目的 探討小金丸聯(lián)合乳安片治療乳腺增生癥的臨床效果。方法 選取2019年5月-2021年5月天津中醫(yī)藥大學第一附屬醫(yī)院收治的96例乳腺增生癥患者,使用隨機數(shù)字表法將所有患者分成對照組和治療組,每組各48例。對照組口服乳安片,5片/次,2次/d。治療組在對照組基礎(chǔ)上口服小金丸,1.2 g/次,2次/d。所有患者均于月經(jīng)來潮第7天開始用藥,連用21 d后停藥7 d,此為1個療程,連續(xù)治療2個療程后評價兩組療效。比較治療前后兩組乳腺疼痛視覺模擬量表(VAS)評分、腫塊最大徑、腫塊評分、乳腺增生區(qū)血流動力學指標及血清雌二醇(E₂)、催乳激素(PRL)、孕酮(P)和血管內(nèi)皮生長因子(VEGF)水平。結(jié)果 治療后,治療組總有效率是93.75%,較對照組79.17%顯著增高(P<0.05)。治療后,兩組乳腺疼痛VAS評分、腫塊最大徑及腫塊大小、硬度、范圍評分均較本組治療前顯著降低(P<0.05);且均以治療組的改善更顯著(P<0.05)。治療后,兩組乳腺增生區(qū)血流信號分級均顯著優(yōu)于同組治療前,RI均顯著降低(P<0.05);但乳腺增生區(qū)血流動力學指標均以治療組改善更顯著(P<0.05)。治療后兩組血清E₂、PRL和VEGF水平均顯著下降,而血清P水平均顯著增高(P<0.05);且治療后,治療組血清E₂、PRL、VEGF、P水平改善優(yōu)于對照組(P<0.05)。結(jié)論 小金丸聯(lián)合乳安片對乳腺增生癥患者具有確切的臨床療效,可安全有效地緩解患者乳腺疼痛,軟化并縮小乳腺腫塊,減少增生區(qū)內(nèi)部血供,糾正內(nèi)分泌功能紊亂,抑制體內(nèi)促血管生成因子的異常表達。

Objective To investigate the clinical effect of Xiaojin Pills combined with Ru’an Tablets in treatment of mammary hyperplasia. Methods A total of 96 patients with mammary hyperplasia admitted to the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine from May 2019 to May 2021 were selected. All patients were divided into control group and treatment group by random number table method, with 48 cases in each group. Patients in the control group were po administered with Ru’an Tablets, 5 tablets/time, twice daily. Patients in the treatment group were po administered with Xiaojin Pills on the basis of the control group, 1.2 g/time, twice daily. All patients started medication on the 7th day of menstrual cramps, and stopped the medication for 7 d after 21 d of continuous use. This was one course of treatment. The curative effects of the two groups were observed after 2 consecutive courses of treatment. The visual analog scale (VAS) score, the maximum diameter of the tumor, the tumor score, the hemodynamic index of the breast hyperplasia area and the serum estradiol (E₂), prolactin (PRL), progesterone (P), and vascular endothelial growth factor (VEGF) were compared between the two groups before and after treatment. Results After treatment, the total effective rate of 93.75% in the treatment group was significantly higher than 79.17% in the control group (P < 0.05). After treatment, VAS score, maximum diameter, mass size, hardness and range score of breast pain in two groups was significantly decreased compared with before treatment (P < 0.05). The improvement was more significant in the treatment group (P < 0.05). After treatment, blood flow signal grade in breast hyperplasia area in both groups was significantly better than before treatment, but RI was significantly decreased (P < 0.05).However, the hemodynamic indexes in the hyperplasia area were improved more significantly than those in the treatment group (P < 0.05). After treatment, serum E₂, PRL, and VEGF levels were significantly decreased, while serum P level was significantly increased in both groups (P < 0.05). After treatment, the levels of E₂, PRL, VEGF, and P in the treatment group were better than those in the control group (P < 0.05). Conclusion Xiaojin Pills combined with Ru’an Tablets has a definite clinical effect on patients with breast hyperplasia, and can safely and effectively relieve breast pain, soften and reduce breast masses, reduce blood supply in the hyperplasia area, correct endocrine dysfunction, and also can inhibit angiogenesis factors in the body abnormal expression.

R984

天津市衛(wèi)生和計劃生育委員會科研基金資助項目（2017KZ091）