二期试验的Afimoxifene (4-hydroxytamoxifen凝胶)周期性乳腺痛在绝经前妇女。

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Mansel R, Goyal A Nestour EL Masini-Eteve V,奥康奈尔K

二期试验的Afimoxifene (4-hydroxytamoxifen凝胶)周期性乳腺痛在绝经前妇女。

乳腺癌Res治疗。2007年12月,106 (3):389 - 97。Epub 2007 3月10。

PubMed ID

17351746 (在PubMed

]

文摘

背景:许多女性经历周期性乳腺痛的症状,如乳房疼痛、压痛,结节状态。三苯氧胺和其他药物被用来缓解周期性乳腺痛症状;然而,他们的使用与潜在的严重副作用。相比当前的研究的安全性和有效性两剂外用凝胶含有4-hydroxytamoxifen(原名4-OHT Afimoxifene)与安慰剂凝胶治疗中度到重度的周期性乳腺痛。方法:绝经前女性至少18岁经历中度到重度症状被随机分配接受安慰剂,2毫克,或4毫克Afimoxifene日常交付作为皮肤hydroalcoholic凝胶4月经周期。意味着疼痛强度的主要功效参数是变化的视觉模拟量表(血管)七个坏的疼痛分数从基线到第四天在一个周期循环。结果:4周期治疗后,显著改善测量相对于安慰剂在血管平均分数4 mg Afimoxifene组(-12.71毫米(95%置信区间,-0.96 - -24.47;P = 0.034)。全球评估病人的疼痛,医生的评估疼痛,温柔在触诊,和结节4周期治疗后明显更可能显示改进4 mg组,与安慰剂比较(P = 0.010(疼痛);P = 0.012(温柔); P = 0.017 [nodularity]). Overall, Afimoxifene was well tolerated with few adverse events and no drug-related SAE occurred in any group. There were no changes in menstrual pattern or plasma hormone levels and no breakthrough vaginal bleeding in patients treated with Afimoxifene. CONCLUSION: After 4 months of treatment, daily topical breast application of Afimoxifene resulted in statistically significant improvements in signs and symptoms of cyclical mastalgia across patient- and physician-rated scales with excellent tolerability and safety.

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药物

Afimoxifene