Human Leukocyte Interferon-α in a Hydrophilic Cream versus in a Gel for the Treatment of Genital Herpes in Males: A Placebo-Controlled,Double-Blind,Comparative Study

The aim of this double-blind, placebo-controlled, comparative study was to differentiate the clinical efficacy and tolerability of human leukocyte interferon-α incorporated (2 times 10⁶ IU/g) in a hydrophilic cream and in a gel to heal males afflicted with first episodes of genital herpes. Patients (n=60), aged 18–40 years (mean 23.2) with culture-confirmed diagnosis of herpes genitalis were randomized to three parallel groups. Each patient was allocated a precoded 40-g tube, containing either preparation or placebo. Cream or gel was applied three times daily for 5 consecutive days. The duration of the active treatment was two weeks. Patients were examined after 48 hours of initial treatment, and thereafter two times a week. A reepithelialized lesion with some residual erythema was recorded as healed. The study demonstrated that patients treated with leukocyte interferon-α cream had both significantly shorter mean duration of lesions than gel and placebo recipients (5.3 days vs. 8 days, 13 days respectively; p<0.001) and a higher number of healed patients (80% vs. 55%, 20% respectively; p<0.001). Of the 60 patients, 49 (82%) complained of no drug-related side effects. Eleven patients predominantly in the cream/gel groups reported non-objective transitory increase in their body temperature (>38°C) with moderate headache, malaise and myalgia. The study was followed-up for 24 months after the first day of the treatment, and out of 31/60 cured patients, 4 had a relapse after 18 months. In conlusion the study affirmed that human leukocyte interferon-α (2 times 10⁶ IU/g) in a hydrophilic cream is more efficacious than its incorporation in gel or placebo, thus suggesting that leukocyte interferon-α in a hydrophilic cream, with a profile of non-objective mild to moderate drug-induced indications, may be considered an alternative and effective treatment modality to cure male patients afflicated with first episodes of genital herpes.     

Treatment of Molluscum Contagiosum in Males with an Analog of Imiquimod 1% in Cream: A Placebo-Controlled,Double-Blind Study

The objective of this double-blind, placebo-controlled study was to evaluate in males the clinical efficacy in treating molluscum contagiosum and tolerance of an analog of imiquimod (1%) in cream. One hundred patients between 9 and 27 years of age (mean 16.3), with 733 lesions (mean 7.3), whose size ranged from 2 to 5 mm diameter (mean spot size 3.4 mm) and a biopsy-confirmed diagnosis of molluscum contagiosum were randomized into two parallel groups. In a double-blind manner, precoded 40-g tubes were dispensed. Patients self-administered the trial medication to their lesions at home three times daily for five consecutive days per week. The study was scheduled with 4 weeks of active treatment (maximum 60 topical applications) and 12 months (on a monthly basis) of follow-up. Patients were examined on a weekly basis. Thirteen patients had atopic dermatitis. A clinically and histopathologically confirmed total elimination of lesions was considered as cured. After four weeks of treatment, 49 patients and 372 lesions were cured. Breaking the code revealed that imiquimod cream had cured 82% of the patients and 86.3% of the lesions. Placebo cleared 16% of the patients and 63 of the lesions (p<0.0001). During the treatment, 88% of the patients experienced no allergic, localized, or drug-related adverse symptoms. Twelve patients, predominantly in the imiquimod cream group reported non-objective, drug-induced, mild reactions with no dropouts. The study was followed-up for 12 months. Among 49 cured patients, 3 had relapses after 10 months. In conclusion, the study demonstrated that 1% imiquimod analog in cream with mild subjective side effects is significantly more efficacious than the placebo in curing molluscum contagiosum in males.     

