摘要
目的:为我国心血管类基本药物调整提供参考。方法:比较《国家基本药物目录·基层医疗卫生机构配备使用部分》(2009版)(以下简称"我国目录")与世界卫生组织(WHO)第16版《基本药物示范目录》(以下简称"WHO目录")中心血管用药的遴选原则、品种、剂型与规格等方面的异同。结果:(1)我国心血管基本药物共29种,WHO心血管基本药物为19种,两目录重合的药物有10种;(2)我国目录中收录了WHO曾经调出的利血平、普鲁卡因胺以及异丙肾上腺素;(3)我国收录同种作用机制的心血管基本药物数量多为2种或2种以上,而WHO收录的同种作用机制的心血管基本药物数量多为1种;(4)我国获批的29种心血管用药存在着48种制剂品种,而WHO目录中的19种药品制剂品种为29种;(5)我国目录中未规定规格,目录中的16种口服常释剂型的心血管用药,在我国共获批了43种规格,平均每种药物有2.68种规格,平均每种规格的药物获批生产的文号数为37.56,固体口服制剂的规格符合其成人口服单次最低剂量的比例占43.8%,而WHO则达到了83.3%。结论:我国目录中心血管用药的数量逐渐接近WHO目录,但是重合率不高,目录调整缺少循证依据,也缺少对剂型、规格的规范;建议加强对心血管用药的循证评价,规范剂型规格。
OBJECTIVE：To provide reference for the adjustment of cardiovascular essential drugs in China. METHODS： Differences in the criteria of selection, categories, dosage forms as well as the specification of cardiovascular medicines in Primary Medical Institution Use Part of National Essential Drug List （2009 edition） （EDL of China） and WHO Essential Medicine Model List （EMML of WHO） were compared by descriptive analysis. RESULTS： There were 29 medicines in EDL of China and 19 medicines in EMML of WHO, 10 of those medicines were the same. There were reserpine, procainamide and isoprenaline in the EDL of China, that had been deleted from EMML of WHO. There were at least 2 cardiovascular medicines with same mechanism in EDL of China, but only 1 in EMML of WHO. So 29 drugs approved in China had 48 preparations, but 19 drugs in EMML of WHO had 29 preparations. EDL of China had not indicated the exact specification, and there were 16 drugs that had oral conventional release dosage forms, among which 43 specifications had approved in China, so each drug had 2.68 specifications, registered number of each specification was 37.56. Solid oral preparation matched single minimum oral dose for adult accounted for 43.8%. That of WHO EMML accounted for 83.3%. CONCLUSIONS： The total number of cardiovascular medicines in EDL of China is close to EMML of WHO, but coincidence rate are relatively low. The evidence-based selection and adjustment of EDL of China are not enough. It lacks of the norm of dosage forms and specification. We suggest enhancing the evidence-based evaluation of cardiovascular medicines and normalizing dosage forms and specification.
出处
《中国药房》
CAS
CSCD
北大核心
2011年第32期2984-2990,共7页
China Pharmacy
基金
WHO中国/世界卫生组织2010-2011年度正规预算合作项目(WPCHN1004601)
关键词
基本药物目录
心血管用药
品种
剂型
规格
Essential Drug List
Cardiovascular medicines
Category
Dosage forms
Specification
