介入性动脉化学栓塞（TACE）被推荐作为无法切除的原发性肝癌（PLC）的一线治疗方法，但由于严重的不良反应，只有部分患者能从TACE中获益。清热解毒（CHRT）是最重要的传统中药治疗原则之一，在PLC患者尤其是在接受TACE后被广泛应用。然而，目前还没有足够的临床证据来证实联合疗法的疗效和安全性。为了全面评估联合CHRT-CHF与TACE治疗PLC的疗效和安全性，我们搜索了从其开始到2023年2月1日的7个数据库。主要研究结果包括生存率（1年、2年）、客观缓解率（ORR）和疾病控制率（DCR）、肝功能指标（AST、ALT）、不良反应（包括发热、上消化道不良反应和骨髓抑制）以及AFP作为次要研究结果。使用RevMan5.4软件评估所包含研究的质量；使用Stata软件12.0进行荟萃分析、亚组分析、荟萃回归分析、发表偏倚和试验顺序分析（TSA）。 共有40个RCT涉及3649例患者。与仅TACE治疗相比，接受TACE联合CHRT-CHF治疗的患者在1年、2年生存率（分别为OR，2.23 [1.67-2.97]；OR，2.13 [1.56-2.92]）、ORR（OR，2.14 [1.82-2.52]）和DCR（OR，2.13 [1.74-2.62]）方面表现显著更好。接受联合TACE与CHRT-CHF治疗的患者中，天门冬氨酸转氨酶（AST）、丙氨酸转氨酶（ALT）、甲胎蛋白（AFP）和栓塞后综合征（PES）的发生率降低。亚组分析发现，较低比例（20-30%）的CHRT-CHF显著增强了生存率和DCR，而较高比例（≥40%）的CHRT-CHF降低了TACE治疗后的PES。 本荟萃分析验证了联合CHRT-CHF与TACE的疗效和安全性，并且20-30%的CHRT-CHF比例可能是增强疗效的最佳比例；此外，较高比例（≥40%）的CHRT-CHF似乎能减少TACE治疗后的PES。在临床实践中，应重视联合CHRT-CHF与TACE的比例对疗效的潜在作用。 版权所有 © 2023. 由Elsevier B.V.出版。

Transcatheter arterial chemoembolization (TACE) is recommended as the first-line therapy for unresected primary liver cancer (PLC), but only partial patients could benefit from TACE due to the serious adverse reactions. Clearing heat and resolving toxin (CHRT), one of most critical traditional Chinese medicine (TCM) therapeutic principles, has been widely used in the treatment of PLC patients especially after TACE. However, there is no enough clinical evidence to confirm the efficacy and safety of the combined therapy.To comprehensively evaluate the efficacy and safety of the combined CHRT-CHF with TACE in the treatment of PLC.7 databases were searched from their inception until February 1, 2023. The primary outcomes included survival rate (1-, 2-year), objective response rate (ORR) and disease control rate (DCR), liver function indicators (AST, ALT), adverse reactions including fever, upper digestive tract side and myelosuppression, AFP were selected as the secondary outcomes. RevMan5.4 software was used to evaluate the quality of included studies; meta-analysis, subgroup analysis, meta-regression analysis, publication bias and trial sequential analyses (TSA) was conducted by Stata software 12.0.There were 40 RCTs involving 3649 patients. Patients treated with TACE plus CHRT-CHF showed significantly better 1-, 2-year survival (respectively: OR, 2.23 [1.67-2.97]; OR, 2.13 [1.56-2.92]), ORR (OR, 2.14 [1.82-2.52]), DCR (OR, 2.13 [1.74-2.62]) compared with TACE alone. There was a decreased incidence of aspartate transaminase (AST), alanine transaminase (ALT), alpha-fetoprotein (AFP) and postembolization syndrome (PES) in patients receiving the combined TACE with CHRT-CHF compared with TACE alone. Subgroup analysis found that lower proportion (20-30%) of CHRT-CHF significantly enhanced survival rate and DCR, higher proportion (≥40%) of CHRT-CHF reduced PES after TACE treatment.The efficacy and safety of the combined CHRT-CHF with TACE were validated in this meta-analysis, the optimal proportion of CHRT-CHF in enhancing the efficacy may be 20-30%; Additionally, higher proportion (≥40%) of CHRT-CHF appears to reduce PES after TACE treatment. The potential role of combined relative proportion of CHRT-CHF with TACE should be emphasized in clinic.Copyright © 2023. Published by Elsevier B.V.