摘要
Abstract
Objective To observe the clinical efficacy and safety of zoledronic acid concentrate injection combined with alendronate sodium tablets in the treatment of elderly postmenopausal patients with type 2 diabetes mellitus(T2DM)complicated with osteoporosis(OP).Methods Elderly postmenopausal T2DM patients with OP were divided into control group and treatment group using random number table method.The control group was given oral alendronate sodium tablets,10 mg per dose,once daily(qd),for a course of 1 year;the treatment group,based on the control group,received additional treatment with zoledronic acid concentrate injection,5 mg per dose,once a year,via intravenous infusion,for a course of 1 year.The clinical efficacy,pain levels at different time points,bone density before and after treatment,bone metabolism indicators before and after treatment and safety were compared between two groups.Results A total of 5 cases were lost during this study,with the final number of patients in the control and treatment groups being 38 cases and 42 cases,respectively.After treatment,the overall effective treatment rates were 84.21％(32 cases/38 cases)for the control group and 97.62％(41 cases/42 cases)for the treatment group,with statistically significant difference(P＜0.05).The visual analogue scale(VAS)pain scores for the treatment group after 6 months and 1 year of treatment were(5.62±0.70)and(5.02±0.68)points,respectively,which were significantly lower than the control group's(6.06±0.75)and(5.65±0.70)points.After 1 year of treatment,the bone density of the lumbar spine L1-4 were(0.89±0.07)and(0.85±0.08)g · cm-3 for the treatment and control groups,respectively;the femoral trochanter bone density were(0.78±0.08)and(0.73±0.09)g · cm-3;the femoral neck bone density was(0.69±0.07)and(0.66±0.06)g · cm-3;the bone density in the Ward triangle area were(0.79±0.08)and(0.73±0.10)g · cm-3;the serum levels of type Ⅰ procollagen amino propeptide were(25.60±6.82)and(30.79±6.90)pg · mL-1;the levels of bone-specific alkaline phosphatase(BALP)were(15.87±4.03)and(17.91±3.71)ng · mL-1;the levels of Klotho protein were(885.20±32.60)and(810.76±33.15)pg · mL-1;the levels of 25-hydroxyvitamin D[25-(OH)D]were(35.70±6.72)and(32.29±6.34)ng · mL-1 for the treatment and control groups,respectively.The above indicators of the treatment group were statistically significantly different from those of the control group(all P＜0.05).The main adverse drug reactions in the control group were mainly gastrointestinal discomfort and fatigue,while in the treatment group were mainly fever,muscle and bone pain,gastrointestinal discomfort and fatigue.The overall incidence of adverse drug reactions were 18.42％(7 cases/38 cases)in the control group and 21.43％(9 cases/42 cases)in the treatment group,with no statistically significant difference(P＞0.05).Conclusion The combined treatment of zoledronic acid concentrate injection and alendronate sodium tablets in elderly postmenopausal T2DM patients with OP is obviously effective,capable of effectively alleviating pain,increasing bone density,raising serum Klotho and 25-(OH)D levels,and reducing BALP levels,with adverse drug reactions being controllable.关键词
注射用唑来膦酸浓溶液/阿仑膦酸钠片/骨质疏松/2型糖尿病/老年/绝经/骨代谢Key words
zoledronic acid concentrate injection/alendronate sodium tablets/osteoporosis/type 2 diabetes mellitus/elderly/menopause/bone metabolism分类
医药卫生
