| Objective:This study,which used randomized controlled clinical trial method,was guided by the theory of TCM and western medicine.In order to evaluate the efficacy of early intervention in patients with prethrombotic state of RSA,we observed the effects of Chinese Medicine for tonifying kidney and promoting blood circulation combined with aspirin on pregnancy outcome,TCM Syndrome,Life quality and changes of Laboratory indexes.To explore the mechanism of kidney-tonifying and blood-activating herbs combined with low-dose aspirin on prethrombotic state of RSA,we not only formed a comprehensive treatment scheme of traditional Chinese and western medicine but also established a comprehensive evaluation system of disease curative effect-TCM symptoms efficacy-quality of life improvement.Methods: The patients who conform to the diagnosis standard were divided into two groups randomly:one is the treatment group another is the control group.The treatment group was treated with Bushen Huoxue Runtai fang combined with aspirin,and the control group was given aspirin.Two groups both began to medicate three months before conception,one month as a course of treatment,were required in strict contraception.When the prethrombotic state markers were in the normal range,we instruct patients to conceive and allow them to join the group After pregnancy.Each group has 40 cases Continuous served three months for a period of treatment and followed until the end of pregnancy.We made a preliminary investigation on TCM Syndromes of pre-thrombotic status in RSA and had a comparison after treatment between the two-group patients including pregnancy outcomes(living rate,full-term production rate,premature birth rate and abortion rate),TCM Syndrome(TCM symptoms total score,TCM symptoms efficacy),Life quality(life quality scores,improvement of quality of Life)and change living rate,term rate,premature rate and abortion rates of Laboratory indexes(D-dimer,APTT,PT,TT,P and HCG).Results: 1 Epidemiological investigation: There are 196 spontaneous abortions in 80 patients with prethrombotic recurrent abortion,among them,177 early spontaneous abortions(90.30%)and 19 late spontaneous abortions(9.70%).It can be seen most of prethrombotic recurrent abortion occur in the first trimester of pregnancy.The distribution of TCM syndrome types is as follows:47 cases of kidney deficiency and blood stasis syndrome(58.75%),16 cases of kidney qi deficiency syndrome(20.00%),9 cases of spleen and kidney deficiency syndrome(11.25%),6 cases of yin deficiency and blood heat syndrome(7.50%),2 cases of qi and blood deficiency syndrome(2.50%).Kidney deficiency and blood stasis syndrome is the most common.2 pregnancy outcome:In the treatment group,the living rate,full-term production rate,premature birth rate and abortion rate was 90.0%,82.5%,7.5%,10.0%,respectively,the control group was 72.5%,62.5%,10.0%,27.5%,respectively,what we can see is that the treatment’s living rate was much higher(P < 0.05).The full-term production rate was higher than that in the control group(P < 0.05).The abortion rate was lower than that of the control group(P <0.05).The premature birth rate was lower than That of the control group(P > 0.05).In the course of treatment,there are no severe adverse reaction such as allergies,bleeding,peptic ulcers and deformity etc.3 Evaluation of TCM syndrome:(1)comparison of TCM symptom score:The scores of TCM symptoms before treatment and after treatment were 13.19±3.98 and 4.27±3.74 in the treatment group and 13.09±3.42 and 6.52±3.96 in the control group respectively,both two groups’ s TCM symptom score were lower than before(P<0.05),and the treatment group was lower than the control group(P<0.05).(2)comparison of TCM symptoms efficacy:In the treatment group: the apparent effective rate,effective rate,ineffective rate,total effective rate was 20.0%(8 cases),52.5%(21 cases),20.0%(8 cases),7.5%(3 cases),92.5%(37 cases),respectively.In the control group was 7.5%(3 cases),25.0%(10 cases),40.0%(16 cases),27.5%(11 cases),the total effective rate was 72.5%(29 cases),respectively,what we can see is that the treatment’s total effective rate was much higher(P < 0.05).Complete random design of two samples of ordered classified variable data by rank sum test shows combined with the experimental data,the treatment group’s therapeutic effect was much better(P < 0.05).4 Evaluation of quality of life:(1)comparison of evaluation scores of quality of life:In the Treatment group evaluation scores of quality of life before and after treatment was 83.60 ±10.15 and 108 ±14.33 respectively,In the control group was 84.70 ±8.50 and 102 ±8.27 respectively,what we can see is that treatment group’improvement of life quality scores was much better(P < 0.05).(2)Comparison of improvement of quality of living evaluation:In the treatment group,the improvement rate was 80.0%(32 cases)and the non-improvement rate was 20%(8 cases),and 60.0%(24 cases)and 40%(16 cases)in the control group respectively.The treatment group was better than the control group(P < 0.05).5 Relevant laboratory index analysis:After treatment,both two groups’ s the levels of serum D-dimer were decreased,and the treatment group was much better(P < 0.05);the levels of APTT,PT were increased,but the comparison between the two groups was not statistically significant(P > 0.05).the levels of TT were increased,and the treatment group was much better(P < 0.05).There was no significant difference in serum β-HCG between the two groups at the end of the 4th and 10 th week of gestation(P > 0.05),but the serum β-HCG level in the treatment group was much higher at the end of the 6th and 8th week of gestation(P < 0.05).There was no significant difference in serum progesterone level between the two groups at the end of the 4th and 6th week of gestation(P > 0.05),but at the 8th and 10 th week of gestation,the treatment group was higher than was much better(P < 0.05).6 Safety analysis:he safety indexes were not abnormal before and after treatment,which indicated that the treatment scheme was safe.Conclusion: Early abortion is the main prethrombotic abortion in recurrent abortion.The main pathogenesis is kidney deficiency and blood stasis and tonifying the kidney and activating blood circulation should be taken as the major method in the treatment.In this study,Bushen Huoxue Runtai decoction combined with low dose aspirin was better than aspirin group in optimizing pregnancy outcome,improving TCM syndrome and quality of life evaluation.The mechanism of action may be related to the regulation of D-dimer and APTT,PT,TT levels to improve the hypercoagulative blood state,which preventing placental’s microthrombosis.To maintain the normal pregnancy by promoting the secretion of β-HCG,from syncytiotrophoblast of pregnancy and the progesterone,from corpora luteum graviditatis. |
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