Bartlett A V, Torun B, Morales C, Cano F, Cruz J R
Department of International Health, Johns Hopkins University, School of Hygiene and Public Health, Baltimore, Maryland.
Acta Paediatr Suppl. 1992 Sep;381:149-54. doi: 10.1111/j.1651-2227.1992.tb12390.x.
We conducted a randomized, double-blind, placebo controlled clinical trial of oral gentamicin (10 milligrams/kilogram body weight/day for five days) in treatment of unselected cases of persistent diarrhea (duration 14-18 days at initiation of treatment) among 3-36-month-old children in a rural Guatemalan community. Following random assignment of each child to a treatment group, the appropriate dose of gentamicin or placebo was administered to the child three times daily by a study nurse; this nurse also identified the presence or absence of diarrhea on each day of treatment and for the next two days. Cure was defined as cessation of diarrhea during the five-day treatment period, sustained through at least the two days after completion of treatment. Among 92 evaluable cases who entered the clinical trial, there was essentially no difference in cure rate between gentamicin and placebo treatment groups (42% versus 43%). Enteroadherent strains of Escherichia coli were identified in 46% of children tested in this trial; no significant difference existed between treatment groups in frequency of isolation of this or any other enteropathogen. Among 40 children having successful duodenal cultures immediately prior to beginning treatment, > or = 10(4) aerobic organisms per milliliter of fluid were identified in 12 (30%); treatment groups did not differ substantially with respect to proportion of children identified with this level of duodenal microbial colonization. Failure of gentamicin treatment did not appear to be explained by emergence of resistance, although a small number of resistant enteropathogens were identified near the end of the study.(ABSTRACT TRUNCATED AT 250 WORDS)
我们在危地马拉农村社区对3至36个月大儿童中未经挑选的持续性腹泻病例(治疗开始时病程为14至18天)进行了一项口服庆大霉素(10毫克/千克体重/天,共五天)的随机、双盲、安慰剂对照临床试验。在将每个儿童随机分配到治疗组后,研究护士每天给儿童服用三次适当剂量的庆大霉素或安慰剂;该护士还确定了治疗期间每天以及之后两天是否存在腹泻。治愈定义为在五天治疗期内腹泻停止,并至少持续到治疗结束后的两天。在进入临床试验的92例可评估病例中,庆大霉素治疗组和安慰剂治疗组的治愈率基本没有差异(42%对43%)。在该试验中接受检测的儿童中,46%鉴定出了肠粘附性大肠杆菌菌株;在该或任何其他肠道病原体的分离频率上,治疗组之间没有显著差异。在开始治疗前十二指肠培养成功的40名儿童中,每毫升液体中有≥10⁴需氧菌的有12名(30%);在确定有这种十二指肠微生物定植水平的儿童比例方面,治疗组之间没有实质性差异。庆大霉素治疗失败似乎不能用耐药性的出现来解释,尽管在研究接近尾声时鉴定出了少数耐药肠道病原体。(摘要截断于250字)