ABSTRACT
Objective::To observe the efficacy of modified Shoutaiwan on recurrent abortion due to prethrombotic status with kidney deficiency and blood stasis and investigate its effect on coagulation factors. Method::The 100 cases were randomly divided into control group and observation group, 50 cases in each group. Bushen Yangxue capsule + enoxaparin sodium were given in control group, while modified Shoutaiwan + enoxaparin sodium were given in observation group, with a treatment course of 60 d in both groups. The serum clotting factor activated protein S (PS), activated protein C (PC), platelet aggregation function (PAF), platelet aggregation rate (PagT), antithrombin (AT), lupus anticoagulant material positive positive predictive value (LA), anti cardiolipin antibody positive rate of positive predictive value (ACA), plasminogen activator inhibitor-1(PAI-1), tissue factor (TF), fibrinogen (Fig), fibrinogen (FIB), fibrinogen alpha granule membrane glycoprotein-140 (GMP-140), fibrinogen fragment (F1+ 2), tissue fibrinogen activation factor (t-PA), D-dimer (D-D), activated partial thromboplastin time (APTT), prothrombin time (PT), and thrombin time (TT) were observed. Clinical efficacy, pregnancy rate, traditional Chinese medicine(TCM) syndromes and adverse reactions were compared between the two groups. Result::4 cases withdrew from the study. The total effective rate in observation group was 97.9% (48/49), higher than 85.1% (40/47) in control group (χ2=5.713, P<0.05). The pregnancy rate in observation group was 89.8% (44/49), higher than 70.2% (33/47) in control group (χ2=6.351, P<0.05). The score of traditional Chinese medicine syndromes in observation group was lower than that in control group. The indexes of PS, PC, AT, TF, Fig, FPA, APTT and TT in observation group were significantly higher than those in control group (P<0.05), while PAF, PagT, LA, ACA, PAI-1, PAP, TAT, FIB, GMP-140, F1+ 2, t-PA, D-D and PT were lower than those in control group (P<0.05). The incidence of adverse reactions in observation group was 10.2% (5/49), lower than 35.4% (17/48) in control group (P<0.05). Conclusion::Modified Shoutaiwan can effectively improve the clinical symptoms of recurrent abortion due to prethrombotic status and improve the coagulation factors in patients with kidney deficiency and blood stasis.
ABSTRACT
Objective:To observe the immune factors， coagulation and curative effect of modified Shoutaiwan with Si Junzitang combined with dydrogesterone tablets in advanced age patients with early threatened abortion， and to explore its mechanism of action. Method:The 90 advanced age patients with threatened abortion and kidney deficiency and blood stasis syndrome differentiation in traditional Chinese medicine （TCM） were randomly divided into control group and observation group by random number table， with 45 cases in each group. Both groups took oral dydrogesterone tablets for luteal support. The control group additionally received natural vitamin E soft capsules by oral administration， while observation group received modified Shoutaiwan with Si Junzitang. The course of treatment was 10 days in both groups. The clinical efficacy， TCM syndrome score， immune factors and coagulation factors of the two groups were compared before and after treatment. Result:There was no statistically significant difference in TCM symptom scores， immune factors， and coagulation factors between two groups before treatment. After treatment， the scores of TCM syndromes were reduced in both groups （P<0.05）， the proportion of helper T lymphocyte （Th）， Th/Ts ratio， D-dimer （D-D） level and fibrinogen （FIB） were reduced while prothrombin time （PT） and the ratio of suppressor T lymphocyte （Ts） were increased in observation group （P<0.05）. After treatment， the proportion of Th， Th/Ts， D-D， and FIB levels in observation group were lower than those in control group， while PT and the proportion of Ts were higher than those in control group （P<0.05）. The proportion of natural killer cells （NK） had no significant change after treatment， also with no significant difference between two groups. The total effective rate was 84.4%（38/45） in observation group， higher than 64.4%（29/45） in control group （χ2=4.398，P<0.05）. There was no obvious adverse reaction in both groups during the treatment. Conclusion:Modified Shoutaiwan with Si Junzitang combined with dydrogesterone tablets can improve symptoms and the therapeutic effect for fetal protection by regulating the immune balance and coagulation function in advanced age patients with threatened abortion.