研究疾病:
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小儿细菌性肺炎
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研究疾病代码:
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Target disease:
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Bacterial pneumonia in children
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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I期临床试验
Phase I clinical trial
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研究目的:
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评价中药足浴联合抗生素治疗儿童细菌性肺炎的临床有效性。
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Objectives of Study:
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To evaluate the clinical efficacy of traditional Chinese medicine foot bath combined with antibiotics in the treatment of children with bacterial pneumonia.
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药物成份或治疗方案详述:
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实验组采用河南中医药大学第一附属医院儿科自拟方剂,石膏60g 大青叶30g 黄芩30g 板蓝根30g 葛根30g 连翘30g 北柴胡30g 绵马贯众30g 蒲公英30g,煎汤装袋。每次取中药汤剂一袋(200ml)于足浴桶内,加入38℃~40℃热水3 L,浸泡双足于药液中持续25~30min,以漫过三阴交穴为最佳,每日1次,1周为1个疗程。对照组采用模拟剂,用法与实验组相同。
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Description for medicine or protocol of treatment in detail:
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The experimental group used the self-prepared prescription of the Department of Pediatrics, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, gypsum 60g, Daqingye 30g, Scutellaria baicalensis 30g, Isatidis 30g, Pueraria 30g, Forsythia 30g, Beibuihu 30g, Mianmaguanzhong 30g, and dandelion 30g, decoction and bagging. Each time, take one bag (200ml) of Chinese herbal decoction in the foot bath bucket, add 3 L of hot water at 38°C to 40°C, and soak the feet in the liquid for 25 to 30 minutes. 1 time, 1 week is a course of treatment. The control group was treated with a simulated agent, and the usage was the same as that of the experimental group.
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纳入标准:
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①符合上述西医诊断标准和中医辨证标准;
②3<年龄≤5岁,性别不限;
③可入院接受常规治疗;
④患儿的法定监护人知情并同意接受治疗。
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Inclusion criteria
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①Comply with the above-mentioned western medicine diagnostic criteria and TCM syndrome differentiation criteria;
②3<Age ≤5 years old, gender is not limited;
③Can be admitted to hospital for routine treatment;
④The legal guardian of the child informed and agreed to receive treatment.
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排除标准:
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①确认或怀疑肺炎由非社区获得性细菌病原体导致者;
②肺部浸润的非传染性原因,如肺栓塞、吸入引起的化学性肺炎等;
③胸膜脓胸(不包括非化脓性肺炎性胸腔积液);
④包括但不限于肺炎合并支气管哮喘、支气管异物者,肺炎合并麻疹、百日咳、流 行性感冒者,肺炎合并肺部其他严重原发性疾病者;
⑤既往对β-内酰胺类抗生素成分过敏者;
⑥入组前72h内使用抗生素者;
⑦既往有癫痫或惊厥病史,除外有明确记录的儿童热性惊厥者;
⑧感染可能需要同时使用全身性皮质类固醇者;
⑨有立即危及生命的疾病证据,包括但不限于当前或即将发生的呼吸衰竭、 急性心力衰竭、休克、急性肝功能衰竭、活动性胃肠道出血者;
⑩合并心、肝、肾、消化及造血系统等原发病者;
?肺炎合并膝关节以下皮肤损伤及外伤;
?对中药汤液有皮肤过敏者;
?研究人员认为会损害患儿安全或数据质量的任何情况;
?无法或不愿遵守研究指定的程序和限制者。
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Exclusion criteria:
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① Confirmed or suspected pneumonia caused by non-community-acquired bacterial pathogens;
② Non-infectious causes of pulmonary infiltration, such as pulmonary embolism, chemical pneumonia caused by inhalation, etc.;
③ Pleural empyema (excluding non-purulent pneumonic pleural effusion);
④ Including but not limited to pneumonia complicated by bronchial asthma, bronchial foreign body, pneumonia complicated by measles, whooping cough, influenza, pneumonia complicated by other serious primary lung diseases;
⑤ Those who are allergic to β-lactam antibiotics in the past;
⑥ Those who used antibiotics within 72 hours before enrollment;
⑦Have a history of epilepsy or convulsions in the past, except those with clearly recorded febrile convulsions in children;
⑧ Infection may require simultaneous use of systemic corticosteroids;
⑨ There is evidence of immediate life-threatening disease, including but not limited to current or imminent respiratory failure, acute heart failure, shock, acute liver failure, active gastrointestinal bleeding;
⑩ Patients with primary diseases such as heart, liver, kidney, digestive and hematopoietic systems;
? Pneumonia combined with skin damage and trauma below the knee joint;
? Those who have skin allergies to traditional Chinese medicine decoction;
? Any situation that the researchers believe will compromise the safety of the patient or the quality of the data;
? Those who are unable or unwilling to comply with the procedures and restrictions specified by the study.
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研究实施时间:
Study execute time:
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从From
2022-08-21
至To
2023-04-15
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征募观察对象时间:
Recruiting time:
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从From
2022-08-21
至To
2023-01-15
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