新生儿临床病例数据库的建立和15490例住院新生儿病例分析
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摘要
目的:近50年来我国新生儿医学发生了快速的发展,取得了巨大的成就,尤其是最近10年来,新生儿疾病谱、诊断方法、治疗技术和护理手段都发生了快速而显著的变化。新生儿医师急需及时了解新生儿专业具体发生了哪些变化?并根据这些变化做出相应的临床决策。但是,面对如此巨大的临床资料进行及时分析总结,只有通过建立数据库和网络手段才能较好地实现。因此,本研究旨在建立新生儿临床病例数据库,并通过该数据库分析5年15490例住院新生儿主要临床资料,以进一步评估该数据库建立的可行性。
方法:(1)设计住院新生儿主要临床资料登记表格;(2)根据登记表建立微软SQL数据库。先输入1个月的住院新生儿临床资料进行试分析,根据新生儿主要临床资料收集的全面性与登记收录工作的依从性,反复修改登记表和数据库软件,在基本确定登记表和数据库框架后,扩大输录规模。(3)病例登记:总共纳入2004年1月1日到2008年12月31日我院新生儿科所有住院新生儿病例,共计15490例,将所有住院新生儿病例在出院时完成登记。(4)病例分析:将登记表记录的新生儿临床数据录入数据库,通过数据库进行分析。
结果:(1)基本情况:我院住院新生儿病人平均胎龄为37.6±3.2周,平均出生体重为2895.5±788.5g(500-6200g),平均住院天数为12.7±12.7天,平均每例住院费用为5940.6±9613.4元。病人主要来源于本市二级医院。(2)围产期情况:64.7%(n=10017)患儿母亲产前进行正规体检,母亲围产期的主要疾病是妊高征、产前感染和妊娠糖尿病,早产儿组中母亲围产期疾病的发生率更高,具有统计学显著性差异(p＜0.001)。胎龄≤34周患儿中22.4%(n=547)患儿母亲接受了产前预防性地塞米松治疗。17.9%(n=2770)患儿生后1分钟Apgar评分≤7分,7.3%(n=1121)5分钟Apgar评分≤7分。(3)临床表现:住院新生儿入院时主要临床症状为呼吸困难(24.2%)、青紫(12.0%)、黄疸(10.6%)、发热(9.4%)、呕吐(7.9%)和惊厥(3.2%)。(4)疾病谱变化:5年来排名最靠前的10种病例分别为,早产儿(30.4%,n=4712)、高胆红素血症(28.5%,n=4412)、感染性肺炎(26.6%,n=4123)、窒息(17.7%,n=2738)、吸入性肺炎(15.6%,n=2419)、湿肺(9.7%,n=1506)、PDA(8.9%,n=1374)、PFO(8.7%,n=1350)、败血症(8.4%,n=1300)和先天性梅毒(7.2%,n=1109)。呼吸系统疾病(56.9%)和感染性疾病(46.3%)在新生儿疾病中占据重要位置。随着早产儿比例的增加,早产儿相关疾病逐年增多。新生儿病房和NICU院内感染率分别为13.4%和14.2%。(5)治疗情况:有67%(n=10380)患儿收住NICU监护抢救,39.5%(n=6123)使用静脉营养,22.7%(n=3511)需要吸氧,8.3%(n=1285)给予CPAP治疗,9.1%(11=1409)使用机械通气,另有0.5%(n=75)患儿使用吸入NO治疗。从2004年到2008年,肺表面活性物质替代治疗病例明显增加。36.2%(n=5607)患儿使用光疗,8.8%(n=1367)接受输血制品治疗。1%(n=148)患儿使用中心置管。(6)预后:住院新生儿的总体预后良好,其中36.5%(n=5647)痊愈,55.8%(n=8651)好转,合计占92.3%。住院病死率为1.5%(n=225)。
结论:(1)本研究显示在新生儿建立临床病例数据库是切实可行的,该数据库有利于进行临床流行病学研究、预后和治疗研究。(2)我院新生儿科住院病人中早产儿逐年增加,早产儿相关疾病明显增多。(3)胎龄、出生体重与住院天数、住院费用、各项治疗措施以及预后密切相关。(4)早产儿、高胆红素血症、感染性肺炎、窒息和吸入性肺炎是我院住院新生儿中病例数最多的。5年来疾病谱更广泛,疑难病例、先天性遗传代谢性疾病、先天畸形等明显增加。(5) 5年来危重新生儿比例增加,NICU监护抢救时间延长、CPAP和机械通气病例增加。(6)住院新生儿总体预后良好,病死率为1.5%。
Objective:After more than 50 years of unremitting effort,we have made great achievements in neonatology.In the past ten years,all aspects in neonatology including disease spectrum,diagnosis,treatment,mortality,morbidity and etc are changing rapidly.The neotologists are eager to know what has happened in the NICU. And all the clinical strategies should be made adapted to these changes.However, analysis of such huge clinical data could only rely on the establishment of database and network.The purpose of this thesis is to evaluate the possibility of establishment of neonatal database in China and to analyze 15490 in-patient cases during the past 5 years based on this database.
