Qiao Chenxi, Hu Shuaihang, Wang Dandan, Cao Kangdi, Wang Zhuo, Wang Xinyan, Ma Xiumei, Li Zheng, Hou Wei
Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Graduate School of Beijing University of Chinese Medicine, Beijing, China.
Front Oncol. 2023 Aug 24;13:1198768. doi: 10.3389/fonc.2023.1198768. eCollection 2023.
To evaluate the efficacy and safety of Shenqi Fuzheng Injection (SFI) combined with platinum-based chemotherapy (PBC) for the treatment of advanced non-small cell lung cancer (NSCLC).
Seven electronic databases, including CNKI and Wanfang, were comprehensively searched to screen randomized controlled trials (RCTs) until May 1, 2022. The quality of each trial was evaluated according to the Cochrane Handbook for Systematic Reviews of Interventions, and systematic reviews were conducted according to the PRISMA guidelines. Statistical analysis was performed using Review Manager 5.3, and the results were expressed as relative risk (RR) and 95% confidence interval (95% CI). The primary outcome measures were objective response rate (ORR) and disease control rate (DCR). The secondary outcome measures were quality of life and toxicity. Subgroup analysis was performed according to the number of days of SFI single-cycle treatment and combined PBC regimen.
A total of 44 RCTs involving 3475 patients were included in the study. The meta-analysis results showed that, compared with PBC alone, SFI combined with PBC significantly improved the ORR (RR = 1.27, 95% CI = 1.18-1.37, P < 0.00001), DCR (RR = 1.12, 95% CI = 1.08-1.15, P < 0.00001), and quality of life (RR = 1.41, 95% CI = 1.31-1.52, P < 0.00001). It also reduced chemotherapy-induced hemoglobin reduction (RR = 0.57, 95% CI = 0.48-0.67, P < 0.00001), leukopenia (RR = 0.61, 95% CI = 0.53-0.71, P < 0.00001), thrombocytopenia (RR = 0.62, 95% CI = 0.55-0.70, P < 0.00001), and simple bone marrow suppression (RR = 0.55, 95% CI = 0.41-0.73, P < 0.0001). Nausea and vomiting (RR = 0.63, 95% CI = 0.52-0.77, P < 0.00001), diarrhea (RR = 0.48, 95% CI = 0.37-0.64, P < 0.00001), and simple digestive tract reactions (RR = 0.63, 95% CI = 0.49-0.80, P = 0.0002) also decreased with the treatment of SFI.
SFI combined with PBC for the treatment of advanced NSCLC improved the ORR, DCR, and quality of life, and reduced the incidence of myelosuppression and gastrointestinal adverse reactions. However, considering the limitations of existing evidence, further verification using high-quality RCTs is required.
https://inplasy.com/inplasy-2022-7-0026, identifier INPLASY202270026.
评价参芪扶正注射液（SFI）联合铂类化疗（PBC）治疗晚期非小细胞肺癌（NSCLC）的疗效和安全性。
全面检索包括中国知网和万方在内的7个电子数据库，以筛选随机对照试验（RCT），检索截至2022年5月1日。根据《Cochrane系统评价干预措施手册》对每项试验的质量进行评估，并按照PRISMA指南进行系统评价。使用Review Manager 5.3进行统计分析，结果以相对危险度（RR）和95%置信区间（95%CI）表示。主要结局指标为客观缓解率（ORR）和疾病控制率（DCR）。次要结局指标为生活质量和毒性。根据SFI单周期治疗天数和联合PBC方案进行亚组分析。
本研究共纳入44项涉及3475例患者的RCT。荟萃分析结果显示，与单纯PBC相比，SFI联合PBC显著提高了ORR（RR = 1.27，95%CI = 1.18 - 1.37，P < 0.00001）、DCR（RR = 1.12，95%CI = 1.08 - 1.15，P < 0.00001）和生活质量（RR = 1.41，95%CI = 1.31 - 1.52，P < 0.00001）。它还减少了化疗引起的血红蛋白降低（RR = 0.57，95%CI = 0.48 - 0.67，P < 0.00001）、白细胞减少（RR = 0.61，95%CI = 0.53 - 0.71，P < 0.00001）、血小板减少（RR = 0.62，95%CI = 0.55 - 0.70，P < 0.00001）以及单纯骨髓抑制（RR = 0.55，95%CI = 0.41 - 0.73，P < 0.0001）。恶心和呕吐（RR = 0.63，95%CI = 0.52 - 0.77，P < 0.00001）、腹泻（RR = 0.48，95%CI = 0.37 - 0.64，P < 0.00001）以及单纯消化道反应（RR = 0.63，95%CI = 0.49 - 0.80，P = 0.0002）也随着SFI治疗而减少。
SFI联合PBC治疗晚期NSCLC提高了ORR和DCR，改善了生活质量，并降低了骨髓抑制和胃肠道不良反应的发生率。然而，考虑到现有证据的局限性，需要使用高质量的RCT进行进一步验证。
https://inplasy.com/inplasy - 2022 - 7 - 0026，标识符INPLASY202270026。
