• 文章类型: Journal Article
    免疫性血小板减少性紫癜(ITP)占怀孕期间血小板减少症病例的约1%至4%。预测新生儿血小板减少症和母亲ITP相关发病率的因素尚不清楚。本研究旨在评估ITP孕妇的新生儿结局。55名患有ITP的孕妇及其婴儿,在2013年1月至2021年4月之间出生,我们进行了回顾性分析.除ITP外的孕产妇和新生儿血小板减少病例被排除在研究之外。体格检查,血细胞计数,记录新生儿的颅/腹部超声检查结果。新生儿血小板减少症定义为血小板计数<150×109/L。探讨新生儿血小板减少症与母体因素的关系。在17/55的婴儿中发现了血小板减少症(30.9%),8/17(47.1%)有出血症状,除了一个是轻微的出血。新生儿血小板计数<100×109/L与产妇脾切除史存在显著相关性。在ITP母亲的新生儿中,中度和重度血小板减少症的发生率更高(统计学上无统计学意义)。母体和新生儿血小板计数之间没有显着相关性。有或没有血小板减少症的母亲的新生儿的血小板计数之间的相关性较弱。发现母亲分娩前脾切除术的存在与新生儿血小板计数<100×109/L之间存在显着相关性。妊娠前诊断为ITP且在妊娠和/或分娩期间需要治疗的母亲的新生儿中,中度和重度血小板减少症较高。但差别不大.对出生后患有ITP的母亲所生的婴儿进行密切随访至关重要,因为没有重要的预测标准来预测新生儿血小板减少症和相关的发病率。
    Immune thrombocytopenic purpura (ITP) comprises ~1% to 4% of thrombocytopenia cases during pregnancy. Factors predicting neonatal thrombocytopenia and associated morbidities due to maternal ITP are unclear. The present study aimed to assess the neonatal outcomes of pregnant women with ITP. Fifty-five pregnant women with ITP and their babies, born between January/2013 and April/2021, were retrospectively reviewed. Maternal and neonatal thrombocytopenia cases other than ITP were excluded from the study. Physical examination, blood count, and cranial/abdominal ultrasonography findings of the newborns were recorded. Neonatal thrombocytopenia was defined as a platelet count < 150 × 109/L. Relationship between neonatal thrombocytopenia and maternal factors was investigated. Thrombocytopenia was detected in 17/55 babies (30.9%), and 8/17 (47.1%) had symptoms of bleeding, all but one being mild bleeding. There was a significant correlation between neonatal platelet counts of < 100 × 109/L and maternal splenectomy history. Incidence of moderate and severe thrombocytopenia was higher (statistically insignificant) in neonates of mothers with ITP. No significant correlation was determined between maternal and neonatal platelet counts. There was a weak insignificant correlation between platelet counts of neonates of mothers with or without thrombocytopenia. A significant correlation was found between the presence of splenectomy before delivery in the mother and a platelet count of < 100 × 109/L in the neonate. Moderate and severe thrombocytopenia was higher in neonates of mothers diagnosed with ITP before pregnancy and needed treatment during pregnancy and/or delivery, but the difference was insignificant. Close follow-up of babies born to mothers with ITP after birth is crucial since there is no significant prediction criterion for developing neonatal thrombocytopenia and associated morbidities.
