LABORATORY AND CLINICAL STUDIES ON RU 28965

We carried out laboratory and clinical studies on RU 28965, a new macrolide antibiotic, with the following results, De. crease in hemoglobin was noted in about 50% of subjects in a phase I study and in about 20% of patients treated with RU 28965. Accordingly, the effect of RU 28965 on hematopoietic...

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Published inCHEMOTHERAPY Vol. 36; no. Supplement4; pp. 293 - 300
Main Authors KUMADA, TEPPEI, SHIMIZU, KIHACHIRO, SAKAMOTO, YASUMI, KATAHIRA, JUNICHI, FUKUDA, TOMOKO
Format Journal Article
LanguageEnglish
Japanese
Published Japanese Society of Chemotherapy 1988
公益社団法人 日本化学療法学会
Online AccessGet full text
ISSN0009-3165
1884-5894
DOI10.11250/chemotherapy1953.36.Supplement4_293

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Abstract We carried out laboratory and clinical studies on RU 28965, a new macrolide antibiotic, with the following results, De. crease in hemoglobin was noted in about 50% of subjects in a phase I study and in about 20% of patients treated with RU 28965. Accordingly, the effect of RU 28965 on hematopoietic stem cells was investigated by in vitro clonal assay using the methylcellulose culture method. RU 28965 inhibited only hematopoietic stem cells of red blood cells (CFU-E) at concentrations above 5μg/ml. RU 28965 was administered to 22 patients: 9 with acute bronchitis, 8 with pneumonia, and 1 each with laryngopharyngitis, acute tonsillitis, chronic bronchitis, diffuse panbronchiolitis and necrotizing lymphadenitis. Clinical response was excellent in 2 patients, good in 11, fair in 6, poor in 1 and unknown in 1. The clinical efficacy rate was 61%. The patient with lymphadenitis was excluded from the analysis, since this disease did not meet the inclusion criteria. Only one adverse reaction, gastric discomfort, was noted. RU 28965 has been reported to produce high plasma concentrations. Although its concentration in bone marrow is not known at present, patients treated with an increased dose of RU 28965 may need careful monitoring of its effects on the hematopoietic system.
AbstractList We carried out laboratory and clinical studies on RU 28965, a new macrolide antibiotic, with the following results, De. crease in hemoglobin was noted in about 50% of subjects in a phase I study and in about 20% of patients treated with RU 28965. Accordingly, the effect of RU 28965 on hematopoietic stem cells was investigated by in vitro clonal assay using the methylcellulose culture method. RU 28965 inhibited only hematopoietic stem cells of red blood cells (CFU-E) at concentrations above 5μg/ml. RU 28965 was administered to 22 patients: 9 with acute bronchitis, 8 with pneumonia, and 1 each with laryngopharyngitis, acute tonsillitis, chronic bronchitis, diffuse panbronchiolitis and necrotizing lymphadenitis. Clinical response was excellent in 2 patients, good in 11, fair in 6, poor in 1 and unknown in 1. The clinical efficacy rate was 61%. The patient with lymphadenitis was excluded from the analysis, since this disease did not meet the inclusion criteria. Only one adverse reaction, gastric discomfort, was noted. RU 28965 has been reported to produce high plasma concentrations. Although its concentration in bone marrow is not known at present, patients treated with an increased dose of RU 28965 may need careful monitoring of its effects on the hematopoietic system.
We carried out laboratory and clinical studies on RU 28965, a new macrolide antibiotic, with the following results, De. crease in hemoglobin was noted in about 50% of subjects in a phase I study and in about 20% of patients treated with RU 28965. Accordingly, the effect of RU 28965 on hematopoietic stem cells was investigated by in vitro clonal assay using the methylcellulose culture method. RU 28965 inhibited only hematopoietic stem cells of red blood cells (CFU-E) at concentrations above 5μg/ml.RU 28965 was administered to 22 patients: 9 with acute bronchitis, 8 with pneumonia, and 1 each with laryngopharyngitis, acute tonsillitis, chronic bronchitis, diffuse panbronchiolitis and necrotizing lymphadenitis. Clinical response was excellent in 2 patients, good in 11, fair in 6, poor in 1 and unknown in 1. The clinical efficacy rate was 61%. The patient with lymphadenitis was excluded from the analysis, since this disease did not meet the inclusion criteria. Only one adverse reaction, gastric discomfort, was noted.RU 28965 has been reported to produce high plasma concentrations. Although its concentration in bone marrow is not known at present, patients treated with an increased dose of RU 28965 may need careful monitoring of its effects on the hematopoietic system. RU 28965はエリスロマイシンから半合成されたマクロライド系抗生物質であり, 胃酸抵抗性であるために腸管よりの吸収が良いことをその特質とする。エリスロマイシンよりも半減期が長く高い血中濃度が持続するが, 抗菌力は同程度であるといわれる。第1相試験や臨床試験でヘモグロビンが低下する症例がみられたため, コロニー法によるクロナールアッセイを行ってこの原因を検討したところ, RU 28965は赤血球系造血幹細胞を選択的に抑制した。呼吸器系疾患について臨床的検討を行った結果, 有効率が65%という良好な結果が得られた。
Author FUKUDA, TOMOKO
SHIMIZU, KIHACHIRO
KATAHIRA, JUNICHI
KUMADA, TEPPEI
SAKAMOTO, YASUMI
Author_FL 清水 喜八郎
坂本 保巳
片平 潤一
熊田 徹平
深田 智子
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公益社団法人 日本化学療法学会
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References 1) 第35回日本化学療法学会総会, 新薬シンポジウムIV. RU 28965, 盛岡, 1987
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