唑来膦酸治疗恶性肿瘤骨转移疼痛的疗效观察

目的随机给予实体瘤骨转移引起的骨痛患者唑来膦酸或帕米膦酸二钠,以评价唑来膦酸的疗效、安全性、耐受性。法采用随机、双盲、阳性药平行对照的研究方法。41例患者被分为唑来膦酸治疗组（A组）或帕米膦酸二钠治疗组（B组）。一次性给药后连续观察28d骨痛变化情况。结果两组总有效率（A组80.9%,B组85%）比较差异无统计学意义（p〉0.05）;两组平均起效时间（A组3.86±0.68d,B组4.70±0.69d）、疗效维持时间（A组19.29±2.52d,B组为15.60±2.08d）比较差异无统计学意义（p〉0.05）;两组不良反应发生率（A组71.5%,B组80%）比较差异无统计学意义（p〉0.05）。结论唑来膦酸对于肿瘤骨转移所引起的骨痛具有较好的治疗作用,缓解率高,疗效维持时间长,其疗效不低于帕米膦酸二钠;唑来膦酸有给药时间短、给药剂量小、不良反应轻的临床特点,具有良好的耐受性和安全性。

To observe the efficacy of therapeutic metastatic bone pain with Zoledronic acid

Objective We investigated that patients with secondary to solid tumors were randomized to the treatment of zoledronic acid or pamidronate and evaluated the efficacy,safety and toleration of zoledronic acid.Methods A randominzed,double-blind and parallel comparative control clinical trial.We recruited 41 patients in treament with zoledronic acid（arm A） or pamidronate（arm B）.The patients were followed up for 28 days to assess the efficacy and safety of the single dose treatment by observing VAS.To deal data with SPSS11.5 software package.Results The total effective rate in arm A was 80.9% compared with 85% in arm B.No statistically significant difference was observed between the two arms（p 〉0.05）.The average to start effective time in arm A was 3.86±0.68d compared with 4.70 ±0.69d in arm B.The therapeutic effect maintenance time in arm A was 19.29±2.52d compared with 15.60±2.08d in arm B.No statistically significant diference was observed between the two arms（p〉 0.05）.The incidence rate of adverse effect in arm A was 71.4% compared with 80% in arm B.No statistically significant difference was observed between the two arms（p 〉0.05）.Conclusions Zoledronic acid has a perfect therapeutic effect for the bone pain caused by malignant metastatic bone disease,with high remission rate,long duration of the pain relief,and it isn’t lower than pamidronate.Zoledronic acid has unique clinic feature with the shortest approved infusion time,low dose of any bisphosphonate therapy and mild side effects.It is well tolerated and safty,so it has potential clinical utility for malignant bone metastatic.