Hansen O P, Galton D A
Scand J Haematol. 1985 Jul;35(1):10-9. doi: 10.1111/j.1600-0609.1985.tb00792.x.
It is difficult to compare the results of treatment obtained in different trials in myelomatosis because different sets of diagnostic criteria are used, and because the criteria by which patients are deemed eligible for entry vary. Thus the composition of different series of patients varies considerably. Furthermore, the outcome of treatment is recorded in different ways. Uniformity in the diagnostic categories entered would reduce the variance in survival between different trials: for example, trials in myelomatosis should exclude patients with monoclonal gammopathy of uncertain significance, non-progressive or indolent myeloma, extramedullary plasmacytoma, and plasma-cell leukaemia. The subdivision into simple prognostic groupings such as those proposed by the Medical Research Council is helpful in interpreting the survival patterns in different trials in which the proportions of patients in different prognostic groups are likely to vary. These groupings and other staging systems do not correlate with responsiveness to treatment. Rapid responders fare worse than slow responders, and this might provide a basis for a second randomisation to test whether a change in treatment could benefit the rapid responders.
由于使用了不同的诊断标准，且患者被视为符合入组条件的标准也不同，因此很难比较在骨髓瘤治疗中不同试验所获得的治疗结果。因此，不同系列患者的组成差异很大。此外，治疗结果的记录方式也不同。纳入诊断类别的一致性将减少不同试验之间生存率的差异：例如，骨髓瘤试验应排除意义未明的单克隆丙种球蛋白病、非进展性或惰性骨髓瘤、髓外浆细胞瘤和浆细胞白血病患者。细分为简单的预后分组，如医学研究委员会提出的那些分组，有助于解释不同试验中的生存模式，在这些试验中，不同预后组患者的比例可能会有所不同。这些分组和其他分期系统与对治疗的反应性无关。快速反应者的预后比缓慢反应者更差，这可能为二次随机化提供依据，以测试治疗方案的改变是否能使快速反应者受益。
