基于循证药学的悦安欣^(®)苦碟子注射液上市后安全性研究

A Post-marketing Safety Research of Kudiezi Injection from Evidence-based Pharmacy

为确保悦安欣苦碟子注射液(简称苦碟子注射液)临床应用安全有效,本研究根据《中药注射剂安全性再评价生产工艺评价等7个技术指导原则》,对苦碟子注射液的上市后研究开展系统梳理,包括生产工艺、质量控制、药理毒理、上市后临床研究、前瞻性的临床安全性医院集中监测、基于国家药品不良反应(ADR)监测中心提供的自发呈报系统(SRS)数据分析、文献研究等多方面。结果显示:苦碟子注射液从GAP到生产过程药品质量严格控制。急性毒性试验、长期毒性试验、特殊毒理学未见不良反应;上市前治疗冠心病和脑血栓的Ⅲ期临床研究未见明显不良反应;上市后治疗冠心病心绞痛(心血瘀阻证)和中风(脑梗死)恢复期的有效性和安全性的随机、仿盲、阳性药平行对照、多中心临床试验表明安全有效;近3年SRS691例ADR报告,PRR法和BCPNN法显示,头痛、头晕是ADR预警信号;通过这一系列的研究荟萃,形成苦碟子注射液安全性的证据系列,为临床、科研、生产企业提供可靠的安全用药依据。

In order to ensure safety and efficacy of Yueanxin Kudiezi Injection （referred to as KDI）we launched a comprehensive re-search ranging from production,quality control,pharmacology,to post-market safety evaluation etc.The results showed KDI was strictly QC’ed from GAP to the production process.No adverse reaction was shown in acute toxicity test,long-term toxicity test,and phase III clinical study for treatment of coronary heart disease and cerebral thrombosis;KDI was approved to be effective and safe in a random-ized,double-blind,positive controlled,multi center clinical trials for treatment of coronary disease angina pectoris （blood stasis syn-drome）and stroke （cerebral infarction）;691 cases reported in SRS,PRR method and BCPNN method displayed,headache is warning signal of ADR;Our research results provided safety information of KDI for clinical use,scientific research and production.