ChiCTR2500114389 版本V1.0 版本创建时间2025/12/11 10:12:49 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：

 ChiCTR2500114389 

最近更新日期：

Date of Last Refreshed on：

 2025-12-11 10:08:26 

注册时间：

Date of Registration：

 2025-12-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

外科手术联合IL-1抑制剂治疗难治性痛风的单中心队列研究

Public title：

Surgical treatment of refractory gout with IL-1 inhibitors: A single-center cohort study

注册题目简写：

外科手术联合IL-1抑制剂治疗难治性痛风

English Acronym：

Treatment of refractory gout by surgery combined with IL-1 inhibitor

研究课题的正式科学名称：

外科手术联合IL-1抑制剂治疗难治性痛风的单中心队列研究

Scientific title：

Surgical treatment of refractory gout with IL-1 inhibitors: A single-center 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：

谭清 

研究负责人：

接力刚 

Applicant：

Tan Qing 

Study leader：

Jie Ligang 

申请注册联系人电话：

Applicant telephone：

 +86 156 0362 6822

研究负责人电话：

Study leader's
telephone：

+86 180 2622 7592

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：

 tannqing2022@163.com

研究负责人电子邮件：

Study leader's E-mail：

 787180599@qq.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：

中国广东省广州市海珠区工业大道中253号

研究负责人通讯地址：

中国广东省广州市海珠区工业大道中253号

Applicant address：

253 Gong Ye da Dao Zhong, Haizhu District, Guangzhou, Guangdong, China

Study leader's address：

253 Gong Ye da Dao Zhong, Haizhu District, Guangzhou, Guangdong, China

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：

南方医科大学珠江医院

Applicant's institution：

Zhujiang Hospital of Southern Medical University

研究负责人所在单位：

南方医科大学珠江医院

Affiliation of the Leader：

Zhujiang Hospital of Southern Medical University

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：

 2025-KY-377-02

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：

南方医科大学珠江医院医学伦理委员会

Name of the ethic committee：

Southern Medical University Committee on medical ethics of Pearl River Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-11-07 00:00:00

伦理委员会联系人：

黄熙华

Contact Name of the ethic committee：

Huang Xihua

伦理委员会联系地址：

中国广东省广州市海珠区工业大道中253号

Contact Address of the ethic committee：

253 Gong Ye da Dao Zhong, Haizhu District, Guangzhou, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 62783254

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：

南方医科大学珠江医院

Primary sponsor：

Zhujiang Hospital of Southern Medical University

研究实施负责（组长）单位地址：

中国广东省广州市海珠区工业大道中253号

Primary sponsor's address：

253 Gong Ye da Dao Zhong, Haizhu 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)：

南方医科大学珠江医院

具体地址：

中国广东省广州市海珠区工业大道中253号

Institution
hospital：

Zhujiang Hospital of Southern Medical University

Address：

253 Gong Ye da Dao Zhong, Haizhu District, Guangzhou, Guangdong, China

经费或物资来源：

长春金赛药业有限责任公司

Source(s) of funding：

Changchun Jinsai Pharmaceutical Co. , Ltd.

研究疾病：

痛风  

Target disease：

Gout

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：

本单中心、前瞻性队列研究的目标是评估外科手术（含开放性手术及微创针刀镜手术）联合伏欣奇拜单抗相对于复方倍他米松注射液在难治性痛风成年患者的临床有效性及安全性。  

Objectives of Study：

The objective of this single-center, prospective cohort study was to evaluate the clinical efficacy and safety of Surgery (Open and minimally invasive acupotomy) in combination with Firsekibart versus compound Diprospan injection in adult patients with refractory gout.

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. 能够自愿签署知情同意书，并且自愿配合按照方案完成试验者 2. 18周岁 <= 年龄 <= 75周岁，性别不限 3. 体重指数（BMI）<= 40 kg/m^2 4. 根据美国风湿病学会（ACR）2015年痛风分类标准诊断为痛风的患者 5. 筛选前1年内有 >= 2次痛风性关节炎发作，符合《中国高尿酸血症与痛风诊疗指南（2019）》首次提出的难治性痛风的定义，满足以下任意一条定义者： (1) 单用或联用常规降尿酸药物足量、足疗程，但血尿酸仍 >= 360 μmol/L； (2) 接受规范化治疗，但痛风发作仍 >= 2次/年； (3) 存在多发性或进展性痛风石 6. 符合外科手术干预适应症患者 7. 愿意在研究期间遵循方案的规定进行降尿酸治疗（ULT），满足以下条件之一： (1) 正在接受ULT患者且稳定治疗 > 14天，在参加试验期间需维持稳定的给药方案至少14天，除非经研究者评估原有降尿酸方案患者出现不耐受、或疗效不佳或尿酸水平过低，可以允许调整降尿酸治疗方案包括更换药物、减量或停药； (2) 给药前没有使用ULT的患者，给药后14天内不允许采取降尿酸治疗，14天后由研究者根据尿酸水平决定是否采取降尿酸治疗； (3) 给药前使用ULT但未稳定14天的患者，给药后14天内不允许采取降尿酸治疗，14天后由研究者根据尿酸水平决定是否采取降尿酸治疗； (4) 要求患者在使用降尿酸治疗的同时，不允许再采用其他药物进行预防痛风性关节炎发作，如口服小剂量糖皮质激素、非甾体抗炎药（NSAID）类药物或秋水仙碱等

