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| 唑来膦酸钠对高转换患者椎体成形术后椎体再骨折发生率影响因素的相关性分析 |
| Correlation analysis on the influencing factors of vertebral fracture reoccurrence after vertebral plasty and zoledronic acid treatment in patients with high bone turnover |
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| DOI：10.3969/j.issn.1006-7108.2017.08.021 |
| 中文关键词: 唑来膦酸钠，椎体成形术，椎体再骨折 |
| 英文关键词:Zoledronic acid sodium, Vertebral plasty, Vertebral body fracture |
| 基金项目: |
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| 摘要点击次数: 1166 |
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| 中文摘要: |
| 目的 分析高转换患者椎体成形术后应用唑来膦酸钠降低骨质疏松性椎体再骨折发生状况，并探讨再骨折发生率与骨转换指标、骨密度、疼痛、生活质量四者之间的相关性。
方法 选取2012年7月至2014年10 月于我院行椎体成形术治疗骨质疏松性椎体压缩性骨折的282名女性患者，治疗组于术后3d开始在口服阿法迪三及钙尔奇D的基础上静脉点滴唑来膦酸钠，（阿法迪三和钙尔奇D用三个月，停半个月），共160名，脱落5名；对照组于术后3d开始口服阿法迪三及钙尔奇D抗骨质疏松基础治疗，共122名，脱落7名；术前3d行骨密度测定、抽血检测β-胶原特殊序列（β-CTx）和总Ⅰ型胶原氨基酸延长肽（t-P1NP）、为了避免由于手术时机不同而导致患者临床症状缓解不佳对调查结果的影响，术后1周后进行VAS评分及生活质量SF-36评分；于术后1年、2年回访记录患者唑来膦酸钠使用次数及再发椎体骨折情况，并再次行骨密度测定、血清检验骨转换指标、疼痛VAS、SF-36评估，统计数据并运用统计学SPSS17.0软件分析，椎体成形术后应用唑来膦酸钠对骨质疏松性椎体压缩性骨折患者再骨折、骨代谢、骨密度、疼痛、生活质量的影响，并探讨它们之间的相关性。结果 实验中共脱落12名，8名出现骨水泥泄露、4名再次骨折后行椎体成形术；治疗组中连续两年口服阿法迪三和钙尔奇D并使用唑来膦酸钠治疗者64例，为治疗A组；第2年由于静滴唑来膦酸钠出现肌痛，关节不适，费用等原因只口服阿法迪三和钙尔奇D而未继续使用唑来膦酸钠者91例，为治疗B组；再骨折发生率，对照组术后1年内椎体再骨折12例，骨折率10.43%，治疗A组再骨折6例，骨折率降为9.38%，治疗B组再骨折8例，骨折率为8.79%，经卡方试验分析，治疗组间差异无统计学意义，P>0.05，而治疗组与对照组间差异有统计学意义，P<0.05；第2年内治疗A组发生椎体再骨折4例，骨折率6.25%，治疗B组再骨折9例，骨折率9.89%，两组比较A组可显著降低骨折发生，P<0.05；对照组再骨折12例，骨折率10.43%，治疗B组与对照组比较，治疗B组可显著降低骨折；组间自身比较，治疗A组在第2年内降低骨折3.13%，治疗B组增加骨折1.10%。于骨转换指标，t-P1NP在实验各组中均无显著差异，均P>0.05；而β-CTx在1、2年后治疗组相较对照组均能显著降低；骨密度1年后治疗A组可提高1.61%，治疗B组可提高1.29%，对照组提高0.32%，两治疗组差异无统计学意义，P>0.05，治疗组与对照组比较，差异均有统计学意义，P<0.05；2年后，治疗A组骨密度可增加3.53%，治疗B组增加1.61%，对照组提高0.64%，治疗组间比较骨密度的提高差异存在统计学意义，P<0.05，治疗B组与对照组比较，差异亦存在统计学意义，P<0.05。疼痛VAS评分及生活质量SF-36评分在1、2年后治疗组与对照组比较，差异均有统计学意义，P<0.05。结论 椎体成形术后应用唑来膦酸钠能降低骨折发生率、提高骨密度、降低骨转换率、缓解疼痛、提高生活质量，连续使用疗效更佳；降低骨折发生率、提高骨密度在观察时间上有相关性，可能是通过降低骨转换率、提高骨密度而降低骨折的发生，从而缓解疼痛、逐步提高生活质量。 |
| 英文摘要: |
| Objective To evaluate the effect of zoledronic acid in reducing the reoccurrence of osteoporotic vertebral fractures after vertebral plasty, and to explore the relationships of fracture reoccurrence with bone turnover, bone mineral density, pain and quality of life.Method The study participants were 282 patients who had vertebral plasty for the treatment of osteoporotic vertebral compression fractures in our hospital from July 2012 to October 2014. The treatment group received intravenous drip of zoledronic acid 3 days after vertebral plasty (n = 160, 5 cases had the plasty fell off), and oral calcium and vitamin D3 supplementation (3 months then stop for half month). The control group received oral calcium and vitamin D3 supplementation as basic anti-osteoporosis treatment 3 days after vertebral plasty (n = 122, 7 cases had plasty fell off). Three days before surgery, bone mineral density (BMD) and serum β-CTx and total P1NP were assessed. One week after surgery, VAS score and quality of life (SF-36 scale) were evaluated. One and two years after surgery, the zoledronic acid use frequency and recurrence of vertebral fractures were recorded, and assessments were made for BMD, serum bone turnover markers, pain VAS and SF-36 scores. Statistical analyses were performed using SPSS 17.0. The effects of Zoledronic acid on the reoccurrence of vertebral fracture, bone metabolism, bone mineral