| Objective To observe the effects of western medicine or western medicine combined with Jiajian Jiaoai Tang on Shenxu Xueyu symptoms,serum C3 a,C5a,TNF-α,IL-1β,D-Di,PAg T level and pregnancy outcomes in patients with obstetric antiphospholipid syndrome.Compare the drug safety of the above mentioned two treatment regimens during pregnancy.Analyze the advantages of Jiajian Jiao Ai Tang combined with Western medicine in the treatment of OAPS.Method A total of 399 pregnant women with Shenxu Xueyu Type who were admitted to the Department of Traditional Chinese Medicine of Maternal and Child Health Hospital of Hubei province from January2014 to January 2018,aged between 21 and 35 years old,who met the diagnostic criteria for Sydney OAPS were selected out.And 50 healthy women with a normal pregnancy history were also selected.Grouping: Healthy women with normal pregnancy history were assigned to the healthy group,and obstetric APS patients diagnosed with Shenxu Xueyu type OAPS were assigned to disease group.Patients in the disease group were divided into western medicine group(low molecular weight heparin + aspirin + folic acid + dydrogesterone)and combination group(Jiajian Jiao Ai Tang + low molecular weight heparin + aspirin + folic acid + dydrogesterone).Patients in the disease group also subgrouped according to the previous pathological pregnancy frequencies(≤ 3 groups,> 3 groups),the type of APL antibody in patients’ serum(type I,type II)and the patient’s mental state(abnormal group,normal group).Drug treatment was started at the time of pregnancy.Peripheral blood C3 a,C5a,TNF-α,IL-1β,D-Di,PAg T,were detected in pre-pregnancy,12 weeks of pregnancy and 24 weeks of pregnancy.Adverse drug events and maternal-fetal outcomes were documented.Results(1)Analysis of non-therapeutic factors:(1)Mental and psychological factors: the patient’s mental state do have no effect on both patient’s live birth rate(r=0.086,P=0.085>0.05),and the incidence of pathological pregnancy(r=0.086,P=0.085>0.05).(2)Previous pathological pregnancy frequencies: There was no significant correlation between the previous pathological pregnancy frequencies and the live birth rate of the patients(r=-0.068,P>0.05),but significantly correlated with the recurrence of pathological pregnancy events after treatements(r=0.124,P< 0.05),and patients have higher previous pathological pregnancy frequencies(“>3 times”group)have a higher re-pathological pregnancy frequencies to “≤3 times”group(P<0.05).(3)serum antibody type: patient serum antibody type can significantly affect the patient’s live birth rate(r = 0.27,P<0.01)and pathological pregnancy rate(r = 0.137,P <0.01).The re-pregnancy live birth rate of patients with type I antibody was significantly lower than that of type II patients(P<0.05);the pathological pregnancy rate of type I patients was significantly higher than that of type II patients(P<0.05).(2)Analysis of treatment factors:(1)Pregnancy outcome: The live birth rate of the combination group(P<0.01)was significantly higher than that of the western medicine group [RR 1.98,95% CI(1.02,3.82)],and the pathological pregnancy rate was significantly lower than that of the western medicine group.[RR 0.32,95% CI(0.18,0.58)].(2)Clinical symptoms: The combination group have relieved the the Shenxu Xueyu Type symptomss in an more effective way than the western medicine group(P<0.05,P<0.01).(3)Serological indicators: The levels of C3 a,C5a,TNF-α,IL-1β,D-Di and PAg T in peripheral blood of women in the disease group before treatment were significantly higher than those in healthy group(P<0.01).After treatments,serum C3 a and C5 a levels in the combination group have a significan decrease in combination group.But no significant decrease was found in Western medicine group(P<0.05).Serum levels of TNF-α,IL-1,D-Di and PAg T were significantly decreased in this two groups.The TNF-α and IL-1 in combination group shew a more obvious decrease than Western medicine group,but there was no significant difference in D-Di and PAg T levels between two groups.(3)adverse drug effects: The risk of gastrointestinal reactions and drug-induced liver and kidney damage,fetal malformation,skin and mucous bleeding(P>0.05),and the risk of vaginal bleeding during pregnancy in two group have no significant difference.(P>0.05).Conclusions(1)Non-therapeutic factors: Mental and psychological factors do not affect the pregnancy outcome of patients after drug treatment.Women who had previous pathological pregnancy were more likely to have a pathological pregnancy after treatment than women with a previous pathological pregnancy.The prognosis(live birth rate,pathological pregnancy rate)of type I antibody in women is worse than that of type II antibody women.(2)Therapeutic factors: The treatment regimen of Jiajian Jiao Ai Tang combined with Western medicine is better than the treatment of western medicine only in improving the pregnancy outcome of patients or improving the quality of life during pregnancy.Moreover,the combination drug regimen does not increase the incidence of adverse drug effects,and was safe for pregnant women.By monitoring serum complement,inflammation,and prethrombotic state related indicators before and after treatment,it was found that the levels of complement activation products and inflammatory factors in OAPS women were significantly higher than those in healthy women.This evidence suggests that complement activation and inflammatory injury may be associated with pathological pregnancy events in OAPS patients.Jiajian Jiao Ai Tang combined with western medicine can significantly inhibit the excessive activation of complement in patients and significantly enhance the anti-inflammatory effect of western medicine.This may be the reason why the combination therapy is better than Western medicine. |
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