地塞米松棕榈酸酯注射液治疗膝骨关节炎的临床疗效和安全性评价
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摘要
目的探讨地塞米松棕榈酸酯(DXP)注射液关节腔注射治疗膝骨关节炎(KOA的临床疗效和安全性。方法设计为多中心、阳性药物对照、随机的临床研究,选择3家医院风湿科收治的66例KOA患者,随机分为试验组和对照组,每组各33例。试验组关节腔注射DXP注射液1 ml,对照组关节腔注射复方倍他米松1 ml,研究为期28 d,在治疗前、治疗后第7日和第28日对患者进行评估,比较2组在治疗前后及组间的疗效指标差异。主要疗效指标为西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评分,次要指标包括Lequesne指数、膝关节周径、超声下髌上囊积液深度、滑膜厚度及其血流信号、ESR、CRP、关节压痛指数。观察2组治疗期间发生的不良反应。结果治疗后,试验组和对照组KOA患者WOMAC评分、膝关节周径、髌上囊积液、ESR、CRP、关节压痛指数均较治疗前改善(P<0.025或<0.05),组间比较差异均无统计学意义(P均> 0.05);2组髌上囊滑膜厚度及其血流信号与治疗前比较差异均无统计学意义(P均> 0.05)。2组疗效比较差异无统计学意义(P> 0.05)。试验组1例患者发生与DXP可能相关的转氨酶轻度升高。结论 DXP注射液关节腔注射治疗KOA,可改善患者的疼痛症状、囊腔积液与炎症状态,不良反应少。
Objective To assess the clinical efficacy and safety of dexamethasone palmitate(DXP) injection in the treatment of knee osteoarthritis(KOA). Methods In this multi-center, positive drug control and randomized clinical trial, 66 patients with KOA from the Department of Rheumatology of 3 hospitals were enrolled and randomly assigned into the study(n=33) and control groups(n=33). In the study group, patients were treated with intra-articular injection of 1 ml of DXP, and those in the control group were administered with intra-articular injection of 1 ml of compound betamethasone for 28 d. The physical conditions of the patients were evaluated at 0, 7 th and 28 th d after corresponding treatment. The indexes used for evaluating clinical efficacy before and after treatment were statistically compared between two groups. The primary index was the WOMAC index. The secondary indexes were Lequesne index, the circumference of the knee, the depth of knee joint effusion, the thickness and the blood signals of knee joint synovial, ESR, CRP and joint tenderness index. The incidence of adverse reactions throughout the treatment were observed in two groups. Results After corresponding treatment, the WOMAC score, the circumference of the superior patellar margin, the suprapatellar bursa effusion, ESR, CRP and joint tenderness index were significantly improved in both groups(P < 0.025 or 0.05), whereas no statistical significance was noted between two groups(all P > 0.05). The thicknesses and the blood signals of synovial in suprapatellar bursa in two groups did not change significantly after treatment(both P > 0.05). There were no statistically differences in the efficacy between two groups(P > 0.05).One patient presented with a slight inecrease in the transaminases level probably associated with DXP in the study group. Conclusions Intra-articular injection of DXP is an efficacious treatment of KOA, which can mitigate the pain symptom, alleviate effusion and inflammation, and reduce the risk of adverse events.
Objective To assess the clinical efficacy and safety of dexamethasone palmitate(DXP) injection in the treatment of knee osteoarthritis(KOA). Methods In this multi-center, positive drug control and randomized clinical trial, 66 patients with KOA from the Department of Rheumatology of 3 hospitals were enrolled and randomly assigned into the study(n=33) and control groups(n=33). In the study group, patients were treated with intra-articular injection of 1 ml of DXP, and those in the control group were administered with intra-articular injection of 1 ml of compound betamethasone for 28 d. The physical conditions of the patients were evaluated at 0, 7 th and 28 th d after corresponding treatment. The indexes used for evaluating clinical efficacy before and after treatment were statistically compared between two groups. The primary index was the WOMAC index. The secondary indexes were Lequesne index, the circumference of the knee, the depth of knee joint effusion, the thickness and the blood signals of knee joint synovial, ESR, CRP and joint tenderness index. The incidence of adverse reactions throughout the treatment were observed in two groups. Results After corresponding treatment, the WOMAC score, the circumference of the superior patellar margin, the suprapatellar bursa effusion, ESR, CRP and joint tenderness index were significantly improved in both groups(P < 0.025 or 0.05), whereas no statistical significance was noted between two groups(all P > 0.05). The thicknesses and the blood signals of synovial in suprapatellar bursa in two groups did not change significantly after treatment(both P > 0.05). There were no statistically differences in the efficacy between two groups(P > 0.05).One patient presented with a slight inecrease in the transaminases level probably associated with DXP in the study group. Conclusions Intra-articular injection of DXP is an efficacious treatment of KOA, which can mitigate the pain symptom, alleviate effusion and inflammation, and reduce the risk of adverse events.
引文
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[3]Marchev AS,Dimitrova PA,Burns AJ,Kostov RV,DinkovaKostova AT,Georgiev MI.Oxidative stress and chronic inflammation in osteoarthritis:can NRF2 counteract these partners in crime?Ann N Y Acad Sci,2017,1401(1):114-135.
[4]Bellamy N,Buchanan WW,Goldsmith CH,Campbell J,Stitt LW.Validation study of WOMAC:a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee.J Rheumatol,1988,15(12):1833-1840.