Inclusion criteria

1. Those who are able to voluntarily sign an informed consent form and voluntarily cooperate to complete the trial in accordance with the protocol 2. 18 years <= age <= 75 years, regardless of sex 3. Body mass index (BMI) <= 40 kg/m^2 4. Patients diagnosed with gout according to the American College of Rheumatology (ACR) 2015 gout classification criteria 5. There were >= 2 episodes of Gouty Arthritis in the 1 year before screening, which met the definition of refractory gout first proposed in the Chinese Hyperuricemia and Gout Diagnosis and Treatment Guidelines (2019), those who met any of the following definitions: (1) sufficient dose and duration of treatment with conventional uric acid-lowering drugs alone or in combination, but still >= 360 μmol/L of serum uric acid; (2) receiving standardized treatment, but still having >= 2 gout attacks per year; (3) the presence of multiple or progressive tophi 6. Patients eligible for surgical intervention 7. Willingness to follow protocol provisions for uric acid-lowering therapy (ULT) during the study period, meeting one of the following conditions: (1) the patient was receiving ULT and stable treatment for > 14 days, and a stable dosing regimen should be maintained for at least 14 days while participating in the trial, unless intolerance, poor response, or low uric acid levels in patients who had been evaluated by the investigator for previous uric-acid-lowering regimens occurred, adjustments to the uric acid-lowering regimen could be permitted, including drug change, reduction, or discontinuation; (2) patients who did not use an ULT before dosing were not allowed to take uric acid-lowering therapy for 14 days after dosing, and after 14 days, uric acid levels were used by the investigator to decide whether or not to take uric acid-lowering therapy; (3) patients who used ULTs before dosing but were not stable for 14 days were not allowed to take uric acid-lowering therapy for 14 days after dosing; after 14 days, uric acid levels were used by the investigators to decide whether to take uric acid-lowering therapy; (4) patients were asked to take uric acid-lowering therapy at the same time as they were not allowed to take other drugs to prevent the onset of gouty arthritis; such as oral low-dose glucocorticoid, non-steroidal anti-inflammatory drug (NSAID) or colchicine

排除标准：

1. 已知对任何计划使用的药物（例如糖皮质激素、伏欣奇拜单抗）或上述药物的任何成分存在过敏或禁忌症 2. 筛选前14天内使用了长效的阿片类药物治疗；筛选前14天内关节内采用了糖皮质激素注射治疗；筛选前12周内连续或累计超过28天，或筛选前14天内连续接受>=5 mg/d强的松（或当量）治疗；筛选前30天内或3个半衰期内使用了任何IL-1β阻断剂、TNF抑制剂、其他生物制剂；筛选前3个月持续使用经全身给药的免疫抑制药物（IS） 3. 存在内脏器官活动性出血疾病，严重的出血倾向，或用肝素进行抗凝治疗者 4. 诊断为继发性痛风者（例如化疗引起的痛风等），存在可能混淆受累关节评估的其他疾病 5. 筛选前7天内存在需要采用全身用药控制的感染 6. 筛选前3个月内接种活疫苗或减毒活疫苗，或计划在研究期间接种活疫苗或减毒活疫苗，或筛选前2周内接种新冠疫苗者 7. 筛选前5年内患有癌症，经过治疗或切除的皮肤基底细胞癌或I期鳞状细胞除外，既往接受过全身照射或全淋巴照射治疗，既往接受过干细胞治疗或任何类型的骨髓移植，既往接受过实体器官移植 8. 存在严重的免疫缺陷病史，合并有严重的心脑血管系统、消化及造血系统等原发性疾病者，以及合并有精神性疾病、意识障碍的患者 9. 符合以下条件之一者： (1) 确诊为活动性结核感染，包括但不限于影像学证实的活动性结核感染； (2) 处于结核潜伏感染期或有感染高危因素可予以入组，但需排除研究者认为不适合入组的患者，如不愿意在进入试验后继续根据当地指南接受抗TB治疗者等 10. 接受肾脏透析者，或eGFR<30ml/min/1.73m^2 11. 孕妇、哺乳期妇女及试验期间有生育计划的男性或女性 12. 经研究者判定，受试者存在不适合参加本临床试验的情况

