雷公藤多苷延缓类风湿性关节炎骨破坏的随机对照试验  

A Randomized Controlled Trial of Tripterygium wilfordii Glycoside in Delaying Bone Destruction in Rheumatoid Arthritis

作　　者：岳铭 姜泉[2] 王雷[2] 李克嵩 刘蔚翔 徐润 YUE Ming;JIANG Quan;WANG Lei;LI Ke-song;LIU Wei-xiang;XU Run(Beijing University of Chinese Medicine,Beijing 100029;Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053)

机构地区：[1]北京中医药大学,北京100029 [2]中国中医科学院广安门医院,北京100053

出　　处：《世界中西医结合杂志》2023年第8期1641-1649,共9页World Journal of Integrated Traditional and Western Medicine

基　　金：北京市科技计划项目(Z161100000516020)。

摘　　要：目的 观察及评价雷公藤多苷延缓类风湿性关节炎(Rheumatoid arthritis,RA)骨破坏的疗效。方法 研究第一阶段(0~24周)采取随机、双盲双模拟、阳性平行对照的研究方法,将患者随机分为雷公藤组和甲氨蝶呤组,雷公藤组予雷公藤多苷片+甲氨蝶呤模拟片口服治疗;甲氨蝶呤组予甲氨蝶呤+雷公藤多苷模拟片口服治疗,治疗24周后,观察两组患者双手X片的放射学评分、疾病活动度(DAS28)和生活质量评价(HAQ总分)。研究第二阶段(1年以上)采取开放性观察对照研究的方法,根据1年以后来院复诊患者在24周之后治疗药物的不同分为雷公藤组和甲氨蝶呤组,观察两组患者双手X片的放射学评分和疾病活动度(DAS28)。结果 雷公藤组和甲氨蝶呤组在基线和24周的Sharp总分、关节间隙评分、关节侵蚀评分比较,差异无统计学意义(P>0.05);雷公藤组和甲氨蝶呤组在基线、24周、1年以上时点Sharp总分、关节间隙、关节侵蚀进展速率(%)比较,差异无统计学意义(P>0.05);治疗24周后,雷公藤组和甲氨蝶呤组Sharp总分进展速率均较治疗前减慢,差异有统计学意义(P<0.05);治疗1年以上后,雷公藤组关节间隙进展速率较治疗前减慢,差异有统计学意义(P<0.05);甲氨蝶呤组关节侵蚀进展速率较疗前增快,差异有统计学意义(P<0.05);在基线、24周、1年以上时点,基线有破坏组Sharp总分、关节间隙评分、关节侵蚀评分均大于基线无破坏组,差异有统计学意义(P<0.05);基线有破坏组的Sharp进展速率大于基线无破坏组,差异有统计学意义(P<0.05);雷公藤组和甲氨蝶呤组在基线、24周、1年以上时点的DAS28评分组间比较,差异无统计学差异(P>0.05),治疗24周后及治疗1年以上后,两组患者DAS28评分均较治疗前降低,差异有统计学意义(P<0.05);雷公藤组和甲氨蝶呤组在基线时HAQ总分比较,差异无统计学意义(P>0.05),治疗24周后,两组患者HAQ总分均较治�Objective To observe and evaluate the efficacy of Tripterygium wilfordii glycoside(TWG)in delaying bone destruction in rheumatoid arthritis(RA).Methods The first phase of the trial(0~24 weeks)employed a randomized,double-blind,double-simulation,positive parallel controlled design.Patients were randomly assigned to a TWG group and a methotrexate group.The TWG group received oral TWG tablets and simulated methotrexate tablets,and the methotrexate group received oral methotrexate and simulated TWG tablets.After 24 weeks of treatment,radiographic scores of hand X-rays,Disease Activity Score-28(DAS28)scores,and Health Assessment Questionnaire(HAQ)total scores of the two groups were evaluated.The second phase(over 1 year)was an open-label observational trial.Patients who revisited the hospital after 1 year were divided into a TWG group and a methotrexate group according to their treatment regimen after 24 weeks.Radiographic scores of hand X-rays and DAS28 scores were observed in both groups.Results No significant differences were found between the TWG group and the methotrexate group in Sharp total score,joint space score,or joint erosion score at baseline and 24 weeks(P>0.05).Additionally,no significant differences were observed in the progression rates of Sharp total score,joint space,or joint erosion between the two groups at baseline,24 weeks,and over 1 year(P>0.05).After 24 weeks of treatment,the progression rates of Sharp total score decreased significantly in both groups compared with those before treatment(P<0.05).Beyond 1 year,the progression rate of joint space decreased significantly in the TWG group compared with that before treatment(P<0.05),while the joint erosion progression rate increased significantly in the methotrexate group(P<0.05).At baseline,24 weeks,and over 1 year,the Sharp total score,joint space score,and joint erosion score in the damage group were higher than those in the non-destruction group at baseline(P<0.05),and the progression rate of Sharp total score was greater in the destruction gr

关 键 词：雷公藤多苷 类风湿性关节炎 骨破坏 放射学 

分 类 号：R593.22[医药卫生—内科学]