150例围产期缺铁性贫血应用生血宁片致不良反应报告

Reports on 150 Cases of Adverse Drug Reactions Induced by Shengxuening Tablets in Treatment of Iron Deficiency Anemia in Perinatal Period

目的:了解生血宁片用于围产期缺铁性贫血所致药品不良反应(adverse drug reaction,ADR)的一般规律及特点,为临床安全用药提供参考。方法:采用回顾性分析方法,对2015年7月-2017年5月深圳市罗湖区妇幼保健院上报的围产期缺铁性贫血患者服用生血宁片所致ADR的一般情况、患者的年龄、引发ADR的用药时间及ADR累及器官和(或)系统及主要临床表现等进行分析。结果:150例ADR报告中,2015年7-12月32例,占21.33%;2016年63例,占42.00%;2017年1-5月55例,占36.67%。患者年龄22~38岁,其中25~30岁者最多。服用生血宁后30 d后发生ADR例数最多,其次为用药后2~3 d。ADR主要累及消化系统,表现为便秘、大便性状改变,如变黑色或褐色;无严重的ADR,均为一般的ADR。结论:围产期缺铁性贫血患者服用生血宁片易引发ADR,临床医师应安全、有效地使用生血宁片,并加强ADR监测。

OBJECTIVE： To investigate the rules and characteristics of adverse drug reactions（ ADR） induced by Shengxuening tablets in treatment of iron deficiency anemia in perinatal period,so as to provide reference for the safety drug application in clinic. METHODS： Retrospective analysis was conducted on data of ADR induced by Shengxuening tablets in treatment of iron deficiency anemia in perinatal period in Shenzhen Luohu District Maternal and Child Health Care Hospital from Jul. 2015 to May 2017 in terms of the general data,patients＇ age,ADR-inducing administration time,ADR involved organs and（ or） systems and major clinical manifestations,etc. RESULTS： Of the 150 cases of ADR,there were 32 cases in Jul.-Dec. 2015,accounting for 21. 33%; and 63 cases in 2016,accounting for 42. 00%;and 55 cases in Jan.-May 2017,accounting for 36. 67%. The patients were aged within 22-38 years old,and patients aged 25-30 years old with ADR took the lead. ADR cases mostly occurred after 30 d of taking Shengxuening tablets,followed by administration of 2-3 d. ADR mainly involved digestive system,performed as constipation,changes of fecal character（ black or brown）; there were no severe ADR,all patients were general ADR. CONCLUSIONS： ADR can be easily induced by Shengxuening tablets in treatment of iron deficiency anemia in perinatal period. The clinicians should apply Shengxuening tablets in an safety and effective way,and strengthen the ADR monitoring.