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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 efficacy and adverse reactions of domestic Ibandronate in the treatment of malignant bone pain. Methods: A randomized, double-blind, positive-control clinical trial was conducted. Patients with bone pain were randomized into 4 mg ibuprofen IV (68 patients in group A) and 60 mg pamidronate (group B, 73 Cases), observed changes in bone pain within 3 weeks and adverse reactions. RESULTS: One hundred and forty-one patients were enrolled and 136 patients were evaluated. A group of treatment efficiency was 72.3% (47/65), B group was 63.4% (45/71), no significant difference between the two groups. Two groups of similar adverse reactions. CONCLUSION: Ibandronate sodium injection is effective in treating bone metastases of malignant tumors and has similar efficacy and adverse reactions compared with pamidronate disodium.