目的 :探讨单用厄贝沙坦、厄贝沙坦与吲达帕胺联合应用对老年高血压病降压疗效及代谢的影响。方法 :采用自身对照方法 ,观察 4 0例轻 中度原发性老年高血压患者 ,随机单盲分成 2组 ,每组各 2 0例。厄贝沙坦组 :单用厄贝沙坦 1 5 0mg ,每日一次 ;厄贝沙坦与吲达帕胺合用组 :厄贝沙坦 1 5 0mg,每日一次 ,吲达帕胺 2 5mg ,每日一次 ;两组疗程均为 1 2周。观察两组治疗前后的偶测血压 (CBP)和 2 4小时动态血压 (ABPM)及生化指标。结果 :厄贝沙坦加吲达帕胺阻降压总有效率为 90 0 % ,但与单用组比较差异无显著意义 (P >0 0 5 ) ;合用组偶测血压、2 4小时动态血压的变化均优于厄贝沙坦单用组 (P <0 0 5和P<0 0 1 ) ,且治疗前后心率和生化指标无明显改变。结论 :厄贝沙坦与小剂量吲达帕胺联合应用对老年高血压疗效显著 ,作用平稳 ,并且对代谢无影响     

厄贝沙坦联合美托洛尔治疗充血性心力衰竭疗效观察

目的观察充血性心力衰竭（cry）应用厄贝沙坦联合美托洛尔治疗的临床疗效。方法选择江苏省无锡市第九人民医院2011年2月至2013年1月收治的CHF患者44例设为对照组,洋地黄、血管扩张剂、利尿剂等综合方法治疗,另选择同期收治的CHF患者46例设为观察组,在对照组治疗的基础上应用厄贝沙坦和美托洛尔治疗。观察治疗前后心功能、左室射血分数（IVEF）、左室舒张末内径（LVEDd）、左室收缩末内径（LVESd）、心率及血压等指标的变化。结果观察组总有效率为91.30％,对照组患者总有效率为81．82％,差异有统计学意义（P〈n05）。治疗后LVEDd、LVESd数值两组均显著缩小,LVEF数值增加,心功能得到改善,观察组改善情况优于对照组义（P〈n05）。结论厄贝沙坦联合美托洛尔治疗充血性心力衰竭患者疗效显著,心功能改善明显,不良反应小。     

厄贝沙坦治疗43例糖尿病肾病的临床疗效及其肾保护作用分析

目的考察厄贝沙坦治疗糖尿病肾病的临床疗效及其肾保护作用。方法将86例患者随机分为观察组和对照组各43例,观察组视患者病情给予个体化的降糖降脂治疗,并在合理口服降糖药与注射胰岛素的同时,帮助其严格控制饮食,指导开展一定程度的体能锻炼,尽量将HbAle控制在6.5%的范围内,观察组在对照组基础上加用厄贝沙坦口服进行治疗。结果两组患者治疗后的HbAle、TP及SCr水平均较治疗前显著降低(P<0.05),且观察组改善程度较对照组更为理想(P<0.05);两组患者治疗后的sICAM-1与sVCAM-1均较治疗前显著降低(P<0.05),且观察组改善效果显著优于对照组(P<0.05);观察组总有效率为93.0%,对照组总有效率为74.4%,观察组临床疗效显著优于对照组,比较有统计学意义(P<0.05)。结论厄贝沙坦治疗DN临床疗效满意,同时具较好保护的作用,有利于DN病情的延缓和治愈,值得临床推广应用。     

厄贝沙坦胶囊溶出度测定方法的改进

目的：建立厄贝沙坦胶囊的溶出度测定方法。方法：照溶出度测定法（《中国药典》2010年版二部附录XC第一法）,以0.1 mol·L-1盐酸溶液为溶剂,转速为100 r·min-1;紫外分光光度法测定,测定波长为245 nm。结果：30 min内产品的溶出率达到75%以上,辅料对主药测定无干扰,厄贝沙坦线性范围为2.5025.00μg·ml-1（r=0.999 9）,回收率为100.5%（RSD=0.13%,n=9）。结论：本法操作简便、准确可靠,适用于厄贝沙坦胶囊的溶出度测定。     

