复方盐酸氨基葡萄糖胶囊与片剂治疗骨关节炎疗效及安全性的对比研究

Comparative Study on Efficacy and Safety of Compound Glucosamine Hydrochloride Capsules and Tablets in Treatment of Osteoarthritis

目的:探讨不同剂型的复方盐酸氨基葡萄糖治疗骨关节炎的疗效及安全性。方法:选取2012年7月—2016年6月湖北省谷城县人民医院收治的骨关节炎患者306例作为研究对象,采用区组随机化分组方法分为胶囊组、片剂组及安慰剂组3组,每组各102例。胶囊组患者给予复方盐酸氨基葡萄糖胶囊3粒,片剂组患者给予复方盐酸氨基葡萄糖片剂3片,安慰剂组患者给予复方盐酸氨基葡萄糖胶囊1粒、片剂1粒、安慰剂1粒,1日3次。观察不同用药方案的安全性与临床疗效。结果:胶囊组、片剂组患者的关节功能与视觉模拟评分法评分均明显低于安慰剂组,差异均有统计学意义(P<0.05);胶囊组与片剂组的总有效率均显著高于安慰剂组,差异均有统计学意义(P<0.05);3组患者不良反应发生率的差异无统计学意义(P>0.05)。结论:采用复方盐酸氨基葡萄糖胶囊剂或片剂治疗骨关节炎,均疗效显著,且安全可靠。

OBJECTIVE： To probe into the efficacy and safety of different formulations of compound Glucosamine hydrochloride capsules and tablets in treatment of osteoarthritis. METHODS： 306 patients with osteoarthritis admitted into Hubei Province Gucheng County People＇s Hospital from Jul. 2012 to Jun. 2016 were selected to be divided into capsule group,tablet group and placebo group via the random number table,with 102 cases in each. The capsule group were given three compound Glucosamine hydrochloride capsules,the tablet group were treated with three Glucosamine hydrochloride tablets,and the placebo group received one Glucosamine hydrochloride capsule,one Glucosamine hydrochloride tablet,three times a day. The clinical efficacy and safety of different therapeutic regimen were observed. RESULTS： The joint function recovery and visual analogue scale score of capsule group and tablet group were significantly lower than that of placebo group,with statistically significant difference（ P〈0. 05）. The total effective rate of capsule group and tablet group were significantly lower than that of placebo group,with statistically significant difference（ P〈0. 05）. And there was no statistical significance between two groups in the incidence of adverse drug reactions（ P〉0. 05）. CONCLUSIONS： The efficacy of compound Glucosamine hydrochloride capsules or tablets in treatment of osteoarthritis is remarkable with high safety.