乳宁颗粒对乳腺增生伴乳痛患者内分泌激素和血管生成因子的影响

Effect of Runing Granule on Endocrine Hormones and Angiogenic Factors in Patients with Hyperplasia of Mammary

目的：观察乳宁颗粒治疗肝郁痰凝型乳腺增生伴乳痛患者的疗效,探讨其对患者孕酮（P）,雌二醇（E2）,催乳素（PRL）,黄体生成素（LH）,卵泡刺激素（FSH）水平及血管生成因子血管生成素-2（Ang-2）,缺氧诱导因子-1α（HIF-1α）,血管内皮细胞生长因子（VEGF）和碱性成纤维细胞生长因子（b FGF）水平的影响。方法：选则女性乳腺增生症患者122例,随机按数字表法分为治疗组和对照组各61例。两组患者均口服逍遥丸,3次/d,8丸/次。对照组口服枸橼酸他莫昔芬片,20 mg/次,2次/d。治疗组在对照组治疗的基础上服用乳宁颗粒,1袋/次,3次/d。两组患者均连续观察8周。比较两组患者乳腺增生症状评分,Mc Gill疼痛问卷表（SF-MPQ）疼痛评分、肝郁痰凝证症状评分及临床疗效比较。检测两组血清内分泌激素P,E2,PRL,LH,FSH水平及Ang-2,HIF-1α,VEGF和b FGF水平。结果：治疗后,治疗组患者乳房肿块硬度、乳腺肿块大小评分及视觉模拟量表评分（VAS）,现有疼痛强度（PPI）,疼痛分级指数（PRI）评分均明显低于对照组（P〈0.01）;治疗后,治疗组患者肝郁痰凝证症状（善郁易怒、胸闷胁胀、失眠多梦、心烦口苦）评分均明显低于对照组（P〈0.01）;治疗组患者的临床总有效率为98.31%,明显高于对照组86.89%（χ2=4.319,P〈0.05）;治疗组治疗后血清内分泌激素E2,PRL和LH水平均明显低于对照组,P和FSH水平均明显高于对照组（P〈0.01）;治疗后,治疗组患者的血清血管生成因子Ang-2,HIF-1α,VEGF和b FGF水平均明显低于对照组（P〈0.01）。结论：治疗组在对照组治疗的基础上,加服乳宁颗粒,对治疗肝郁痰凝型乳腺增生伴乳痛均有明显疗效,调节患者体内的内分泌激素（P,E2,PRL,LH,FSH水平）和血管生成因子（Ang-2,HIF-1α,VEGF和b FGF）水平可能与其疗效有关。

Objective： To observe the efficacy of Runing granule in treating hyperplasia of mammary glands with syndrome of liver qi depression and phlegm stasis,and investigate its effects on progesterone（P）,estradiol（E2）,prolactin（PRL）,luteinizing hormone（LH）,follicle stimulating hormone（FSH） and angiogenic factors angiopoietin（Ang）-2,hypoxia inducible factor（HIF）-1α,vascular endothelial growth factor（VEGF）,and basic fibroblast growth factor（b FGF）. Method： One hundred and twenty-two female patients with hyperplasia of mammary glands were selected and randomly divided into treatment group and control group with 61 cases in each group according to random number table. Both groups were orally with Xiaoyao wan（8 pills/time and tid）. The patients in control group were additionally treated with Tamoxifen citrate tablets（20 mg/time and bid）. Based on the treatment in control group,the patients in treatment group were additionally treated with Runing granule（1 bag/time and tid）. Both groups were treated for 8 weeks. Scores of mammary gland hyperplasia symptoms,simple Mc Gill pain questionnaire（SF-MPQ）,and symptoms of syndrome of liver Qi depression and phlegm stasis and efficacy were compared between two groups. Serum levels of P,E2,PRL,LH,and FSH as well as Ang-2,HIF-1α,VEGF,and b FGF were detected in both groups. Result： After treatment,scores of hyperplasia of mammary glands for breast lump hardness and gland tumor size,as well as SF-MPQ scale visual analogue scale（VAS）,present pain intensity（PPI）,pain rating index（PRI） of treatment group were evidently lower than those in control group（P〈0. 01）. After treatment,scores of symptoms of syndrome of liver qi depression and phlegm stasis（depression and irritability,chest distress,insomnia and dreamy sleep,upset and bitter mouth） of treatment group were evidently lower than those of control group（P〈0. 01）. Total clinical effective rate of treatment group was 98. 31%,obviously higher than 86. 89% in control group（χ2= 4. 319,P〈0. 05）. After treatment,serum levels of E2,PRL,and LH in treatment group were remarkably lower,while P and FSH level were obviously higher than those in control group（P〈0. 01）. After treatment,serum levels of ngiogenic factors Ang-2,HIF-1α,VEGF,and b FGF in treatment group were obviously lower than those in control group（P〈0. 01）. Conclusion： Based on routine therapy,the efficacy of additional Runing Granule in treating hyperplasia of mammary glands with syndrome of liver qi depression and phlegm stasis is significant,which may be correlated with regulation of endocrine hormones（P,E2,PRL,LH,and FSH） and angiogenic factors（Ang-2,HIF-1α,VEGF,and b FGF）.