咖啡酸片聯(lián)合大劑量地塞米松治療ITP的療效和安全性研究
發(fā)布時(shí)間：2018-08-07 09:33
【摘要】：研究背景原發(fā)免疫性血小板減少癥(primary immune thrombocytopenia,ITP)是一種常見(jiàn)的出血性疾病,約占出血性疾病的33%。ITP主要臨床表現(xiàn)為皮膚、粘膜自發(fā)性出血,嚴(yán)重者可出現(xiàn)顱內(nèi)出血,甚至危及生命。目前公認(rèn)的ITP發(fā)病機(jī)制是患者對(duì)自身抗原耐受性的丟失,進(jìn)而導(dǎo)致血小板破壞增加及/或巨核細(xì)胞成熟障礙。大劑量地塞米松(high-doesdexamethasone,HD-DXM)沖擊治療(40mg/天,連用4天,2星期為1個(gè)周期)是當(dāng)前治療ITP的一線方案。但是大劑量地塞米松治療ITP患者的長(zhǎng)期緩解率不高�？Х人�(caffeic acid,CFA)具有抗氧化、提升白細(xì)胞數(shù)目、抗炎、提升血小板數(shù)目、止血等作用。我們的一項(xiàng)多中心臨床研究發(fā)現(xiàn),咖啡酸能夠顯著提高ITP患者的血小板數(shù)量,對(duì)ITP可能具有一定的治療價(jià)值。ITP的發(fā)病機(jī)制具有多樣化的特點(diǎn),單藥治療ITP存在不足與風(fēng)險(xiǎn)。研究目的評(píng)價(jià)咖啡酸片聯(lián)合大劑量地塞米松治療新診斷ITP的療效和安全性。研究方法本試驗(yàn)采用系統(tǒng)性回顧分析的研究方法。共收集就診于山東大學(xué)齊魯醫(yī)院60名新診斷的ITP患者,其中A組包含34人,B組包括26人。A組患者接受了大劑量地塞米松1個(gè)周期或2個(gè)周期沖擊治療,同時(shí)口服咖啡酸片(0.9g/天,每天3次)12周。B組患者僅接受大劑量地塞米松1個(gè)周期或2個(gè)周期沖擊治療。主要研究患者的總反應(yīng)率(overall response,OR)、完全反應(yīng)率(complete response,CR)、治療后各時(shí)間點(diǎn)(第7天、第14天、第21天、第28天、2個(gè)月、3個(gè)月、4個(gè)月、5個(gè)月、6個(gè)月)血小板數(shù)目、出血評(píng)分、起效時(shí)間(time to response,TTR)及藥物不良反應(yīng)。同時(shí)統(tǒng)計(jì)患者的性別、年齡、初始血小板數(shù)目等基本情況。結(jié)果(1)A組患者中位年齡為45(18～69)歲,男女比例為8/26,初始血小板中位數(shù)為4.5(0～27)×109/L;B組患者中位年齡49.5(27～67)歲,男女比例為9/17,初始血小板中位數(shù)是7(0～28)×109/L。兩組患者的性別、年齡及初始血小板數(shù)目均無(wú)顯著統(tǒng)計(jì)學(xué)差異(P值分別為:0.87、0.35、0.54)。(2)治療28天后,A組總反應(yīng)率是79.4%(27/34),完全反應(yīng)率是58.8%(20/34);B組總反應(yīng)率是57.7%(15/26),完全反應(yīng)率是50%(13/26),兩組總反應(yīng)率及完全反應(yīng)率的差異無(wú)顯著統(tǒng)計(jì)學(xué)差異(P值分別為0.069、0.496)。(3)治療后,兩組各時(shí)間點(diǎn)(第7天、第14天、第21天、第28天、第2個(gè)月、第3個(gè)月、第4個(gè)月、第5個(gè)月、第6個(gè)月)血小板數(shù)目差異無(wú)統(tǒng)計(jì)學(xué)意義(P 值分別為:0.84、0.21、0.90、0.75、0.62、0.23、0.46、0.56、0.52)。各時(shí)間點(diǎn)(第7天、第14天、第21天、第28天、第2個(gè)月、第3個(gè)月、第4個(gè)月、第5個(gè)月、第6個(gè)月)血小板數(shù)目增值也無(wú)顯著統(tǒng)計(jì)學(xué)差異(P值分別為:0.90、0.19、0.86、0.81、0.79、0.18、0.18、0.33、0.32)。(4)A組患者出血評(píng)分的降低值明顯大于B組(P=0.019),即咖啡酸聯(lián)合大劑量地塞米松組比大劑量地塞米松單藥組更好的改善患者的出血癥狀。(5)A組中位起效時(shí)間是4.5(1～22)天,B組中位起效時(shí)間是6(2～57)天,無(wú)顯著統(tǒng)計(jì)學(xué)差異(P=0.95)。(6)A組和B組的不良反應(yīng)輕微,無(wú)需停藥,均可自行緩解。結(jié)論咖啡酸片聯(lián)合大劑量地塞米松治療成人新診斷的ITP的總反應(yīng)率為79.4%,具有良好的療效,但與單藥組相比無(wú)統(tǒng)計(jì)學(xué)差異�？Х人崞�(lián)合大劑量地塞米松比單用大劑量地塞米松可以更好的改善患者的出血癥狀。兩組患者各時(shí)間點(diǎn)的血小板計(jì)數(shù)相比均無(wú)顯著統(tǒng)計(jì)學(xué)差異。兩組的起效時(shí)間無(wú)顯著統(tǒng)計(jì)學(xué)差異�？Х人崞�(lián)合大劑量地塞米松治療ITP與大劑量地塞米松單藥組相比,不良反應(yīng)沒(méi)有疊加,耐受性良好。
[Abstract]:Background primary immuno thrombocytopenia (primary immune thrombocytopenia, ITP) is a common hemorrhagic disease. The main clinical manifestation of 33%.ITP in hemorrhagic disease is skin and spontaneous bleeding of mucous membrane. Severe patients can appear intracranial hemorrhage and even endanger life. The present pathogenesis of ITP is that the pathogenesis of ITP is the patient's resistance to itself. Loss of primary tolerance leads to increased platelet destruction and / or megakaryocyte maturation. Large dose high-doesdexamethasone (HD-DXM) impact therapy (40mg/ days, 4 days, 2 weeks for 1 cycles) is the first line of current treatment for ITP, but the long-term remission rate of ITP patients with large dose of dexamethasone is not high. Caffeic acid (CFA) has antioxidation, increases the number of leukocytes, increases the number of white blood cells, increases the number of platelets, and stops blood. Our multicenter clinical study has found that caffeic acid can significantly increase the number of platelets in ITP patients, and the pathogenesis of ITP, which may have a certain therapeutic value, is characterized by a variety of characteristics, single drug treatment. The purpose of this study was to evaluate the efficacy and safety of ITP with a large dose