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乙酰吉他霉素干混悬剂治疗儿童肺炎支原体肺炎的临床研究

Clinical study of Acetylkitasamycin Dry Suspension in treatment of Mycoplasma pneumoniae pneumonia in children
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摘要 目的观察乙酰吉他霉素干混悬剂治疗儿童肺炎支原体肺炎的临床疗效及安全性。方法选择2022年4月—2023年5月肇庆市妇幼保健院收治的肺炎支原体肺炎患儿为研究对象,随机分为试验组(乙酰吉他霉素干混悬剂组)及对照组(阿奇霉素干混悬剂组)。两组同时给予常规治疗,包括给予退热、止咳、平喘等基础对症治疗,疗程1~2周。比较两组患儿治疗后的临床疗效,观察症状消退情况及治疗期间药物不良反应发生情况。结果试验组60例和对照组60例纳入分析,试验期间有6例患儿脱落或失访。治疗后,两组的总有效率均为100%,无统计学差异。两组药物均可有效改善患者发热、湿啰音、咳嗽、咳痰等症状。访视1[首次用药后(5±2)d]时,乙酰吉他霉素干混悬剂在湿啰音较基线改善率、显效率方面优于阿奇霉素,可能乙酰吉他霉素治疗肺炎支原体肺炎起效更快。访视2[首次用药后(10±2)d]时,乙酰吉他霉素干混悬剂在咳嗽症状缓解率方面优于阿奇霉素,但未能排除年龄因素对结论的影响。治疗期间,试验组和对照组的药物不良反应发生率差异无统计学意义(P>0.05)。依从性调研发现,两组患者依从性评价良好,差异无统计学意义(P>0.05)。结论乙酰吉他霉素干混悬剂可有效治疗儿童肺炎支原体肺炎,患儿依从性好,耐受性好。乙酰吉他霉素干混悬剂治疗可快速有效缓解咳嗽、湿啰音等临床症状症状,具有一定优势。 Objective To observe the clinical efficacy and safety of Acetylkitasamycin Dry Suspension on Mycoplasma pneumoniae pneumonia(MPP)in children.Methods From April 2022 to May 2023,the children with MPP diagnosed in Zhaoqing Maternal and Child Health Hospital were collected as the research objects.The subjects were randomly divided into a treatment group(oral administrate Acetylkitasamycin Dry Suspension)and a control group(oral administrate Azithromycin Dry Suspension).The two groups were given routine treatment,including basic symptomatic treatment such as antipyretic,relieving cough,resolving phlegm and relieving asthma,The treatment last for 1—2 weeks.Compare with the clinical efficacy of the two groups after treatment,disappearance and adverse drug reactions during treatment were compared before and after treatment.Results There were 60 cases in treatment group and 60 cases in control group.During the treatment period,six children were dropped out or lost to follow-up.Two group drugs can effectively improve the symptoms of fever,cough,sputum and pans.At interview 1[(5±2)days after the first dose],the improvement rate of crackles baseline and efficiency in the Acetylkitasamycin Dry Suspension group were better than that in Azithromycin group,which may indicate that acetylkitasamycin has a faster effect on MPP.At the interview 2[(10±2)days after the first administration],Acetylkitasamycin Dry Suspension had a better remission rate of cough symptoms than azithromycin,but could not be ruled out the influence of ages.During the treatment period,the incidences of adverse drug reactions in treatment group and control group during treatment were no significant difference(P>0.05).Through the survey of compliance,two groups have good medical compliance.Conclusion Acetylguitamycin Dry Suspension can effectively treat MPP Children with good compliance and tolerance.Acetylkitasamycin Dry Suspension has good clinical efficacy in treatment of children with MPP advantages in onset time and remission rate of cough symptoms.
作者 陈雅杏 陈少君 苏定邦 梁燕芬 卢华贤 梁颖欣 江珏贤 CHEN Yaxing;CHEN Shaojun;SU Dingbang;LIANG Yanfen;LU Huaxian;LIANG Yingxin;JIANG Juexian(Zhaoqing Maternal and Child Health Hospital,Zhaoqing 526020,China)
出处 《药物评价研究》 CAS 北大核心 2024年第3期611-616,共6页 Drug Evaluation Research
基金 广东省肇庆市科技创新指导类立项项目(2022040310001)。
关键词 乙酰吉他霉素干混悬剂 阿奇霉素 儿童 肺炎支原体肺炎 疗效 Acetylkitasamycin Dry Suspension Azithromycin children Mycoplasma pneumoniae pneumonia clinical effect
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