ChiCTR2500113319 版本V1.0 版本创建时间2025/11/27 09:07:38 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500113319 

最近更新日期：

Date of Last Refreshed on：

2025-11-27 09:07:31 

注册时间：

Date of Registration：

2025-11-27 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

BAL联合镜下喷洒吸入用痰粘液溶解剂在儿童非喘息性难治性肺炎治疗中的临床应用研究

Public title：

Clinical Application of BAL Combined with Microscopic Spraying Inhalation of Sputum Mucus Lysate in the Treatment of Non asthmatic and Refractory Pneumonia in Children

注册题目简写：

English Acronym：

研究课题的正式科学名称：

BAL联合镜下喷洒吸入用痰粘液溶解剂在儿童非喘息性难治性肺炎治疗中的临床应用研究

Scientific title：

Clinical Application of BAL Combined with Microscopic Spraying Inhalation of Sputum Mucus Lysate in the Treatment of Non asthmatic and Refractory Pneumonia in Children

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

蔡杰荣 

研究负责人：

蔡杰荣 

Applicant：

Cai Jierong 

Study leader：

Cai Jierong 

申请注册联系人电话：

Applicant telephone：

+86 138 2449 3238

研究负责人电话：

Study leader's telephone：

+86 138 2449 3238

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

xmg668@163.com

研究负责人电子邮件：

Study leader's E-mail：

xmg668@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

No. 8 Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou City, Guangdong Province. Pediatrics Department of Panyu District Central Hospital

申请注册联系人通讯地址：

中国广东省广州市番禺区桥南街福愉东路8号

研究负责人通讯地址：

中国广东省广州市番禺区桥南街福愉东路8号

Applicant address：

No. 8, Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou, Guangdong, China

Study leader's address：

No. 8, Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou, Guangdong, China

申请注册联系人邮政编码：

Applicant postcode：

511400

研究负责人邮政编码：

Study leader's postcode：

511400

申请人所在单位：

广州市番禺区中心医院

Applicant's institution：

Guangzhou Panyu District Central Hospital

研究负责人所在单位：

广州市番禺区中心医院

Affiliation of the Leader：

Guangzhou Panyu District Central Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

PYRC-2022-009

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

广州市番禺区中心医院伦理委员会

Name of the ethic committee：

Ethics Committee of Panyu District Central Hospital in Guangzhou

伦理委员会批准日期：

Date of approved by ethic committee：

2022-05-14 00:00:00

伦理委员会联系人：

陈汉威

Contact Name of the ethic committee：

Chen Hanwei

伦理委员会联系地址：

中国广东省广州市番禺区桥南街福愉东路8号

Contact Address of the ethic committee：

No. 8, Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 189 2223 8906

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

广州市番禺区中心医院

Primary sponsor：

Guangzhou Panyu District Central Hospital

研究实施负责（组长）单位地址：

中国广东省广州市番禺区桥南街福愉东路8号

Primary sponsor's address：

No. 8, Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou, Guangdong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

广州

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

广州市番禺区中心医院

具体地址：

中国广东省广州市番禺区桥南街福愉东路8号

Institution
hospital：

Guangzhou Panyu District Central Hospital

Address：

No. 8, Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou, Guangdong, China

经费或物资来源：

2022 广州市卫健委一般引导项目

Source(s) of funding：

2022 Guangzhou Health Technology General Guidance Project

Target disease：

Non wheezing refractory pneumonia in children

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究在临床常规治疗基础上应用BAL，并联合局部喷洒吸入用乙酰半胱氨酸溶液，或吸入用盐酸氨溴索溶液，观察其临床疗效及对免疫功能的影响，以期寻找一种能够明显改善呼吸道分泌物增多的难治性肺炎患儿临床症状，纠正免疫紊乱，提高临床治疗效果，且安全性较高的治疗方法，并进行推广应用。  

Objectives of Study：

This study applies BAL on the basis of routine clinical treatment, combined with local spraying of inhaled acetylcysteine solution or inhaled ambroxol hydrochloride solution, to observe its clinical efficacy and impact on immune function, in order to find a treatment method that can significantly improve the clinical symptoms of refractory pneumonia in children with increased respiratory secretions, correct immune disorders, improve clinical treatment effectiveness, and has high safety, And promote and apply it.

药物成份或治疗方案详述：

在本项目中，我们计划选取2022年1月至2023年12我院收治的108例儿童非喘息性难治性肺炎患儿作为研究对象，采用随机数字表法分为对照组和研究组1、研究组2，每组各36例，三组均进行常规抗感染、止咳化痰、雾化治疗，同时均给予BAL术治疗，研究组1患儿在此基础上联合纤维支气管镜下对肺炎累及叶段局部喷洒吸入用乙酰半胱氨酸溶液，研究组2患儿在此基础上联合纤维支气管镜下对肺炎累及叶段局部喷洒吸入用氨溴索溶液，治疗期间观察、记录三组患儿临床表现情况（体温恢复时间、咳嗽消失时间、肺部啰音消失时间、影像学恢复时间、住院时间），治疗后比较三组患儿的上述治疗效果。三组患儿分别于治疗前和治疗后，留取EDTA抗凝全血应用流失细胞计数检测T淋巴细胞群，及采用酶联免疫法测定患儿血清中细胞因子CD3 +、CD4 +、CD8 +、 TNF-α、IL-6和IL-10水平，探讨支气管镜肺泡灌洗联合局部喷洒吸入用痰粘液溶解剂对非喘息性难治性肺炎患儿免疫功能及细胞因子的影响。并记录三组患儿在治疗过程中不良反应发生情况。 

