Meta-analysis of aspirin-heparin therapy for un-explained recurrent miscarriage

Objective This study was designed to evaluate the efficacy and safety of aspirin-heparin treatment for un-explained recurrent spontaneous abortion(URSA). Methods Literatures reporting the studies on the aspirin-heparin treatment of un-explained recurrent miscarriage with randomized controlled trials(RCTs) were collected from the major publication databases. The live birth rate was used as primary indicator, preterm delivery, preeclampsia, intrauterine growth restriction, and adverse reactions(thrombocytopenia) were used as the secondary indicators. The quality of the included studies was evaluated using RCT bias risk assessment tool in the Cochrane Handbook(v5.1.0). Meta-analysis was conducted using RevM an(v5.3) software. Subgroup analyses were conducted with an appropriately combined model according to the type of the treatments if heterogeneity among the selected studies was detected. Results Six publications of RCTs were included in this study. There were a total of 907 pregnant women with diagnosis of URSA, 367 of them were pooled in the study group with aspirin-heparin therapy and 540 women in the control group with placebo, aspirin or progesterone therapy. Meta-analysis showed that the live birth rate in the study group was significantly different from that in the control group [RR = 1.18, 95% CI(1.00-1.39), P=0.04]. Considering the clinical heterogeneity among the six studies, subgroup analysis were performed. Live birth rates in the aspirin-heparin treated groups and placebo groups were compared and no significant difference was found. There were no significant differences found between the two groups in the incidence of preterm delivery [RR=1.22, 95% CI(0.54-2.76), P=0.64], preeclampsia [RR=0.52, 95% CI(0.25-1.07), P=0.08], intrauterine growth restriction [RR=1.19, 95% CI(0.56-2.52), P=0.45] and thrombocytopenia [RR=1.17, 95% CI(0.09-14.42), P=0.90]. Conclusion This meta-analysis did not provide evidence that aspirin-heparin therapy had beneficial effect on un-explained recurrent miscarriage in terms of live birth rate, but it was relatively safe for it did not increase incidence of adverse pregnancy and adverse events. More well-designed and stratified double-blind RCT, individual-based meta-analysis regarding aspirin-heparin therapy are needed in future.

Relationship between expression of COX-2,TNF-α,IL-6 and autoimmune-type recurrent miscarriage

Objective:To investigate the roles of COX-2,TNF-α,IL-6 in the pathogenesis of autoimmunetype recurrent spontaneous abortion(RSA).Methods:RT-PCR was used to detect the mRNA of COX-2,TNF-α.IL-6 in the trophoblast cells of murine RSA and normal pregnant models.The COX-2,TNF-α.IL-6 protein expressions were determined by using immunohistochemisry staining method.The COX-2,TNF-α,IL-6 protein expressions were determined by ELISA.Results:The embryo loss rates in experiment group was significantly higher than that in normal pregnancy control group,the expression of COX-2,TNF-α,IL-6 in the trophoblast cells of murine RSA and normal pregnant models.The expression of COX-2 in autoimmunetype recurrent spontaneous abortion was significantly lesser than in normal pregnant models.The expression of TNF-α,IL-6 in autoimmune-type recurrent spontaneous abortion was significantly higher than in normal pregnant models.There was a positively correlation between TNF-αand IL-6.There was no relationship between COX-2,TNF-αand IL-6.Conclusions:The abnormal expression of COX-2,TNF-αand IL-6 may result in RSA.

