摘要
目的:研究国产卡维地洛治疗轻、中度原发性高血压的临床疗效及安全性。方法:采用多中心随机、单盲、平行对照临床试验,以拉贝洛尔为对照药。200例轻、中度原发性高血压(SBP<200mmHg,DBP95～114mmHg)患者口服安慰剂2周后DBP仍在95～114mmHg,随机分别给予卡维地洛(1O～40mg qd)和拉贝洛尔(50～125mg bid)治疗,每组各100例。疗程为10周。安慰剂期末和治疗2,4,6,10周测量坐位、立位血压和心率,记录不良反应。结果:①10周末,卡维地洛(卡组)SBP降低18.9mmHg(11.7％);DBP由(99.0±4.3)mmHg降至(85.2±8.1)mmHg,降低13.8mmHg(13.9％);拉贝洛尔(对照组)SBP/DBP降低16.4/13.0mmHg(10.4％/13.0％)。各组内与治疗前相比均有显著的差别,P<0.01,而组间差异不显著.P>0.05。两组的心率均在正常范围内降低。②卡组和对照组的总有效率分别为82％和77％,总显效率分别为68％和59％,两组差异无统计学意义,P>0.05。③卡维地洛主要的不良反应:头晕(13％)、乏力(1％)、心动过速(2％)、头痛(5％)、嗜睡(3％)、皮肤过敏(1％)、一过性GPT轻度增高(1％)。结论:每日口服1次卡维地洛治疗轻、中原发性高血压疗效确切、安全。
Objective: To investigate the clinic effects of the a, P - blocker carvedilol in patients with mild to moderate essential hypertension.Methods: The two hundred cases of mild to moderate essential hypertension with SBP < 200mmHg and DBP 95 -114 mmHg were selected for this multiple center, random single - blind, paralleling controlled clinical study. Patients were randomized to take 10 - 40mg carvedilol tablet once daily or labetalol tablet 50 - 125mg twice daily for 10 weeks if DBP was still in the range of 95-114mmHg after 1 weeks wash - out and 2 weeks placebo baseline. Blood pressure and heart rate were measured and symptoms and signs were recorded. Results: ① The reduction of SBP of carvedilol group was 18.9 mmHg and the mean changes in diastolic blood pressure (DBP) at the end of 10 weeks were (13.8± 8.3) mmHg from (99.0±4.3) mmHg to (85.2± 8.1) mmHg treated by carvedilol as well as (13.0± 7.5)mmHg used by labetalol.The reduction of blood pressure was 16.4/13.0 mmHg in labetalol group. ② The overall efficacy rate for carvedilol therapy was 82%, which reduction rate of SBP/DBP was 11.7% and 13.9%, respectively. That was Me higher than the efficacy of using labetalol 77% obtained which reduction rate of SBP/DBP was 10.4% and 13.0%, respectively . There were no significant differences between the two groups. ③ Carvedilol was well - tolerated with less side effects which concluded mild headache, tiredness, dizziness, skin allergy, tachycardia, slightly elevating of serum GPT. Conclusion: Carvedilol can well treated the mild to moderate essential hypertension effectively and safely by 10- 40mg once daily as mono - therapy.
出处
《中国医药导刊》
2002年第5期368-370,共3页
Chinese Journal of Medicinal Guide
