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高灵敏度快速链球菌检测的培养确认是否有意义?一项医学决策分析。

Does culture confirmation of high-sensitivity rapid streptococcal tests make sense? A medical decision analysis.

作者信息

Webb K H

机构信息

Department of Pediatrics, Tufts University Medical School, Baystate Medical Center, Springfield, Massachusetts, and Holyoke Pediatric Associates, South Hadley, Massachusetts, USA.

出版信息

Pediatrics. 1998 Feb;101(2):E2. doi: 10.1542/peds.101.2.e2.

Abstract

OBJECTIVE

Since the 1990 publication of a decision analysis, in which the treatment of pharyngitis in children was evaluated, a number of assumptions important in that analysis have changed. Updating many of the assumptions and costs used in that analysis to reflect the conditions currently found in a large, suburban pediatric practice, a cost-effectiveness analysis was performed in which four strategies for the treatment of pharyngitis were considered: treat all, high-sensitivity antigen test, culture, and high-sensitivity antigen test with culture confirmation.

DESIGN

Decision analysis.

RESULTS

Using microbiology data from the 13 published studies in which a high-sensitivity antigen test (Strep A OIA; BioStar Inc., Boulder, CO) and blood agar plate culture were evaluated against a variety of gold standards, the sensitivity and specificity of the high-sensitivity antigen test were 89.1% and 95%, respectively. The sensitivity and specificity of blood agar plate throat culture were 83.4% and 99%, respectively. Penicillin V was used as the treatment of choice for uncomplicated pharyngitis; erythromycin was used in cases of penicillin allergy. Rates of suppurative and nonsuppurative complications reflect those currently seen in the United States. Other assumptions and cost data were taken from a large, suburban pediatric practice and its affiliated tertiary care medical center, except where noted. Despite the potential induction of resistance and the high number of allergic reactions associated with the treat-all strategy, this strategy had the lowest average cost per patient encounter and was the most cost-effective in terms of dollars per suppurative and nonsuppurative complication prevented. Of the strategies in which a diagnostic test was used, the high-sensitivity antigen test strategy had the lowest average cost and was the most cost-effective. The high-sensitivity antigen test with culture confirmation strategy had the highest average cost and was the least cost-effective. In the sensitivity analyses, a number of assumptions used in the original model were varied within a reasonable range. Under most conditions, the treat-all strategy remained the most cost-effective strategy used. One notable exception: when the wholesale cost of the antibiotic exceeded $10.76, as would be seen if any cephalosporin were used as the primary therapy of uncomplicated pharyngitis, the high-sensitivity antigen test strategy became the most cost-effective strategy. Under most conditions, the high-sensitivity antigen test strategy was the most cost-effective of the strategies in which a diagnostic test was used. Notable exceptions included: 1) conditions in which there was a low probability of streptococcal infection, 2) the use of an antigen test whose sensitivity is inferior to that of culture, and 3) during an epidemic of acute rheumatic fever. Culture confirmation of a negative high-sensitivity antigen test is the most cost-effective testing strategy only under conditions in which the probability of acute rheumatic fever approaches those levels last seen in the United States more than 40 years ago.

CONCLUSIONS

Although most cost-effective, the treat-all strategy is not recommended because of concerns about antibiotic resistance, which could not be included in the model, and the high number of allergic reactions found in children who did not have streptococcal infection. Use of the high-sensitivity antigen test without culture confirmation of all negative results was the most cost-effective strategy in which a diagnostic test was used with respect to prevention of suppurative and nonsuppurative complications of streptococcal pharyngitis. Culture confirmation of negative high-sensitivity antigen tests was not cost-effective under any of those conditions currently seen in the United States.

摘要

目的

自1990年发表一项评估儿童咽炎治疗方法的决策分析以来,该分析中一些重要的假设已经发生了变化。更新了该分析中使用的许多假设和成本,以反映目前在一个大型郊区儿科诊所中发现的情况,进行了一项成本效益分析,其中考虑了四种治疗咽炎的策略:全部治疗、高灵敏度抗原检测、培养以及高灵敏度抗原检测并进行培养确认。

设计

决策分析。

结果

利用13项已发表研究中的微生物学数据,在这些研究中,针对多种金标准评估了高灵敏度抗原检测(A群链球菌OIA;BioStar公司,科罗拉多州博尔德)和血琼脂平板培养,高灵敏度抗原检测的灵敏度和特异性分别为89.1%和95%。血琼脂平板咽培养的灵敏度和特异性分别为83.4%和99%。青霉素V被用作单纯性咽炎的首选治疗药物;对青霉素过敏的病例使用红霉素。化脓性和非化脓性并发症的发生率反映了目前在美国所观察到的情况。其他假设和成本数据取自一个大型郊区儿科诊所及其附属的三级医疗中心,另有说明的除外。尽管“全部治疗”策略可能会诱导耐药性,且与过敏反应的发生率较高相关,但该策略每位患者每次就诊的平均成本最低,就预防化脓性和非化脓性并发症而言,也是最具成本效益的。在使用诊断检测的策略中,高灵敏度抗原检测策略的平均成本最低,也是最具成本效益的。高灵敏度抗原检测并进行培养确认策略的平均成本最高,成本效益最低。在敏感性分析中,原始模型中使用的一些假设在合理范围内有所变化。在大多数情况下,“全部治疗”策略仍然是最具成本效益的策略。一个显著的例外情况是:当抗生素的批发成本超过10.76美元时,如将任何头孢菌素用作单纯性咽炎的主要治疗药物时所见到的情况,高灵敏度抗原检测策略就成为最具成本效益的策略。在大多数情况下,高灵敏度抗原检测策略是使用诊断检测的策略中最具成本效益的。显著的例外情况包括:1)链球菌感染可能性较低的情况,2)使用灵敏度低于培养的抗原检测,3)急性风湿热流行期间。仅在急性风湿热的概率接近美国40多年前最后一次见到的水平的情况下,对高灵敏度抗原检测阴性结果进行培养确认才是最具成本效益的检测策略。

结论

尽管“全部治疗”策略最具成本效益,但由于担心抗生素耐药性(这无法纳入模型)以及在非链球菌感染儿童中发现的过敏反应发生率较高,因此不推荐使用。在预防链球菌性咽炎的化脓性和非化脓性并发症方面,使用高灵敏度抗原检测且不对所有阴性结果进行培养确认是使用诊断检测的最具成本效益的策略。在美国目前所见的任何情况下,对高灵敏度抗原检测阴性结果进行培养确认都不具有成本效益。

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