补肾壮骨方联合盐酸氨基葡萄糖治疗膝骨关节炎临床研究

Clinical study on "Bushen Zhuanggu Decoction" combined glucosamine hydrochloride for knee osteoarthritis

目的探讨中药补肾壮骨方联合西药盐酸氨基葡萄糖治疗膝骨关节炎的疗效及安全性。方法 90例患者随机分为治疗组和对照组,各45例。治疗组给予中药补肾壮骨方联合西药盐酸氨基葡糖口服,对照组仅服用盐酸氨基葡萄糖,疗程均为6周;疗效评价采用Lequesne指数和VAS评分(疼痛视觉模拟评分),并随时记录治疗过程中的任何不良反应。结果治疗组42例、对照组41例患者完成了本试验。治疗组治疗前后Lequesne指数中疼痛、行走、日常活动评分及总分变化差异均有统计学意义(P<0.05),对照组治疗前后疼痛评分和Lequesne总分变化差异有统计学意义(P<0.05);治疗后组间比较,上述四项变化差异均有统计学意义(P<0.05)。两组VAS疼痛评分治疗前后组内比较,差异有统计学意义(P<0.05);治疗后组间比较,差异有统计学意义(P<0.05)。两组均未出现严重不良反应。结论中药补肾壮骨方加减配合西药盐酸氨基葡萄糖在改善膝骨关节炎患者疼痛行走能力及日常活动方面疗效良好。

Objective To explore the clinical efficacy and safety of “Bushen Zhuanggu Decoction” combined glucosamine hydrochloride in the treatment of knee osteoarthfitis. Methods Ninety cases were randomized into two groups ： treatment group in which 45 cases were treated by combination of “Bushen Zhuanggu De- coction” once a day with glucosamine hydrochlofide 0.75 g, twice a day orally. Control group in which 45 cases were treated by glucosamine hydroehloride 0.75 g, twice a day orally, with the course of 6 weeks. The clinical efficacy was evaluated by Lequesne index and VAS score, and the adverse reaction was recorded at any time. Results Forty-two cases in treatment group and 41 cases in control group were finished the experiment. In treatment group, there were significant differ- ences in scores of pain, mobility, daily activities and Lequesne between before and after treatment （ P 〈 0.05） ; in control group, the scores of pain and Lequesne were different significantly between before and after treatment （ P 〈 0.05 ）. After treatment, there were significant differences in the four indexes between the two groups （P 〈 0.05）. In both of the two groups, there were significant differences in VAS scores between before and after treatment （P 〈 0.05） ; after treatment, there were significant differences between the two groups （ P 〈 0.05 ）. No severe adverse reaction was appeared in both of the groups. Conclusion “ Bushen Zhuanggu Decoction”combined glucosamine hydrochloride is more effective than glucosamine hydrochloride in improving the scores of VAS, Lequesne and pain, especially in mobility and daily activities.