骨质增生丸治疗原发性骨质疏松症的临床研究

Guzhizengsheng pill in the treatment of primary osteoporosis intervention study on bone mineral density

目的：观察骨质增生丸治疗原发性骨质疏松症的疗效。方法：2012年8月~2013年8月就诊于新疆医科大学附属中医医院骨科门诊,确诊为为原发性骨质疏松症的患者180例,按随机数字表法分为2组,每组90例以钙剂、骨化三醇及阿仑磷酸钠作为基础治疗,对照组为基础治疗加安慰剂口服,治疗组为基础治疗加骨质增生丸口服（8g,每日3次）,两组均以四周为一个疗程,连续治疗四个疗程,治疗结束后进行疗效评估;观察分析两组患者腰背、四肢痛积分,进行骨密度（bone mineral density,BMD）、血碱性磷酸酶（ALP）、血钙（Ca）、血磷（P）、尿钙/尿肌酐比（尿Ca/Cr）等值比较。结果：实验结束共计脱落8例患者,脱落率为4.4%,其中治疗组脱落3例,对照组脱落5例,本试验最终纳入病例172例。治疗12月后,治疗组、对照组总有效率分别为93.1%、61.2%（P〈0.01）;与治疗前及对照组比较,治疗组患者腰背部、四肢痛积分明显下降;治疗组L4、左股骨颈、左Words三角区BMD均有所提高（P〈0.05）;治疗组血ALP、尿Ca/Cr较均有所降低（P〈0.05）。随访期间两组患者未出现不良反应。结论：骨质增生丸结合骨质疏松基础治疗,能够有效缓解疼痛,改善症状,增加骨质疏松症患者BMD,且能够降低尿Ca/Cr及血ALP,改善骨代谢。

Objective： To observe the Guzhizengsheng pill in the treatment of primary osteoporosis curative effect observation. Methods： 180 cases of primary osteoporosis patients. Divided into 2 groups according to random number table method,90 cases in each group,based on calcium,calcitriol and alendronate sodium phosphate treatment,the control group on the basis of oral treatment with placebo,the treatment group on the basis of Guzhizengsheng pill oral treatment. Results： Until the end of the fall off a total of 8 patients,loss rate was 4. 4%,among them off3 cases of treatment group,control group fall off in 5 cases,this experiment finally in 172 cases; 12 month after treatment,the treatment group,control group total effective rate were 93. 1%,93. 1%,treatment group curative effect due to the control group,the difference was statistically significant（ P 〈 0. 01）; Two groups of patients before treatment,limb pain in the small of your back integral comparison,there was no statistically significant difference（ P 〉 0. 05）; Points are better than the before treatment,after treatment group comparison difference was statistically significant（ P 〈 0. 05）; Comparison between groups after treatment,the treatment group is better than that of control group,the difference was statistically significant（ P 〈 0. 05）; Comparing two groups before treatment in patients with bone mineral density test result,there was no statistically significant difference（ P 〉 0. 05）; Treatment group after treatment L3 and L4,left femoral neck,left Words triangle BMD value was increased,the difference was statistically significant（ P 〈 0. 05）; The control group after treatment of L3 and L4BMD value was increased,the difference was statistically significant（ P 〈 0. 05）; L4,left the two groups after treatment of the femoral neck,left Words triangle BMD value comparison,the treatment group is better than that of control group,the difference was statistically significant（ P 〈 0. 05）; Treatment group blood ALP,urinary Ca /Cr was significantly decreased,the comparison in the group difference was statistically significant（ P 〈 0. 05）; Control group there was no statistically significant difference compared before and after the blood and urine indexes（ P 〉 0. 05）,and compare the differences between groups was statistically significant（ P 〈 0. 05）,the treatment group can inhibit ALP increases,inhibit bone metabolism,promote bone formation; Two groups of patients did not appear adverse reactions during the follow-up period. Conclusion： Guzhizengsheng pill combined with osteoporosis foundation treatment of primary osteoporosis can effectively relieve pain,improve symptoms,increase BMD in patients with osteoporosis,and can reduce the Ca /Cr,inhibiting osteoclast,high safety,is worth further clinical application.