国产尼索地平片治疗原发性高血压的疗效观察

本研究采用自身对照开放试验方法,观察国产尼索地平片对轻、中度原发性高血压患者的疗效和耐受性.共有268例患者进入研究,其舒张压在95-114mmHg之间.经过7—10天的观察期,给予国产尼索地平片10mg-20mg,每日2次.治疗6周后病人收缩压和舒张压分别从162.26±16.92mmHg和103.63±7.15mmHg降至139.90±12.65mmHg和88.36±9.10mmHg(P<0.005),降压显效率达75.37%(202/268),有效率达21.27%(57/268).总有效率达96.63%.不良反应多为轻中度头痛、面红、踝部浮肿等.其中60例患者接受了单用尼索地平片6个月的长期治疗,结果显示血压得到稳定的控制,平均收缩压和舒张压分别波动在136.3—141.2 mmHg和86.3—88.0mmHg.16例病人进行了24h动态血压监测,结果显示24h平均收缩压和平均舒张压分别从143.20±20.68mmHg和88.87±10.20mmHg降至136.87±13.58mmHg和84.93±9.66mmHg(p<0.05).由此可见,国产尼索地平片是一种有效且易于耐受的抗高血压药物.

The efficacy of Chinese-made nisoldipine in patients with mild to moderate essential hypertension.

The antihypertensive effects and tolerability of Chinese-made nisoldipine were assessed in 268 patients with mild to moderate essential hypertension, whose diastolic blood pressure(DBP) were between 95 - 114 mmHg. After a 2-week placebo run-in period, the patients received 10 - 20 mg nisoldipine twice daily. After 6-week therapy, the systolic blood pressure(SBP) and DBP were reduced from 162. 26±16. 92 mmHg, 103. 63±7. 15 mmHg to 139. 90±12. 65 mmHg, 88. 36±9. 10 mmHg, respectively(P<0. 005). The markedly effective rate and totally effective rate of nisoldipine were 75. 37 % and 96. 64 %. Mild to moderate and transient adverse events were noted, such as headache, rushing, dizziness and lower limb edema. 60 of the patients receiving 6-month nisoldipine kept their blood pressure under satisfactory control without drug intolerability. Their SBP and DBP range were 136. 3 - 141. 2 mmHg and 86. 3 - 88. 0 mmHg. In 16 of the patients who had 24-hour ambulatory blood pressure monitoring, the 24-hour mean SBP and DBP were reduced from 143. 20 ± 20. 68 mmHg, 88. 87±10. 20 mmHg to 136. 87±13. 58 mmHg, 84. 93 ±9. 66 mmHg, respectively(P<0. 05). In conclusion, Chinese-made nisoldipine is effective with good drug tolerance in mild to moderate essential hypertension.