density, pain and quality of life, and their correlation were evaluated in patients with osteoporotic vertebral compression fractures who had vertebral plasty. Results During the study, there were 12 cases who had the plasty fell off, 8 because of leaks of bone cement, and 4 fractured again after vertebral plasty. Sixty-four cases in the treatment group had zoledronic acid treatment and oral calcium and vitamin D supplementation for two consecutive years, defined as Treatment group A; 91 cases discontinued the use of Zoledronic acid during the second year due to adverse reactions or cost and had oral calcium and vitamin D supplementation only, defined as Treatment group B. For the incidence of fracture, in the first year 12 cases in the control group had vertebral fracture (fracture rate 10.43%), 6 cases in Treatment group A had fracture (fracture rate 9.38%), and 8 cases in Treatment group B had fracture (fracture rate 8.79%). There were no significant differences between the two treatment groups in the chi-square test (P > 0.05), but the treatment group had significantly lower re-fracture rate compared with the control group ((P < 0.05). In the second year, 4 cases in Treatment group A (6.25%) re-fractured, 9 cases in the Treatment group B re-fractured (9.89%), and the re-fracture rate was significantly lower in Treatment group A compared with Treatment group B (P < 0.05). Control group had 12 cases (10.43%) of fracture, and the re-fracture rate of Treatment group B was significantly lower than that of the control group. For within group comparison, treatment group A had 3.13% lower re-fracture rate and treatment group B had 1.10% increase in re-fracture rate in the second year. For bone turnover markers, there were no significant differences between groups in t - P1NP (P > 0.05), while β-CTx levels were significantly lower at year 1 and 2 in the treatment group compared with the control group. For bone mineral density, at 1 year Treatment group A increased by 1.61%, Treatment group B increased by 1.29%, and the control group increased by 0.32%. There were no significant differences between the two treatment groups (P > 0.05), while there were significant differences between the treatment and the control groups (P < 0.05). At 2 years, bone mineral density in Treatment group A increased by 3.53%, in Treatment group B increased by 1.61% and in the control group increased by 0.64%. There were significant differences between the two treatment groups on the improvement in bone mineral density (P < 0.05). Also BMD of Treatment group B significantly different from that of the control group (P < 0.05). At 1 and 2 years, the pain VAS score and quality of life SF-36 scale of the treatment group were significantly different to those of the control group (P < 0.05). Conclusion Application of Zoledronic acid after vertebral plasty can decrease re-fracture rate, increase bone mineral density, reduce bone turnover, relieve pain, and improve the quality of life. Consecutive use had the best curative effect. Reduced fracture occurrence and increased bone density correlated with each other during observation time. Therefore, the reduced fracture rate could be related to reduce bone turnover rate and increased bone density, and thus pain were reduced and quality of life gradually improved. |
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