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  • 文章类型: Case Reports
    药物性免疫性血小板减少症是一种以血小板加速破坏为标志的不良反应。在癌症治疗中,血小板减少症还有许多其他原因,包括化疗药物引起的骨髓抑制,感染,和癌症的进展;药物性血小板减少容易被误诊或忽视。这里,我们介绍了一例有混合性结缔组织疾病病史的卵巢癌患者,该患者接受了手术,然后接受了紫杉醇治疗,顺铂,和贝伐单抗.患者在第六个周期后出现急性孤立性血小板减少症。血清抗血小板抗体测试显示针对糖蛋白IIb的抗体。在我们分析了这个病人的整个治疗过程之后,假定药物诱导的免疫性血小板减少症,贝伐单抗被推测为最可能的药物.血小板减少症最终使用重组人血小板生成素成功治疗,泼尼松,和重组人白细胞介素-11。本文总结了现有关于贝伐单抗诱导的免疫性血小板减少症的文献,并讨论了药物诱导的免疫性血小板减少症的相关机制和触发因素。本病例强调了贝伐单抗诱导免疫介导的血小板减少症的潜力,强调需要提高对自身免疫性疾病或自身免疫激活状态的警惕,这些疾病或自身免疫激活状态是癌症治疗中罕见药物诱导的免疫性血小板减少症的合理触发因素。
    Drug-induced immune thrombocytopenia is an adverse reaction marked by accelerated destruction of blood platelets. In cancer therapy, thrombocytopenia has many other causes including bone marrow suppression induced by chemotherapeutic agents, infection, and progression of cancer; drug-induced thrombocytopenia can easily be misdiagnosed or overlooked. Here, we present a case of an ovarian cancer patient with a history of mixed connective tissue disease who underwent surgery followed by treatment with paclitaxel, cisplatin, and bevacizumab. The patient developed acute isolated thrombocytopenia after the sixth cycle. Serum antiplatelet antibody testing revealed antibodies against glycoprotein IIb. After we analyzed the whole therapeutic process of this patient, drug-induced immune thrombocytopenia was assumed, and bevacizumab was conjectured as the most probable drug. Thrombocytopenia was ultimately successfully managed using recombinant human thrombopoietin, prednisone, and recombinant human interleukin-11. We provide a summary of existing literature on immune thrombocytopenia induced by bevacizumab and discuss related mechanisms and triggers for drug-induced immune thrombocytopenia. The present case underscores the potential of bevacizumab to induce immune-mediated thrombocytopenia, emphasizing the need for heightened vigilance towards autoimmune diseases or an autoimmune-activated state as plausible triggers for rare drug-induced immune thrombocytopenia in cancer therapy.
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  • 文章类型: Journal Article
    背景:免疫性血小板减少症(ITP)是一种以自身抗体介导的血小板破坏为特征的自身免疫性疾病。用新型抗CD38单克隆抗体CM313治疗,可以导致CD38阳性细胞的靶向清除,包括浆细胞.
    方法:我们进行了1-2期开放标签研究,以评估CM313在成年ITP患者中的安全性和有效性。CM313以每公斤体重16mg的剂量每周静脉给药8周,随后是16周的随访期。主要结果是不良事件和记录的两个或多个连续的血小板计数至少50×109每升在CM313的第一剂量后8周内。监测患者外周血免疫细胞的状态以及接受抗CD38治疗的ITP被动小鼠模型中单核吞噬系统的变化。
    结果:纳入研究的22例患者中,21(95%)在治疗期间连续两次血小板计数至少为每升50×109,中位累积反应持续时间为23周(四分位距,17至24)。首次血小板计数至少为每升50×109的中位时间为1周(范围,1至3)。研究期间发生的最常见的不良事件是输液相关反应(32%的患者)和上呼吸道感染(32%)。CD38靶向治疗后,CD56dimCD16+自然杀伤细胞的百分比,外周血中单核细胞CD32b的表达,ITP被动小鼠模型的脾脏中巨噬细胞数量均减少。
    结论:在这项研究中,抗CD38靶向治疗通过抑制血小板抗体依赖性细胞介导的细胞毒性迅速提高血小板水平,通过清除浆细胞维持长期疗效,主要与低度毒性作用有关。(由中国医学科学院医学科学创新基金等资助;ClinicalTrials.gov编号,NCT05694767)。
    BACKGROUND: Immune thrombocytopenia (ITP) is an autoimmune disease characterized by autoantibody-mediated platelet destruction. Treatment with CM313, a novel anti-CD38 monoclonal antibody, can result in targeted clearance of CD38-positive cells, including plasma cells.
    METHODS: We conducted a phase 1-2, open-label study to evaluate the safety and efficacy of CM313 in adult patients with ITP. CM313 was administered intravenously at a dose of 16 mg per kilogram of body weight every week for 8 weeks, followed by a 16-week follow-up period. The primary outcomes were adverse events and documentation of two or more consecutive platelet counts of at least 50×109 per liter within 8 weeks after the first dose of CM313. The status of peripheral-blood immune cells in patients and changes in the mononuclear phagocytic system in passive mouse models of ITP receiving anti-CD38 therapy were monitored.