Predicting adverse maternal and perinatal outcome after threatened miscarriage

Objectives: Threatened miscarriage is the most common complication of pregnancy, occurring in 20% - 25% of ongoing pregnancies. The purpose is to study maternal and perinatal outcome in women with threatened miscarriage. Methods: A prospective study was conducted over a period of 20 months in the Department of Obstetrics and Gynaecology, Pannadhay Mahila Chikitsalaya, a tertiary care center in Udaipur, India. It included a cohort of pregnant patients with a history of threatened miscarriage during the first twenty weeks of pregnancy. They were registered, followed up prospectively at antenatal clinics and delivered in the same hospital. For the purpose of comparison, another group of booked patients (controls) without a history of threatened miscarriage were recruited, similarly scanned and followed throughout pregnancy and labour. All women were matched for age, parity, social class, BMI and gestational age at booking. Discrete variables were taken as counts (or frequencies) and were evaluated by Chi-square test. Continuous variables with normal distribution were presented as mean ± standard deviation (SD) and were compared by unpaired Student’s t test. Data were fed into a Microsoft Excel worksheet and were analyzed by using the SPSS ver.17 (SPSS Inc., Chicago, IL, USA). p-value > 0.05 was considered statistically significant. Results: Out of 62 cases, 13 (21%) patients spontaneously aborted after diagnosis of threatened miscarriage. Women with threatened miscarriage had a significantly higher incidence of low lying placenta (p = 0.02) when compared with those without firsttrimester bleeding. They were more likely to experience PROM (p = 0.02), preterm delivery (p = 0.02) and to have babies with low Birthweight (p = 0.03). Conclusion: Pregnancies complicated by threatened miscarriage are at a higher risk for obstetric complications.

Application of “Swanson’s Middle Range Caring Theory” in Sweden after miscarriage

Objective: The aim of this study was to apply Swanson’s Middle Range Caring Theory to the follow-up visit with a midwife for Swedish women who have suffered early miscarriage or received care for late missed miscarriage in preg-nancy week 18-20. Methods: Twenty-five tape recorded interviews with women four weeks after their early miscarriages and thirteen tape recorded semi-structured interviews with midwives and nurses who had the experience of caring for women who have been diagnosed with a missed miscarriage during a routine ultrasound scan. The interviews were transcribed verbatim and interpreted deductively from the text using the theory. Results: Each woman described her personal experience of miscarriage in the relative terms of a human experience. The midwives and nurses described their experiences with women who received care for missed miscarriage. The interviews included information about the treatment provided by the caregivers during the period afterward of the diagnosis. The caregiver attitude was formed from Swanson’s caring categories: “Maintaining belief”, “knowing”, “being with”, “doing for”, “enabling”. Conclusions: Swanson’s Middle Range Caring Theory as applied to the caregiver includes being emotionally present, giving support with respect for the woman’s dignity, being competent, meeting each woman’s own individual needs. Given the proper care after a miscarriage every woman has the power within herself to improve their wellbeing.

A Specific Pattern in the Basal Body Temperature Chart during the First Week of Pregnancy May Warn of a Miscarriage Crisis

We studied the efficiency of acupuncture for patients who were unable to give birth though they had experienced conventional infertility treatment for more than 2 years by medical specialists. We then investigated characteristics of difficult pregnancy cases with measurement of body temperature and observation of basal body temperature (BBT) charts. Thirty-three patients had acupuncture every week for more than 2 years and 17 of them delivered. At the same time, their cutaneous body temperature was measured at five locations. Moreover, patients and acupuncturists had a weekly discussion of the patient’s BBT chart. The delivery group showed more balanced and higher cutaneous body temperatures than the miscarriage and no pregnancy groups. The delivery group showed a smooth increase in the BBT chart while the miscarriage group showed a specific pattern in shifting temperatures from low to high zones. Acupuncture might suppress excess sympathetic dominance, which induced hyperthermia as well as interruption of pregnancy. Additionally, weekly discussion and medical advice could help patients. However, further study of males, healthy women, or larger, comparative studies exploring the social and cultural background of other countries were needed to add support to these factors.