厄贝沙坦治疗糖尿病肾病的临床研究

目的探讨厄贝沙坦治疗糖尿病肾病的临床效果。方法选取本院2010年10月～2012年7月糖尿病肾病患者39例,随机分为两组,服用马来酸氨氯地平患者19例为对照组,服用厄贝沙坦患者20例为观察组,治疗3个月,比较两组患者的临床指征。结果治疗前后,对照组与观察组收缩压、舒张压、空腹血糖变化不显著,差异无统计学意义（P〉0.05）。治疗后,对照组与观察组24h尿蛋白均明显下降,观察组24h尿蛋白明显低于对照组,差异均有统计学意义（P〈0.05）。结论厄贝沙坦是治疗糖尿病肾病的有效方法,可明显改善患者的临床病症,减少尿蛋白,具有显著的临床疗效。     

厄贝沙坦对大鼠急性胰腺炎局部微循环改变的实验研究

目的 探讨血管紧张素受体拮抗剂对大鼠急性胰腺炎（AP）的保护作用.方法 40只Wistar 大鼠随机分为对照组和AP组,AP组分为模型组和高中低剂量组.测定血浆血管紧张素Ⅱ（AngⅡ）、淀粉酶（AMY）水平,观察胰腺组织病理学改变;采用异硫氰酸荧光素标记红细胞（FITC-RBC）技术及微循环观测系统观察大鼠胰腺微循环血液流速.结果 随着病变的进展,AP组胰腺炎病理由水肿向出血坏死发展,AngⅡ、AMY同步上升,胰腺局部组织血液流速降低.中剂量厄贝沙坦干预组则胰腺炎病理改变减轻,胰腺局部组织血液流速改善,且血浆AngⅡ、AMY水平低于模型组,其他剂量组之间各指标差异无统计学意义.结论血管紧张素受体拮抗剂对AP时胰腺微循环有明显的改善作用.     

Hypotensive and Prophylactic Effects of Angiotensin II Subtype 1 Receptor Antagonist,Irbesartan, in Stroke‐Prone Spontaneously Hypertensive Rats

We determined the acute hypotensive effect of a single administration and the prophylactic effect of chronic treatment with Irbesartan, an angiotensin II receptor antagonist, on the development of end‐organ damage in stroke‐prone spontaneously hypertensive rats (SHRSP). The acute hypotensive effect was determined by a telemetrical method in SHRSP fed a normal diet. The prophylactic effect was examined by biochemical, histopathological and immunohistochemical methods in SHRSP fed a high‐salt and low‐protein diet. Irbesartan (3, 10, 30 and 100 mg/kg) reduced blood pressure in a dose‐dependent manner without affecting heart rate. Irbesartan (3, 10 and 30 mg/kg) increased the survival rate in SHRSP fed a high‐salt and low‐protein diet. Furthermore, Irbesartan ameliorated the appearance of stroke symptoms in dose‐dependent manner showing association with the prevention of microscopic lesions. Irbesartan ameliorated the increases in urinary protein excretion and N‐acetyl‐D‐glucosamidase activity by preventing nephrosclerosis, as judged by microscopic observations, and ameliorated the increases in the expression of collagen IV and fibronectin in the kidney. These findings demonstrate that Irbesartan is a potent antihypertensive drug offering a protective effect on the development of hypertension‐induced end‐organ damages in SHRSP. Thus, Irbesartan is useful for the therapy of hypertension with end‐organ damage.     

Evidence for the efficacy of ARBs across the cardiovascular continuum

Abstract

Introduction:

Angiotensin II receptor blockers (ARBs) are antihypertensive agents with considerable evidence of efficacy and safety for the reduction of cardiovascular (CV) disease risk in numerous patient populations from one end of the CV continuum (i.e., primary prevention among patients with CV risk factors) to the other (i.e., secondary prevention in the post-MI setting). There are several agents within the ARB class, all of which have contributed to various degrees to this evidence base.