Objective:To investigate the efficacy and safety of intra-articular injection of low-dose compound betamethasone in the treatment of mild knee osteoarthritis.Methods:From September 2018 to December 2019,90 patients wi...Objective:To investigate the efficacy and safety of intra-articular injection of low-dose compound betamethasone in the treatment of mild knee osteoarthritis.Methods:From September 2018 to December 2019,90 patients with mild knee osteoarthritis were divided into complete dose group and low dose group according to the treatment sequence,45 cases in each group.The complete dose group was treated with intra-artiular injection of betamethasone(1ml)and sodium hyaluronate(2ml),once a week,three times as a course of treatment.The low dose group was treated with intra-artiular injection of betamethasone(0.3ml)and sodium hyaluronate(2ml),once a week,three times as a course of treatment.Lysholm scores、the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)and visual analogue scale(VAS)were compared between the two groups before and after treatment,and the efficacy and safety of the two groups were evaluated.Results:80 patients were followed up with an average of(4.96±1.50)months ranging from 3 to 8 months,and 10 cases(11.11%)were dropped out,including 2 cases in the complete dose group,2 cases in the midway withdrawal group,and 1 case in the treatment course less than the treatment course;3 cases in the low dose group lost the follow-up,and 2 cases dropped out.Compared with that before treatment,Lysholm scores were significantly improved,WOMAC scores and VAS scores were significantly decreased in the two groups at 3 weeks,6 weeks and 12 weeks after treatment(P<0.001).The Lysholm scores of low dose group were78.10±2.16,86.78±2.55,80.90±2.26,WOMAC scores were 61.00±1.38,39.03±1.98,45.76±1.66 and VAS scores were 2.23±0.89,0.78±0.73 and 1.05±0.85 in low dose group at 3 weeks,6 weeks and 12 weeks after treatment.There was no significant difference between the two groups(P>0.05).No drugrelated adverse reactions occurred in both groups.Conclusion:The curative effect of low dose compound betamethasone intra-articular injection in the treatment of mild knee osteoarthritis is equivalent to that of complete dose compound betamethasone.It can improve the function and symptoms of knee joint,and is safe and effective.展开更多
This phase 3 trial evaluated the efficacy and safety of Firsekibart,a novel,fully human anti-interleukin-1βmonoclonal antibody,in patients with frequent acute gout flares unsuitable for standard therapy.Pa-tients wer...This phase 3 trial evaluated the efficacy and safety of Firsekibart,a novel,fully human anti-interleukin-1βmonoclonal antibody,in patients with frequent acute gout flares unsuitable for standard therapy.Pa-tients were randomized(1:1,stratified by baseline pain visual analog scale[VAS])to the Firsekibart(200 mg)or compound betamethasone(CB;7 mg)group.Co-primary endpoints included change in pain inten-sity in the target joint at 72 h(non-inferiority testing)and time to first new flare within 12 weeks(superiority testing).The non-inferiority margin was 10 mm.The full analysis set included 311 patients(Firseki-bart:N=156;CB:N=155).At 72 h,the least squares mean change in pain VAS scores from baseline was-57.09 mm(95%confidence in-terval[CI]:-60.08 to-54.10)for Firsekibart and-53.77 mm(95%CI:-56.77 to-50.77)for CB,with treatment difference of-3.32 mm(95%CI:-7.56 to 0.91),establishing non-inferiority.The median time to first new flare was not reached within 12 weeks in the Firsekibart group compared with 45.0 days(95%CI:28.00 to 63.00)in the CB group.Firsekibart significantly reduced the risk of new flare by 90%vs.CB(haz-ard ratio:0.10;95%CI:0.06 to 0.17;stratified log rank p<0.0001).Effi-cacy was consistent across subgroups.Treatment-emergent adverse events occurred in 71.2%of Firsekibart-treated patients and 69.9%of those receiving CB.In conclusion,Firsekibart is effective and well toler-ated for acute gout flares in patients unsuitable for standard therapy,demonstrating non-inferiority in rapid pain relief and significant superi-ority in preventing flare compared with CB.展开更多
