Objective:To investigate the maternal and fetal immune tolerance effect mediated by human leukocyte antigen-G (HLA-G) in the early threatened abortion patients given by Zishen-Yutai pills.Methods:The current study was a single-blind randomized controlled trial. Totally 150 early threatened abortion patients were enrolled into this study, who had received outpatient and inpatient treatment in the Second Department of Gynecology, Suzhou Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine from January 2018 to December 2019. Randomization was used according to a randomized number which was generated by computer. Patients were divided into the Zishen-Yutai Pills group ( n=50), Bushen-Jianpi Recipe group ( n=50) and Dydrogesterone Tablets group ( n=50). They were treated until 12 weeks of gestation. Primary indicators were serum HLA-G and pregnancy outcome; minor indicators were: 1) level of CD4, CD8, CD4/CD8, natural killer (NK) cells; 2) level of serum oestradiol, progesterone, human chorionic hormone (hCG); 3) ultrasound situation of pelvic; 4) symptom scores of Traditional Chinese Medicine. Results:1) The HLA-G levels of the three groups were all increased after the treatment (all P<0.05), which were higher in Zishen-Yutai Pills group [(352.54±102.40) IU/mL] and Bushen-Jianpi Recipe group [(353.76±98.92) IU/mL] than in Dydrogesterone Tablets group [(306.90±60.74) IU/mL; P=0.024, P=0.016)]. There was no statistical significant difference between Zishen-Yutai Pills group and Bushen-Jianpi Recipe group ( P>0.05). 2) The CD4 levels of the Zishen-Yutai Pills group (34.82%±6.99%) and the Bushen-Jianpi Recipe group (36.10%±6.44%) were decreased after the treatment (37.66%±7.43%, P=0.004; 39.72%±7.07%, P<0.001). The CD8 levels of the three groups were all decreased after the treatment (all P<0.05),which decreased obviously in Zishen-Yutai Pills group (20.40%±4.12%) and Bushen-Jianpi Recipe group (19.92%±4.68%) compared with Dydrogesterone Tablets group (24.06%±5.29%; P<0.001, P<0.001). The CD4/CD8 levels of the three groups were all increased ( P<0.001, P<0.001, P=0.001), which were statisticaly higher in Bushen-Jianpi Recipe group (1.94±0.65) than in Dydrogesterone Tablets group (1.64±0.50) after the treatment ( P=0.044). The NK cell levels of Zishen-Yutai Pills group (10.78%±2.79%) and Bushen-Jianpi Recipe group (10.70%±3.22%) were all decreased after the treatment (14.36%±3.73%, 15.12%±6.06%; all P<0.001), which were significantly lower than that in Dydrogesterone Tablets group (14.03%±5.48%; P=0.001 , P=0.001). 3) The serum estradiol, progesterone, hCG levels of the three groups were all increased after the treatment (all P<0.001), the progesterone level of Zishen-Yutai Pills group [(33.20±6.19) ng/L] and Bushen-Jianpi Recipe group [(33.92±7.83) ng/L] was statistically significantly different from that of Dydrogesterone Tablets group [(25.56±6.06) ng/L; P<0.001, P<0.001]. 4) The TCM symptoms′ scores of the three groups were all decreased after the treatment (all P<0.001), while it was lower in Zishen-Yutai Pills group [2.00(1.25)] than that in Bushen-Jianpi Recipe group [3.00(2.00)] and Dydrogesterone Tablets group [9.00(2.00)] ( P=0.002, P<0.001). 5) The clinical pregnancy outcome of the three groups had no significant difference ( P>0.05). Conclusion:The Zishen-Yutai pills can mediate maternal and fetal immune tolerance by upregulating HLA-G level, and improve the pregnancy outcome. Its clinical effect was similar to that of the Bushen-Jianpi Recipe, and better than that of the Dydrogesterone Tablets. It is worth popularizing in the treatment of early threatened abortion because of its definite clinical effect, convenient to carry and take.

