伊班膦酸钠治疗141例恶性肿瘤骨痛的随机双盲对照临床研究

Randomized Double-blind Clinical Trial of Sodium Ibandronate and Pamidronate Disodium Treatment of 141 Patients with Osteodynia

目的:评价国产伊班膦酸钠(Ibandronate)治疗恶性肿瘤骨痛的疗效和不良反应。方法:采用随机双盲阳性药物对照临床研究方法,将骨痛患者随机分为静脉滴注伊班膦酸钠4mg(A组68例)、静脉滴注帕米膦酸二钠60mg(B组73例),观察3周内骨痛变化和不良反应。结果:141例患者入组,可评价疗效136例。A组治疗有效率为72.3%(47/65),B组为63.4%(45/71),两组间无统计学差异。两组不良反应类似。结论:伊班膦酸钠注射液治疗恶性肿瘤骨转移疼痛疗效确切,与帕米膦酸二钠相比疗效和不良反应相似。

Objective： To evaluate the therapeutic effect of and adverse reaction to Sodium Ibandronate （SI） in patients with osteodynia resulting from osseous metastasis from malignant tumors. Methods： Sixty-eight patients were randomly assigned to group A that received 4 mg SI i.v., and 73 patients were randomized into group B that received 60 mg PD i.v., using a randomized, double-blind clinical trial. The change in bone pain intensity and any side effects that occurred within three weeks were observed. Results： A total of 141 patients were enrolled in the study, with 136 cases suitable for efficacy appraisal. The effective rate was 72.3% （47/65） in group A and 63.4% （45/71） in group B. There was no significant difference between the 2 groups. The adverse effects were similar in group A and B. Conclusion： The SI injection, with a pronounced effect, can relieve bone pain caused by osseous metastasis of malignant tumor. The curative and adverse effects were sinfilar to those found with pamidronate disodium.