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目的 通过大样本比较中国药典与中国其他质量标准所收载药品不良反应(ADR)的发生概率,探讨我国不同标准所收载药品的安全性,为中国药典的完善及品种遴选提供依据.方法 运用药物流行病学方法分析2013-2015年江苏省ADR监测网收集到266 869例ADR报告,分为中国药典组(ChPD组)和其他质量标准组(NChPD组),通过r检验比较两组间发生新的、严重的、以及中成药和中药注射剂严重ADR的差异性;收集并采用t检验比较江苏省四家综合性医院两组药品的品规数和使用频次(DDDs).结果 ChPD组和NChPD组ADR报告总例数分别为121 490、145 379例,其中“新的”分别为28 861 (23.76％)、41 640 (28.64％)例,“严重的”分别为8 786 (7.23％)、11 116 (7.64％)例;中成药ADR总例数分别为15 727 (12.95％)、35 513 (24.42％)例,其中“严重的”分别为225 (1.43％)、2 138 (6.02％)例;中药注射剂ADR总例数分别为1 135 (7.21％)、18 416 (51.86％)例,其中“严重的”分别为67 (5.90％)、1 809 (9.82％)例;两组间报告例数差异显著(P＜0.01);四家医院两组总的药品平均品规数分别为(577±25)个和(583±31)个,DDDs分别为(2 490.64±268.95)万次和(2 522.31±341.12)万次;两组间数据无明显差异(P＞0.05);中成药平均品规数分别为(263±14)个和(216±37)个,DDDs分别为(997.22±27.70)万次和(852.17±87.86)万次;两组间数据无显著差异(P＞0.05);中药注射剂平均品规数分别为(4±1)个和(27±4)个,DDDs分别为(82.09±6.67)和(125.30±16.99)万次;两组间数据有显著差异(P＜0.05).结论 ChPD组中新的、严重的、以及中成药和中药注射剂严重的ADR数目均显著低于NChPD组;ChPD组总体药品和中成药ADR发生概率相对较低,安全性较高.“,”AIM To explore the safety of drugs recorded by Chinese Pharmacopoeia and the other drug standards and then to provide a basis for the perfection and medicine selection of Chinese Pharmacopoeia by the difference analysis of pharmacopoeia standard drugs and non pharmacopoeia standard drugs ADR incidence based on big data.METHODS Totally 266 869 ADR reports collected by ADR Monitoring Center ranging from 2013 to 2015 in Jiangsu province were classified into two groups,Chinese Pharmacopoeia standard drug group (ChPD group) and non Chinese Pharmacopoeia standard drug group (NChPD group),the statistical differences were analyzed according to the new,severe ADRs,and the severe ADRs of the traditional Chinese medicine and the severe ones of traditional Chinese medicine injections in different standards by Chi-square test;the drug varieties and DDDs from four hospitals of two groups were analyzed by Student's t test.RESULTS The total ADR reports from the ChPD group and NChPD group were 121 490 and 145 379,with the new ADRs 28 861 (23.76％) and 41 640 (28.64％),and the sever ADRs 8 786 (7.23％) and 11 116 (7.64％);the ADRs of traditional medicine were 15 727 (12.95％) and 35 513 (24.42％),of which the sever ADRs were 225 (1.43％) and 2 138 (6.02％);the traditional medicine injections ADRs were 1 135 (7.21％) and 18 416 (51.86％),of which the sever ADRs were 67 (5.90％) and 1 809 (9.82％),respectively;there were statistically significant difference between the two groups (P ＜ 0.01);the total drug varieties and DDDs from two groups were (577 ± 25) and (583-± 31),((2 490.64 ± 268.95) and (2 522.31 ± 341.12) × 10 000),there were no statistically significant difference between the two groups (P ＞ 0.05);the TCM varieties and DDDs from two groups were (263 ± 14) and (216±37),((997.22 ± 27.70) and (852.17 ± 87.86) × 10 000),there were no statistically significant difference between the two groups (P ＞ 0.05);the TCMI varieties and DDDs from two groups were (4 ± 1) and (27 ±-4),((82.09 ± 6.67) and (125.30 ± 16.99) × 10 000),there was statistically significant difference between the two groups (P ＜ 0.05).CONCLUSION The new,sever ADRs,and the sever ones of traditional Chinese medicine and the traditional Chinese medicine injections from the ChPD group are much less than those of NChPD group;the total and TCM ADR incidence of ChPD group is lower and the drugs of which are more secure.