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目的研究“十二五”期间我国血液制品批签发供应情况,对倍增计划实施情况进行总结分析,并提出目前我国血液制品行业存在的主要问题。方法对8家生物制品检定官方机构公布的血液制品批签发资料进行数据采集和统计,并按照批签发日期对11种血液制品品种进行年度信息处理、汇总和分析。结果 2010-2015年,人血白蛋白(10g/瓶)从1 492.08万瓶增长至3 256.04万瓶;静注人免疫球蛋白(p H4)(2.5 g/瓶)从463.02万瓶增长至783.43万瓶;破伤风人免疫球蛋白(250 IU/瓶)从214.55万瓶增长至278.77万瓶;狂犬病人免疫球蛋白(200 IU/瓶)从276.92万瓶增长至395.65万瓶;乙型肝炎人免疫球蛋白(200 IU/瓶)从270.11万瓶增长278.77万瓶;人纤维蛋白原(0.5 g/瓶)从17.77万瓶增长至50.17万瓶;人凝血酶原复合物(200 IU/瓶)从22.30万瓶增长至64.87万瓶;人凝血因子Ⅷ(200 IU/瓶)从33.42万瓶增长至75.07万瓶。结论 “十二五”末血液制品供应倍增目标基本实现,但仍存在供需紧张的局面。原料血浆匮乏、产品结构单一、血浆综合利用率低仍然是制约我国血液制品行业的主因。
Objective To study the issue and approval of blood products wholesale in China during the 12th Five-Year Plan period, summarize and analyze the implementation of the double-plan and propose the main problems that exist in the current blood product industry in China. Methods Data collection and statistics were carried out on the data of blood product batch distribution issued by 8 biological product testing official agencies. The annual information processing, summary and analysis of 11 blood product varieties were conducted according to the batch issuance date. Results From 2010 to 2015, human albumin (10 g / bottle) increased from 14.0280 million bottles to 32.460 million bottles; the volume of intravenous human immunoglobulin (p H4) (2.5 g / bottle) increased from 4.63 million to 783.43 10,000 bottles; tetanus immunoglobulin (250 IU / bottle) increased from 2,145,500 bottles to 2,787,700 bottles; Rabies immunoglobulin (200 IU / bottle) increased from 2,769,200 bottles to 3,95,650 bottles; Hepatitis B The number of human fibrinogen (0.5 g / bottle) increased from 177,700 bottles to 501,700 bottles; the human prothrombin complex (200 IU / bottle) increased by 2.7877 million bottles from 2,701,100 bottles; From 223,000 bottles to 648,700 bottles; human factor VIII (200 IU / bottle) increased from 334,200 bottles to 750,700 bottles. Conclusion The goal of doubling the supply of blood products at the end of the “Twelfth Five-Year Plan” has basically been achieved, but there is still a tight supply and demand situation. The lack of raw plasma, a single product structure, low comprehensive utilization of plasma is still the main factor restricting China’s blood products industry.