外用非甾体抗炎药联合玻璃酸钠及氨基葡萄糖治疗骨关节炎的多中心、Ⅳ期临床研究

A multi-center,phase IV clinical study of topical non-steroidal anti-inflammatory drugs combined with sodium hyaluronate and glucosamine in the treatment of osteoarthritis

目的评价外用非甾体抗炎药联合玻璃酸钠及氨基葡萄糖治疗骨关节炎的有效性及安全性。方法本研究选取2019年3月~2019年12月三个医院的骨关节炎患者200例作为研究对象,共入组三个中心患者,所有患者分为五组,每组40例患者,均行关节腔注射玻璃酸钠及口服氨基葡萄糖,分别联合洛索洛芬钠凝胶膏、氟比洛芬凝胶膏、洛索洛芬钠贴、吲哚美辛凝胶膏以及吡罗昔康贴剂进行敷贴治疗4周。结果五组总有效率分别为92.5%、87.5%、87.5%、85.0%、90.0%,差异无统计学意义(P>0.05)。五组患者的VAS疼痛评分、WOMAC综合评分显著改善,治疗前后差异具有统计学意义(P<0.05),相比其他组,A组WOMAC综合评分更低(P<0.05)。五组药物不良反应发生率无显著差异(P>0.05)。结论外用非甾体抗炎药联合玻璃酸钠和氨基葡萄糖治疗骨关节炎有效,且安全性良好。

Objective To evaluate the effecacy and safety of topical non-steroidal anti-inflammatory drugs combined with sodium hyaluronate and glucosamine in the treatment of osteoarthritis.Methods In this study,200 patients with osteoarthritis from three hospitals from March to December 2019 were selected as the research objects.A total of three centers were enrolled,and 200 patients were divided into five group,each group of 40 patients.All patients received the treatment of injection of sodium hyaluronate in the joint cavity and oral glucosamine.At the same time,they were respectively combined with loxoprofen sodium gel ointment,flurbiprofen gel ointment,loxoprofen sodium patch,indomethacin gel ointment and piroxicam patch for 4 weeks.Results The effective rates of the five groups were 92.5%、87.5%、87.5%、85.0%、90.0%,and the difference was not statistically significant(P>0.05).The VAS pain score and WOMAC comprehensive score in 5 groups were significantly lower than those before treatment(P<0.05),and WOMAC comprehensive score in group A was lower than that in other groups(P<0.05).There was no significant difference in the incidence of adverse drug reactions in the five groups(P>0.05).Conclusion The topical non-steroidal anti-inflammatory drugs combined with sodium hyaluronate and glucosamine are effective in the treatment of osteoarthritis.