Supplementary file 1_8 specific Chinese herbal injections combined with chemotherapy for breast cancer: a systematic review and network meta-analysis of comparative safety and efficacy.xlsx

BackgroundBreast cancer (BC) poses a major threat to human health. Since the beginning of the 21st century, numerous clinical studies conducted in China have reported the therapeutic advantages of combining Chinese herbal injections (CHIs) with chemotherapy; however, comparative evaluations of different CHIs remain scarce. This multidimensional network meta-analysis was designed to compare the efficacy of various CHIs and to identify the optimal combination regimen of CHI plus chemotherapy for breast cancer treatment.
MethodsBy searching multiple databases, we screened randomized controlled trials (RCTs) on Chinese herbal injections (CHIs) combined with chemotherapy interventions for breast cancer (BC) from database inception to 25 October 2024. Studies meeting inclusion criteria with methodologically sound quality were included. Data analysis was performed using Stata 17.0 and R 4.2.1 software, with odds ratio (OR) and standardized mean difference (SMD) as effect size measures. The surface under the cumulative ranking curve (SUCRA) method was applied to rank the evaluated treatment regimens.
ResultsThis network meta-analysis included 44 eligible RCTs, involving 3,982 patients and 8 CHIs. Shenqifuzheng Injection (SQFZ) combined with chemotherapy was most effective in enhancing the efficacy of chemotherapy, improving the quality of life of breast cancer patients, ameliorating the CD4+/CD8+ T-cell ratio, and inhibiting the decrease in white blood cell (WBC) count after chemotherapy. Compound Sophora Injection (FFKS) combined with chemotherapy performed best in increasing post - chemotherapy CD4+ and CD8+, lowering tumor marker CA125, and reducing post-chemotherapy platelet (PLT) and hemoglobin (HGB) declines. Kangai Injection (KA) combined with chemotherapy was most effective for CD3+ improvement. Kanglaite Injection (KLT) combined with chemotherapy had the best effect on reducing tumor markers CEA and CA153. Although a 2021 network meta-analysis (Comparative Efficacy and Safety of Chinese Herbal Injections Combined With Cyclophosphamide and 5-Fluorouracil Chemotherapies in Treatment of Breast Cancer: A Bayesian Network Meta-Analysis) examined chemotherapy combined with Chinese medicine injections for breast cancer, it was limited to the CF regimen and assessed few outcomes, with some lower-quality studies included (excluded herein). Our study improves methodology by incorporating high-quality RCTs across all chemotherapy regimens and evaluating multiple outcomes. This provides more comprehensive results, identifying SQFZ as most effective for improving response rate and Karnofsky Performance Status (KPS), thereby enhancing clinical utility.
Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO/myprospero, identifier [CRD42024589306].

背景 乳腺癌（Breast cancer, BC）严重威胁人类健康。21世纪以来，国内多项临床研究均证实中药注射剂（Chinese herbal injections, CHIs）联合化疗的治疗优势，但针对不同中药注射剂的对比评价仍较为匮乏。本项多维度网络Meta分析旨在对比各类中药注射剂的疗效，筛选出乳腺癌治疗中中药注射剂联合化疗的最优方案。
方法 本研究通过检索多个数据库，筛选自建库至2024年10月25日期间，关于中药注射剂联合化疗干预乳腺癌的随机对照试验（randomized controlled trials, RCTs）。纳入符合纳入标准且方法学质量可靠的研究。采用Stata 17.0与R 4.2.1软件进行数据分析，以比值比（odds ratio, OR）和标准化均数差（standardized mean difference, SMD）作为效应量指标。采用累积排序曲线下面积（surface under the cumulative ranking curve, SUCRA）法对所评估的治疗方案进行排序。
结果 本项网络Meta分析共纳入44项符合标准的随机对照试验，涉及3982例患者与8种中药注射剂。其中，参芪扶正注射液（Shenqifuzheng Injection, SQFZ）联合化疗在增强化疗疗效、改善乳腺癌患者生活质量、调节CD4+/CD8+ T细胞比值以及抑制化疗后白细胞（white blood cell, WBC）计数下降方面效果最优。复方苦参注射液（Compound Sophora Injection, FFKS）联合化疗在提升化疗后CD4+、CD8+水平，降低肿瘤标志物CA125，以及减轻化疗后血小板（platelet, PLT）与血红蛋白（hemoglobin, HGB）降低幅度方面表现最佳。康艾注射液（Kangai Injection, KA）联合化疗对改善CD3+水平效果最为显著。康莱特注射液（Kanglaite Injection, KLT）联合化疗在降低肿瘤标志物CEA与CA153方面效果最优。尽管2021年已有一项网络Meta分析（《中药注射剂联合环磷酰胺及5-氟尿嘧啶化疗治疗乳腺癌的疗效与安全性比较：贝叶斯网络Meta分析》）探讨了中药注射剂联合化疗治疗乳腺癌的方案，但该研究仅局限于CF化疗方案，评估的结局指标较少，且纳入了部分低质量研究（本研究已排除此类研究）。本研究优化了研究方法，纳入了所有化疗方案下的高质量随机对照试验，并对多维度结局指标进行评估，所得结果更为全面，明确参芪扶正注射液在提升缓解率与卡氏功能状态评分（Karnofsky Performance Status, KPS）方面效果最优，进一步提升了研究的临床应用价值。
系统评价注册：https://www.crd.york.ac.uk/PROSPERO/myprospero，注册号[CRD42024589306]。