一项中药联合抗生素治疗儿童细菌性肺炎的随机、双盲、安慰剂对照、多中心临床试验，旨在评估其疗效和安全性。
A randomized, double-blind, placebo-controlled, multicenter clinical trial for efficacy and safety of traditional Chinese medicine combined with antibiotics in the treatment of bacterial pneumonia in children.
机构信息
First Affiliated Hospital to Changchun University of Chinese Medicine, Jilin.
Beijing University of Chinese Medicine.
出版信息
Medicine (Baltimore). 2020 Dec 11;99(50):e23217. doi: 10.1097/MD.0000000000023217.
BACKGROUND
Pneumonia is the second leading cause of death in children worldwide after preterm birth and certification. Bacteria, viruses, mycoplasma, and other microorganisms are known to be the main causes of pneumonia, of which bacterial pathogenic factors account for 12.5% of cases. The invention and application of antibiotics have improved the prognosis of children with community-acquired bacterial pneumonia (CABP) to a certain extent, but with the emergence of antibiotic resistance worldwide, the mortality of children with CABP is still high. "Maxing Shigan Decoction" and "Qingfei Decoction" have significant efficacy in the treatment of CABP in children, but there is no standardized randomized controlled trial to systematically evaluate the outcomes.
METHODS
This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial that will randomize 240 patients with CABP to group of Oral Maxing Shigan Decoction, group of Qingfei Decoction or group of placebos administered 3 times a day for 7 days. This study will observe a wide range of clinically relevant endpoints that have been used in clinical trials of pneumonia, including but not limited to clinical cure rate, antibiotic application days, complete antipyretic rate, complete antipyretic days, disease efficacy, traditional Chinese medicine syndrome effect, and antibiotic upgrade treatment rates. Safety will be assessed by monitoring for the incidence of adverse events during the study.
DISCUSSION
This clinical trial is the first to evaluate the efficacy and safety of "Maxing Shigan Decoction" and "Qingfei Decoction" in the treatment of children with CABP. The research results will provide a reference for future research design.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, ChiCTR1900025354. Registered on 14th October 2019-Retrospectively registered, http://www.chictr.org.cn/.
背景
肺炎是全球范围内仅次于早产和认证后的第二大儿童死亡原因。细菌、病毒、支原体等微生物是已知的肺炎主要病因，其中细菌致病因素占病例的 12.5%。抗生素的发明和应用在一定程度上改善了儿童社区获得性细菌性肺炎（CABP）的预后，但随着全球抗生素耐药性的出现，CABP 患儿的死亡率仍然很高。“麻杏石甘汤”和“清肺汤”在治疗儿童 CABP 方面具有显著疗效，但目前尚无标准化的随机对照试验来系统评估其疗效。
方法
本研究是一项随机、双盲、安慰剂对照、多中心临床试验，将 240 例 CABP 患儿随机分为口服麻杏石甘汤组、清肺汤组或安慰剂组，每天 3 次，疗程 7 天。本研究将观察广泛的临床相关终点，这些终点已在肺炎临床试验中使用，包括但不限于临床治愈率、抗生素使用天数、完全退热率、完全退热天数、疾病疗效、中医证候疗效和抗生素升级治疗率。安全性将通过监测研究期间不良事件的发生情况进行评估。
讨论
本临床试验是首次评估“麻杏石甘汤”和“清肺汤”治疗 CABP 儿童的疗效和安全性。研究结果将为未来的研究设计提供参考。
试验注册
中国临床试验注册中心，ChiCTR1900025354。注册于 2019 年 10 月 14 日-回顾性注册，http://www.chictr.org.cn/。
Zotero 插件