Li Lin-Lu, Su Yi-Xin, Mao Yun, Jiang Peng-Yuan, Chu Xue-Lei, Xue Peng, Jia Bo-Hui, Zhu Shi-Jie
Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China.
Department of Oncology, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing 100102, China.
Evid Based Complement Alternat Med. 2021 Feb 5;2021:8852261. doi: 10.1155/2021/8852261. eCollection 2021.
Cinobufotalin injection is a water-soluble preparation extracted from the skin secretion of Cantor or Schneider, which has been widely used as an adjuvant treatment in lung cancer patients. This study aimed to evaluate the clinical efficacy and safety of cinobufotalin (PubChem CID: 259776) injection as an adjunctive treatment for lung cancer. We designed a meta-analysis that performed following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. We aim to include randomized controlled trials by systematically searching the PubMed, EMBASE, CNKI, Wanfang database, VIP, CBM, the Cochrane Central Register of Controlled Trials, and Chinese Clinical Trial Registry from inception to Mar 1, 2020, comparing the difference between the use of cinobufotalin injection as an adjunctive treatment and a control group without cinobufotalin injection. The objective response rate (ORR) and quality of life (QOL) will be defined as the primary outcomes, and the disease control rate (DCR) and adverse events will be defined as the secondary outcomes. We included 21 articles with 1735 cases of lung cancer patients. Comparison results show that combining with cinobufotalin injection can improve ORR (OR = 1.77, 95% CI [1.43, 2.21], < 0.001), with low heterogeneity ( = 0.94, = 0%); DCR (OR = 2.20, 95% CI [1.70, 2.85], < 0.001), with low heterogeneity ( = 0.60, = 0%); KPS score (OR = 3.10, 95% CI [2.23, 4.32], < 0.001), with low heterogeneity ( = 0.85, = 0%); and the effect of pain relief (OR = 2.68, 95% CI [1.30, 5.55], = 0.008), with low heterogeneity ( = 0.72, = 0%). Low-to-moderate evidence shows that cinobufotalin injection combined with chemotherapy can significantly increase ORR, DCR, QOL, and the effect of pain relief. Meanwhile, cinobufotalin injection did not bring additional adverse events such as hematological toxicity, gastrointestinal toxicity, cardiotoxicity, hepatotoxicity, and nephrotoxicity; however, multicenter, large-sample, high-quality clinical research results are still needed to reveal the therapeutic effect of cinobufotalin injection in small-cell lung cancer (PROSPERO registration number: CRD42020170052).
华蟾素注射液是一种从中华大蟾蜍或黑眶蟾蜍皮肤分泌物中提取的水溶性制剂，已被广泛用作肺癌患者的辅助治疗药物。本研究旨在评估华蟾素（PubChem CID：259776）注射液作为肺癌辅助治疗的临床疗效和安全性。我们按照PRISMA（系统评价和Meta分析的首选报告项目）指南设计了一项Meta分析。我们旨在通过系统检索PubMed、EMBASE、CNKI、万方数据库、维普、中国生物医学文献数据库、Cochrane对照试验中心注册库和中国临床试验注册中心，纳入从建库至2020年3月1日的随机对照试验，比较使用华蟾素注射液作为辅助治疗与未使用华蟾素注射液的对照组之间的差异。客观缓解率（ORR）和生活质量（QOL）将被定义为主要结局，疾病控制率（DCR）和不良事件将被定义为次要结局。我们纳入了21篇文章，涉及共1735例肺癌患者。比较结果显示，联合使用华蟾素注射液可提高ORR（OR = 1.77，95%CI [1.43, 2.21]，P < 0.001），异质性较低（I² = 0.94，P = 0%）；DCR（OR = 2.20，95%CI [1.70, 2.85]，P < 0.001），异质性较低（I² = 0.60，P = 0%）；KPS评分（OR = 3.10，95%CI [2.23, 4.32]，P < 0.001），异质性较低（I² = 0.85，P = 0%）；以及疼痛缓解效果（OR = 2.68，95%CI [1.30, 5.55]，P = 0.008），异质性较低（I² = 0.72，P = 0%）。低至中等质量的证据表明，华蟾素注射液联合化疗可显著提高ORR、DCR、QOL和疼痛缓解效果。同时，华蟾素注射液并未带来血液学毒性、胃肠道毒性、心脏毒性、肝毒性和肾毒性等额外不良事件；然而，仍需要多中心、大样本、高质量的临床研究结果来揭示华蟾素注射液在小细胞肺癌中的治疗效果（PROSPERO注册号：CRD42020170052）。
