十补丸加味治疗脾肾阳虚型卵巢功能早衰的疗效及作用机制

Efficacy of Shibuwan Jiawei in Treating Premature Ovarian Failure with Syndrome of Yang Deficiency of Spleen and Kidney and Its Mechanism

目的：探讨十补丸加味治疗脾肾阳虚型卵巢功能早衰（POF）的疗效及对Thl7和Treg平衡及其相关细胞因子水平的凋整作用。方法：将就诊的POF患者122例，采用区组随机按数字表法分为对照组和观察组各61例。对照组采用雌孕激素序贯疗法，口服戊酸雌二醇片，1g／次，鲥，连续治疗21d，最后10d加黄体酮胶丸，200mg／次，1次／d。观察组在对照组治疗的基础上内服十补丸加味治疗，1剂／d。两组连续治疗6周。比较两组脾肾阳虚证症状，Kupperman评分、血清中卵泡刺激素（FSH），雌二醇（E2），黄体生成素（LH）水平及临床疗效。检测两组外周血中Treg和Thl7及血清中白细胞介素（IL）-6，IL-21，干扰素（IFN）-γ和转化生长因子（TGF）-β，水平。结果：观察组脾肾阳虚证症状各指标评分均明显低于对照组（P〈O．01）。治疗后3周和6周，观察组Kupperman评分均明显低于对照组（P〈0．01）。观察组患者血清FSH和LH水平均低于对照组，E2水平高于对照组（P〈0．01）。观察组患者临床总有效率为88．33％，高于对照组71．19％（P〈0．05）。治疗后，观察组外周血Treg水平显著高于对照组，Thl7低于对照组（P〈0．01）。观察组治疗后血清中IL-6，IL-21，IFN-γ水平均明显低于对照组，TGFlB，多于对照组（P〈0．01）。结论：十补丸加味治疗脾肾阳虚型POF可调整患者激素水平，改善临床症状，可能与调整Treg和Thl7平衡及其相关细胞因子水平有关。

Objective ： To investigate the efficacy of Shibuwan jiawei in treating premature ovarian failure （POF） with syndrome of yang deficiency of spleen and kidney and regulating the balance of Treg and Th17 and relevant cytokine level. Method： Totally 122 POF cases were randomly divided into control group and observation group by random number table, with 61 cases in each group. Control group was given the progesterone sequential therapy, orally administered with estradiol valerate tablets, 1 g/time, qd, for 21 days, and also took progesterone pills, 200 mg/time, qd, from the 12th days to the 21st days. In addition to the therapy of control group, observation group was treated with Shibuwan jiawei, 1 dose/day, bid. The courses of treatment were 6 weeks for both groups. Syndromes of Yang deficiency of spleen and kidney, Kupperman scores, serum follicle-stimulating hormone （FSH） , estradiol （E2） and luteinizing hormone （LH） and efficacy were compared between two groups. Treg and Thl7 in peripheral blood and serum interleukin （IL） -6, IL-21, interferon （IFN）-T and transformation growth factor （TGF） -ill in both groups were detected. Result： After treatment, scores of syndrome of Yang deficiency of spleen and kidney of observation group were obviously lower than those of control group （P 〈 0.01 ）. 3 weeks and 6 weeks after treatment, Kupperman score of observation group was remarkably lower than that of control group （P 〈 O. O1 ）. After treatment, serum FSH and LH of observation group were evidently lower, while E2was evidently higher than those of control group （P 〈 O. 01 ）. Total efficacy rate of observation group was 88.33% , which was higher than 71.19% of control group （P 〈 0.05）. After treatment, Treg in peripheral blood of observation group was higher, while Thl7 cell was lower than that of control group （P 〈 0.01 ）. Serum IL-6, IL-21 , IFN-γ of observation group were evidently lower, while TGF-β was higher than those of control group （P 〈 O. 01 ）. Conclusion： Shibuwan jiawei in treating syndrome of Yang deficiency of spleen and kidney of POF can alleviate clinical symptoms, adjust hormone level, and increase efficacy, which may be related to the adjustment of the balance of Treg and Thl7 and relevant cytokines level.