Nishimura T, Takashima T, Hiromatsu K, Tabuki K, Takagi M
Jpn J Antibiot. 1982 May;35(5):1199-206.
The authors have carried out laboratory and clinical studies of 9,3"-diacetylmidecamycin (MOM) and obtained the following results. 1. Absorption and excretion of MOM. MOM was administered orally to 4 patients at a dose of 10 mg/kg in the fasting condition. The peak of serum levels was found at 30 minutes after administration. The mean values were 1.3 +/- 0.5 microgram/ml, and 1.1 +/- 0.9 microgram/ml after 30 minutes and 1 hour respectively. The serum levels were detectable in 2 cases after 2 hours (1.0 and 0.78 microgram/ml), in 1 case after 4 hours (0.78 microgram/ml) and were not detectable in all cases after 6 hours. Half-life was able to calculate in 2 cases (2.5 and 1.5 hours). The mean urinary recovery rate examined in 3 cases was 0.33% for initial 6 hours. 2. Clinical result. MOM was administered to 35 children at a daily dose of 16.7--51.1 mg/kg divided into 3 or 4 doses for 4 to 19 days: 18 cases with bacterial infection (9 cases with tonsillitis, 7 cases with scarlet fever and each 1 case with bronchitis and pneumonia) and 17 cases with Mycoplasma infection (5 cases with bronchitis and 12 cases with pneumonia). The overall clinical response was good in 28 cases (80.0%), fair in 6 cases and poor in 1 case. The efficacy rate in bacterial infections and Mycoplasma infections were 66.7 and 94.1% respectively. Eight strains of S. pyogenes and 1 strain of S. pneumoniae were isolated from 9 cases. One strain of S. pyrogenes was eradicated and the others were unchanged. The eradication rate was 11.1%. The MIC of MOM against S. pyogenes was above 50 micrograms/ml in 3 strains out of measured 5 isolated strains. 3. Side effect. Side effects were examined with all the 54 cases involving 19 drop-out cases. Although clinical side effects were not observed, a mild elevation in GOT and a mild rise in eosinophil were observed in 2 cases and 1 case respectively.
作者对9,3”-二乙酰麦迪霉素（MOM）进行了实验室和临床研究，获得了以下结果。1. MOM的吸收与排泄。在空腹状态下，以10mg/kg的剂量给4例患者口服MOM。给药后30分钟时血清水平达到峰值。30分钟和1小时后的平均值分别为1.3±0.5微克/毫升和1.1±0.9微克/毫升。2小时后2例患者血清水平仍可检测到（分别为1.0和0.78微克/毫升），4小时后1例患者可检测到（0.78微克/毫升），6小时后所有患者均检测不到。2例患者能够计算半衰期（分别为2.5小时和1.5小时）。3例患者最初6小时的平均尿回收率为0.33%。2. 临床结果。给35例儿童使用MOM，日剂量为16.7 - 51.1mg/kg，分3或4次给药，疗程4至19天：18例细菌感染患者（9例扁桃体炎、7例猩红热，支气管炎和肺炎各1例），17例支原体感染患者（5例支气管炎，12例肺炎）。总体临床反应良好的有28例（80.0%），一般的有6例，差的有1例。细菌感染和支原体感染的有效率分别为66.7%和94.1%。从9例患者中分离出8株化脓性链球菌和1株肺炎链球菌。1株化脓性链球菌被清除，其他菌株无变化。清除率为11.1%。在所检测的5株分离菌株中，3株化脓性链球菌对MOM的最低抑菌浓度高于50微克/毫升。3. 副作用。对包括19例退出病例在内的所有54例患者进行了副作用检查。虽然未观察到临床副作用，但分别有2例患者出现谷草转氨酶轻度升高，1例患者嗜酸性粒细胞轻度升高。
