原发免疫性血小板减少症合并血栓形成的临床研究
发布时间：2018-10-09 15:09
【摘要】：研究背景与目的原发免疫性血小板减少症(primary immune thrombocytopenia,ITP)是临床最常见的出血性疾病。目前治疗手段以减少血小板破坏及促血小板生成为主,以期达到提升血小板计数,预防或减轻出血的目的。但在临床实践中,我们观察到少数ITP患者在治疗中或治疗结束后并发了动静脉血栓,而且发生血栓时血小板计数多低于正常范围。血栓的发生不仅平添了患者的病痛,延长了住院时间,增加了治疗花费,也提高了我们对后续治疗方案选择的难度,陷入该如何兼顾血栓形成需要抗凝治疗和血小板减少导致出血风险增加的两难境地。近年来,部分国外研究报道ITP患者血栓发生率高于普通人群,但国内尚未见相关报道。为此,我们采用回顾性队列研究分析了山东大学齐鲁医院收治的669例ITP患者发生动静脉血栓的情况,探讨影响血栓发生的危险因素,以早期发现伴有易栓倾向的ITP患者,做到及时监测、提前干预并调整治疗方案和治疗目标,预防或减少血栓形成,降低病残和病死率。研究对象与方法收集山东大学齐鲁医院于2007年1月1日至2016年7月30日收治的成人ITP患者共758例,排除失访41例,未接受ITP治疗48例,共669例患者纳入研究。其中男性252例,女性417例,中位诊断年龄为40岁。包括新诊断ITP 166例,持续性ITP 191例,慢性ITP 312例。诊断标准依据2016年ITP中国专家共识。所有纳入患者在随访期间至少接受过1次ITP治疗。通过我院病案检索系统搜集纳入队列研究的ITP患者的个人基本资料,依次对患者进行电话随访,记录随访期间所有的血栓事件,并对患者信息进行基线调查,收集初诊时患者的个人信息、实验室数据及治疗情况。根据随访期间内是否发生血栓分为血栓组和无血栓组。两组之间各指标的比较采用单因素方差分析(连续性变量)和卡方检验(分类变量),计算ITP患者的发病密度和5年累积发病率,队列资料用COX比例风险回归模型来评估不同危险因素对血栓发生的影响。研究结果1、ITP患者血栓的发病密度为1.28/100人年(95%CI:0.83-1.94),动脉血栓和静脉血栓则分别为 0.93/100 人年(95%CI:0.60-1.43)、0.42/100 人年(95%CI:0.15-1.12)。60 岁的 ITP 患者动脉血栓的发生率(IR=2.49,95%CI:1.52-3.89)比40岁的人群(IR=0.13,95%CI:0.05-0.34)高出18倍,静脉血栓的发生率高出11倍,总血栓的发生率高出5倍。2、调整了混杂因素前后,年龄40岁(P0.01)、合并2个及以上心血管危险因素(P0.01)、既往血栓史1(P0.01)、3次及以上治疗次数(P0.05)与血栓的发生始终存在显著的关联性。3、应用利妥西单抗,在调整模型前与血栓的发生无统计学意义(HR=0.48,95%CI:0.2-1.2,P0.05),在调整模型后存在显著的统计学意义(HR=0.21,95%CI:0.1-0.5,P=0.001)。调整混杂因素前后,脾切除术、激素发生血栓的危险度略有变化,但P值始终大于0.05,结果无统计学意义。研究结论1、随着年龄增加,ITP患者发生血栓的风险增高。2、合并多个心血管危险因素、既往血栓史及多次治疗是ITP患者发生血栓的独立危险因素。3、应用利妥昔单抗可以降低ITP患者的总血栓发生率,提示该药可以作为一个预防血栓发生的保护性因素。
[Abstract]:Background and Objective Primary immune thrombocytopenia (ITP) is the most common hemorrhagic disease in clinic. Current treatment means to reduce platelet destruction and platelet production, with a view to achieving the goal of improving platelet count, preventing or reducing bleeding. In clinical practice, however, we observed that a few ITP patients complicated the venous thrombosis after or after the end of the treatment, and platelet counts were much lower in patients with thrombosis than in the normal range. The occurrence of the thrombus not only increases the pain of the patient, prolongs the hospitalization time, increases the treatment cost, but also improves the difficulty of selecting the subsequent treatment scheme, and falls into the dilemma of how to balance the thrombosis and reduce the risk of bleeding caused by coagulation therapy and thrombocytopenia. In recent years, some foreign studies reported that the incidence of thrombosis in ITP patients was higher than that of the general population, but there were no relevant reports in China. To this end, we analyzed 669 patients with ITP from Qilu Hospital of Shandong University using retrospective cohort study, and discussed the risk factors of influencing the occurrence of thrombus. Early intervention and adjustment of therapeutic regimen and treatment objectives to prevent or reduce thrombosis, reduce morbidity and mortality. Methods A total of 758 adults with ITP from Jan. 1, 2007 to July 30, 2016 were collected from Qilu Hospital of Shandong University from Jan. 1, 2007 to Jul. 30, 2016. Forty-four patients with ITP were excluded, and the total of 669 patients were included in the study. Among them 252 males and 417 females, the median age was 40 years. Including 166 cases of newly diagnosed ITP, 191 cases of persistent ITP and 312 cases of chronic ITP. Diagnostic criteria are based on the 2016 ITP China Expert Consensus. All patients included at least 1 ITP treatment during follow-up. Collect individual basic data of ITP patients included in cohort study through our medical record retrieval system, conduct telephone follow-up in sequence, record all thrombus events during follow-up period, conduct baseline survey on patient information, collect personal information of patients at the time of follow-up, Laboratory data and treatment. The thrombus was divided into thrombus group and no thrombus group according to whether there was thrombus in the follow-up period. A single-factor analysis of variance (continuity variable) and a card square test (categorical variable) were used to evaluate the incidence and cumulative incidence of ITP patients, and the Cox proportional risk regression model for cohort data was used to assess the effect of different risk factors on the occurrence of thrombus. Results 1. The incidence density of thrombus in ITP patients was 1. 28/ 100 (95% CI: 0. 83-1. 94), and arterial thrombosis and venous thrombosis were 0. 93/ 100 (95% CI: 0. 60-1. 43), 0. 42/ 100 person years (95% CI: 0. 15-1. 12). The incidence of arterial thrombosis in ITP patients (IR = 2.49, 95% CI: 1.52-3.89) was 18 times higher than that of 40-year-old (IR = 0. 13, 95% CI: 0. 05-0. 34), respectively. The incidence of venous thrombosis was 11 times higher, and the incidence of total thrombosis was 5 times higher. There was no significant correlation between the previous thrombus history 1 (P 0.01), 3 times and the number of treatments (P0.05) and the occurrence of thrombosis. There was a slight change in the risk of splenectomy and hormone thrombosis before and after the confounding factors, but the P value was always greater than 0.05. The results showed no statistical significance. Study conclusion 1: As age increases, there is an increased risk of thrombosis in ITP patients. 2. Multiple cardiovascular risk factors, past thrombus history and multiple treatments are independent risk factors for thrombosis in patients with ITP. It is suggested that the drug can be used as a protective factor for preventing thrombosis.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R558.2
