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| 雷奈酸锶治疗原发性骨质疏松症慢性腰背痛的前瞻性随机双盲对照研究 |
| A prospective, randomized, double-blinded, and controlled trial of treatment of chronic low back pain with strontium ranelate in patients with primary osteoporosis |
| 投稿时间：2012-12-04 |
| DOI： |
| 中文关键词: 雷奈酸锶 骨质疏松症 慢性腰背痛 前瞻性 双盲对照研究 |
| 英文关键词:Strontium ranelate Osteoporosis Chronic low back pain Prospective RCT |
| 基金项目: |
| 作者 | 单位 | E-mail | | 彭亦良 | 武警重庆总队医院骨科,重庆,400061 | pyl-jj@163.com | | 吴雪辉 | 第三军医大学西南医院骨科,重庆,400038 | | | 张彦 | 武警重庆总队医院骨科,重庆,400061 | | | 张劲松 | 第三军医大学西南医院骨科,重庆,400038 | | | 罗飞 | 第三军医大学西南医院骨科,重庆,400038 | | | 胡安慧 | 武警重庆总队医院骨科,重庆,400061 | | | 李永锋 | 武警重庆总队医院骨科,重庆,400061 | | | 吴青蔓 | 武警重庆总队医院骨科,重庆,400061 | |
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| 中文摘要: |
| 目的：比较雷奈酸锶与阿仑膦酸钠治疗原发性骨质疏松症慢性腰背痛患者的临床疗效。方法采用前瞻性随机双盲对照观察，从2009年3月至2011年8月，94例被确诊为原发性骨质疏松症并获得知情同意的患者进入研究，所有入选者均按照随机码对应的治疗方案进行治疗，治疗完成后，所有患者均随访6个月以上，分别观察记录两组患者治疗前后的临床疗效、视觉疼痛模拟评分（ VAS）、日常活动功能情况（ Barthel指数和SF-36评分）和药物不良反应。所有资料都登记和记录在标准化病例报告表（ CRF）上，每月递交给研究组统计中心。结果研究结束时共有78例患者完成了观察，其中实验组38例，对照组40例。实验组的临床疗效明显优于对照组（P＜0.05），治疗后两组患者骨密度均有改善，治疗后与治疗前相比，差异有统计学意义（P＜0.05），但治疗组的改善程度比对照组更明显（P＜0.05）。两组患者的VAS评分治疗后均有明显改善（P＜0.01或P＜0.05），两组患者之间比较，各个时段的VAS评分均有显著性差异（P＜0.05），但两组患者治疗前后评价日常活动功能的Barthel指数和SF-36评分之间无显著性差异（ P＞0.05）。结论雷奈酸锶治疗原发性骨质疏松症慢性腰背痛患者效果理想，其最大优点是见效快，缓解疼痛明显，应用方便，患者依从性好，因而值得临床推广应用。 |
| 英文摘要: |
| Objective To compare the clinical effect of strontium ranelate and alendronate in the treatment of chronic low back pain in patients with primary osteoporosis.Methods A prospective randomized, double-blinded, and controlled clinical study was performed.From September 2009 to August 2011, 94 patients, who were diagnosed with primary osteoporosis and well consent informed, were enrolled.All the selected subjects received the treatment according to the treatment scheme corresponding to the random code.After the treatment, all patients were followed up for more than 6 months.The clinical therapeutic effect, VAS score, daily activity function ( Barthel index and SF-36 score) , and adverse reaction in both groups before and after the treatment were observed and recorded.All the data were recorded in the table of standardized case report form ( CRF) , and were send to the research group statistic center monthly.Results When the study ended, the observation of 78 patients, including 38 patients in study group and 40 patients in control group, was accomplished.The clinical effect in study group was better than that in control group (P<0.05).The bone mineral density after the treatment improved in both groups, and significance was observed comparing to that before the treatment in both groups (P<0.05).However, the improved extent in study group was more obvious than that in control group ( P <0.05 ) .The VAS score in both groups after the treatment improved obviously ( P <0.01 or P <0.05 ) . Significant difference of VAS score at each period was observed between the 2 groups (P<0.05).But no significant difference of Barthel index and SF-36 score, which reflected the daily activity function, was observed before and after the treatment in both groups (P>0.05).Conclusion The effect of strontium ranelate in the treatment of chronic low back pain in patients with primary osteoporosis is ideal .The most advantages of this medicine are fast effect , remarkable pain relief , convenient application , and good compliance of patients .So it is worthy of being recommended in clinical work . |
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