Clinical trial of Xianling Gubao capsules combined with Jintiange capsules in treating patients with primary osteoporosis
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 L2-4 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.
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