Salam M A, Dhar U, Khan W A, Bennish M L
International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.
Lancet. 1998 Aug 15;352(9127):522-7. doi: 10.1016/S0140-6736(97)11457-X.
Infections caused by multiply resistant Shigella species are a major cause of childhood morbidity and mortality in Third World countries. The fluoroquinolone agent ciprofloxacin is active in vitro against these strains of bacteria, but has not been routinely used to treat acute childhood infections because of concern that quinolones may cause arthropathy in children. We undertook a randomised double-blind study to test the effects of ciprofloxacin treatment in children with shigella dysentery.
We compared the efficacy and toxic effects of ciprofloxacin suspension (10 mg/kg every 12 h for 5 days, maximum individual dose 500 mg) with those of pivmecillinam tablets (15-20 mg/kg every 8 h for 5 days, maximum individual dose 300 mg). We enrolled 143 children aged 2-15 years with dysentery of 72 h or less duration. Patients stayed in hospital for 6 days, and were followed up 7, 30, and 180 days after hospital discharge. Joint symptoms and function were assessed daily for 6 days. Clinical success was defined as the absence of frank dysentery on day 3, and on day 5 no bloody-mucoid stools, one or no watery stool, six or fewer total stools, and no fever. If no shigella were isolated from faecal samples on day 3 or thereafter, treatment was judged bacteriologically successful.
13 patients were excluded since they did not meet eligibility criteria; 10 withdrew before day 5. Thus 120 patients (60 in each group) completed the study. Treatment was clinically successful in 48 (80%) of 60 patients who received ciprofloxacin and in 39 (65%) of 60 patients who received pivmecillinam (p=0.10). Treatment was bacteriologically successful in all of the patients receiving ciprofloxacin, and in 54 (90%) of the patients receiving pivmecillinam (p=0.03). Joint pain after treatment began in 13 (18%) of 71 patients who received ciprofloxacin and 16 (22%) of 72 patients who received pivmecillinam (p>0.2), and no patient had signs of arthritis.
In our trial, ciprofloxacin suspension and pivmecillinam had the same clinical efficacy. Ciprofloxacin had greater bacteriological efficacy and was not associated with the development of arthropathy. We conclude that ciprofloxacin is an effective and safe drug for use in multiply resistant childhood shigellosis.
多重耐药志贺菌属引起的感染是第三世界国家儿童发病和死亡的主要原因。氟喹诺酮类药物环丙沙星在体外对这些菌株具有活性，但由于担心喹诺酮类药物可能导致儿童关节病，尚未常规用于治疗儿童急性感染。我们进行了一项随机双盲研究，以测试环丙沙星治疗儿童志贺菌痢疾的效果。
我们比较了环丙沙星混悬液（每12小时10mg/kg，共5天，最大单次剂量500mg）与匹美西林片（每8小时15 - 20mg/kg，共5天，最大单次剂量300mg）的疗效和毒性作用。我们纳入了143名年龄在2至15岁、痢疾病程在72小时或更短时间的儿童。患者住院6天，并在出院后7天、30天和180天进行随访。连续6天每天评估关节症状和功能。临床成功定义为第3天无明显痢疾，第5天无血性黏液便、有1次或无水样便、总便次6次或更少且无发热。如果在第3天或之后从粪便样本中未分离出志贺菌，则判定治疗在细菌学上成功。
13名患者因不符合入选标准被排除；10名患者在第5天前退出。因此，120名患者（每组60名）完成了研究。接受环丙沙星的60名患者中有48名（80%）治疗临床成功，接受匹美西林的60名患者中有
