| Objective:In this study,we evaluated the clinical effect of Antai granules in treating patients with threatened abortionof spleen and kidney yang deficiency by observing the improvement of clinical symptoms,the changes of serum pregnancy hormone(E2、P、β-HCG),CA125 levels;through the detection of Treg water level,we explored the mechanism of Antai granules improving the immune function of threatened abortion patients with spleen and kidney yang deficiency.Methods:From March 2019 to March 2020,60 patients who met the diagnostic criteria of threatened abortion of spleen and kidney yang deficiency in the gynecological clinic of Jiangsu Provincial Hospital of Traditional Chinese Medicine were collected and randomly divided into treatment group and control group by digital table.Treatment group:Antai granules,200ml,orally after breakfast and dinner;progesterone soft capsule,0.1g,2 times/day,orally;control group:progesterone soft capsule,0.1g,2 times/day,orally;4 weeks is a course of treatment,and one course of treatment is observed;after the embryo is formed,the progesterone soft capsule is decremented by conventional methods to discontinue the treatment.Observe changes in TCM syndrome scores,serum pregnancy hormones(E2、P、β-HCG),Treg and serum CA125 levels before and after treatment in the two groups of patients.SPSS26.0 statistical software was used to process and analyze the data to evaluate the clinical efficacy of Antai Granules and explore its mechanism of improving immune tolerance in patients with threatened abortion of spleen and kidney yang deficiency.Results:1.Changes in TCM syndrome scores:TCM syndrome scores before treatment in the treatment group were 11.33 ± 4.44,TCM syndrome scores after treatment were 2.00±4.03;TCM syndrome scores in the control group were 11.17 ± 4.86 before treatment,and TCM syndromes after treatment were 4.07±4.54;after treatment,the TCM syndrome scores of the two groups were significantly lower than before treatment(P<0.01).Comparison between groups:The TCM syndrome score of the treatment group was significantly lower than that of the control group after treatment(P<0.01).2.Changes in serum pregnancy hormone levels:The serum pregnancy hormones(E2,P,β-HCG)of patients in the treatment group before treatment were 580.63±232.24,23.16±6.43,21544.03±21218.51,and the serum pregnancy hormones after treatment were 2289.70±883.99,35.14±5.60,149912.63 ± 60492.73;the serum pregnancy hormones in the control group before treatment were 593.47 ± 195.48,23.81 ± 5.04,19989.83±17090.56,and the serum pregnancy hormones after treatment were 1904.27 ± 237.70,32.56 ± 4.71,121447.23±24634.29;It can be seen from the line chartthat the serum pregnancy hormone levels of the two groups of patients increased with the increase in the number of gestational days,and the increase in the treatment group was greater than that in the control group.Comparison between groups:Serum pregnancy hormone levels in the treatment group were higher than those in the control group after treatment(P<0.05).3.Changes in serum CA125 levels:The serum CA125 value before treatment in patients in the treatment group was 70.24 ± 32.99,the serum CA125 value after treatment was 42.85 ±38.40;the serum CA125 value before treatmentin the control group was 76.24±37.58,and the serum CA125 value after treatmentwas 53.43 ± 48.47;after treatment,the serum CA125 values in both groups were significantly lower than before treatment(P<0.01).Comparison between groups:The serum CA125 of the treatment group was lower than that of the control group(P<0.05).4.Changes in Treg levels:the serum Treg value before treatment in the treatment group was 4.71 ± 1.00,and the serum Treg value after treatment was 7.49 ± 1.68;the serum Treg value before treatment in the control groupwas 4.60 ± 0.91,and the serum Treg value after treatment was 6.59 ± 1.50;the two groups after treatment Treg values were significantly higher than before treatment(P<0.01).Comparison between groups:The Treg value of the treatment group was higher than that of the control group after treatment(P<0.05).5.Comprehensive effect:12 cases(40%)were cured in the treatment group,14 cases(46.67%)were markedly effective,2 cases(6.67%)were effective,and the total effective rate was 93.33%;6 cases(20%)were cured in the control group,9 cases(30%)were markedly effective,11 cases(36.67%)were effective,and the total effective rate was 86.67%.Comparing the two groups,the treatment group was better than the control group(P<0.01).6.Safety observation:blood routine,liver and kidney function(ALT,AST,Cr,BUN)were monitored before and after treatment.No significant abnormalities were seen in the two groups of patients.No significant adverse reactions and side effectswere seen in the two groups of patients during the treatment.Conclusion:The clinical effect of Antai granule in the treatment of threatened abortion with deficiency of spleen and kidney yang is definite.It can not only effectively improve the clinical symptoms,increase the level of serum pregnancy hormone,but also reduce the level of serum CA125,increase the level of Treg,improve the immune tolerance of pregnant women to fetus,and it is safe and non-toxic.The immune mechanism of Antai granule in the treatment of threatened abortion of spleen kidney yang deficiency type may be to improve the level of serum Treg and regulate the immune balance of the body,so as to improve the immune tolerance of pregnant women to the fetus and maintain pregnancy. |
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