国产伊曲康唑治疗念珠菌性阴道炎临床观察

目的　观察国产伊曲康唑治疗念珠菌性阴道炎的临床疗效。方法　口服国产伊曲康唑胶囊 2 0 0mg ,1次 /d ,共 3天 ,治疗 99例念珠菌性阴道炎患者 ,观察其治疗前后症状评分变化。结果　痊愈率 81.82 %例 ,有效率90 .91%。结论　国产伊曲康唑可有效治疗念珠菌性阴道炎 ,无明显不良反应。     

伊曲康唑在中国的应用：十年临床经验回顾

评价适合于中国人的伊曲康唑治疗方案。方法：复习10年来在中文期刊发表的有关报告。结果：伊曲康唑每日100mg，连用14d的方案治疗体股癣最好，每口200mg连用7天是治疗花斑癣的最好方案，而每日400mg，连用7d的方案治疗手足癣的疗效最好。每日400mg，连用7d间歇冲击疗法对甲真菌病效果最佳。伊曲康唑对念珠菌病和深部真真菌的疗效确切。安全性和依从性亦很好。结沦：伊曲康唑在中国人中的应用安全有效。     

伊曲康唑与氟康唑治疗66例复发性念珠菌阴道炎疗效比较

目的：了解应用伊曲康唑与氟康唑治疗复发性念珠菌阴道炎的临床疗效。方法：66例临床确诊为念珠菌阴道炎,随意分类两组：伊曲康唑组：200mg,每日一次,连续3天为一疗程,氟康唑组：100mg,每日一次,连续3天为一疗程,两组均连续治疗三个月共3个疗程。结果：伊曲康唑组,治疗后1、4、8、12周的总有效率分别为：85．3％、88．2％、91．2％、91．2％,氟康唑组治疗后1、4、8、12周的总有效率分别为81．3％、87．5％、78．1％、75．0％。治疗后1、4、8、12周两种药物治疗的总有效率相比差异无显性（P＞0．05）,但伊曲康唑治疗后第8、12周的复发率远低于氟康唑治疗组。结论：伊曲康唑与氟康唑治疗复发性念珠菌阴道炎均有较好的疗效,其远期疗效伊曲康唑优于氟康唑。     

特比萘芬与伊曲康唑治疗念珠菌性阴道炎疗效比较

目的：比较特比萘芬与伊曲康唑治疗念珠菌性阴道炎的疗效。方法：134例患分为两组，治疗组作真菌镜检及培养，A组口服特比萘芬0．25g，1次／d，连服7d，B组口服伊曲康唑0．2g，1次／d，连服7d；停药时、停药2周后复诊、作真菌镜检，判定疗效。结果：A组停药时及2周后有效率分别为79．4％，85．3％；B组停经时及2周后有效率分别为81．8％，83．3％，两组比较有效率无显性差异(P＞0．05)。结论：特比萘芬与伊曲康唑均对念珠菌性阴道炎有较好的疗效。     

伊曲康唑4周疗法治疗儿童头癣128例临床疗效观察

目的：了解伊曲康唑治疗儿童头癣的疗效与安全性。方法：采用伊曲康唑治疗128例头癣患儿，4岁以上的剂量为100mg／d，4岁以下剂量为50mg／d，晚餐后服用，连续服用4周。结果：128例患儿在疗程结束后4周的痊愈率为80．47％。所有患儿服药期间均未出现不良反应。结论：伊曲康唑4周疗法治疗儿童头癣疗效确切，安全性好。     

国产伊曲康唑治疗皮肤浅部真菌病216例疗效观察

为观察国产伊曲康唑（美扶）治疗浅部真菌病的疗效。选择216例皮肤浅部真菌病患者，均口服美扶治疗，其中手足癣组口服美扶200mg，bid，连服7天；其余各组口服美扶200mg，qd，连服7天。停药3周评价疗效。结果：手足癣、体股癣、花斑癣、马拉色菌毛囊炎、念珠菌性包皮龟头炎和念珠菌性阴道炎总有效率分别为94．12％、97．47％、95．65％、81．25％、100％、81．25％。国产伊曲康唑治疗浅部真菌病疗效好、经济而安全。     

特比萘芬与伊曲康唑序贯疗法治疗复发性念珠菌性阴道炎疗效观察

为探索复发性念珠菌性阴道炎更有效治疗方法,按就诊次序收集病例,随机分为治疗组、对照1组、对照2组.治疗组给予特比萘芬250 mg每日1次口服,连服7天,接着给予伊曲康唑200 mg每日1次口服,连服7天.对照1组给予特比萘芬250 mg每日1次口服,连服14天.对照2组给予伊曲康唑200 mg每日1次口服,连服14天.结果:治疗结束后第8周和第12周,治疗组的有效率和复发率显著优于对照1组、对照2组.特比萘芬与伊曲康唑序贯疗法治疗复发性念珠菌性阴道炎疗效高,复发率低.     