    RESULTS: Of the 22 patients included in the study, 21 (95%) had two consecutive platelet counts of at least 50×109 per liter during the treatment period, with a median cumulative response duration of 23 weeks (interquartile range, 17 to 24). The median time to the first platelet count of at least 50×109 per liter was 1 week (range, 1 to 3). The most common adverse events that occurred during the study were infusion-related reaction (in 32% of the patients) and upper respiratory tract infection (in 32%). After CD38-targeted therapy, the percentage of CD56dimCD16+ natural killer cells, the expression of CD32b on monocytes in peripheral blood, and the number of macrophages in the spleen of the passive mouse models of ITP all decreased.
    CONCLUSIONS: In this study, anti-CD38 targeted therapy rapidly boosted platelet levels by inhibiting antibody-dependent cell-mediated cytotoxicity on platelets, maintained long-term efficacy by clearing plasma cells, and was associated with mainly low-grade toxic effects. (Funded by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences and others; ClinicalTrials.gov number, NCT05694767).
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    文章类型: Journal Article
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  • 文章类型: Case Reports
    高压氧治疗(HBOT)可用于坏死性软组织感染,梭菌心肌坏死(气体坏疽),挤压伤,急性创伤性缺血,伤口愈合延迟,和受损的皮肤移植物。我们的病例是一名17个月大的Noonan综合征男性患者,特发性血小板减少性紫癜,和双侧睾丸未降。双侧睾丸固定术和包皮环切术后的第二天,阴囊和阴茎出现血肿和水肿。术后第二天在阴茎和阴囊皮肤上观察到缺血性表现。根据血液学的建议,开始使用依诺肝素钠和新鲜冷冻血浆。考虑到组织坏死的可能性,开始了高压氧治疗。我们观察到在五天内迅速愈合。我们提出这种情况是为了强调HBOT可以被认为是类似疾病患者的额外治疗选择。据我们所知,文献中未报道类似病例.
    Hyperbaric oxygen treatment (HBOT) can be utilised for necrotising soft tissue infections, clostridial myonecrosis (gas gangrene), crush injuries, acute traumatic ischaemia, delayed wound healing, and compromised skin grafts. Our case was a 17-month-old male patient with Noonan syndrome, idiopathic thrombocytopenic purpura, and bilateral undescended testicles. Haematoma and oedema developed in the scrotum and penis the day after bilateral orchiopexy and circumcision. Ischaemic appearances were observed on the penile and scrotal skin on the second postoperative day. Enoxaparin sodium and fresh frozen plasma were started on the recommendation of haematology. Hyperbaric oxygen treatment was initiated considering the possibility of tissue necrosis. We observed rapid healing within five days. We present this case to emphasise that HBOT may be considered as an additional treatment option in patients with similar conditions. To our knowledge, no similar cases have been reported in the literature.
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  • 文章类型: Journal Article
    我们旨在观察脂肪间充质干细胞(ADSCs)对原发性免疫性血小板减少症(ITP)模型小鼠辅助性T细胞17(Th17)/调节性T细胞(Treg)和T-box转录因子(T-bet)/GATA结合蛋白3(GATA-3)的影响。选择32只BALB/C小鼠。从2只小鼠中分离ADSCs并培养。将其他30只小鼠随机分为正常对照组,ITP模型对照组,和ITP实验组。血小板计数(PLT),Th17/Treg细胞,相关血清细胞因子[白细胞介素-6(IL-6),IL-17A,IL-10和转化生长因子β1(TGF-β1)],检测3组外周血单个核细胞(PBMC)中T-bet和GATA-3mRNA水平。ITP试验组PLT、Treg明显低于正常对照组(P<0.05),但明显高于ITP模型对照组(P<0.05)。ITP实验组Th17和Th17/Treg明显高于正常对照组(P<0.05),但明显低于ITP模型对照组(P<0.05)。血清IL-6和IL-17A水平,ITP实验组T-betmRNA水平明显高于正常对照组(P<0.05),但明显低于ITP模型对照组(P<0.05)。血清IL-10和TGF-β水平,ITP实验组GATA-3mRNA水平明显低于正常对照组(P<0.05),但明显高于ITP模型对照组(P<0.05)。ADSCs能有效调节ITP模型小鼠Th17/Treg平衡,提高T-bet/GATA-3mRNA表达水平。
