藤黄健骨胶囊治疗膝骨关节炎合并骨质疏松症临床分析

Clinical Analysis of Tenghuang Jiangu Capsules on Knee Osteoarthritis Complicated with Osteoporosis

目的观察藤黄健骨胶囊联合阿法骨化醇和双氯芬酸钠治疗膝骨关节炎(KOA)合并骨质疏松症的临床疗效。方法 86例患者随机分为对照组和观察组各43例,对照组予阿法骨化醇软胶囊和双氯芬酸钠缓释片,观察组加服藤黄健骨胶囊,3个月为1个疗程。比较两组临床疗效、视觉模拟量表(VAS)疼痛评分、西安大略和麦克马斯特大学骨关节炎指数(WOMAC)量表,检测血清中Ⅰ型胶原羧基端肽β特殊序列(β-CTX)、总Ⅰ型前胶原氨基端前肽(T-PINP)、N端骨钙素(N-MID)、25羟维生素D3[25-(OH)VD3]水平,记录不良反应。结果观察组有效率为83.7%(36/43),明显高于对照组的率62.8%(27/43)(P<0.05)。治疗后,两组各指标均显著改善(P<0.05);组间比较,观察组VAS评分,WOMAC量表中疼痛、日常活动及总分,血清β-CTX、T-PINP、N-MID含量均显著降低,25-(OH)VD3显著升高(P<0.05)。两组不良反应发生率差异无显著统计学意义(P>0.05)。结论藤黄健骨胶囊联合阿法骨化醇和双氯芬酸钠治疗KOA合并骨质疏松安全且有效。

Objective To observe the clinical effects of Tenghuang Jiangu Capsules combined with alfacalcidol and diclofenac sodium on knee osteoarthritis(KOA) complicated with osteoporosis.Methods Eighty-six cases were randomly divided into control group(43 cases) and study group(43 cases).The control group received alfacalcidol soft capsules and diclofenac sodium sustained release tablets.The study group took Tenghuang Jiangu Capsules additionally.All treated for 3 months,the clinical effects,visual analogue scale(VAS) and WOMAC scale were compared,the levels of β-CTX,T-PINP,N-MID and 25-(OH)-VD3 were determined,and the adverse reactions were recorded.Results The study group had higher total effective rate as 83.7%(36/43) than 62.8%(27/43) of the control group(P<0.05).After treatment,the indexes improved in both groups.Compared with the control group,the VAS,daily activity and total score in WOMAC scale,the serum levels of β-CTX,T-PINP and N-MID decreased greatly,the serum levels of 25-(OH)-VD3 increased greatly in the study group(P<0.05).The occurrence rate of adverse reactions was similar(P>0.05).Conclusion Tenghuang Jiangu Capsules combined with alfacalcidol and diclofenac sodium are safe and effective for patients with KOA complicated with osteoporosis.