Methods:(1) Clinical form of all in-patient newboms was designed.(2) A standardized neonatal clinical database was constructed to collect all the information extracted from clinical forms.We carried out a preliminary study to test the compliance of operators and whether it could contain all the major information.After making the final edition of form and database based on results of preliminary study, we started full-scale study.(3) Data collection:15490 infants who were admitted to the Division of Neonatology from January 1~(st) 2004 to December 31st 2008 were enrolled in the study.(4)Analysis:A retrospective research was made in this database. Statistical analyses were performed in this database.
Results:(1) Basic characteristics:The majority of the 15490 patients were male full-term newborns.Gestational age was 37.6±3.2wk,birth weigh was 2895.5±788.5g (range 500-6200g),and the overall length of stay was 12.7±12.7d.(2) Maternal history:Only 64.7%(n=10017) mothers of newborns had regular prenatal care. Pregnancy induced hypertension,intrauterine infections and gestational diabetics accounted for the most common diseases during pregnancy.And the preterm had the higher incidence of maternal diseases(p＜0.001).22.4%(n=547) mothers of GA less than 34wk received antenatal dexamethasone treatment.17.9%(n=2770) at 1 min postnatal age and 7.3%(n=1121) at 5 min postnatal age had an Apgar score less than 7.(3) Manifestation:The major symptoms of neonates were dyspnea(24.2%), cyanosis(12.0%),jaundice(10.6%),fever(9.4%),vomiting(7.9%) and seizure (3.2%).(4) Disease spectrum:There were preterm(30.4%,n=4712), hyberbilirubinemia(28.5%,n=4412),infectious pneumonia(26.6%,n=4123), asphyxia(17.7%,n=2738),aspiratory pneumonia(15.6%,n=2419),wet lung(9.7%, n=1506),PDA(8.9%,n=1374),PFO(8.7%,n=1350) sepsis(8.4%,n=1300) and congenital syphilis(7.2%,n=1109) among the highest incidence of neonatal diseases. Recently,respiratory diseases(56.9%) and infectious diseases(46.3%) played important roles in neonatal diseases.Nosocomial infection rate in our division and NICU were 13.4%and 14.2%,respectively.(5) Treatment:67%(n=10380) were admitted to NICU.22.7%(n=3511) was given oxygen,8.3%(n=1285) were treated with CPAP and 9.1%(n=1409) with ventilator.Only 0.5%(n=75) received inhaled NO therapy.There was obviously increment in using pulmonary surfactant from 2004 to 2008.36.2%(n=5607) were accepted photo therapy and 8.8%(n=1367) with blood transfusion.1%(n=148) use central lines.39.5%(n=6123) got intravenous nutrition. (6) Prognosis:The prognosis of all newborns was good.The infants who discharged with doctor's approval accounted for 92.3%(n=14298) and died for 1.5%(n=225).
Conclusions:(1) This study suggests that the establishment of neonatal clinical database is feasible and it do help studying the epidemiology,outcomes and health services of neonates which can improve efficacy and efficiency of neonatal care.(2) The proportion of preterm infants increased annually,and meanwhile preterm related diseases increased a lot in the past five years.(3) Gestational age and birth weight are highly associated with the length of stay,hospital costs,treatment and prognosis.(4) Preterm,hyperbilirubinemia,pneumonia,asphyxia and aspiration pneumonia listed top 5 among all the neonatal diseases.The disease spectrum became broader.The proportion of complicated cases,metabolic diseases and congenital malformation increased.(5) Critically ill newborns became an important part of all in-patient cases, therefore,the length of NICU stay prolonged and the use of CPAP and mechanical ventilation increased.(6) The prognosis of all in-patient newborns was good,and mortality rate was 1.5%.
