摘要
目的探讨健脾生血片(颗粒)治疗妊娠期缺铁性贫血(iron deficiency anemia,IDA)患者的临床疗效、安全性及对妊娠结局的影响。方法于2017年3月至2018年11月,采用前瞻性病例注册登记的研究方法分层随机抽取二级及以上医院共200家,每家医院注册登记由同一名产检医生接诊的连续50例门诊产检诊断为妊娠期IDA并给予健脾生血片(颗粒)治疗的病例,合计10000例妊娠期IDA病例。注册登记变量包括:患者基本信息、孕产史、血常规、铁代谢指标、贫血相关临床症状、贫血之外的其他妊娠合并症、贫血治疗史、合并用药、血红蛋白改善情况、血清铁蛋白改善情况、药品相关不良反应、母婴妊娠结局。结果共189家二级以上医院完整有效地完成了9214例病例注册登记。妊娠期IDA病例经健脾生血片(颗粒)治疗后,不良妊娠结局总发生率为3.50%,包括胎膜早破(1.67%)、产褥感染(0.16%)、产后出血(1.03%)、早产(0.28%)、新生儿窒息(0.16%)、低体重儿(0.20%),未发现畸形儿,无母胎死亡情况。4周总有效率为97.38%;轻、中、重度贫血孕妇之间,早、中、晚孕期孕妇之间,注册登记前使用过其他贫血药物与否的孕妇之间,疗效差异均无统计学意义(均P>0.05)。未发现需要停药的严重不良反应,不良反应总发生率为4.72%,包括恶心呕吐(1.80%)、便秘(1.14%)、腹痛(0.91%)、腹泻(0.84%)、皮疹(0.03%)。结论单用健脾生血片(颗粒)治疗妊娠期IDA疗效明确,安全性与依从性良好,不良妊娠结局发生率低,值得临床应用。
Objective To explore the clinical effect and the safety of Jianpishengxue tablets/granules and its influence on pregnancy outcome of patients with iron deficiency anemia during pregnancy.Methods By prospective case registration research method,from March 2017 to November 2018,a total of 200 hospitals at GradeⅡand above were randomly selected and stratified.From each hospital,50 consecutive patients diagnosed with IDA during pregnancy by the same obstetrist were chosen and treated with Jianpishengxue tablets/granules,totally 10000 cases.Registration variables included:patient’s name,age and other basic information,pregnancy history,blood routine,iron metabolism indicators,clinical symptoms related to anemia,other comorbidities of pregnancy other than anemia,anemia treatment history,combined medication,hemoglobin improvement,serum ferritin improvement,drug-related adverse reactions,and maternal and infant pregnancy outcomes.Results A total of 189 hospitals at or above GradeⅡcompleted the registration of 9214 cases effectively.In patients with iron deficiency anemia during pregnancy treated with Jianpishengxue tablets,the total incidence of adverse pregnancy outcomes was 3.50%,including premature rupture of membranes(1.67%),puerperal infection(0.16%),postpartum hemorrhage(1.03%),premature delivery(0.28%),neonatal as phyxia(0.16%),and lowbirth-weight infants(0.20%);no deformities were found,and there was no maternal death.The total effective rate at 4 weeks was 97.38%.Among pregnant women with mild,moderate and severe anemia,and among pregnant women with early,middle and late pregnancy,and between the pregnant women taking drugs for anemia before registration and those not taking,there was no significant difference in efficacy(P>0.05).No serious adverse reactions requiring drug discontinuation were found.The total incidence of adverse reactions was 4.72%,including nausea and vomiting(1.80%),constipation(1.14%),abdominal pain(0.91%),diarrhea(0.84%),and rash(0.03%).Conclusion The use of Jianpishengxue tablets/gra
作者
王少帅
冯玲
黄健
杨金英
胡盈
陈萍英
刘羽
WANG Shao-shuai;FENG Ling;HUANG Jian;YANG Jin-ying;HU Ying;CHEN Ping-ying;LIU Yu(Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology,Wuhan 430030,China)
出处
《中国实用妇科与产科杂志》
CAS
CSCD
北大核心
2020年第11期1110-1115,共6页
Chinese Journal of Practical Gynecology and Obstetrics
基金
国家重点研发计划(2016YFC1000400)。
关键词
妊娠期缺铁性贫血
健脾生血片(颗粒)
病例登记研究
临床疗效
不良妊娠结局
iron deficiency anemia in pregnancy
Jianpishengxue tablets/granule
case registration study
clinical efficacy
adverse pregnancy outcome
