CAJ | 학술논문

目的评价小剂量红霉素治疗新生儿胃食管反流病的疗效及安全性。方法检索并选取2000～2010年国内外公开发表的小剂量红霉素治疗新生儿胃食管反流病的随机对照临床试验文献，筛选符合纳入标准的文献进行研究。按照Jadad评价量表，对文献质量进行评价。由于对照疗法的不同，将纳入文献按对照疗法分类后进行meta分析。计算每种对照疗法的综合效应值。结果符合纳入标准的文献共20篇，对照组采用的疗法主要有三种：体位疗法（5篇），支持疗法（5篇），西咪替丁疗法（5篇）。其他疗法5篇，共纳入患者1201例，其中治疗组604例，对照组597例；患者的日龄均＜28d；治疗组红霉素剂量范围为3～8mg/（kg?d）。小剂量红霉素与主要的三种对照疗法Meta分析结果：体位疗法OR=0.12（0.06～0.25）；支持疗法0R=0.17，（0.07～0.39）；西咪替丁疗法OR=0.41（0.24～0.70）；表明小剂量红霉素的治疗效果优于其他疗法。另外，其不良事件的统计结果显示：发生率均＜5‰（前胸部药疹3.3‰，大便次数增多3.3‰，腹泻1.7‰，代谢性酸中毒3.3‰），说明该疗法比较安全。结论小剂量红霉素治疗新生儿胃食管反流病有效，优于体位疗法、支持疗法，西咪替丁疗法，且不良事件发生率较低。
목적평개소제량홍매소치료신생인위식관반류병적료효급안전성。방법검색병선취2000～2010년국내외공개발표적소제량홍매소치료신생인위식관반류병적수궤대조림상시험문헌，사선부합납입표준적문헌진행연구。안조Jadad평개량표，대문헌질량진행평개。유우대조요법적불동，장납입문헌안대조요법분류후진행meta분석。계산매충대조요법적종합효응치。결과부합납입표준적문헌공20편，대조조채용적요법주요유삼충：체위요법（5편），지지요법（5편），서미체정요법（5편）。기타요법5편，공납입환자1201례，기중치료조604례，대조조597례；환자적일령균＜28d；치료조홍매소제량범위위3～8mg/（kg?d）。소제량홍매소여주요적삼충대조요법Meta분석결과：체위요법OR=0.12（0.06～0.25）；지지요법0R=0.17，（0.07～0.39）；서미체정요법OR=0.41（0.24～0.70）；표명소제량홍매소적치료효과우우기타요법。령외，기불량사건적통계결과현시：발생솔균＜5‰（전흉부약진3.3‰，대편차수증다3.3‰，복사1.7‰，대사성산중독3.3‰），설명해요법비교안전。결론소제량홍매소치료신생인위식관반류병유효，우우체위요법、지지요법，서미체정요법，차불량사건발생솔교저。
Objective To evaluate the curative effect and safety of low-dose erythromycin in the neonate gastroesphageal reflux with Meta-analysis methods. Methods The documents of randomized controlled clinical trials of neonate gastroesophageal reflux disease, which had been published in domestic and foreign journals from the year 2000 to 2010, have been retrieved and screened by the study inclusion criteria. According to the Jadad evaluation questionaire,the documents’ quality had been evaluated. The meta-analysis of comparing with different control methods have been done for evaluating the therapeutic agent of low-dose erythromycin. In addition, the adverse events occurred during treatment were analyzed. Result There are 20 documents iftting inclusion criteria. 1201 cases of children(604 cases in treatment groups and 597 cases in control groups)have been included in these randomized controlled clinical trials, and adopted in three kinds of controls. The results of meta-analysis show that the OR(OR95%CI) are 0.12(0.06~0.25) compared with posture therapy;0.17(0.07~0.39) compared with supportive therapy;0.41(0.24~0.70) compared with the cimetidine treatment. These results show that low-dose erythromycin is more effective than other therapeutic agents. Furthermore, their adverse events reported in these documents are drug eruption (3.3‰), increased stool frequency (3.3‰), diarrhea (1.7‰), metabolic acidosis (3.3‰), all of them were less than 5‰. Therefore, low-dose erythromycin is safe for neonates. Conlusion Low-dose erythromycin therapy is better than postural therapy, supportive therapy and Cimetidine for neonate gastroesphageal relfux,and there are a few of adverse events.