注册号：
Registration number：
ChiCTR2600116007 最近更新日期：
Date of Last Refreshed on：
2026-01-04 16:04:13 注册时间：
Date of Registration：
2026-01-04 00:00:00 注册号状态：
预注册Registration Status：
Prospective registration注册题目：
IL-1抑制剂在痛风石手术切除患者围术期的疗效与安全性：单中心前瞻性随机阳性对照研究Public title：
Efficacy and Safety of an IL-1 Inhibitor in the Perioperative Period of Patients Undergoing Tophus Resection: A Single-Center, Prospective, Randomized, Positive-Controlled Study注册题目简写：English Acronym：研究课题的正式科学名称：
IL-1抑制剂在痛风石手术切除患者围术期的疗效与安全性：单中心前瞻性随机阳性对照研究Scientific title：
Efficacy and Safety of an IL-1 Inhibitor in the Perioperative Period of Patients Undergoing Tophus Resection: A Single-Center, Prospective, Randomized, Positive-Controlled 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：
郭华
研究负责人：
郭华 Applicant：
Hua Guo
Study leader：
Hua Guo 申请注册联系人电话：
Applicant telephone：
+86 29 8469 6442
研究负责人电话：
Study leader's telephone：
+86 29 8435 5392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：
13991817800@139.com
研究负责人电子邮件：
Study leader's E-mail：
13991817800@139.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：
西安市莲湖区西关正街112号
研究负责人通讯地址：
西安市莲湖区西关正街112号Applicant address：
112 Xiguan Zhengjie Street, Lianhu District, Xi'an City, Shaanxi Province, China
Study leader's address：
NO.112 xiguanstreet lianhu district xi'an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：
西安市第五医院Applicant's institution：
The Fifth Hospital of Xi'an研究负责人所在单位：
西安市第五医院Affiliation of the Leader：
The Fifth Hospital of Xi'an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：
2025-113
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：
西安市第五医院医学伦理委员会Name of the ethic committee：
Approval Letter of Medical Ethics Committee of Xi'an No.5 Hospital伦理委员会批准日期：
Date of approved by ethic committee：
2025-09-28 00:00:00伦理委员会联系人：
郭曼玉Contact Name of the ethic committee：
Guo ManYu伦理委员会联系地址：
西安市莲湖区西关正街112号Contact Address of the ethic committee：
NO.112 xiguanstreet lianhu district xi'an伦理委员会联系人电话：
Contact phone of the ethic committee：
+86 29 84696445
伦理委员会联系人邮箱：
Contact email of the ethic committee：
wyyxgmy@163.com研究实施负责（组长）单位：
西安市第五医院Primary sponsor：
The Fifth Hospital of Xi'an研究实施负责（组长）单位地址：
西安市莲湖区西关正街112号Primary sponsor's address：
NO.112 xiguanstreet lianhu district xi'an试验主办单位(项目批准或申办者)：
Secondary sponsor：
国家：
中国
省(直辖市)：
陕西省
市(区县)：
Country：
China
Province：
Shaanxi
City：
单位(医院)：
西安市第五医院
具体地址：
西安市莲湖区西关正街112号
Institution
hospital：
The Fifth Hospital of Xi'an
Address：
NO.112 xiguanstreet lianhu district xi'an经费或物资来源：
自选课题（自筹）Source(s) of funding：
Self-Proposed Project (Self-Funded)研究疾病：
痛风性关节炎 Target disease：
Gouty Arthritis研究疾病代码：Target disease code：研究类型：
干预性研究Study type：
Interventional study研究所处阶段：
上市后药物 Study phase：
4研究设计：
随机平行对照 Study design：
Parallel 研究目的：
评价IL-1β抑制剂（伏欣奇拜单抗）联合秋水仙碱在痛风石切除围术期预防急性发作的疗效与安全性。 Objectives of Study：
Evaluation of the efficacy and safety of IL-1β inhibitor (Vunakizumab) combined with colchicine in preventing acute flares in the perioperative period of tophus resection.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. 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；