[5]Lequesne M.Indices of severity and disease activity for osteoarthritis.Semin Arthritis Rheum,1991,20(6 Suppl 2):48-54.
[6]金宏亮,白广超,李宽新,雷堃.全膝关节置换术后疗效评分系统的研究进展.生物骨科材料与临床研究,2018,15(1):64-68.
[7]陈学均,周勤,文传兵.依托考昔联合关节腔内注射皮质类固醇治疗急性痛风性关节炎的疗效观察.西部医学,2013,25(8):1186-1188.
[8]任杰,郑荣琴,黄冬梅,李天旺,古洁若.彩色多普勒超声对膝关节炎关节内注射激素的疗效评估作用.中国临床康复,2005,9(11):26-27.
[9]鄢海波,马宁,崔春丽,刘涛,赵令,姜振宇.非布司他治疗痛风性关节炎的疗效及其安全性评价.吉林大学学报(医学版),2017,43(1):135-140.
[10]招淑珠,郭紫石,于清宏,邱敏丽,杨明灿,祁军,曹双燕,成红英,古洁若.地塞米松棕榈酸酯注射液治疗急性痛风性关节炎的临床疗效和安全性研究.新医学,2018,49(11):821-827.
[11]崔永建,王建,李艳,张红霞,刘佳.塞米松棕榈酸酯、维生素B12、利多卡因关节腔内注射对膝关节骨性关节炎患者血清IL-1,MMP-3及TIMP-1水平的影响.现代生物医学进展,2017,17(24):4664-4667.
[12]冯美杰.复方倍他米松联合透明质酸钠治疗膝骨关节炎45例体会.实用临床医药杂志,2012,16(21):142-143.
[13]高丽.玻璃酸钠联合得宝松及鹿瓜多肽治疗膝骨关节炎的疗效观察.内蒙古医科大学学报,2013,35(5):387-389.
[14]谢志进,王彦川,胡云洲.倍他米松联合玻璃酸钠治疗膝骨关节炎83例观察.现代临床医学,2013,39(3):192-193.
[15]黄建林,徐莉,罗敏琪,巫世瑶,曹双燕,古洁若.地塞米松棕榈酸酯注射液膝关节腔注射治疗类风湿关节炎疗效和安全性观察.广东医学,2010,31(11):1474-1475.
[2]Mizushima Y,Hamano T,Yokoyama K.Tissue distribution and anti-inflammatory activity of corticosteroids incorporated in lipid emulsion.Ann Rheum Dis,1982,41(3):263-267.
[3]Marchev AS,Dimitrova PA,Burns AJ,Kostov RV,DinkovaKostova AT,Georgiev MI.Oxidative stress and chronic inflammation in osteoarthritis:can NRF2 counteract these partners in crime?Ann N Y Acad Sci,2017,1401(1):114-135.
[4]Bellamy N,Buchanan WW,Goldsmith CH,Campbell J,Stitt LW.Validation study of WOMAC:a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee.J Rheumatol,1988,15(12):1833-1840.
[5]Lequesne M.Indices of severity and disease activity for osteoarthritis.Semin Arthritis Rheum,1991,20(6 Suppl 2):48-54.
[6]金宏亮,白广超,李宽新,雷堃.全膝关节置换术后疗效评分系统的研究进展.生物骨科材料与临床研究,2018,15(1):64-68.
[7]陈学均,周勤,文传兵.依托考昔联合关节腔内注射皮质类固醇治疗急性痛风性关节炎的疗效观察.西部医学,2013,25(8):1186-1188.
[8]任杰,郑荣琴,黄冬梅,李天旺,古洁若.彩色多普勒超声对膝关节炎关节内注射激素的疗效评估作用.中国临床康复,2005,9(11):26-27.
[9]鄢海波,马宁,崔春丽,刘涛,赵令,姜振宇.非布司他治疗痛风性关节炎的疗效及其安全性评价.吉林大学学报(医学版),2017,43(1):135-140.
[10]招淑珠,郭紫石,于清宏,邱敏丽,杨明灿,祁军,曹双燕,成红英,古洁若.地塞米松棕榈酸酯注射液治疗急性痛风性关节炎的临床疗效和安全性研究.新医学,2018,49(11):821-827.
[11]崔永建,王建,李艳,张红霞,刘佳.塞米松棕榈酸酯、维生素B12、利多卡因关节腔内注射对膝关节骨性关节炎患者血清IL-1,MMP-3及TIMP-1水平的影响.现代生物医学进展,2017,17(24):4664-4667.
[12]冯美杰.复方倍他米松联合透明质酸钠治疗膝骨关节炎45例体会.实用临床医药杂志,2012,16(21):142-143.
[13]高丽.玻璃酸钠联合得宝松及鹿瓜多肽治疗膝骨关节炎的疗效观察.内蒙古医科大学学报,2013,35(5):387-389.
[14]谢志进,王彦川,胡云洲.倍他米松联合玻璃酸钠治疗膝骨关节炎83例观察.现代临床医学,2013,39(3):192-193.
[15]黄建林,徐莉,罗敏琪,巫世瑶,曹双燕,古洁若.地塞米松棕榈酸酯注射液膝关节腔注射治疗类风湿关节炎疗效和安全性观察.广东医学,2010,31(11):1474-1475.