5%咪喹莫特乳膏治疗尖锐湿疣多中心、随机、双盲研究

目的观察5%咪喹莫特乳膏治疗肛周和外生殖器尖锐湿疣的临床疗效和安全性。方法采用随机、双盲、平行对照的临床研究方法,受试者每周3次局部外搽研究药物,用药后6￣8h用清水清洗,疗程8周。疣体完全消退者继续随访1个月以观察复发率。结果共有231例肛周及外生殖器尖锐湿疣患者参加本次研究,其中5%咪喹莫特乳膏治疗组116例,安慰剂对照组115例。治疗后2、4、6、8周的痊愈率在治疗组分别为8.41%、30.84%、49.53%及61.68%,对照组分别为2.68%、7.14%、16.07%及24.11%,两组间差异有统计学意义(P<0.001);疗后2、4、6、8周的有效率在治疗组分别为34.58%、60.75%、68.22%及74.77%,对照组分别为10.72%、18.75%、28.57%及32.14%,两组间差异有统计学意义(P<0.001)。治疗组痊愈患者随访1个月后的复发率为10.61%,与对照组相比差异无统计学意义。治疗组无系统不良反应,仅有给药部位的局部不良反应,以轻度和中度红斑为多见,发生率为34.55%。结论5%咪喹莫特乳膏治疗肛周和外生殖器尖锐湿疣疗效好,安全性好,使用方便。     

Management of Toenail Onychomycosis with 2% Butenafine and 20% Urea Cream: A Placebo-controlled,Double-blind Study

Onychomycosis is an increasingly common and recalcitrant fungal nail infection worldwide. The purpose of this placebo-controlled, double-blind study was to determine the clinical efficacy, chemical avulsion, and tolerability of 2% butenafine hydrochloride and 20% urea incorporated in a cream to cure toenail onychomycosis in a preselected population. Sixty patients (38M, 22F), ranging between 18 and 60 years (mean 27.4), with more than 25% involvement of the big toenail were enrolled in the study. The diagnosis of onychomycosis was established by mycologic identification and reconfirmed by positive fungal culture. A precoded 25-g tube was randomly assigned to each patient (50 active and 10 placebo) with instructions to apply the trial medication to their infected toenail twice daily with an occlusive dressing for one week. The affected nail was removed with a nail clipper. No occlusive dressing was maintained after the initial one week regimen. To assess the chemical avulsion of the infected toenail, mycologic cure, clinical effectiveness of the treatment, and overall success, patients were examined twice a week for 16 weeks and thereafter on a weekly basis for a further 36 weeks. The treatment was well tolerated by all the patients throughout the study, with no dropouts. Marked improvement was seen in 73.3% patients after weeks 8, 16 and 24 with clinically and mycologically confirmed negative fungal culture. Code disclosure revealed that active butenafine and urea cream cured significantly more patients than placebo (88% versus 0%; p<0.0001). Of the 60 patients 91.6% reported no drug-related adverse symptoms. Five patients reported non-objective mild inflammation without discontinuation of the treatment. During one year follow-up of the study phase, none of the cured patients had a relapse. In conclusion, the mycologic and overall assessment of this study demonstrate that 2% butenafine HCl and 20% urea incorporated in a cream for keratinolysis is safe to use and significantly more effective than placebo in curing big toenail onychomycosis.     

Topical imiquimod 5% cream in external anogenital warts: a randomized, double-blind, placebo-controlled study

The complete treatment of anogenital warts has not been obtained with any combination of methods; therefore, new methods are still under investigation. In this study the activity and side effects of imiquimod 5% cream were investigated. The study group consisted of 23 male and 11 female volunteers and the control group of 9 male and 2 female volunteers. Patients applied the cream three times a week, every other day in the evenings for a period of 12 weeks. After the treatment, patients were regularly monitored for six months for recurrences. At the end of the study, 23 (69.7%) patients (all of females and 54.5% of males) in the study group displayed a complete clearance, 9 patients displayed 50-90% clearance and 1 patient displayed less than 50% clearance. In the control group, only 1 patient displayed a complete clearance, 1 patient displayed 50-90% clearance, and the other 8 patients showed no alteration in the lesions. These results were statistically significantly different (p<0.01). In 15 patients in the study group, no side effects were reported; the most frequently seen side effects were erythema and erosion. In six patients that were observed for a period of six months, recurrences occurred. Imiquimod 5% cream is a topically applied medicament that should be considered as an effective and reliable medical option in the treatment of anogenital warts.     

