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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。
Objective To evaluate the efficacy, safety and tolerability of zoledronic acid in patients with bone pain caused by bone metastasis of solid tumors. Method using randomized, double-blind, positive drug parallel control method. 41 patients were divided into zoledronic acid treatment group (group A) or pamidronate disodium treatment group (group B). One-time administration of continuous observation of 28d bone pain changes. Results The total effective rate (80.9% in group A, 85% in group B) had no significant difference (p> 0.05). The mean effective time of the two groups was 3.86 ± 0.68d in group A and 4.70 ± 0.69d in group B, , The duration of treatment (19.29 ± 2.52 days in group A, 15.60 ± 2.08 days in group B) had no significant difference (p> 0.05); The incidence of adverse reactions in both groups was 71.5% in group A and 80% in group B The difference was not statistically significant (p> 0.05). Conclusion Zoledronic acid has a good therapeutic effect on bone pain caused by tumor bone metastasis, with high remission rate and long-term curative effect, and its efficacy is not lower than that of pamidronate. Zoledronic acid has administration time Short, small dose, mild adverse clinical features, with good tolerance and safety.