Description for medicine or protocol of treatment in detail：

In this project, we plan to select 108 children with non wheezing refractory pneumonia admitted to our hospital from January 2022 to December 2023 as the research subjects. They will be randomly divided into a control group, a study group 1, and a study group 2 using a random number table method, with 36 cases in each group. All three groups will receive routine anti infection, cough and phlegm relief, nebulization treatment, and BAL surgery treatment, On this basis, Study Group 1 children combined with fiberoptic bronchoscopy to locally spray inhaled acetylcysteine solution on the affected lung segments of pneumonia. Study Group 2 children combined with fiberoptic bronchoscopy to locally spray inhaled ambroxol solution on the affected lung segments of pneumonia. During the treatment period, observation was conducted Record the clinical manifestations of three groups of children (temperature recovery time, cough disappearance time, lung rale disappearance time, imaging recovery time, and hospitalization time), and compare the above treatment effects of the three groups of children after treatment. Before and after treatment, EDTA anticoagulant whole blood was collected from three groups of children, and T lymphocyte populations were measured by loss cell count. Enzyme linked immunosorbent assay was used to measure cytokines CD3+, CD4+, CD8+, and TNF in the serum of the children- α Exploring the effects of bronchoalveolar lavage combined with local spraying of sputum mucus solubilizers on immune function and cytokines in children with non asthmatic refractory pneumonia, based on the levels of IL-6 and IL-10. And record the occurrence of adverse reactions during the treatment process in three groups of children. 

纳入标准：

1.符合难治性肺炎的诊断标准：针对肺部感染采取了全面、有效的措施后，临床仍然不能获得明显疗效或理想结果的肺炎称为难治性肺炎，包括（1）部分疗效不佳的重症肺炎、（2）久治不愈的肺炎及（3）吸收缓慢的肺炎。其中：1）重症肺炎是指出现严重的通气和（或）换气功能障碍或肺内外并发症者；2）久治不愈指病程延长（＞2周），经积极治疗无效且病情恶化、迁延不愈者；3）吸收缓慢是指患者在使用抗感染药物治疗后症状、体征虽有好转，但2周后复查肺部影响学检查，病灶吸收＜50%者； 2.纤支镜检查排除气道异物、先天性肺发育不良情况； 3.患儿家长知情同意。

Inclusion criteria

1.The diagnostic criteria of refractory pneumonia: pneumonia that has not achieved obvious clinical efficacy or ideal results after comprehensive and effective measures have been taken for pulmonary infection is called refractory pneumonia, including (1) some severe pneumonia with poor efficacy, (2) pneumonia that has not been cured for a long time, and (3) pneumonia with slow absorption. Among them: 1) Severe pneumonia refers to severe ventilation and/or gas exchange dysfunction or extrapulmonary complications; 2) Prolonged disease course (> 2 weeks), refractory to active treatment and deterioration; 3) Slow absorption refers to the patients whose symptoms and signs were improved after the use of anti-infective drugs, but the pulmonary pathological examination after 2 weeks showed that the absorption of lesions was less than 50%; 2. Airway foreign body and congenital pulmonary dysplasia were excluded by fiberoptic bronchoscopy; 3. Informed consent was obtained from the parents.

排除标准：

（1）有喘鸣音/哮鸣音症状或体征患者； （2）严重心肺功能减退者； （3）严重心律紊乱； （4）高热； （5）活动性大咯血者； （6）严重的出血性疾病； （7）凝血功能障碍；严重的肺动脉高压及可能诱发大咯血者等； （8）严重营养不良，不能耐受手术者； （9）对研究所用药物过敏者； （10）其他严重不良反应、并发症，难以继续治疗。

Exclusion criteria：

(1) patients with wheezing/wheezing symptoms or signs; (2) severe cardiopulmonary dysfunction; (3) severe arrhythmia; (4) high fever; (5) patients with active hemoptysis; (6) severe hemorrhagic disease; (7) coagulation dysfunction; Severe pulmonary hypertension and may induce massive hemoptysis; (8) patients with severe malnutrition who could not tolerate surgery; (9) allergic to investigational drugs; (10) other serious adverse reactions and complications, which were difficult to continue treatment.

