伊曲康唑与碘化钾治疗孢子丝菌病的临床观察与对照研究

发布时间：2018-08-28 14:31

【摘要】：背景：孢子丝菌病是一种常见的深部真菌病,致病菌是双相申克孢子丝菌,本病分布于世界各地,在我国东北地区较流行,近年来发病率有增高趋势。对于本病的治疗,国内首选KI,但其局限性影响了在临床上的应用,ITC为欧美治疗本病的一线用药,但目前仍然没有大样本的前瞻性随机对照试验对ITC和KI的治疗疗效进行评估和比较,也缺乏设计良好的评价KI疗效的临床试验。目的：明确ITC与10%KI溶液治疗皮肤型孢子丝菌病的起效时间、疗效及安全性,并将两者进行比较分析。从而评价这两种药物的临床应用价值。方法：本研究采用前瞻性、随机分组对照的研究方法,研究对象选自2010年1月～7月在我院皮肤科经真菌培养阳性明确诊断为皮肤型孢子丝菌病,并通过纳入及排除标准筛选的81例患者。按照随机数字表法分为ITC组和KI组,ITC组给予ITC100mg日二次口服,KI组给予10%KI溶液10ml日三次口服,统一表格登记患者信息。比较两组疗法的起效时间、治疗效果和不良反应发生情况。对于计量资料采用t检验,计数资料采用Fisher确切概率法。结果：81例患者中,ITC组纳入41例,完成治疗36例,治疗失败1例,脱落4例；KI组纳入40例,完成治疗39例,脱落1例。总治疗患者数76例,总计脱落5例,脱落率：6%。 (1)一般情况：男性28例(36.8%),女性48例(63.2%)；平均年龄45.5±12.8岁；病程20天～5年,平均为7.5±8.9月；固定型34例(44.7%),淋巴管型42例(55.3%)。两组患者一般情况的各个方面均无显著性差异(p0.05)。 (2)起效时间：ITC组6例(16.2%)在7日内起效,11例(29.7%)在8～15日起效,5例(13.5%)在16～30日起效,1例(2.7%)在31～60日起效；KI组16例(41.0%)在7日内起效,2例(5.1%)在8～15日起效,1例(2.6%)在16～30日起效。ITC组较KI组起效慢。 (3)疗效：ITC组治愈36例,平均疗程2.36±0.91月,3个月治愈率86.5%,6个月治愈率97.3%；KI组治愈39例,平均疗程1.97±0.79月,3个月治愈率94.9%,6个月治愈率100%。两组疗程的差别无统计学意义(p0.05)。两组疗法3个月及6个月治愈率均无显著差异(p0.05)。 (4)不良反应：ITC组不良反应主要以头痛、胃部不适为主,不良反应发生率16.2%；KI组不良反应主要以面部浮肿、感冒样症状为主,不良反应发生率30.8%。两组不良反应发生率无显著差异(p0.05)。结论： (1)ITC和KI治疗皮肤型孢子丝菌病安全有效 (2)ITC与KI治疗孢子丝菌病的疗效、不良反应无差异 (3)ITC起效较KI慢
[Abstract]:Background: spore filariasis is a common deep mycosis, which is caused by biphasic schenck spore filariasis, which is distributed all over the world and is prevalent in Northeast China. The incidence of spore mycosis is increasing in recent years. For the treatment of this disease, KI, is the first choice in China, but its limitation has affected the clinical application of KI, as a first-line drug for the treatment of this disease in Europe and the United States. However, there is still no prospective randomized controlled trial with a large sample to evaluate and compare the efficacy of ITC and KI, and there is no well-designed clinical trial to evaluate the efficacy of KI. Objective: to determine the time, efficacy and safety of ITC and 10%KI in the treatment of dermatocystis. The clinical application value of these two drugs was evaluated. Methods: a prospective, randomized and controlled study was carried out in our dermatology department from January to July 2010. The patients were diagnosed as dermatocystis from January to July 2010. 81 patients were selected by inclusion and exclusion criteria. According to the random digital table method, the ITC group and the KI group were divided into two groups: the ITC100mg group and the KI group were given the 10%KI solution 10ml three times a day, and the information of the patients was registered in a unified form. The onset time, therapeutic effect and adverse reaction of the two groups were compared. T test is used for measurement data and Fisher exact probability method is used for counting data. Results among the 81 cases, 41 cases were included in the control group, 36 cases completed the treatment, 1 case failed in the treatment, 40 cases in the KI group, 39 cases in the control group, and 1 case in the control group. The total number of patients in treatment was 76, with a total loss of 5 cases. (1) General conditions: male 28 (36.8%), female 48 (63.2%), mean age 45.5 卤12.8 years, course of disease 20 days to 5 years, mean 7.5 卤8.9 months; 34 cases were fixed type (44.7%), 42 cases were lymphatic type (55.3%). There was no significant difference between the two groups in all aspects of general condition (p0. 05). (2). 6 cases (16. 2%) of the two groups were effective within 7 days, 11 cases (29. 7%) were effective within 7 days, 5 cases (13. 5%) were effective from 8 to 15 days and 1 case (2. 7%) from 16 to 30 days. In KI group, 16 cases (41.0%) were effective within 7 days (5.1%), 1 case (2.6%) in 8-15 day group, and 1 case (2.6%) in 16-30 day group. (3) 36 cases were cured in the control group, the average course of treatment was 2.36 卤0.91 months, the cure rate in 3 months was 86.5 and the cure rate in 6 months was 97.3B. 39 cases were cured in KI group, the average course of treatment was 1.97 卤0.79 months, the cure rate was 94.9 in 3 months and 100 in 6 months. There was no significant difference in the course of treatment between the two groups (p0.05). There was no significant difference in the cure rate between the two groups at 3 and 6 months (p0. 05). (4). The main adverse reactions of the two groups were headache and stomach discomfort, and the incidence of adverse reactions was mainly facial edema in the 16. 2% KI group, and there was no significant difference in the cure rate between the two groups (p0. 05). (4). The incidence of adverse reactions was 30.8%. There was no significant difference in the incidence of adverse reactions between the two groups (p 0.05). Conclusion: (1) ITC and KI are safe and effective in the treatment of dermatocystis. (2) there is no difference in the efficacy of ITC and KI in the treatment of spore mycosis. (3) the onset of ITC is slower than that of KI.
【学位授予单位】：吉林大学
【学位级别】：硕士
【学位授予年份】：2011
【分类号】：R756.6

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