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目的:利用长江流域医院用药信息系统数据库,对医院新产品的使用趋势、结构等进行分析,特别筛选出那些使用覆盖面广、短时期内用量急增、治疗范围广泛的新品,同时查阅临床文献资料,跟踪相关品种的药物不良反应信息,提示药品生产、经营企业、医疗机构新上市品种的安全性隐患、加强追踪监管,为药品监督管理部门、卫生行政部门的监管和医疗机构的临床合理用药提供参考。方法:应用长江流域医院用药信息系统数据库2004～2006年上海地区样本医院的购药数据,对使用新产品信息进行分类汇总、销售额及厂商排序、各级医院的使用状况,作出包括其使用趋势、用药结构、价格走势以及和同类品种对照的分析;同时通过对临床文献的荟萃分析,对新产品的不良反应发生情况做相关的跟踪研究。结果:对2004～2006年三年间上海地区样本医院使用的新药品种进行统计分析,数据显示:1、排名列前且增幅较快的品种主要集中在抗肿瘤药、肝病用药以及治疗脑血管疾病药三类中;2、2004年为低谷仅33个、2005年为高潮45个而2006年又回落到36个,其中三个拥有自主知识产权的产品:先声药业的依达拉奉(必存)和重组人血管内皮抑制素(恩度),加上上海赛达生物药业的重组改构人肿瘤坏死因子(纳科思),在各自的治疗领域有重要突破性;3、江苏省医药企业的创新能力优势明显:包括先声药业两个拥有自主知识产权的产品——依达拉奉(必存)和重组人血管内皮抑制素(恩度)、正大天晴药业的异甘草酸镁(天晴甘镁)和唑来膦酸(天晴依泰)和南京东捷的奈达铂(捷佰舒)。另外,以新型铂类抗癌药物奈达铂为例的临床文献汇萃分析表明:其不良反应主要为由骨髓抑制引起的白细胞减少和血小板减少,其分布的百分比分别高达59.37%和46.07%,其中严重不良反应(Ⅲ—Ⅳ度)分布的百分比分别为15.73%和11.11%;消化系统恶心呕吐的分布百分比也达39.58%,其中严重不良反应(Ⅲ—Ⅳ度)分布百分比为3.76%。
OBJECTIVE: To analyze the usage trend and structure of new products in hospitals based on the database of hospital medication information system in the Yangtze River Basin. In particular, the new products with wide coverage, rapid increase in dosage in a short period of time and wide range of treatment were screened out, and the clinical literatures , Tracking the adverse drug reaction information of the related species, suggesting the potential safety hazard of the newly listed varieties of pharmaceutical production, operation enterprises and medical institutions, and strengthening the follow-up supervision so as to provide clinical and rational drug use for supervision and medical institutions of drug regulatory agencies and health administrative departments reference. Methods: The data of drug purchase in sample hospitals of Shanghai area from 2004 to 2006 in the database of hospital drug information system of the Yangtze River Basin were used to analyze the use of new products, the classification of sales and manufacturers, the use of hospitals at all levels, , Drug structure, price trend and comparison with similar species; at the same time, through the meta-analysis of clinical literature, the new product adverse reactions to do related tracking research. Results: Statistical analysis was made on the new drug varieties used in the sample hospitals in Shanghai during the three years from 2004 to 2006. The data showed that: 1. The varieties with the highest growth rate in the top three were mainly anti-tumor drugs, drugs for liver diseases and drugs for the treatment of cerebrovascular diseases Three categories; 2, 2004, only 33 troughs, climax in 2005 45 and fell back to 36 in 2006, of which three have their own intellectual property rights of products: ) And recombinant human endostatin (Endostar), combined with the Shanghai Saida bio-pharmaceutical recombinant human tumor necrosis factor (NAX), in their respective areas of treatment have important breakthroughs; 3, Jiangsu Province Pharmaceutical companies have obvious advantages in innovation ability: including Simcere two products with independent intellectual property rights - edaravone (essential deposit) and recombinant human endostatin (Endo), Chia Tai Pharmaceutical magnesium glycyrrhetic acid (Sunny sweet magnesium) and zoledronic acid (sunny according to Thailand) and Nanjing Dongjie Nida Platinum (Jie Bai Shu). In addition, the clinical literature of nedaplatin, a new type of platinum anticancer drug, showed that the main adverse reactions were leukopenia and thrombocytopenia caused by myelosuppression, with the percentages of distribution being as high as 59.37% and 46.07%, respectively. The percentages of severe adverse reactions (Ⅲ-Ⅳ degrees) were 15.73% and 11.11%, respectively. The percentage of nausea and vomiting in digestive system was also 39.58%, and the percentage of serious adverse reactions (Ⅲ-Ⅳ degrees) was 3.76%.