唑来膦酸注射液治疗绝经后骨质疏松的临床研究

Clinical trial of zoledronic acid injection in the treatment of patients with postmenopausal osteoporosis

目的观察唑来膦酸注射液治疗绝经后骨质疏松(PMOP)的临床疗效及安全性。方法入选我院骨科收治的绝经后骨质疏松患者182例,按随机数字表法分为对照组和试验组,每组91例。对照组给予骨化三醇胶丸0.50μg,每天2次,口服+碳酸钙D3咀嚼片Ⅱ600 mg,每天1次,口服;试验组在对照组基础上给予唑来膦酸注射液5 mg,每月1次,静脉恒量恒速输注>15 min。2组患者均治疗12个月。比较2组患者的临床疗效、骨密度(BMD)、血清骨代谢指标水平、血清炎症因子水平及药物不良反应发生情况。结果治疗后,试验组和对照组的总有效率分别为90.11%(82例/91例)和78.02%(71例/91例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的腰椎1-4的骨密度值分别为(0.75±0.09)和(0.69±0.07)g·cm^(-2),股骨颈骨密度值分别为(0.69±0.08)和(0.63±0.09)g·cm^(-2),Ward三角区骨密度值分别为(0.54±0.06)和(0.48±0.06)g·cm^(-2),血清碱性磷酸酶(ALP)水平分别为(112.18±14.39)和(129.73±15.77)U·L^(-1),β胶原降解产物(β-Crosslaps)水平分别为(0.31±0.04)和(0.38±0.05)μg·L^(-1),血清Ⅰ型原胶原氨基端前肽水平分别为(46.75±6.12)和(40.38±5.54)μg·L^(-1),差异均有统计学意义(均P<0.05)。试验组药物不良反应主要有头痛、肌肉疼痛、关节痛、发热、口干,药物不良反应发生率为18.68%(17例/91例);对照组药物不良反应主要有头痛、肌肉疼痛、关节痛、发热、口干,药物不良反应发生率为10.99%(10例/91例),差异无统计学意义(P>0.05)。结论唑来膦酸能有效增加绝经后骨质疏松患者的骨密度,减轻腰背疼痛症状,抑制骨吸收,促进骨形成,降低炎性细胞因子水平,临床疗效及安全性较高。

Objective To investigate the clinical efficacy and safety of zoledronic acid in the treatment of patients with postmenopausal osteoporosis（ PMOP）. Methods A total of 182 patients with PMOP in department of orthopaedics in our hospital were randomly divided into treatment group and control group,91 cases in each group. Control group was received calcitriol soft capsules 0.5 μg, bid, calcium carbonate D3 chewable tablets Ⅱ 600 mg,qd. Treatment group received zoledronic acid injection 5 mg,once a month,constant intravenous infusion〉15 min on the basis of control group. Two groups were treated for 12 months. The clinical efficacy,bone mineral density（BMD）,degree of lumbago and back pain,the levels of serum bone metabolism,the levels of serum inflammatory factors and adverse drug reactions were comparedin two groups. Results After treatment,the total effective rates of treatment group and control group were 90. 11%（82 cases/91 cases） and 78.02%（ 71 cases/91 cases）,with significant difference（ P〈0.05）. After treatment,the levels of BMD of lumbar 1 to 4 in treatment group and control group were（0.75 ± 0.09） and（0.69 ± 0.07） g·cm^-2,the levels of BMD of femoral neck were（0.69 ± 0.08） and（0.63 ± 0.09） g·cm^-2,the Ward triangle region BMD values were（0.54 ± 0.06） and（0.48 ± 0.06） g·cm^-2, the levels of serum alkaline phosphatase（ALP） were（112.18 ± 14.39） and（ 129.73 ± 15.77） U·L^-1,the levels of serum βcollagen degradation products（ β-Crosslaps） were（ 0.31 ± 0.04） and（ 0.38 ± 0.05） μg·L^-1,the levels of serum procollagen type I amino terminal propeptide（ PINP） were（ 46.75 ± 6.12） and（ 40.38 ± 5.54） μg·L^-1,all with significant difference（ all P〈0. 05）. The adverse drug reactions were headache,muscle pain,arthralgia,fever and dry mouth in treatment group,the adverse drug reactions were headache,muscle pain,arthralgia,fever and dry mouth in control group. The total incidence of adverse drug reactions in treatment group and control group were 18. 68%（ 17 cases/91 cases） and 10.99%（ 10 cases/91 cases）,with no significant difference（ P〉0.05）. Conclusion Zoledronic acid can effectively increase the bone mineral density in PMOP patients,alleviate the symptoms of waist and back pain,inhibit bone absorption and promote bone formation,reduce the level of inflammatory cytokines,with high efficacy and safety.