廖星 于丹丹 谢雁鸣 +张允岭 何燕 张寅 刘艳 易丹辉 王永炎

[摘要]旨在獲得碟脉灵苦碟子注射液（DML）不良反应（adverse drug reaction，ADR）发生率及其特征和影响因素以及DML真实世界中的使用情况。采用前瞻性单队列研究，历时4年在25家医院（包括中医院和西医院）观察使用该药的住院患者。通过采用频数描述方法分析病例的一般信息，用关联规则方法分析合并疾病之间以及合并用药之间的相关性，用交叉列联方法、卡方检验初步筛选不良反应的影响因素，再用Group LASSAO方法做进一步分析。结果显示，一共观察到30 233例患者，发生54例ADE，其中30例ADR。总体不良反应发生率为0099%[95%CI（006%，013%）]。ADR发生为“一般”的27例，“严重”的1例（过敏性休克），“新发”2例。ADR在用药30 min以内发生较多，共计16例。ADR多表现为心悸11例次，呕吐7例次，寒战、皮肤瘙痒、皮疹均为6例次。碟脉灵苦碟子注射液总体不良反应发生率属罕见不良反应，其安全性较好。该研究仍可能低估ADR的真实发生率，且未获取ADR患者血样，需进一步开展机制研究。

[关键词]医院集中监测； 碟脉灵苦碟子注射液； 上市后监测； 不良反应； 真实世界

Postmarketing safety surveillance of Diemailing Kudiezi injection：

real world study in 30 233 cases

LIAO Xing1， YU Dandan1， XIE Yanming1*， ZHANG Yunling2， HE Yan3， ZHANG Yin1， LIU Yan4， YI Danhui4， WANG Yongyan1

（1Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， Beijing 100700， China；

2 Dongfang Hospital， Beijing University of Chinese Medicine， Beijing 100078， China；

3Affiliated Hospital of Chengdu University of Taditional Chinese Medicine， Chengdu 610072， China；

4 School of Statistics， Renmin University of China， Beijing 100872， China）

[Abstract]This study was aimed to obtain the incidence of adverse drug reaction （ADR） of Diemailing Kudiezi injection， explore its characteristics， related risk factors and application in real world A prospective single cohort study was conducted from 25 hospitals （including Chinese medicine hospitals and Western medicine hospitals） for 4 years 30 233 consecutive inpatients using Diemailing Kudiezi injection were observed Their general information was analyzed by using statistic frequency description Association rules were used to analyze the correlation between comorbidities or drug combinations； the influential factors for ADRs were initially screened by using cross contingency method and Chisquare test， and then Group LASSAO method was used for further analysis 54 patients with adverse drug events and 30 patients with ADRs were reported among 30 233 patients， with a total ADR incidence of 0099%[95%CI （006%， 013%）] There were 27 patients identified as the "general" ADR， one patients with "severe" ADR （anaphylactic shock） and two patients with new ADRs ADR occurred most in 30 min after using Diemailing Kudiezi injection， in a total of 16 patients The most ADRs were palpitation， vomiting， chills， pruritus and rash， 6 times for each symptom Diemailing Kudiezi injection was well tolerated in the general population The overall incidence of adverse reactions was rare， with high safety However， the real incidence of ADRs may be underestimated in this study， and the blood samples were not obtained for the patients， so further mechanism studies shall be conductedendprint

[Key words]hospital based intensive monitoring； Diemailing Kudiezi injection； postmarketing safety surveillance； ADR； real world

苦碟子為菊科二年苦荬菜属植物，学名抱茎苦荬菜Ixeris sonchifolia（Bge）Hance，收录于《内蒙古中草药》。蝶脉灵苦碟子注射液为抱茎苦荬菜提取物加工制备而成，其说明书显示该药具有活血止痛，清热祛瘀的功效，使用方式为静脉滴注，每次10～40 mL，用5%葡萄糖或09%氯化钠注射液稀释至250～500 mL后应用。该药1998 年上市，属于我国医保乙类药物。广泛运用于治疗冠心病、心绞痛、脑梗死等。目前国内有 2 家公司生产苦碟子注射液，均有国药准字号。……