3. 年龄>=18岁，性别不限；
4. 有痛风石的手术指征，具体如下:（1）影响日常生活功能：当痛风石导致关节及周围组织出现持续性疼痛，严重影响患者的日常生活质量，甚至无法进行基本的活动（如走路、站立、穿衣、上下楼梯等），手术治疗可以有效减轻症状，改善患者的生活质量。 （2）骨关节及肌腱破坏：痛风石的长期存在会引起局部慢性炎症反应，逐渐导致骨关节面损害、软骨破坏以及肌腱损伤。表现为关节肿胀、畸形、活动受限，甚至出现关节功能丧失。此时，手术治疗不仅可以缓解疼痛，还能有效修复损伤的组织，恢复关节功能，避免进一步的结构性破坏。 （3）频繁的急性痛风发作：若患者在短期内（如一个月内）多次出现急性痛风发作，且发作次数超过三次，提示疾病未得到良好的控制，药物治疗的效果有限，且患者症状未得到有效缓解。此时，手术治疗有助于减少急性发作的频率，降低疼痛发生的风险，从根本上减轻疾病负担。 （4）药物治疗无效或耐药性：在某些情况下，患者可能对传统药物（如非甾体抗炎药、糖皮质激素、降尿酸药物等）产生耐药性或副作用过大，导致药物治疗无法有效控制病情。这时，手术治疗成为一种有效的补充手段，可以直接去除痛风石，减轻局部炎症反应，恢复关节功能。 （5）尿酸水平控制困难且持续升高：对于尿酸水平持续升高、无法通过药物控制的患者，尿酸过多会导致痛风石的沉积，并加剧关节破坏。当这些患者的病情发展至无法通过非手术治疗进行有效管理时，手术干预显得尤为重要。 （6）并发症的出现：当痛风石引起继发性并发症，如关节感染、深静脉血栓形成等，尤其是长期未能有效控制病情，可能会威胁到患者的健康和生命安全。这时需要考虑手术治疗以消除病灶，防止进一步的并发症发生。 （7）患者要求：部分患者由于长期遭受痛风石引起的剧烈疼痛和功能受限，无法忍受持续的病痛，并希望通过手术改善生活质量。对于这类患者，若符合手术指征，且术后预期效果良好，可进行手术治疗;
5. 需行痛风相关手术的患者;Inclusion criteria
1. Able to voluntarily sign the informed consent form and willing to comply with the protocol throughout the trial;
2. Diagnosed with gout according to the 2015 American College of Rheumatology (ACR) classification criteria for gout;
3. Age >=18 years, regardless of gender;
4. Has surgical indications for tophus removal, specifically as follows: (1) Impairment of daily living functions: Tophi cause persistent pain in joints and surrounding tissues, significantly affecting the patient’s quality of life and impairing basic activities (e.g., walking, standing, dressing, climbing stairs). Surgical intervention can effectively alleviate symptoms and improve quality of life. (2) Bone, joint, and tendon destruction: Long-standing tophi induce chronic local inflammation, progressively leading to articular surface damage, cartilage erosion, and tendon injury. This manifests as joint swelling, deformity, restricted mobility, and even complete loss of joint function. Surgery not only relieves pain but also helps repair damaged tissues, restore joint function, and prevent further structural deterioration. (3) Frequent acute gout flares: Patients experiencing multiple acute gout attacks within a short period (e.g., more than three episodes within one month) indicate poor disease control. When pharmacological treatment fails to adequately relieve symptoms, surgical removal of tophi may reduce flare frequency and lower the risk of recurrent pain, thereby alleviating the overall disease burden. (4) Ineffectiveness or intolerance to medical therapy: In some cases, patients develop resistance to or experience intolerable side effects from conventional medications (e.g., NSAIDs, glucocorticoids, urate-lowering therapies), rendering pharmacological management inadequate. Surgery serves as an effective adjunctive approach by directly removing tophi, reducing local inflammation, and restoring joint function. (5) Poorly controlled or persistently elevated serum uric acid levels: Patients with chronically high uric acid levels that cannot be managed with medication are at increased risk of