中药注射液治疗儿童肺炎支原体感染临床疗效的增强作用：一项随机对照试验方案。
Clinical efficacy enhancement of a Chinese herbal injection in the treatment of mycoplasma pneumonia in children: A protocol of randomized controlled trial.
机构信息
The First People's Hospital of Tianmen City, Tianmen.
The Central Hospital of Wuhan, Wuhan, Hubei Province.
出版信息
Medicine (Baltimore). 2021 Mar 26;100(12):e25135. doi: 10.1097/MD.0000000000025135.
BACKGROUND
Mycoplasma pneumonia is a common disease in pediatrics, and macrolides is the first choice for the treatment. However, the increase of antibiotic resistance of macrolides makes it more and more complicated for clinical treatment. Due to the long term treatment of macrolides, it may increase the incidence of nausea, vomiting, abdominal pain, diarrhea, and other gastrointestinal symptoms, vascular phlebitis, liver and kidney function damage. Tanreqing injection, a Chinese herbal extraction injection, has advantages in the treatment of mycoplasma pneumonia in children, and it could improve the curative effect, shortening the course of disease, and reducing the side effects. Yet there is a lack of standard clinical studies to verify it, so this randomized controlled trial (RCT) will evaluate the efficacy and safety of Tanreqing injection combined with azithromycin in the treatment of mycoplasma pneumonia in children.
METHODS
This is a prospective RCT to study the efficacy and safety of Tanreqing injection combined with azithromycin in the treatment of mycoplasma pneumonia in children. It is approved by the Clinical Research Society of our hospital. According to the 1:1 ratio, the patients will be randomly divided into Tanreqing injection combined with azithromycin group (observation group) and azithromycin group (control group). Duration of hospitalization, clinical improvement 7 days after admission, changing laboratory tests, pulmonary function, immunoglobulin level, and adverse reactions will be compared between the 2 groups. The data will be analyzed by SPSS 16.0 software.
DISCUSSION
This study will evaluate the efficacy and safety of Tanreqing injection combined with azithromycin in the treatment of mycoplasma pneumonia in children. The results of this experiment will provide clinical basis for the treatment of mycoplasma pneumonia in children with Tanreqing injection combined with azithromycin.
TRIAL REGISTRATION
OSF Registration number: DOI 10.17605/OSF.IO/X6VFS.
背景
肺炎支原体是儿科的常见病，大环内酯类药物是治疗的首选。然而，由于大环内酯类药物的抗生素耐药性增加，使得临床治疗越来越复杂。由于长期使用大环内酯类药物，可能会增加恶心、呕吐、腹痛、腹泻等胃肠道症状、血管静脉炎、肝肾功能损害的发生率。痰热清注射液是一种中药提取注射液，在儿童肺炎支原体治疗方面具有优势，可提高疗效，缩短病程，减少副作用。但缺乏标准的临床研究来验证，因此本随机对照试验（RCT）将评估痰热清注射液联合阿奇霉素治疗儿童肺炎支原体的疗效和安全性。
方法
这是一项前瞻性 RCT 研究，评估痰热清注射液联合阿奇霉素治疗儿童肺炎支原体的疗效和安全性。该研究已获得我院临床研究学会的批准。按照 1:1 的比例，将患者随机分为痰热清注射液联合阿奇霉素组（观察组）和阿奇霉素组（对照组）。比较两组患者的住院时间、入院后 7 天临床改善情况、实验室检查结果变化、肺功能、免疫球蛋白水平及不良反应。采用 SPSS 16.0 软件进行数据分析。
讨论
本研究将评估痰热清注射液联合阿奇霉素治疗儿童肺炎支原体的疗效和安全性。该实验的结果将为儿童肺炎支原体采用痰热清注射液联合阿奇霉素治疗提供临床依据。
试验注册
OSF 注册号：DOI 10.17605/OSF.IO/X6VFS。
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