多中心随机双盲双模拟阳性药平行对照临床研究:评价国产盐酸氨基葡萄糖片在治疗骨关节炎中的有效性和安全性

Clinical Investigation of the Efficacy and Safely of Glucosamine Hydrochloride Tablet for Osteoarthritis

目的:通过6周临床观察国产盐酸氨基葡萄糖片治疗膝骨性关节炎(OA)的疗效和安全性,方法:采用多中心、随机、双盲双模拟阳性药平行对照前瞻性临床研究对2组各72例OA患者分别用试验药国产盐酸氨基葡萄糖片和阳性对照药盐酸氨基葡萄糖胶囊治疗前后的临床指标和实验室指标进行观察。结果:两组组内治疗前后临床指标和实验室指标明显改善,均有显著统计学意义(P<0.05);组间相比除压痛构成比差异P<0.05有统计学意义外,其余异常症征构成比差异均P>0.05,无统计学意义。两组的临床总有效率为80.56%(58/72)和84.72%(61/72),无统计学意义(P>0.05);不良应发生率为8.33%(6/72)和9.72%(7/72),差异无统计学意义(P=0.771)。结论:氨基葡萄糖片治疗骨性关节炎疗效确切,不良反应少,患者耐受性好,服用方便,为安全有效的治疗骨性关节炎药物,值得临床推广使用。

Objective： To investigate the efficacy and safety of home made glucosamine hydrochloride tablet for the treatment of osteoarttu＇itis. Methods： Double blind, double simulation, prospevtive, randomized parallel control trial was designed, were 2 groups enrolled each 72 patients in this trial. Clinical manifestation and the lab markers are observed carefully. Results： Clinical manifestation and the lab markers of two groups received with the treatment of glucosamine hydrochloride tablet were improved （ P 〈 0.05）. Total effective rates are approximately equal （ 80.56 % vs 84.72% ; P 〉 0.05 ）, and adverse drug effects of two groups were not significant （8.33% vs 9.72% ; P = 0.771 ）. Conclusion： Glucosamine hydrochloride tablet may be an effective and safe drug for osteoarthritis, suggesting that glucosamine hydrochloride may help for certain patients with OA.