不同剂量、剂型美托洛尔对急慢性房颤控制和术后房颤防治的卫生技术评估

Health Technology Assessment of Different Doses of Metoprolol for Atrial Fibrillation

目的对不同剂量、剂型的美托洛尔在控制慢性房颤快室率和预防术后房颤发生方面的疗效和安全性进行评估。方法采用卫生技术评估方法,全面检索PubMed(1966～2006)、EMbase(1980～2005)、Cochrane图书馆(2006年第3期)和中文生物医学期刊数据库,及各国心血管专业数据库和不良反应中心等数据库,依据纳入和排除标准筛选文献,评价纳入文献质量,并提取有效数据进行分析。结果针对慢性快室率房颤,静脉注射美托洛尔10～15mg能有效控制其快室率,但<10mg则不能达到最大疗效,而>15mg临床疗效亦未见提高,且副作用有增加;口服美托洛尔100mg/d较50mg/d在静息和运动时对慢性房颤患者的心室率控制更好;预防术后房颤研究显示,口服美托洛尔150mg/d组术后房颤发生率和住院时间均较100mg/d组有下降趋势;静注20mg组及30mg组术后房颤发生率显著低于10mg组;且静滴美托洛尔与口服美托洛尔相比,术后48h内房颤发生率明显降低。各国药物不良反应中心的数据显示美托洛尔不良反应低。目前尚缺乏不同人种在剂量变化上的安全性研究。结论现有研究认为,大剂量美托洛尔的疗效优于小剂量,但缺乏高质量证据,有待于针对性强的临床试验进一步证实。在安全性上两者无差别。

Objective According to health technology assessment （HTA） methodology, to assess the efficacy and safety of different doses of metoprolol in the treatment of atrial fibrillation （AF）. Methods Based on the principles of HTA, we searched some important medical databases including MEDLINE, EMBASE, The Cochrane Library and CMCC, as well as several national special heart disease databases and side effect centers. We selected eligible studies based on the inclusion and exclusion criteria and critically assessed their quality. Results Intravenous metoprolol 10 mg - 15 mg could control rapid ventricular rate in patients with chronic AF. On either rest or exercise, oral metoprolol 150 mg/d had a better control of rapid ventricular rate than 50 mg/d in patients with chronic AF. For preventing postoperative AF （POAF）, the intravenous metoprolol 20 mg group and the 30 mg group could decrease the incidence of POAF compared to the 10 mg group. Oral metoprolol 150 mg/d was more effective than 100 mg/d in preventing POAF. In addition, intravenous metoprolol therapy was well-tolerated and more effective than oral metoprolol therapy in preventing atrial fibrillation after cardiac surgery. Results from several national side effect centers demonstrated that the incidence of adverse reactions associated with metoprolol was low. Conclusion Present evidence showed that high dose of metoprolol was superior to low dose in treating AF, however, the evidence available is insufficient. It is suggested that adequate evidence through further studies are needed. The safety profile of different doses of metoprolol is similar.