红金消结胶囊联合他莫昔芬治疗绝经后妇女乳腺增生症的疗效观察

Efficacy Observation of Hongjin Xiaojie Capsule Combined with Tamoxifen for Breast Hyperplasia of Postmenopausal Women

目的:观察红金消结胶囊联合他莫昔芬治疗绝经后妇女乳腺增生症的疗效和安全性。方法:选取我院2009年7月-2012年5月收治的558例绝经后乳腺增生症患者,按随机数字表法分为对照组(230例)和观察组(328例)。对照组采取单纯他莫昔芬治疗,口服每次10mg,每日2次,对病情较重的患者口服每次20mg,每日2次,均于饭后30min内以温开水送服;观察组采取红金消结胶囊联合他莫昔芬治疗,他莫昔芬用法同对照组,红金消结胶囊口服每次4粒(1.6g),每日3次,饭后1h内温开水送服。两组患者疗程均为12周。比较两组患者疗效、疼痛评分、复发率等,并观察不良反应情况。结果:观察组患者治疗有效率为92.7%,明显优于对照组的81.7%(P<0.05);两组患者疼痛程度均有显著降低(P<0.01),且观察组降低程度显著优于对照组(P<0.01);观察组患者复发率、不良反应发生率亦显著低于对照组(P<0.01)。结论:红金消结胶囊联合他莫昔芬治疗绝经后妇女乳腺增生症疗效良好,复发率较低,安全性较高。

OBJECTIVE： To observe therapeutic efficacy and safety of Hongjin xiaojie capsule combined with tamoxifen in the treatment of breast hyperplasia in postmenopausal women. METHODS： 558 postmenopausal women with breast hyperplasia were collected from our hospital during Jul. 2009- May 2012. They were randomized into control group （230 cases） and observation group （328 cases）. The control group was treated with tamoxifen alone orally, every time 10 mg, 2 times a day; the patients with severe disease were given tamoxifen 20 mg orally, 2 times a day, with lukewarm water within 30 min after meal. The observation group was given Hongiin xiaojie capsule and tamoxifen; the use of tamoxifen was same to control group and 4 pills （1.6 g） of Hon- gjin xiaojie capsule was took each time with lukewarm water within 1 h after meal, 3 times a day. Therapeutic duration of 2 groups lasted for 12 weeks. Therapeutic efficacy, pain score and recurernce rate were compared between 2 groups, and ADR was ob- served. RESULTS： The total effective rate of observation group was 92.7%, which was significantly better than 81.7% in control group （P〈0.05） ; the degree of pain decreased significantly in 2 group （P〈0.01）, and the decrease of pain degree in observation group was significantly better than in control group （P〈0.01） ; the recurernce rate and the incidence of ADR of observation group were significantly lower than that of control group （P〈0.01）. CONCLUSION： Hongiin xiaojie capsule combined with tamoxifen shows good therapeutic effect on breast hyperplasia of postmenopausal women with high safety and low recurrence rate.