本文關(guān)鍵詞： 骨髓增生異常綜合征 TPO受體激動(dòng)劑 羅米司亭 艾曲波帕 meta分析　出處：《山西醫(yī)科大學(xué)》2017年碩士論文　論文類型：學(xué)位論文

【摘要】：目的:應(yīng)用循證學(xué)評(píng)價(jià)TPO受體激動(dòng)劑艾曲波帕和羅米司亭在骨髓增生異常綜合征中應(yīng)用的療效及安全性,為臨床提供可靠依據(jù)。方法:計(jì)算機(jī)檢索Pub Med、Cochrane圖書館、Embase數(shù)據(jù)庫;檢索時(shí)限:2000年至2017年2月。同時(shí)對(duì)美國血液學(xué)雜志、美國臨床腫瘤學(xué)會(huì)及歐洲血液學(xué)會(huì)收錄的會(huì)議論文及相關(guān)出版物文獻(xiàn)進(jìn)行檢索。文獻(xiàn)包括TPO受體激動(dòng)劑艾曲波帕和羅米司亭與安慰劑或者TPO受體激動(dòng)劑聯(lián)合MDS治療藥物與安慰劑聯(lián)合MDS治療藥物對(duì)比的所有隨機(jī)對(duì)照試驗(yàn)。對(duì)文獻(xiàn)進(jìn)行數(shù)據(jù)提取及質(zhì)量評(píng)價(jià),采用軟件Rev Man5.3和stata12.0進(jìn)行統(tǒng)計(jì)分析;相對(duì)危險(xiǎn)度(RR)及95%可信區(qū)間(CI)、加權(quán)均數(shù)差(WMD)或者標(biāo)準(zhǔn)化均數(shù)差(SMD)及95%可信區(qū)間(CI)分別對(duì)計(jì)數(shù)和計(jì)量資料進(jìn)行評(píng)價(jià)。對(duì)異質(zhì)性進(jìn)行檢驗(yàn),無異質(zhì)性或者異質(zhì)性較低用固定效應(yīng)模型,反之應(yīng)用隨機(jī)效應(yīng)模型。采用漏斗圖和Begg’s、Egger's檢驗(yàn)對(duì)納入文獻(xiàn)偏倚性進(jìn)行評(píng)估。結(jié)果:共檢索到7篇符合文獻(xiàn),患者1003例。結(jié)果示:艾曲波帕及羅米司亭組在治療后血小板反應(yīng)率高于安慰劑組(38.8%/11.0%),但兩組差異無統(tǒng)計(jì)學(xué)意義[RR=3.05,95%CI(0.78,11.92)P0.05]�；颊咴趹�(yīng)用艾曲波帕及羅米司亭后血小板輸注率低于安慰劑組(28.5%/32.4%),且兩組差異有統(tǒng)計(jì)學(xué)意義[RR=0.79,95%CI(0.65,0.97)P0.05];患者在應(yīng)用艾曲波帕及羅米司亭后出血事件發(fā)生率低于安慰劑組(22.4%/32.0%),但兩組差異無統(tǒng)計(jì)學(xué)意義[RR=0.71,95%CI(0.43,1.17)P0.05];嚴(yán)重出血事件發(fā)生率TPO受體激動(dòng)劑組低于安慰劑組(5%/11.5%),且兩組差異有統(tǒng)計(jì)學(xué)意義[RR=0.45,95%CI(0.23,0.89)P0.05];在CSTES事件發(fā)生率兩組差異無統(tǒng)計(jì)學(xué)意義[RR=0.84,95%CI(0.66,1.07)P0.05]。TPO受體激動(dòng)劑組與安慰劑組在不良事件、嚴(yán)重不良事件方面與安慰劑組相近分別為(96.0%/93.8%)、(47.4%/36.5%),相對(duì)危險(xiǎn)度分別為[RR=1.03,95%CI(0.98,1.08)P0.05]、[RR=1.16,95%CI(0.81,1.65)P0.05];對(duì)于TPO受體激動(dòng)劑會(huì)不會(huì)加重MDS病情進(jìn)展,我們對(duì)MDS轉(zhuǎn)化AML率進(jìn)行了評(píng)估:二者M(jìn)DS轉(zhuǎn)化AML率相近(13.3%/12.0%)且兩組差異無統(tǒng)計(jì)學(xué)意義[RR=1.24,95%CI(0.78,1.97)P0.05];TPO受體激動(dòng)劑組與安慰劑組在總的死亡率(包括治療相關(guān)及其他原因)方面相近(34.4%/34.7%)兩組差異無統(tǒng)計(jì)學(xué)意義[RR=0.95,95%CI(0.79,1.13)P0.05].結(jié)論:TPO受體激動(dòng)劑在骨髓增生異常綜合征中有較好的療效,治療后血小板反應(yīng)率高于安慰劑組,血小板輸注率低于安慰劑組。且TPO受體激動(dòng)劑的安全性較好;在不良事件和嚴(yán)重不良事件發(fā)生率方面與安慰劑組相近;在嚴(yán)重出血事件發(fā)生率方面要低于安慰劑組。Meta分析結(jié)果示:并沒有證據(jù)表明TPO受體激動(dòng)劑會(huì)增加MDS轉(zhuǎn)化AML的風(fēng)險(xiǎn)。
[Abstract]:Objective: to evaluate the efficacy and safety of TPO receptor agonists Etrappa and Romistin in patients with myelodysplastic syndrome (MDS). Methods: Pub MedCochrane Library was searched by computer. Search time: 2000 to February 2017. Also for the American Journal of Hematology. The American Society of Clinical Oncology and the European Society of Hematology have been searched for articles on conference papers and related publications. The literature includes TPO receptor agonists Etrappa and Romistin with placebo or TPO receptor agonists. All randomized controlled trials of comparison of drugs in combination with MDS and placebo and MDS. Data extraction and quality evaluation were performed in the literature. The software Rev Man5.3 and stata12.0 were used for statistical analysis. Relative risk (RR) and 95% confidence interval (CI). Weighted mean difference (WMD) or standardized mean difference (SMD) and 95% confidence interval (CI) were used to evaluate the counting and measurement data respectively. The heterogeneity was tested. Fixed-effect model was used for non-heterogeneity or low heterogeneity, whereas stochastic effect model was used. Funnel graph and Begg's were used. Egger's test was used to evaluate the bias of the included literature. Results: a total of 7 articles were retrieved. The results showed that the platelet response rate in the atropa and romistin groups was higher than that in the placebo group (38.8% / 11.0%), but there was no significant difference between the two groups. [RRU 3.05 / 95 / CI0.78. The platelet transfusion rate was lower than that in the placebo group (28.5R / 32.4g), and the difference between the two groups was statistically significant. [RRX 0.79 ~ 95CIQ 0.65 0.97 (P0.05); The incidence of haemorrhage in patients treated with atropa and romistin was lower than that in placebo group (22. 4% vs 32. 0%), but there was no significant difference between the two groups. [RRX 0.71 ~ 95CIQ 0.43 ~ 1.17 (P0.05); The incidence of severe bleeding events in the TPO receptor agonist group was lower than that in the placebo group, and the difference between the two groups was statistically significant. [There was no significant difference in the incidence of CSTES events between the two groups (P 0.05). [RRN 0.84 ~ 95CIN 0.660.07 (P0.05). TPO receptor agonist group and placebo group were in adverse events. The severity of adverse events was similar to that of the placebo group, and the relative risk was 96.0% / 93.8and 47.4% / 36.5%, respectively. [RRX 1.03 + 95% (P 0.05), [RRRL 1.16 ~ 95% ~ 0.81% ~ 1.65 ~ (-1) P _ (0.05); Whether TPO receptor agonists may aggravate the progression of MDS. We evaluated the conversion rate of MDS to AML: the rate of MDS transforming AML between the two groups was close to 13.3R / 12.0 and there was no significant difference between the two groups. [RRX 1.24 ~ 95% CI0.78 ~ 1.97% (P0.05); There was no significant difference between the TPO receptor agonist group and the placebo group in the total mortality (including treatment-related and other causes) between the two groups. [Conclusion the effect of TPO receptor agonist on myelodysplastic syndrome is better. After treatment, the platelet reaction rate was higher than that in the placebo group, and the platelet transfusion rate was lower than that in the placebo group, and the safety of TPO receptor agonist was better than that of the placebo group. The incidence of adverse events and severe adverse events was similar to that in the placebo group. There was no evidence that TPO receptor agonists increased the risk of AML transformation from MDS to AML as compared with the placebo group in terms of the incidence of severe haemorrhage events.
【學(xué)位授予單位】：山西醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R551.3

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