Brown J, Mellis C M, Wood R E
Am J Dis Child. 1985 Aug;139(8):836-9. doi: 10.1001/archpedi.1985.02140100098043.
In vitro and animal experimental data suggest the combination of edetate sodium (EDTA) by aerosol plus oral antimicrobials might be effective in the treatment of chronic Pseudomonas infection in patients with cystic fibrosis (CF). For six months we studied the effects of edetate sodium administered by ultrasonic nebulizer to ten children with CF and chronic Pseudomonas aeruginosa infection in a double-blind, placebo-controlled, crossover study. The children had evidence of mild to moderate disease at entry in the study, with a mean (+/- SD) forced expiratory volume in the first second of 85% (+/- 18%) of the predicted value and a mean (+/- SD) Shwachman-Kulczycki score of 83 (+/- 7)/100. Each child was on a three-month regimen of aerosolized edetate sodium plus oral tetracycline twice daily followed by three months of placebo aerosol plus tetracycline or vice versa. Progress was assessed by measurement of pulmonary function, physical examination, and sputum cultures at four weekly intervals, plus chest roentgenograms on entry and after each of the three-month treatment periods. Daily symptoms were assessed using a diary card system. Two patients could not complete the study, one because of severe respiratory relapse, the other because of antibiotic side effects. Of the remaining eight patients, none showed any improvement in pulmonary function, weight gain, or growth acceleration, and none was rendered free of Pseudomonas lung infection. Daily symptom scores and chest roentgenograms were unaltered by edetate sodium. We conclude that the combination of aerosol edetate sodium plus oral tetracycline over a three-month period does not modify the clinical course nor the pulmonary flora in patients with CF with chronic Pseudomonas lung infection.
体外和动物实验数据表明，雾化乙二胺四乙酸钠（EDTA）联合口服抗菌药物可能对治疗囊性纤维化（CF）患者的慢性铜绿假单胞菌感染有效。在一项双盲、安慰剂对照、交叉研究中，我们对10名患有CF和慢性铜绿假单胞菌感染的儿童进行了为期6个月的研究，通过超声雾化器给予乙二胺四乙酸钠。这些儿童在研究开始时具有轻度至中度疾病的证据，第一秒用力呼气量平均（±标准差）为预测值的85%（±18%），Shwachman-Kulczycki评分平均（±标准差）为83（±7）/100。每个儿童接受为期三个月的雾化乙二胺四乙酸钠加口服四环素每日两次的治疗方案，随后是三个月的安慰剂雾化加四环素治疗，或反之亦然。通过每四周测量肺功能、体格检查和痰培养，以及在研究开始时和每个三个月治疗期后进行胸部X线检查来评估进展情况。使用日记卡系统评估每日症状。两名患者无法完成研究，一名是因为严重的呼吸复发，另一名是因为抗生素副作用。在其余8名患者中，没有一人在肺功能、体重增加或生长加速方面有任何改善，也没有一人摆脱铜绿假单胞菌肺部感染。乙二胺四乙酸钠对每日症状评分和胸部X线检查没有影响。我们得出结论，为期三个月的雾化乙二胺四乙酸钠联合口服四环素治疗方案并不能改变患有慢性铜绿假单胞菌肺部感染的CF患者的临床病程和肺部菌群。