tophus deposition and progressive joint destruction. When non-surgical strategies fail to control the condition, surgical intervention becomes essential. (6) Presence of complications: Tophi may lead to secondary complications such as joint infection or deep vein thrombosis. In cases where uncontrolled disease poses a threat to the patient’s health or life, surgical removal of the lesion is necessary to prevent further complications. (7) Patient request: Some patients suffer prolonged, severe pain and functional limitations due to tophi and strongly desire surgical improvement in their quality of life. If surgical criteria are met and a favorable postoperative outcome is anticipated, surgery may be offered;
5. Patients requiring surgery related to gout;排除标准：
1. 存在对研究药物或同类药物的过敏反应史；
2. 接受过以下任何药物或治疗措施者： 在随机前 4 小时内使用了布洛芬、对乙酰氨基酚； 在随机前 6 小时内使用了双氯芬酸、曲马多，或应用了局部冰袋/冷冻包； 在随机前 12 小时内使用了萘普生、洛索洛芬、洛芬待因； 在随机前 24 小时内使用了 >=10 mg 强的松或相当剂量的激素； 在随机前 24 小时内使用了依托考昔、塞来昔布、美洛昔康或其他短效止痛药物； 筛选前 14 天内使用了长效的阿片类药物治疗； 筛选前 14 天内采用关节腔内注射糖皮质激素治疗； 筛选前 12 周内累计超过 28 天或筛选前 14 天内连续接受 >= 5 mg/d 强的松（或当量的皮质类固醇）治疗； 筛选前 30 天内或 3 个半衰期内（以较长者为准，或者依据当地法规之规定）使用了任何 IL-1 阻断剂、TNF 抑制剂、其他生物制剂； 筛选前 3 个月内持续使用经全身给药的免疫抑制剂治疗。
3. 存在内脏器官活动性出血疾病，或有严重的出血倾向（如血友病等），或需要进行抗凝治疗者（包括肝素、阿司匹林等药物）；
4. 合并其他活动性关节炎（如类风湿关节炎、感染性关节炎等）可能干扰疼痛和复发评估者；
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 个月内接种过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；
7. 筛选前 5 年内患有癌症，经过充分治疗或切除的皮肤基底细胞癌或 I 期鳞状细胞癌除外；
8. 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；全身长期使用免疫抑制剂治疗；
9. 合并其他重大疾病： 有未控制的严重心血管疾病（近期心梗、心衰NYHA III/IV级等）、中风后遗症、消化道溃疡活动期；严重肝功能损害（ALT/AST超过正常上限3倍以上）或Ⅳ期及以上肾功能不全（eGFR < 15 ml/min）；
10. 妊娠或哺乳期女性；
11. 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. a history of allergic reaction to the study drug or a comparable drug;
2. have received any of the following medications or treatments: ibuprofen, acetaminophen within 4 hours prior to randomisation; diclofenac, tramadol, or topical ice packs/freezer packs within 6 hours prior to randomisation; naproxen, loxoprofen, lofenadine within 12 hours prior to randomisation; >=10 mg of prednisone or equivalent within 24 hours prior to randomisation; etoricoxib, celecoxib, or meloxicam or other short-acting pain medication within 24 hours prior to randomisation; or Use of etoricoxib, celecoxib, meloxicam, or other short-acting pain medication within 24 hours prior to randomisation; Long-acting opioid therapy within 14 days prior to screening; Intra-articular glucocorticosteroid therapy within 14 days prior to screening; Predominant treatment with prednisone (or corticosteroid equivalent) for more than 28 cumulative days in the 12 weeks prior to screening, or continuously for more than 14 days prior to screening >= 5 mg/d; Use of any IL-1 blocker, TNF inhibitor, or other biological agent within 30 days or 3 half-lives (whichever is longer, or as required by local regulations) prior to Screening; Continuous immunosuppressive therapy via systemic administration within 3 months prior to Screening.
