Meta-analysis results of adverse drug reactions.

Background
Ginseng-containing traditional medicine preparations (G-TMPs) in combination with fluoropyrimidine-based chemotherapy (FBC) are well-known treatments for advanced gastric cancer (AGC), with a superior efficacy to FBC alone. However, evidence regarding their efficacy remains limited. The purpose of this meta-analysis is to evaluate the efficacy and safety of G-TMPs in combination with FBC for the treatment of AGC.
Methods
Eight electronic databases were searched for randomized controlled trials (RCTs) using G-TMPs with FBC for the treatment of AGC. The primary outcome included the tumor response, while the secondary outcomes included the quality of life (QoL), proportions of peripheral blood lymphocytes, adverse drug reactions (ADRs), and levels of cancer biomarkers. The quality of evidence for each outcome was assessed using GRADE profilers.
Results
A total of 1,960 participants were involved in the 26 RCTs included. Patients treated with FBC plus G-TMPs had better objective response (risk ratio [RR] = 1.23, 95% confidence interval [CI]: 1.13 to 1.35, p < 0.00001) and disease control (RR = 1.13, 95% CI: 1.08 to 1.19, p < 0.00001) rates than those treated with FBC alone. Additionally, the combination group had a better QoL, higher proportions of CD3+ T cells, CD4+ T cells, and natural killer cells, as well as a higher CD4+/CD8+ T-cell ratio. Furthermore, lower levels of CA19-9, CA72-4, and CEA were confirmed in the combination treatment group. In addition, G-TMPs reduced the incidence of ADRs during chemotherapy.
Conclusion
In combination with FBC, G-TMPs can potentially enhance efficacy, reduce ADRs, and improve prognosis for patients with AGC. However, high-quality randomized studies remain warranted.
Systematic review registration
PROSPERO Number: CRD42021264938.

背景
含人参传统中药制剂（ginseng-containing traditional medicine preparations, G-TMPs）联合氟嘧啶类化疗（fluoropyrimidine-based chemotherapy, FBC）是晚期胃癌（advanced gastric cancer, AGC）的公认治疗方案，其疗效优于单用氟嘧啶类化疗。然而，目前关于该联合方案疗效的相关证据仍较为有限。本荟萃分析旨在评估含人参传统中药制剂联合氟嘧啶类化疗治疗晚期胃癌的疗效与安全性。

方法
检索8个电子数据库，纳入采用含人参传统中药制剂联合氟嘧啶类化疗治疗晚期胃癌的随机对照试验（randomized controlled trial, RCT）。主要结局指标为肿瘤应答情况，次要结局指标包括生活质量（quality of life, QoL）、外周血淋巴细胞比例、药物不良反应（adverse drug reactions, ADRs）以及肿瘤生物标志物水平。采用GRADE分级工具（GRADE profiler）对各项结局指标的证据质量进行评估。

结果
最终纳入26项随机对照试验，共涉及1960名受试者。与单用氟嘧啶类化疗组相比，联合含人参传统中药制剂治疗组的客观缓解率（风险比（risk ratio, RR）= 1.23，95%置信区间（confidence interval, CI）：1.13~1.35，p<0.00001）与疾病控制率（RR=1.13，95%CI：1.08~1.19，p<0.00001）均更优。此外，联合治疗组的生活质量更佳，外周血CD3+T细胞、CD4+T细胞及自然杀伤细胞比例更高，CD4+/CD8+T细胞比值也更高。进一步分析显示，联合治疗组患者的CA19-9、CA72-4及癌胚抗原（carcinoembryonic antigen, CEA）水平均更低。此外，含人参传统中药制剂可降低化疗期间药物不良反应的发生率。

结论
综上，含人参传统中药制剂联合氟嘧啶类化疗可潜在提升晚期胃癌患者的治疗疗效、降低药物不良反应发生率并改善其预后。但目前仍需开展高质量的随机对照研究以进一步验证该方案的临床价值。

系统评价注册
PROSPERO编号：CRD42021264938。