Topical treatment for human papillomavirus-associated genital warts in humans with the novel tellurium immunomodulator AS101: assessment of its safety and efficacy

Background  Various methods are currently used for the treatment of anogenital warts. However, a complete cure is unlikely, and the rate of recurrence is high.
Objectives  The purpose of this open-label, multicentre trial was to evaluate the safety and clinical efficacy of a new treatment using the immunomodulator ammonium trichloro (dioxoethylene- O , O ') tellurate (AS101; Biomas Ltd, Kefar Saba, Israel) 15% w/w cream to clear vulval/perianal condylomata acuminata.
Methods  Study participants comprised 48 women and 26 men, age range 18–62 years. Of the 48 woman, 44 were diagnosed with vulval condylomata and four with perianal condylomata. All 26 men were diagnosed with perianal condylomata. All the patients in the study received AS101 15% w/w cream twice a day. Maximal treatment duration was 16 weeks. To evaluate the safety and clinical efficacy, patients were examined and lesional areas photographed on a biweekly basis.
Results  By the end of the treatment, 56 of 74 (76%) patients were considered completely cleared. Complete cure was achieved in 35 of 44 (80%) patients with vulval condylomata and in 21 of 30 (70%) patients with perianal condylomata. No scarring of treated areas was observed. Complete cure was achieved within a time range of 10–109 days. The most frequent side-effects observed were mild-to-moderate itching, soreness, burning and erythema. In post-treatment follow up of up to 6 months, disease recurrence was observed in two patients (4%), at 105 and 144 days following completion of treatment.
Conclusions  AS101 15% w/w cream is an effective and safe, self-administered therapy used for the treatment of external vulval and perianal warts. The cream is applied topically twice daily for up to 16 weeks. A very low recurrence rate was reported.     

国产咪喹莫特乳膏治疗尖锐湿疣随机双盲对照临床研究

目的:观察国产5％咪喹莫特乳膏治疗外生殖器和肛周尖锐湿疣的临床疗效和安全性。方法:采用随机、双盲、平行对照的临床研究方法,入选病例外搽试验药物,并轻轻按摩,每周3次,疗程8周。结果:治疗组疗后4、6、8周的治愈率分别为28.57％,52.38％,71.43％;对照组分别为18.18％,22.73％,27.27％;治疗组疗后4、6、8周的有效率分别为66.67％,76.19％,80.95％。对照组分别为31.82％(P=0.0337),31.82％(P=0.0058),31.82％(P=0.0019)。结论:5％咪喹莫特乳膏治疗外生殖器和肛周尖锐湿疣疗效好,不良反应轻,使用方便。     

Imiquimod 5% cream for external genital or perianal warts in human immunodeficiency virus-positive patients treated with highly active antiretroviral therapy: an open-label, noncomparative study

Background  Human immunodeficiency virus (HIV)+ patients have an increased risk of anogenital warts. High-risk (HR) human papillomaviruses (HPVs), especially types 16 and 18, are major risk factors for precancerous and cancerous lesions of the anogenital tract, while low-risk (LR) HPVs are associated with benign lesions. Cure of genital warts with ablative techniques, surgical excision, podophyllotoxin or trichloroacetic acid is frequently difficult. Treatment with imiquimod cream showed a total clearance of external genital or perianal warts in about 50% of immunocompetent subjects. However, total clearance was reduced in HIV+ subjects not treated with highly active antiretroviral therapy (HAART).
Objectives  To assess clinically and by monitoring HPV content the efficacy of 5% topical imiquimod to treat anogenital warts in HIV+ subjects with at least partially restored immune functions.
Methods  Fifty HIV+ patients successfully treated with HAART (total CD4+ cells ≥ 200 cells mm⁻³ and plasma HIV RNA load < 10⁴ copies mL⁻¹) with anogenital warts were included. Imiquimod 5% cream was applied on external genital or perianal warts three times weekly for up to 16 weeks. Warts were tested at entry and after treatment for human LR- and HR-HPV DNA.
Results  Total wart clearance was observed in 16 of 50 (32%) patients at week 16. At enrolment, HPV DNA was present in more than 90% of lesions with a majority of lesions co-infected by HR- and LR-HPV. At study end, the HPV load decreased or became undetectable in 40% of cases studied.
Conclusions  Imiquimod 5% cream did not show safety concerns and is suitable for use in HIV+ subjects with anogenital warts and successful HAART treatment.     

