Cohen H J, Silberman H R, Tornyos K, Bartolucci A A
Blood. 1984 Mar;63(3):639-48.
A randomized controlled trial was initiated in 1972 to compare two chemotherapeutic regimens [1-3-bis (2-chloroethyl) 1-nitrosourea (BCNU), cyclophosphamide, and prednisone versus melphalan and prednisone], to determine whether the two regimens are cross-resistant, and to evaluate the effectiveness of sodium fluoride, vitamin D, calcium gluconate, and fluoxymesterone in the promotion of bone healing. Initial responses (50%) and survival (36 mo median) for patients treated with the two chemotherapeutic regimens were the same. Patients on either regimen who failed to respond after 6 mo had a very low response rate to the alternative regimen (approximately 10%). Initially responding patients were randomly assigned to either an active drug regimen (sodium fluoride, vitamin D, calcium gluconate, fluoxymesterone) or placebo tablets. There was no significant difference in the low percentage of patients demonstrating bone improvement. Thus, the BCNU, cyclophosphamide, prednisone regimen is as effective as melphalan and prednisone. Fluoride, calcium, vitamin D, and androgenic steroids should not be routinely recommended in myeloma, as they seem to add little to effective chemotherapy and may contribute to morbidity.
1972年启动了一项随机对照试验，以比较两种化疗方案[1,3 - 双（2 - 氯乙基）-1 - 亚硝基脲（卡氮芥）、环磷酰胺和泼尼松与美法仑和泼尼松]，确定这两种方案是否存在交叉耐药性，并评估氟化钠、维生素D、葡萄糖酸钙和氟甲睾酮在促进骨愈合方面的有效性。接受两种化疗方案治疗的患者的初始缓解率（50%）和生存率（中位生存期36个月）相同。两种方案中在6个月后无反应的患者对替代方案的反应率非常低（约10%）。初始有反应的患者被随机分配至活性药物方案（氟化钠、维生素D、葡萄糖酸钙、氟甲睾酮）或安慰剂片。显示骨改善的患者比例较低，两者之间无显著差异。因此，卡氮芥、环磷酰胺、泼尼松方案与美法仑和泼尼松一样有效。在骨髓瘤中，不应常规推荐氟化物、钙、维生素D和雄激素类甾体，因为它们似乎对有效的化疗作用不大，且可能增加发病率。
