"降压0号"治疗原发性高血压长期疗效和安全性评价

目的 系统评价长期服用"降压0号"治疗原发性高血压的降压效果和安全性.方法 采用以社区为基础的实验研究方法,将确诊的原发性高血压患者随机分至"降压0号"治疗组(0号组)或常规治疗组(常规组)治疗3年,比较两组的降压效果和观察不良反应.结果 两组共计1799人完成3年随访.与治疗前相比,0号组与常规组的收缩压分别下降13 mm Hg(1 mm Hg=0.133 kPa)和7 mm Hg,舒张压分别下降8 mm Hg和4 mm Hg,0号组的血压下降幅度大于常规组.治疗3年后,0号组和常规组的血压达标率分别为90.0%和79.5%,均较基线有显著提高.3年间0号组共有33人报告出现不良反应,占随访人数的2.6%.常见的不良反应有头晕、头痛、心悸、乏力等.服用"降压0号"1年后出现TG升高、血钾升高、血钠升高,也出现TC下降、HDL-C升高、LDL-C下降等变化,且这些指标的变化均具有统计学意义.结论 社区人群的轻中度原发性高血压患者应用"降压0号"治疗与常规治疗相比,具有更方便、有效且安全的特点.

Study on the Iong-term efficacy and safety of medicine named 'Beijing Hypertensive No.0'in patients with primary hypertension

OBJECTIVE: To assess the antihypertensive effect and safety on medicine named 'Beijing Hypertensive No. 0' in a three-year treatment of primary hypertension. METHODS: A community-based intervention study was conducted. The antihypertensive effects and adverse events were observed. RESULTS: 4000 patients with primary hypertension were randomly divided into two groups with 1529 patients treated with 'Beijing Hypertensive No. 0' and 976 patients treated with other antihypertensive drugs, among which 946 and 853 patients in the two groups completed the three-year study. After treatment, the systolic blood pressure decreased 13 mm Hg and 7 mm Hg while diastolic blood pressure decreased 8 mm Hg and 4 mm Hg in the 'No. 0' group and controlled group respectively. After three years of treatment, 90.0% and 79.5% in the 'No.0' group and in the control group had reached the BP 'fulfillment criteria', which were much higher than the baseline data. Side effects occurred in 33/1274 (2.6%) cases during three years' treatment with most commonly seen as dizziness, headache, palpitation and weakness. No serious adverse reactions occurred. There were some positive effects after treated by 'No. 0', including 0.13 mmol/L decrease of TC, 0.70 mmol/L decrease of LDL-C and an average 0.12 mmol/L increase of HDL-C. All of these changes were statistically significant. There were also opposite effects as 0.13 mmol/L increase of TG, 0.24 mmol/L increase of K+, and 0.88 mmol/L increase of Na+ on average, which were also statistically significant. CONCLUSION: Compared with the conventional treatment, this treatment of 'Beijing Hypertensive No.0' was more convenient, safe and effective in treating mild to moderate primary hypertension in the community.