Efficacy,safety and tolerability of green tea catechins in the treatment of external anogenital warts: a systematic review and meta‐analysis

Background External anogenital warts (EGWs) are non‐malignant skin tumours caused by human papillomavirus. They are one of the fastest growing sexually transmitted diseases. Current treatments are unsatisfactory. Green tea sinecatechin Polyphenon E ointment is a botanical extract from green tea leaves exhibiting anti‐oxidant, anti‐viral and anti‐tumour properties. Objective The aim of this study was to integrate valid information and provide basis for rational decision making regarding efficacy and safety of green tea extracts in the treatment of EGWs. Methods A systematic search in electronic databases was conducted using specific key terms. Main search was performed independently by two reviewers. The accumulated relevant literature was subsequently systematically reviewed and a meta‐analysis was conducted. Results Three randomized, double‐blind, placebo‐controlled studies evaluating efficacy and safety of Polyphenon E 15% and 10% in the treatment of warts were included in the systematic review and meta‐analysis. A total of 660 men and 587 women were enrolled. Regarding primary outcome, both Polyphenon E 15% and 10% demonstrated significantly higher likelihood of complete clearance of baseline and baseline and new warts compared with controls. No significant heterogeneity was detected. Recurrence rates were very low. Commonest local skin sign was erythema and local skin symptom was itching. Conclusions Efficacy of Polyphenon 15% and 10%, at least for the primary endpoint, is clearly indicated. Polyphenon E treatment exhibits very low recurrence rates and appears to have a rather favourable safety and tolerability profile. Recommendations for future studies should include evaluation of the efficacy of green tea catechins in the treatment of internal anogenital warts and direct comparison with its principal comparator, imiquimod.     

咪喹莫特乳膏治疗尖锐湿疣随机、双盲、多中心研究

目的 了解5%咪喹莫特乳膏治疗肛周和外生殖器尖锐湿疣的临床疗效和安全性。方法 采用随机、双盲、平行对照的临床研究方法,受试者每周3次外搽研究药物,疗程8周。疣体完全消退者继续随访1月以观察复发率。结果 共有258例肛周及外生殖器尖锐湿疣患者参加本次研究,其中5%咪喹莫特乳膏治疗组129例,安慰剂对照组129例。治疗后2、4、6、8周的痊愈率在治疗组分别为12.30%、32.79%、50%及60.66%,对照组分别为4.88%、14.63%、19.51%及26.02%,两组间差异有非常显著性(P<0.001);疗后2、4、6、8周的有效率在治疗组分别为36.89%、59.84%、68.03%及70.49%,对照组分别为13.82%、26.83%、32.52%及32.52%,两组间差异有非常显著性(P<0.001)。治疗组74例痊愈患者经随访1月后有4例复发,复发率为5.41%,与对照组相比差异无显著性。治疗组给药部位局部不良反应包括:红斑60.94%、水肿31.26%、糜烂42.96%、溃疡4.68%、灼热20.32%、疼痛36.72%、瘙痒17.18%。无系统不良反应。结论 5%咪喹莫特乳膏治疗肛周和外生殖器尖锐湿疣疗效好,安全性好,使用方便。     

