Fujii R, Shinozaki T, Meguro H, Arimasu O, Yoshioka H, Fujita K, Sakata H, Maruyama S, Wagatasuma Y, Fukushima N
Department of Pediatrics, School of Medicine, Teikyo University.
Jpn J Antibiot. 1988 Jun;41(6):646-62.
In a study of rokitamycin (RKM) dry syrup for its usefulness in pediatric infections, the following results were obtained: 1. Frequencies of RKM-resistant strains among fresh isolates from sick children were very low, and 4.4% of 68 isolates of Staphylococcus aureus, 4.2% of 48 isolates of Streptococcus pneumoniae, and none of 96 isolates of Streptococcus pyogenes were found to be RKM-resistant. 2. Hypo- to achlorhydria was found in 2 (3.77%) of 53 children. 3. When children were administered once orally with 5, 10 and 15 mg/kg of RKM dry syrup at fasting, mean peak values of plasma concentration were 0.25, 0.55 and 0.74 micrograms/ml with a T1/2 (beta) of 2.18, 1.97 and 2.00 hours, respectively. Urinary recovery rates during the first 0-6 hours were quite low, and values were 1.21, 1.38 and 2.23%, respectively. 4. The clinical efficacy of RKM dry syrup was studied on children chiefly with acute pneumonia, mycoplasmal pneumonia and tonsillitis. Among 379 children from whom pathogens had been determined, responses to the treatment were excellent in 186, good in 144, fair in 24, poor in 20 and unknown in 5 patients, the overall efficacy rate being 88.2%. Among all 598 treated patients, including those with undetermined pathogens, responses were excellent in 247, good in 269, fair in 42, poor in 35 and unknown in 5 patients, the efficacy rate being 87.0%. 5. The clinical efficacy of the drug in treating Chlamydia infection in 12 patients including a Chlamydia carrier and the clinical efficacy in treating Campylobacter enteritis in 36 patients were studied. All the cases showed "good" responses. Among 66 patients with mycoplasmal pneumonia, responses were excellent in 33 and good in 27 patients, with an efficacy rate of 90.9%. 6. The optimal dose of RKM dry syrup seemed to be in the range between 20 and 40 mg/kg. It appeared, however, that a dose of about 40 mg/kg would be required to eradicate the pathogen from the pharynx in S. pyogenes infection. 7. Adverse reactions to RKM dry syrup were found in 9 (1.45%) of 622 patients. The reactions were gastrointestinal symptoms except eruption occurred in 1 patient, but they were all mild. Laboratory examinations revealed eosinophilia in 19 and abnormal hepatic enzyme activities in 8 of 455 patients studied, but such abnormalities were all transient and mild.
在一项关于罗他霉素(RKM)干糖浆对小儿感染疗效的研究中,获得了以下结果:1. 患病儿童新鲜分离株中对RKM耐药菌株的频率非常低,在68株金黄色葡萄球菌中,4.4%对RKM耐药;在48株肺炎链球菌中,4.2%对RKM耐药;在96株化脓性链球菌中,未发现对RKM耐药的菌株。2. 53名儿童中有2名(3.77%)出现胃酸过少至胃酸缺乏。3. 儿童空腹口服5、10和15mg/kg的RKM干糖浆一次后,血浆浓度的平均峰值分别为0.25、0.55和0.74μg/ml,T1/2(β)分别为2.18、1.97和2.00小时。最初0至6小时的尿回收率相当低,分别为1.21%、1.38%和2.23%。4. 主要对患有急性肺炎、支原体肺炎和扁桃体炎的儿童研究了RKM干糖浆的临床疗效。在已确定病原体的379名儿童中,治疗反应优的有186名,良的有144名,中(尚可)的有24名,差的有20名,不明的有5名,总有效率为88.2%。在包括病原体未确定的所有598名接受治疗的患者中,反应优的有247名,良的有269名,中(尚可)的有42名,差的有35名,不明的有5名,有效率为87.0%。5. 研究了该药物对12例包括衣原体携带者的衣原体感染的临床疗效以及对36例弯曲菌肠炎的临床疗效。所有病例均显示“良好”反应。在66例支原体肺炎患者中,反应优的有33例,良的有27例,有效率为90.9%。6. RKM干糖浆的最佳剂量似乎在20至40mg/kg之间。然而,在化脓性链球菌感染中,似乎需要约40mg/kg的剂量才能从咽部清除病原体。7. 622例患者中有9例(1.45%)出现了对RKM干糖浆的不良反应。这些反应均为胃肠道症状,仅有1例出现皮疹,但均较轻微。实验室检查显示,在455名接受研究的患者中,19例嗜酸性粒细胞增多,8例肝酶活性异常,但这些异常均为短暂且轻微的。