方法:(1)设计住院新生儿主要临床资料登记表格;(2)根据登记表建立微软SQL数据库。先输入1个月的住院新生儿临床资料进行试分析,根据新生儿主要临床资料收集的全面性与登记收录工作的依从性,反复修改登记表和数据库软件,在基本确定登记表和数据库框架后,扩大输录规模。(3)病例登记:总共纳入2004年1月1日到2008年12月31日我院新生儿科所有住院新生儿病例,共计15490例,将所有住院新生儿病例在出院时完成登记。(4)病例分析:将登记表记录的新生儿临床数据录入数据库,通过数据库进行分析。
结果:(1)基本情况:我院住院新生儿病人平均胎龄为37.6±3.2周,平均出生体重为2895.5±788.5g(500-6200g),平均住院天数为12.7±12.7天,平均每例住院费用为5940.6±9613.4元。病人主要来源于本市二级医院。(2)围产期情况:64.7%(n=10017)患儿母亲产前进行正规体检,母亲围产期的主要疾病是妊高征、产前感染和妊娠糖尿病,早产儿组中母亲围产期疾病的发生率更高,具有统计学显著性差异(p＜0.001)。胎龄≤34周患儿中22.4%(n=547)患儿母亲接受了产前预防性地塞米松治疗。17.9%(n=2770)患儿生后1分钟Apgar评分≤7分,7.3%(n=1121)5分钟Apgar评分≤7分。(3)临床表现:住院新生儿入院时主要临床症状为呼吸困难(24.2%)、青紫(12.0%)、黄疸(10.6%)、发热(9.4%)、呕吐(7.9%)和惊厥(3.2%)。(4)疾病谱变化:5年来排名最靠前的10种病例分别为,早产儿(30.4%,n=4712)、高胆红素血症(28.5%,n=4412)、感染性肺炎(26.6%,n=4123)、窒息(17.7%,n=2738)、吸入性肺炎(15.6%,n=2419)、湿肺(9.7%,n=1506)、PDA(8.9%,n=1374)、PFO(8.7%,n=1350)、败血症(8.4%,n=1300)和先天性梅毒(7.2%,n=1109)。呼吸系统疾病(56.9%)和感染性疾病(46.3%)在新生儿疾病中占据重要位置。随着早产儿比例的增加,早产儿相关疾病逐年增多。新生儿病房和NICU院内感染率分别为13.4%和14.2%。(5)治疗情况:有67%(n=10380)患儿收住NICU监护抢救,39.5%(n=6123)使用静脉营养,22.7%(n=3511)需要吸氧,8.3%(n=1285)给予CPAP治疗,9.1%(11=1409)使用机械通气,另有0.5%(n=75)患儿使用吸入NO治疗。从2004年到2008年,肺表面活性物质替代治疗病例明显增加。36.2%(n=5607)患儿使用光疗,8.8%(n=1367)接受输血制品治疗。1%(n=148)患儿使用中心置管。(6)预后:住院新生儿的总体预后良好,其中36.5%(n=5647)痊愈,55.8%(n=8651)好转,合计占92.3%。住院病死率为1.5%(n=225)。
结论:(1)本研究显示在新生儿建立临床病例数据库是切实可行的,该数据库有利于进行临床流行病学研究、预后和治疗研究。(2)我院新生儿科住院病人中早产儿逐年增加,早产儿相关疾病明显增多。(3)胎龄、出生体重与住院天数、住院费用、各项治疗措施以及预后密切相关。(4)早产儿、高胆红素血症、感染性肺炎、窒息和吸入性肺炎是我院住院新生儿中病例数最多的。5年来疾病谱更广泛,疑难病例、先天性遗传代谢性疾病、先天畸形等明显增加。(5) 5年来危重新生儿比例增加,NICU监护抢救时间延长、CPAP和机械通气病例增加。(6)住院新生儿总体预后良好,病死率为1.5%。
Objective:After more than 50 years of unremitting effort,we have made great achievements in neonatology.In the past ten years,all aspects in neonatology including disease spectrum,diagnosis,treatment,mortality,morbidity and etc are changing rapidly.The neotologists are eager to know what has happened in the NICU. And all the clinical strategies should be made adapted to these changes.However, analysis of such huge clinical data could only rely on the establishment of database and network.The purpose of this thesis is to evaluate the possibility of establishment of neonatal database in China and to analyze 15490 in-patient cases during the past 5 years based on this database.
