探索扶正解毒方對ITP患兒PLT、血小板相關(guān)抗體水平的影響
本文選題:持續(xù)性、慢性 切入點:兒童 出處:《北京中醫(yī)藥大學(xué)》2017年碩士論文 論文類型:學(xué)位論文
【摘要】:目的原發(fā)免疫性血小板減少癥(Primary immune thrombocytopenia,ITP)原名血小板減少性紫癜,2009年國內(nèi)正式進行了更名,其是兒童最常見的出血性疾病,是由于體液和細胞免疫異常引起自身抗血小板抗體產(chǎn)生,導(dǎo)致血小板破壞增加。其發(fā)病率為0.46/10萬,20%-30%ITP患兒逐漸演變成持續(xù)性、慢性血小板減少癥。ITP至今尚無特效的治療方法,目前主要采用糖皮質(zhì)激素、靜脈丙種球蛋白等治療。臨床治療中運用糖皮質(zhì)激素與靜脈丙種球蛋白可引起骨質(zhì)疏松癥、糖尿病、腎功能衰竭、血栓形成等不良反應(yīng)。因此,積極尋找治療ITP有效的方法是必須的。導(dǎo)師以自擬"扶正解毒方"臨床療效滿意。因此,我們提出扶正解毒方能調(diào)理兒童持續(xù)性、慢性ITP患兒多種發(fā)病機制如體液和細胞免疫功能異常這一假說,擬以血小板相關(guān)抗體為切入點,借助導(dǎo)師前期對血免疫細胞亞群的相關(guān)臨床研究,客觀評價扶正解毒方在兒童持續(xù)性、慢性ITP治療和機制研究中的價值,為ITP診療提供新思路。方法研究對象:為我院門診就診兒童中篩選符合入組標(biāo)準(zhǔn)的30名氣不攝血型持續(xù)性、慢性ITP患兒。觀察周期:觀察12周,隨訪4周。干預(yù)措施:將符合納入標(biāo)準(zhǔn)的30名兒童隨機分為A、B兩組。A為治療組,予扶正解毒方協(xié)同小劑量激素西醫(yī)常規(guī)治療進行干預(yù);B為對照組,予中藥模擬劑協(xié)同小劑量激素西醫(yī)常規(guī)治療進行干預(yù)。兩組受試者皮膚及黏膜出血明顯者,輔助多維片、復(fù)方蘆丁片治療。觀察指標(biāo):入組當(dāng)天:A、B兩組必須首先簽署知情同意書,然后進行體格檢查,治療前(入組當(dāng)天)完成安全性檢測(血常規(guī)、尿常規(guī)、肝功能、腎功能、心電圖)以及主要觀察指標(biāo)(血常規(guī)、血小板相關(guān)抗體)。2/4/6/8/10周:A、B兩組進行體格檢查,完成血常規(guī)。12周:A、B兩組進行體格檢查,完成安全性檢測(血常規(guī)、尿常規(guī)、肝功能、腎功能、心電圖)以及主要觀察指標(biāo)(血常規(guī)、血小板相關(guān)抗體)。結(jié)果1.兩組PLT整體走向是為上升趨勢,對照組中個別患兒PLT有所下降;兩組治療前PLT均值相近,但隨治療周期展開兩組PLT均值拉開距離,相比來說治療組較對照組整體上升趨勢明顯,且更為平穩(wěn)。2.治療組:總有效9例(64.3%),完全反應(yīng)8例(42.9%),有效3例(21.4%),無效5例(35.7%);對照組:總有效4例(28.6%),完全反應(yīng)0例(0%),有效4例(28.6%),無效10例(71.4%);兩組在治療效果方面相比有顯著差異,具有統(tǒng)計學(xué)意義(P0.05),隨著治療周期的延長,治療組療效優(yōu)勢更為明顯且更為平穩(wěn)。在臨床觀察周期中,未發(fā)現(xiàn)兩組治療前后的安全性指標(biāo)有任何不良影響,提示兩組干預(yù)措施臨床安全性均比較好。3.兩組血小板相關(guān)抗體陽性率較低,可能與樣本量太少及本研究對象特殊有關(guān),具體的原因尚需要進一步的進行探討。對四種抗體進行統(tǒng)計發(fā)現(xiàn),血小板相關(guān)抗體大部分數(shù)值均有所下降,相比來說治療組下降例數(shù)稍多一些,但兩觀察組檢測的四種抗體治療后與治療前相比并無統(tǒng)計學(xué)意義(P0.05),且兩組差異也并無統(tǒng)計學(xué)意義。說明扶正解毒方一定程度上可對血小板相關(guān)抗體產(chǎn)生影響,但其變化差異并不顯著,由于時間及經(jīng)費的限制,不排除可能為觀察周期及監(jiān)測次數(shù)對本研究造成的影響,具體原因仍尚需進一步探討。另外有相關(guān)報道過ITP患者的血小板相關(guān)抗體增高值與血小板壽命及血小板計數(shù)呈負向的關(guān)系,本研究數(shù)據(jù)并無直接表明,其關(guān)系也有待進一步的探討。結(jié)論1.扶正解毒方能安全、平穩(wěn)、有效地提高氣不攝血型持續(xù)性、慢性ITP患兒的血小板數(shù)目,治療效果確切,值得進一步研究及推廣。2.扶正解毒方對血小板相關(guān)抗體在一定程度產(chǎn)生影響,具體作用機理尚需要進一步的進行研究及探討。
[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.
【學(xué)位授予單位】:北京中醫(yī)藥大學(xué)
【學(xué)位級別】:碩士
【學(xué)位授予年份】:2017
【分類號】:R272
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