Department of Medical Oncology, Tianjin Hospital of Integrated Traditional Chinese and Western Medicine, Nankai Hospital , Tianjin , China.
Pharm Biol. 2019 Dec;57(1):612-624. doi: 10.1080/13880209.2019.1660383.
Shenqi FuZheng injection (SFI) has been suggested as a complementary treatment of chemotherapy in China. However, little is known about it in western countries. This study assesses the clinical effect of SFI combined with chemotherapy for breast cancer patients. Both English and Chinese databases were searched covering the time period of 1999- 2018 for relevant studies comparing the effect of SFI plus chemotherapy treatment with chemotherapy alone in patients with breast cancer. Target outcomes concerning treatment effect, performance status, immune system and toxic effects were extracted and combined using Stata version 15.0 software. Quality assessment was performed using the Jadad scale. Forty-nine trials were included based on certain selection criteria. Only seven studies were rated as high-quality publications. Results of meta-analysis showed that SFI intervention can significantly improve objective tumour response, performance status, NK, CD, CD and CD/CD ratio and reduce occurrence of leucopenia, thrombocytopenia, haemoglobin reduction, liver dysfunction, gastrointestinal reaction, nausea and vomiting, bone marrow suppression and ECG changes. However, no significant difference was found between SFI and the control group regarding CD levels, and renal disorders. SFI intervention appeared to be effective in improving clinical efficacy, immune function and reducing toxicity when combined with chemotherapy for breast cancer. However, our findings still need verification by high-quality trials.
参芪扶正注射液（SFI）已被建议作为中国化疗的辅助治疗方法。然而，在西方国家，人们对它知之甚少。本研究评估了 SFI 联合化疗治疗乳腺癌患者的临床疗效。检索了 1999 年至 2018 年期间的中英文数据库，以比较 SFI 加化疗与单纯化疗治疗乳腺癌患者的疗效。使用 Stata 版本 15.0 软件提取并合并有关治疗效果、体能状态、免疫系统和毒副作用的目标结局。使用 Jadad 量表进行质量评估。基于某些选择标准，纳入了 49 项试验。只有 7 项研究被评为高质量出版物。荟萃分析结果表明，SFI 干预可显著提高客观肿瘤反应、体能状态、NK、CD、CD 和 CD/CD 比值，并降低白细胞减少、血小板减少、血红蛋白减少、肝功能障碍、胃肠道反应、恶心呕吐、骨髓抑制和心电图改变的发生率。然而，SFI 与对照组之间的 CD 水平和肾功能障碍没有显著差异。SFI 干预与化疗联合应用似乎可有效提高乳腺癌患者的临床疗效、免疫功能并降低毒性。然而，我们的研究结果仍需要高质量试验的验证。
