The randomized controlled trial is the best evidence in the evidence-based medicine. The cardiovascular disease internal department is the typical example of the evidence-based medicine. A serial large-scale randomized controlled trials provided the evidence and improved clinical treatment level. For normal development of a large-scale randomized controlled trials need to enhance the standard management.
Objective To research clinic characteristics, therapies and 2-year progress of female patients with Non-ST-segment Elevation Acute Coronary Syndrome (NSTE-ACS). Methods This study was part of the internationalized Organization to Assess Strategies for Ischemic Syndromes (OASIS) registry. There was no intervention in the therapy. Patients admitted to hospital with NSTE-ACS (including unstable angina and non-Q wave myocardial infarction) were enrolled. The patients’ clinical characteristics, treatment procedure, major events in hospital and two-year progress were recorded by filling in Case Report Forms. Single-variate analyses were made between patients of difference genders. Results A total of 2 294 patients with NSTE-ACS were enrolled in China. The female patients were 37.7% (n=864), whose mean age was 65.1±6.7 years. Unstable angina dominant (90.7%) was noted on admission. The percentage of patients with abnormal ECG was 92.6%. The prior hypertension and diabetes were 64.1% and 23.4%, respectively, in female patients which were evidently higher than those of males (P≤0.001). The prior coronary heart disease, old myocardial infarction, smoking, and percutaneous coronary intervention (PCI) were 39.4%, 16.8%, 11.7%, and 2.3% respectively, in females, which were evidently lower than in males (P≤0.001). The prior history of coronary artery bypass graft (CABG) surgery was 0.5% in females, which was evidently lower than in males (P≤0.05). During hospitalization, the therapeutic rates of anti-platelets and β-adrenergic blockers were 92.8% and 64.8%, respectively, in female patients, which were observably lower than in males (P≤0.05). The therapeutic rates of nitrates, angiotensin-converting enzyme inhibitor (ACEI), calcium antagonists, lipid lowering agents were 96.9%, 60.0%, 59.1%, and 47.1%, respectively, in females, which were not significantly different from those of males. The medication rate in females fell off gradually after discharge, which was more evident than in males. In two-year follow up, the therapeutic rates of anti-platelets, β-adrenergic blockers, ACEI, and lipid lowering agents were 68.4%, 39.5%, 27.4%, and 19.4%, respectively, in female patients, which were markedly lower than those in males (P≤0.05). During hospitalization, the therapeutic rates of PCI and CABG were 10.5% and 2.7%, respectively. In two year follow-up, their therapeutic rates were 13.4% and 4.8%, respectively. The rate of females performing revascularization procedures was evidently lower than that of males (P≤0.001), either during hospitalization or in two-year follow up. In two years of follow up, mortality and incidence rates of new myocardial infarction, stroke, heart failure, hospitalization because of refractory angina were 7.4%, 4.7%, 6.8%, 15.4%, and 31.3%, respectively, in female patients. There were no significant differences between females and males (Pgt;0.05). Conclusion Compared with male patients, female patients with NSTE-ACS are less likely to adopt and / or attach importance to treatment. As to the reason why there are no significant differences in major events of NSTE-ACS between females and males under the current circumstance that females’ treatment is inferior to males’, gender of females is an important protective factor.
Background and Aim Morbidity due to hypertension morbidity is increasing in the Chinese population, and the blood pressure control rate is low. The aim of this trial is to optimize the hypertension treatment plan, promote blood pressure goals and reduce cardio-cerebrovascular events. Objective and Methods Patients are eligible for inclusion if they are diagnosed with essential hypertension, aged 50-79 years with at least one cardiovascular risk factor and sign the consent forms. This project is a multi-centre, randomized, controlled and blind-endpoint trial. 12 000 patients will be randomly assigned to low-dose Amlodipine and Telmisartan or Amlodipine and diuretics. Patients whose blood cholesterol is between 4.0-6.1mmol/L will also be randomized into small dose of statin-based regimen or standard management regimen; and patients will be randomly assigned to intensive lifestyle intervention group or standard intervention group according to the community area where they live. The primary study outcome is a composite of non-fatal stroke/myocardial infarction and cardiovascular death. Patients will be followed-up for 4 years. Expected Results The cumulative primary outcome is estimated to be 500 cases, and the hypertension control rate is expected to reach 70%. Cardiovascular events are expected to be reduced by 20% in the optimized treatment group and poor lifestyle will be markedly improved. A total of 150 clinical centres in China will join in the study, which will be completed at the end of 2011.