氟康唑预防极低出生体重儿侵袭性真菌感染疗效和安全性的Meta分析

Efficacy and safety of fluconazole in prophylaxis of invasive fungal infections in very low birth weight infants: a Meta analysis

摘要:

目的 系统评价使用氟康唑预防极低出生体重儿（VLBWI）侵袭性真菌感染的疗效和安全性，为临床更好地预防性使用氟康唑提供依据。方法 计算机检索PubMed、Embase、Cochrane图书馆、万方数据库、中国科技期刊数据库（维普）和中国知网，纳入VLBWI预防性使用氟康唑的随机对照试验（RCT）研究。采用Review Manager 5.3统计软件对符合纳入标准的临床研究进行Meta分析。结果 共纳入12篇RCT研究，合计1 679例VLBWI。Meta分析结果显示：试验组（使用氟康唑）侵袭性真菌感染的发生率显著低于安慰剂对照组（RR=0.44，95% CI：0.27~0.71，P < 0.001）；真菌定植率低于对照组（RR=0.31，95% CI：0.24~0.40，P < 0.001）；住院期间病死率低于对照组（RR=0.74，95% CI：0.58~0.94，P=0.01）。使用不同预防剂量氟康唑的两组侵袭性真菌感染发生率和真菌定植率比较差异均无统计学意义（P > 0.05）；耐药情况及并发症发生率在试验组和对照组组间比较差异均无统计学意义（P > 0.05）。结论 氟康唑预防VLBWI侵袭性真菌感染有效且相对安全。小剂量给药可取得类似预防效果。

Abstract:

Objective To assess the efficacy and safety of fluconazole in the prophylaxis of invasive fungal infection in very low birth weight (VLBW) infants. Methods Databases including PubMed, Embase, the Cochrane Library, Wanfang Data, Weipu, and CNKI were searched for randomized controlled trials (RCTs) of prophylactic fluconazole in VLBW infants. Review Manager 5.3 software was used to perform a Meta analysis of the included studies. Results A total of 12 RCTs were included, involving 1 679 VLBW infants. The Meta analysis showed that prophylactic fluconazole significantly reduced the incidence of invasive fungal infection (RR=0.44, 95%CI:0.27-0.71, P < 0.001), the incidence of fungal colonization (RR=0.31, 95%CI:0.24-0.40, P < 0.001), and the mortality during hospitalization (RR=0.74, 95%CI:0.58-0.94, P=0.01) compared with the control group. There were no significant differences between VLBW infants using different doses of fluconazole in the incidence of invasive fungal infection and fungal colonization (P > 0.05). No significant differences were found in the incidence of fluconazole resistance and complications between the fluconazole and control groups (P > 0.05). Conclusions Prophylactic fluconazole can effectively and safely prevent invasive fungal infection in VLBW infants, even at a small dose.