Swedish Women’S Emotional Experience of the First Trimester in a New Pregnancy after One or More Miscarriages: A Qualitative Interview Study

Objectives: The aim of this study was to evaluate how Swedish women describe their emotional state of being during the eighth week through the eleventh week after they have become pregnant again after suffering a previous miscarriage. Method: A qualitative content analysis with an inductive approach has been used to analyze fourteen interviews that served as the data base for this study. The content analysis resulted in the development of five categories which evolved into one primary theme. Findings: The five categories identified were Worry and preoccupation;Distance;managing their feelings;Mourning what is lost;Guarded happiness and expectations. These categories were compiled into a main theme, “Worry consumes a lot of energy, but on the other side lies happiness”. This theme focused on whether the women could feel any happiness about being pregnant again despite their concerns with the previous miscarriage. Conclusions: The emotional states of the women when they get pregnant again are typically characterized by anxiety, worry and concerns about their current pregnancy. The women have a tendency to distance themselves emotionally from their pregnancy but also strive to find the joy of being pregnant again. During the new pregnancy they find themselves in need of support from their family and friends as well as in need of support from the healthcare system.

Intravenous Immunoglobulin Treatment of Recurrent Miscarriage:an Update of Placebo-controlled Trials

Background Immunological disturbances which may be treated with intravenous immunoglobulin (IvIg) play a significant role in the majority of patients with recurrent miscarriage (RM). The present study aimed to review the current knowledge about IvIg treatment in RM primarily based on results from published placebo controlled trials. Seven placebo controlled trials were identified comprising a total of 343 patients. The background variables, the treatment protocols and the results were extremely different between the trials. Among the patients with secondary RM, a meta analysis showed that the pooled odds ratio for live birth among IvIg treated women compared with women infused with placebo was 1.69 (95 % CI = 0.72～3.96, not significant). IvIg also seemed to be efficacious in patients with repeated second trimester intrauterine fetal deaths. A new big placebo controlled trial should be conducted which focus on RM patients with secondary RM or recurrent second trimester fetal deaths. Sufficient IvIg doses should be given with optimal time intervals.

Miscarriage—Evidence Based Information for the Web and Its Development Procedure

Objective: The aim of this paper is to describe the process of developing web information on miscarriage based on scientific evidence, for women and couples in Sweden experiencing miscarriage. Method: A participatory design was used which included researchers, professional experts and users. A participatory design was used involving researchers, professional experts and users. The information was developed in six stages: 1) identifying the needs of information;2) identifying and constructing the main areas of information and its paths;3) identifying and inviting experts for revision;4) developing the text;5) reviewing the text;6) design and structuring for adaption to website. Results: The text of information developed gradually based on the seven steps. The final text comprised three parts: 1) what is miscarriage;2) experiences of miscarriage;3) processing and planning for new pregnancy. Conclusion: Using participatory design was time and resource consuming, however it was functional for producing appropriate information for the target group. The developed evidence based facts text is assumed to be a complement to the information that is provided by the health care system.

Recurrent Miscarriage: Hysteroscopy-Assisted Management

Objective: To apply office hysteroscopy in assessment/management of patients with recurrent miscarriage, thus to/or not to recommend office hysteroscopy as a routine procedure in such cases. Study design: Retrospective analysis. Setting: University hospital’s outpatient abortion clinic. Subjects & Methodology: Patients’ records during the period between March 2015 and January 2017 for subjects with at least 2 previous miscarriages, who had undergone office hysteroscopy were reviewed. Results: Cases with 2 previous miscarriages (n = 95) were assessed and compared with those with 3 or more miscarriages (n = 105). Abnormal uterine findings were diagnosed in 24.1% of the former, and 43.8% of the latter group. The prevalence of uterine lesions among cases with 2 recurrent miscarriages was 42.1%;meanwhile, for subjects with 3 or more consecutive miscarriages, it was 43.8%. Conclusion: In addition to safety profile, simplicity and outpatient basis of use, outpatient hysteroscopy in recurrent miscarriages would be an added-value to practitioners as a diagnostic and therapeutic tool.

