探索扶正解毒方对ITP患儿PLT、血小板相关抗体水平的影响

发布时间：2018-03-06 08:07

本文选题：持续性、慢性　切入点：儿童　出处：《北京中医药大学》2017年硕士论文　论文类型：学位论文

【摘要】：目的原发免疫性血小板减少症(Primary immune thrombocytopenia,ITP)原名血小板减少性紫癜,2009年国内正式进行了更名,其是儿童最常见的出血性疾病,是由于体液和细胞免疫异常引起自身抗血小板抗体产生,导致血小板破坏增加。其发病率为0.46/10万,20%-30%ITP患儿逐渐演变成持续性、慢性血小板减少症。ITP至今尚无特效的治疗方法,目前主要采用糖皮质激素、静脉丙种球蛋白等治疗。临床治疗中运用糖皮质激素与静脉丙种球蛋白可引起骨质疏松症、糖尿病、肾功能衰竭、血栓形成等不良反应。因此,积极寻找治疗ITP有效的方法是必须的。导师以自拟"扶正解毒方"临床疗效满意。因此,我们提出扶正解毒方能调理儿童持续性、慢性ITP患儿多种发病机制如体液和细胞免疫功能异常这一假说,拟以血小板相关抗体为切入点,借助导师前期对血免疫细胞亚群的相关临床研究,客观评价扶正解毒方在儿童持续性、慢性ITP治疗和机制研究中的价值,为ITP诊疗提供新思路。方法研究对象:为我院门诊就诊儿童中筛选符合入组标准的30名气不摄血型持续性、慢性ITP患儿。观察周期:观察12周,随访4周。干预措施:将符合纳入标准的30名儿童随机分为A、B两组。A为治疗组,予扶正解毒方协同小剂量激素西医常规治疗进行干预;B为对照组,予中药模拟剂协同小剂量激素西医常规治疗进行干预。两组受试者皮肤及黏膜出血明显者,辅助多维片、复方芦丁片治疗。观察指标:入组当天:A、B两组必须首先签署知情同意书,然后进行体格检查,治疗前(入组当天)完成安全性检测(血常规、尿常规、肝功能、肾功能、心电图)以及主要观察指标(血常规、血小板相关抗体)。2/4/6/8/10周:A、B两组进行体格检查,完成血常规。12周:A、B两组进行体格检查,完成安全性检测(血常规、尿常规、肝功能、肾功能、心电图)以及主要观察指标(血常规、血小板相关抗体)。结果1.两组PLT整体走向是为上升趋势,对照组中个别患儿PLT有所下降;两组治疗前PLT均值相近,但随治疗周期展开两组PLT均值拉开距离,相比来说治疗组较对照组整体上升趋势明显,且更为平稳。2.治疗组:总有效9例(64.3%),完全反应8例(42.9%),有效3例(21.4%),无效5例(35.7%);对照组:总有效4例(28.6%),完全反应0例(0%),有效4例(28.6%),无效10例(71.4%);两组在治疗效果方面相比有显著差异,具有统计学意义(P0.05),随着治疗周期的延长,治疗组疗效优势更为明显且更为平稳。在临床观察周期中,未发现两组治疗前后的安全性指标有任何不良影响,提示两组干预措施临床安全性均比较好。3.两组血小板相关抗体阳性率较低,可能与样本量太少及本研究对象特殊有关,具体的原因尚需要进一步的进行探讨。对四种抗体进行统计发现,血小板相关抗体大部分数值均有所下降,相比来说治疗组下降例数稍多一些,但两观察组检测的四种抗体治疗后与治疗前相比并无统计学意义(P0.05),且两组差异也并无统计学意义。说明扶正解毒方一定程度上可对血小板相关抗体产生影响,但其变化差异并不显著,由于时间及经费的限制,不排除可能为观察周期及监测次数对本研究造成的影响,具体原因仍尚需进一步探讨。另外有相关报道过ITP患者的血小板相关抗体增高值与血小板寿命及血小板计数呈负向的关系,本研究数据并无直接表明,其关系也有待进一步的探讨。结论1.扶正解毒方能安全、平稳、有效地提高气不摄血型持续性、慢性ITP患儿的血小板数目,治疗效果确切,值得进一步研究及推广。2.扶正解毒方对血小板相关抗体在一定程度产生影响,具体作用机理尚需要进一步的进行研究及探讨。
[Abstract]:The purpose of primary immune thrombocytopenia (Primary immune thrombocytopenia, formerly known as ITP) thrombocytopenic purpura, 2009 China officially had changed its name, which is the most common bleeding disorder in children, is due to the humoral and cellular immune abnormalities caused by antiplatelet autoantibodies, resulting in increased platelet destruction. The incidence rate of 0.46/10 million, 20%-30%ITP the children gradually evolved into a persistent treatment of chronic thrombocytopenia.ITP has no effects, mainly by corticosteroids, intravenous immunoglobulin therapy. Clinical treatment can cause osteoporosis, use of corticosteroids and intravenous immunoglobulin therapy in diabetes, renal failure, thrombosis and other adverse reactions. Therefore, actively looking for effective treatment of ITP is a must. Clinical tutor from "Fuzheng Jiedu Decoction". Therefore, we propose a centralizer Antidotarium can regulate the persistence of children, many children with chronic ITP pathogenesis such as humoral and cellular immune dysfunction of this hypothesis, intends to platelet associated antibody as the starting point, with the help of tutor for clinical research of blood immune cell subsets, the objective evaluation of Fuzheng Jiedu Decoction in children with persistent, ITP treatment and mechanism of chronic the value of ITP, and provide new ideas for the diagnosis and treatment. Methods: our hospital for children in the screening meet the standard set of 30 famous photo blood persistence of children with chronic ITP. The observation period: Observation of 12 weeks, 4 weeks of follow-up. Intervention measures: will meet the inclusion criteria of 30 children were randomly divided into A, B.A in the two groups for the treatment group, treated with Fuzheng Jiedu recipe collaborative low-dose hormone routine treatment intervention; group B were treated with Chinese medicine agent of low dose hormone analog routine western medicine