大补阴丸加减联合克龄蒙对卵巢早衰患者卵巢储备功能和免疫功能的影响

Effect of Modified Da Bu Yin Pill Combined with Climen on Ovarian Reserve and Immune Function of Premature Ovarian Failure Patients

目的:观察大补阴丸加减联合克龄蒙(戊酸雌二醇片、雌二醇环丙孕酮片)治疗卵巢早衰肾阴虚证的临床疗效及对巢储备功能和免疫功能的影响。方法:将120例患者随机分为对照组和观察组,每组60例。对照组采用克龄蒙(戊酸雌二醇片、雌二醇环丙孕酮片)治疗,观察组在对照组治疗基础上加用大补阴丸加减汤(熟地黄30 g,知母15 g,黄柏10 g,龟板30 g,女贞子20 g,北沙参20 g,淫羊藿15 g,丹参20 g,桑葚子20 g,夜交藤30 g,山萸肉10 g,黄精30 g)治疗。两组患者均以2个月经周期为1个疗程,共治疗2个疗程。两组患者均进行治疗前后Kupperman评分和肾阴虚证评分,检测治疗前后促卵泡激素(follicle stimulating hormone,FSH)、促黄体生成素(luteinizing hormone,LH)、雌二醇(estradiol,E2)水平;进行治疗前后妇科彩超检查,记录卵巢最大平面的平均卵巢直径(mean ovarian diameter,MOD)、卵巢动脉收缩期峰值流速(peak systolic velocity,PSV)和子宫内膜厚度;检测治疗前后CD3+、CD4+和CD8+水平,并进行安全性评价。结果:治疗后两组患者Kupperman评分和肾阴虚证评分均显著下降,差异有统计学意义(P<0.01),治疗后观察组Kupperman评分和肾阴虚证评分均低于对照组,差异有统计学意义(P<0.01);治疗后观察组FSH和LH水平低于对照组,差异有统计学意义(P<0.01),E2水平高于对照组,差异有统计学意义(P<0.01);治疗后两组患者MOD和子宫内膜厚度均较治疗前增加,观察组增加更为显著,两组比较,差异有统计学意义(P<0.01),治疗后两组患者PSV较治疗前增多,治疗后观察组PSV多于对照组,差异有统计学意义(P<0.01);治疗后观察组CD3+和CD4+水平高于对照组,CD8+水平低于对照组,差异有统计学意义(P<0.01);未发现与中药相关不良反应,两组均没有严重不良事件发生。结论:大补阴丸加减方联合克龄蒙治疗卵巢早衰肾阴虚证患者,能改善症状,纠正性激素的紊乱,促进卵巢功能恢复,调节机体免疫机能,且安全性好。

Objective ： To observe the clinical efficacy of Da Bu Yin Pill combined with Climen in treatment of Premature Ovarian Failure with Kidney Yin Deficiency Syndrome and the effect on ovarian reserve and immune function of patients. Methods ：120 pa-tients were randomly divided into control group and observation group, with 60 cases in each group. The control group was treated with Clime,while the observation group was treat with modified Da Bu Yin Pill in addition to that of the control group,with the pre- scription as follows ： Rehmannia 30 g, Anemarrhena 15 g, Treats 10 g, Turtle shell 30 g, Ligustrum lucidum 20 g, Littoralis 20 g, Epimedium 15 g, Salvia 20 g, Mulberry 20 g, Caulis 30 g, Comus 10 g, Polygonatum 30 g. Both groups of patients experienced 4 menstrual cycles, which was 2 courses of treatment. Before and after treatment, Kupperman Symptoms scores and Kidney Yin Defi- ciency Syndrome scores,follicle stimulating hormone （FSH） ,luteinizing hormone （LH）, estradiol E2 levels, mean ovarian diame- ter （ MOD）, peak systolic velocity （ PSV）, endometrial thickness, CD3 ＋ , CD4 ＋ and CD8＋ levels of both groups were detected and safety evaluation was made. Results ： After treatment, the Kupperman scores and the Kidney Yin Deficiency syndrome scores of pa- tients in both groups significantly decreased,the differences were statistically significant respectively （P 〈 0.01 ）. After treatment the Kupperman scores and the Kidney Yin Deficiency syndrome scores of observation group were significantly lower than that of the control group respectively （P 〈 0. 01 ）. After treatment, the FSH and LH level of the observation group was significantly lower while the E2 level was significantly higher than that of the control group respectively （P 〈 0.01 ）,, the difference was statistically significant （P 〈 0.01 ）. After treatment, the MOD, the endometrial thickness and PSV of the observation group increased signifi- cantly than that of the observation group （P 〈 0.01 ）. After treatment, CD3＋ and CD4 ＋ level of the observation group was signifi- cantly higher than that of the control group respectively, while CD8 ＋ level was significant lower than that of the control group （P 〈0. 01 ）. There was no adverse reaction which was associated with traditional Chinese medicine and there was no serious ad- verse event in both groups. Conclusion ： Da Bu Yin Pill combined with Climen can effectively improve the clinical symptoms of pa- tients with Premature Ovarian Failure with Kidney Yin Deficiency Syndrome with safety, by correcting hormone disorders, promo- ting ovarian function recovery, regulating immune function.