首都医科大学 附属北京妇产医院,北京妇幼保健院,北京 100026
黄千千,在读博士,从事中西医结合生殖内分泌研究,E-mail:huangqianqian@mail.ccmu.edu.cn
辛明蔚,博士,主任医师,博士生导师,从事中西医结合生殖内分泌研究,E-mail:xinmingwei@ccmu.edu.cn
收稿:2026-01-15,
修回:2026-04-06,
录用:2026-04-10,
网络首发:2026-08-21,
纸质出版:2026-10-20
移动端阅览
黄千千,韩倩,辛明蔚等.温肾养血方联合子宫内膜微刺激治疗肾虚血瘀证多囊卵巢综合征不孕症的随机对照[J].中国实验方剂学杂志,2026,32(20):181-190.
HUANG Qianqian,HAN Qian,XIN Mingwei,et al.Randomized Controlled Study on Wenshen Yangxue Decoction Plus Endometrial Microstimulation for Polycystic Ovary Syndrome (PCOS) Infertility with Syndrome of Kidney-Yang Deficiency and Blood Stasis[J].Chinese Journal of Experimental Traditional Medical Formulae,2026,32(20):181-190.
黄千千,韩倩,辛明蔚等.温肾养血方联合子宫内膜微刺激治疗肾虚血瘀证多囊卵巢综合征不孕症的随机对照[J].中国实验方剂学杂志,2026,32(20):181-190. DOI: 10.13422/j.cnki.syfjx.20260512.
HUANG Qianqian,HAN Qian,XIN Mingwei,et al.Randomized Controlled Study on Wenshen Yangxue Decoction Plus Endometrial Microstimulation for Polycystic Ovary Syndrome (PCOS) Infertility with Syndrome of Kidney-Yang Deficiency and Blood Stasis[J].Chinese Journal of Experimental Traditional Medical Formulae,2026,32(20):181-190. DOI: 10.13422/j.cnki.syfjx.20260512.
目的
2
评价温肾养血方联合子宫内膜微刺激治疗肾虚血瘀证多囊卵巢综合征(PCOS)不孕患者的临床疗效与安全性。
方法
2
采用随机、阳性药物平行对照、开放性临床研究方法,将符合纳入和排除标准的240例肾虚血瘀证PCOS不孕患者随机分为4组,每组各60例,对照组采用枸橼酸氯米芬(50~100 mg·d
-1
,连服5~10 d)促排卵,温肾组在对照组的基础上加用温肾养血方(早晚各温服250 mL),刺激组在对照组基础上早卵泡期行子宫内膜微刺激,联合组采用枸橼酸氯米芬联合温肾养血方(用药剂量同前)及子宫内膜微刺激,疗程均为3个月经周期。观察各组妊娠率、排卵情况、性激素水平、糖代谢指标、凝血功能、子宫内膜厚度、中医证候评分及不良反应。
结果
2
最终纳入分析239例,其中温肾组59例,其余各组60例。联合组妊娠率为43.3%(26/60),温肾组妊娠率为32.2%(19/60),均显著高于对照组的10%(
χ
2
=17.56,
P
<
0.01)。联合组与温肾组的成熟卵泡率显著高于对照组(
P
<
0.01),温肾组的黄素化率低于对照组(
P
<
0.05)。各组治疗后中医证候积分均较治疗前显著降低(
P
<
0.01),温肾组和联合组中医证候评分较对照组显著改善
(P<
0.01)。4组不良反应发生率差异无统计学意义,均为轻度不良反应。
结论
2
温肾养血方联合子宫内膜微刺激可改善肾虚血瘀证PCOS不孕患者的中医证候,促进卵泡成熟与排出,提高累积妊娠率,安全性良好,可为PCOS不孕的中西医结合治疗提供新的临床证据。
Objective
2
To evaluate the clinical efficacy and safety of Wenshen Yangxue decoction combined with endometrial microstimulation in the treatment of infertile patients with polycystic ovary syndrome (PCOS, syndrome of kidney-Yang deficiency and blood stasis).
Methods
2
A randomized, positive-drug parallel-controlled, open-label clinical study was conducted. A total of 240 infertile PCOS patients with the syndrome of kidney-Yang deficiency and blood s
tasis who met the inclusion and exclusion criteria were randomly assigned into 4 groups, with 60 patients in each group. The control group was treated with clomiphene citrate (50-100 mg·d
-
¹, orally for 5-10 consecutive days) for ovulation induction. On the basis of the therapy in the control group, the Wenshen group was additionally treated with Wenshen Yangxue decoction (250 mL, warm oral administration, twice daily, in the morning and evening), and the stimulation group received endometrial microstimulation during the early follicular phase. The combined group was treated with clomiphene citrate plus Wenshen Yangxue decoction (at the same dosages as aforementioned) and endometrial microstimulation. The course of treatment for all the groups was 3 menstrual cycles. The pregnancy rate, ovulation status, sex hormone levels, glucose metabolism indicators, coagulation function, endometrial thickness, traditional Chinese medicine (TCM) symptom scores, and adverse reactions were observed in each group.
Results
2
A total of 239 patients were included in the final analysis, with 59 patients in the Wenshen group and 60 patients in each of the other three groups. The pregnancy rates were 43.3%(26/60) in the combined group and 32.2%(19/60) in the Wenshen group, both significantly higher than that (10%) in the control group (
χ
2
=17.56,
P
<
0.01). Compared with the control group, the combined and Wenshen groups had increased mature follicle rates (
P
<
0.01), while the Wenshen group showed a decreased luteinization rate (
P
<
0.05). All the groups exhibited significant reductions in TCM symptom scores after treatment, and the Wenshen and combined groups had lower scores than the control group (
P
<
0.01). No statistically significant difference was found in the incidence of adverse events among the four groups, and all the adverse events were mild.
Conclusion
2
Wenshen Yangxue decoction combined with endometrial microstimulation can alleviate the TCM symptoms of infertile PCOS patients with the syndrome of kidney-Yang deficiency and blood stasis, promote follicular maturation and ovulation, increase the cumulative pregnancy rate, and has good safety. It can provide new clinical evidence for the integrated traditional Chinese and Western medicine treatment of PCOS infertility.
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