国内抗幽门螺旋杆菌治疗在儿童原发免疫性血小板减少症中疗效的Meta分析和试验序贯分析

Efficacy of anti-Helicobacter pylori therapy in children with immune thrombocytopenia in China:a Meta-analysis and trial sequential analysis

目的:系统评价国内抗幽门螺旋杆菌治疗在儿童原发免疫性血小板减少症的疗效。方法:计算机检索VIP、CNKI、Wanfang、SinoMed、Medline、Cochrane Library、PubMed,检索时间为各数据库建库至2019年4月16日,按照预先制定的遴选标准筛选出抗Hp(幽门螺旋杆菌)治疗儿童ITP(原发免疫性血小板减少症)的随机对照试验。用Rev Man5.3软件进行Meta分析,用TSA 0.9.5.10Beta软件进行试验序贯分析。结果:共检索出268篇文献,最终纳入14个研究,总样本量为833例。Meta分析结果显示:常规治疗联合抗Hp治疗在临床疗效、复发率、血小板计数、血液流变学指标和Hp阳性率等方面优于单纯常规治疗组,但在不良反应方面,由于文献数量较少,暂不能得出结论。试验序贯分析显示:在临床总有效率方面,累积Z值穿过了传统界值和TSA界值,提前得到肯定结论;在半年内复发率方面,累积Z值虽然穿过了传统界值,但并未与TSA界值相交,提示Meta分析结果可能为假阳性。结论:本研究结果提示常规治疗联合抗Hp治疗能增加儿童ITP的临床疗效,降低复发率。但因纳入研究质量等问题,本研究结论还有待更多关于抗Hp治疗的儿童ITP患者的高质量、随机双盲的随机对照试验。

OBJECTIVE To systematically evaluate the efficacy of anti-Helicobacter pylori therapy in children with primary immune thrombocytopenia. METHODS A computerized search of VIP, CNKI, Wanfang, SinoMed, Medline, Cochrane Library, and PubMed was performed from inseption to April 16, 2019 to screen for randomized controlled trials of anti-HP(Helicobacter pylori) in children with ITP(primary immune thrombocytopenia) according to predetermined selection criteria. Meta analysis was performed with RevMan5.3 software, and trial sequential analysis was performed with TSA 0.9.5.10 Beta software. RESULTS A total of 268 articles were retrieved and 14 studies were finally included. The total sample size was 833. The results of Meta analysis showed that conventional therapy combined with anti-hp therapy was superior to the conventional therapy group in clinical efficacy, recurrence rate, platelet count, hemorheology indexes and Hp positive rate, etc. However, in terms of adverse reactions, conclusions can not be confirmed temporarily due to the small number of literatures. The sequential analysis of the trial showed that the cumulative Z value crossed the traditional cut-off value and TSA cut-off value in terms of clinical overall response rate, and a positive conclusion was obtained in advance;in terms of the recurrence rate within 6 months, although the cumulative Z value crossed the traditional cut-off value, it did not intersect the TSA cut-off value, suggesting that the meta-analysis results may be false positive. CONCLUSION The results of this study suggest that conventional therapy combined with anti-Hp therapy can increase the clinical efficacy and reduce the recurrence rate of ITP in children.However, due to the quality of the included studies and other issues, the conclusion of this study remains to be confirmed with more high-quality, randomized double-blind randomized controlled trials on pediatric ITP patients treated with anti-Hp.