Effect of <italic style="font-style: italic">HE</italic>’<italic style="font-style: italic">s Yangchao</italic> Granule combined with acupuncture in treating infertile patients with diminished ovarian reserve with kidney deficiency syndrome: a randomized, double-blind, controlled trial

WANG Ling; MA Jing; XU Jiayu; ZHANG Han; GONG Yan; DU Tingting; MA Yang; JIN Shuo; ZHANG Qin

doi:10.3969/j.issn.1006-2157.2023.09.005

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Effect of HE’s Yangchao Granule combined with acupuncture in treating infertile patients with diminished ovarian reserve with kidney deficiency syndrome: a randomized, double-blind, controlled trial

Special Theme: TCM Prevention and Treatment of Gynecologic Diseases | 更新时间：2023-10-09

- Effect of HE’s Yangchao Granule combined with acupuncture in treating infertile patients with diminished ovarian reserve with kidney deficiency syndrome: a randomized, double-blind, controlled trial
- Journal of Beijing University of Traditional Chinese Medicine Vol. 46, Issue 9, Pages: 1218-1226(2023)
- 作者机构：
  
  浙江中医药大学附属杭州市中医院　杭州　310007
- 作者简介：
  
  Prof. ZHANG Qin, Chief Physician, Doctoral Supervisor. Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University, No.453, Tiyuchang Road, Xihu District, Hangzhou 310007. E-mail: zhaqin01@163.com.
- 基金信息：
  
  Key R & D Program of Zhejiang Province(2019C03086);Traditional Chinese Medicine Modernization Special Project of Traditional Chinese Medicine Science and Technology Plan of Zhejiang Province(20GZS20220221ZX012);Traditional Chinese Medicine Innovation Team of Zhejiang Province(2022SJCXTD);Construction Project of National Famous Old Chinese Medicine Experts Inheritance Studio of State Administration of Traditional Chinese Medicine(国中医药人教函〔2022〕75号)
- DOI：10.3969/j.issn.1006-2157.2023.09.005
  CLC： R271.9
- Received：17 February 2023，
  
  Online First：11 July 2023，
  
  Published：30 September 2023
- 稿件说明：
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WANG Ling, MA Jing, XU Jiayu, et al. Effect of HE’s Yangchao Granule combined with acupuncture in treating infertile patients with diminished ovarian reserve with kidney deficiency syndrome: a randomized, double-blind, controlled trial[J]. Journal of Beijing University of Traditional Chinese Medicine, 2023, 46(9): 1218-1226. DOI: 10.3969/j.issn.1006-2157.2023.09.005.
DOI：

WANG Ling, MA Jing, XU Jiayu, et al. Effect of HE’s Yangchao Granule combined with acupuncture in treating infertile patients with diminished ovarian reserve with kidney deficiency syndrome: a randomized, double-blind, controlled trial[J]. Journal of Beijing University of Traditional Chinese Medicine, 2023, 46(9): 1218-1226. DOI: 10.3969/j.issn.1006-2157.2023.09.005. DOI：

摘要

目的

评估何氏养巢颗粒联合针灸治疗卵巢储备功能减退(DOR)伴不孕症肾虚证患者的疗效。

方法

使用随机、双盲、对照的临床试验方法，纳入120例DOR伴不孕症肾虚证患者，按1∶1∶1∶1的比例随机分配到何氏养巢颗粒＋假针灸组、安慰剂＋针灸组、何氏养巢颗粒＋针灸组、安慰剂＋假针灸组，每组各30例。1个月经周期为1个疗程，所有患者接受3个疗程治疗，治疗结束后随访3个月。治疗前及每个疗程结束后月经周期第2～3天，静脉血检测患者抗米勒管激素(AMH)、卵泡刺激素(FSH)含量及FSH/黄体生成素(LH)值，超声检查窦卵泡计数(AFC)。治疗前及每个疗程结束后月经周期第5天，计算患者中医证候积分、月经失血图评分。治疗结束后3个月，进行妊娠情况随访。

结果

3个疗程后，与安慰剂＋假针灸组比较，何氏养巢颗粒＋针灸组AMH升高(

0.05)、AFC增多(

0.05)，FSH及FSH/LH值下降(

0.05)。3个疗程后，与安慰剂＋假针灸组比较，何氏养巢颗粒＋针灸组、安慰剂＋针灸组、何氏养巢颗粒＋假针灸组月经失血图评分均升高(

0.05)，中医证候积分均下降(

0.05)。

结论

针药结合、单纯针灸、单纯何氏养巢颗粒在改善DOR伴不孕症肾虚证患者的中医症状、月经量方面均有一定疗效。针药结合可明显提高DOR伴不孕症肾虚证患者AMH含量、降低FSH含量及FSH/LH值、增加AFC数量，比单纯何氏养巢颗粒或针灸效果更佳。

Abstract

Objective

To evaluate the efficacy of

’

s Yangchao

Granule(HSYC) combined with acupuncture for infertile patients with diminished ovarian reserve(DOR) with kidney deficiency syndrome.

Methods

This was a randomized

double-blinded

controlled clinical trial. A total of 120 infertile patients with DOR with kidney deficiency syndrome were randomly assigned into the HSYC+ sham-acupuncture group

placebo+ acupuncture group

HSYC+ acupuncture group

and placebo+ sham-acupuncture group at a 1∶1∶1∶1 ratio

with 30 patients each group. One menstrual cycle was one course of treatment

and all participants received three courses of treatment and were followed for an additional three months. Before and after each treatment course

anti-Müllerian hormone(AMH)

follicle stimulating hormone(FSH)

and the value of FSH/luteinizing hormone(LH) were measured on the second or third day of menstruation through blood tests. Meanwhile

the antral follicle count(AFC) was examined by ultrasound. Before and after each treatment course

the traditional Chinese medicine(TCM) syndrome score and menstrual blood loss map score were calculated on the fifth day of menstruation. Besides

the pregnancy condition was followed three months after treatment.

Results

After three courses of treatment

compared with the placebo+ sham-acupuncture group

AMH was increased(

0.05)

AFC was increased(

0.05)

FSH and FSH/LH were decreased(

0.05) in the HSYC+ acupuncture group. After three courses of treatment

compared with the placebo+ sham-acupuncture group

the menstrual blood loss map score was increased(

0.05)

and the TCM syndrome score was decreased(

0.05) in the HSYC+ acupuncture

placebo+ acupuncture

and HSYC+ sham-acupuncture group.

Conclusion

The combination of HSYC and acupuncture

or acupuncture

or HSYC has a certain effect on improving the TCM symptoms and menstrual blood volume of infertile patients with DOR with kidney deficiency syndrome. The combination of HSYC and acupuncture can significantly increase the level of AMH

reduce the level of FSH and the value of FSH/LH

and increase AFC of infertile patients with DOR with kidney deficiency syndrome

which is better than the effects of HSYC or acupuncture treatment alone.

关键词

Keywords

references

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Effect of HE’s Yangchao Granule combined with acupuncture in treating infertile patients with diminished ovarian reserve with kidney deficiency syndrome: a randomized, double-blind, controlled trial

DOI：10.3969/j.issn.1006-2157.2023.09.005

摘要

Abstract

关键词

Keywords

references