呼吸系统吸入制剂研发现状的系统评价

Research and Development Status Quo of Respiratory Inhalation Preparations:A Systematic Review

目的:系统评价呼吸系统吸入制剂的研发现状。方法:在5个文献数据库(PubMed、Embase、中国知网、万方数据和维普网)和4个临床试验注册平台、15个国家/地区药品监督管理平台及药智网中检索有关国内外呼吸系统吸入制剂研发现状的相关文献或数据,采用描述性方法分析其研究现状。结果与结论:共纳入二次研究文献27篇,并收集到欧盟、美国、加拿大、日本以及我国批准上市的呼吸系统吸入制剂信息和我国正在注册审批中的相关药品信息。呼吸系统吸入制剂的市场情况方面:从剂型角度分析,全球各剂型按销售金额统计,粉雾剂占46%,气雾剂占32%,雾化吸入溶液占22%;从市场份额角度分析,英国AstraZeneca、德国Boehringer Ingelheim和英国GlaxoSmithKline等公司的市场份额合计约70%。目前,呼吸系统吸入制剂在欧盟上市了39种,美国上市了121种,加拿大上市了111种,日本上市了37种,我国上市了国产吸入制剂69种、进口吸入制剂80种。呼吸系统吸入制剂正在进行的临床试验国外有511项,国内有69项。呼吸系统吸入制剂仿制障碍主要包括研发、临床试验、审批和生产障碍等。目前,我国通过一系列政策对国产药品创新和医疗器械国产化提供支持,将有助于促进吸入制剂的国产化研发。未来研发可更多关注吸入制剂药物联用、适应证、剂型、装置等方面。

OBJECTIVE:To systematically evaluate the research and development status quo of respiratory inhalation preparations.METHODS:Related literatures or data about R&D status quo of domestic and foreign respiratory inhalation preparations were retrieved from 5 databases(PubMed,Embase,CNKI,Wanfang database and VIP),4 clinical trial registration platforms,15 national/regional drug administration platforms and yaozhi.com.The status quo of related studies was analyzed by descriptive analysis.RESULTS&CONCLUSIONS:A total of 27 second literatures were included.The information of respiratory inhalation preparations approved by European Union,the United States,Canada,Japan and China was collected,and the information of related drugs under registration and approval in China was also collected.The market situation of respiratory inhalation preparations was analyzed from the perspective of dosage form:powder aerosols accounted for 46%,aerosols accounted for 32%,and atomized inhalation solutions accounted for 22%in the global consumption sum of each dosage form.From the perspective of market share,companies such as AstraZeneca in the UK,Boehringer Ingelheim in Germany and GlaxoSmithKline in the UK had a total market share of about 70%.At present,there were 39 kinds of respiratory inhalation preparations on the market in European Union,121 kinds in the United States,111 kinds in Canada,37 kinds in Japan,69 kinds of domestic inhalation preparations and 80 kinds of imported inhalation preparations in China.Respiratory inhalation preparations were undergoing clinical trials with 511 cases abroad and 69 cases in China.The barriers to the imitation of respiratory inhalation preparations mainly included research and development,clinical trial,approval and production barriers.At present,the support is provided for domestic drug innovation and localization of medical devices in China through a series of policies,which is helpful to promote the localization research and development of inhaled preparations.Future research and development can pay more attention to combination,indication,dosage and device of inhalation preparation.