机构地区:[1]首都医科大学附属北京中医医院,北京100010
出 处:《安徽中医药大学学报》2024年第5期16-20,共5页Journal of Anhui University of Chinese Medicine
基 金:北京市医管局培育计划(pz2018021)。
摘 要:目的观察益肾健骨丸治疗老年男性骨质疏松症患者的临床疗效及对血清骨代谢指标和性激素水平的影响。方法将104例老年男性骨质疏松症患者随机分为治疗组与对照组,每组52例。最终治疗组共48例、对照组共47例患者完成治疗。治疗组每日予益肾坚骨丸和钙尔奇D片模拟剂,对照组每日予钙尔奇D片和益肾坚骨丸模拟剂,治疗周期为180 d。比较两组患者治疗前后骨密度、临床症状评分、骨代谢指标[β降解产物(β-isomerized C-terminal telopeptide of typeⅠcollagen,β-CTX)、抗酒石酸酸性磷酸酶(tartrate-resistant acid phosphatase,TRACP)、Ⅰ型胶原N端前肽(propeptide of typeⅠprocollagen,PINP)、骨性碱性磷酸酶(bone alkaline phosphatase,BALP)],性激素[睾酮(testosterone,T)、雌二醇(estradiol,E 2)]水平的变化及不良反应发生率。结果与治疗前比较,治疗组患者治疗后骨密度T值显著增加(P<0.05),骨质疏松症症状评分显著降低(P<0.05)。两组患者临床疗效比较,治疗组优于对照组(P<0.05)。两组患者治疗后β-CTX、TRACP水平均较治疗前显著下降(P<0.05),且治疗组患者下降程度更显著(P<0.05);PINP、BALP水平均较治疗前显著上升(P<0.05),且治疗组上升程度更显著(P<0.05)。与治疗前比较,治疗组患者治疗后血清T水平显著升高,且较对照组升高程度更显著(P<0.05)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论益肾坚骨丸可改善老年男性骨质疏松症患者的临床症状及骨密度,具有促进骨形成、抑制骨吸收及提高血清性激素水平的作用,且安全性好。Objective To investigate the clinical effect of Yishen Jiangu Pill in the treatment of elderly male patients with osteoporosis and its influence on serum bone metabolic markers and sex hormone levels.Methods A total of 104 elderly male patients with osteoporosis were randomly divided into treatment group and control group,with 52 patients in each group,and finally 48 patients in the treatment group and 47 in the control group completed the study.The patients in the treatment group were given Yishen Jiangu Pill and caltrate D placebo daily,while those in the control group were given caltrate D tablets and Yishen Jiangu Pill placebo daily;the course of treatment was 180 days for both groups.The two groups were compared in terms of the changes in bone mineral density,osteoporosis symptom scores,bone metabolic markers[β-isomer of C-terminal telopeptides(β-CTX),tartrate-resistant acid phosphatase(TRACP),propeptide of typeⅠprocollagen(PINP),and bone alkaline phosphatase(BALP)),and sex hormones[testosterone(T)and estradiol(E 2)]after treatment,and the incidence rate of adverse reactions.Results After treatment,the treatment group had a significant increase in the T value of bone mineral density(P<0.05),and had a significant decrease in OP syndrome score(P<0.05).The treatment group had a significantly better clinical outcome than the control group(P<0.05).After treatment,both groups had significant reductions in the levels ofβ-CTX and TRACP(P<0.05),and the treatment group had significantly greater reductions than the control group(P<0.05);both groups had significant increases in the levels of PINP and BALP(P<0.05),and the treatment group had significantly greater increases than the control group(P<0.05).After treatment,the treatment group had a significant increase in serum T level(P<0.05).There was no significant difference in the incidence rate of adverse reactions between the two groups.Conclusion Yishen Jiangu Pill can improve clinical symptoms and bone mineral density in elderly male patients with osteoporosis,
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