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体外发散式冲击波治疗膝关节骨性关节炎的临床疗效及安全性研究
Extracorporeal shockwave therapy versus oral non-steroidal anti-inflammatory drug combined with glucosamine sulfate for the treatment of knee osteoarthritis:a randomized, open-label trial.
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DOI:
作者:
吴玮,叶乐,郑蓓洁,冯晶晶,陈雪青,吕焕然,徐伟豪,王祥瑞
WU Wei,YE Le,ZHENG Peijie,FENG Jingjing,CHENG Xueqin,LV Huanran,XU Weihao,WANG Xiangrui.
作者单位:
上海交通大学医学院附属仁济医院疼痛科
Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University,Shanghai 200001, China
关键词:
体外发散式冲击波;非甾体抗炎药;膝关节骨性关节炎;疼痛
Extracorporeal shockwave therapy;NSAIDs;Knee osteoarthritis;Pain
摘要:
目的 比较体外发散式冲击波(ESWT)和非甾体抗炎药联合硫酸氨基葡萄糖来研究体外发散式冲击波治疗膝关节骨性关节炎的早期疗效和安全性。方法 随机53名患者分别接受ESWT(n=27)和药物(n=26)治疗。ESWT组患者每周接受3000次冲击波治疗,连续4周。药物组患者给予非甾体抗炎药(依托考昔)60mg,1次/日,联合硫酸氨基葡萄糖0.25g,3次/日,连续服用4周。通过视觉模拟评分法(VAS)和膝关节损伤和骨关节炎评分(KOOS)量表评估膝关节骨性关节炎的的治疗疗效。分别在治疗前,治疗后2周及治疗后6周对患者进行评估。同时记录患者在治疗过程中发生的不良事件。结果 两组患者治疗后VAS评分均值都有所下降(药物组:从治疗前5.68治疗6周后降低至3.6,ESWT组从治疗前5.86治疗6周后降低至2.64,两组P均<0.001),并且两组患者KOOS量表各个维度评分均有提高。同时在降低VAS评分和提升KOOS量表疼痛,运动功能,生活质量三个维度评分方面,ESWT组与药物组相比存在显著差异( P=0.013,P=0.001,P=0.007, P=0.035 )。而两组患者不良反应的发生率并未见显著差异(P=0.318)。结论 药物组及ESWT组均能缓解疼痛和改善膝关节功能,且ESWT组对比药物组在疼痛、KOOS量表运动功能和生活质量方面的改善更为突出。两组的不良事件发生率未有明显差异。
Objective:The aim of this study was to clarify the efficacy and safety of extracorporeal shockwave therapy(ESWT) in comparison to those of non-steroidal anti-inflammatory drug(NSAIDs) combined with glucosamine sulfate for patients with knee osteoarthritis. Methods We randomized 53 patients to receive ESWT(n=27) or pharmacological interventions (n=26). For ESWT, patients received 3000 pulses of shockwave weekly for 4 weeks .In the pharmacological interventions group,people received NSAIDs(Etoricoxib) once and glucosamine sulfate three times per day for 4 weeks.The effect on osteoarthritis was assessed by pain on a visual analog scale (VAS) and Knee injury and Osteoarthritis Outcome Score(KOOS).Evaluation was performed at baseline and after 2 and 6 weeks.All patients were questioned regarding any adverse events during treatment. Results Mean VAS scores before and 6 weeks after treatment were 5.68 and 3.6 for the ESWT group and 5.86 and 2.64 for the pharmacological interventions group.For the VAS socres, there was a significant effect for time in both groups.The Knee injury and Osteoarthritis Outcome Score both increased in two groups. The mean of KOOS scores at weeks 0, 2, and 6 showed significant improvement when compared with the baseline in both groups.The mean difference of KOOS Pain, KOOS Sport and KOOS QOL scores at week 6 adjusted by values at week 0 of ESWT were superior to those for pharmacological interventions group (P=0.001,P=0.007 and P=0.035).Conclusions The early efficacy of ESWT is suggested to be superior to that of NSAIDs combined with glucosamine sulfate, and that the safety of ESWT is not superior to that of NSAIDs combined with glucosamine sulfate for patients with knee osteoarthritis.
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