Gotzsche P C, Johansen H K
The Nordic Cochrane Centre, Rigshospitalet, Blegdamsvej 9, Copenhagen O, Denmark, 2100.
Cochrane Database Syst Rev. 2000(2):CD000026. doi: 10.1002/14651858.CD000026.
Systemic fungal infection is considered to be an important cause of morbidity and mortality in cancer patients, particularly those with neutropenia. Antifungal drugs are often given prophylactically, or to patients with persistent fever.
The objective of this review was to assess the effect of antifungal drugs in cancer patients with neutropenia.
We searched the Cochrane Controlled Trials Register (October 1997), MEDLINE (to September 1997) and the reference lists of articles. We searched the proceedings of the ICAAC, General Meeting of the ASM (from 1990 to 1995), and the 7th European Congress of Clinical Microbiology and Infectious Diseases (1995) and contacted researchers in the field.
Randomised trials of amphotericin B, AmBisome, fluconazole, ketoconazole, miconazole, or itraconazole compared with placebo or no treatment in cancer patients with neutropenia.
Two reviewers independently assessed trial eligibility, methodological quality and abstracted data.
Twenty-five trials involving 2912 patients were included. In 19 trials, prophylactic or later treatment with antifungal drugs had no effect on mortality (odds ratio 0.92, 95% confidence interval 0.75 to 1.14). Only amphotericin showed a significant benefit (odds ratio 0.58, 95% confidence interval 0.37 to 0.93) based on seven trials, but the studies were small and the difference in number of deaths was only 15. Overall it would be necessary to treat 59 patients (95% confidence interval 37 to 131) with an antifungal drug to prevent one case of fungal invasion in surviving patients, although only amphotericin and fluconazole showed a clear beneficial effect. Antifungal treatment decreased fungal colonisation and the need for additional antifungal therapy, but there was heterogeneity across the trials.
REVIEWER'S CONCLUSIONS: Routine prophylactic or later therapy with antifungal drugs in cancer patients with neutropenia does not appear to have a beneficial effect on mortality and only a modest effect on fungal invasion.
系统性真菌感染被认为是癌症患者发病和死亡的重要原因,尤其是那些中性粒细胞减少的患者。抗真菌药物通常用于预防性给药,或用于持续发热的患者。
本综述的目的是评估抗真菌药物对中性粒细胞减少的癌症患者的疗效。
我们检索了Cochrane对照试验注册库(1997年10月)、MEDLINE(至1997年9月)以及文章的参考文献列表。我们检索了美国微生物学会年会(1990年至1995年)和第七届欧洲临床微生物学与传染病大会(1995年)的会议记录,并联系了该领域的研究人员。
在中性粒细胞减少的癌症患者中,将两性霉素B、安必素、氟康唑、酮康唑、咪康唑或伊曲康唑与安慰剂或不治疗进行比较的随机试验。
两名评价员独立评估试验的合格性、方法学质量并提取数据。
纳入了25项涉及2912名患者的试验。在19项试验中,抗真菌药物的预防性或后期治疗对死亡率没有影响(优势比0.92,95%置信区间0.75至1.14)。基于7项试验,只有两性霉素显示出显著益处(优势比0.58,95%置信区间0.37至0.93),但研究规模较小,死亡人数差异仅为15例。总体而言,需要用抗真菌药物治疗59名患者(95%置信区间37至131)才能预防1例存活患者发生真菌感染,尽管只有两性霉素和氟康唑显示出明显的有益效果。抗真菌治疗减少了真菌定植以及额外抗真菌治疗的需求,但各试验之间存在异质性。
在中性粒细胞减少的癌症患者中,常规预防性或后期使用抗真菌药物治疗似乎对死亡率没有有益影响,对真菌感染仅有适度影响。