    We aimed to observe the effects of adipose-derived mesenchymal stem cells (ADSCs) on T helper 17 (Th17)/regulatory T cells (Treg) and T-box transcription factor (T-bet)/GATA-binding protein 3 (GATA-3) in model mice with primary immune thrombocytopenia (ITP). 32 BALB/C mice were selected. ADSCs were isolated from 2 mice and cultured. The other 30 mice were randomly divided into the normal control group, the ITP model control group, and the ITP experimental group. Platelet count (PLT), Th17/Treg cells, related serum cytokines [interleukin-6 (IL-6), IL-17A, IL-10, and transforming growth factor β1 (TGF-β1)], T-bet and GATA-3 mRNA levels in peripheral blood mononuclear cells (PBMCs) in the 3 groups were detected. PLT and Treg in the ITP experimental group were significantly lower than those in the normal control group (P<0.05), but significantly higher than those in the ITP model control group (P<0.05). Th17 and Th17/Treg in the ITP experimental group were significantly higher than those in the normal control group (P<0.05), but significantly lower than those in the ITP model control group (P<0.05). Serum IL-6 and IL-17A levels, and T-bet mRNA levels in the ITP experimental group were significantly higher than those in the normal control group (P<0.05), but significantly lower than those in the ITP model control group (P<0.05). Serum IL-10 and TGF-β levels, and GATA-3 mRNA levels in the ITP experimental group were significantly lower than those in the normal control group (P<0.05), but significantly higher than those in the ITP model control group (P<0.05). ADSCs can effectively regulate Th17/Treg balance and improve T-bet/GATA-3 mRNA expression levels in ITP model mice.
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  • 文章类型: Journal Article
    背景:疾病登记处是综合数据库,记录诊断为特定疾病的患者的详细信息,为他们的诊断提供有价值的见解,治疗,和结果。这项研究旨在描述伊朗国家儿科免疫性血小板减少症(ITP)注册(NPITP)的试点阶段,作为就职解释性报告。
    方法:这个以患者为中心的软件系统是在伊朗多个儿科中心实施的国家计划。进行了几个焦点小组,以建立包括六个主要类别的最小数据集(MDS),14个子类,和187个数据元素。在专家就最终数据集达成共识后,由专门的IT团队开发了基于Web的软件工具,可通过https://disreg在线和离线访问。sbmu.AC.ir/q/ITP。html.注册包括年龄在2个月至18岁之间,血小板计数低于100×109/L的儿童,基于预定义的纳入标准。
    结果:在四个月内,共有60名ITP患者登记,包括41例(68.3%)新诊断病例,68例(13.6%)持续性病例,慢性ITP14例(23.3%)。登记患者的平均年龄为55.93±9.72个月。最常见的出血症状是瘀点(68.3%),紫癜(51.6%),和瘀斑(13.3%)。在新诊断的患者中,20(33.3%)接受静脉注射免疫球蛋白(IVIG),17例(28.3%)患者接受泼尼松龙治疗,17人(28.3%)接受IVIG和类固醇联合治疗。在所有患者中,40人(66.7%)对治疗有完全反应,16人(26.7%)表现出部分反应。4名患者(6.7%)对治疗无反应。治疗相关并发症,比如库欣综合征,水肿,体重增加,多毛症,和情绪障碍,报告10例患者(16.6%)。然而,大多数患者(81.7%)未出现治疗相关并发症.
    结论:NPITP注册的试点阶段成功实现了基于Web的数据收集软件工具,旨在提高护理质量,促进临床研究,并支持未来的卫生服务规划。
    BACKGROUND: Disease registries are comprehensive databases that record detailed information on patients diagnosed with specific conditions, providing valuable insights into their diagnosis, treatment, and outcomes. This study aims to describe the pilot phase of the national pediatric Immune Thrombocytopenia(ITP) registry (NPITP) in Iran, serving as the inaugural interpretive report.