Coagulation Factor XII Congenital Deficiency in Women with Recurrent Miscarriage

Factor XII (Hageman factor) is an important protease that plays a major role in the initiation of the intrinsic pathway of blood coagulation and fibrinolysis and kinin formation. It is still unclear whether factor XII deficiency causes any disorders during pregnancy. Because the main clinical feature in patients with factor XII deficiency is thrombosis rather than bleeding, low dose aspirin would be expected to prevent first trimester miscarriage and a decrease in factor XII level itself was found to be an independent risk factor in recurrent miscarriage. The woman in a 31-year-old patient, with personal and family antecedents without interest and preceding obstetrics of two spontaneous abortions in the first quarter of the pregnancy without apparent cause. In the study of infertility practiced emphasizes a partition of not more than one centimetre of length in the uterine found by hysteroscopy exploration and in the study of hipercoagulability a light deficiency of the factor XII. Himself guideline processing with low dose of aspirin (125 mgr/day) and preconception folic acid (5 mgr/day), remains expectant mother and in the week 12 of her third pregnancy itself guideline antitrombotic prophylaxis with heparin of low molecular weight by subcutaneous way. The pregnancy reaches the week 39 without incidents of interest and the expectant mother give birth of spontaneous form to health boy. Repeated abortions may be associated with reduced level of factor XII activity of unknown origin and low-dose aspirin may prevent miscarriage caused for decreased factor XII levels in patients with a history of recurrent first trimester miscarriage.

Abortion, ectopic pregnancy and miscarriages in Sub Saharan Africa: Challenges of Rhesus isoimmunisation in Rhesus negative women

The implementation of a program on routine antenatal anti-D prophylaxis (RAADP) in the developed world has led to a significant decline in the residual numbers of Rhesus negative women becoming sensitized. However, a significant number of Rhesus D negative women in SSA are not fortunate because of lack of access to prophylactic immunoglobulin D and thus they continue to be affected. The management of Rhesus negative pregnancy in Sub-Saharan Africa is associated with several daunting challenges: absence of a policy on universal access to Rh D immunoglobulin, lack of fetomaternal testing facilities, unaffordability of prophylactic anti-D immunoglobulin, poor uptake of quality antenatal care, poor health infrastructure, sub optimal management of potentially sensitizing events during pregnancy, shortage of qualified medical personnel, poor data management, high incidence of illegal abortion and quackery. There is a need for the formulation of necessary guidelines on Rhesus immunoprophylaxis in SSA. Health authorities need to implement evidence-based policy on universal access to anti-D immunoglobulin. There is also the need to optimize the knowledge of obstetricians on anti-D prophylaxis, implementation of the readily available and affordable Kleihauer fetomaternal haemorrhage testing for all women who experience a potentially sensitizing event antenatally post 20 weeks gestation and postnatally. These factors can facilitate the effective management of Rh negative pregnancy in the region and reduce the risk of Rhesus D immunization and Rhesus D haemolytic disease of the foetus and newborn.

A successful birth of severe secondary recurrent miscarriage case after a decline of phosphatidylserine-dependent anti-prothrombin antibody by intravenous immunoglobulin administration

A 33 years old woman was referred to our hospital since her sixth pregnancy had been revealed. In fact, at 19 years of age she had diagnosed as having systemic lupus erythematosus without organ failure. In addition, she had a past history of uncontrollable severe pregnancy-induced hypertension occurred during the second pregnancy, resulting in extremely premature delivery and following postpartum HELLP syndrome. It was so severe that we employed administration of dexamethasone and plasma exchange to ameliorate a life-threatening situation. In the course of her recovery it was revealed that she had been complicated with antiphospholipid antibodies, and at the same time we observed that phosphatidylserine-dependent anti-prothrombin antibody IgG levels were declining as her condition was getting better. There-after, she became pregnant three times, but all pregnancies ended in miscarriage despite administration of prednisolone and anticoagulant therapy. Therefore, we realized that her recurrent miscarriages could not be prevented with generally acceptable therapies, so we tried intravenous immunoglobulin shortly after fetal heart beats were detected. In fact, her sixth pregnancy was going well, but we had to terminate it at the 35th week of gestation due to the onset of HELLP syndrome-like condition. However, she could achieve an almost intact pregnancy outcome without neonatal complications or persistently worsening postpartum HELLP syndrome-like condition. Considering the etiologic relation overlapping between systemic lupus erythematosus, antiphospholipid syndrome and recurrent miscarriage, intravenous immunoglobulin can be one of the treatment options for severe secondary recurrent miscarriage, although the evidence of the treatment is always certain. In addition, a decline of phosphatidylserine-dependent anti-prothrombin antibody IgG levels we observed in this case may represent its therapeutic immunomodulatory effects.

