关键词: 高血压, 降压宝系列中成药, Cox比例风险回归, 队列研究

Abstract: Background　There is a close causal relationship between hypertension and the risk of cardiovascular disease morbidity and mortality. Jiangyabao series of Chinese patent medicines （a sort of hypotensors） have good effects on essential hypertension. Objective　To evaluate the effect of long-term administration of Jiangyabao series of Chinese patent medicines on the outcome of patients with hypertension. Methods　This study was carried out from 2001 to 2003 based on a cohort design. The 1 364 participants with essential hypertension were recruited from Henan Hypertension Management Center of Integrated Traditional Chinese and Western Medicine. All of them received standardized secondary prevention interventions for hypertension and oral administration of Jiangyabao series of Chinese patent medicines. In accordance with the duration of voluntary administration，they were assigned to short-term medication group （n=236，≤42 months），long-term medication group （n=1 128，>42 months），respectively. Data of age，family history of early onset of hypertension，duration of hypertension，stage of hypertension，use of western antihypertensive drugs，smoking history，drinking history，education level，amount of exercise and sleeping status were collected. All of them were followed up for 42 months，during which the incidence of adverse outcomes （death caused by cardiovascular and cerebrovascular diseases，myocardial infarction，cerebral infarction，cerebral hemorrhage） was recorded. Cox proportional hazards regression analysis was used to analyze the effect of long-term administration of Jiangyabao series of Chinese patent medicines on the outcome. Results　The incidence of adverse outcomes in new included participants during the whole study period was 15.90%（217/1 364），and 22.22%（80/360），13.06%（64/490） and 14.20%（73/514） in 2001，2002 and 2003. By the end of the experiment，the incidence of adverse outcomes in the long-term medication group was lower than that in the short-term medication group 〔10.17%（24/236）vs 17.11%（193/1 128），χ2=7.03，P=0.008〕．Analyses with different Cox proportional risk regression models showed that the incidence of adverse outcomes in short-term medication group was higher than that of the long-term medication group （HR>1.00，P<0.05）．Conclusion　Long-term administration of Jiangyabao series of Chinese patent medicines can significantly reduce the incidence of adverse outcomes in patients with hypertension.

Key words: Hypertension, Jiangyabao Chinese patent medicine series, Cox proportional risk regression, Cohort study