Huo Yong, Zhang Jian, He Qing, Chen Hong, Ma Jishun, Landen Harald
Beijing University First Hospital, Beijing, China.
Blood Press Suppl. 2007 Mar;1:18-23. doi: 10.1080/08038020601154575.
This post-marketing surveillance study assessed the efficacy, safety and tolerability of the treatment with nifedipine GITS (gastro-intestinal therapeutic system) in hypertensive patients under normal daily practice conditions in China.
A total of 3003 patients were included in 174 outpatient clinics. Patients received 30 mg or 60 mg of nifedipine GITS. Data were collected at up to three follow-up visits.
At the end of the observation period, mean treatment duration was 13.3 weeks. Mean blood pressure reduction was 27.6/13.6 mmHg, 62.1% of patients had a systolic blood pressure <140 mmHg, and 82.2% had a diastolic blood pressure <90 mmHg. Blood pressure control according to international guidelines was achieved in 45.0% of all patients. A total of 1515 patients received additional antihypertensive medications, of which angiotensin-converting enzyme (ACE) inhibitors were mostly used (42.2%) followed by beta-blockers (33.7%). Twenty-two patients (0.7%) experienced 27 adverse events. Physicians' assessments of efficacy, tolerability and patient acceptance had ratings of "very good" and "good" in 88.7% (efficacy), 92.8% (tolerability) and 89.1% (patient acceptance) of patients.
Nifedipine GITS proved to be effective and well tolerated for the treatment of hypertension in 3003 Chinese patients. The results confirm the findings of previously performed clinical studies.
本上市后监测研究评估了硝苯地平胃肠道治疗系统（GITS）在中国正常日常实践条件下治疗高血压患者的疗效、安全性和耐受性。
174家门诊诊所共纳入3003例患者。患者接受30mg或60mg硝苯地平GITS治疗。在多达三次随访中收集数据。
观察期末，平均治疗时长为13.3周。平均血压降低27.6/13.6mmHg，62.1%的患者收缩压<140mmHg，82.2%的患者舒张压<90mmHg。所有患者中45.0%达到了国际指南规定的血压控制目标。共有1515例患者接受了额外的抗高血压药物治疗，其中血管紧张素转换酶（ACE）抑制剂使用最多（42.2%），其次是β受体阻滞剂（33.7%）。22例患者（0.7%）发生了27起不良事件。医生对疗效、耐受性和患者接受度的评估中，88.7%（疗效）、92.8%（耐受性）和89.1%（患者接受度）的患者评分为“非常好”和“好”。
硝苯地平GITS被证明对3003例中国高血压患者的治疗有效且耐受性良好。结果证实了先前进行的临床研究结果。
