盐酸氨基葡萄糖联合低剂量NSAIDS类药物与单纯用药治疗小关节骨关节炎伴下腰痛的随机对照研究

Randomized controlled study of lumbar facet joint osteoarthritis with low back pain:glucosamine hydrochloride combined with low dose of NSAIDS versus drug alone

背景:腰背痛是一个常见的临床问题。盐酸氨基葡萄糖对膝关节骨关节炎的治疗作用已得到证实,在治疗腰背痛中的有效性仍有待进一步研究。目的:探讨盐酸氨基葡萄糖与低剂量非甾体类抗炎药(non-steroid anti-inflammatory drug,NSAID)联用与常规剂量NSAID、相同剂量盐酸氨基葡萄糖、小剂量NSAID相比治疗腰椎小关节骨关节炎伴下腰痛的临床效果。方法:160例小关节骨关节炎伴下腰痛患者,男93例,女67例,年龄29～65岁,平均(46.4±10.9)岁。随机分为A、B、C、D组。A组口服盐酸氨基葡萄糖750mg,1日2次,加用双氯酚酸钠片25mg,1日1次;B组口服双氯酚酸钠缓释片75mg,1日1次;C组口服盐酸氨基葡萄糖750mg,1日2次;D组口服双氯酚酸钠片25mg,1日1次。治疗前(0周)、8周和16周使用Oswestry残疾指数(Oswestry disability index,ODI)、视觉模拟疼痛评分(vis-ual analog score,VAS)和SF-36量表进行评估。结果:147例获得随访,失访率为8.13%。各组患者的腰痛VAS评分、ODI评分和SF-36评分在治疗前后比较均有显著性改善(P<0.05)。A、B两组间的各个评价参数在各随访点比较均无显著性差异(P>0.05),但A、B两组的疗效明显优于C、D两组。无一例出现药物不良反应。结论:联合盐酸氨基葡萄糖可减少治疗小关节骨关节炎伴下腰痛中NSAID类药物的用量,可成为降低NSAID药物相关风险的替代治疗选择。

Background： Back Pain is a common clinical problem. Glucosamine hydrochloride is effective for knee joint osteoarthri-tis, but its effect on back pain caused by facet joint degeneration still needs to validated.Objective： The purpose of the stcedy is to compare the clinical outcomes between glucosamine hydrochloride combined with low dose of non-steroid anti-inflammatory drug （NSAID） and regular dose or low dose of NSAID for facet joint degeneration and low back pain.Methods ： A total of 160 patients with degenerative facet joints and low back pain were randomly divided into three groups. There were 93 males and 67 females with an average age of 46. 4 通信作者：刘浩.E-mail：liuha06304@163.com10. 9 （29 -65） years old. Oral administration of glu- cosamine hydrochloride 750mg bid plus diclofenac sodium tablets 25mg qd was for group A; Diclofenac sodium tablets 75mg qd for group B; glucosamine hydrochloride 750mg bid for group C; diclofenac sodium tablets 25mg qd for group D. The treatment lasted for 8 weeks. Oswestry disability index （ODI）, Visual Analog Score （VAS） and SF-36 were used for evaluation before treatment, 8 and 16 weeks after treatment.Results： There were 147 patients at the last follow-up, and the lost ratio was 8. 13%. ODI, lumbar pain VAS and SF-36 were significantly improved in each groups before and after treatment （ P 〈 0. 05 ）. Group A and B achieve comparable out- come in each fellow-up, P 〉0. 05. However, the outcomes of Group A and B were significantly better than Group C and D, P 〈 O. 05. No treatment-related adverse events were observed. No drug related adverse event was observed.Conclusions： There is significant improvement in pain, lumbar function and quality of life for patients with lumbar facet joint degeneration and low back pain in the 16-week follow-up with the two treatments. However, there is no difference of effectiveness between the two treatments. The combined therapy might reduce the use of NSAID and could be an alternative to those who need to control the risks of NSAID by low doses.