研究实施时间：

Study execute time：

从 From 2022-05-17 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2022-05-17 00:00:00 至 To 2023-11-13 00:00:00  

干预措施：

Interventions：

组别：

研究组1

样本量：

36

Group：

Research Group 1

Sample size：

干预措施：

支气管镜肺泡灌洗术联合支气管镜镜下喷洒吸入用盐酸氨溴索溶液

干预措施代码：

Intervention：

BAL+Injecting Acetylcysteine Solution for Inhalation under bronchoscopy

Intervention code：

组别：

研究组2

样本量：

36

Group：

Research Group 2

Sample size：

干预措施：

支气管镜肺泡灌洗术联合支气管镜镜下喷洒吸入用盐酸氨溴索溶液

干预措施代码：

Intervention：

BAL+Injecting Ambroxol Hydrochloride Solution for Inhalation under bronchoscopy

Intervention code：

组别：

对照组

样本量：

36

Group：

Control Group

Sample size：

干预措施：

支气管镜肺泡灌洗术

干预措施代码：

Intervention：

BAL

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

 广州 

Country：

China 

Province：

Guangdong 

City：

Guangzhou 

单位(医院)：

广州市番禺区中心医院 

单位级别：

三甲 

Institution
hospital：

Guangzhou Panyu District Central Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

热退时间

指标类型：

主要指标

Outcome：

Hot annealing time

Type：

Primary indicator

测量时间点：

入院后每天测量

测量方法：

体温计测量

Measure time point of outcome：

Measuring temperature every day after admission.

Measure method：

Measuring temperature by thermometer

指标中文名：

肺部啰音消失时间

指标类型：

主要指标

Outcome：

Lung rale disappearance time

Type：

Primary indicator

测量时间点：

入院后每天听诊

测量方法：

听诊器听诊肺部

Measure time point of outcome：

Measuring temperature every day after admission.

Measure method：

Stethoscope auscultates the lungs

指标中文名：

血白介素6

指标类型：

主要指标

Outcome：

Interleukin-6

Type：

Primary indicator

测量时间点：

支气管镜检查+肺泡灌洗术前后

测量方法：

ELISA方法检测血清

Measure time point of outcome：

Before and after BAL

Measure method：

Detection of serum by ELISA

指标中文名：

血白介素10

指标类型：

主要指标

Outcome：

Interleukin-10

Type：

Primary indicator

测量时间点：

支气管镜检查+肺泡灌洗术前后

测量方法：

ELISA方法检测血清

Measure time point of outcome：

Before and after BAL

Measure method：

Detection of serum by ELISA

指标中文名：

肿瘤坏死因子-α

指标类型：

主要指标

Outcome：

Tumor Necrosis Factor-α

Type：

Primary indicator

测量时间点：

支气管镜检查+肺泡灌洗术前后

测量方法：

ELISA方法检测血清

Measure time point of outcome：

Before and after BAL

Measure method：

Detection of serum by ELISA

指标中文名：

分化簇3+因子

指标类型：

次要指标

Outcome：

Cluster of Differentiation 3+

Type：

Secondary indicator

测量时间点：

支气管镜检查+肺泡灌洗术前后

测量方法：

流式细胞术

Measure time point of outcome：

Before and after BAL

Measure method：

Flow cytometry

指标中文名：

分化簇4+因子

指标类型：

次要指标

Outcome：

Cluster of Differentiation 4+

Type：

Secondary indicator

测量时间点：

支气管镜检查+肺泡灌洗术前后

测量方法：

流式细胞术

Measure time point of outcome：

Before and after BAL

Measure method：

Flow cytometry

指标中文名：

分化簇8+因子

指标类型：

次要指标

Outcome：

Cluster of Differentiation 8+

Type：

Secondary indicator

测量时间点：

支气管镜检查+肺泡灌洗术前后

测量方法：

流式细胞术

Measure time point of outcome：

Before and after BAL

Measure method：

Flow cytometry

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

血液

Sample Name：

Blood

Tissue：

Blood

人体标本去向

 使用后销毁  

说明

使用后销毁

Fate of sample：

Destruction after use  

Note：

Destruction after use

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由研究者使用信封随机分组法分组：把写有黑色字编号1-36号纸条放进信封作为对照组病例编号，把写有蓝色字编号1-36号纸条放进同一信封作为研究组1病例编号，把写有色字编号1-36号纸条放进同一信封，充分摇匀纸条，每个入组病例抽取一张纸条租入。

Randomization Procedure (please state who generates the random number sequence and by what method)：

Researchers used envelope random grouping method to group: black numbered 1-36 paper strips were placed in the envelope as the control group case number, blue numbered 1-36 paper strips were placed in the same envelope as the study group 1 case number, and colored numbered 1-36 paper strips were placed in the same envelope. The paper strips were thoroughly shaken, and one paper strip was taken from each enrolled case and rented.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

正常程序揭盲：先在试验结束后，核对CRF与签名后，进行揭盲。

Blinding：

Normal procedure unblinding: First, after the experiment is completed, check the CRF and signature before unblinding.

是否共享原始数据：

IPD sharing

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

公开原始数据方式：邮箱：BAL_Ab_Ac@163.com，密码：Bal12345678，公开日期时间：2025年11月26日

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Method for publicly releasing the original data: Email: BAL_Ab_Ac@163.com, Password: Bal12345678, Public release date and time: November 26, 2025

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

采用记录表(Case Record Form, CRF)方式

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Using Case Record Form (CRF)

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-11-27 09:07:31