国内强直性脊柱炎药物临床试验关键入排标准的设计考量  

The issues in the critical inclusion and exclusion criteria for new drug clinical trials on ankylosing spondylitis

作　　者：穆艳飞 王晓霞[1] 吴珮涵 毛小琦 池艳春 韩涛 尹梅林 Mu Yanfei;Wang Xiaoxia;Wu Peihan;Mao Xiaoqi;Chi Yanchun;Han Tao;Yin Meilin(Department of Rheumatology and Immunology,the Second Hospital of Shanxi Medical University,Taiyuan 030001,China)

机构地区：[1]山西医科大学第二医院风湿免疫科,太原030001

出　　处：《中华风湿病学杂志》2024年第9期656-659,共4页Chinese Journal of Rheumatology

基　　金：山西医科大学第二医院青年基金(202002-1)。

摘　　要：目的分析总结强直性脊柱炎(AS)新药临床试验方案设计与实施要点。方法检索国家药品监督管理局药品审评中心(CDE)官网"药物临床试验登记与信息公示平台",获得数据,进行分类统计。采用定量资料的统计学描述采用±s或M(Q_(1),Q_(3))描述,定性资料的统计学描述用率、构成比或相对比。结果筛选符合要求的临床试验项目共23项,其中19项生物制品中Ⅲ期临床试验项目有9项,4项化学药品中Ⅱ期临床试验项目有2项。AS临床试验诊断标准采用1966年纽约标准1项,占4%;1984年纽约标准19项,占83%;其他未明确的诊断标准3项,占13%。临床试验对年龄的要求,至少要求≥16岁,23项临床试验项目中对年龄要求≥16岁1项,18~65岁有9项,≥18岁有6项。临床试验活动性AS的定义中BASDAI≥4有19项;同时满足BASDAI、总背痛、脊柱痛、晨僵4项。结论国内AS临床试验项目持续增多;建议采用1984年标准为临床试验使用的诊断标准;建议入组标准中年龄可以定为下限18岁,适当地放宽上限;可通过BASDAI评分,结合夜间背痛、整体脊柱疼痛及晨僵等综合指标进行AS疾病活动的评估。ObjectiveTo analyze and summarize the key points of design and implementation of new drug clinical trials for ankylosing spondylitis.MethodsThe platform for drug clinical trial registration and information published on the official website of center for drug review and evaluation of national medical products administration(CDE)was searched to obtain data and classified statistics was conducted then.The Mean±SD and M(Q_(1),Q_(3))were used for quantitative data for statistical description,and the rate,composition or relative ratio of qualitative data were used for statistical description.ResultsA total of 23 clinical trials meeting the requirements were screened,among which 19 were biological products included in nine phaseⅢclinical trials.Among the four chemical drugs,two were phaseⅡclinical trials.One of the clinical trials on AS adopted the 1966 New York classification criteria,accounting for 4%.Nineteen of the trials adopted the1984 New York classification criteria,accounting for 83%.Three other trials adopted unspecified classification criteria,accounting for 13%.In one of these clinical trials,the age of patients included was older than 16 years old,9 trials were 18 to 65 years old,6 were 18 years old but without upper limit.In the definition of active AS,19 trials took BASDAI≥4 as the cut-off value for active disease,and BASDAI,total back pain,spinal pain and morning stiffness were regarded as active disease in 4.ConclusionThe number of dosestic AS clinical trial projects continnes to rise.The 1984 classification criteria is adopted as the classification criteria in clinical trials.The minimum age in the inclusion criteria is 18 years old,there is no upper limit in age for inclusion.Disease activity can be evaluated by BASDAI score,combined with comprehensive indicators such as night-time back pain,global spinal pain and morning stiffness.

关 键 词：脊柱炎 强直性 药用制剂 临床试验方案 

分 类 号：R593.23[医药卫生—内科学]