intervention. The two groups of subjects The skin and mucous membrane bleeding obvious, auxiliary multivitamin tablets, Compound Rutin Tablets treatment. Observation index: on the day of admission: A, B two groups must first sign the informed consent, and physical examination before treatment (on the day of admission) complete safety inspection (blood routine, urine routine, liver function, renal function, ECG) and the main observation indexes (blood routine, platelet associated antibody.2/4/6/8/10 weeks): A, B two groups of physical examination, complete blood.12 week: A, B two groups of physical examination, complete safety inspection (blood routine, urine routine, liver function, renal function, ECG) and main outcome measures (blood routine, platelet associated antibody the results of two groups of PLT 1.). The overall trend is upward trend, with the individual PLT in the control group decreased; the two groups before treatment the mean PLT is similar, but with the expansion of the treatment cycle two group PLT average distance, compared with the treatment group than the control group overall The rising trend is obvious, and more stable.2. treatment group: total effective 9 cases (64.3%), 8 cases of complete response (42.9%), effective in 3 cases (21.4%), invalid in 5 cases (35.7%); the control group: the total effective 4 cases (28.6%), 0 cases of complete response (0%), effective in 4 cases (28.6%), invalid in 10 cases (71.4%); the two groups in treatment effect was significant, with statistical significance (P0.05), with the time of treatment, the curative effect of treatment group was more obvious advantages and is more stable. In the clinical observation period, did not find any adverse effects of safety indicators before and after the two the treatment group, suggesting that the positive rate of antibody against the intervention of the two groups were compared the clinical safety of.3. two groups of platelet was low, and the sample size is too small and the specific research object, the specific reasons still need further study. The four kinds of antibodies were statistically found that platelet associated antibodies were most numerical under the Drop, compared with the treatment group decreased the number of cases a little more, but four kinds of antibody therapy two observation group detection compared with before the treatment was not statistically significant (P0.05), and the difference between the two groups has no statistical significance. To a certain extent that Fuzheng Jiedu Decoction can affect platelet associated antibody, but the change is not significant because of the time difference, and funding constraints, do not rule out the possibility to observe the effects of period and frequency of monitoring caused by this study, the specific reasons still need to be further discussed. And there are some reported platelet associated antibodies in patients with ITP increased was negatively related to the life of platelets and platelet count, the data is not directly show that the relationship also needs to be further discussed. Conclusion 1. Fuzheng Jiedu Decoction can effectively improve the safety, stability, gas does not contain the blood type of continuity, number of platelets in children with chronic ITP, treatment effect It is worthy of further research and promotion of.2. Fuzheng Jiedu recipe to influence platelet related antibody to some extent. The specific mechanism is still need further research and discussion.

【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R272

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