An Automated System for Early Prediction of Miscarriage in the First Trimester Using Machine Learning

Currently, the risk factors of pregnancy loss are increasing andare considered a major challenge because they vary between cases. The earlyprediction of miscarriage can help pregnant ladies to take the needed careand avoid any danger. Therefore, an intelligent automated solution must bedeveloped to predict the risk factors for pregnancy loss at an early stage toassist with accurate and effective diagnosis. Machine learning (ML)-baseddecision support systems are increasingly used in the healthcare sector andhave achieved notable performance and objectiveness in disease predictionand prognosis. Thus, we developed a model to help obstetricians predictthe probability of miscarriage using ML. And support their decisions andexpectations about pregnancy status by providing an easy, automated way topredict miscarriage at early stages using ML tools and techniques. Althoughmany published papers proposed similar models, none of them used Saudiclinical data. Our proposed solution used ML classification algorithms tobuild a miscarriage prediction model. Four classifiers were used in this study:decision tree (DT), random forest (RF), k-nearest neighbor (KNN), andgradient boosting (GB). Accuracy, Precision, Recall, F1-score, and receiveroperating characteristic area under the curve (ROC-AUC) were used to evaluatethe proposed model. The results showed that GB overperformed the otherclassifiers with an accuracy of 93.4% and ROC-AUC of 97%. This proposedmodel can assist in the early identification of at-risk pregnant women to avoidmiscarriage in the first trimester and will improve the healthcare sector inSaudi Arabia.

Histopathologic Profile of Miscarriages during First Trimester of Pregnancy in Teaching Hospital of Grand Yoff in Dakar (Senegal)

Background: Mainly for economic reasons, histopathologic analysis is not a systematic practice in medical structures in Senegal, and the utility of this exam is being questioned by many authors. The purpose of this paper is to report the results of this exam, in our medical practice and try to determine if this exam should be systematic of kept only for individualized cases. Material and Methods: It was a retrospective study from January 2010 to December 2018, carried out in the Laboratory of Pathology of the Teaching Hospital of Grand Yoff in Dakar. The data were collected from the register of pathologic examinations of the laboratory. Results: We registered 543 results of histopathologic examination of products of conception from the first trimester abortion. The women mean age was 22.4 years ± 6.2 with extremes of 17 and 46 years. The routine histopathologic assessment of products of first- trimester miscarriages highlighted in our study three pathologies: hydatidiform mole (24.7%), infection (4.6%) and ectopic pregnancy (0.09%). Only 11.7% of cases of Hydatidiform mole (HM) were suspected before the histopathologic assessment. In our sample, molar pregnancy seems to be higher in anembryonic conception with a prevalence of 45%. The prevalence of Complete Hydatidiform Mole (CHM) was higher than the one of Partial Hydatidiform Mole (PHM) (14.8% vs. 9.9% of miscarriages). Indeed, both require follow up to prevent or manage at time the occurrence of choriocarcinoma. Conclusion: The results of the histologic analysis after abortion in the first trimester of pregnancy show that this exam should be practiced systematically in routine in our context because of high prevalence of hydatidiform mole.

History of recurrent miscarriage in traditional Chinese medicine literature

Recurrent miscarriage （RM） as a gynecological disorder was recognized by traditional Chinese medicine （TCM）practitioners long before the age of modern medicine. TCM physicians reported and recorded RM in the canonical TCMliterature, which dates back more than 1500 years. The first cases of RM as a fertility abnormality were reported inChanjing, which was written during the Nanbei Dynasty of China （420 A.D. – 589 A.D.）. Some prescriptions for thetreatment of RM are still actively used by modern TCM practitioners. In addition, many recent pharmacological andclinical studies have focused on the TCM therapy for RM. To identify the new therapeutic targets for RM and furtherpromote the interest in treating RM with TCM, we reviewed the etiology, pathogenesis, treatment, and prevention of RMdiscussed both in the TCM literature and in contemporary pharmacological and clinical studies.

