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Z-100治疗放疗所致白细胞减少症的临床疗效——与肌苷的多中心双盲对照研究

[Clinical efficacy of Z-100 for the treatment of leukopenia caused by radiotherapy--a multi-center double-blind comparative study with inosine].

作者信息

Hashimoto S, Ohkawa T, Takekawa Y, Horiuchi J, Mori T, Amino S, Morita K, Tanaka Y, Mochizuki Y, Yanagisawa T

机构信息

Department of Radiology, Keio University School of Medicine.

出版信息

Nihon Igaku Hoshasen Gakkai Zasshi. 1990 Aug 25;50(8):977-92.

PMID:2235345
Abstract

The clinical usefulness and the optimal dose of Z-100 for the treatment of leukopenia caused by radiotherapy for malignant tumors was evaluated in a double-blind study comparing 20 micrograms and 30 micrograms injections of Z-100 and inosine (Z-20, Z-30 and IN group, respectively). The effective rate according to the evaluation by the attending physicians was 67.4%, 79.1% and 48.9% in the Z-30, Z-20 and IN groups, respectively, with a significantly higher efficacy rate for the Z-20 group than for the IN group. The frequency of adverse reactions was 14.3%, 3.9% and 5.6% in the Z-30, Z-20 and IN groups, respectively, with the highest rate in the Z-30 group, but there was no significant difference among the three groups. The useful rate based on total evaluation considering the effective rate and the safety profile in each group was 60.8%, 77.3% and 46.8% in the Z-30, Z-20 and IN groups, respectively, with the highest rate in the Z-20 group showing significant difference from that in the IN group. The above data confirmed the clinical usefulness of Z-100 and suggested that the optimal dose was 20 micrograms twice weekly for Z-100.

摘要

在一项双盲研究中,比较了注射20微克和30微克的Z-100以及肌苷(分别为Z-20、Z-30和肌苷组)治疗恶性肿瘤放疗引起的白细胞减少症的临床疗效和最佳剂量。根据主治医生的评估,Z-30组、Z-20组和肌苷组的有效率分别为67.4%、79.1%和48.9%,Z-20组的有效率显著高于肌苷组。不良反应发生率在Z-30组、Z-20组和肌苷组分别为14.3%、3.9%和5.6%,Z-30组最高,但三组之间无显著差异。综合考虑每组的有效率和安全性概况进行总体评估,Z-30组、Z-20组和肌苷组的有效利用率分别为60.8%、77.3%和46.8%,Z-20组最高,与肌苷组有显著差异。上述数据证实了Z-100的临床疗效,并表明Z-100的最佳剂量为每周两次20微克。

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