Ru Yi, Luo Ying, Zhou Yaqiong, Kuai Le, Sun Xiaoying, Xing Meng, Liu Liu, Lu Yi, Hong Seokgyeong, Chen Xi, Song Jiankun, Luo Yue, Fei Xiaoya, Li Bin, Li Xin
Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Institute of Dermatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai, China.
Front Pharmacol. 2019 Nov 6;10:1250. doi: 10.3389/fphar.2019.01250. eCollection 2019.
Hook F can cause adverse effects (AEs) in clinical application and may be harmful to human health. This study aim to summarize the AEs caused by tgpolyglycoside (TWP), the most common preparation of Hook F for clinical use. The Cochrane Library, EMBASE, PubMed, and Web of Science were searched to identify potential articles on this topic. All single-arm trials, controlled clinical trials, and randomized controlled trials were selected and summarized. Meta-regression was used to determine the sources of heterogeneity, and subgroups were used to identify factors leading to AEs. Forty-six studies, comprising 25 randomized controlled trials, 13 controlled clinical trials, and 8 single-arm trials, were included in this meta-analysis, representing 2437 enrolled TWP-treated participants. Combined intervention, drug dosage, medication treatment, pharmaceutical manufacturers, and specific organ toxicity were identified as potential factors leading to TWP-induced AEs in this meta-analysis. In patients treated with TWP, the global incidence of AEs was 30.75% (95% confidence interval [21.18-40.33], = 97%), and that of severe grade AEs was 4.68% (95% confidence interval [0.00-12.72], = 53%). Organ-specific analyses indicated that TWP treatment elicited intestinal toxicity, reproductive toxicity, hepatotoxicity, nephrotoxicity, hematotoxicity, cutaneous toxicity, and other damages. The AEs analyzed in the subgroups of combined intervention, drug dosage, medication treatment, and pharmaceutical manufacturers were considered as primary outcomes, and organic-specific AEs were considered as secondary outcomes. The occurrence of TWP-induced AEs was systemic, organ-specific, and related to medication course, combined intervention, and drug dosage.
钩吻素子在临床应用中可引起不良反应(AE),可能对人体健康有害。本研究旨在总结临床使用最常见的钩吻素子制剂雷公藤多苷(TWP)引起的AE。检索了Cochrane图书馆、EMBASE、PubMed和Web of Science以识别关于该主题的潜在文章。选择并总结了所有单臂试验、对照临床试验和随机对照试验。采用Meta回归确定异质性来源,并通过亚组分析确定导致AE的因素。本Meta分析纳入了46项研究,包括25项随机对照试验、13项对照临床试验和8项单臂试验,共2437名接受TWP治疗的受试者。联合干预、药物剂量、药物治疗、制药厂商和特定器官毒性被确定为该Meta分析中导致TWP引起AE的潜在因素。在接受TWP治疗的患者中,AE的总体发生率为30.75%(95%置信区间[21.18 - 40.33],I² = 97%),严重AE的发生率为4.68%(95%置信区间[0.00 - 12.72],I² = 53%)。器官特异性分析表明,TWP治疗可引起肠道毒性、生殖毒性、肝毒性、肾毒性血细胞毒性、皮肤毒性和其他损害。联合干预、药物剂量、药物治疗和制药厂商亚组中分析的AE被视为主要结局,器官特异性AE被视为次要结局。TWP引起AE的发生具有全身性、器官特异性,且与疗程、联合干预和药物剂量有关。