ChiCTR2600125113 版本V1.0 版本创建时间2026/05/21 14:42:00 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：

 ChiCTR2600125113 

最近更新日期：

Date of Last Refreshed on：

 2026-05-21 14:41:51 

注册时间：

Date of Registration：

 2026-05-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

2016年至2026年中国中毒性表皮坏死松解症死亡率趋势：一项全国多中心回顾性队列研究

Public title：

Trends in Mortality Due to Toxic Epidermal Necrolysis in China from 2016 to 2026: A National Multicenter Retrospective Cohort Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

2016年至2026年中国中毒性表皮坏死松解症死亡率趋势：一项全国多中心回顾性队列研究

Scientific title：

Trends in Mortality Due to Toxic Epidermal Necrolysis in China from 2016 to 2026: A National Multicenter Retrospective Cohort Study

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：

党宁宁 

研究负责人：

党宁宁 

Applicant：

Ningning Dang 

Study leader：

Ningning Dang 

申请注册联系人电话：

Applicant telephone：

 +86 531 68778303

研究负责人电话：

Study leader's
telephone：

+86 531 8569 5173

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：

 dangningning@sdfmu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 15318816250@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)：

申请注册联系人通讯地址：

山东省济南市槐荫区经五纬七路324号

研究负责人通讯地址：

山东省济南市槐荫区经五纬七路324号

Applicant address：

No. 324, Jingwu Weiqi Road, Huaiyin District, Jinan City, Shandong Province

Study leader's address：

No. 324, Jingwu Weiqi Road, Huaiyin District, Jinan City, Shandong Province

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

山东第一医科大学附属省立医院

Applicant's institution：

Shandong Provincial Hospital Affiliated to Shandong First Medical University

研究负责人所在单位：

山东省立医院

Affiliation of the Leader：

Shandong Provincial Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 省医伦批第（SWYX:NO. 2026-1029）

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：

山东省立医院涉及人的生物医学研究伦理委员会

Name of the ethic committee：

Biomedical Research Ethic Committee of Shandong Provincial Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-23 00:00:00

伦理委员会联系人：

杨爱辉

Contact Name of the ethic committee：

Yang AiHui

伦理委员会联系地址：

山东省济南市槐荫区经五纬七路324号

Contact Address of the ethic committee：

No. 324, Jingwu Weiqi Road, Huaiyin District, Jinan City, Shandong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 531 68776025

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 yangaihui@sdfmu.edu.cn

研究实施负责（组长）单位：

山东省立医院（山东省儿童医院）

Primary sponsor：

Shandong Provincial Hospital

研究实施负责（组长）单位地址：

山东省济南市槐荫区经五纬七路324号

Primary sponsor's address：

No. 324, Jingwu Weiqi Road, Huaiyin District, Jinan City, Shandong Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

山东省

市(区县)：

Country：

China

Province：

Shandong

City：

单位(医院)：

山东省立医院（山东省儿童医院）

具体地址：

山东省济南市槐荫区经五纬七路324号

Institution
hospital：

Shandong Provincial Hospital

Address：

No. 324, Jingwu Weiqi Road, Huaiyin District, Jinan City, Shandong Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-funded project

研究疾病：

中毒性表皮坏死松解症  

Target disease：

Toxic Epidermal Necrolysis

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

研究旨在评估2016年至2026年十年间中国中毒性表皮坏死松解症（Toxic Epidermal Necrolysis，TEN）的死亡率变化趋势，探究影响TEN死亡率变化的关键因素（如诊疗水平、药物使用、人口结构等），全面掌握我国TEN的死亡流行特征及防控效果，从而为临床TEN诊疗规范的优化、高风险人群的精准防控及全国性TEN防控体系的完善提供科学、可靠的临床依据。  

Objectives of Study：

This study is designed to assess the changing trend of mortality associated with toxic epidermal necrolysis (TEN) in China over the ten-year period from 2016 to 2026, and to explore the key factors that affect the variations in TEN mortality, such as the level of diagnosis and treatment, drug application, population structure. By comprehensively grasping the epidemiological characteristics of TEN-related deaths and the effectiveness of prevention and control measures in China, this study aims to provide scientific and reliable clinical evidence for the optimization of clinical diagnosis and treatment standards for TEN, the precise prevention and control of high-risk populations, and the improvement of the national TEN prevention and control system.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 确诊为中毒性表皮坏死松解症（TEN）的受试者，诊断严格符合 2021 年《Stevens-Johnson 综合征/中毒性表皮坏死松解症诊疗专家共识》中 TEN 的诊断标准，且经研究团队复核确认，排除与 Stevens-Johnson 综合征（SJS）的混淆； 2. 发病时间介于 2016 年至 2026 年之间； 3. 病例资料完整，可清晰获取明确的发病时间、诱因（如药物暴露史）、诊疗过程（含干预措施）、预后结局（存活/死亡）及相关影响因素（如年龄、基础疾病）数据； 4. 病例来源于本研究纳入的全国多中心合作医疗机构； 5. 病例相关诊疗及随访资料可追溯、可核查，符合回顾性队列研究数据采集要求。