    METHODS: This patient-centered software system was implemented as a national program across multiple pediatric centers in Iran. Several focus groups were conducted to establish a minimum data set (MDS) comprising six main classes, 14 sub-classes, and 187 data elements. Following expert consensus on the final data set, a web-based software tool was developed by the dedicated IT team, accessible online and offline via https://disreg.sbmu.ac.ir/q/ITP.html . The registry included children aged between two months and 18 years with a platelet count below 100 × 109/L, based on predefined inclusion criteria.
    RESULTS: Within a four-month period, a total of 60 ITP patients were registered, including 41 (68.3%) newly diagnosed cases, 68 (13.6%) persistent cases, and 14 (23.3%) with chronic ITP. The mean age of the registered patients was 55.93 ± 9.72 months. The most frequently observed bleeding symptoms were petechiae (68.3%), purpura (51.6%), and ecchymosis (13.3%). Among the newly diagnosed patients, 20 (33.3%) received intravenous immunoglobulin (IVIG), 17 (28.3%) were treated with prednisolone, and 17 (28.3%) received combined IVIG and steroid therapy. Of all patients, 40 (66.7%) demonstrated a complete response to treatment, while 16 (26.7%) exhibited a partial response. Four patients (6.7%) remained unresponsive to therapy. Treatment-related complications, such as Cushing\'s syndrome, edema, weight gain, hirsutism, and mood disorders, were reported in 10 patients (16.6%). However, the majority of patients (81.7%) did not experience therapy-related complications.
    CONCLUSIONS: The pilot phase of the NPITP registry successfully implemented a web-based software tool for data collection, aiming to enhance the quality of care, facilitate clinical research, and support health service planning in the future.
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  • 文章类型: Journal Article
    免疫性血小板减少症(ITP)是一种由于对血小板自身抗原失去免疫耐受而引起的自身免疫性疾病,导致血小板生成减少和血小板破坏增加。巨核细胞分化和成熟受损是ITP发病和治疗的关键因素。Sarcandraglabra,菊科的一种植物,在临床实践中通常用于治疗ITP,而daucosterol(Dau)是其活性成分之一。然而,Dau能否治疗ITP及其作用的关键机制尚不清楚。在这项研究中,在Dami和HS-5细胞共培养构建的巨核细胞分化障碍模型中,我们发现Dau能有效促进巨核细胞的分化成熟和多倍体的形成。体内实验表明,Dau不仅可以增加ITP大鼠模型中多倍体巨核细胞的数量,还能促进血小板计数的恢复。此外,通过网络药理学分析,我们推测JAK2-STAT3信号通路可能参与了Dau促进巨核细胞分化的过程。Westernblot结果显示Dau抑制P-JAK2和P-STAT3的表达。总之,这些结果为进一步研究Dau治疗ITP的药理机制提供了依据。
    Immune thrombocytopenia (ITP) is an autoimmune disease caused by the loss of immune tolerance to platelet autoantigens, resulting in reduced platelet production and increased platelet destruction. Impaired megakaryocyte differentiation and maturation is a key factor in the pathogenesis and treatment of ITP. Sarcandra glabra, a plant of the Chloranthaceae family, is commonly used in clinical practice to treat ITP, and daucosterol (Dau) is one of its active ingredients. However, whether Dau can treat ITP and the key mechanism of its effect are still unclear. In this study, we found that Dau could effectively promote the differentiation and maturation of megakaryocytes and the formation of polyploidy in the megakaryocyte differentiation disorder model constructed by co-culturing Dami and HS-5 cells. In vivo experiments showed that Dau could not only increase the number of polyploidized megakaryocytes in the ITP rat model, but also promote the recovery of platelet count. In addition, through network pharmacology analysis, we speculated that the JAK2-STAT3 signaling pathway might be involved in the process of Dau promoting megakaryocyte differentiation. Western blot results showed that Dau inhibited the expression of P-JAK2 and P-STAT3. In summary, these results provide a basis for further studying the pharmacological mechanism of Dau in treating ITP.
