| Objective:To systematically evaluate the efficacy,safety of TPO and TPO-RAs on primary immune thrombocytopenia using statistical method of Meta-analysis.Methods:This study included randomized controlled trials of TPO and TPO-RAs on primary immune thrombocytopenia.We searched the databases of CNKI,Wanfang,VIP,CBM,Ovid MEDLINE,EMBASE and Cochrane with computer from the date of their establishment to December 2017,Putting the Chinese phrase“??????????????????????????”and in English“Romiplostim,Eltrombopag,TPO,thrombocytopenia”as the key words or free words,And manually retrieve relevant content magazines to extend the scope.Two reviewers independently accomplished screened literatures according to including and excluding criteria,and exchanged check and asked third party to help solve the doubt.Taking the included literature on risk and quality assessment by Cochrane risk bias assessment tool,and extracting the data.Using Review Manager 5.3 software supplied with the cochrane collaboration for statistical analysis of the raw data.To continuous variable,according to the comparability of different test data,weighted mean difference or standard mean difference and 95%confidence interval were selected and about dichotomous data,using the relative risk and 95%CI.The main outcome targets were:platelet response,durable response,adverse events,severe adverse events,bleeding events,and rescue treatments.Results:In the study,we screened and incorporated the original RCTs conformi-ng to the inclusion criteria 18 literatures.Trials involving 1459 cases of patients were retrieved.A meta-analysis of the outcome indicators was performed,and the results were shown(1)platelet response[RR=4.51,95%CI(3.03,6.71),P<0.00001],it is suggested that TPO-RAs have a higher overall response rate for the treatm-ent of ITP patients.Durable response[RR=6.45,95%CI(3.77,11.01,P<0.00001],shows that TPO-RAs have higher durable response compared to placebo.Adverse events[RR=1.00,95%CI(0.92,1.09),P=0.93],it cannot be demonstrated that TPORAs are used to treat patients with ITP and increase the adverse events.Severe adverse events[RR=0.86,95%CI(0.59,1.27),P=0.45],it cannot prove that TPORAs increase the rate of Severe adverse events in patients with ITP.Bleeding events[RR=0.88,95%CI(0.80,0.94),P=0.01],It is suggested that TPO-RAs used to treat ITP patients will reduce the incidence of bleeding events.Rescue treatments[RR=0.39,95%CI(0.27,0.58),P<0.00001)],this suggests that TPO-RAs may reduce the rescue treatments of ITP patients.(2)Combined TPO vs.Non-TPO:platelet response[RR=1.77,95%CI(0.94,3.33),P=0.08],It was shown that the combin ed use of rhTPO for the treatment of ITP had a higher overall response rate than hormone or danazol alone.Durable response[RR=1.77,95%CI(0.94,3.33),P=0.08],it shows that the combination of TPO and hormone alone has no sign ificant increase of durable response.Adverse events[RR=1.02,95%CI(0.73,1.44),P=0.90],it cannot be shown that the use of rhTPO in the treatment of ITP patients raises the incidence of adverse events.Conclusions:Compared with the control group,TPO and TPO-RAs can significantly increase the platelet response,while it does not increase the incidence of adverse events.It has good efficacy and safety.In addition,TPO-RAs can also increase durable response and reduce the incidence of any bleeding events in patients with ITP.More notably,our results suggest that TPO-RAs significantly reduce the need for rescue treatments.In the TPO group,rescue treatments and durable response will be further confirmed by more studies. |
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