阿仑膦酸钠口服治疗骨质疏松症患者服药依从性研究

Effects of bi-weekly oral alendronate sodium on medication adherence in patients with osteoporosis

目的研究阿仑膦酸钠服药间隔对骨质疏松症患者药物治疗依从性的影响。方法 164例患有骨质疏松症妇女随机分为试验组(n=83)接受阿仑膦酸钠70 mg,2周1次治疗,对照组(n=81)接受阿仑膦酸钠70 mg,每周1次治疗。观察治疗两年的服药顺应性、服药持续性和不良反应。以治疗期间的药物持有率(MPR)判断患者服药顺应性,MPR≥80%为服药有顺应性;采用治疗期间开始用药至终止用药的天数表达患者服药持续性,停药间隔超过30 d判断为终止用药,在治疗期间患者停药间隔不超过30 d判断为服药有持续性。结果在2年随访期,试验组和对照组的MPR(%)中位数分别为50.0(4.0,100.0)和40.0(8.0,100.0)(P=0.92),服药有持续性的患者分别为39%和33%,差异无显著意义(P=0.49)。经过校正后,在2年随访期,试验组患者服药顺应性并不比对照组高(OR=1.44,95%CI:0.72~2.86,P=0.30)。结论阿仑膦酸钠2周1次口服治疗并不能提高骨质疏松症患者药物治疗的顺应性和持续性,还需进一步研究提高服用骨质疏松症药物患者依从性的方法。

AIM To evaluate the effects of alendronate sodium dosing interval on medication adherence in patients with osteoporosis. METHODS A total of 164 women with osteoporosis were randomized to receive either alendronate sodium 70 mg once every two weeks （trial group, n = 83） or alendronate sodium 70 mg once a week （control group, n = 81 ）. Follow-up was conducted for 2 years. The study outcomes were compliance, persistence and adverse reactions. Medication compliance during the treatment was measured using medication possession ratio （MPR） with compliant defined as 〉 80%. Persistence was expressed as the number of the day from initiation to eventual discontinuation of therapy, where discontinuation was defined as at least 30 days without any medication available. Patients were classified as persistent if the gap between prescriptions was 〈 30 days. RESULTS The median MPR （%） was 50.0 （interquartile range （IQR） 4.0, 100.0） and 40.0 （IQR 8.0,100.0） in the trial group and control group at 2-year follow-up （P = 0.92）. Persistence at 2 years was also similar in both groups （39% vs. 33%, respectively, P = 0.49）. After adjustment for study covariates, patients in the trial group were not more likely to be compliant （OR = 1.44, 95% CI： 0.72-2.86, P = 0.30） than in the control group at 2 years. CONCLUSION Intervention with 70 mg alendronate sodium once every 2 weeks can＇t improve the compliance and persistence in patients with osteoporosis. Further strategies are needed to improve adherence to osteoporosis medications.