of dexamethasone combined with a large dose of dexamethasone in the treatment of a new ITP. A systematic retrospective analysis was used in this study. A total of 60 newly diagnosed ITP patients diagnosed in Qilu Hospital of Shandong University were collected, including 34 in group A, and 26 in B group.A. Group patients received 1 cycles or 2 cycles of shock treatment with large dose of dexamethasone, and oral caffeic acid tablets (0.9g/ days, 3 times per day) for 12 weeks of group.B patients received only 1 cycles or 2 cycles of severe dexamethasone. The total response rate (overall response, OR), the total response rate (complete response, CR), and the cure rate (complete response, CR) were studied. Each time point (seventh days, fourteenth days, twenty-first days, twenty-eighth days, 2 months, 3 months, 4 months, 5 months, 6 months) the number of platelets, bleeding score, time to response, TTR and adverse drug reactions. Meanwhile, statistics of sex, age, and initial platelet count in patients (1) the median age of patients in group A was 45 (18~69) years. The proportion of men and women was 8/26, the median of the initial platelets was 4.5 (0~27) x 109/L; the median age of the B group was 49.5 (27~67) years and the male and female ratio was 9/17. The median of the initial platelets was 7 (0~28) x 109/L. two, and there was no significant difference between the age and the initial platelets (P value, 0.87,0.35,0.54). (2) after 28 days, A The total reaction rate was 79.4% (27/34), the total reaction rate was 58.8% (20/34), the total reaction rate in the B group was 57.7% (15/26), the total reaction rate was 50% (13/26). There was no significant difference between the two groups of total reaction rate and complete reaction rate (P value 0.069,0.496 respectively). (3) after treatment, the two groups of time points (seventh days, fourteenth days, twenty-first days, twenty-eighth days, second months,) There was no significant difference in the number of platelets in third months, fourth months, fifth months and sixth months (P value was 0.84,0.21,0.90,0.75,0.62,0.23,0.46,0.56,0.52). There was no significant difference in the number of platelets at all time points (seventh days, fourteenth days, twenty-first days, twenty-eighth days, second months, third months, fourth months, fifth, sixth months) (P The value of 0.90,0.19,0.86,0.81,0.79,0.18,0.18,0.33,0.32). (4) the decrease value of bleeding score in group A was significantly greater than that of group B (P=0.019), that is, caffeic acid combined with large dose dexamethasone group was better than the large dose of dexamethasone single drug group to improve the patient's bleeding symptoms. (5) the onset time of the A group was 4.5 (1~22) days, and the middle effect time of group B was at the middle level. 6 (2~57) days, no significant statistical difference (P=0.95). (6) the adverse reaction of group A and group B was mild, no need to stop drugs, and it could be relieved. Conclusion the total reaction rate of caffeic acid tablets combined with large dose of dexamethasone in the treatment of adult newly diagnosed ITP has good effect, but there is no statistical difference compared with that of the single drug group. There was no significant difference in the platelet count at all time points between the two groups. There was no significant difference in the onset time between the two groups. There was no significant difference in the onset time between the two groups. The combination of the caffeic acid tablets combined with the large dose of dexamethasone was compared with the large dose of the dexamethasone group. The adverse reactions were not superimposed and well tolerated.