3. the presence of active bleeding disorders of internal organs, or severe bleeding tendency (e.g. haemophilia), or the need for anticoagulant therapy (including drugs such as heparin, aspirin, etc.);
4. those with a combination of other active arthritis (e.g. rheumatoid arthritis, infectious arthritis, etc.) that may interfere with the assessment of pain and recurrence;
5. infections requiring control with systemic medication within 7 days prior to screening;
6. have received a live or live attenuated vaccine within 3 months prior to screening or plan to receive a live or live attenuated vaccine during the study;
7. cancer within 5 years prior to screening, except adequately treated or excised basal cell carcinoma of the skin or stage I squamous cell carcinoma;
8. previous treatment with total body irradiation or total lymphatic irradiation; previous stem cell therapy or bone marrow transplantation of any type; previous solid organ transplantation; long-term systemic treatment with immunosuppressive agents;
9. Combination of other major diseases: uncontrolled severe cardiovascular disease (recent heart attack, heart failure NYHA class III/IV, etc.), post-stroke sequelae, active peptic ulcer; severe hepatic impairment (ALT/AST more than 3 times the upper limit of normal) or stage IV or higher renal insufficiency (eGFR < 15 ml/min);
10. pregnant or lactating females;
11. conditions that, in the judgement of the investigator, render the subject unsuitable for participation in this clinical trial.研究实施时间：
Study execute time：
从
From
2025-12-01 00:00:00至
To
2027-11-01 00:00:00
征募观察对象时间：
Recruiting time：
从
From
2026-01-10 00:00:00
至
To
2027-05-01 00:00:00干预措施：
Interventions：
组别：
试验组
样本量：
27
Group：
Experimental Group
Sample size：
干预措施：
术前皮下注射伏欣奇拜单抗200 mg并口服秋水仙碱0.5 mg/日
干预措施代码：
Intervention：
Preoperatively, 200 mg of Vunakizumab was administered subcutaneously, along with daily oral colchicine 0.5 mg.
Intervention code：
组别：
对照组
样本量：
27
Group：
Control Group
Sample size：
干预措施：
口服秋水仙碱0.5 mg/日
干预措施代码：
Intervention：
Oral colchicine 0.5 mg daily
Intervention code：研究实施地点：
Countries of recruitment and research settings：
国家：
中国
省(直辖市)：
陕西省
市(区县)：
Country：
China
Province：
Shaanxi
City：
单位(医院)：
西安市第五医院
单位级别：
三级甲等
Institution
hospital：
Xi'an Fifth Hospital
Level of the institution：
Tertiary A测量指标：
Outcomes：
指标中文名：
术后7天内急性痛风发作率
指标类型：
主要指标
Outcome：
Rate of acute gout attacks within 7 days after the surgery
Type：
Primary indicator
测量时间点：
术后7天
测量方法：
从手术结束至第7天内出现符合急性痛风关节炎诊断标准的发作比例, 主要终点直接反映预防干预效果
Measure time point of outcome：
postoperative day 7
Measure method：
The proportion of cases that met the diagnostic criteria for acute gouty arthritis within 7 days after the surgery. The primary endpoint directly reflects the effectiveness of the preventive intervention.
指标中文名：
痛风复发的疼痛程度和持续时间
指标类型：
次要指标
Outcome：
The severity and duration of the pain during a recurrence of gout
Type：
Secondary indicator
测量时间点：
术后随访24周
测量方法：
术后随访24周内是否发生痛风急性关节炎的复发，并记录复发的时间、次数及严重程度。复发定义为治疗后患者再次出现符合痛风急性发作症状且需要接受抗炎治疗的事件
Measure time point of outcome：
Postoperative follow-up for 24 weeks
Measure method：
During the 24-week postoperative follow-up period, whether there was a recurrence of acute gouty arthritis was observed, and the time, frequency and severity of the recurrence were recorded. Recurrence was defined as an event where the patient experienced symptoms consistent with an acute gout attack again after treatment and required anti-inflammatory treatment.
