Dai Zhan-Jing, Huang Yan-Qin, Lu Yun
Center for Health Care Policy Research, School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, China.
Transl Pediatr. 2021 Feb;10(2):244-255. doi: 10.21037/tp-20-178.
Multiagent chemotherapy is the primary treatment for acute lymphoblastic leukemia (ALL), of which asparaginases including L-asparaginase ( L-Asp) and pegylated-asparaginase (PEG-Asp), are cornerstone components. The study aimed to conduct a meta-analysis to compare the efficacy and safety of PEG-Asp with L-Asp in Chinese children with ALL.
A systematic literature search was conducted to collect randomized controlled trials (RCTs) on PEG-Asp versus L-Asp in Chinese children with ALL. Two reviewers independently selected articles and extracted data. Risk-of-bias assessment was conducted with Cochrane recommendation tool. Pooled estimates and risk ratios (RRs) with 95% confidence intervals (CIs) were calculated for all outcomes in Review Manager 5.3.
Out of the 470 publications screened, 15 studies were included, involving 1,194 patients. Pooled estimates showed that there were no significant differences in complete responses (CR), overall response rate (ORR), gastrointestinal symptoms, and coagulation abnormalities rate between the PEG-Asp and L-Asp groups (all P>0.05). Hypersensitivity (RR =0.63; 95% CI, 0.40-1.01; Ρ=0.05) and hepatic injury rate (RR =0.45; 95% CI, 0.27-0.75; Ρ=0.002) were lower in the PEG-Asp group. The frequency of administration and length of hospital stay of patients in the PEG-Asp group were less than those in the L-Asp group (both Ρ<0.0001).
Current evidence pointed out a similar efficacy in the two groups. The PEG-Asp group showed a lower hypersensitivity and hepatic injury rate. In addition, using PEG-Asp decreased the frequency of administration and the length of hospital stay, which, to some extent, might reduce patients' burden caused by medical resource consumption.
多药联合化疗是急性淋巴细胞白血病（ALL）的主要治疗方法，其中包括左旋门冬酰胺酶（L-Asp）和聚乙二醇化门冬酰胺酶（PEG-Asp）在内的门冬酰胺酶是关键组成部分。本研究旨在进行一项荟萃分析，比较PEG-Asp与L-Asp在中国ALL儿童患者中的疗效和安全性。
进行系统的文献检索，以收集关于PEG-Asp与L-Asp在中国ALL儿童患者中的随机对照试验（RCT）。两名审阅者独立选择文章并提取数据。使用Cochrane推荐工具进行偏倚风险评估。在Review Manager 5.3中计算所有结局的合并估计值和风险比（RR）以及95%置信区间（CI）。
在筛选的470篇出版物中，纳入了15项研究，涉及1194例患者。合并估计值显示，PEG-Asp组和L-Asp组在完全缓解（CR）、总缓解率（ORR）、胃肠道症状和凝血异常率方面无显著差异（所有P>0.05）。PEG-Asp组的过敏反应（RR =0.63；95%CI，0.40-1.01；P=0.05）和肝损伤率（RR =0.45；95%CI，0.27-0.75；P=0.002）较低。PEG-Asp组患者的给药频率和住院时间均少于L-Asp组（均P<0.0001）。
目前的证据表明两组疗效相似。PEG-Asp组的过敏反应和肝损伤率较低。此外，使用PEG-Asp降低了给药频率和住院时间，这在一定程度上可能减轻患者因医疗资源消耗而产生的负担。
