5％咪喹莫特乳膏治疗外生殖器/肛周疣随机对照研究

目的评价5％咪喹莫特乳膏（艾达乐）治疗外生殖器／肛周疣的有效性和安全性。方法采用随机、双盲、平行对照、七个中心临床研究。患者随机入组，一组患者先接受咪喹莫特治疗16周或至所有基线疣消失，然后给予赋形剂4周。另一组患者先接受赋形剂治疗4周，然后再接受咪喹莫特治疗16周或至所有基线疣消失。每周外用乳膏3次（晚上应用，至少保留8h），每4周评估一次临床疗效。结果共144例患者人选。在研究结束时（20周），综合两个治疗组合并显示，基线疣计数减少≥50％的患者为75．0％（意向性治疗分析，ITT）和83．5％（符合方案完成试验集分析，PP），疣完全清除率分别为79．9％（ITT分析）和89．8％（PP分析）。在第4周时，咪喹莫特组基线疣计数减少≥50％的患者为48．6％，赋形剂组为19．4％，P=0．0004；咪喹莫特组疣完全清除率为22．2％，赋形剂组为6．9％，P=0．009。最常见的不良事件发生是用药部位的皮肤反应（38．9％），无严重不良事件发生。结论咪喹莫特乳膏治疗外生殖器／肛周疣疗效明显优于赋形剂，每周3次，疗程16周，安全有效，使用方便。     

Imiquimod 5% cream is an acceptable treatment option for external anogenital warts in uncircumcised males

OBJECTIVES: To determine the safety and efficacy of imiquimod (Aldara) 5% cream in the treatment of prepuce-associated warts in uncircumcised males. METHODS: An open-label study in six UK medical centres with 35 uncircumcised males with prepuce-associated warts treated with imiquimod 5% cream three times per week for up to 16 weeks. Other anogenital warts were also treated. RESULTS: Three times weekly application of imiquimod was found to be safe, with erythema as the most commonly reported local skin reaction. Forty per cent of patients had complete clearance of anogenital warts within 16 weeks. CONCLUSIONS: Imiquimod cream at a dosing regimen of three times per week, is effective and has an acceptable safety profile in the treatment of prepuce associated warts and other external anogenital warts in uncircumcised males.     

Randomized, comparative trial on the sustained efficacy of topical imiquimod 5% cream versus conventional ablative methods in external anogenital warts

Conventional ablative treatments for external anogenital warts are affected by high recurrence rates. This study compared sustained clearance after ablation vs. treatment with imiquimod 5% cream vs. the combination of both methods. This was a 3-arm, open-label, randomized clinical study comparing ablation alone (Group A), imiquimod 5% cream monotherapy (Group B), or combined ablation followed by topical imiquimod (Group C). Subjects whose anogenital warts were completely cleared entered a 6-month follow-up to evaluate sustained clearance.After 3 months follow-up, 83.9% (73/87), 93.8% (90/96) and 91.7% (66/72) of subjects in Groups A, B, C, respectively, remained free of recurrent anogenital warts. After 6-months follow-up, 73.6% (64/87), 93.7% (89/95) and 91.5% (65/71) of subjects presented free of recurrence (Group A vs. B & C p-values each p < 0.004 in favour of the imiquimod-treated groups).Imiquimod 5% cream, as monotherapy or in combination with ablation, was superior to ablation alone in reducing the recurrence of successfully treated anogenital warts.     

Successful treatment of periungual warts with topical cidofovir

Periungual warts represent a treatment challenge because of its high recurrence rate and recalcitrance. These are benign lesions produced by the human papilloma virus (HPV) that often do not respond to habitual treatment. Cidofovir is a potent antiviral drug that acts inactivating viral DNA polymerase. Topical cidofovir for the treatment of HPV‐related cutaneous and mucous lesions is becoming increasingly common. Our aim was to assess the efficacy and safety of cidofovir cream for the treatment of viral periungual warts. We undertook a retrospective observational study of patients with periungual warts who received treatment with topical cidofovir between January 2010 and December 2013 at the Dermatology Service of the Hospital Costa del Sol, Marbella, Spain. Data were recorded about the rate of treatment response, the adverse effects and recurrences, as well as the characteristics of the patient cohort. We identified 41 patients who had received some previous treatment. The concentration of cidofovir was 3% in all cases, usually applied twice a day (in 37 of the 41 cases). A greater or lesser response was noted in 35 cases. There were six recurrences in the follow‐up period. Topical cidofovir seems to be a useful alternative for the therapeutic management of recalcitrant periungual common warts that fail to respond to usual treatment. Our experience with the use of this antiviral agent has been satisfactory, although in our opinion, it should be reserved for specific cases as its economical cost represents an important limitation.     

