氟康唑治疗全身真菌病随机双盲对照研究

FLUCONAZOLE VERSUS KETOCONAZOLE IN SYSTEMIC FUNGAL INFECTION: A DOUBLE BLIND RANDOMIZED STUDY

为观察国产氟康唑对全身性真菌病的临床疗效和安全性，采用国产氟康唑与酮康唑随机双盲对照和开放治疗全身真菌病共２２２例，其中随机双盲对照试验１２４例，包括氟康唑组６４例，酮康唑组６０例；开放组９８例。氟康唑治疗根据病情分首剂４００ｍｇ及２００ｍｇ，以后２００ｍｇ及１００ｍｇ，每日１次，疗程１～８周；阴道真菌病１５０ｍｇ单剂；酮康唑每次２００ｍｇ，每天２次，疗程１～８周，阴道真菌病疗程５天。氟康唑和酮康唑治疗深部真菌病的痊愈率和有效率分别为７５．０％、４４．４％和８９．３％、６６．７％，两组差异有显著性（Ｐ＜０．０１），但两组浅部真菌病疗效差异无显著性（Ｐ＞０．０５）；氟康唑组和酮康唑组总的痊愈率分别为８１．３％（５２／６４）和５８．０％（３５／６０），疗效差异有显著性（Ｐ＜０．０５）。开放试验痊愈率和有效率各为８５．７％和９５．９％。氟康唑１６２例总的痊愈率为８４．０％，有效率为９５．１％。真菌培养阳性率为１００．０％，真菌清除率氟康唑和酮康唑分别为８５．７％和７０．０％，清除率差异无显著性，开放组清除率为９２．９％。不良反应发生率氟康唑和酮康唑分别为３．１％及５．０％，两组差异无显著性，开放组为６．１％。本结?

We carried out a multiple center study, including a double blined randomized clinical trial on fluconazole (Flu, group A) and ketoconazole (Keto, group B) and an open trial on Flu only for evaluating the efficacy and safety of Flu in treating deep and shallow fungal infection. 222 patients participated in the study and most of them had severe underlying diseases. The dosage and therapeutic duration were as follows: Flu 200～400mg daily for 1～8 weeks in 34 patients with fungal infection and 150mg as a single dose in 30 patients with fungal vaginitis; Keto 400mg daily for 1～8 weeks in 30 patients with fungal diseases and for 5 days in 30 patients with fungal vaginitis. In the trial 124 patients were randomized to receive either Flu (64 patients) or Keto (60). The cure rate in group A and B was 81.3% (52/64) and 58.0% (35/60) respectively ( P <0.05). The fungal eradication rates of the two groups were 85.7% and 70.0% ( P >0.05) respectively. 98 patients entered the open trial. They included fungal infection of the respiratory tract and urinary tract, cryptococal meningitis, fungal sepesis and systemic dissemination of mycosis and fungal vaginitis. 84 (85.7%) were cured. The fungal eradication rate of this group was 92.9%. The side effect rates of the three groups were 3.1%(2/64), 5.0%(3/60) and 6.1%(6/98) res pectively. They were mild and transient vomiting, nausea, and anorexia. In group B and the open group however, there was one case of ALT elevation in each group ( P >0.05). This study suggests that Flu is a safe, effective and useful drug for the treatment of severe fungal infection.