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  • 文章类型: Journal Article
    免疫性血小板减少症(ITP)的治疗具有挑战性,治疗结果取决于许多未知和患者特异性因素。皮质类固醇是ITP治疗的基石,但是它们与许多副作用有关。在这项回顾性队列研究中,我们在2022年11月15日至2023年3月15日期间,对214例ITP患者的治疗结局和治疗依从性进行了调查.多项回归分析模型用于确定治疗结果的预测因素。小于0.05的p值被认为是统计学上显著的。大多数研究参与者是女性161(75.5%),大多数172人(80.4%)只服用泼尼松龙。在治疗依从性方面,178(83.2%)的研究参与者坚持他们的ITP药物。3个月时的完全缓解率为139(65.0%)。部分反应的预测因素是ITP对健康相关生活质量的负面影响增加(AOR=1.221,95%CI1.096-1.360),与完全缓解患者相比,在TikurAbessaSepcialazed医院接受治疗(AOR=0.431,95%CI0.197-0.941)且存在大量月经出血(AOR=2.255,95%CI0.925-5.497)。乙型肝炎病毒感染的ITP患者(AOR=0.052,95%CI0.004-0.621)也是无反应的预测因素。
    The treatment of immune thrombocytopenia (ITP) is challenging and treatment outcomes depend on numerous unknown and patient-specific factors. Corticosteroids are the cornerstone of ITP treatment, but they are associated with many side effects. In this retrospective cohort study, treatment outcomes and treatment adherence in patients with ITP were investigated in 214 ITP patients from November 15, 2022 to March 15, 2023. Multinomial regression analysis models were used to identify predictive factors for treatment outcomes. A p value of less than 0.05 was considered statistically significant. Most study participants were female 161 (75.5%), and the majority 172 (80.4%) of them were taking prednisolone only. In terms of treatment adherence, 178 (83.2%) of the study participants adhered well to their ITP medications. The complete response rate at 3 months was 139 (65.0%). Predictive factors for partial response were increased negative impact of ITP on health-related quality of life (AOR = 1.221, 95% CI 1.096-1.360), being treated at Tikur Abessa Sepcialazed Hospital (AOR = 0.431, 95% CI 0.197-0.941) and the presence of heavy menstrual bleeding (AOR = 2.255, 95% CI 0.925-5.497) compared to patients with complete response. Hepatitis B virus-infected ITP patients (AOR = 0.052, 95% CI 0.004-0.621) were also a predictive factor for no response compared to complete response.
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  • 文章类型: Journal Article
    目的:探讨健脾益气活血汤早期止血机制(,JYSD)治疗免疫性血小板病(ITP),方法:非药物治疗病例:选择健康志愿者作为正常对照组,与功能失调性子宫出血患者进行比较,胃肠道肿瘤出血和ITP,检测血液中5-羟色胺(5-HT)的变化,β-内啡肽(β-EP),血管活性肠肽(VIP),比较不同疾病症状患者血液神经递质的变化。药物治疗病例:根据随机对照多中心临床试验,将272例ITP患者随机分为三组:医治组(JYSD)结合组(JYSD+泼尼松)对比组(泼尼松)。血液神经递质(5-HT,β-EP,VIP)治疗前后检测外周血血小板(PLT)及分级评分。
    结果:非药物治疗病例:与正常对照组比较,5-HT水平较高,ITP组VIP和β-EP水平均较低(P<0.001),还有5-HT,消化道肿瘤出血组的VIP和β-EP水平也低于正常对照组(P<0.05,0.001)。药物治疗病例:联合组和对照组治疗后PLT评分均低于治疗前(P<0.05、0.001)。3组患者治疗后PLT分级评分进行配对比较:3组中联合组最低,比治疗组好,但不优于对照组(与治疗组相比,P=0.005,与对照组相比,P=0.709)。全分析集(FAS)和每个方案集(PPS)的统计结果是一致的。治疗组和联合组的出血症状评分在治疗后7d开始下降。治疗后14d持续下降至研究结束(P<0.05)。另一方面,对照组在治疗后14d开始出现良好的效果(P<0.05)。FAS和PPS分析结果一致。在对照组中,治疗后5-HT水平较高,VIP水平较低,与治疗前比较(P<0.05,0.001)。治疗组和联合组治疗后β-EP水平均升高,与治疗前比较(P<0.05)。治疗后,治疗组和对照组的β-EP水平明显低于联合组(P<0.05)。治疗后,与对照组相比,治疗组和联合治疗组的VIP水平上调,经秩和检验,差异有统计学意义(P<0.01),并通过t检验(P=0.0002,0.0001)。
    结论:泼尼松片在增加PLT水平方面优于JYSD,而强的松片联合JYSD在改善患者外周血PLT水平方面更具优势。然而,改善ITP患者的出血时间,与单一使用相比,两种药物的组合显着延迟,显示了中医药的特点和优势。JYSD可以通过脑-肠轴功能调节ITP患者的神经递质水平,动员ITP患者血液中的5-HT,促进血管和平滑肌的收缩,激活凝血机制是JYSD的早期止血机制。上调β-EP水平和平衡VIP水平可能是JYSD调节ITP患者免疫机制的重要组成部分。
