TPO受体激动剂在骨髓增生异常综合征中疗效及安全性的meta分析

发布时间：2018-01-29 07:56

本文关键词： 骨髓增生异常综合征 TPO受体激动剂罗米司亭艾曲波帕 meta分析　出处：《山西医科大学》2017年硕士论文　论文类型：学位论文

【摘要】：目的:应用循证学评价TPO受体激动剂艾曲波帕和罗米司亭在骨髓增生异常综合征中应用的疗效及安全性,为临床提供可靠依据。方法:计算机检索Pub Med、Cochrane图书馆、Embase数据库;检索时限:2000年至2017年2月。同时对美国血液学杂志、美国临床肿瘤学会及欧洲血液学会收录的会议论文及相关出版物文献进行检索。文献包括TPO受体激动剂艾曲波帕和罗米司亭与安慰剂或者TPO受体激动剂联合MDS治疗药物与安慰剂联合MDS治疗药物对比的所有随机对照试验。对文献进行数据提取及质量评价,采用软件Rev Man5.3和stata12.0进行统计分析;相对危险度(RR)及95%可信区间(CI)、加权均数差(WMD)或者标准化均数差(SMD)及95%可信区间(CI)分别对计数和计量资料进行评价。对异质性进行检验,无异质性或者异质性较低用固定效应模型,反之应用随机效应模型。采用漏斗图和Begg’s、Egger's检验对纳入文献偏倚性进行评估。结果:共检索到7篇符合文献,患者1003例。结果示:艾曲波帕及罗米司亭组在治疗后血小板反应率高于安慰剂组(38.8%/11.0%),但两组差异无统计学意义[RR=3.05,95%CI(0.78,11.92)P0.05]。患者在应用艾曲波帕及罗米司亭后血小板输注率低于安慰剂组(28.5%/32.4%),且两组差异有统计学意义[RR=0.79,95%CI(0.65,0.97)P0.05];患者在应用艾曲波帕及罗米司亭后出血事件发生率低于安慰剂组(22.4%/32.0%),但两组差异无统计学意义[RR=0.71,95%CI(0.43,1.17)P0.05];严重出血事件发生率TPO受体激动剂组低于安慰剂组(5%/11.5%),且两组差异有统计学意义[RR=0.45,95%CI(0.23,0.89)P0.05];在CSTES事件发生率两组差异无统计学意义[RR=0.84,95%CI(0.66,1.07)P0.05]。TPO受体激动剂组与安慰剂组在不良事件、严重不良事件方面与安慰剂组相近分别为(96.0%/93.8%)、(47.4%/36.5%),相对危险度分别为[RR=1.03,95%CI(0.98,1.08)P0.05]、[RR=1.16,95%CI(0.81,1.65)P0.05];对于TPO受体激动剂会不会加重MDS病情进展,我们对MDS转化AML率进行了评估:二者MDS转化AML率相近(13.3%/12.0%)且两组差异无统计学意义[RR=1.24,95%CI(0.78,1.97)P0.05];TPO受体激动剂组与安慰剂组在总的死亡率(包括治疗相关及其他原因)方面相近(34.4%/34.7%)两组差异无统计学意义[RR=0.95,95%CI(0.79,1.13)P0.05].结论:TPO受体激动剂在骨髓增生异常综合征中有较好的疗效,治疗后血小板反应率高于安慰剂组,血小板输注率低于安慰剂组。且TPO受体激动剂的安全性较好;在不良事件和严重不良事件发生率方面与安慰剂组相近;在严重出血事件发生率方面要低于安慰剂组。Meta分析结果示:并没有证据表明TPO受体激动剂会增加MDS转化AML的风险。
[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.
【学位授予单位】：山西医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R551.3

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