药品不良反应严重程度分级评分标准的制定及药品不良反应严重度指数的应用

目的：制定及评估药品不良反应（ADR）严重程度分级评分标准。方法：对现有ADR严重程度分级进行调整，制定新的ADR分级评分标准，提出ADR严重度指数的概念，即用某种药品或某类药物引起的ADR严重程度分级评分总和除以ADR总例数。用3种ADR严重程度分析方法对7605例ADR报告分析比较。结果：ADR按轻、中、重度分级分别占48．5％、41．4％和10．1％。按现行网上自愿呈报系统分类方法，一般级占95．5％，严重级占2．9％；新ADR的一般级占1．5％，新ADR的严重级占0．1％。按本研究新制定的标准分级及评分，ADR严重程度分为6级，从轻至重分别为1～6分，得分为1分者占48．5％，2分者占41．4％，3分者占6．9％，4分者占1．4％，5分者占1．4％．6分者占0．4％。按药理学分类，以发生频率排序，β-内酰胺类抗生素以2298例居首；以严重度指数排序，性激素类与避孕药以2．278居首。按药品通用名分类，以ADR频率排序，第一位为左氧氟沙星注射液370例；以严重度指数排序，琥珀酰明胶注射液以3．67列第一。结论：用本研究新制定的ADR严重程度分级评分法分析ADR严重程度，可使ADR严重程度细化、量化并具有加和性；也便于不同药品之间ADR严重程度的比较。用新制定的标准分析ADR严重程度可使不良反应较严重的品种凸显出来。ADR严重程度分级评分法在ADR严重程度的个例分析和集中分析中都是可行的。

Establishment of a new standard for evaluation of grade of adverse drug reaction severity and application of adverse drug reaction severity index

Objective： To establish and evaluate a new standard for rating grade and score of adverse drug reaction （ADR） severity. Methods： A new standard for rating grade and score of ADR severity was established on the basis of modification of the current related standards. Three different methods were used for analyzing and evaluating 7 605 ADR reports. The concept of severity index of ADR （SIADR） was defined. SIADR equals the sum of all ADR severity scores divided by the total number of ADRs. Results： Analyzed by the three grade standard of ADR severity, there were 10.1% of severe ADRs,41.4 % moderate and 48.5% mild in the 7 605 ADR reports. By the standard of spontaneous ADR reporting system,there were 95. 5% of general ADRs,2.9% severe ADRs,1.5% of general new ADRs and 0. 1% of severe new ADRs. By the new standard established in this study,whose ADR severity was divided into 6 grades scoring 1-6 from mild to severe,48.5% of ADRs scored 1,41.4% scored 2,6.9% scored 3,1.4% scored 4,1.4% scored 5 and 0.4% scored 6. According to the pharmacological classification,β-lactam antibiotics took the first place with 2 298 cases in the ADR reports;gonadal hormones and contraceptive agents ranked first with 2. 278 in the value of SIADR. Classified by Chinese approved drug names, ADRs of levofloxacin injection were most frequently reported （370 cases） ; succinyl gelatin injection took the first place with 3.67 in the value of SIADR. Conclusion： This new standard for rating grade and score of ADR severity makes the evaluation of ADR severity more specific,quantitative and additive. It also helps compare different drugs＇ ADR severity and reveal the drugs with severe ADRs. This new standard is proved to be practical and feasible in analyzing individual and multiple cases.