Objective:To investigate the maternal and fetal immune tolerance effect mediated by human leukocyte antigen-G (HLA-G) in the early threatened abortion patients given by Zishen-Yutai pills.Methods:The current study was a single-blind randomized controlled trial. Totally 150 early threatened abortion patients were enrolled into this study, who had received outpatient and inpatient treatment in the Second Department of Gynecology, Suzhou Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine from January 2018 to December 2019. Randomization was used according to a randomized number which was generated by computer. Patients were divided into the Zishen-Yutai Pills group ( n=50), Bushen-Jianpi Recipe group ( n=50) and Dydrogesterone Tablets group ( n=50). They were treated until 12 weeks of gestation. Primary indicators were serum HLA-G and pregnancy outcome; minor indicators were: 1) level of CD4, CD8, CD4/CD8, natural killer (NK) cells; 2) level of serum oestradiol, progesterone, human chorionic hormone (hCG); 3) ultrasound situation of pelvic; 4) symptom scores of Traditional Chinese Medicine. Results:1) The HLA-G levels of the three groups were all increased after the treatment (all P<0.05), which were higher in Zishen-Yutai Pills group [(352.54±102.40) IU/mL] and Bushen-Jianpi Recipe group [(353.76±98.92) IU/mL] than in Dydrogesterone Tablets group [(306.90±60.74) IU/mL; P=0.024, P=0.016)]. There was no statistical significant difference between Zishen-Yutai Pills group and Bushen-Jianpi Recipe group ( P>0.05). 2) The CD4 levels of the Zishen-Yutai Pills group (34.82%±6.99%) and the Bushen-Jianpi Recipe group (36.10%±6.44%) were decreased after the treatment (37.66%±7.43%, P=0.004; 39.72%±7.07%, P<0.001). The CD8 levels of the three groups were all decreased after the treatment (all P<0.05),which decreased obviously in Zishen-Yutai Pills group (20.40%±4.12%) and Bushen-Jianpi Recipe group (19.92%±4.68%) compared with Dydrogesterone Tablets group (24.06%±5.29%; P<0.001, P<0.001). The CD4/CD8 levels of the three groups were all increased ( P<0.001, P<0.001, P=0.001), which were statisticaly higher in Bushen-Jianpi Recipe group (1.94±0.65) than in Dydrogesterone Tablets group (1.64±0.50) after the treatment ( P=0.044). The NK cell levels of Zishen-Yutai Pills group (10.78%±2.79%) and Bushen-Jianpi Recipe group (10.70%±3.22%) were all decreased after the treatment (14.36%±3.73%, 15.12%±6.06%; all P<0.001), which were significantly lower than that in Dydrogesterone Tablets group (14.03%±5.48%; P=0.001 , P=0.001). 3) The serum estradiol, progesterone, hCG levels of the three groups were all increased after the treatment (all P<0.001), the progesterone level of Zishen-Yutai Pills group [(33.20±6.19) ng/L] and Bushen-Jianpi Recipe group [(33.92±7.83) ng/L] was statistically significantly different from that of Dydrogesterone Tablets group [(25.56±6.06) ng/L; P<0.001, P<0.001]. 4) The TCM symptoms′ scores of the three groups were all decreased after the treatment (all P<0.001), while it was lower in Zishen-Yutai Pills group [2.00(1.25)] than that in Bushen-Jianpi Recipe group [3.00(2.00)] and Dydrogesterone Tablets group [9.00(2.00)] ( P=0.002, P<0.001). 5) The clinical pregnancy outcome of the three groups had no significant difference ( P>0.05). Conclusion:The Zishen-Yutai pills can mediate maternal and fetal immune tolerance by upregulating HLA-G level, and improve the pregnancy outcome. Its clinical effect was similar to that of the Bushen-Jianpi Recipe, and better than that of the Dydrogesterone Tablets. It is worth popularizing in the treatment of early threatened abortion because of its definite clinical effect, convenient to carry and take.