本文编号：2259793
[Abstract]:Background and Objective Primary immune thrombocytopenia (ITP) is the most common hemorrhagic disease in clinic. Current treatment means to reduce platelet destruction and platelet production, with a view to achieving the goal of improving platelet count, preventing or reducing bleeding. In clinical practice, however, we observed that a few ITP patients complicated the venous thrombosis after or after the end of the treatment, and platelet counts were much lower in patients with thrombosis than in the normal range. The occurrence of the thrombus not only increases the pain of the patient, prolongs the hospitalization time, increases the treatment cost, but also improves the difficulty of selecting the subsequent treatment scheme, and falls into the dilemma of how to balance the thrombosis and reduce the risk of bleeding caused by coagulation therapy and thrombocytopenia. In recent years, some foreign studies reported that the incidence of thrombosis in ITP patients was higher than that of the general population, but there were no relevant reports in China. To this end, we analyzed 669 patients with ITP from Qilu Hospital of Shandong University using retrospective cohort study, and discussed the risk factors of influencing the occurrence of thrombus. Early intervention and adjustment of therapeutic regimen and treatment objectives to prevent or reduce thrombosis, reduce morbidity and mortality. Methods A total of 758 adults with ITP from Jan. 1, 2007 to July 30, 2016 were collected from Qilu Hospital of Shandong University from Jan. 1, 2007 to Jul. 30, 2016. Forty-four patients with ITP were excluded, and the total of 669 patients were included in the study. Among them 252 males and 417 females, the median age was 40 years. Including 166 cases of newly diagnosed ITP, 191 cases of persistent ITP and 312 cases of chronic ITP. Diagnostic criteria are based on the 2016 ITP China Expert Consensus. All patients included at least 1 ITP treatment during follow-up. Collect individual basic data of ITP patients included in cohort study through our medical record retrieval system, conduct telephone follow-up in sequence, record all thrombus events during follow-up period, conduct baseline survey on patient information, collect personal information of patients at the time of follow-up, Laboratory data and treatment. The thrombus was divided into thrombus group and no thrombus group according to whether there was thrombus in the follow-up period. A single-factor analysis of variance (continuity variable) and a card square test (categorical variable) were used to evaluate the incidence and cumulative incidence of ITP patients, and the Cox proportional risk regression model for cohort data was used to assess the effect of different risk factors on the occurrence of thrombus. Results 1. The incidence density of thrombus in ITP patients was 1. 28/ 100 (95% CI: 0. 83-1. 94), and arterial thrombosis and venous thrombosis were 0. 93/ 100 (95% CI: 0. 60-1. 43), 0. 42/ 100 person years (95% CI: 0. 15-1. 12). The incidence of arterial thrombosis in ITP patients (IR = 2.49, 95% CI: 1.52-3.89) was 18 times higher than that of 40-year-old (IR = 0. 13, 95% CI: 0. 05-0. 34), respectively. The incidence of venous thrombosis was 11 times higher, and the incidence of total thrombosis was 5 times higher. There was no significant correlation between the previous thrombus history 1 (P 0.01), 3 times and the number of treatments (P0.05) and the occurrence of thrombosis. There was a slight change in the risk of splenectomy and hormone thrombosis before and after the confounding factors, but the P value was always greater than 0.05. The results showed no statistical significance. Study conclusion 1: As age increases, there is an increased risk of thrombosis in ITP patients. 2. Multiple cardiovascular risk factors, past thrombus history and multiple treatments are independent risk factors for thrombosis in patients with ITP. It is suggested that the drug can be used as a protective factor for preventing thrombosis.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R558.2
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