伊曲康唑治疗不同免疫状态下小鼠白念珠菌性阴道炎的实验研究

目的：研究不同免疫状态下伊曲康唑治疗小鼠白念珠菌性阴道炎的疗效。方法：构建ICR小鼠白念珠菌性阴道炎模型，并应用地塞米松构建免疫抑制鼠模型；采用伊曲康唑灌服治疗；其中F组同时采用γ-IFN治疗，在灌药后不同时间动态观察阴道灌洗液真菌载量。结果：伊曲康唑治疗正常免疫组（A组）与对照组（D组）之间的疗效差异有显著性（P〈0．01）；免疫抑制组（E组）及免疫抑制后并进行免疫调节治疗组（F组）与对照组（G组）之间差异均有显著性（P〈0．01）；而A、E、F组在接种后的第5、6、7、9、11天其阴道灌洗液真菌载量无明显差异（P〉0．05）。结论：伊曲康唑治疗不同免疫状况（即正常免疫、免疫抑制、免疫调节治疗状态下）的小鼠白念珠菌性阴道炎疗效均显著，而且正常免疫、免疫抑制及免疫增强状态下对伊曲康唑的抗真菌疗效无明显影响。     

伊曲康唑与特比萘芬治疗念珠菌性慢性前列腺炎附睾炎的疗效观察

目的 对性病治疗后有慢性前列腺炎附睾炎的673例患者做精液或前列腺液的真菌培养，发现45例念珠菌感染，占6．69％，给予伊曲康唑及特比萘芬治疗并进行临床观察。方法 采用科玛嘉定位显色真菌培养，对念珠菌阳性患者随机分为2组，1组口服伊曲康唑200mg，每日1次，连服14d，2组口服特比萘芬250mg，每日1次，连服14d。结果 45例念珠菌阳性者中，光滑念珠菌2l例，白念珠菌16例，热带念珠菌5例，克柔念珠菌3例。随机分组治疗后，1组临床总有效率为82．6l％，2组临床总有效率为86．36％，1组真菌学治愈率为78．26％，2组真菌学治愈率为72．73％，两组临床有效率及真菌学治愈率经卡方检验差异无显著性。结论 念珠菌是性病治疗后慢性前列腺炎附睾炎的致病原因之一，伊曲康唑和特比萘芬可作为治疗念珠菌性慢性前列腺炎附睾炎的有效和安全药物。     

重组人粒细胞巨噬细胞集落刺激因子与伊曲康唑联合对白念珠菌抗菌作用的实验研究

目的 研究重组人粒细胞巨噬细胞集落刺激因子(rhGM-CSF)与伊曲康唑联合抗白念珠菌的作用。方法 体内实验:制备系统性白念珠菌感染小鼠模型,用不同剂量伊曲康唑单独或与rhGM-CSF联合应用于感染小鼠,观测其28d内的存活情况。体外实验:分离鼠外周血中性粒细胞及腹腔巨噬细胞,分别将其与不同浓度的伊曲康唑及伊曲康唑加rhGM-CSF与白念珠菌共同培养,通过计数菌落形成单位(cfu)来判定伊曲康唑单独或与rhGM-CSF联合应用的抗白念珠菌效果。结果 伊曲康唑1.0mg/kg与rhGM-CSF25μg/kg联合应用能显著延长小鼠28d内的存活期,效果与单用伊曲康唑2.5mg/kg相等,而rhGM-CSF25μg/kg与伊曲康唑5mg/kg联合应用时效果相当于单用伊曲康唑10mg/kg。体外实验亦显示rhGM-CSF与伊曲康唑联用能减少白念珠菌数量。结论 rhGM-CSF与伊曲康唑联合应用对抗小鼠系统性白念珠菌感染有较好的协同作用。     

Itraconazole in the Treatment of Two Young Brothers with Chronic Mucocutaneous Candidiasis

Abstract: We report on two children affected by chronic mucocutaneous candidiasis involving the mouth and all the nails who were successfully treated with itraconazole at 200 mg/day for 2 months. This therapy produced a rapid cure of both candidal nail and mouth infections. The drug was very well tolerated, and routine laboratory monitoring during treatment did not reveal any abnormalities.     

