Short-term efficacy and safety of rhTPO combined with traditional monotherapy regimen for the treatment of ITP: a Meta-analysis

Abstract

Objective To evaluate the short-term efficacy and safety of recombinant human thrombopoietin(rhTPO) combined with glucocorticoid or danazol regimen and traditional monotherapy regimen in the treatment of idiopathic thrombocytopenic purpura(ITP). Methods All the randomized controlled trial(RCT) about short-term efficacy and safety of combined rhTPO regimen with hormone or danazol regimen and traditional monotherapy regimen in the treatment of ITP were electronically collected by searching databases, including PubMed, Wanfang database, VIP database, China National Knowledge Infrastructure (CNKI), China Biology Medicine disc(CBMdisc). Retrieval time is up to September 2017.Independent search of the literature by two trained researchers, excluding articles that were not available and of non-compliant quality, and using the Jadad scale for literature quality scoring.Then, Meta-analysis of the efficacy and safety of rhTPO combined with traditional glucocorticoids or danazol and traditional monotherapy regimenin the treatment of ITP were preformed by using R software. Results A total of 10 RCTs involving 625 ITP patients were included by tracking the literatures and follow-up to relevant references with full text. Among them, there were 319 patients in the experimental group and 306 patients in the control group. Ten RCTs in 10 articles have lower Jadad scores which are low quality RCTs. The Meta-analysis of the short-term efficacy and adverse effects of 10 studies on ITP in the study were as follows. ①Comparison of significant efficiency rate: 7 RCTs of 420 ITP patients from 7 studies were found to have relatively high heterogeneity (I2=62.3%, P=0.01). There was significant difference in significant efficiency rate between experimental group and the control group by the random effects model of Meta-analysis(OR=2.95, 95% CI: 1.37-6.37, P=0.06). After removing factor of high-dose dexamethasone interference, 5 RCTs involving 287 ITP patients had mild heterogeneity (I2=45%, P=0.12), and Meta-analysis using a fixed-effect model showed that the significant efficiency rate of the experimental group was higher than that of the control group, and the difference was statistically significant (OR=5.28, 95% CI: 2.95-9.44, P<0.000 1). ②Comparison of good efficiency rate: Six RCTs involving 358 patients with ITP had mild heterogeneity (I2=38%, P=0.15). Meta-analysis showed that there was no statistically significant difference in good efficiency rate between the experimental group and the control group by the fixed-effect model(OR=1.30, 95%CI: 0.82-2.07, P=0.27). ③Comparison of total effective rate: The heterogeneity between the 9 RCTs included in the 563 patients with ITP was low (I2=0%, P=0.65). The Meta-analysis using the fixed-effect model showed that the total effective rate of the test group was higher than that of the control group (OR=3.79, 95% CI: 2.50-5.73, P<0.01). ④Comparison of incidence of adverse reactions showed there was no significant difference in the incidence of adverse reactions between the experimental group and the control group (OR=3.56, 95% CI: 0.85-14.95, P=0.08) among 4 RCTs. Conclusions Compared with traditional monotherapy regimen, rhTPO combined with glucocorticoid or danazol regimen can improve significant efficiency rate and the total effective rate of ITP patients, but there were no significant differences in good efficiency rate and incidence of adverse reaction. Key words: Thrombocytopenia; Thrombopoietin; Glucocorticoids; Danazol; Meta-analysis