Balsløv J T, Brun C, Jørgensen F, Jørgensen H E, Larsen M, Larsen S, Lorenzen I, Thomsen A C
Acta Med Scand. 1978;203(5):339-44.
Sequential statistical testing of the development of the disease in the single patient was used in the assessment of immunosuppressive treatment of renal glomerular diseases. After an initial period of prednisone (P) treatment, this was supplemented first by azathioprine (A) and later in addition by cyclophosphamide (C). The time of transition from one treatment to another was determined by the result of the current statisical testing of the correlation between serum creatinine concentration and proteinuria on the one hand and the time and the varying doses of the drugs on the other. Twenty-nine patients entered the study. Thirteen were withdrawn, eight for technical reasons, three due to side-effects and two on account of renal deterioration and transfer to dialysis treatment. Eight patients were cured, one during P treatment, five during P + A, and two during the combination of P, A and C. Eight patients completed treatment without being cured. In the overall material no statistically significant change in serum creatinine was noted, whereas the proteinuria decreased during P + A and P + A + C. No dose-dependent therapeutic effect of the drugs was demonstrated. In conclusion, this combined treatment with P, A and C did not seem to yield any major therapeutic progress. The technic of sequential statistical testing may be a useful tool in clinical research.
在评估肾小球疾病的免疫抑制治疗时,对单个患者疾病发展进行序贯统计检验。在泼尼松(P)治疗的初始阶段后,首先加用硫唑嘌呤(A)进行补充,随后又加用环磷酰胺(C)。从一种治疗转换到另一种治疗的时间取决于当前对血清肌酐浓度与蛋白尿之间相关性的统计检验结果,一方面与时间有关,另一方面与药物的不同剂量有关。29名患者进入研究。13名患者退出,8名因技术原因,3名因副作用,2名因肾功能恶化并转至透析治疗。8名患者治愈,1名在P治疗期间治愈,5名在P + A治疗期间治愈,2名在P、A和C联合治疗期间治愈。8名患者完成治疗但未治愈。在总体资料中,未观察到血清肌酐有统计学意义的变化,而蛋白尿在P + A和P + A + C治疗期间有所下降。未显示出药物的剂量依赖性治疗效果。总之,这种P、A和C的联合治疗似乎未取得任何重大治疗进展。序贯统计检验技术可能是临床研究中的一种有用工具。