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.     

The role of imiquimod 3.75% cream in the treatment of external genital warts

Imiquimod 3.75% cream has recently been approved by both the U.S. Federal Drug Administration and Health Canada for the treatment of external genital warts. Herein, we provide an overview of external genital warts, review the phase 3 clinical trials leading to the approval of imiquimod 3.75% cream, and compare its efficacy and clinical use with imiquimod 5% cream. Moreover, therapeutic options have further expanded with the relatively recent introduction of sinecatechins 15% ointment, an extract of green tea leaves.     

Efficacy of imiquimod 5% cream in the treatment of recalcitrant warts in children

Long-lasting cutaneous warts are a therapeutic challenge, especially widespread or symptomatic recalcitrant warts in children. It can be speculated that natural immunity to these human papillomavirus (HPV)- induced lesions is extremely poor. Therefore ideally treatment should focus on increasing local immune response. Recently imiquimod, a topical immune modifier, has been successfully used in the treatment of external genital warts. Our purpose is to report on our experiences with imiquimod 5% cream applied to therapy-resistant, long-lasting (duration 2-7 years) common warts in children. In 18 children, imiquimod cream was self-applied by the patients or by their parents to the warts twice a day. Assessment for response and occurrence of adverse effects was performed every 4 weeks until clinical cure. Follow-ups could be arranged in 14 of the 18 patients 1-2 years after total clearance. Sixteen of 18 patients experienced total clearance of their warts; 2 showed partial improvement but were lost to follow-up. The mean duration of treatment was 5.8 months. Two of the 14 patients in whom a follow-up was performed showed a small number of new warts after a period of at least 1 year without recurrence. Our data demonstrate that the topical application of imiquimod 5% cream is an effective treatment for long-lasting cutaneous warts in children.     

Treatment of non-genital warts with topical imiquimod 5% cream

Common warts (verrucae vulgaris) are associated with human papillomavirus infection and are routinely treated by ablative procedures such as cryotherapy, electrodessiccation and salicylic acid. We report 10 cases of recurrent warts treated with a potential new topical therapy, imiquimod 5% cream. Nine of the 10 patients were successfully treated with imiquimod 5% cream applied, under occlusion, once daily for 4 weeks. No recurrences were reported during 3 months of follow up.     

Pimecrolimus 1% cream for anogenital lichen sclerosus in childhood

Background

Lichen sclerosus is a chronic inflammatory disease with a predilection of the anogenital region. Because of the potential side effects of repeated local application of potent glucocorticosteroids, equally-effective, safer therapeutic options are required, especially in the treatment of children.

Case presentations

We report on the efficacy of twice-daily application of pimecrolimus 1% cream in four prepubertal girls (range of age: 4 to 9 years) who suffered from anogenital lichen sclerosus. After three to four-month treatment, all patients had almost complete clinical remission including relief from itch, pain and inflammation. Only minor improvement was observed for the white sclerotic lesions. No significant side effects have been observed.

Conclusions

Topical pimecrolimus appears to be an effective and safe treatment for children with anogenital lichen sclerosus. The clinical benefits observed in the four patient presented particularly include relief of pruritus, pain and inflammation. Vehicle-controlled studies on a larger number of patients are now warranted to substantiate our promising findings, and to investigate long-term efficacy and safety of topical pimecrolimus in anogenital lichen sclerosus.

     

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.     

Efficacy and tolerability of luliconazole cream 1% for dermatophytoses: A Meta‐analysis

We evaluated the efficacy and safety of luliconazole cream 1% in the treatment of dermatophytoses. According to our meta‐analysis, short‐term treatment of luliconazole cream 1% can result in the complete clearance of dermatophytoses. It showed that 1% luliconazole was more effective than controlled drugs or vehicle (week 4: odds ratio = 1.46, 95% confidence interval = 1.12–1.91), and no more adverse events occurred in the 1% luliconazole group (week 4: odds ratio = 1.01, 95% confidence interval = 0.71–1.44). This effect strengthens the evidence for luliconazole cream 1% being more effective than vehicle, 1% terbinafine, 1% bifonazole, and 0.1% or 0.5% luliconazole.     