Exclusion criteria：

1. Known allergies or contraindications to any of the drugs planned for use (e.g. . Glucocorticoid, vosintuzumab) or to any of the ingredients of such drugs 2. Long-acting opioid therapy was used within 14 days before screening, intra-articular glucocorticoid was administered within 14 days before screening, and more than 28 consecutive or cumulative days were used within 12 weeks before screening, or received ≥5 mg/d of prednisone (or equivalent) continuously for 14 days prior to screening; used any IL-1 beta blocker, TNF inhibitor, or other biologic within 30 days or 3 half-lives prior to screening; Continuous systemic administration of immunosuppressive drug (IS) for 3 months prior to screening 3. Patients with active bleeding disease of internal organs, severe bleeding tendency, or anticoagulant therapy with heparin 4. In patients diagnosed with secondary gout (e.g. , chemotherapy-induced gout) , there are other conditions that may confound the assessment of the affected joint 5. Infections requiring systemic control within 7 days before screening 6. Those who received a live injection or live attenuated vaccine within 3 months before screening, or who planned to receive a live or live attenuated vaccine during the study period, or a covid-19 vaccine within 2 weeks before screening 7. Cancer within 5 years before screening, except for treated or resected skin basal-cell carcinoma or stage I squamous cells, previous treatment with total body irradiation or total lymphatic irradiation, previous cell therapy or any type of bone marrow transplant previous solid organ transplant 8. Patients with a history of severe immunodeficiency, combined with severe primary diseases of the cardiovascular and cerebrovascular systems, digestive and hematopoietic systems, and patients with psychiatric disorders and disorders of consciousness 9. Those who met one of the following criteria: (1) confirmed active tuberculosis infection, including but not limited to radiographically confirmed active tuberculosis infection; and (2) were in latent tuberculosis infection or had risk factors for infection were enrolled, patients deemed unsuitable for enrollment by the investigators, such as those unwilling to continue anti-TB treatment according to local guidelines after entering the trial, should be excluded 10. Those on renal dialysis, or eGFR < 30 ml/min/1.73 m^2 11. Pregnant women, lactating women and men or women who had Planned Parenthood during the trial period 12. Subjects were judged by the investigators to be unfit for participation in this clinical trial

研究实施时间：

Study execute time：

从 From 2025-12-17 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-17 00:00:00 至 To 2027-06-30 00:00:00

干预措施：

Interventions：

组别：

伏欣奇拜组

样本量：

 50

Group：

Firsekibart group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

得宝松组

样本量：

 50

Group：

Diprospan group

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)：

 广东 

市(区县)：

 广州 

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

 南方医科大学珠江医院 

单位级别：

 三甲 

Institution
hospital：

Southern Medical University Pearl River Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

痛风复发的中位时间

指标类型：

主要指标

Outcome：

Median time to gout recurrence

Type：

Primary indicator

测量时间点：

12周

测量方法：

Measure time point of outcome：

12 weeks

Measure method：

指标中文名：

给药后疼痛VAS评分（0-100 mm）评价两组患者基线受累关节的疼痛程度

指标类型：

次要指标

Outcome：

The pain VAS score (0-100 mm) was used to evaluate the degree of pain in the affected joints at baseline in both groups

Type：

Secondary indicator

测量时间点：

6h；24h；72h

测量方法：

视觉模拟评分法(VisualAnalogue Scale/Score,AS)具体做法为在纸上面划一条 10cm 的横线，横线的一端为0，表示无痛;另一端为 10，表示剧痛;中间部分表示不同程度的疼痛。让病人根据自我感觉在横线上划一记号，表示疼痛的程度。

Measure time point of outcome：

6h; 24h; 72h

Measure method：

On the visual analogue Scale (AS) , a 10 cm line is drawn on a piece of paper, with a 0 at one end indicating no pain, a 10 at the other end indicating severe pain, and the middle indicating varying degrees of pain. Ask the patient to make a mark on the line according to his feeling to indicate the degree of pain.