基金General project of national natural science foundation of China(No.81473695)2019 Clinical collaborative capacity building project of traditional Chinese and western medicine for major and difficult diseases(No.201803190106)。
文摘Objective:To investigate the efficacy and safety of intra-articular injection of low-dose compound betamethasone in the treatment of mild knee osteoarthritis.Methods:From September 2018 to December 2019,90 patients with mild knee osteoarthritis were divided into complete dose group and low dose group according to the treatment sequence,45 cases in each group.The complete dose group was treated with intra-artiular injection of betamethasone(1ml)and sodium hyaluronate(2ml),once a week,three times as a course of treatment.The low dose group was treated with intra-artiular injection of betamethasone(0.3ml)and sodium hyaluronate(2ml),once a week,three times as a course of treatment.Lysholm scores、the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)and visual analogue scale(VAS)were compared between the two groups before and after treatment,and the efficacy and safety of the two groups were evaluated.Results:80 patients were followed up with an average of(4.96±1.50)months ranging from 3 to 8 months,and 10 cases(11.11%)were dropped out,including 2 cases in the complete dose group,2 cases in the midway withdrawal group,and 1 case in the treatment course less than the treatment course;3 cases in the low dose group lost the follow-up,and 2 cases dropped out.Compared with that before treatment,Lysholm scores were significantly improved,WOMAC scores and VAS scores were significantly decreased in the two groups at 3 weeks,6 weeks and 12 weeks after treatment(P<0.001).The Lysholm scores of low dose group were78.10±2.16,86.78±2.55,80.90±2.26,WOMAC scores were 61.00±1.38,39.03±1.98,45.76±1.66 and VAS scores were 2.23±0.89,0.78±0.73 and 1.05±0.85 in low dose group at 3 weeks,6 weeks and 12 weeks after treatment.There was no significant difference between the two groups(P>0.05).No drugrelated adverse reactions occurred in both groups.Conclusion:The curative effect of low dose compound betamethasone intra-articular injection in the treatment of mild knee osteoarthritis is equivalent to that of complete dose compound betamethasone.It can improve the function and symptoms of knee joint,and is safe and effective.
基金supported by Changchun GeneScience Pharmaceutical Co.,Ltd.,Changchun,China.
文摘This phase 3 trial evaluated the efficacy and safety of Firsekibart,a novel,fully human anti-interleukin-1βmonoclonal antibody,in patients with frequent acute gout flares unsuitable for standard therapy.Pa-tients were randomized(1:1,stratified by baseline pain visual analog scale[VAS])to the Firsekibart(200 mg)or compound betamethasone(CB;7 mg)group.Co-primary endpoints included change in pain inten-sity in the target joint at 72 h(non-inferiority testing)and time to first new flare within 12 weeks(superiority testing).The non-inferiority margin was 10 mm.The full analysis set included 311 patients(Firseki-bart:N=156;CB:N=155).At 72 h,the least squares mean change in pain VAS scores from baseline was-57.09 mm(95%confidence in-terval[CI]:-60.08 to-54.10)for Firsekibart and-53.77 mm(95%CI:-56.77 to-50.77)for CB,with treatment difference of-3.32 mm(95%CI:-7.56 to 0.91),establishing non-inferiority.The median time to first new flare was not reached within 12 weeks in the Firsekibart group compared with 45.0 days(95%CI:28.00 to 63.00)in the CB group.Firsekibart significantly reduced the risk of new flare by 90%vs.CB(haz-ard ratio:0.10;95%CI:0.06 to 0.17;stratified log rank p<0.0001).Effi-cacy was consistent across subgroups.Treatment-emergent adverse events occurred in 71.2%of Firsekibart-treated patients and 69.9%of those receiving CB.In conclusion,Firsekibart is effective and well toler-ated for acute gout flares in patients unsuitable for standard therapy,demonstrating non-inferiority in rapid pain relief and significant superi-ority in preventing flare compared with CB.
