Nappi C, Affinito P, Di Carlo C, Esposito G, Montemagno U
Cattedra di Endocrinologia Ginecologica, Università di Torino, Italy.
J Endocrinol Invest. 1992 Dec;15(11):801-6. doi: 10.1007/BF03348808.
The clinical effectiveness and safety of vaginal micronized progesterone treatment in mastodynia were evaluated in a double-blind placebo controlled study. Eighty regularly menstruating women affected by severe cyclical mastodynia were randomly assigned to two groups of 40 patients. One group was treated for 6 cycles from the 19th to the 25th day of the cycle with 4 g of vaginal cream containing 2.5% natural progesterone. The other group was similarly treated with placebo. The treatment was preceded by a control cycle. All patients reported every day their breast pain on a 100 mm visual linear analogue scale (VAS). The response of breast tenderness and nodularity to treatment was assessed by clinical examination. Vaginal progesterone resulted significantly more efficacious than placebo in reducing mean ratings of breast pain on VAS and mean scores of breast tenderness to touch. Success of treatment, defined as reduction greater than 50% of basal mean score of breast pain on VAS, was achieved in the 64.9% of patients treated with progesterone and in the 22.2% of patients receiving placebo (p < 0.01). Conversely, at the end of treatment, the improvement in breast nodularity showed a not statistically significant difference between the two groups. No major side-effects were detected.
在一项双盲安慰剂对照研究中，评估了阴道用微粉化孕酮治疗乳腺疼痛的临床有效性和安全性。80名受重度周期性乳腺疼痛影响的规律月经女性被随机分为两组，每组40例。一组在月经周期的第19天至25天用含有2.5%天然孕酮的4克阴道乳膏治疗6个周期。另一组用安慰剂进行类似治疗。治疗前有一个对照周期。所有患者每天用100毫米视觉线性模拟量表（VAS）报告其乳房疼痛情况。通过临床检查评估乳房压痛和结节对治疗的反应。阴道用孕酮在降低VAS上乳房疼痛的平均评分以及乳房触痛的平均得分方面比安慰剂显著更有效。治疗成功定义为VAS上乳房疼痛基础平均得分降低超过50%，接受孕酮治疗的患者中有64.9%达到这一标准，接受安慰剂治疗的患者中有22.2%达到这一标准（p<0.01）。相反，在治疗结束时，两组之间乳房结节的改善情况无统计学显著差异。未检测到重大副作用。