指标中文名：

健康调查简表（SF-36）评分评价两组患者在日常生活中进行常规活动的能力

指标类型：

次要指标

Outcome：

Health Survey Short Form (SF-36-RRB- scores were used to assess the ability of patients in both groups to perform routine activities of daily living

Type：

Secondary indicator

测量时间点：

基线、第12、24周

测量方法：

SF-36量表评价健康相关生命质量（HRQoL）的8个方面，分属于生理健康和心理健康两个大类中，即生理功能（PF）、生理职能（RP）、躯体疼痛（BP）、总体健康（CH）、活力（VT）、社会功能（SF）、情感职能（RE）、精神健康（MH）。另外，SF-36量表还包括另一项指标——健康变化（HT），用于评价过去一年内的健康改变。SF-36生活质量评分变化使用重复测量ANOVA或混合效应模型分析。

Measure time point of outcome：

Baseline, 12 and 24 Weeks

Measure method：

The SF-36 scale evaluates 8 aspects of health-related quality of life (HRQOL) , which belong to physical health and mental health, they are physiological function (PF) , physiological function (RP) , physical pain (BP) , general health (CH) , vitality (VT) , social function (SF) , emotional function (RE) and mental health (MH) . In addition, the SF-36 includes another indicator, health change (HT) , which is used to assess health changes in the past year. SF-36 quality-of-life score changes were

指标中文名：

给药后疼痛VAS评分（0-100 mm）评价两组患者基线受累关节疼痛程度较基线的变化

指标类型：

次要指标

Outcome：

The pain VAS score (0-100 mm) was used to evaluate the changes of the involved joint pain in the two groups

Type：

Secondary indicator

测量时间点：

6h；24h；72h

测量方法：

Measure time point of outcome：

6h; 24h; 72h

Measure method：

指标中文名：

给药后疼痛VAS评分（0-100 mm）基线评价两组患者受累关节的疼痛程度首次下降至≤基线50%的时间

指标类型：

次要指标

Outcome：

Post-dose pain VAS scores (0-100 mm) were used to assess the time to the first decrease in pain to ≤50% of baseline in the affected joints in both groups

Type：

Secondary indicator

测量时间点：

6h；24h；72h

测量方法：

Measure time point of outcome：

6h; 24h; 72h

Measure method：

指标中文名：

两组患者采用补救治疗的比例及使用药物的剂量

指标类型：

次要指标

Outcome：

The ratio of salvage treatment and the dosage of drugs used were compared between the two groups

Type：

Secondary indicator

测量时间点：

12周

测量方法：

Measure time point of outcome：

12 weeks

Measure method：

指标中文名：

术后炎症指标较基线的变化

指标类型：

次要指标

Outcome：

Changes of post-operative inflammatory markers compared with baseline

Type：

Secondary indicator

测量时间点：

第2；4；12；24周

测量方法：

Measure time point of outcome：

2 weeks; 4 weeks; 12 weeks and 24 weeks

Measure method：

指标中文名：

痛风急性发作的次数

指标类型：

次要指标

Outcome：

Number of gout flares within 12 and 24 weeks

Type：

Secondary indicator

测量时间点：

12、24周

测量方法：

Measure time point of outcome：

12 weeks and 24 weeks

Measure method：

指标中文名：

安全性指标：不良事件、临床安全性实验室检查、心电图、生命体征、以及常规体格检查

指标类型：

次要指标

Outcome：

Safety measures: adverse events, clinical safety laboratory tests, electrocardiograms, vital signs, and routine physical examinations

Type：

Secondary indicator

测量时间点：

24周

测量方法：

研究期间安全性评价的主要内容包括对不良事件的个例分析和安全性数据的汇总分析，对观察到的具体特定的风险事件进行监测和记录收集，并定期审查所有已完成和正在进行的临床研究的安全性数据及其他重要相关安全性信息，基于积累的数据，针对该不良事件进行汇总分析和系统性评估。

Measure time point of outcome：

24 weeks

Measure method：

The main components of the safety evaluation during the study period included case-by-case analysis of adverse events and pooled analysis of safety data, monitoring of observed specific risk events, and record collection, as well as reporting of adverse events, safety data and other important relevant safety information from all completed and ongoing clinical studies were regularly reviewed, and based on the accumulated data, a pooled analysis and systematic review were performed for this advers

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

Tissue：

None

人体标本去向

 其它  

说明

无

Fate of sample：

0thers  

Note：

None

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 18 岁 years
最大 Max age 75 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：

Blinding：

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）：

需要与研究者联系，经过研究者同意后开放共享。

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

Need to contact the researchers, after the researchers agreed to open sharing.

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：

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 DataCapture,EDC)

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

Data collection and management consist of two components: the first being the Case Report Form (CRF), and the second being the Electronic Data Capture (EDC) system.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-12-11 10:08:26