Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, China.
Beijing University of Chinese Medicine, Beijing, China.
Integr Cancer Ther. 2023 Jan-Dec;22:15347354231210811. doi: 10.1177/15347354231210811.
Gastric cancer (GC) is a prevalent malignant tumor of the digestive tract. Chemotherapy (CT) is the primary treatment for GC, but it is accompanied by toxic side effects. Several systematic reviews and meta-analyses (SRs/MAs) on the combination of Shenqi Fuzheng injection (SFI) with CT for GC have been published; however, the conclusions have been inconsistent. This overview of SRs/MAs aims to assess the effectiveness and safety of SFI for GC, establishing a dependable foundation for its clinical application.
We utilized 7 databases, namely PubMed, Embase, Cochrane Library, CNKI, Wanfang, VIP, and SinoMed, to conduct our search. The retrieval period spanned from inception to August 2023. The methodological quality, bias risk, reporting quality, and evidence quality of the SRs/MAs were assessed using the evaluation tools AMSTAR-2, ROBIS, PRISMA 2020, and GRADE, respectively. Subsequently, the randomized controlled trials (RCTs) included in the SRs/MAs were quantitatively analyzed through the implementation of RevMan 5.4 software.
Eleven SRs/MAs were included in this study, comprising 54 RCTs involving a total of 9539 patients with GC. The studies covered the period from 2012 to 2021, with the number of original RCTs per study ranging from 3 to 20 and sample sizes ranging from 159 to 1413. The methodological quality of all 11 SRs/MAs was assessed as low or very low, and the quality of evidence was determined to range from moderate to very low. The comprehensive quantitative meta-analysis revealed that the combination of SFI with CT improved the objective response rate (ORR) (RR = 1.30, 95% CI = [1.21, 1.41], < .00001) and disease control rate (DCR) (RR = 1.13, 95% CI = [1.09, 1.18], < .00001) in GC patients, without heterogeneity observed among the studies. In comparison with CT alone, SFI combined with CT also demonstrated improvements in the Karnofsky performance status (KPS) (RR = 1.36, 95% CI = [1.25, 1.49], < .00001) and CD4/CD8 level (RR = 1.16, 95% CI = [0.87, 1.46], < .00001) of patients. In terms of adverse reactions, the combination therapy of SFI with CT was associated with a reduced incidence of gastrointestinal reactions (RR = 0.67, 95% CI = [0.58, 0.78], < .00001) and neurotoxicity (RR = 0.64, 95% CI = [0.50, 0.81], = .0002).
SFI combined with CT can enhance the clinical effectiveness and enhance the quality of life in patients with GC, while minimizing adverse reactions. Nonetheless, the evaluation of overall quality remains deficient, thus restricting the reliability and stability of the conclusions. High-quality, large-sample RCTs remain crucial for establishing dependable clinical evidence.
INPLASY20239004.
胃癌（GC）是一种常见的消化道恶性肿瘤。化疗（CT）是 GC 的主要治疗方法，但伴随有毒副作用。已经发表了几项关于参芪扶正注射液（SFI）联合 CT 治疗 GC 的系统评价和荟萃分析（SRs/MAs）；然而，结论并不一致。本 SRs/MAs 综述旨在评估 SFI 治疗 GC 的有效性和安全性，为其临床应用奠定可靠基础。
我们使用了 7 个数据库，即 PubMed、Embase、Cochrane Library、CNKI、万方、维普和中国生物医学文献数据库，进行检索。检索时间从建库到 2023 年 8 月。使用 AMSTAR-2、ROBIS、PRISMA 2020 和 GRADE 评估工具分别评估 SRs/MAs 的方法学质量、偏倚风险、报告质量和证据质量。随后，通过实施 RevMan 5.4 软件对 SRs/MAs 中包含的随机对照试验（RCT）进行定量分析。
共纳入 11 项 SRs/MAs，包含 54 项 RCT，涉及 9539 例 GC 患者。这些研究涵盖了 2012 年至 2021 年期间，每项研究的原始 RCT 数量从 3 到 20 不等，样本量从 159 到 1413 不等。所有 11 项 SRs/MAs 的方法学质量均被评估为低或极低，证据质量被确定为从中等到极低。综合定量荟萃分析显示，SFI 联合 CT 提高了 GC 患者的客观缓解率（ORR）（RR=1.30，95%CI=[1.21, 1.41]， < .00001）和疾病控制率（DCR）（RR=1.13，95%CI=[1.09, 1.18]， < .00001），且研究间无异质性。与 CT 单药治疗相比，SFI 联合 CT 还改善了 GC 患者的卡氏功能状态（KPS）（RR=1.36，95%CI=[1.25, 1.49]， < .00001）和 CD4/CD8 水平（RR=1.16，95%CI=[0.87, 1.46]， < .00001）。在不良反应方面，SFI 联合 CT 治疗与胃肠道反应（RR=0.67，95%CI=[0.58, 0.78]， < .00001）和神经毒性（RR=0.64，95%CI=[0.50, 0.81]， = .0002）发生率降低相关。
SFI 联合 CT 可增强 GC 患者的临床疗效，提高生活质量，同时减少不良反应。然而，整体质量评估仍存在不足，限制了结论的可靠性和稳定性。高质量、大样本 RCT 对于建立可靠的临床证据仍然至关重要。
INPLASY20239004。
