仙灵骨葆胶囊联合金天格胶囊治疗原发性骨质疏松症患者的临床研究

Clinical trial of Xianling Gubao capsules combined with Jintiange capsules in treating patients with primary osteoporosis

目的探讨仙灵骨葆胶囊联合金天格胶囊对原发性骨质疏松症的临床疗效及骨密度、骨代谢、骨硬化蛋白水平的影响。方法将原发性骨质疏松症患者按照随机数表法分为对照组和试验组。对照组口服碳酸钙D3咀嚼片,每次2片(每片含碳酸钙600 mg),qd;同时口服金天格胶囊,每次1.2 g,tid;试验组在对照组的基础上口服仙灵骨葆胶囊,每次1.5 g,bid,治疗持续6个月。比较2组患者治疗前后的临床疗效及骨密度、骨代谢、骨硬化蛋白水平。结果试验过程中共脱落4例,最终试验组和对照组均纳入63例。治疗后,试验组和对照组总有效率分别为87.30%(55例/63例)和71.43%(45例/63例),在统计学上差异有统计学意义(P<0.05)。治疗后对照组和试验组患者的腰椎L_(2-4)密度分别为(0.73±0.09)和(0.96±0.10)g·cm^(-3),股骨颈密度分别为(0.68±0.07)和(0.78±0.10)g·cm^(-3),血钙水平分别为(1.25±0.30)和(1.56±0.41)mmol·L^(-1),骨钙素水平分别为(25.51±2.23)和(35.91±5.30)ng·mL^(-1),碱性磷酸酶水平分别为(97.54±7.34)和(79.50±6.23)U·L^(-1),骨硬化蛋白水平分别为(13.87±4.95)和(10.11±2.99)pg·mL^(-1),试验组上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有过敏反应、消化道反应及全身乏力;对照组的药物不良反应主要有过敏反应、消化道反应及外周水肿。试验组和对照组的总药物不良反应发生率分别为9.52%和7.94%,在统计学上差异无统计学意义(P<0.05)。结论仙灵骨葆胶囊联合金天格胶囊可显著提升原发性骨质疏松症患者临床疗效,增加骨密度及骨代谢水平。

Objective To explore the clinical efficacy of Xianling Gubao capsules combined with Jintiange capsules in primary osteoporosis and their effects on bone density,bone metabolism,and osteosclerosis protein levels.Methods Patients with primary osteoporosis were randomly divided into control and treatment groups using a random number table.The control group received chewable calcium carbonate with vitamin D3,2 tablets per dose(each containing 600 mg of calcium carbonate),qd;simultaneously,they took Jintiange capsules orally,1.2 g per dose,bid.The treatment group received Xianling Gubao capsules orally,in addition to the treatment received by the control group,1.5 g per dose,bid,for a duration of 6 months.The clinical efficacy,bone density,bone metabolism,and osteosclerosis protein levels before and after treatment were compared between the two groups.Results Four patients dropped out during the trial,and finally,63 patients were included in each of the treatment and control groups.After treatment,the total effective rate in the treatment group were 87.30%(55 cases/63 cases) and in the control group were 71.43 %(45 cases/63 cases),with statistically significant difference(P <0.05).After treatment,the lumbar spine L_(2-4) density in the treatment and control groups were(0.73±0.09) and(0.96±0.10) g·cm^(-3);the femoral neck density were(0.68±0.07) and(0.78±0.10) g·cm^(-3);blood calcium levels were(1.25±0.30) and(1.56±0.41) mmol·L^(-1);bone calcium levels were(25.51±2.23)and(35.91±5.30) ng · mL^(-1);alkaline phosphatase levels were(97.54±7.34) and(79.50±6.23) U·L^(-1);osteosclerosis protein levels were(13.87±4.95) and(10.11±2.99) pg · mL^(-1),respectively.The comparison of these indicators between the treatment and control groups showed statistically significant differences(all P <0.05).The main adverse drug reactions in the treatment group were allergic reactions,gastrointestinal reactions,and general fatigue;while in the control group,they were allergic reactions,gastrointestinal reactions,and peripheral edema.The total incidence of adverse drug reactions in the treatment and control groups were 9.52% and 7.94%,respectively,with no statistically significant difference(P>0.05).Conclusion Xianling Gubao capsules combined with Jintiange capsules can significantly improve the clinical efficacy of patients with primary osteoporosis,increase bone density,and enhance bone metabolism levels.