Objective To observe the clinical efficacy of self -made Bushengujin prescription on the treatment of knee osteoarthritis ( KOA). Methods A total of 72 consecutive patients with KOA were randomly divided into Bushengujin prescription treatment group ( TCM group, n = 35 ) and meloxicam control group ( western medicine group, n = 37 ). An intact course included 8-week continuous treatment. After 2 intact courses of treatment, drugs were withdrawn for 2 weeks. The clinical efficacy was statistically analyzed. And the main clinical symptoms before and after treatment were compared. Results The total efficacy rate in TCM group and in meloxicam control group was 90. 62% and 88. 89%, respectively, which showed no significant difference ( P ＞ 0. 05). Concerning the quality of life, the efficacy rate in TCM group was 44. 5% and 46. 12%, respectively, and the total efficiency was 90. 62%. In western medicine group it was 42. 8% and 46. 09%, respectively, and the total efficiency was 88. 89%. No statistical significance was observed ( P ＞ 0. 05 ). Comparing the clinical symptom improvement rates, the patients in two groups showed significant difference ( P ＜ 0. 01), indicating that both medicines could improve the condition. Comparing of integral change, P value of total score of patients in two groups was 0. 952, which was higher than 0. 05. P value of pain scores was less than 0. 01, and P value of TCM syndrome integral was less than 0. 01. All showed significant difference. Conclusion Bushengujin prescription showed similar effect on improving clinical symptoms with meloxicam, but the former has certain advantages on improving the quality of life, function, and syndrome of traditional Chinese medicine. Comparing with meloxicam, Bushengujin prescription can increase cartilage matrix synthesis, promote the damaged articular cartilage repair, effectively delay the KOA cartilage degeneration, and exert certain protective function.%目的 观察自拟补肾固筋方治疗KOA(膝关节骨性关节炎)的临床疗效.方法 72例KOA患者按就诊先后顺序随机分组对照,分为补肾固筋方治疗组(中药组)35例和美洛昔康对照组(西药组)37例.连续治疗8周为一疗程,治疗2个疗程后停药2周,进行临床疗效统计及治疗前后主要临床症状体征改善率比较.结果 两组总有效率无显著性差异(P>0.05).补肾固筋方组总有效率为90.62%,美洛昔康组总有效率为88.89%.1.生活质量比较:中药组显效率为44.5%,有效率为46.12%,总有效率为90.62%;西药组显效为42.8%,有效率为46.09%,总有效率为88.89%.无统计学意义(P>0.05).2.临床症状体征改善率比较:两组患者各项积分改善具有显著性差异(P＜0.01),提示均能不同程度改善病情.3 积分变化比较:两组患者的组间总积分P=0.952>0.05,疼痛积分比较P＜0.01,中医证候积分比较P＜0.01,均有显著性差异.结论 1.补肾固筋方与美洛昔康在改善临床症状体征方面效果相当,但前者改善生活质量、功能及中医证候上有一定的优势.2.补肾固筋方比美洛昔康增进软骨基质的合成,促进受损关节软骨的修复,可有效延缓 KOA软骨的退变,起到一定的保护作用.
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