比索洛尔／氢氯噻嗪复方片治疗中国轻中度原发性高血压的临床疗效和安全性研究

The clinical efficiency and safety of bisorpolol hydrochlorothiazide in patients with mild to moderate essential hypertension

目的采用24小时动态血压监测观察比索洛尔／氢氯噻嗪复方片(Lodoz)治疗90例中国轻、中度高血压患者的降压效果和安全性。方法选择90例收缩压<180 mm Hg(1 mm Hg= 0．133 kPa),舒张压95-109 mm Hg的轻、中度高血压患者,口服Lodoz(2．5 mg/6．25 mg)共4周或Lodoz(5 mg／6．25 mg)8周,用24小时动态血压监测评价治疗4周、8周后动态血压变化及安全性。结果(1)4周和8周末诊室收缩压/舒张压分别降低(14．89±10．99)／(10．37±7．35)mm Hg和(19．40±10．55)／(13．31±7．77)mm Hg,全天、日间、夜间的24小时动态平均血压均明显降低,差异有统计学意义(P均<0．05)。4周和8周末的总有效率分别为59．3％和69．8％。(2)Lodoz(2．5 mg／6．25 mg)对收缩压和舒张压的谷／峰比值(T／P比值)分别为91．5％和94．4％,降压平滑指数(SI)为9．07／6．48;Lodoz(5 mg／6．25 mg)对收缩压和舒张压的T／P比值为79．9％和80．5％,SI为4．17／4．47。(3)Lodoz可能有使“非勺型”血压转变为“勺型”血压的趋势。(4)不良反应主要有血尿酸升高、头晕、头痛、腹泻、口干、肢端发凉、蚁行感,均为轻度。结论Lodoz能够持续、平稳、有效地降低24小时血压,且安全性良好。

Objective To investigate the efficacy and safety of bisorpolol/hydrochlorothiazide （Lodoz） in patients with mild and moderate essential hypertension. Methods After 2 weeks of placebo run-in period, 90 hypertensive patients with sitting diastolic blood pressure （ DBP ） between 95 and 109 mm Hg（ 1 mm Hg =0. 133 kPa） and systolic blood pressure （SBP） below 180 mm Hg were treated by Lodoz （2.5mg/6. 25mg/day） for4 weeks. If DBP 〉90 mm Hg at4 weeks, Lodoz （5mg/6. 25 mg/day） was given for another 8 weeks. Clinic systolic and diastolic blood pressure measurements and ambulatory blood pressure monitoring （ABPM） were performed at the end of placebo run-in period and at 4 and 8 weeks. Results After 4 or 8 weeks treatment with Lodoz, clinic systolic and diastolic blood pressure, the 24-hour mean, daytime and nocturnal blood pressures reduced significantly compared to placebo run-in period [SBP and DBP reduced （14.89 ± 10.99）/（10.37 ±7.35） mm Hg （4 weeks） and （19.40 ± 10. 55 ） / （ 13. 31 ± 7.77） mm Hg （ 8 weeks ） ] respectively （ P 〈 0. 05 ）. The total efficacy rate is 59. 3 % for Lodoz 2. 5mg/6. 25 mg and 69. 8% for Lodoz 5 mg/6. 25 mg. The trough：peak ratio for SBP and DBP were 91.5% and 94.4% with Lodoz 2.5mg/6.25 rag, and 79.9% and 80.5% with Lodoz 5mag/6.25 rag. The smoothness index （SI） for SBP and DBP were 9. 07 and 6.48 with Lodoz 2. 5mg/6. 25mg, and 4. 17 and 4. 47 with Lodoz 5 mg/6.25 mg, respectively. Few side effects were observed during treatment including mild headache and dizziness and slightly increased serum urea acid. Conclusion Lodoz （2. 5 mg/6. 25 mg and 5 mg/6. 25 mg） can effectively reduce the 24 hours blood pressure in patients with mild to moderate essential hypertension.