Topical imiquimod 5% cream as an effective treatment for external genital and perianal warts in different patient populations

BACKGROUND: Genital infection with human papillomavirus, the cause of genital warts, is one of the most common sexually transmitted diseases. GOAL: The aim of this analysis was to determine whether patients' demographic variables affect the efficacy of imiquimod 5% cream versus vehicle cream for the treatment of external genital and perianal warts. STUDY DESIGN: Male and female immunocompetent patients applied imiquimod 5% cream topically to external genital warts 3 times a week until wart clearance or for up to 16 weeks. RESULTS: As previously published, the intent-to-treat (ITT) clearance rate was 50% (54/109) in the imiquimod-treated group and 11% (11/100) in the vehicle-treated group ( P< 0.0001). The ITT clearance rate in the imiquimod-treated group was higher in females (72%) than in males (33%). We have examined the clearance rates for subgroups based on variables of gender, baseline wart area, duration of current outbreak of warts, previous wart treatment, and tobacco use. For each of these subgroups, imiquimod was statistically more effective than vehicle in eradicating external genital and perianal warts. CONCLUSION: Imiquimod 5% cream is an effective treatment for external genital and perianal warts and provides a significant benefit in comparison with vehicle cream, independent of gender, initial wart size, duration of current outbreak of warts, previous wart treatment, or tobacco use.     

L-抗坏血酸-2-磷酸酯镁霜外用治疗黄褐斑临床疗效观察

目的:观察L-抗坏血酸-2-磷酸酯镁(VC-PMG)霜外用治疗黄褐斑的疗效及安全性.方法:外用10%VC-PMG霜治疗25例黄褐斑患者,并用Micmskin Ⅱ多功能偏振光皮肤镜图像分析系统对治疗前、后黄褐斑皮损进行客观测量及评价.结果:经10%VC-PMG霜外用治疗各型黄褐斑16周后,平均有效率为20%,其中单一蝶形皮损效果最佳,有效率为44.4%,同一患者治疗前后对色素斑L*、a*、b*值检测结果显示差异有统计学意义(P<0.05).在临床治疗观察的整个过程中未见明显不良反应发生.结论:局部外用10%VC-PMG霜可以减少黄褐斑患者皮损部位的黑素含量、毛细血管扩张程度,以及减轻黄色素和脂色素以改善色素斑,达到治疗黄褐斑的目的.     

A comparison of topical azelaic acid 20% cream and topical metronidazole 0.75% cream in the treatment of patients with papulopustular rosacea

Background: Although it is important for physicians to have sufficient clinical data on which to base treatment decisions, little comparative data exist regarding newer treatment modalities for rosacea. Objective: The goal of the study was to compare the efficacy and safety of topical azelaic acid 20% cream and topical metronidazole 0.75% cream in the treatment of patients with papulopustular rosacea. Parameters of patient satisfaction to treatment were also assessed. Methods: Forty patients with the clinical manifestation of symmetric facial rosacea were investigated in this single-center, double-blind, randomized, contralateral split-face comparison clinical trial. Results: After 15 weeks of treatment, both azelaic acid and metronidazole induced significant, albeit equal reductions in the number of inflammatory lesions (pustules and papules). A significantly higher physician rating of global improvement was achieved with azelaic acid. Changes in the rosacea signs and symptoms of dryness, burning, telangiectasia, and itching were equal between treatments. A reduction in erythema tended toward significance with azelaic acid at week 15. A trace amount of stinging on application was noted with azelaic acid; however, such discomfort did not appear to concern patients because their overall impression of azelaic acid was superior to that of metronidazole. Conclusion: Azelaic acid 20% cream provides an effective and safe alternative to metro-nidazole 0.75% cream with the added benefit of increased patient satisfaction. (J Am Acad Dermatol 1999;40:961-5.)     

Unsuccessful treatment of extragenital lichen sclerosus with topical 1% pimecrolimus cream

Lichen sclerosus most commonly affects the anogenital region. Spreading into the extragenital regions is rare, and its course is most commonly asymptomatic. Women have been reported to be affected 6 to 10 times more often than men. The etiology of lichen sclerosus is still unknown. The disease is characterized by ivory-white atrophic plaques, and no treatment ensuring complete recovery is available. T-cells are also involved in its pathogenesis. Pimecrolimus is a topical inhibitor of T-cells. In the present paper, we present a male patient with lichen sclerosus located only in extragenital regions and report an unsuccessful outcome of treatment with pimecrolimus 1% cream administered topically twice a day for 16 weeks.