强骨饮治疗骨关节炎合并骨质疏松患者的临床研究

The Clinical Research of Qiangguyin for Treating Osteoarthritis Patients with Osteoporosis

目的:观察、评价强骨饮治疗骨关节炎合并骨质疏松症患者的临床疗效及安全性,并初步探讨其作用机制。方法:将符合入选标准的患者随机分为强骨饮组及对照组塞来昔布组和仙灵骨葆组,每组各30例。观察方法:治疗组服用强骨饮每天1付,分早晚2次服用,塞来昔布组每日服塞来昔布胶囊2次,1次1粒,200mg。仙灵骨葆组服用仙灵骨葆胶囊每天2次,1次3粒,1.5g。3组均治疗2个月,疗程结束后,进行临床症状评估值,测定关节滑液IL-6、TNF-α值和骨密度值。结果:强骨饮组总有效率为90.00%、塞来昔布组总有效率为76.67%、仙灵骨葆组总有效率为83.33%。强骨饮组关节滑液IL-6、TNF-α值下降最明显,与服药前相比差异有统计学意义(P<0.01),仙灵骨葆组的IL-6、TNF-α值下降明显,与服药前比较差异有统计学意义(P<0.05);2组比较差异有统计学意义(P<0.05);塞来昔布组服药前后关节滑液IL-6、TNF-α值比较差异无统计学意义(P>0.05)。强骨饮组和仙灵骨葆组服药前骨密度明显增加(P<0.05),两者比较差异无统计学意义(P>0.05),塞来昔布组服药前后骨密度比较差异无统计学意义(P>0.05)。结论:强骨饮不但能够明显改善骨关节炎合并骨质疏松患者的临床症状和体征,而且应用该剂后关节滑液IL-6、TNF-α值明显下降,骨密度明显提高。

Objective：To observe and evaluate the clinical efficacy and safety of the Qiangguyin on osteoarthritis patients with osteoporosis, and to explore its mechanism. Methods： All 90 cases were randomly divided into the treatment group （Qiangguyin group）. the control group 1 （Celecoxib group）, and the control group 2 （Xianlinggubao group）, with 30 cases in each group. The methods of observation： the patients of treatment group were given Qiguyin one dose everyday taking in morning and evening especially; the control 1 group given Celecoxib capsule 2 times per day,each time take I capsule, 200rag; the control 2 group given Xianlinggubao capsule 2 times per day, each time take 3 capsules, 1.5g. All patients were given 2 months treatment. The IL-6 and TNF-α in synovial fluid of joint and the bone mineral density were detected after treatment. The standards of clinical efficacy and parameters： Assessed value of clinical symptoms according to the ＂Chinese medicine clinical research guidelines＂. The index of physical and chemical included 2 month before and after drug taking, The IL-6 and TNF-α in synovial fluid of joint were measured by enzymc; linked immunosorbent assay method. The BMD of right distal radius was determined. Results： Two months after treating, the totally effective rates were 90.00G, 76.67%, and 83.33G in the treatment group, the celecoxib group, and the Xianlinggubae group especially. There were significant differences in the three groups （P ~ 0. 05）. The level of IL-6 and TNF-α of Xianlinggubao group decreased mostly, there was significant difference before and after treatment （P〈0. 01）. While, which decreased significantly in Xianlinggubao group （P〈0.05）. There was statistical significance between the two groups （P〈 0.05）. The level of IL-6 and TNF-α were no difference before and after treatment in the Celecoxib group （P〉0.05）. The bone mineral density increased significantly in both Qiangguyin group and Xianlinggubao group （P〈0.05）, there was no significant difference between the two groups （P〈0.05）, and there was no significantly different before and after treatment in Celecoxib group （P〉0. 05）. Conchtsion= Qianguyin is not only able to significantly improve the clinical symptoms of osteoarthritis patients with osteoporosis, but also obviously decrease the level of IL-6, TNF-α and promoted the bone mineral density.