特比萘芬治疗念珠菌性外阴阴道炎疗效和安全性评价

目的观察特比萘芬治疗念珠菌性外阴阴道炎的疗效及安全性。方法选择本院念珠菌性外阴阴道炎患者,随机分为治疗组34例,口服特比萘芬250mg,1次/d;对照组31例,口服伊曲康唑200mg,1次/d。两组均连用10天。结果治疗组和对照组有效率分别为67.65%和87.10%,真菌清除率分别为82.35%和83.87%,两组有效率和真菌清除率比较差异均无显著性意义(P均>0.05)。结论口服特比萘芬治疗念珠菌性外阴阴道炎疗效肯定,安全性高。     

Treatment of head and neck dermatitis comparing itraconazole 200 mg and 400 mg daily for 1 week with placebo

BACKGROUND: Head and neck dermatitis (HND) is a variant of atopic dermatitis often seen in young adults. A hypersensitivity to Malassezi antigens is considered to be of pathogenic importance. Previous mostly uncontrolled studies have shown that oral antimycotics might be of use in this condition. OBJECTIVE: To evaluate the efficacy of itraconazole in the treatment of HND in a randomized, double-blind, placebo-controlled trial. PATIENTS: Adult patients with HND were included. Systemic steroids and oral/topical antimycotics were avoided 1 and 2 months prior to the trial. Topical steroids were not allowed in the head and neck area within 2 weeks. Patients in generally good health were included and female patients had to have had a negative urine pregnancy test. The patients signed an informed consent. STUDY DESIGN: The study included a 7-day treatment period and a follow-up period of 105 days. Control visits were carried out on days 3, 7 and 14 and after 15 weeks. METHODS: The SCORAD index (one for the head and neck area and one for the remaining surface area) and global evaluations by patient and investigator were used for clinical evaluation at each visit. Prick tests with Malassezia antigens and Candida albicans antigen were carried out at the start of the trial and included positive and negative controls. The patients were randomized into three groups, which were treated with 400 mg itraconazole daily, 200 mg itraconazole daily or placebo, respectively, for 7 days. RESULTS: The number of patients included was 53: 18 had 200 mg itraconazole daily, 17 had 400 mg itraconazole daily and 18 placebo. At days 7 and 14, significant improvement was seen in the SCORAD of the head and neck area for the groups given 400 mg itraconazole daily (P = 0.0385 and P = 0.0134), and 200 mg daily (P = 0.0104 and P = 0.0006). Patients in the placebo group improved slightly (P = 0.0785). At day 14, comparison of improvement of SCORAD of the head and neck area between all three groups showed a significant difference in favour of the 200 mg itraconazole group compared to the placebo group (P = 0.0318). The prick test was positive for Pityrosporum ovale in 37% and negative for C. albicans in all patients. CONCLUSIONS: One week of treatment with 200 or 400 mg itraconazole as a single treatment has a significant effect on the head and neck area. Compared to placebo there was a significant improvement in SCORAD of the head and neck area in favour of the 200 mg itraconazole group after 14 days. The important observation seems to be that antifungal systemic treatment has a significant SCORAD reduction of atopic dermatitis, irrespective of the presence of allergy.     

An evaluation of itraconazole in the management of onychomycosis

At present the reported use of itraconazole, a new oral triazole antifungal, has been confined to short-term treatments. This investigation is an appraisal of itraconazole in the treatment of three different forms of onychomycosis. Six patients with nail infections due to Candida albicans not associated with paronychia affecting a total of 20 nails received itraconazole (100 mg daily) for a mean period of 5.9 months. Complete remission was achieved in all cases. Twenty six patients with dermatophyte onychomycosis affecting a total of 45 finger and 80 toe-nails were treated with itraconazole (100-200 mg daily). In 24 cases the causative organism was Trichophyton rubrum. Remission was achieved in 64% of finger and 73% of toe-nails in 5 and 9.4 months, respectively. Treatment failures were experienced in patients with finger-nail infections due to T. violaceum (I) and those concurrently receiving phenytoin and phenobarbitone (3). Three patients with infections due to Hendersonula toruloidea failed to respond to treatment. Adverse effects were experienced by four patients (abdominal discomfort 3, diarrhoea I), but none were serious enough to lead to abandonment of treatment. No persistent changes were seen in serum biochemical values. This study suggests that itraconazole is potentially effective in the long-term treatment of superficial fungal infections such as onychomycosis, and comparative studies with alternatives such as griseofulvin should now be carried out.     

