摘要
目的观察替勃龙联合唑来膦酸治疗绝经后骨质疏松症(PMOP)患者的临床疗效。方法回顾性分析2014年1月至2017年1月陕西省榆林市第一医院就诊的PMOP患者120例,采用随机数字表法随机分为替勃龙联合唑来膦酸治疗组(A组),替勃龙治疗组(B组)及唑来膦酸治疗组(C组),每组40例。A组予以唑来膦酸5 mg静脉滴注,每年1次,联合替勃龙2.5 mg qd,1年后替勃龙减至维持量1.25 mg qd,总疗程2年;B组予以替勃龙2.5 mg qd,1年后减至维持量1.25 mg qd,总疗程2年;C组予以唑来膦酸5 mg静脉滴注,每年1次,总疗程2年。各组均于治疗第0、3、6、12、24个月进行视觉模拟评分(VAS)及血清Ⅰ型原胶原N-端前肽(P1NP)及血清Ⅰ型胶原羧基末端肽片段(β-CTX)的测定;于治疗第0、6、12、24个月测定25羟维生素D(25OHD)、雌激素及卵泡刺激素(FSH);于治疗第0、12、24个月采用双能X线吸收法测定腰椎1~4(L1~4)及右侧股骨颈骨密度;并监测药物不良反应事件的发生率。结果治疗第3、6、12、24个月A组及C组临床疼痛症状有效缓解,VAS较治疗前明显降低(F=66.236、104.766,P均<0.05),B组VAS无显著变化。治疗第6、12、24个月3组P1NP、β-CTX及25OHD水平较治疗前均得到明显改善(F=14.291~65.044,P均<0.05);治疗第6、12、24个月A组P1NP、β-CTX水平降低优于其他两组(F=3.517~110.317,P均<0.05),且在治疗第3个月仅A组β-CTX水平显著改善(F=36.584,P<0.05)。治疗第12、24个月3组L1~4及右侧股骨颈骨密度值较治疗前均明显增加(F=13.455~77.341,P均<0.05);治疗第24个月A组L1~4及右侧股骨颈骨密度值增加优于其他两组(F=13.958、10.759,P均<0.05);与同组治疗12个月后相比,A组治疗24个月后L1~4及右侧股骨颈骨密度进一步增加(F=48.450、77.314,P均<0.05)。A组及B组在治疗后绝经相关症状显著改善,FSH水平降低(F=43.097、52.818,P均<0.05),但雌激素水平无明显变化。A组轻微的药物不良反应发生率高于其他两组(χ^2=25.048,P<0.05),但无严重的药物不良反应事件发生。结论替勃龙联合唑来膦酸治疗PMOP临床疗效显著,安全性高。
Objective To observe the clinical effect of tibolone combined with zoledronic acid in the treatment of patients with postmenopausal osteoporosis(PMOP). Methods A total of 120 cases of PMOP were collected from the First Hospital of Yulin City in Shanxi province from January 2014 to January 2017, and were randomly divided into tibolone combined with zoledronic acid therapy group (group A), tibolone therapy group(group B) and zoledroni acid group (group C), with 40 cases in each group, using the random number table method. Group A was treated with zoledronic acid 5 mg intravenous infusion once a year in combination with tibolone 2.5 mg qd, after 1 year tibolone was reduced to a maintenance dose of 1.25 mg qd for a total course of 2 years. Group B was received tibolone 2.5 mg qd alone, which was reduced to 1.25 mg qd after 1 year treatment, for a total course of 2 years. Group C was given zoledronic acid 5 mg intravenous infusion alone once a year for a total course of 2 years. The visual analogue scale (VAS), procollagen type 1 N-terminal peptide (P1NP),β cross-linked C-telopeptide of type 1 collagen (β-CTX) were detected at the 0, 3th, 6th, 12th, 24th month. 25-hydroxy-vitamin D (25OHD), estrogen and follicle stimulating hormone (FSH) were detected at the 0, 6th, 12th, 24th month. The bone mineral density of lumbar vertebra 1-4(L1-4) and right femoral neck were determined by dual-energy X-ray absorption method at 0, 12th and 24th month. The incidence of drug side effects was supervised. Results At the 3th, 6th, 12th, 24th month after treatment, the clinical pain symptom was effectively relieved and the VAS was significantly reduced (F=66.236, 104.766, all P<0.05)in both group A and C, however, there was no significant change of VAS in group B. At the 6th, 12th, 24th month after treatment, the levels of P1NP,β-CTX and 25OHD were significantly improved(F=14.291-65.044, all P<0.05)in all groups. At the 6th, 12th, 24th month after treatment, the decrease of P1NP and β-CTX in group A were much significant than those in other two groups (F=3.517-110.317, all P<0.05). The β-CTX level in group A was significantly improved at the 3th month after treatment(F=36.584, P<0.05). At the 12th, 24th month after treatment, bone mineral density of L1-4 and right femoral neck were increased (F=13.455-77.341, all P<0.05) in three groups. At the 24th month after treatment, bone mineral density of the L1-4 and right femoral neck of group A was better than that in other two groups (F=13.958, 10.759, all P<0.05). Compared with the same group at the 12th month after treatment, bone mineral density of the L1-4 and right femoral neck in group A was furtherly increased at the 24th month after treatment (F=48.450, 77.314, all P<0.05). After treatment, in group A and group B, the postmenopausal symptoms were significantly relieved and the FSH levels were significantly reduced(F=43.097, 52.818, all P<0.05), but there was no significant effect on estrogen level. The incidence of mild drug side effects in group A was higher than that in the other two groups (χ^2=25.048, P<0.05), but the severe drug side effects were rarely observed. Conclusion The treatment of tibolone combined with zoledronic acid in patient with PMOP shows significant clinical effects and higher safety.
作者
王荣
马江卫
Wang Rong;Ma Jiangwei(Department of Endocrinology, The First Hospital of Yulin City, Shanxi Province, Yulin 719000, China;Department of Orthopedics, The First Hospital of Yulin City, Shanxi Province, Yulin 719000, China)
出处
《国际内分泌代谢杂志》
2019年第2期77-82,96,共7页
International Journal of Endocrinology and Metabolism
关键词
替勃龙
只会来膦酸
绝经后骨质疏松
骨转换标志物
骨密度
Tibolone
Zoledronic acid
Postmenopausal osteoporosis
Bone turnover makers
Bone mineral density
