大剂量非那雄胺可治疗女性型脱发

vassili168

　布拉格——葡萄牙里斯本市Cuf Descobertas 医院的Oliveira-Soares博士在欧洲皮肤病与性病学会(EADV)年会上报告，一项纳入43例绝经前女性的为期18个月的研究证实，超适应证应用非那雄胺5 mg/d治疗女性型脱发安全有效。

　　

Rui Oliveira-Soares博士

　　外用2%米诺地尔是女性型脱发的标准治疗。其他药物包括氟他胺和安体舒通，但这些药物可能有肝毒性，而另一种治疗药物醋酸环丙孕酮可能有心血管副作用。非那雄胺1 mg/d可有效治疗男性型脱发，这一结论已被认可长达15年以上，并且非那雄胺5 mg/d被核准用于治疗男性型脱发和良性前列腺增生。但在12年前，研究者发现，非那雄胺1 mg/d治疗女性型脱发无效(J. Am. Acad. Dermatol. 2000;43:768-76)。并且关于非那雄胺2.5mg/d治疗女性雄激素源性脱发的研究得出的结果很不一致。近期一项尚未发表的研究显示，非那雄胺5 mg/d治疗对于绝经后女性雄激素源性脱发是有益的，鉴于这项研究的结果，Oliveira-Soares医生希望了解这种方案对于绝经前女性患者是否安全和有效。

　　在本次研究中，给予43例患者非那雄胺5 mg/d治疗18个月，每6个月进行1次正式评估。从两个方面评估治疗的有效性：患者满意度评分，由2名不知情研究者对照片进行评估。作为参与研究的先决条件，要求患者的血清雄激素水平正常，无临床高雄激素血症的体征，并且此后无妊娠意愿。患者还必须接受屈螺酮/炔雌醇口服避孕。

　　结果显示，治疗6个月时，25例患者(58%)认为 病情发生“巨大” 改善，14例(33%)认为改善为中度；4例报告无改善。随时间进展，这些结果保持稳定，在随访12个月和18个月时患者报告的结果相同。研究者对患者照片的盲态评估不如患者评估的结果乐观：他们认为19例患者(44%)改善非常明显，17例有一定程度的改善，7例患者无改善。

　　安全性方面，8例患者报告性欲减退；4例有一过性恶心或头痛，4例报告一过性月经增多。1例患者肝功能检查结果异常，并因此退出研究。

　　Oliveira-Soares博士的研究得到医院研究基金的资助。他报告无相关利益冲突。

By: BRUCE JANCIN, Internal Medicine News Digital Network

PRAGUE – Off-label use of oral finasteride at 5 mg/day proved safe and effective for the treatment of female pattern hair loss in 43 premenopausal women in an 18-month study.

Treatment effectiveness was assessed in two ways: patient satisfaction scores and two blinded investigators’ evaluation of photographs. As a precondition for study participation, patients needed to have normal serum androgen levels, no clinical signs of hyperandrogenism, and no wish to become pregnant ever again. They also had to go on drospirenone/ethinyl estradiol for oral contraception.

At the 6-month mark, 25 patients (58%) characterized their improvement as "huge" and 14 (33%) as moderate; 4 reported no improvement. These results were stable across time, with the women reporting the same results at 12 and 18 months of follow-up.

The investigators’ blinded assessments of patient photos were less generous: They characterized 19 patients (44%) as very improved, 17 as somewhat improved, and 7 as unimproved.

Diminished libido was reported by 8 patients; 4 had transient nausea or headaches, and 4 reported transient metrorrhagia. One patient had elevated liver function test results and was dropped from the study, Dr. Rui Oliveira-Soares said at the annual congress of the European Academy of Dermatology and Venereology.

"None of us are very pleased with the results we’re having with other drugs," Dr. Oliveira-Soares said. "Sometimes they are unsuccessful or have unacceptable adverse effects. Sometimes there is progression of disease despite every drug we use."

It has been known for more than 15 years that finasteride at 1 mg/day is an effective treatment for male pattern hair loss. It is approved for that indication, as well as for benign prostatic hypertrophy at 5 mg/day.

However, investigators found 12 years ago that finasteride at 1 mg/day is ineffective for female pattern hair loss (J. Am. Acad. Dermatol. 2000;43:768-76). And there have been conflicting reports as to whether the therapy is effective in female androgenetic alopecia at 2.5 mg/day, noted Dr. Oliveira-Soares of Hospital Cuf Descobertas in Lisbon.

Having recently shown in an as-yet-unpublished study that finasteride at a dosage of 5 mg/day was beneficial in postmenopausal women with androgenetic alopecia, Dr. Oliveira-Soares said he sought to learn whether this regimen was safe and effective in premenopausal women affected by the disorder. He reported on 43 patients treated with finasteride at 5 mg/day for 18 months, with formal outcome assessments conducted every 6 months.

Future studies should focus on how to identify likely nonresponders. Also, an 18-month study is not sufficient to draw solid conclusions about the possible long-term risks of extended therapy. An increased risk of breast cancer is a theoretic concern, although there are no clinical data to suggest it is an issue, he said.

The problem in conducting larger, longer-term studies of finasteride at 5 mg/day for female pattern hair loss is that because the drug is available as a relatively inexpensive generic, there is no industry interest in funding such research, he added.

Topical 2% minoxidil is the standard treatment for female pattern hair loss. Among the other drugs used are flutamide and spironolactone, which can have hepatic toxicity, and cyproterone acetate, which can have cardiovascular side effects.

Dr. Oliveira-Soares’ study was supported by hospital research funds. He reported having no relevant financial conflicts.

summer0

    好像看看他们的效果怎么样

纯老爷们

43例太少了

博罗

临床没有真正的说法……
不过在国外看到过一些帖子，有人尝试，但很少有后续