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目的:研究比较非放射性钐乙二胺四亚甲基膦酸盐(Sm-EDTMP,冷钐)和放射性钐乙二胺四亚甲基膦酸盐(153Sm-EDTMP,热钐)治疗恶性肿瘤骨转移疼痛的不良反应。方法:240例恶性肿瘤骨转移有中重度疼痛患者,随机分组接受冷钐和热钐治疗。冷钐组:将冷钐1支(相当于EDTMP76mg),溶于5 mL注射用水,静脉推注;热钐组:根据患者体重,按3.7×107Bq.kg-1计算放射性153Sm-EDTMP剂量,溶于5 mL注射用水,静脉推注。观察14 d疼痛评分变化及不良反应(患者的血象、血生化、心电图、血电解质等的改变)。结果:冷钐组镇痛的有效率为52.5%(64/122),热钐组为60.0%(69/115),经χ2检验两组无显著差异。与冷钐组相比,热钐组骨髓抑制较严重。两组均有疼痛加剧、皮疹、头晕、恶心、呕吐、血尿、乏力、发热和全身不适等不良反应,全部为轻至中度,两组发生率相似。结论:冷钐治疗恶性肿瘤骨转移疼痛疗效与热钐相当,无明显骨髓抑制,耐受性更好。
AIM: To compare the efficacy and safety of non-radioactive samarium ethylenediaminetetramethylene phosphonate (Sm-EDTMP, samarium) and radioactive samarium ethylenediaminetetramethylene phosphonate (153Sm-EDTMP, samarium) Adverse reactions to metastases. METHODS: Two hundred and forty patients with moderate to severe bone metastases of malignant tumors were randomized to receive cold samarium and thermal samarium. Cold samarium group: Sm Samarium 1 (equivalent to EDTMP76mg), dissolved in 5 mL of water for injection, intravenous injection; hot samarium group: according to the patient’s body weight, calculated by the amount of radioactive 153Sm-EDTMP 3.7 × 107Bq.kg- In 5 mL of water for injection, intravenous injection. The 14-day pain score changes and adverse reactions (changes in blood, blood biochemistry, electrocardiogram, blood electrolytes, etc.) were observed. Results: The effective rate of analgesia was 52.5% (64/122) in cold samarium group and 60.0% (69/115) in hot samarium group. There was no significant difference between the two groups by χ2 test. Compared with the cold samarium group, heat samarium group bone marrow suppression is more serious. Both groups had pain exacerbations, rash, dizziness, nausea, vomiting, hematuria, fatigue, fever and general malaise and other adverse reactions, all mild to moderate, similar to the two groups. Conclusion: The effect of cold samarium on the treatment of malignant bone metastasis is similar to that of samarium, no obvious myelosuppression and better tolerability.