“十二五”期间我国血液制品批签发供应情况分析

Analysis on the situation and progress of blood products during the National Twelfth Five-Year Plan

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 inspect the supply situation of the blood products during the period of the national twelfth five-year plan in China, to summarize and analyze the doubling plan, and to put forward the major problems facing blood products in our country at present. Methods Data on blood products from lot release system of eight biological products veri- fication authorities were collected. Eleven kinds of blood products varieties were analyzed on annual information processing according to the number of products issued. Results From 2010 to 2015, production of human albumin （ 10 g/bottle） has grown to 32. 56 million bottles from 14. 92 million bottles. Human immunoglobulin for intravenous injection （2.5g/bottle） has grown to 7. 83 million bottles from 4. 63 million bottles. Human tetanus immunoglobulin （250IU/bottle） has grown to 2. 79 million bottles from 2. 15 million bottles. Human rabies immunoglobulin （200IU/bottle） has grown to 3. 96 million bot- tles from 2. 77 million bottles. Human hepatitis B immunoglobulin （200IU/bottle） has grown to 2. 79 million bottles from 2. 70 million bottles. Human fibrinogen （0. 5g/bottle） has grown to 0. 50 million bottles from 0. 18 million bottles. Human prothrombin （200IU/bottle） has grown to 0. 65 million bottles from 0. 22 million bottles. Human coagulation clotting factor Ⅶ （200IU/bottle） has grown to 0. 75 million bottles from 0. 33 million bottles. Conclusion The doubling plan on supply of the blood products is almost completed at the end of the national twelfth five-year plan, but the relationship between supply and demand are still strained. The major causes of restriction on blood products are the following： lack of plasma, homogene- ous product structure, and low comprehensive utilization rate of plasma.