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浙江中医药大学附属杭州市中医院 杭州 310007
王玲,女,在读硕士生
# 章勤,女,主任医师,教授,博士生导师,主要研究方向:中西医结合诊治妇科疾病,E-mail:zhaqin01@163.com
收稿日期:2023-02-17,
网络出版日期:2023-07-11,
纸质出版日期:2023-09-30
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王玲, 马景, 许嘉瑜, 等. 何氏养巢颗粒联合针灸治疗卵巢储备功能减退伴不孕症肾虚证患者的随机双盲对照研究[J]. 北京中医药大学学报, 2023,46(9):1218-1226.
WANG Ling, MA Jing, XU Jiayu, et al. Effect of
王玲, 马景, 许嘉瑜, 等. 何氏养巢颗粒联合针灸治疗卵巢储备功能减退伴不孕症肾虚证患者的随机双盲对照研究[J]. 北京中医药大学学报, 2023,46(9):1218-1226. DOI: 10.3969/j.issn.1006-2157.2023.09.005.
WANG Ling, MA Jing, XU Jiayu, et al. Effect of
目的
2
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
2
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
2
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(
P
<
0.05)、AFC增多(
P
<
0.05),FSH及FSH/LH值下降(
P
<
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(
P
<
0.05),中医证候积分均下降(
P
<
0.05)。
结论
2
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。
Objective
2
To evaluate the efficacy of
HE
’
s Yangchao
Granule(HSYC) combined with acupuncture for infertile patients with diminished ovarian reserve(DOR) with kidney deficiency syndrome.
Methods
2
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
2
After three courses of treatment
compared with the placebo+ sham-acupuncture group
AMH was increased(
P
<
0.05)
AFC was increased(
P
<
0.05)
FSH and FSH/LH were decreased(
P
<
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(
P
<
0.05)
and the TCM syndrome score was decreased(
P
<
0.05) in the HSYC+ acupuncture
placebo+ acupuncture
and HSYC+ sham-acupuncture group.
Conclusion
2
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.
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