金乌骨通胶囊联合阿仑膦酸钠片治疗老年骨质疏松症的临床研究

Clinical study on Jinwu Gutong capsule combined with alendronate sodium tablet in treatment of senile osteoporosis

目的 探讨金乌骨通胶囊联合阿仑膦酸钠片治疗老年骨质疏松症的临床疗效及安全性。方法 选择2019年4月—2020年2月于本院就诊的102例老年骨质疏松患者作为研究对象,随机分为对照组和治疗组两组,每组各51例。对照组给予口服阿仑膦酸钠片,10 mg/次,1次/d;治疗组在对照组治疗的基础上给予口服金乌骨通胶囊,3粒/次,3次/d。两组共计治疗8周。比较两组患者的临床疗效、VAS评分、骨密度(全髋、腰椎、股骨颈)、血清骨代谢指标(TRACP-5b、BGP和BALP)及炎症因子(TNF-α、IL-6)表达水平、生活质量量表评分(SF-36)及不良反应发生率的差异。结果 对照组和治疗组总有效率分别为82.35%和96.08%,与对照组相比,治疗组总有效率显著升高(c2=4.993,P=0.025)。治疗前,两组VAS评分、骨密度(全髋、腰椎和股骨颈)、血清骨代谢指标(TRACP-5b、BGP和BALP)及炎症因子(TNF-a、IL-6)表达水平、SF-36评分相比较均无显著差异(P>0.05);治疗后,与治疗前相比,两组骨密度(全髋、腰椎和股骨颈)、血清BGP表达水平和SF-36评分均显著升高,而VAS评分、血清TRACP-5b、BALP、TNF-α及IL-6表达水平均显著降低,差异均具有统计学意义(P<0.05);治疗后,与对照组相比,治疗组骨密度(全髋、腰椎和股骨颈)、血清BGP表达水平和SF-36评分均显著升高,而VAS评分、血清TRACP-5b、BALP、TNF-α及IL-6表达水平均显著降低,差异均具有统计学意义(P<0.05)。对照组和治疗组两组不良反应发生率相比较无显著差异(c2=0.060,P=0.807)。结论 金乌骨通胶囊联合阿仑膦酸钠片治疗老年骨质疏松症临床疗效显著,能有效改善患者的疼痛程度并提高生活质量,金乌骨通胶囊能显著增强骨质疏松症患者的骨密度,缓解系统炎症状态并改善骨代谢进程。

Objective To investigate the clinical efficacy and safety of Jinwu Gutong capsule combined with alendronate sodium tablet in the treatment of senile osteoporosis.Methods A total of 102 patients suffered from senile osteoporosis those visited our hospital between April 2019 to February 2020 were enrolled as study subjects,and they were randomly divided into control group and treatment group,with 51 cases in each group.Patients in the control group administered with Alendronate sodium tablet,10 mg/time,once daily.Patients in the treatment group administered with Jinwu Gutong capsule based on the control group,3 capsules/time,3 times/day.Both groups were treated for 8 weeks.The differences in clinical efficacy,VAS scores,bone mineral density(total hip,lumbar spine and femoral neck),serum levels of bone metabolism indicators(TRACP-5b,BGP and BALP)and inflammatory factors(TNF-a and IL-6),life quality scale(SF-36)scores and incidence of adverse reaction rate were compared between the two groups.Results The total clinical efficacy of the control group and treatment group were 82.35%and 96.08%,respectively.Compared with the control group,the clinical efficacy in observation group was significantly increased(c 2=4.993,P=0.025).Before treatment,there were no significant differences in the VAS scores,bone mineral density(total hip,lumbar spine and femoral neck),serum levels of bone metabolic indicators(TRACP-5b,BGP,BALP)and inflammatory factors(TNF-α,IL-6),SF-36 scores between the two groups(P>0.05).After treatment,bone mineral density(total hip,lumbar spine,femoral neck),serum BGP expression levels and SF-36 scores were significantly increased in both groups,while VAS scores,serum TRACP-5b,BALP,TNF-αand IL-6 expression levels were significantly decreased,and the differences were statistically significant(P<0.05).After treatment,when compared with the control group,bone mineral density(total hip,lumbar spine and femoral neck),serum BGP expression levels and SF-36 scores in treatment group were significantly increased,while VAS scores,serum TRACP-5b,BALP,TNF-αand IL-6 expression levels were significantly decreased,and the differences were statistically significant(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(c 2=0.060,P=0.807).Conclusions Jinwu Gutong capsule combined with alendronate sodium tablet achieves a significant clinical efficacy in the treatment of senile osteoporosis,which can effectively reduce the pain degree and improve the quality of life.Jinwu Gutong capsule can significantly enhance the bone density,and alleviate systemic inflammation,improve bone metabolism process in senile patients suffered from osteoporosis.