Overview of genetic causes of recurrent miscarriage and the diagnostic approach

Recurring miscarriage(RM)is a frustrating reproductive complication with variable etiology.Numerous genetic defects have been known to play a crucial role in the etiology of RM.Chromosomal abnormalities are frequently detected,while other genetic defects cannot be diagnosed through routine research,such as cryptic chromosomal anomalies,single nucleotide polymorphism,single-gene defect,and gene copy number variation.Diagnostic laboratories have recently used variable advanced techniques to detect potential genetic abnormalities in couples with RM and/or in products of conception.Here we aim to summarize the known genetic causes of RM,with a focus on the new diagnostic techniques.Knowledge of the genetic profile of miscarriages is important for prognosis and potential counseling planning,as well as the prenatal diagnostic strategy in subsequent pregnancies.

Expression of E2A in Mid-secretory Endometrium of Women Suffering from Recurrent Miscarriage

E2A is involved in promoting forkhead box P3（FOXP3） and retinoid-related orphan receptor gamma t（RORγt） gene transcription, which are pivotal transcription factors of T regulatory cells and Th17 cells, respectively. Little is known about the involvement of E2 A in pregnancy process. This study aimed to investigate the expression of E2 A, cytotoxic T-lymphocyte-associated protein 4（CTLA-4）, and Foxp3 in luteal phase endometrium of women suffering recurrent miscarriage（RM）（n=21） and control group（n=11） by immunohistochemistry, with the Vectra？ automated quantitative pathology imaging system for analysis. The percentage of E2 A＋ cells and CTLA-4＋ cells was significantly higher in the endometrium of women with RM than in the controls. There was positive correlation between E2 A and CTLA-4（r=0.523, P=0.002）, E2 A and FOXP3（r=0.380, P=0.032）, and FOXP3 and CTLA-4（r=0.625, P=0.000） in the mid-secretory phase of endometrium for all subjects. It was concluded that the abnormal expression of endometrial E2 A existed in mid-secretory endometrium of women with RM, and there was a positive correlation between E2 A and FOXP3, and E2 A and CTLA-4, suggesting the possible regulation role of E2 A involved in regulating endometrium receptivity.

基于超声子宫内膜容受性参数和淋巴细胞免疫表型对复发性流产再孕早期流产的影响因素分析

目的基于超声子宫内膜容受性参数和淋巴细胞免疫表型探究不明原因复发性流产患者再妊娠后妊娠结局的影响因素。方法选择2022年4-8月南通市妇幼保健院收治的不明原因复发性自然流产再次妊娠患者166例。根据妊娠结局分为成功分娩组和再次流产组,检测子宫内膜容受性参数及外周血T淋巴细胞,筛查不明原因复发性流产患者再次妊娠流产的影响因素。结果166例患者中成功分娩102例(61.45%),再次流产64例(38.55%)。成功分娩组患者的子宫内膜厚度、内膜容积、血管化血流指数(VFI)均高于再次流产组(P<0.05)。成功分娩组患者的CD4^(+)、CD4^(+)/CD8^(+)低于再次流产组(P<0.05)。CD4^(+)、CD4^(+)/CD8^(+)是妊娠失败的危险因素(P<0.05),子宫内膜厚度、内膜容积、VFI是妊娠失败的保护因素(P<0.05)。结论不明原因复发性流产患者再妊娠的妊娠结局与子宫内膜厚度、内膜容积、VFI、CD4^(+)、CD4^(+)/CD8^(+)有关。

