[Criteria for the establishment of limits for antibacterial chemotherapy].

G Linzenmeier
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Abstract

The safety of patients asks for stringent standards when fixing limit values of the minimal inhibition concentration (MIC) in mg/l. It should be possible to recognize resistant bacterial strains with a low error on the basis of the recommendations of the bacteriological laboratory which are eventually important for therapy. Attention is drawn to the use of recognized methods such as DIN 58940 and 58944 and the participation in interlaboratory studies. Only such bacteria should be interpreted as "susceptible" whose MIC's are reliably below or, which is even better, much below the generally recognized average blood and tissue levels. Thus the break-points for the rating "susceptible" must be within the range of low variation. As a result, a few strains more would come within the "moderately susceptible" range. This would not exclude them from being selected if chemotherapy is performed with a correspondingly higher dosage (provided it is tolerated). Information on the chances of a success of therapy is improved in this way. A generous interpretation of pharmacokinetic data will in the end be more to the patient's detriment. In addition, there are numerous factors determining success or failure of therapy which cannot be established in vitro so that it is advisable to fix laboratory parameters in a stringent manner like that applied in the annexes (evaluation steps) to parts 3 and 4 of DIN 58940.

【抗菌化疗药物限量制定标准】。
在以mg/l为单位确定最小抑制浓度(MIC)的极限值时,对患者的安全要求有严格的标准。根据细菌学实验室的建议,应该有可能以低误差识别耐药菌株,这最终对治疗很重要。注意使用公认的方法,如DIN 58940和58944,并参与实验室间的研究。只有这样的细菌才应该被解释为“易感”,其MIC值可靠地低于,甚至更好,远低于一般公认的平均血液和组织水平。因此,“易受影响”等级的断点必须在低变化范围内。结果,更多的菌株将进入“中等易感”的范围。如果化疗以相应的高剂量进行(只要它是耐受的),这并不排除它们被选择。通过这种方式,有关治疗成功几率的信息得到了改善。对药代动力学数据的宽泛解释最终会对患者造成更大的损害。此外,有许多因素决定治疗的成功或失败,这些因素无法在体外建立,因此建议以严格的方式固定实验室参数,如DIN 58940第3部分和第4部分的附件(评估步骤)中所应用的方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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