CAJ | 학술논문

目的评价应用小儿肺热咳喘口服液联合阿奇霉素治疗肺炎支原体(MP)感染的临床价值,为中西医结合治疗儿童MP感染提供依据.方法本研究为前瞻性、随机、开放、平行、阳性药物对照的多中心临床研究.2012年8月到2013年8月将符合入选标准及排除标准的疑似MP下呼吸道感染的发热伴咳嗽患儿作为研究对象,通过简单随机化分组方法分为治疗组和对照组,对照组应用阿奇霉素,治疗组除阿奇霉素外,联用小儿肺热咳喘口服液.收集所有患儿的临床病例资料、咽拭子标本和/或血清.应用巢式PCR检测咽拭子标本中MP23S rRNA,ELISA法或乳胶凝集法检测血清中MP抗体.对PCR阳性和/或血清阳性的下呼吸道感染患儿的临床病例资料进行总结和统计分析.结果对符合入选标准、同时咽拭子MP-DNA和/或血清MP抗体阳性的下呼吸道感染的79例患儿进行分析,对照组42例,治疗组37例,2组患儿在年龄、性别、治疗前病情方面差异无统计学意义(P＜0.05).治疗结束时,对2组患儿的临床疗效按病程进行分析,治疗组患儿的退热时间[(5.14±1.40)d比(6.12±2.45) d,P =0.014]、咳嗽减轻时间[(6.00±1.38)d比(6.92±1.63)d,P=0.026]及消失时间[(8.06±2.16)d比(9.83±2.60)d,P=0.036]均较对照组短,差异有统计学意义.结论小儿肺热咳喘口服液联合阿奇霉素治疗儿童MP下呼吸道感染疗效优于单纯应用西药治疗,可作为临床辅助用药.
목적 평개응용소인폐열해천구복액연합아기매소치료폐염지원체(MP)감염적림상개치,위중서의결합치료인동MP감염제공의거.방법 본연구위전첨성、수궤、개방、평행、양성약물대조적다중심림상연구.2012년8월도2013년8월장부합입선표준급배제표준적의사MP하호흡도감염적발열반해수환인작위연구대상,통과간단수궤화분조방법분위치료조화대조조,대조조응용아기매소,치료조제아기매소외,련용소인폐열해천구복액.수집소유환인적림상병례자료、인식자표본화/혹혈청.응용소식PCR검측인식자표본중MP23S rRNA,ELISA법혹유효응집법검측혈청중MP항체.대PCR양성화/혹혈청양성적하호흡도감염환인적림상병례자료진행총결화통계분석.결과 대부합입선표준、동시인식자MP-DNA화/혹혈청MP항체양성적하호흡도감염적79례환인진행분석,대조조42례,치료조37례,2조환인재년령、성별、치료전병정방면차이무통계학의의(P＜0.05).치료결속시,대2조환인적림상료효안병정진행분석,치료조환인적퇴열시간[(5.14±1.40)d비(6.12±2.45) d,P =0.014]、해수감경시간[(6.00±1.38)d비(6.92±1.63)d,P=0.026]급소실시간[(8.06±2.16)d비(9.83±2.60)d,P=0.036]균교대조조단,차이유통계학의의.결론 소인폐열해천구복액연합아기매소치료인동MP하호흡도감염료효우우단순응용서약치료,가작위림상보조용약.
Objective To evaluate the effectiveness of traditional drug(oral feirekechuan liquid for children) combined Azithromycin for children with Mycoplasma pneumoniae(MP) lower respiratory infection,and to provide optional method for the treatment of MP pneumonia with the combination approach.Methods This study was designed as prospective,randomized,open,paralleled,positive medicine controlled multi-center clinical trial.During Aug.2012 to Aug.2013,patients were included in the study who were suspected of MP infection in pediatric clinics and wards according to the inclusion criteria.All patients were randomly divided into two groups:treatment group (oral feirekechuan liquid for children plus Azithromycin) and control group (Azithromycin).Throat swab and serum specimens were obtained from patients,and also clinical data of all children were collected.MP DNA was detected by the nested PCR method with primers sets for amplification of the binding site of erythromycin at 23S rRNA.ELISA or particle agglutination method was applied to detect MP antibodies in serum.Clinical information of the patients was analyzed and their MP DNA was detected and/or MP-antibodies were positive.Results Seventy-nine patients with perfect clinical data and Nested PCR positive and/or MP-antibodies positive were analyzed.Thirty-seven patients received traditional chinese drug and Azithromycin(treatment group) and 42 patients received only Azithromycin(control group).There were no statistical significance in the sex,age,patients' fundamental conditions between the two groups.After treatment,in the treatment group the time of the fever was shorter than the control group [(5.14 ±-1.40) d vs (6.12 ± 2.45) d,P =0.014].Also,the treatment group took less time for coughing reduction [(6.00 ± 1.38) d vs (6.92 ± 1.63) d,P =0.026]and disappearing[(8.06 ±2.16) d vs (9.83 ±2.60) d,P =0.036].Conclusions Oral feirekechuan liquid for children combined with Azithromycin is more effective than Azithromycin used alone for the treatment of mycoplasma pneumoniae infection in children,and can be used as complementary medicine.