A Double-Blind,Randomized, Placebo-Controlled Trial of Eutectic Lidocaine/Prilocaine Cream 5% (EMLA)® for Analgesia Prior to Cryotherapy of Warts in Children and Adults

Abstract: Liquid nitrogen cryotherapy is an effective treatment modality for verrucae in children. However, sometimes the pain of the procedure is too much for the young child. In such instances the availability of an effective topical anesthetic would be of tremendous benefit. Warts are usually present on hardened skin, that is, the palms, periungual areas, and soles. In a double-blind, randomized, placebo-controlled, single-center, parallel-group trial with one visit, children (6–18 years old) and adults (> 18 years old) had 2.5 g of lidocaine/prilocaine cream 5% applied under an occlusive dressing to the wart and a 1 to 2 mm area surrounding it 1 hour prior to liquid nitrogen cryotherapy. In both age groups the warts were subdivided by location—hardened skin areas versus nonhardened skin sites. The topical anesthetic was then removed and cryotherapy applied for 5 to 10 seconds. The pain of cryotherapy was assessed by the patient on a visual analogue scale (VAS) immediately after the cryotherapy and 4 and 8 hours later. There was no statistically significant difference in the pain of cryotherapy experienced following the application of active cream (n= 64) and placebo (n = 64). Exploratory subgroup analysis by wart location showed promising results for lidocaine/ prilocaine cream 5% over placebo in children with warts on hardened skin sites (palms and soles). The topical anesthetic was safe and generally well-tolerated. Lidocaine/prilocaine cream 5% may provide some anesthesia in children receiving cryotherapy when the wart is on the palms or soles. Further studies are needed to better understand the site and age specificity of the anesthetic properties of lidocaine/prilocaine cream 5% when used to reduce the pain experienced during cryotherapy of warts.     

喷昔洛韦凝胶治疗复发性生殖器疱疹的随机双盲平行对照临床试验

目的评价1%喷昔洛韦凝胶治疗复发性生殖器疱疹的临床疗效及安全性。方法采用随机双盲、有效对照、平行分组试验,与1%喷昔洛韦乳膏作对照进行疗效和安全性比较。结果观察可供疗效评价的生殖器疱疹病例55例,其中试验组27例,对照组28例。痊愈率70.37%(对照组75.00%),有效率88.89%(对照组100.00%)。不良反应发生率为3.70%(对照组3.57%)。两组的痊愈率、有效率及不良反应发生率在统计学上均无显著性差异。结论1%喷昔洛韦凝胶治疗生殖器疱疹的疗效和不良反应发生率与1%喷昔洛韦乳膏相似,1%喷昔洛韦凝胶生殖器疱疹具有较好的疗效和安全性。     

Management of Psoriasis Vulgaris with Methotrexate 0.25% In a Hydrophilic Gel: A Placebo-Controlled, Double-Blind Study

Background: Methotrexate has been used as one of the first and systemic therapies for psoriasis. In general, 70% of patients with psoriasis prefer topical therapy as the treatment of choice. Objective: The purpose of this placebo-controlled double-blind study was to evaluate the clinical efficacy and tolerability of methotrexate 0.25% incorporated in a hydrophilic gel (hydroxyethylcellulose 1%) to treat patients afflicted with psoriasis vulgaris. Methods: Sixty patients (37M/23F) ranging between 18 and 70 years of age, with slight to moderate chronic plaque-type psoriasis and PASI (Psoriasis Area and Severity Index) scores between 5.3 and 17.5 joined the study. The mean duration of the disease at entry was 9.6 years (range 1-24 years). The diagnosis of psoriasis was established by clinical and histopathologic methods. Patients were sequentially randomized into two parallel groups. Each patient was allocated a precoded 100-g tube (active or placebo) with instructions on how to self-administer the trial medication topically (without occlusion) to their lesions two times daily for 5 consecutive days per week. The study lasted for 12 weeks with 4 weeks of active treatment. Patients were examined on a weekly basis and those showing total clearing or remission of lesions were considered effectively treated. Results: By the end of the treatment, breaking the code disclosed that methotrexate 0.25% gel had significantly treated more patients than placebo (83.3% vs. 6.7%; p < 0.0001), reduced the PASI score to a mean of 2.2, and cleared more plaques (82.2% vs. 4.3%; p < 0.0001). Laboratory evaluations, including CBC with differential and platelet count, renal function, liver chemistry [SGOT (aspartate transaminase) and SGPT (alanine transaminase)], and serum creatinine, were within the normal limits. The treatment was well-tolerated by all the patients, with no adverse drug-related symptoms and no dropouts. The study was followed up for 12 months from the first day of the treatment; two cured patients had relapsed after 8 months. Conclusion: The findings of this study demonstrate that methotrexate 0.25% in a hydrophilic gel is well tolerated and significantly more effective than placebo as a patient-applied topical medication to treat psoriasis vulgaris.     