Therapeutic efficacy and safety of one-week intermittent therapy with itraconazole for onychomycosis in a Chinese patient population.

OBJECTIVE: To evaluate the efficacy and safety of a 1-week intermittent itraconazole dosing schedule for onychomycosis. METHODS: In this multicenter, open-label study, 646 patients received itraconazole 200 mg twice daily for 1 week/month, followed by 3 weeks without therapy. Patients with fingernail infections received 2 treatment cycles, patients with toenail or combined toenail and fingernail infections received 3 cycles. Efficacy was evaluated at week 9 (2-month regimen), week 13 (3-month regimen) and 3, 6 or 9 (toenails only) months after completion of therapy. RESULTS: Clinical and mycologic cure rates for fingernails were greater than 90% 6 months after completion of 2 treatment cycles. Clinical and mycologic cure rates for toenails were 84 and 98%, respectively, 9 months after completion of 3 cycles. Treatment was well tolerated; adverse events (mostly mild) occurred in 4.6% of patients. CONCLUSION: A 1-week intermittent itraconazole dosing regimen is a safe and effective treatment for onychomycosis.     

Fluconazole and itraconazole in pityriasis versicolor

Pityriasis versicolor is a common superficial fungal infection caused by Malassezia species. It has a high incidence and prevalence in tropical climates. Although it responds well to treatment, relapses and recurrences are frequent. In the present study the therapeutic response of single dose fluconazole (400 mg) with itraconazole (100mg twice daily ? 7 days) was compared in sixty patients of pityriasis versicolor. No significant statistical difference (p>0.05%) was observed between efficacy of two drugs. Therapy with fluconazole is preferable in view of single dose administration and lesser cost as compared to itraconazole.     

Lack of in vitro resistance of Candida albicans to ketoconazole, itraconazole and clotrimazole in women treated for recurrent vaginal candidiasis.

OBJECTIVE--To determine whether in vitro resistance of Candida albicans to the imidazoles (ketoconazole, clotrimazole and itraconazole) is associated with recurrence of candida vaginitis. DESIGN--Candida isolates were collected before, during and after treatment from women with recurrent vaginal candidiasis (> or = 4 episodes/year), randomised into two prospective studies: (1) 56 women treated with ketoconazole 400 mg/daily for 7 days; (2) 44 women randomised to receive itraconazole 200 mg orally, or clotrimazole 200 mg intravaginally, twice weekly for six months. SETTING--Women's Candida Clinic at St. Michael's Hospital, a University of Toronto teaching Hospital, Toronto, Ontario, Canada. MAIN OUTCOME, MEASURES--Isolates of yeasts recovered pre and post treatment were tested for significant changes in 50% inhibitory concentration (IC50). Resistance was defined as a greater than fourfold increase in baseline IC50 of post treatment isolates compared with pretreatment isolates. RESULTS--Over 250 strains of C albicans were tested and none showed development of resistance to any of the agents. CONCLUSION--Recurrence of vaginal candidiasis is not related to the development of drug resistance.     

Oral itraconazole for the treatment of seborrhoeic dermatitis: an open, noncomparative trial

