【摘要】：背景：孢子絲菌病是一種常見(jiàn)的深部真菌病,致病菌是雙相申克孢子絲菌,本病分布于世界各地,在我國(guó)東北地區(qū)較流行,近年來(lái)發(fā)病率有增高趨勢(shì)。對(duì)于本病的治療,國(guó)內(nèi)首選KI,但其局限性影響了在臨床上的應(yīng)用,ITC為歐美治療本病的一線用藥,但目前仍然沒(méi)有大樣本的前瞻性隨機(jī)對(duì)照試驗(yàn)對(duì)ITC和KI的治療療效進(jìn)行評(píng)估和比較,也缺乏設(shè)計(jì)良好的評(píng)價(jià)KI療效的臨床試驗(yàn)。 目的：明確ITC與10%KI溶液治療皮膚型孢子絲菌病的起效時(shí)間、療效及安全性,并將兩者進(jìn)行比較分析。從而評(píng)價(jià)這兩種藥物的臨床應(yīng)用價(jià)值。 方法：本研究采用前瞻性、隨機(jī)分組對(duì)照的研究方法,研究對(duì)象選自2010年1月～7月在我院皮膚科經(jīng)真菌培養(yǎng)陽(yáng)性明確診斷為皮膚型孢子絲菌病,并通過(guò)納入及排除標(biāo)準(zhǔn)篩選的81例患者。按照隨機(jī)數(shù)字表法分為ITC組和KI組,ITC組給予ITC100mg日二次口服,KI組給予10%KI溶液10ml日三次口服,統(tǒng)一表格登記患者信息。比較兩組療法的起效時(shí)間、治療效果和不良反應(yīng)發(fā)生情況。對(duì)于計(jì)量資料采用t檢驗(yàn),計(jì)數(shù)資料采用Fisher確切概率法。 結(jié)果：81例患者中,ITC組納入41例,完成治療36例,治療失敗1例,脫落4例；KI組納入40例,完成治療39例,脫落1例�？傊委熁颊邤�(shù)76例,總計(jì)脫落5例,脫落率：6%。 (1)一般情況：男性28例(36.8%),女性48例(63.2%)；平均年齡45.5±12.8歲；病程20天～5年,平均為7.5±8.9月；固定型34例(44.7%),淋巴管型42例(55.3%)。兩組患者一般情況的各個(gè)方面均無(wú)顯著性差異(p0.05)。 (2)起效時(shí)間：ITC組6例(16.2%)在7日內(nèi)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組16例(41.0%)在7日內(nèi)起效,2例(5.1%)在8～15日起效,1例(2.6%)在16～30日起效。ITC組較KI組起效慢。 (3)療效：ITC組治愈36例,平均療程2.36±0.91月,3個(gè)月治愈率86.5%,6個(gè)月治愈率97.3%；KI組治愈39例,平均療程1.97±0.79月,3個(gè)月治愈率94.9%,6個(gè)月治愈率100%。兩組療程的差別無(wú)統(tǒng)計(jì)學(xué)意義(p0.05)。兩組療法3個(gè)月及6個(gè)月治愈率均無(wú)顯著差異(p0.05)。 (4)不良反應(yīng)：ITC組不良反應(yīng)主要以頭痛、胃部不適為主,不良反應(yīng)發(fā)生率16.2%；KI組不良反應(yīng)主要以面部浮腫、感冒樣癥狀為主,不良反應(yīng)發(fā)生率30.8%。兩組不良反應(yīng)發(fā)生率無(wú)顯著差異(p0.05)。 結(jié)論： (1)ITC和KI治療皮膚型孢子絲菌病安全有效 (2)ITC與KI治療孢子絲菌病的療效、不良反應(yīng)無(wú)差異 (3)ITC起效較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 鹵12.8 years, course of disease 20 days to 5 years, mean 7.5 鹵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 鹵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 鹵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.
【學(xué)位授予單位】：吉林大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2011
【分類(lèi)號(hào)】：R756.6

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