摘要：
Objective To investigate the clinical efficacy and safety of caffeine citrate combined with duo positive airway pressure (DuoPAP) in treatment of premature infants with respiratory distress syndrome (RDS).Methods From January 2016 to November 2017,a total of 90 preterm infants with RDS (28 weeks ≤gestational age ＜32 weeks) who were hospitalized in the Affiliated Xuzhou Hospital of Southeast University,were chosen as research subjects.They were randomly divided into two groups by random number table method.In the combined treatment group (n=47),they were given caffeine citrate combined with DuoPAP;and in the control group (n=43),they were given DuoPAP without caffeine citrate.The general clinical data,results of blood gas analysis and indicators of respiratory function at 0 h,24 h and 48 h of breath support therapy,clinical efficacy,related complications of breath support therapy and adverse drug reactions between two groups of premature infants were compared statistically by independent-samples t test,chi-square test and Kruskal-Wallis H rank sum test.The study was reviewed and approved by the Medical Ethics Committee of the Affiliated Xuzhou Hospital of Southeast University (Approval Number:2015No.32),and the informed consents were signed by all the guardians of preterm infants.Results ① There were no significant differences between two groups in general clinical data including the proportion of male,gravidity,gestational age,birth weight,1 min and 5 min Apgar scores after birth of RDS premature infants;and the rate of premature rupture of membranes,cesarean section rate,glucocorticoid application rate within 24 h to 7 d before delivery,the incidence rate of hypertensive disorders complicating pregnancy of mother (P＞ 0.05).② There were no significant differences between two groups of RDS premature infants in pH value,partial pressure of arterial carbon dioxide (Paco2),partial pressure of arterial oxygen (Pao2) and Pao2/fraction of inspired oxygen (P/F) at 0 h of breath support therapy,also pH value at 24 h,48 h after breath support therapy (P＞0.05).The PaO2 and P/F of RDS premature infants in combined treatment group at 24 h,48 h after breath support therapy were higher than those in control group,while PaCO2 were lower than that in control group,and the differences were statistically significant (24 h:t=3.431,P=0.017;t=3.451,P=0.047;t=-4.241,P=0.008.48 h:t=3.238,P=0.048;t=3.576,P=0.009;t=-3.527,P=0.031).③ The duration of DuoPAP ventilation therapy and total oxygen inhaling,the days of hospitalization,the times of apnea,the failure rate of withdrew from the machine,the usage rate of one dose of pulmonary surfactant (PS) in combined treatment group were 3.0 d (1.0-14.0 d),7.5 d (4.0-21.0 d),16.0 d (6.0-28.0 d),10.0 h(7.0-14.0),8.5％ and 21.3％,which were significant shorter,or less,or lower than those in control group,which were 5.5 d (2.0-18.0 d),11.5 d (6.0-32.0 d),21.0 d (7.0-35.0 d),24.0 (18.0-28.0),25.6％ and 41.9 ％,and all the differences were statistically significant (Z=-2.030,P =0.012;Z=-2.129,P=0.011;Z=-2.889,P=0.009;Z=-2.105,P=0.018;x2=4.712,P=0.030;x2=4.439,P=0.035).④ There were no significant differences between two groups of RDS premature infants in related complication of breath support therapy including air leak syndrome,bronchopulmonary dysplasia (BPD),retinopathy of prematurity (ROP),periventricular-intraventricular hemorrhage (PVH-IVH) and neonatal necrotic enterocolitis (NEC),also caffeine associated adverse reactions including incidence rate of feeding intolerance and heart rate abnormal (P ＞ 0.05).Conclusions Caffeine citrate combined with DuoPAP treatment strategy to premature infants with RDS can effectively improve oxygenation,reduce CO2 retention,shorten the duration of noninvasive mechanical ventilation and total oxygen inhaling,increase the success rate of machine withdrawal.It is safe and effective.%目的 探讨枸橼酸咖啡因联合双水平正压通气(DuoPAP),治疗早产儿呼吸窘迫综合征(RDS)的临床疗效及安全性.方法 选择2016年1月至2017年11月,于东南大学附属徐州医院收治的90例胎龄为28～32周的RDS早产儿为研究对象.采用随机数字表法,将其分为联合治疗组(n=47,采用枸橼酸咖啡因联合DuoPAP治疗)及对照组(n=43,采用DuoPAP治疗,不使用枸橼酸咖啡因).采用成组t检验、x2检验及Kruskal-Wallis H秩和检验,对2组患儿一般临床资料,呼吸支持后0、24、48 h血气分析及呼吸功能指标,临床疗效,呼吸支持治疗相关并发症及药物不良反应等,进行统计学比较.本研究经东南大学附属徐州医院医学伦理委员会审核批准(审批文号:2015伦审第32号),患儿监护人均签署知情同意书.结果 ①2组RDS早产儿中,男性患儿比例、孕次、胎龄、出生体重、生后1 min及5 min Apgar评分,以及母亲胎膜早破率、剖宫产率、产前24 h至7d皮质激素使用率、妊娠期高血压疾病发生率等一般临床资料比较,差异均无统计学意义(P＞0.05).②2组RDS早产儿呼吸支持0h的pH值、动脉血二氧化碳分压(PaCO2)、动脉血氧分压(PaO2)及PaO2/吸入氧气分数比值(P/F)比较,以及呼吸支持24、48 h的pH值比较,差异均无统计学意义(P＞0.05).联合治疗组RDS早产儿呼吸支持后24、48 h的PaO2及P/F,均高于对照组,PaCO2则低于对照组,并且差异均有统计学意义(24 h:t=3.431,P=0.017;t=3.451,P=0.047;t=-4.241,P=0.008.48 h:t=3.238,P=0.048;t=3.576,P=0.009;t=-3.527,P=0.031).③联合治疗组RDS早产儿DuoPAP使用时间、总吸氧治疗时间、住院时间、呼吸暂停次数、撤机失败率、1剂肺表面活性剂(PS)使用率分别为3.0 d(1.0～14.0 d),7.5 d(4.0～21.0 d),16.0 d(6.0～～28.0d),10.0次(7.0～14.0次),8.5％,21.3％,均显著短于、少于、低于对照组的5.5 d(2.0～18.0 d),11.5 d(6.0～32.0 d),21.0 d(7.0～35.0 d),24.0次(18.0～28.0次),25.6％,41.9％,并且差异均有统计学意义(Z=-2.030,P=0.012;Z=-2.129,P=0.011;Z=-2.889,P=0.009;Z=-2.105,P=0.018;x2 =4.712,P=0.030;x2 =4.439,P=0.035).④2组RDS早产儿气漏综合征、支气管肺发育不良(BPD)、早产儿视网膜病(ROP)、脑室周围-脑室内出血(PVH-IVH)及新生儿坏死性小肠结肠炎(NEC)等呼吸支持治疗相关并发症发生率比较,以及喂养不耐受发生率、心率变化等枸橼酸咖啡因药物不良反应发生率比较,差异均无统计学意义(P＞0.05).结论 枸橼酸咖啡因联合DuoPAP治疗早产儿RDS,能有效改善其氧合,减少CO2潴留,缩短无创机械通气及用氧时间,提高撤机成功率,并且安全、有效.