BACKGROUND: Seborrhoeic dermatitis is an inflammatory cutaneous disorder in which the colonization of the affected area by Malassezia has been proved to play a key role. OBJECTIVE: To perform a noncomparative open clinical study with oral itraconazole capsule (200 mg/day x 7 days) and consecutive usage 200 mg/day for the first 2 days of the following 2 months in patients with seborrhoeic dermatitis. METHODS: Twenty-nine patients were enrolled to determine the efficacy and safety of oral itraconazole. The patients were evaluated according to itching, burning, erythema, desquamation and seborrhoea, each scored on a 0-4 scale on days 15 (T15), 30 (T30), 60 (T 60) and 90 (T90). Itraconazole capsule 100 mg was given twice a day for 1 week and then, after a 3-week interval, patients used itraconazole capsule 200 mg/day for the first 2 days of the following 2 months. The clinical response was graded as markedly effective, effective, moderate or ineffective. RESULTS: A clinical improvement (evaluated as markedly effective or effective) was observed in 23 patients (83%) at T15, 21 (76%) at T30, 20 (72%) at T60 and 17 (61%) at T90. At baseline, the mean +/- SD total clinical scores were 10.44 +/- 2.45, 1.98 +/- 0.5, 2.97 +/- 1.12, 3.15 +/- 1.74 and 3.30 +/- 1.90 at T0, T15, T30, T60 and T90, respectively. Compared with baseline values, itraconazole capsule significantly reduced the mean +/- SD total score as well as individual erythema and desquamation (Wilcoxon's signed test-two tailed) (P < 0.0001). No drug-related systemic adverse event was observed during the study. CONCLUSIONS: Seborrhoeic dermatitis shows marked reduction in inflammation when treated with itraconazole. The anti-inflammatory activity of oral itraconazole and efficacy on Malessezia suggests that itraconazole capsule will be first oral treatment option in future in severe seborrhoeic dermatitis.     

Safety of itraconazole in diabetic patients.

BACKGROUND: Onychomycosis and dermatomycoses can result in serious complications in patients with underlying chronic diseases such as diabetes. To avoid these complications, these dermatological disorders need to be treated efficiently, for example with the triazole antifungal itraconazole. Itraconazole can inhibit the metabolism of drugs by CYP 3A4 and therefore might affect the efficacy of antidiabetic agents. OBJECTIVE: To investigate this, we assessed the safety of itraconazole in diabetic patients with onychomycosis or dermatomycoses. METHODS: We reviewed pharmacokinetic and safety data from clinical trials and postmarketing surveillance over the past 10 years. RESULTS: Postmarketing surveillance (a review of all adverse-event reports in patients receiving itraconazole concomitantly with insulin or an oral antidiabetic agent) revealed 15 reports suggestive of hyperglycemia and 9 reports suggestive of hypoglycemia; in most patients, no change in antidiabetic effect was reported. From clinical trials including a total of 189 diabetic patients treated with itraconazole for various infections (mainly systemic infections and vaginal candidiasis), only one itraconazole-related adverse event was recorded; this was a case of aggravated diabetes in a renal transplant recipient who was also receiving cyclosporine. Adverse effects due to drug-drug interactions are not expected in diabetic patients receiving oral antidiabetic agents that are not metabolized through the CYP 3A4 system (e.g. tolbutamide, gliclazide, glibenclamide, glipizide and metformin). CONCLUSION: Itraconazole can be used safely and efficiently for the treatment of dermatological disorders in diabetic patients.     

Efficacy of itraconazole in the prophylactic treatment of pityriasis (tinea) versicolor.

BACKGROUND: Pityriasis (tinea) versicolor has a high tendency to recur after being treated successfully. Prophylactic treatment to reduce recurrence is needed. OBJECTIVE: To determine whether recurrence of pityriasis versicolor could be prevented by prophylactic itraconazole treatment. DESIGN: Open treatment followed by a randomized, double-blind, placebo-controlled phase. SETTING: Multinational outpatient centers. PATIENTS: A total of 239 consecutive patients were included; 238 started open treatment. A total of 209 patients started prophylactic treatment: 106 in the itraconazole group and 103 in the placebo group. INTERVENTIONS: Open treatment: itraconazole, 200 mg once daily for 7 days. Prophylactic treatment: itraconazole, 200 mg, or placebo twice daily 1 day per month for 6 consecutive months. MAIN OUTCOME MEASURES: Mycological cure rates at the end of open treatment and at the end of prophylactic treatment. RESULTS: Mycological cure at the end of open treatment was 92% (205/223). At the prophylactic treatment end point (6 months), mycological cure was 88% (90/102) in the itraconazole group and 57% (56/99) in the placebo group (P<.001). In open treatment, 11 patients were not able to be evaluated for efficacy. In prophylactic treatment, 4 patients in the itraconazole group and 4 in the placebo group were not able to be evaluated. Adverse events were reported during open treatment by 26 patients (11%) and during prophylactic treatment by 17 (16%) in the itraconazole group and 14 (14%) in the placebo group. No patients experienced any serious adverse events. CONCLUSIONS: Prophylactic itraconazole treatment is efficacious for pityriasis versicolor after 6 months, as is itraconazole in the treatment of pityriasis versicolor.