5%咪喹莫特乳膏治疗尖锐湿疣的多中心、随机双盲、对照研究

目的评价5%咪喹莫特乳膏治疗尖锐湿疣的疗效和安全性,并与2.5%5-氟脲嘧啶乳膏进行对照。方法对尖锐湿疣患者进行多中心、随机双盲、平行对照的临床试验研究。5%咪喹莫特乳膏试验组和2.5%5-氟脲嘧啶乳膏对照组均每周外用药物3次,共治疗8周。结果本研究共244例患者完成全部观察,其中,咪喹莫特组125例,5-氟脲嘧啶组119例。咪喹莫特组治疗后2、4、6、8周的痊愈率分别为52.00%、74.40%、81.60%、92.80%、有效率分别为79.20%、93.60%、97.60%、97.60%.5-氟脲嘧啶组治疗后2、4、6、8周的痊愈率分别为52.10%、70.59%,78.15%、89.92%、有效率分别为84.03%、94.12%、94.96%、97.48%。两组差异均无统计学意义(P>0.05)。不良事件主要为局部不良反应,如局部红斑、疼痛、糜烂,瘙痒等,未见系统性不良反应。结论5%咪喹莫特乳膏治疗尖锐湿疣疗效确切,使用方法简便,耐受性较好。     

Efficacy and Safety of Pueraria lobata Extract in Gray Hair Prevention: A Randomized,Double-Blind,Placebo-Controlled Study

Background

Graying of hair-a sign of aging-raises cosmetic concerns. Individuals with gray hair often look older than others their age; therefore, some dye their hair for aesthetic purposes. However, hair colorants can induce many problems including skin irritation, allergic reaction and hair-breakage.

Objective

This randomized, double-blind clinical trial was performed in order to examine the effects of APHG-1001, a compound including an extract from Pueraria lobata, on graying hair.

Methods

A total of 44 female subjects were randomly treated with either APHG-1001 or placebo twice daily for 24 weeks. Using the phototrichogram analysis, a count of newly developed gray hair was estimated. Investigator assessment and subject self-assessment were also performed in order to evaluate the efficacy of the compound.

Results

The mean number of newly developed gray hair at 24 weeks was 6.3/cm² in the APHG-1001 group and 11.4/cm² in the placebo group; the difference was statistically significant (p<0.05). However, the investigator assessment and subject self-assessment did not show any significant change in the gross appearance of hair grayness by the end of the study. No severe adverse events in either group were observed. Moreover, the incidence of adverse events did not differ between the groups.

Conclusion

This clinical trial revealed that APHG-1001, which contains an extract of P. lobata, could prevent the development of new gray hair without any remarkable adverse effects. Thus, it can be considered as a viable treatment option for the prevention of gray hair.     

