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目的引用德国骨肉瘤协作组(COSS)-96方案治疗骨肉瘤,从临床疗效分析、药物剂量及给药方式、不良反应的防治方面,探讨国内治疗儿童骨肉瘤的最佳综合治疗方案。方法对15例初诊的骨肉瘤患儿采用COSS-96方案,进行术前、术后化疗及手术综合治疗及疗效分析;检测大剂量甲氨蝶呤(HD-MTX)给药后的血清水平,根据血药水平调整HD-MTX给药剂量及甲酰四氢叶酸(CF)解救剂量及次数。结果 15例患儿术前化疗后均有局部肿块缩小及疼痛消失等症状好转及影像学改变;肿瘤坏死组织学评估Ⅰ级2例,Ⅱ级3例,Ⅲ级6例,Ⅳ级4例;HD-MTX剂量12 g.m-2给药结束0 h血清药物水平为700~1 000μmol.L-1。随访时间5 a 10个月,中位随访时间3 a 2个月,肺转移3例,肺及多部位骨骼转移1例,死亡2例。5 a生存率71%,5 a无瘤生存率57%。结论术前化疗具有清扫转移病灶,局部肿块缩小及疼痛消失、减小手术范围和难度的作用;依据术后肿瘤坏死组织学评估制定术后化疗方案,不仅达到避免患儿因化疗敏感性差使化疗方案强度不足,肿瘤易复发而生存期缩短的目的 ,而且可避免对化疗敏感的患儿因“过强”化疗后的不良反应及死亡的发生;血清药物水平监测下调整HD-MTX给药剂量,在确保有效杀灭瘤细胞药物剂量的同时,也为HD-MTX不良反应的防治提供客观依据。
Objective To evaluate the efficacy and safety of COSS -96 regimen in the treatment of osteosarcoma in China. The purpose of this study was to evaluate the best combination therapy for osteosarcoma in children from the aspects of clinical curative effect, drug dosage and mode of administration, and prevention and treatment of adverse reactions. Methods Fifteen newly diagnosed children with osteosarcoma were enrolled in this study. COSS-96 regimen was used to evaluate the effect of chemotherapy and surgery combined with preoperative and postoperative chemotherapy. The serum levels of HD-MTX after high dose methotrexate (HD-MTX) HD-MTX dosage and leucovorin (CF) rescue dose and frequency were adjusted according to blood level. Results All the 15 cases showed improvement of local lesion, disappearance of pain, and imaging changes after operation. The histological evaluation of tumor necrosis was grade Ⅰ in 2 cases, grade Ⅱ in 3 cases, grade Ⅲ in 6 cases and grade Ⅳ in 4 cases. HD-MTX dose of 12 gm-2 0 h after the end of drug serum levels of 700 ~ 1 000μmol.L-1. The follow-up time was 5 months and 10 months. The median follow-up time was 3 months and 2 months. There were 3 lung metastases, 1 lung and multi-site bone metastases, and 2 deaths. 5 a 71% survival rate, 5 a tumor-free survival rate of 57%. Conclusions The preoperative chemotherapy has the function of clearing the metastatic lesions, reducing the local mass and disappearing the pain, reducing the scope and difficulty of the operation. According to the histological evaluation of the postoperative tumor necrosis, formulating the postoperative chemotherapy regimen not only avoids the patients with chemotherapy-induced poor chemotherapy Program intensity is not enough, the tumor is easy to recur and survival shortened, but also to avoid chemotherapy-sensitive children due to “too strong ” chemotherapy after the adverse reactions and death occurred; serum drug levels to monitor the adjustment of HD-MTX In order to ensure the effective dose of drugs to kill tumor cells, it also provides an objective basis for the prevention and control of HD-MTX adverse reactions.