摘要
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.
出处
《中华内科杂志》
CAS
CSCD
北大核心
1997年第5期317-320,共4页
Chinese Journal of Internal Medicine