【學(xué)位授予單位】：山東大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類(lèi)號(hào)】：R558.2
本文編號(hào)：2169605
[Abstract]:Background primary immuno thrombocytopenia (primary immune thrombocytopenia, ITP) is a common hemorrhagic disease. The main clinical manifestation of 33%.ITP in hemorrhagic disease is skin and spontaneous bleeding of mucous membrane. Severe patients can appear intracranial hemorrhage and even endanger life. The present pathogenesis of ITP is that the pathogenesis of ITP is the patient's resistance to itself. Loss of primary tolerance leads to increased platelet destruction and / or megakaryocyte maturation. Large dose high-doesdexamethasone (HD-DXM) impact therapy (40mg/ days, 4 days, 2 weeks for 1 cycles) is the first line of current treatment for ITP, but the long-term remission rate of ITP patients with large dose of dexamethasone is not high. Caffeic acid (CFA) has antioxidation, increases the number of leukocytes, increases the number of white blood cells, increases the number of platelets, and stops blood. Our multicenter clinical study has found that caffeic acid can significantly increase the number of platelets in ITP patients, and the pathogenesis of ITP, which may have a certain therapeutic value, is characterized by a variety of characteristics, single drug treatment. The purpose of this study was to evaluate the efficacy and safety of ITP with a large dose of dexamethasone combined with a large dose of dexamethasone in the treatment of a new ITP. A systematic retrospective analysis was used in this study. A total of 60 newly diagnosed ITP patients diagnosed in Qilu Hospital of Shandong University were collected, including 34 in group A, and 26 in B group.A. Group patients received 1 cycles or 2 cycles of shock treatment with large dose of dexamethasone, and oral caffeic acid tablets (0.9g/ days, 3 times per day) for 12 weeks of group.B patients received only 1 cycles or 2 cycles of severe dexamethasone. The total response rate (overall response, OR), the total response rate (complete response, CR), and the cure rate (complete response, CR) were studied. Each time point (seventh days, fourteenth days, twenty-first days, twenty-eighth days, 2 months, 3 months, 4 months, 5 months, 6 months) the number of platelets, bleeding score, time to response, TTR and adverse drug reactions. Meanwhile, statistics of sex, age, and initial platelet count in patients (1) the median age of patients in group A was 45 (18~69) years. The proportion of men and women was 8/26, the median of the initial platelets was 4.5 (0~27) x 109/L; the median age of the B group was 49.5 (27~67) years and the male and female ratio was 9/17. The median of the initial platelets was 7 (0~28) x 109/L. two, and there was no significant difference between the age and the initial platelets (P value, 0.87,0.35,0.54). (2) after 28 days, A The total reaction rate was 79.4% (27/34), the total reaction rate was 58.8% (20/34), the total reaction rate in the B group was 57.7% (15/26), the total reaction rate was 50% (13/26). There was no significant difference between the two groups of total reaction rate and complete reaction rate (P value 0.069,0.496 respectively). (3) after treatment, the two groups of time points (seventh days, fourteenth days, twenty-first days, twenty-eighth days, second months,) There was no significant difference in the number of platelets in third months, fourth months, fifth months and sixth months (P value was 0.84,0.21,0.90,0.75,0.62,0.23,0.46,0.56,0.52). There was no significant difference in the number of platelets at all time points (seventh days, fourteenth days, twenty-first days, twenty-eighth days, second months, third months, fourth months, fifth, sixth months) (P The value of 0.90,0.19,0.86,0.81,0.79,0.18,0.18,0.33,0.32). (4) the decrease value of bleeding score in group A was significantly greater than that of group B (P=0.019), that is, caffeic acid combined with large dose dexamethasone group was better than the large dose of dexamethasone single drug group to improve the patient's bleeding symptoms. (5) the onset time of the A group was 4.5 (1~22) days, and the middle effect time of group B was at the middle level. 6 (2~57) days, no significant statistical difference (P=0.95). (6) the adverse reaction of group A and group B was mild, no need to stop drugs, and it could be relieved. Conclusion the total reaction rate of caffeic acid tablets combined with large dose of dexamethasone in the treatment of adult newly diagnosed ITP has good effect, but there is no statistical difference compared with that of the single drug group. There was no significant difference in the platelet count at all time points between the two groups. There was no significant difference in the onset time between the two groups. There was no significant difference in the onset time between the two groups. The combination of the caffeic acid tablets combined with the large dose of dexamethasone was compared with the large dose of the dexamethasone group. The adverse reactions were not superimposed and well tolerated.
【學(xué)位授予單位】：山東大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類(lèi)號(hào)】：R558.2
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