Increased risk of dementia in patients with genital warts: A nationwide cohort study in Taiwan

Genital warts are a common sexually transmitted disease caused by human papillomavirus (HPV) infections. The prevalence of dementia is 4–8% in those aged 65 years or older in Taiwanese community studies, with a high social and economic burden for patients, family caregivers, the community and society. Previous studies have shown that viral infections such as herpes simplex and herpes zoster were associated with dementia. This study aimed to investigate the association between dementia and HPV infections. A population-based cohort study using data from Taiwan’s National Health Insurance Research Database was conducted. Fine and Grays’s survival analysis was employed to estimate the hazard ratios (HR) and 95% confidence intervals (CI) for the association between genital warts and dementia. From all of the potential participants aged 50 years or more, a total of 16 116 patients were enrolled, including 4029 genital warts-infected patients, with 12 087 sex-, age- and indexed date-matched controls (1:3). The cumulative incidences of dementia were 10.72 per 10³ person-years and 6.43 per 10³ person-years in the genital warts and control group, respectively. There were 475 dementia cases from the genital warts cohort during the follow-up period of 15 years. The adjusted HR for dementia was 1.485 (95% CI, 1.321–1.668; P < 0.001) for genital warts patients after adjusting for all of the covariates. Our study indicates that genital warts infection may increase the risk of dementia.     

An Open, Randomized, Comparative Clinical and Histological Study of Imiquimod 5% Cream Versus 10% Potassium Hydroxide Solution in the Treatment of Molluscum Contagiosum

Background

Although molluscum contagiosum (MC) resolves spontaneously, there are several reasons to treat this dermatological disorder.

Objective

To evaluate the safety and efficacy of 5% imiquimod cream versus 10% potassium hydroxide (KOH) solution in treating MC, and to propose the mechanism of cure by observing the histological findings.

Methods

Imiquimod or KOH were applied by the patient or a parent 3 days per week until all lesions cleared. The number of MC lesions was counted and side effects were evaluated at 5 points during the treatment (the initial visit, week 2, week 4, week 8, and week 12). Histological changes were compared between 2 patients of each group, before and after the 2 weeks of application.

Results

In both group, the mean lesion counts decreased all through to week 12, and the reduction in number of lesions were statistically significant in both groups (p <0.005). Over 40% of each group developed local side effects, and no systemic side effects were noted in either group. Before treatment, histological findings showed little or no dermal infiltrates. After treatment, specimens showed dense lymphocytic infiltrates, especially T cells, around the lesions which had resolved.

Conclusion

Both 10% KOH solution and 5% imiquimod cream are effective and safe treatment of MC.     

O.25%盐酸阿莫洛芬霜治疗体股癣多中心的临床试验

目的评价0.25%盐酸阿莫罗芬霜治疗体股癣临床非劣效性及安全性.方法101例患者入选,采用随机单盲、阳性药(1%联苯苄唑霜)平行对照临床试验,根据临床症状改善及病原学检查、不良反应发生情况评价治愈率及安全性.结果试验组和对照组治愈率分别为80.0%、73.3%(P＞0.05,RR 1.09,C10.87-1.37);直接显微镜检查真菌阴转率分别为82.2%和73.3%(P＞0.05);真菌培养清除率分别为80.0%和73.3%(P＞0.05).个别患者发生与研究药物有关的不良反应,主要表现为红斑、瘙痒、灼热感、脱屑,不影响治疗,均自行缓解.ITT分析结果相似.结论0.25%盐酸阿莫罗芬霜治疗体股癣高效安全,且临床疗效、真菌学疗效和安全性均与1%联苯苄唑霜相似.     

2%夫西地酸乳膏多中心治疗细菌性皮肤病的疗效和安全性观察

目的评价2%夫西地酸乳膏治疗细菌性皮肤病的临床疗效与安全性。方法多中心、开放性试验;外用2%夫西地酸乳膏,2次/d,疗程为7天。结果共有73例细菌性皮肤病纳入研究,其中41例(56.16%)痊愈,29例(39.73%)显效,3例(4.11%)好转,无效0例;有效率为95.89%;治疗结束时未见不良反应。结论2%夫西地酸乳膏外用治疗细菌性皮肤病时,具有良好的临床疗效和安全性。