国产和进口缬沙坦治疗原发性高血压疗效比较

国产和进口缬沙坦治疗原发性高血压疗效比较

【摘要】目的探讨国产缬沙坦胶囊（Valsartan Capsule，商品名：托平Tuoping）和进口缬沙坦胶囊（商品名：代文Diovan）对轻中度原发性高血压患者的降压疗效及安全性。方法采用互相对照方式。将58例轻中度原发性高血压患者随机分成2组，托平组（80 mg，），代文组（80 mg 1次/d），疗程均4周。每2周随访BP、HR，并记录不良反应。观察服药前、服药后2周和4周的BP、HR变化，进行记录比较。结果经4周治疗，2组血压平均SBP由（153.1±11.6）mm Hg分别降至（130.9±10.5）、（130.8±10.8）mm Hg；DBP由（96.1±12.6）mm Hg分别降至和（81.1±6.9，80.9±7.3）mm Hg，2组较服药前均有显著降低（P ＜0.01），总有效率均为68.97%，2组服药后同期疗效无统计学差异（P＞0.05）；2组治疗期间均未见明显不良反应。结论托平和代文对轻中度原发性高血压具有相同降压效性，两者同样安全可靠，不良反应少，但托平价格低廉。

【Abstract】PurposeDiscuss the curative effect and safety of Valsartan Capsule which is made in China (trade name: Tuoping) and import from foreign country (trade name: Diovan) in curing light and moderate essential hypertension patients. MethodThe 58 light or moderate essential hypertension patients are divided into two groups: Tuoping group (80mg qd) and Diovan group (80 mg qd). The courses of treatment of each group are 4 weeks. The change of blood pressure before and after taking medicine during 2 weeks is observed. Also, the change of blood pressure during 4 weeks is recorded. After that, the curative effect of each group is compared. ResultsAfter taking medicine 4 weeks, the average SBP of blood pressure of Tuoping group was reduced from (153.1±11.6) mm Hg to (130.9±10.5) mm Hg, the average SBP of Diovan group was reduced to (130.8±10.8) mm Hg. The average DBP of Tuoping group was reduced from (96.1±12.6) mm Hg to (81.1±6.9), and the average DBP of Diovan group was reduced to (80.9±7.3) mm Hg. The blood pressure of each group has notable reduced after taking medicine (P＜0.01). For both group, the total effective rate is all 68.97%. In the same term, the curative effect of both group do not have statistics differences. Both groups do not have adverse reactions. ConclusionTuoping and Diovan have the same effect in depress blood pressure to light or moderate essential hypertension patients. Both Valsartan Capsule are reliable and safety. However, the price of Tuoping is lower, the side effects of Tuoping is less.

【Keywords】Valsartan;Essential Hypertension;Curative Effect;Safety

肾素－血管紧张素系统（RAS）中主要有效成分为血管紧张素Ⅱ（AngⅡ），AngⅡ与血管紧张素Ⅱ受体（AT1受体）结合介导一系列的生理反应，如收缩血管，肾小球滤过率下降，使醛甾酮、儿茶酚胺、去甲肾上腺素（NE）释放增加，使血压升高[1]。缬沙坦类降压药物通过抑制AT1受体，来阻断AngⅡ，而发挥降压作用，本文采用托平和代文治疗原发性轻中度高血压的疗效比较，现报告如下。

1资料与方法

1.1一般资料自2004年8月至2005年7月我院门诊连续收治轻中度原发性高血压患者58例，符合1999年WHO/ISH高血压指南诊断标准，确诊为轻中度原发性高血压（SBP 140~179 mm Hg，DBP 90~109 mm Hg）。其中男36例，女22例，年龄（63.3±13.6）年，所有病例均排除其他疾病引起的继发性高血压。

1.2方法将58例入选患者已服用降压药物，则停药5个半衰期，并随机分为2组：托平组29例（天大药业珠海有限公司，批号0406101）80mg 1次/d，口服；代文组29例（北京诺华制药有限公司生产，批号X0009）80mg 1次/d，口服。每天早餐后同一时间分别服用，疗程均为4周，所有患者治疗前和治疗4周末进行血常规、肝肾功能，ECG等检查。每2周随访坐位BP（用标准水银柱血压计测右上臂肱动脉BP）、HR 1次,每次测3个值，取平均值，并记录不良反应。同一患者每次测BP、HR时间尽量一致，受试者至少先休息20 min，30 min内不喝浓茶或咖啡。