Methods:(1) Clinical form of all in-patient newboms was designed.(2) A standardized neonatal clinical database was constructed to collect all the information extracted from clinical forms.We carried out a preliminary study to test the compliance of operators and whether it could contain all the major information.After making the final edition of form and database based on results of preliminary study, we started full-scale study.(3) Data collection:15490 infants who were admitted to the Division of Neonatology from January 1~(st) 2004 to December 31st 2008 were enrolled in the study.(4)Analysis:A retrospective research was made in this database. Statistical analyses were performed in this database.
Results:(1) Basic characteristics:The majority of the 15490 patients were male full-term newborns.Gestational age was 37.6±3.2wk,birth weigh was 2895.5±788.5g (range 500-6200g),and the overall length of stay was 12.7±12.7d.(2) Maternal history:Only 64.7%(n=10017) mothers of newborns had regular prenatal care. Pregnancy induced hypertension,intrauterine infections and gestational diabetics accounted for the most common diseases during pregnancy.And the preterm had the higher incidence of maternal diseases(p＜0.001).22.4%(n=547) mothers of GA less than 34wk received antenatal dexamethasone treatment.17.9%(n=2770) at 1 min postnatal age and 7.3%(n=1121) at 5 min postnatal age had an Apgar score less than 7.(3) Manifestation:The major symptoms of neonates were dyspnea(24.2%), cyanosis(12.0%),jaundice(10.6%),fever(9.4%),vomiting(7.9%) and seizure (3.2%).(4) Disease spectrum:There were preterm(30.4%,n=4712), hyberbilirubinemia(28.5%,n=4412),infectious pneumonia(26.6%,n=4123), asphyxia(17.7%,n=2738),aspiratory pneumonia(15.6%,n=2419),wet lung(9.7%, n=1506),PDA(8.9%,n=1374),PFO(8.7%,n=1350) sepsis(8.4%,n=1300) and congenital syphilis(7.2%,n=1109) among the highest incidence of neonatal diseases. Recently,respiratory diseases(56.9%) and infectious diseases(46.3%) played important roles in neonatal diseases.Nosocomial infection rate in our division and NICU were 13.4%and 14.2%,respectively.(5) Treatment:67%(n=10380) were admitted to NICU.22.7%(n=3511) was given oxygen,8.3%(n=1285) were treated with CPAP and 9.1%(n=1409) with ventilator.Only 0.5%(n=75) received inhaled NO therapy.There was obviously increment in using pulmonary surfactant from 2004 to 2008.36.2%(n=5607) were accepted photo therapy and 8.8%(n=1367) with blood transfusion.1%(n=148) use central lines.39.5%(n=6123) got intravenous nutrition. (6) Prognosis:The prognosis of all newborns was good.The infants who discharged with doctor's approval accounted for 92.3%(n=14298) and died for 1.5%(n=225).
Conclusions:(1) This study suggests that the establishment of neonatal clinical database is feasible and it do help studying the epidemiology,outcomes and health services of neonates which can improve efficacy and efficiency of neonatal care.(2) The proportion of preterm infants increased annually,and meanwhile preterm related diseases increased a lot in the past five years.(3) Gestational age and birth weight are highly associated with the length of stay,hospital costs,treatment and prognosis.(4) Preterm,hyperbilirubinemia,pneumonia,asphyxia and aspiration pneumonia listed top 5 among all the neonatal diseases.The disease spectrum became broader.The proportion of complicated cases,metabolic diseases and congenital malformation increased.(5) Critically ill newborns became an important part of all in-patient cases, therefore,the length of NICU stay prolonged and the use of CPAP and mechanical ventilation increased.(6) The prognosis of all in-patient newborns was good,and mortality rate was 1.5%.
引文
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