Etoricoxib versus indometacin in the treatment of Chinese patients with acute gouty arthritis： a randomized double-blind trial  

作　　者：LI Ting CHEN Shun-le DAI Qing HAN Xing-hai LI Zhan-guo WU Dong-hai ZHANG Xiao GU Jie-ruo YANGNan-ping SUN Ling-yun ZHANG Miu-jia LI Xing-fu and BAO Chun-de 

机构地区：[1]Department of Rheumatology, Renji Hospital, Shanghai JiaotongUniversity School of Medicine, Shanghai 200001, China [2]Department of Rheumatology, Changhai Hospital, Shanghai 200438,China [3]Department of Rheumatology, Beijing University People's Hospital,Beijing 100044, China [4]Department of Rheumatology, China-Japan Friendship Hospital,Beijing 100029, China [5]Department of Rheumatology, Guangdong Provincial People'sHospital, Guangzhou, Guangdong 510120, China [6]Department of Rheumatology, Third Affiliated Hospital, Sun Yat-SenUniversity, Guangzhou, Guangdong 510630, China [7]Department of Rheumatology, West China Hospitall SichuanUniversity, Chengdu, Sichuan 610041, China_ [8]Department of Rheumatology, Nanjing Drum Tower Hospital,Nanjing, Jiangsu 210008, China [9]Department of Rheumatology, Jiangsu Province Hospital, Nanjing,Jiangsu 210029, China [10]Department of Rheumatology, Qilu Hospital, Jinan, Shandong250012, China

出　　处：《Chinese Medical Journal》2013年第10期1867-1871,共5页中华医学杂志（英文版）

摘　　要：Background Acute gout is an intensely painful, inflammatory arthritis. Although the non-steroidal anti-inflammatory drugs （NSAIDs） are widely used for this condition, the efficacy is based on only a few studies, particularly in China. We tried to assess the safety and efficacy of etoricoxib in the treatment of acute gouty arthritis in China. Methods A randomized, double-blind, active comparator study was conducted at 10 sites in China. Patients （n=178; 〉18 years of age） with acute gouty attack （〈48 hours） were treated for 5 days with etoricoxib （120 mg/d; n=89） or indometacin （75 mg twice daily; n=89）. The primary efficacy end point was self-assessed pain in the affected joint （0-4 point Likert scale） from days 2-5. Secondary end points included investigator assessments of tenderness and swelling, patient/ investigator global assessments of response to therapy, and patients discontinuing treatment. Safety was assessed by adverse events （AEs）. Results Etoricoxib and indometacin had comparable primary and secondary end points. Mean change difference from baseline from days 2-5 was 0.03 （95% confidence interval （CI） -0.19 to 0.25; P=0.6364）, which fell within the prespecifled comparative bounds of -0.5 to 0.5. No severe AEs were associated with etoricoxib use. Non-severe AEs were mainly digestive and general, and most （73.7%） were mild, although they caused withdrawal of two subjects in the etoricoxib group, due to bilateral renal calculi and uronephrosis of the left kidney （unrelated to etoricoxib） and fever and chills （potentially etoricoxib-related）. Overall, AEs were similar, although the absolute number of AEs in the etoricoxib group （n=31） was less than the indometacin group （n=34）. Conclusions Etoricoxib （120 mg once daily） is effective in treating acute gout, is generally safe and well-tolerated, and is comparable in efficacy to indometacin （75 mg twice daily）.Background Acute gout is an intensely painful, inflammatory arthritis. Although the non-steroidal anti-inflammatory drugs （NSAIDs） are widely used for this condition, the efficacy is based on only a few studies, particularly in China. We tried to assess the safety and efficacy of etoricoxib in the treatment of acute gouty arthritis in China. Methods A randomized, double-blind, active comparator study was conducted at 10 sites in China. Patients （n=178; 〉18 years of age） with acute gouty attack （〈48 hours） were treated for 5 days with etoricoxib （120 mg/d; n=89） or indometacin （75 mg twice daily; n=89）. The primary efficacy end point was self-assessed pain in the affected joint （0-4 point Likert scale） from days 2-5. Secondary end points included investigator assessments of tenderness and swelling, patient/ investigator global assessments of response to therapy, and patients discontinuing treatment. Safety was assessed by adverse events （AEs）. Results Etoricoxib and indometacin had comparable primary and secondary end points. Mean change difference from baseline from days 2-5 was 0.03 （95% confidence interval （CI） -0.19 to 0.25; P=0.6364）, which fell within the prespecifled comparative bounds of -0.5 to 0.5. No severe AEs were associated with etoricoxib use. Non-severe AEs were mainly digestive and general, and most （73.7%） were mild, although they caused withdrawal of two subjects in the etoricoxib group, due to bilateral renal calculi and uronephrosis of the left kidney （unrelated to etoricoxib） and fever and chills （potentially etoricoxib-related）. Overall, AEs were similar, although the absolute number of AEs in the etoricoxib group （n=31） was less than the indometacin group （n=34）. Conclusions Etoricoxib （120 mg once daily） is effective in treating acute gout, is generally safe and well-tolerated, and is comparable in efficacy to indometacin （75 mg twice daily）.

关 键 词：gout  arthritis  etoricoxib  indometacin CYCLOOXYGENASE-2 

分 类 号：S858.317.1[农业科学—临床兽医学] TQ460.6[农业科学—兽医学]