CAJ | 학술논문

目的评价依托考昔治疗中国人群膝或髋关节骨关节炎患者的疗效和安全性.方法在该多中心、随机双盲、活性药物平行对照的临床研究中,符合入选标准的患者随机进入试验组(90例,口服依托考昔60 mg,每日1次),活性药物对照组(90例,口服双氯芬酸钠缓释片75 mg/次,每日2次).疗程4周.主要疗效终点为治疗后2组的西安大略大学和麦克马斯特大学骨关节炎指数(WOMAC)疼痛评分.次要疗效终点包括WOMAC进行日常活动的难度评分、WOMAC关节僵硬评分、患者对治疗反应的综合评价(PGART)、研究者对疾病状况的综合评估(IGADS)、因治疗无效而终止研究的情况以及为缓解症状服用的对乙酰氨基酚(扑热息痛片)计数.通过体格检查、实验室检查等评估用药的安全性.主要统计学方法采用方案分析集(PP)和全分析集(FAS).结果治疗4周后,2组的WOMAC疼痛评分均较用药前有显著改善,依托考昔组:51±16与21±19；双氯芬酸钠组:53±16与22±19 (P＜0.01),但组间比较差异无统计学意义.2组的WOMAC进行日常活动的难度评分、WOMAC关节僵硬评分、PGART、IGADS较用药前均有显著改善(P均＜0.01),但组间比较差异无统计学意义.研究过程中未发生药物相关的严重不良事件.2组药物之间总的药物相关不良事件发生率差异无统计学意义.2种药物的安全性和耐受性良好.结论依托考昔60 mg每日1次能够有效缓解骨关节炎患者的临床症状和体征.该结果在各项评价指标中均得到证实.依托考昔的疗效不劣于双氯芬酸钠缓释片75 mg每天2次的疗效.在连续4周治疗期内,依托考昔总体安全性和耐受性良好.
목적 평개의탁고석치료중국인군슬혹관관절골관절염환자적료효화안전성.방법 재해다중심、수궤쌍맹、활성약물평행대조적림상연구중,부합입선표준적환자수궤진입시험조(90례,구복의탁고석60 mg,매일1차),활성약물대조조(90례,구복쌍록분산납완석편75 mg/차,매일2차).료정4주.주요료효종점위치료후2조적서안대략대학화맥극마사특대학골관절염지수(WOMAC)동통평분.차요료효종점포괄WOMAC진행일상활동적난도평분、WOMAC관절강경평분、환자대치료반응적종합평개(PGART)、연구자대질병상황적종합평고(IGADS)、인치료무효이종지연구적정황이급위완해증상복용적대을선안기분(복열식통편)계수.통과체격검사、실험실검사등평고용약적안전성.주요통계학방법채용방안분석집(PP)화전분석집(FAS).결과 치료4주후,2조적WOMAC동통평분균교용약전유현저개선,의탁고석조:51±16여21±19；쌍록분산납조:53±16여22±19 (P＜0.01),단조간비교차이무통계학의의.2조적WOMAC진행일상활동적난도평분、WOMAC관절강경평분、PGART、IGADS교용약전균유현저개선(P균＜0.01),단조간비교차이무통계학의의.연구과정중미발생약물상관적엄중불량사건.2조약물지간총적약물상관불량사건발생솔차이무통계학의의.2충약물적안전성화내수성량호.결론 의탁고석60 mg매일1차능구유효완해골관절염환자적림상증상화체정.해결과재각항평개지표중균득도증실.의탁고석적료효불렬우쌍록분산납완석편75 mg매천2차적료효.재련속4주치료기내,의탁고석총체안전성화내수성량호.
Objective To compare the clinical response with etoricoxib 60 mg once daily with diclofenac sodium tablet 75 mg two times daily in the treatment of osteoarthritis of the knee or hip joint.Methods A 4-week multicenter,randomized,double-blinded and active comparator-controlled clinical trial was performed during January 2005 and June 2005 in 6 medical centers in China.Eligible patients (≥40 years old Chinese patients with osteoarthritis of the knee and hip) were randomized (1:1 ratio) to receive etoricoxib 60 mg once daily (n=90),or diclofenac sodium 75 mg twice daily (n=90).Primary efficacy end point is the change of WOMAC (Western Ontario and McMaster Universities osteoarthritis index) pain subscale from baseline to 4 weeks; non-inferiority bounds were pre-defined [if the upper bound of 95％ confidence interval (CI) for the difference is less than 10 mm on a 100-mm VAS WOMAC pain subscale] for the comparison of the change between the two groups.The secondary efficacy endpoints include WOMAC physical function subscale,WOMAC stiffness subscale,patient's global assessment of response to therapy (PGART),investigator's global assessment of disease status (IGADS),discontinuation due to lack of efficacy and rescue paracetamol tablet count.Safety was assessed by physical examination,adverse experience reported,and laboratory safety data.Results C6mpared to baseline,the changes of WOMAC pain subscale after 4 weeks treatment were statistically significant (P＜0.01) in both groups (etoricoxib group:51±16 vs 21± 19; diclofenac sodium group:53±16 vs 22±19).There was no difference in the change of WOMAC pain subscale between the two groups.The change in WOMAC stiffness subscale,WOMAC physical function subscale,PGART and IGADS in both groups were statistically significant (P＜0.01),but there was no difference between treatment groups according to the pre-defined non-inferiority criteria.No drug related serious adverse events were observed during the study.The difference in drug-related adverse event incidence between the two groups was not statistically significant.Etoricoxib and diclofenac sodium were generally safe and well tolerated.Conclusion Etoricoxib 60 mg administered once daily is efficacious and shows clinical efficacy notinferior to that of diclofenac sodium 75 mg administered twice daily for the treatment of osteoarthritis.Etoricoxib 60 mg administered once daily for 4 weeks is generally safe and well tolerated.