Division of Medicine, Klang Hospital, Bangkok, Thailand.
Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.
Technol Cancer Res Treat. 2020 Jan-Dec;19:1533033820937008. doi: 10.1177/1533033820937008.
Acute promyelocytic leukemia, a subtype of acute myeloid leukemia, is highly curable. In subgroup of patients with non-high-risk acute promyelocytic leukemia, intravenous arsenic trioxide plus all-trans-retinoic acid is considered the preferred regimen for acute promyelocytic leukemia. Recently, there are interests in the use of the oral form of arsenic, named the Realgar-Indigo naturalis formula, but the data on its efficacy and safety are still relatively limited. The current study was conducted with the aims to identify and summarize the results of all available randomized-controlled studies. A systematic review was conducted in the 2 major databases, utilizing the terms for arsenic and acute promyelocytic leukemia. Eligible studies had to be randomized-controlled studies that compared efficacy and/or adverse effects of oral arsenic versus intravenous arsenic for treatment of patients with acute promyelocytic leukemia. The Mantel-Haenszel method was used to pool the effect estimates and 95% confidence intervals of the included studies together. A total of 4 randomized controlled studies with 482 patients with acute promyelocytic leukemia (258 in Realgar-Indigo naturalis formula group and 224 in intravenous arsenic trioxide group) were included in the meta-analysis. The chances of achieving complete remission were numerically higher in the Realgar-Indigo naturalis formula group but the difference was not statistically significant (pooled odds ratio: 4.59, 95% CI: 0.74-28.57, = 0%). Similarly, other efficacy outcomes, including 30-day mortality rate, overall survival, and event-free survival, also tended to favor the Realgar-Indigo naturalis formula group but the difference was not statistically significant. There was no significant difference in the chance of developing differentiation syndrome, cardiac complications, grades 3 to 4 liver toxicity, grades 3 to 4 renal toxicity, and infection between the 2 groups. The results may suggest that all-trans-retinoic acid plus oral Realgar-Indigo naturalis formula regimen is, at minimum, not a worse alternative to the standard all-trans-retinoic acid plus intravenous intravenous arsenic trioxide regimen for treatment of acute promyelocytic leukemia, especially for patients with low-to-intermediate risk.
急性早幼粒细胞白血病是急性髓细胞白血病的一种亚型，其具有高度可治愈性。在非高危急性早幼粒细胞白血病患者亚组中，静脉注射三氧化二砷联合全反式维甲酸被认为是急性早幼粒细胞白血病的首选治疗方案。最近，人们对口服砷制剂——雄黄-青黛复方的应用产生了兴趣，但关于其疗效和安全性的数据仍然相对有限。本研究旨在通过识别和总结所有现有随机对照研究的结果来评估该药物的疗效和安全性。我们在两个主要数据库中进行了系统评价，使用了砷和急性早幼粒细胞白血病的术语。纳入的研究必须是随机对照研究，比较了口服砷剂与静脉注射砷剂治疗急性早幼粒细胞白血病的疗效和/或不良反应。采用 Mantel-Haenszel 法对纳入研究的效应估计值和 95%置信区间进行合并。共有 4 项随机对照研究（共 482 例急性早幼粒细胞白血病患者，雄黄-青黛复方组 258 例，静脉注射三氧化二砷组 224 例）纳入荟萃分析。虽然在雄黄-青黛复方组中完全缓解的可能性更高，但差异无统计学意义（合并优势比：4.59，95%CI：0.74-28.57， = 0.08）。同样，其他疗效指标，包括 30 天死亡率、总生存率和无事件生存率，也倾向于雄黄-青黛复方组，但差异无统计学意义。两组患者分化综合征、心脏并发症、3-4 级肝毒性、3-4 级肾毒性和感染的发生率差异无统计学意义。结果表明，全反式维甲酸联合口服雄黄-青黛复方方案至少不比标准全反式维甲酸联合静脉注射三氧化二砷方案差，特别是对于中低危患者。
