ChiCTR2200064314CompletedUnknown
头孢菌素皮肤敏感性试验对过敏反应发生影响的多中心真实世界研究
Not provided30 sites in 1 country150,000 target enrollmentStarted: October 1, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Enrollment
- 150,000
- Locations
- 30
- Primary Endpoint
- 头孢菌素过敏反应的发生率
Study Overview
Brief Summary
目前全国多数医院一直用头孢菌素的皮试来预测用药后过敏反应的发生,但学术界对于头孢菌素类药物使用前是否需要进行皮试尚存在争议。国外有研究表明头孢菌素皮试并没有降低药物使用后过敏反应的发生,而我国也没有与之相关的大型多中心临床研究。因此本项目拟进行回顾性的多中心真实世界研究,纳入 32 家浙江省医疗机构共约 15 万例病例,收集 2021 年 4 月-6 月静脉注射头孢菌素药物的年满 18 周岁的住院患者的基本信息、既往过敏史、皮试相关信息、使用头孢后发生过敏反应的相关情况等信息。旨在探索头孢菌素皮试对过敏反应发生的影响和皮试阴性组和未皮试组过敏反应发生率的比值比,此外,进一步研究使用头孢菌素类药物后发生过敏反应的高危因素和各种头孢菌素使用后的过敏反应发生率。
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 80 (—)
- Sex
- All
Inclusion Criteria
- •使用头孢菌素类及头孢菌素酶复合制剂静注治疗的住院患者。
Exclusion Criteria
- •未使用头孢菌素及头孢菌素酶复合制剂注射液的患者;
Arms & Interventions
Case series
Outcomes
Primary Outcomes
头孢菌素过敏反应的发生率
皮试阴性组和未皮试组过敏反应发生率的比值比
Secondary Outcomes
- 头孢菌素过敏反应发生的高危因素
- 各类头孢菌素的过敏反应的发生率及致死率
Investigators
Study Sites (30)
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