Inclusion criteria

1. Participants with a confirmed diagnosis of toxic epidermal necrolysis (TEN). The diagnosis must strictly meet the TEN diagnostic criteria specified in the 2021 Expert Consensus on the Diagnosis and Treatment of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis, and must be reviewed and confirmed by the research team to exclude misclassification with Stevens-Johnson syndrome (SJS). 2. Disease onset occurred between 2016 and 2026, inclusive. 3. Complete case records are available, including clearly documented disease onset time, suspected triggers such as drug exposure history, diagnostic and treatment process including interventions, clinical outcome including survival or death, and relevant influencing factors such as age, underlying diseases, and SCORTEN score. 4. Cases are from the nationwide multicenter participating medical institutions included in this study. 5. Relevant diagnosis, treatment, and follow-up data are traceable and verifiable, and meet the data collection requirements for a retrospective cohort study.

排除标准：

1. 临床表现疑似 TEN，但经研究团队复核，因表皮松解面积不典型、特征模糊，无法明确鉴别为 TEN，难以确认 TEN 为主要发病及致死原因； 2. 病例资料不完整，关键信息（如发病时间、诊疗措施、预后结局）缺失或无法核查，影响研究数据的准确性； 3. 合并严重的终末期基础疾病（如晚期恶性肿瘤、严重心脑血管疾病、终末期肾病等），经研究团队复核确认，患者死亡明确由基础疾病导致，与 TEN 病变及诊疗过程无关联； 4. 病例经研究团队复核后，确认存在误诊、漏诊情况，不符合 TEN 诊断标准； 5. 随访期间失访，经医疗机构病案系统查询、电话随访等多种方式干预后，仍无法明确患者最终预后结局（存活/死亡）。

Exclusion criteria：

1. Cases with clinical manifestations suspected of TEN, but after review by the research team, cannot be clearly confirmed as TEN due to atypical epidermal detachment area or ambiguous clinical features, making it difficult to determine whether TEN was the primary cause of disease onset and death. 2. Cases with incomplete medical records, in which key information such as disease onset time, treatment measures, or clinical outcome is missing or cannot be verified, thereby affecting the accuracy of the research data. 3. Cases complicated by severe end-stage underlying diseases, such as advanced malignant tumors, severe cardiovascular or cerebrovascular diseases, or end-stage renal disease, where the research team confirms that death was clearly caused by the underlying disease and was unrelated to TEN lesions or the TEN diagnosis and treatment process. 4. Cases confirmed by the research team to involve misdiagnosis or missed diagnosis, and therefore not meeting the diagnostic criteria for TEN. 5. Cases lost to follow-up, for which the final clinical outcome (survival or death) cannot be determined despite multiple attempts, including searches of the medical institution's medical record system and telephone follow-up.

研究实施时间：

Study execute time：

从 From 2026-06-01 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2027-06-01 00:00:00

干预措施：

Interventions：

组别：

TEN患者回顾性队列

样本量：

 2000

Group：

Retrospective cohort of patients with TEN

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

  

Country：

China

Province：

Shandong

City：

单位(医院)：

 山东省立医院 

单位级别：

 三级甲等 

Institution
hospital：

Shandong Provincial Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China

Province：

Zhejiang

City：

单位(医院)：

 浙江大学医学院附属第一医院 

单位级别：

 三级甲等 

Institution
hospital：

The First Affiliated Hospital of Zhejiang University School of Medicine

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 中山大学孙逸仙纪念医院 

单位级别：

 三级甲等 

Institution
hospital：

The First Affiliated Hospital of Zhejiang University School of Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

TEN患者死亡率

指标类型：

主要指标

Outcome：

Mortality rate among patients with toxic epidermal necrolysis

Type：

Primary indicator

测量时间点：

出院时或随访终点

测量方法：

根据病案系统、出院记录、死亡记录及随访资料，判断患者最终转归为存活或死亡，并计算死亡率。

Measure time point of outcome：

At discharge or at the end of follow-up

Measure method：

Mortality will be determined based on medical records, discharge summaries, death records, and follow-up information. The mortality rate will be calculated as the number of deaths divided by the total number of included TEN cases.