寿胎丸加减治疗复发性流产的疗效及对患者凝血功能、Th17细胞相关因子的影响

目的:探究寿胎丸加减治疗复发性流产的疗效及其对患者凝血功能、辅助T淋巴细胞17(Th17)细胞相关因子的影响。方法:对2021年3月—2022年3月石家庄市第六医院收治的120例复发性流产患者相关资料予以回顾性分析,按治疗方式将患者分为对照组与研究组,对照组57例接受黄体酮治疗,研究组63例在对照组基础上加用寿胎丸加减治疗。比较两组临床疗效,治疗前后中医证候积分、凝血功能、Th17与调节性T细胞(Treg)水平、Th17/Treg细胞相关因子,以及不良反应发生率。结果:研究组患者临床总有效率90.48%高于对照组75.44%(P<0.05);两组患者治疗后中医证候积分、凝血功能、Th17与Treg水平、Th17/Treg细胞相关因子均明显改善(P<0.01),研究组患者治疗后中医证候积分均明显低于对照组(P<0.01),研究组患者治疗后中医证候积分、凝血功能、Th17与Treg水平、Th17/Treg细胞相关因子等改善均优于对照组(P<0.01);研究组患者治疗期间不良反应发生率7.94%低于对照组12.28%,但差异无统计学意义(P>0.05)。结论:应用寿胎丸加减治疗复发性流产疗效显著,有助于减轻患者凝血功能障碍,纠正患者Th17细胞相关因子水平异常,临床应用效果良好。

补肾安胎方治疗肾虚型早期先兆流产患者的临床疗效及对其Th1/Th2相关因子、Th17/Treg细胞平衡的影响

目的探讨补肾安胎方治疗肾虚型早期先兆流产临床疗效及对Th1/Th2相关因子、Th17/Treg细胞平衡的影响。方法选取2021年1月—2022年12月期间南京市妇幼保健院收治的126例肾虚型早期先兆流产患者为研究对象,按随机数字表法分为对照组和观察组,每组各63例。对照组给予口服地屈孕酮治疗,观察组在对照组基础上增加补肾安胎方治疗。连续治疗14 d后,观察比较两组患者临床疗效及治疗前后中医证候积分、性激素[人绒毛膜促性腺激素(Human chorionic gonadotropin,β-HCG)、孕酮(Progesterone,P)、雌二醇(Estradiol,E_(2))、卵泡刺激素(Follicle stimulating hormone,FSH)]、Th1/Th2相关因子[白细胞介素-2(Interleukin-2,IL-2)、白细胞介素-4(Interleukin-4,IL-4)、白细胞介素-10(Interleukin-10,IL-10)、干扰素-γ(Interferonγ,INF-γ)]、Th17/Treg水平。结果治疗后观察组临床总有效率92.06%(58/63)明显高于对照组79.37%(50/63),差异有统计学意义(P<0.05)。治疗后两组患者阴道流血时间、出血量、小腹疼痛或坠胀、腰酸痛、头晕耳鸣、夜尿频数、两膝酸软积分及总积分均较治疗前降低,差异有统计学意义(P<0.05);且观察组阴道流血时间、出血量、小腹疼痛或坠胀、腰酸痛、头晕耳鸣、夜尿频数、两膝酸软积分及总积分均明显低于对照组,差异有统计学意义(P<0.05)。治疗后两组患者性激素β-HCG、P、E_(2)、FSH水平均较治疗前升高,差异有统计学意义(P<0.05);且观察组性激素β-HCG、P、E_(2)、FSH水平均明显高于对照组,差异有统计学意义(P<0.05)。治疗后两组患者血清IL-4、IL-10水平较治疗前升高,IL-2、INF-γ水平较治疗前降低,差异有统计学意义(P<0.05);且观察组IL-4、IL-10水平高于对照组,IL-2、INF-γ水平低于对照组,差异有统计学意义(P<0.05)。治疗后两组患者血清Th17及Th17/Treg水平较治疗前降低,差异有统计学意义(P<0.05);且观察组血清Th17及Th17/Treg水平较明显低于对照组,差异有统计学意义(P<0.05)。两组患者Treg水平治疗前后比较,差异无统计学意义(P>0.05)。结论在地屈孕酮治疗基础上结合补肾安胎方治疗,可显著缓解肾虚型早期先兆流产患者临床症状,并可改善性激素水平及免疫状态。