指标中文名：
随访期间至少有1次复发的患者比例和人均复发次数
指标类型：
次要指标
Outcome：
The proportion of patients with at least one recurrence during the follow-up period and the average number of recurrences per patient
Type：
Secondary indicator
测量时间点：
术后1天、3天、1个月、3个月、6个月
测量方法：
更为细化的评估两组治疗在不同时间节点的痛风急性发作控制情况
Measure time point of outcome：
One day after the operation, three days after the operation, one month after the operation, three mo
Measure method：
A more detailed assessment of the control of acute gout attacks in the two treatment groups at different time points
指标中文名：
安全性
指标类型：
次要指标
Outcome：
Safety
Type：
Secondary indicator
测量时间点：
术后随访24周
测量方法：
治疗过程中和随访期内不良事件（AE）的发生率和性质，以及严重不良事件（SAE）的发生情况。特别关注感染发生率和肝肾功能变化，以评估患者对该药物的耐受性。
Measure time point of outcome：
Postoperative follow-up for 24 weeks
Measure method：
During the 24-week postoperative follow-up period, whether there was a recurrence of acute gouty arthritis was observed, and the incidence and nature of adverse events (AE) during the treatment process and within the follow-up period were recorded. The occurrence and severity of serious adverse events (SAE) were also noted. Special attention was paid to the incidence of infections and changes in liver and kidney functions to assess the patient's tolerance to the drug.采集人体标本：
Collecting sample(s)
from participants：
标本中文名：
血液
组织：
Sample Name：
Blood
Tissue：
人体标本去向
使用后销毁
说明
Fate of sample：
Destruction after use
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
18
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）：
随机化序列由不参与临床研究实施的独立统计人员使用SAS® 9.4版本中的PROC PLAN程序生成，采用计算机生成的伪随机数，并按区组大小进行分层随机分配。随机序列在研究启动前密封保存，仅由项目负责人和数据管理员在必要时查阅。Randomization Procedure (please state who
generates the
random number sequence and by what method)：
The randomization sequence was generated by an independent statistician, who was not involved in the clinical trial conduct, using the PROC PLAN procedure in SAS® version 9.4. Computer-generated pseudo-random numbers were employed, and stratified randomization with block sizes was performed. The randomization list was kept under access restriction prior to study initiation and was accessible only to the principal investigator and data manager when necessary.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：
开放标签，对评估者隐藏分组Blinding：
Open-label study with blinded-evaluators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）：
通过受控访问机制共享去标识化的个体参与者数据（Individual Participant Data, IPD）The way of sharing IPD”(include metadata and
protocol,
If use web-based public database, please provide
the
url)：
Sharing de-identified individual participant data (IPD) via controlled access after approval by the study principal investigator and institutional review board.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：
采用电子病例报告表（eCRF）系统进行数据采集，所有数据由研究协调员录入，双人独立审核，确保准确性与完整性。原始数据保存于医院信息系统（HIS）及研究中心服务器中，实行分级权限管理，仅限授权人员访问。数据备份每周一次，存储期限不少于5年。Data collection and Management (A
standard data collection and management system
include a CRF and an electronic data capture：
Data will be collected using electronic case report forms (eCRFs) through a secure clinical data management system (e.g., REDCap or Medidata Rave). All data entries will be double-checked by independent reviewers for accuracy. Original source documents (e.g., medical records, lab reports) will be stored securely in the hospital’s information system and research center servers with restricted access. Data backups will be performed weekly, and data will be retained for at least 5 years post-study completion. All modifications will be logged with audit trails to ensure traceability and integrity数据与安全监察委员会：
Data and Safety Monitoring Committee：
无/No注册人：
Name of Registration：
2026-01-04 16:04:00