指标中文名：

年度死亡率

指标类型：

次要指标

Outcome：

Annual mortality rate among patients with toxic epidermal necrolysis

Type：

Secondary indicator

测量时间点：

按发病年份统计，出院时或随访终点确认结局

测量方法：

根据病案系统、出院记录、死亡记录及随访资料，按发病年份统计每年度死亡例数和纳入病例总数。年度死亡率=该年度死亡例数/该年度纳入TEN患者总例数×100%。

Measure time point of outcome：

By year of disease onset, with outcome confirmed at discharge or at the end of follow-up

Measure method：

Annual mortality will be determined based on medical records, discharge summaries, death records, and follow-up information. Patients will be grouped by year of disease onset. Annual mortality will be calculated as the number of deaths in each year divided by the total number of included TEN patients in that year, multiplied by 100%.

指标中文名：

地区死亡率

指标类型：

次要指标

Outcome：

Regional mortality rate among patients with toxic epidermal necrolysis

Type：

Secondary indicator

测量时间点：

出院时或随访终点

测量方法：

根据参研中心所在地区及患者预后结局，按地区统计死亡例数和纳入病例总数。地区死亡率=该地区死亡例数/该地区纳入TEN患者总例数×100%。

Measure time point of outcome：

At discharge or at the end of follow-up

Measure method：

Regional mortality will be determined according to the region of each participating center and patient outcome status. Regional mortality will be calculated as the number of deaths in each region divided by the total number of included TEN patients in that region, multiplied by 100%.

指标中文名：

死亡相关危险因素

指标类型：

主要指标

Outcome：

Risk factors associated with mortality among patients with toxic epidermal necrolysis

Type：

Primary indicator

测量时间点：

出院时或随访终点完成结局确认后分析

测量方法：

根据病案系统、入院记录、病程记录、用药记录、实验室检查、治疗记录及随访资料，收集患者年龄、性别、基础疾病、疑似诱发药物、SCORTEN评分、治疗方式、ICU监护情况及地区等因素，并采用多因素logistic回归分析其与死亡结局的相关性

Measure time point of outcome：

After outcome confirmation at discharge or at the end of follow-up

Measure method：

Risk factors will be assessed based on medical records, admission records, progress notes, medication records, laboratory findings, treatment records, and follow-up information. Variables including age, sex, underlying diseases, suspected causative drugs, SCORTEN score, treatment modality, intensive care unit monitoring, and region will be analyzed for their association with mortality using multivariable logistic regression.

指标中文名：

不同治疗方案组死亡率

指标类型：

次要指标

Outcome：

Mortality rate according to treatment modality among patients with toxic epidermal necrolysis

Type：

Secondary indicator

测量时间点：

出院时或随访终点

测量方法：

根据医嘱记录、治疗记录及出院记录，记录患者接受的TEN相关治疗方式，包括常规综合治疗、系统性糖皮质激素、静脉注射免疫球蛋白、生物制剂、JAK抑制剂及其他治疗。不同治疗方案组死亡率=该治疗方案组死亡例数/该治疗方案组纳入患者总例数×100%。

Measure time point of outcome：

At discharge or at the end of follow-up

Measure method：

Treatment modality will be determined based on medication orders, treatment records, and discharge summaries, including conventional supportive care, systemic corticosteroids, intravenous immunoglobulin, biologic agents, Janus kinase inhibitors, and other treatments. Mortality in each treatment group will be calculated as the number of deaths in that group divided by the total number of included patients in the same group, multiplied by 100%.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

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）：

无

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

None

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：

无

Blinding：

None

是否共享原始数据：

IPD sharing

否No

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）：

无

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

None

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：

本研究采用统一病例报告表（CRF）收集研究数据。各参与中心由经过培训的研究人员根据病案系统、出院记录、检查检验结果及随访资料进行数据提取。所有病例均采用研究编号进行去标识化处理，研究数据库中不录入姓名、身份证号等直接识别信息。数据录入后由研究团队进行双人交叉核查，对缺失、异常或逻辑不一致的数据进行复核和更正。研究数据由专人负责管理，采用加密存储和权限控制，仅限授权研究人员访问。研究结果仅以汇总统计形式进行分析和发表，不展示任何可识别个体身份的信息。

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

Data will be collected using a standardized case report form. Trained investigators at each participating center will extract data from medical record systems, discharge summaries, laboratory and examination results, and follow-up records. All cases will be de-identified using study codes. Direct identifiers, such as names, national identification numbers will not be entered into the research database. Data will be checked by two independent researchers, and missing, abnormal, or inconsistent data will be verified and corrected when necessary. The study data will be stored securely with password protection and access control, and will only be accessible to authorized study personnel. Study results will be analyzed and reported only in aggregate form, without disclosing any identifiable personal information.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-05-21 14:41:51