Prasad K, Haines T
Department of Neurology, All India Institute of Medical Sciences, New Delhi.
J Neurol Neurosurg Psychiatry. 1995 Jul;59(1):31-7. doi: 10.1136/jnnp.59.1.31.
A methodological appraisal of the published randomised controlled trials on the use of dexamethasone as an adjunct treatment in acute bacterial meningitis was carried out to examine whether the available evidence is strong enough to support the routine use of the drug. Studies were eligible for inclusion if they were published in indexed journals after 1966, written in English, and were randomised controlled trials with dexamethasone as adjunct to antimicrobials in patients with acute bacterial meningitis. All studies were extracted and their adherence to eight methodological principles was graded as adequate, inadequate, or unclear. A sensitivity analysis was done to examine the robustness of the conclusions. Seven studies met the eligibility criteria. No report adhered to all the principles. Major threats to validity of the conclusions included potential bias in analysis in all the studies, and lack of adjustment for baseline imbalances in four. Inadequate reporting of adverse effects hindered risk-benefit analysis. Sensitivity analysis showed that the numbers of patients withdrawn from analysis were enough to invalidate the conclusions. It is concluded that the available evidence is not strong enough to support a routine use of dexamethasone in acute bacterial meningitis. Further research is needed to determine the effect of a policy to use dexamethasone early in the management of suspected acute bacterial meningitis. Future studies should adopt a pragmatic approach, be methodologically rigorous, and meticulously measure the risk as well as the benefit of this policy.
对已发表的关于地塞米松作为急性细菌性脑膜炎辅助治疗的随机对照试验进行了方法学评估,以检验现有证据是否足以支持该药物的常规使用。如果研究在1966年之后发表于被索引的期刊、用英文撰写,并且是将地塞米松作为急性细菌性脑膜炎患者抗菌药物辅助治疗的随机对照试验,则符合纳入条件。提取了所有研究,并将它们对八项方法学原则的遵循情况评为充分、不充分或不清楚。进行了敏感性分析以检验结论的稳健性。七项研究符合纳入标准。没有报告遵循所有原则。结论有效性的主要威胁包括所有研究中分析存在潜在偏倚,以及四项研究中未对基线不平衡进行调整。不良反应报告不充分妨碍了风险效益分析。敏感性分析表明,从分析中剔除的患者数量足以使结论无效。得出的结论是,现有证据不足以支持在急性细菌性脑膜炎中常规使用地塞米松。需要进一步研究以确定在疑似急性细菌性脑膜炎管理中早期使用地塞米松这一策略的效果。未来的研究应采用务实的方法,在方法上严谨,并仔细衡量该策略的风险和益处。