肤癣洗剂水提和醇提液治疗马拉色菌皮肤病的随机对照研究

Treatment of Malassezia dermatosis by Fuxuan Lotion prepared by water extraction and alcohol extraction: A randomized controlled study

目的:评价肤癣洗剂水提和醇提液治疗马拉色菌皮肤病患者的有效性和安全性。方法:将218例马拉色菌皮肤病患者按照随机对照、双盲原则分为水提组109例、醇提组109例,分别给予肤癣洗剂水提液和醇提液治疗,每次取药液0.04g/cm2在患处局部涂抹并搓揉1min,每日2次,疗程4周。观察记录两组患者治疗后的临床疗效和不良反应。结果:用药4周后醇提组有效率优于水提组(P<0.001)。花斑癣用药4周后醇提组有效率均优于水提组(P<0.05)。头部脂溢性皮炎用药2周后水提组有效率优于醇提组(P<0.05),用药4周后醇提组有效率优于水提组(P<0.001)。醇提组和水提组治疗后镜检阳性率均优于治疗前(P<0.001)。结论:肤癣洗剂的醇提和水提液治疗马拉色菌相关皮肤病安全、有效,但两种不同工艺下的提取物的起效过程不尽相同,可根据临床需要作适当选择。

Objective： To evaluate the efficacy and safety of Fuxuan Lotion prepared by water extraction and alcohol extraction in the treatment of Malassezia dermatosis. Methods： A total of 218 cases of Malassezia dermatosis were randomly divided by random number table method into two groups, 109 cases in water extraction group, and 109 cases in alcohol extraction group. The treatment of the water extraction group treated by Fuxuan Lotion prepared by water extraction and the alcohol extraction group were treated by Fuxuan Lotion prepared by alcohol extraction. Both groups treated with 0.04 g/cm2 of those drugsin affected area, and then rubbed for 1 minute, twice a day, last for 4 weeks. The clinical efficacy and adverse reactions of the two groups were observed. Results： After 4 weeks treatment, the efficiency of the alcohol group was better than that of the water group（P0.001）. The effective rate of the alcohol group was better than that of the water group in treating tinea versicolor for 4 weeks（P0.05）. After 2 weeks of treatment of the head seborrheic dermatitis, the water extract group was more effective than the alcohol group（P0.05）, but after 4 weeks, the effective rate of the alcohol group was better than that in the water group（P0.001）. The positive rate of microscopy after treatment was better in the alcohol group and the water group than before the treatment（P0.001）. Conclusion： It is safe and effective to treat Malassezia dermatosis with the Fuxuan Lotion both in alcohol extraction and water extraction. But the effectual procedure in these two different techniques is not the same, appropriate choice can be made according to the clinical need.