孕康口服液联合地屈孕酮及低分子肝素治疗复发性流产合并血栓前状态孕妇的疗效

The efficacy of Yunkang oral liquid combined with dexamethasone and low-molecular-weight heparin in the treatment of recurrent miscarriage complicated with prethrombotic state in pregnant women

目的探讨孕康口服液联合地屈孕酮及低分子肝素治疗复发性流产(RSA)合并血栓前状态(PTS)的临床疗效以及其对患者血栓弹力图和血清孕酮、β-人绒毛膜促性腺激素(β-hCG)、辅助性T细胞(Th)1/Th2细胞因子水平的影响。方法前瞻性选取2015年1月至2020年12月保定市第二中心医院收治的94例RSA合并PTS患者,以随机数字表法分为两组,每组各47例。对照组给予地屈孕酮联合低分子肝素治疗,观察组在对照组基础上加用孕康口服液治疗。连续治疗至孕12周评价两组疗效以及观察两组不良反应情况。比较治疗前后两组血栓弹力图参数[血凝块形成时间(K值)、凝血反应时间(R值)、血凝块形成速率(α角)、血凝块最大强度(MA值)和凝血综合指数(CI)],以及血清孕酮、β-hCG、Th1/Th2细胞因子水平。并随访两组妊娠结局。结果观察组总有效率[95.7%(45/47)]显著高于对照组[83.0%(39/47),P<0.05]。治疗后,两组K、R值较治疗前均显著延长(均P<0.05),α角、MA值、CI值较治疗前均显著减小(均P<0.05);且治疗后,观察组K、R值均显著长于对照组(均P<0.05),α角、MA值、CI值均显著小于对照组(均P<0.05)。治疗后,两组血清孕酮、β-hCG水平均显著高于治疗前(均P<0.05),且治疗后观察组血清孕酮、β-hCG均高于对照组(均P<0.05)。治疗后,两组血清Th1细胞因子[干扰素γ(INF-γ)、肿瘤坏死因子-α(TNF-α)]水平较治疗前均显著下降(均P<0.05),血清Th2细胞因子[白细胞介素(IL)-4、IL-10]水平较治疗前均显著升高(均P<0.05);且治疗后,观察组血清IFN-γ、TNF-α水平均显著低于对照组(均P<0.05),血清IL-4、IL-10水平均显著高于对照组(均P<0.05)。观察组活产率为87.2%(41/47),高于对照组[70.2%(33/47)](P<0.05)。观察组不良反应发生率[6.4%(3/47)]与对照组[4.3%(2/47)]比较差异无统计学意义(P>0.05)。结论孕康口服液联合地屈孕酮及低分子肝素治疗RSA合并PTS能显著缓解患者血液高凝状态、提高生殖内分泌激素水平及调节Th1/Th2细胞因子平衡,提高活产率及临床疗效,且安全可靠。

Objective To investigate the clinical efficacy of Yunkang oral liquid combined with dexamethasone and low-molecular-weight heparin in the treatment of recurrent spontaneous abortion(RSA)complicated with pre thrombotic state(PTS),and its effects on thromboelastogram and serum progesterone,β-human chorionic gonadotropin(β-hCG),and helper T cell(Th)1/Th2 cytokine levels in patients with recurrent spontaneous abortion(RSA).Methods A prospective selection of 94 RSA patients with PTS admitted to the Baoding Second Central Hospital from January 2015 to December 2020 was conducted.They were randomly divided into two groups using a random number table method,with 47 patients in each group.The control group was treated with dexamethasone combined with low molecular weight heparin,while the observation group was treated with Yunkang oral liquid in addition to the control group.Continuously treat until 12 weeks of pregnancy to evaluate the efficacy of both groups and observe the adverse reactions in both groups.Two sets of thromboelastogram parameters were compared before and after treatment,including clot formation time(K value),clot reaction time(R value),and clot formation rate(αangle),maximum clot strength(MA value),and coagulation comprehensive index(CI),as well as serum progesteroneβ-hCG,Th1/Th2 cytokine levels.The pregnancy outcomes of the two groups were followed up.Results The total effective rate of the observation group[95.7%(45/47)]was significantly higher than that of the control group[83.0%(39/47),P<0.05].After treatment,the K and R values of both groups were significantly prolonged compared to before treatment(all P<0.05),the angleα,MA value,and CI value were significantly reduced compared to those before treatment(all P<0.05);After treatment,the K and R values in the observation group were significantly longer than those in the control group(al P<0.05),The angleα,MA value,and CI value were significantly lower than those of the control group(all P<0.05).After treatment,the levels ofβ-hCG serum progesterone of the two groups were significantly higher than those before treatment(all P<0.05),and Theβ-hCG levels of the serum progesterone were all higher than those in the control group(all P<0.05).After treatment,The levels serum Th1 cytokines[interferon-γ(INF-γ),tumor necrosis factor-α(TNF-α)]of both groups were significantly decreased compared to those before treatment(all P<0.05),and the levels of serum Th2 cytokines[interleukin-4,IL-10]were significantly increased compared to those before treatment(all P<0.05);After treatment,the observation group's serum IFN-γ,TNF-αwere significantly lower than those of the control group(all P<0.05),and The levels of serum IL-4 and IL-10 were significantly higher than those of the control group all P<0.05).The live birth rate of the observation group was 87.2%(41/47),which was higher than that of the control group[70.2%(33/47)](P<0.05).There was no statistically significant difference in the adverse reaction rate between the observation group[6.4%(3/47)]and the control group[4.3%(2/47)](P>0.05).Conclusions The treatment of RSA combined with PTS with Yunkang oral liquid,dexmedroxyprogesterone,and low molecular weight heparin can significantly alleviate blood hypercoagulability,increase reproductive endocrine hormone levels,regulate Th1/Th2 cytokine balance,improve live birth rate and clinical efficacy,and is safe and reliable.