摘要
目的运用循证药学的方法评价伐地那非用于治疗肺动脉高压的临床证据,为超说明书用药循证评价提供参考。方法系统检索PubMed、EMBASE、Cochrane Library、CNKI、万方数据库,国外药品说明书及MICROMEDEX循证数据库,由两名评价者独立的根据纳入排除标准筛选文章,评价文献质量,提取数据并分析。结果共纳入FDA与EMA药品说明书、循证数据库MICROMEDEX、4项国内外指南与2篇系统评价/Meta分析。伐地那非与安慰剂相比,可以改善肺动脉高压患者的WHO功能分类、6分钟步行距离等指标。安全性方面伐地那非和安慰剂相比可能增加不良事件的发生率,其中头痛、肠胃不适、潮红以及肌肉酸痛和关节痛发生率较高。结论伐地那非用于肺动脉高压的治疗具有良好的疗效,但是需要注意患者胃肠道、肌肉关节等方面的安全性。
OBJECTIVE To use evidence-based pharmacy to evaluate the use of Vardenafil in the treatment of pulmonary arterial hypertension.METHODS The clinical studies of the effect of Vardenafil on PAH were searched in the database of PubMed,EMBASE,Cochrane Library,CNKI,Wanfang database,foreign drug instruction website and MICROMEXEXevidence-based database.Two reviewers selected articles based on inclusion and exclusion criteria,evaluated study quality,extracted and analyzed data independently.RESULTS The FDA and EMA package insert,data from MICROMEX,4 Guidelines and 2 systematic reviews/Meta analysis were included.Vardenafil could reduced the WHO functional class and 6 minutes walking distance of PAH patients compared with placebo.In terms of safety,t he ratio of Vardenafil stopped treatment due to adverse reactions was significantly higher than that of placebo,and the incidence of headache,gastrointestinal adverse reactions,flushing,muscle soreness and joint pain was higher.CONCLUSION Vardenafil is effective in the treatment of patients with PAH.But attention should be paid to the gastrointestinal reactions,Muscle soreness and joint pain.
作者
陈泽鹏
余晓霞
陈楚雄
赵文霞
伍俊妍
郑志华
CHEN Zepeng;YU Xiaoxia;CHEN Chuxiong;ZHAO Wenxia;WU Junyan;ZHENG Zhihua(Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University,Guangzhou,Guangdong 510120,China;Guangdong Pharmaceutical Association,Guangzhou,Guangdong 510080,China)
出处
《今日药学》
CAS
2020年第6期381-384,393,共5页
Pharmacy Today
关键词
伐地那非
超说明书
循证评价
vardenafil
off-label
evidence-based evaluation
