小剂量两性霉素B治疗恶性血液病侵袭性真菌感染的效果观察

Efficacy of low dose amphotericin B for treating invasive fungal infection in hematologic malignancies

目的探讨小剂量两性霉素B治疗恶性血液病侵袭性真菌感染的有效性及安全性。方法我院2008年1月至2012年6月接受治疗的恶性血液病合并侵袭性真菌感染患者98例，应用计算机随机分为对照组和实验组，对照组47例，两性霉素B维持剂量为50—60mg／d；实验组51例，两性霉素B维持剂量为25—30mg／d。比较两组的疗效和不良反应发生率。结果两性霉素B中位累计剂量对照组为725（175，1595）mg，实验组为735（225，1485）mg，差异无统计学意义（P=0．834）；治疗中位时间对照组为19（8，34）d，实验组为29（11，58）d，差异有统计学意义（P=0．000）。治疗14d对照组与实验组可评估疗效者分别为37例和48例，两组总有效率、无进展率、热退率差异均无统计学意义（P均〉0．05）。因不良反应终止治疗者对照组14例（29．8％），实验组6例（11．8％），差异有统计学意义（P=0．027）；对照组肝肾功能损害发生率高于实验组[27．7％（13／47）与11．8％（6／51），P=0．047]。结论两性霉素B维持剂量25～30mg／d临床疗效不低于维持剂量50～60mg／d，不良反应少，临床可操作性强，具有可实践性。

Objective To investigate the efficacy and safety of low dose amphotericin B for treating invasive fungal infection （IFI） in hematologic malignancies . Methods Ninety-eight patients with hematologic diseases who visited our hospital from January 2008 to June 2012 were randomly divided into the control group （ n = 47 ） and the treatment group （ n -- 51 ）. Patients in the control group were treated with amphotericin B, 50 - 60 mg per day and patients in treatment group were given amphotericin B, 25 - 30 mg per day. Clinical efficacy and side effects were compared between the two groups. Results There was no significant difference on the median cumulative dose between the control group and the treatment group（725 （175, 1595 ） mg vs 735 （225, 1485） mg,P = 0. 834）. But there was significant difference on median treatment days between the control group and the treatment group（ 19 （8,34） d vs 29 （ 11,58 ） d, P = 0. 000）. After treatment for 14 days, the patients who can be evaluated for efficacy were 37 and 48 cases respectively in the control group and in the treatment group, and there was no significant difference on the total efficacy rate, the rate of progress and the rate of fever between the control group and the treatment group （ all P 〉 0. 05 ）. There were 14 patients and 6 patients terminated treatment because of adverse reaction, and the difference was significant （29. 8% vs 11.8% ,P = 0. 027 ）. The side effect rates of hepatic and renal impairment in the control group was significantly higher than that in the treatment group （ 27. 7% （ 13/47 ） vs 11.8 % （6/51 ）, P = 0. 047 ）. Conclusion The efficacy of 25 - 30 mg per day＇s amphotericin B treatment is not lower than amphotericin B at 50 - 60 mg per day on IFI in hematologic malignancies. It is not only relatively safe and less expensive, but also operability and practicality in the treatment of IFI.