本文選題：復(fù)方黃黛片 + 急性早幼粒細(xì)胞白血病�。� 參考：《廣州中醫(yī)藥大學(xué)》2017年碩士論文

【摘要】：目的:本研究旨在通過對比分析復(fù)方黃黛片和三氧化二砷在急性早幼粒細(xì)胞白血病誘導(dǎo)治療中的臨床療效,進(jìn)一步探究復(fù)方黃黛片在該疾病誘導(dǎo)緩解治療中的確切療效與安全性,為急性早幼粒細(xì)胞白血病誘導(dǎo)治療的優(yōu)化方案選擇提供參考。方法:本試驗采用單盲、平行、隨機(jī)對照的方法,共納入病例30例,隨機(jī)分為口服復(fù)方黃黛片聯(lián)合維甲酸為誘導(dǎo)治療方案的復(fù)方黃黛片組(治療組)14例,和以三氧化二砷聯(lián)合維甲酸為基礎(chǔ)方案的三氧化二砷組(對照組)16例。統(tǒng)計和比較兩組病人誘導(dǎo)治療前后的臨床癥狀、血分析、骨髓形態(tài)、基因和染色體,凝血功能、肝腎功能及其它主要不良事件,并運(yùn)用統(tǒng)計學(xué)方法對比和分析兩組病人的數(shù)據(jù),得出結(jié)論。結(jié)果:1、復(fù)方黃黛片組誘導(dǎo)治療的完全緩解率(CR,complete remission)為92.8%,三氧化二砷組完全緩解率則為100%,二者完全緩解率無統(tǒng)計學(xué)意義。復(fù)方黃黛片組達(dá)CR時間為43.76±9.51天,而三氧化二砷組為39.96±8.60天,兩組達(dá)CR時間有統(tǒng)計學(xué)差異,說明兩組的誘導(dǎo)緩解率相似,但復(fù)方黃黛片組達(dá)CR所需時間稍長于三氧化二砷組。2、誘導(dǎo)緩解后,兩組的PML-RARα基因轉(zhuǎn)陰率,無統(tǒng)計學(xué)差異,直至研究結(jié)束,兩組血液學(xué)、分子學(xué)均呈持續(xù)緩解,未出現(xiàn)復(fù)發(fā)。3、兩組PT、APTT恢復(fù)時間無差異,但Fib、D-二聚體恢復(fù)時間有統(tǒng)計學(xué)差異,復(fù)方黃黛片組凝血功能恢復(fù)所需時間較三氧化二砷組縮短,說明復(fù)方黃黛片組對凝血功能的恢復(fù)有裨益,并可減少治療過程中血液制品的輸注量。4、誘導(dǎo)治療中兩組彌散性血管內(nèi)凝血的發(fā)生率無統(tǒng)計學(xué)差異,主要表現(xiàn)為皮膚黏膜出血、牙齦出血、尿血。5、誘導(dǎo)治療過程中,兩組在高白細(xì)胞峰值、高白細(xì)胞的持續(xù)時間及相關(guān)臨床表現(xiàn),無統(tǒng)計學(xué)差異。6、心電圖異常、肝功能損害、胃腸道反應(yīng)等其他不良反應(yīng)的發(fā)生率,兩組無明顯差異,停藥或?qū)ΠY治療后可恢復(fù)正常。說明以復(fù)方黃黛片為主的誘導(dǎo)治療方案與靜脈用砷劑有著相似的安全性。結(jié)論:1、以復(fù)方黃黛片聯(lián)合維甲酸為基礎(chǔ)的誘導(dǎo)治療方案的完全緩解率等同靜脈用三氧化二砷,但達(dá)完全緩解的時間稍長。2、以復(fù)方黃黛片為基礎(chǔ)的誘導(dǎo)方案可縮短凝血功能恢復(fù)時間,減少早期出血及相關(guān)并發(fā)癥的出現(xiàn),并可減少治療中的血制品輸注。3、兩組心電圖異常、肝功能損害、胃腸道反應(yīng)等不良反應(yīng)的發(fā)生率無明顯差異,說明以復(fù)方黃黛片為主的誘導(dǎo)治療方案與靜脈用砷劑有著相似的安全性。因此,以復(fù)方黃黛片為基礎(chǔ)的誘導(dǎo)治療方案是可行的臨床選項,復(fù)方黃黛片聯(lián)合維甲酸這一完全口服方案可作為常規(guī)誘導(dǎo)治療方案在臨床中推廣。
[Abstract]:Objective: to compare and analyze the clinical effect of compound Huangdai tablets and arsenic trioxide in the induction of acute promyelocytic leukemia. To further explore the exact efficacy and safety of compound Huangdai tablets in the treatment of the disease induced remission, and to provide a reference for the selection of optimal regimen for the induction treatment of acute promyelocytic leukemia. Methods: a single blind, parallel, randomized control method was used in this study. 30 patients were randomly divided into two groups: compound Huangdai tablet combined with retinoic acid as induction therapy group (treatment group, n = 14). And arsenic trioxide combined with retinoic acid as the basic scheme of arsenic trioxide group (control group, 16 cases). The clinical symptoms, blood analysis, bone marrow morphology, gene and chromosome, coagulation function, liver and kidney function and other major adverse events before and after induction treatment were statistically analyzed and compared between the two groups. come to conclusion Results the complete remission rate of compound Huangdai tablet group was 92.8%, and that of arsenic trioxide group was 100%. There was no significant difference between the two groups. The CR time of compound Huangdai tablet group was 43.76 鹵9.51 days, while that of arsenic trioxide group was 39.96 鹵8.60 days. However, the time required to reach CR in compound Huangdai tablet group was slightly longer than that in arsenic trioxide group. After induction and remission, there was no significant difference in the conversion rate of PML-RAR 偽 gene between the two groups. Until the end of the study, the hematology and molecular studies of the two groups showed a sustained remission. The recovery time of PTT APTT was not different between the two groups, but the recovery time of FibD- dimer was statistically different. The coagulation function recovery time of compound Huangdai tablet group was shorter than that of arsenic trioxide group. The results showed that compound Huangdai tablet group was beneficial to the recovery of coagulation function, and could reduce the transfusion volume of blood products. There was no significant difference in the incidence of disseminated intravascular coagulation between the two groups in induction therapy, and the main manifestation was skin and mucosal hemorrhage. Gingival bleeding, urine blood. 5. During induction treatment, there was no significant difference between the two groups in peak white blood cell, duration of high white blood cell and related clinical manifestations, abnormal electrocardiogram and liver function damage. There was no significant difference in the incidence of other adverse reactions such as gastrointestinal reactions between the two groups. The results showed that the induction therapy of compound Huangdai tablet was similar to that of arsenic for intravenous use. Conclusion the complete remission rate of the induced therapy based on compound Huangdai tablets combined with retinoic acid is equivalent to that of intravenous arsenic trioxide. However, the time of complete remission was a little longer. The induction regimen based on compound Huangdai tablet could shorten the recovery time of coagulation function, reduce the occurrence of early bleeding and related complications, and reduce the transfusion of blood products. There was no significant difference in the incidence of adverse reactions such as liver function damage and gastrointestinal reaction, which indicated that the induction therapy regimen with compound Huangdai tablet was similar to that of arsenic for intravenous use. Therefore, the induction therapy based on compound Huangdai tablet is a feasible clinical option, and the complete oral regimen of compound Huangdai tablet combined with retinoic acid can be used as a routine induction therapy in clinical practice.
【學(xué)位授予單位】：廣州中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R733.71

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