Direct comparisons of efficacy and safety between actinomycin-D and methotrexate in women with low-risk gestational trophoblastic neoplasia: a meta-analysis of randomized and high-quality non-randomized studies.
Direct comparisons of efficacy and safety between actinomycin-D and methotrexate in women with low-risk gestational trophoblastic neoplasia: a meta-analysis of randomized and high-quality non-randomized studies.
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放线菌素- d和甲氨蝶呤治疗低风险妊娠滋养细胞瘤的疗效和安全性的直接比较：一项随机和高质量非随机研究的荟萃分析
DOI：
10.1186/s12885-021-08849-7
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发表时间：
2021-10-18
期刊：
影响因子：
3.8
通讯作者：
Xue Y
中科院分区：
文献类型：
--
作者：
Hao J;Zhou W;Zhang M;Yu H;Zhang T;An R;Xue Y
放线菌素- d （Act-D）和甲氨蝶呤（MTX）都是治疗低风险妊娠滋养细胞瘤（LRGTN）的有效一线药物，关于哪一种更有效或毒性更小尚无共识。本荟萃分析的主要目的是比较Act-D与MTX治疗LRGTN的疗效。我们系统地检索了随机对照试验（rct）和高质量非随机对照试验（non- rct）的电子数据库、会议摘要和试验注册库，比较Act-D与MTX治疗LRGTN患者的疗效。对研究进行全文筛选，以进行质量评估和数据提取。符合条件的研究必须报告完全缓解率。进行固定效应荟萃分析，分别量化Act-D和MTX在优势比（ORs）和95%置信区间（95% ci）上的疗效和安全性。共纳入8项rct和9项非rct（1674例患者）。就疗效而言，Act-D在完全缓解方面优于MTX （80.2% [551/687] vs 65.1% [643/987]; OR 2.15, 95%CI 1.70 - 2.73）。在分层分析中，来自rct和非rct的患者在基于act - d的方案中均有更好的完全缓解（rct: 81.2% [259/319] vs 66.1% [199/301], OR 2.17, 95%CI 1.49至3.16；非rct: 79.3% [292/368] vs 65.0% [444/686], OR 2.14, 95%CI 1.57至2.92）。在安全性方面，接受Act-D治疗的患者出现恶心（OR 2.35, 95%CI 1.68 - 3.27）、呕吐（OR 2.40, 95%CI 1.63 - 3.54）和脱发（OR 2.76, 95%CI 1.60 - 4.75）的风险较高。值得注意的是，肝毒性（OR 0.38, 95%CI 0.19至0.76）是唯一符合接受MTX的患者具有较高风险的因素。此外，合并结果显示Act-D与MTX在贫血、白细胞减少、中性粒细胞减少、血小板减少、便秘、腹泻、厌食、疲劳等方面无显著差异。我们的荟萃分析表明，Act-D总体上具有更好的疗效，而MTX对LRGTN的毒性更小。未来的临床试验应该更好地安排，以提供更有效的疗效和毒性数据。在线版本包含补充材料，可在10.1186/s12885-021-08849-7获得。
Actinomycin-D (Act-D) and Methotrexate (MTX) are both effective first-line agents for low-risk gestational trophoblastic neoplasia (LRGTN) with no consensus regarding which is more effective or less toxic. The primary objective of this meta-analysis is to compare Act-D with MTX in the treatment of LRGTN. We systematically searched electronic databases, conferences abstracts and trial registries for randomized controlled trials (RCTs) and high-quality non-randamized controlled trials (non-RCTs), comparing Act-D with MTX for patients with LRGTN. Studies were full-text screened for quality assessment and data extraction. Eligible studies must have reported complete remission rate. A fixed-effects meta-analysis was conducted to quantify the efficacy and safety of Act-D and MTX on odds ratios (ORs) and 95% confidence intervals (95%CIs), respectively. A total of 8 RCTs and 9 non-RCTs (1674 patients) were included. In terms of efficacy, Act-D is superior to MTX in complete remission (80.2% [551/687] vs 65.1% [643/987]; OR 2.15, 95%CI 1.70 to 2.73). In the stratified analysis, patients from RCTs and non-RCTs both had a better complete remission from Act-D-based regimen (RCTs: 81.2% [259/319] vs 66.1% [199/301], OR 2.17, 95%CI 1.49 to 3.16; non-RCTs: 79.3% [292/368] vs 65.0% [444/686], OR 2.14, 95%CI 1.57 to 2.92). In terms of safety, patients receiving Act-D had higher risks of suffering nausea (OR 2.35, 95%CI 1.68 to 3.27), vomiting (OR 2.40, 95%CI 1.63 to 3.54), and alopecia (OR 2.76, 95%CI 1.60 to 4.75). Notably, liver toxicity (OR 0.38, 95%CI 0.19 to 0.76) was the only one that was conformed to have a higher risk for patients receiving MTX. In addition, the pooled results showed no significant difference of anaemia, leucocytopenia, neutropenia, thrombocytopnia, constipation, diarrhea, anorexia, and fatigue between Act-D and MTX. Our meta-analysis suggests that Act-D had better efficacy profile in general, and MTX had less toxicities in LRGTN. Future clinical trials should be better orchestrated to provide more valid data on efficacy and toxicity. The online version contains supplementary material available at 10.1186/s12885-021-08849-7.
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影响因子：
4.7
作者：
Abrao, Renato Antonio;de Andrade, Jurandyr Moreira;Clagnan, Willian Simoes
通讯作者：
Clagnan, Willian Simoes
DOI：
10.1111/j.1479-828x.2005.00366.x
发表时间：
2005-04-01
影响因子：
1.7
作者：
Gilani, MM;Yarandi, F;Hanjani, P
通讯作者：
Hanjani, P
DOI：
10.1111/igc.0b013e3181a8333d
发表时间：
2009-07-01
影响因子：
4.8
作者：
Lertkhachonsuk, Arb-aroon;Israngura, Nathpong;Tangtrakul, Somsak
通讯作者：
Tangtrakul, Somsak
影响因子：
4.7
作者：
Matsui, H;Suzuka, K;Sekiya, S
通讯作者：
Sekiya, S
影响因子：
4.7
作者：
Chapman-Davis, Eloise;Hoekstra, Anna V.;Lurain, John R.
通讯作者：
Lurain, John R.