Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China; Department of Respiratory and Critical Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, 210029, China.
School of Chinese Medicine, School of Integrated Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, 210029, China.
Phytomedicine. 2022 Sep;104:154315. doi: 10.1016/j.phymed.2022.154315. Epub 2022 Jul 6.
Compound Kushen injection (CKI) is a Chinese patented medicine that improves the immunity level of cancer patients and inhibits tumor cell proliferation and metastasis. Clinically, CKI is widely used in combination with platinum-based chemotherapy (PBC) for non-small cell lung cancer (NSCLC) treatment. This study attempted to systemically evaluate the efficacy and safety of a combination of CKI and PBC for NSCLC treatment by modulating the immune function.
To evaluate the clinical efficacy and safety of CKI in combination with PBC for NSCLC.
English and Chinese databases were retrieved for randomized controlled trials (RCTs) of NSCLC treatment using a combination of CKI and PBC, and the changes of peripheral blood T lymphocytes (such as CD3 T cells, CD4 T cells, CD8 T cells), and CD4/CD8 T cell ratio among NSCLC patients were detected before and after treatment using CKI with PBC. The search deadline was set as November 2021. The systemic evaluation was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The methodology and quality of each study included in the systemic evaluation were assessed. Review Manager 5.4, Stata12.0, and trial sequential analysis (TSA) were used for data analysis. The outcome indicators were qualified using GRADEprofiler software.
A total of 25 RCTs involving 2460 cases of patients were included. The results showed that the combination of CKI with PBC effectively increased the objective response rate (ORR) [relative risk (RR) = 1.31, 95% confidence interval (CI) (1.19, 1.44)] and disease control rate (DCR) [RR = 1.16, 95%CI (1.09,1.23)], regulated the expression of peripheral blood T lymphocytes (such as CD3T cells, CD4T cells, CD8T cells, and CD4/CD8T cell ratio), upregulated the level of serum immunoglobulins (such as IgA, IgG, and IgM), and reduced the frequency of gastrointestinal reaction, marrow inhibition, hepatorenal toxicity, reduction of white blood cells and blood platelets, baldness, infection, neutrophilic granulocyte counts, diarrhea, or constipation. According to subgroup analysis results, chemotherapy cycles (1-2) had a more significant effect on DCR. A combination of CKI and GP regimens had better effects on improving CD3T cell levels, and there were no significant changes among other chemotherapies regiments.
A combination of CKI and PBC had a marked effect in improving tumor response, priming immune function, and decreasing the frequency of adverse reactions, which was safe for NSCLC treatment.
复方苦参注射液（CKI）是一种中国专利药物，可提高癌症患者的免疫水平并抑制肿瘤细胞的增殖和转移。临床上，CKI 广泛与铂类化疗（PBC）联合用于非小细胞肺癌（NSCLC）的治疗。本研究试图通过调节免疫功能，系统地评估 CKI 联合 PBC 治疗 NSCLC 的疗效和安全性。
评估 CKI 联合 PBC 治疗 NSCLC 的临床疗效和安全性。
检索了使用 CKI 联合 PBC 治疗 NSCLC 的随机对照试验（RCT）的英文和中文数据库，并使用 CKI 联合 PBC 治疗前后检测 NSCLC 患者外周血 T 淋巴细胞（如 CD3T 细胞、CD4T 细胞、CD8T 细胞）和 CD4/CD8T 细胞比值的变化。搜索截止日期为 2021 年 11 月。根据系统评价和荟萃分析的首选报告项目指南进行系统评价。评估了纳入系统评价的每项研究的方法学和质量。使用 Review Manager 5.4、Stata12.0 和试验序贯分析（TSA）进行数据分析。使用 GRADEprofiler 软件对合格结果指标进行了评估。
共纳入 25 项 RCT，涉及 2460 例患者。结果表明，CKI 联合 PBC 有效提高了客观缓解率（ORR）[相对风险（RR）=1.31，95%置信区间（CI）（1.19，1.44）]和疾病控制率（DCR）[RR=1.16，95%CI（1.09，1.23）]，调节外周血 T 淋巴细胞（如 CD3T 细胞、CD4T 细胞、CD8T 细胞和 CD4/CD8T 细胞比值）的表达，上调血清免疫球蛋白（如 IgA、IgG 和 IgM）水平，并降低胃肠道反应、骨髓抑制、肝肾功能毒性、白细胞和血小板减少、脱发、感染、中性粒细胞计数、腹泻或便秘的发生率。根据亚组分析结果，化疗周期（1-2 个）对 DCR 的影响更为显著。CKI 联合 GP 方案在改善 CD3T 细胞水平方面效果更好，而其他化疗方案之间则没有明显变化。
CKI 联合 PBC 对改善肿瘤反应、启动免疫功能和降低不良反应频率具有显著作用，是治疗 NSCLC 的一种安全方法。