    OBJECTIVE: To explore the early hemostatic mechanism of Jianpi Yiqi Shexue decoction (, JYSD) in treating immune thrombocytopathy (ITP), based on the functional homeostasis of brain-intestine axis and blood neurotransmitter METHODS: Non-drug treatment cases: Healthy volunteers were selected as normal control group and compared with patients with dysfunctional uterine bleeding, gastrointestinal tumors with bleeding and ITP, to detect the changes of blood 5-hydroxytryptamine (5-HT), β-endorphin (β-EP), vasoactive intestinal peptide (VIP) and compare the changes of blood neuro-transmitters in patients with different disease symptoms. Drug treatment cases: According to the randomized controlled multicenter clinical trial, 272 ITP patients were randomly divided into three groups: treatment group (JYSD) combined group (JYSD + Prednisone) control group (Prednisone). The changes of blood neuro-transmitter (5-HT, β-EP, VIP) before and after treatment were detected on the basis of peripheral blood platelet (PLT) and grade score.
    RESULTS: Non-drug treatment cases: compared with the normal control group, the 5-HT level was higher, and the VIP and β-EP levels were both lower in the ITP group (P < 0.001), and the 5-HT, VIP and β-EP levels in the Gastrointestinal tumors with bleeding group were also lower compared with the normal control group (P < 0.05, 0.001). Drug treatment cases: The PLT grading scores of the combination group and the control group after treatment were lower than that before treatment (P < 0.05, 0.001). The PLT grading score of the 3 groups were compared in pairs after treatment: the combination group was the lowest among the 3 groups, which was better than the treatment group, but no better than the control group (vs the treatment group, P = 0.005, vs the control group, P = 0.709). The statistical results of full analysis set (FAS) and per protocol set (PPS) were consistent. The bleeding symptom scores of the treatment and combination groups began to drop 7 d after treatment, and kept dropping 14 d after treatment until the end of the study (P < 0.05). On the other hand, the control group started to show favorable results 14 d after treatment (P < 0.05). The FAS and PPS analysis results were consistent. In the control group, the 5-HT level was higher and VIP level was lower after treatment, compared with those before treatment (P < 0.05, 0.001). The β-EP levels were both increased in the treatment and combination group after treatment, compared with those before treatment (P < 0.05). After treatment, the β-EP levels in the treatment and control groups were significantly lower compared with the combination groups (P < 0.05). After treatment, compared with the control group, the VIP levels in the treatment and combination groups were up-regulated, and the differences were statistically significant by rank sum test (P < 0.01), and by t-test (P = 0.0002, 0.0001).
    CONCLUSIONS: The prednisone tablet is better than the JYSD in increasing the level of PLT, while prednisone tablet combined with JYSD has more advantages in improving patients\' peripheral blood PLT levels. However, in improving the bleeding time of ITP patients, the combination of the two drugs was significantly delayed compared with the single usage, showing the characteristics and advantages of traditional Chinese medicine. JYSD can regulate the neurotransmitter level of ITP patients through the function of the brain-gut axis, mobilize 5-HT in the blood of ITP patients to promote the contraction of blood vessels and smooth muscles, and activate the coagulation mechanism are the early hemostatic mechanisms of JYSD. Up-regulate the levels of β-EP and balancing VIP levels may be an important part of the immune mechanism of JYSD for regulating ITP patients.
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