目的 探討乳塊消顆粒聯(lián)合乳腺增生口服液治療乳腺增生癥的臨床效果。方法 選取2017年1月-2018年12月天津中醫(yī)藥大學第一附屬醫(yī)院收治的120例乳腺增生癥，隨機分成對照組（n=60）和治療組（n=60）。對照組口服乳腺增生口服液，20 mL/次，2次/d，服時搖勻，經(jīng)期停服。治療組在對照組基礎上口服乳塊消顆粒，1袋/次，3次/d，開水沖服，經(jīng)期停服。兩組均連續(xù)治療2個月。比較兩組臨床療效，治療前后主要癥狀及體征評分、乳腺超聲參數(shù)值及血清性激素指標[雌二醇（E₂）、孕酮（P）、催乳激素（PRL）]、促血管新生因子[血管內(nèi)皮生長因子（VEGF）、堿性成纖維細胞生長因子（βFGF）]水平變化情況。結果 治療組總有效率為95.0%，較對照組（83.3%）顯著升高（P<0.05）。兩組治療后主要癥狀、體征（乳痛及腫塊硬度、范圍、大?。┰u分均顯著低于治療前（P<0.05），且治療組治療后以上主要癥狀、體征評分均較對照組同期顯著更低（P<0.05）。與治療前對比，兩組治療后乳腺超聲相關參數(shù)（腫塊直徑、腺體層厚度、輸乳管內(nèi)徑、低回聲區(qū)直徑）值均顯著縮?。?i>P<0.05）；但治療后，治療組上述乳腺超聲相關參數(shù)值均顯著小于對照組同期（P<0.05）。兩組治療后血清E₂、PRL、VEGF及βFGF水平均顯著低于治療前（P<0.05），血清P含量則均顯著升高（P<0.05）；且治療后，治療組血清E₂、P、PRL、VEGF、βFGF水平的改善效果均顯著優(yōu)于對照組同期（P<0.05）。結論 乳塊消顆粒聯(lián)合乳腺增生口服液治療乳腺增生癥的整體療效顯著，可有效緩解患者的癥狀和體征，改善局部乳腺結構和形態(tài)，正性調控內(nèi)分泌，抑制促血管生長因子過度表達，具有一定的臨床推廣應用價值。

Objective To investigate the clinical effect of Rukuaixiao Granules combined with Mammary Hyperplasia Oral Liquid in treatment mammary of hyperplasia. Methods 120 Patients with mammary hyperplasia admitted to First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from January 2017 to December 2018 were randomly divided into control group (n=60) and treatment group (n=60). The control group was po administered with Mammary Hyperplasia Oral Liquid, 20 mL/time, twice daily, shake well when taking, stop taking during menstruation. The treatment group was po administered with Rukuaixiao Granules on the basis of the control group, 1 bag/time, three times daily. All patients were treated for 2 months. The clinical effects of the two groups were compared. The main symptom and sign scores, breast ultrasound parameter values, serum sex hormone indexes[estradiol (E₂), progesterone (P), prolactin (PRL)], and angiogenesis promoting factors[vascular endothelial growth factor (VEGF), basic fibroblast growth factor (βFGF)] levels before and after treatment were compared. Results The total effective rate of the treatment group was 95.0%, significantly higher than that of the control group (83.3%) (P<0.05). After treatment, the scores of main symptoms and signs (breast pain and mass hardness, range and size) in the two groups were significantly lower than those before treatment (P<0.05), and the scores of main symptoms and signs in the treatment group were significantly lower than those in the control group at the same time (P<0.05). Compared with before treatment, the breast ultrasound-related parameters (tumor diameter, gland layer thickness, inner diameter of breast duct and diameter of hypoechoic region) of the two groups decreased significantly after treatment (P<0.05). However, after treatment, the above-mentioned breast ultrasound-related parameters in the treatment group were significantly lower than those in the control group at the same time (P<0.05). After treatment, the levels of serum E₂, PRL, VEGF and βFGF in the two groups were significantly lower than before treatment (P<0.05), while the levels of serum P were significantly increased (P<0.05). After treatment, the improvement effect of serum E₂, P, PRL, VEGF, βFGF concentration in the treatment group was significantly better than that in the control group at the same time (P<0.05). Conclusion Rukuaixiao Granules combined with Mammary Hyperplasia Oral Liquid has a significant overall curative effect in treatment of mammary hyperplasia, can effectively relieve the symptoms and signs of patients, improve the structure and morphology of local mammary glands, and can positively regulate endocrine, inhibit the overexpression of vascular growth factor, which has a certain clinical application value.

R984