PDF(Pubmed)
Abstract：
Introduction: The incidence and mortality of gastric cancer ranks among the highest, and the 5-year survival rate of advanced gastric cancer (AGC) is less than 10%. Currently, chemotherapy is the main treatment for AGC, and oxaliplatin is an important part of the commonly used chemotherapy regimen for AGC. A large number of RCTs have shown that Chinese herbal medicine (CHM) combined with oxaliplatin-based chemotherapy can improve objective response rate (ORR) and disease control rate (DCR), reduce the toxic and side effects of chemotherapy. There is currently a lack of systematic evaluation of the evidence to account for the efficacy and safety of CHM combined with oxaliplatin-based chemotherapy in AGC. Therefore, we carried out this study and conducted the sensitivity analysis on the herbal composition to explore the potential anti-tumor efficacy. Methods: Databases of PubMed, EMBASE, CENTRAL, Web of Science, the Chinese Biomedical Literature Database, the China National Knowledge Infrastructure, the Wanfang database, and the Chinese Scientific Journals Database were searched from their inception to April 2022. RCTs evaluating the efficacy of CHM combined with oxaliplatin-based chemotherapy on AGC were included. Stata 16 was used for data synthesis, RoB 2 for quality evaluation of included RCTs, and GRADE for quality of synthesized evidence. Additional sensitivity analysis was performed to explore the potential anti-tumor effects of single herbs and combination of herbs. Results: Forty trials involving 3,029 participants were included. Most included RCTs were assessed as \"Some concerns\" of risk of bias. Meta-analyses showed that compare to oxaliplatin-based chemotherapy alone, that CHM combined with oxaliplatin-based chemotherapy could increase the objective response rate (ORR) by 35% [risk ratio (RR) = 1.35, 95% confidence intervals (CI) (1.25, 1.45)], and disease control rate (DCR) by 12% [RR = 1.12, 95% CI (1.08, 1.16)]. Subgroup analysis showed that compare to SOX, FOLFOX, and XELOX regimens alone, CHM plus SOX, CHM plus FOLFOX, and CHM plus XELOX could significantly increase the ORR and DCR. Sensitivity analysis identified seven herbs of Astragalus, Liquorice, Poria, Largehead Atractylodes, Chinese Angelica, Codonopsis, and Tangerine Peel with potentials to improve tumor response of oxaliplatin-based chemotherapy in AGC. Conclusion: Synthesized evidence showed moderate certainty that CHM plus oxaliplatin-based chemotherapy may promote improvement in tumor response in AGC. CHM treatment is safe for AGC. Due to the poor quality of included RCTs and small samplesizes, the quality of synthesized evidence was not high. Specific combinations of herbs appeared to produce higher contributions to ORR than the herb individually. Each of this seven above mentioned herbs has been shown in experimental studies to potentially contribute to the improvement of tumor response. To support this conclusion, these seven herbs are worthy of further clinical research. Systematic Review Registration: [http://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=262595], identifier [CRD42022262595].
摘要：
简介:胃癌的发病率和死亡率位居世界前列,晚期胃癌（AGC）的5年生存率低于10％。目前,化疗是AGC的主要治疗方法，而奥沙利铂是AGC常用化疗方案的重要组成部分。大量RCT研究表明,中药(CHM)联合奥沙利铂为主的化疗方案可提高客观缓解率(ORR)和疾病控制率(DCR),减少化疗的毒副作用。目前缺乏对CHM联合奥沙利铂为基础的化疗在AGC中的有效性和安全性的系统评价。因此,我们进行了这项研究，并对中药组合物进行了敏感性分析，以探索潜在的抗肿瘤功效。方法：PubMed数据库，EMBASE,中部,WebofScience,中国生物医学文献数据库,中国国家知识基础设施，万方数据库，和中国科学期刊数据库从成立到2022年4月进行了搜索。纳入评价CHM联合奥沙利铂化疗对AGC疗效的RCT。Stata16用于数据合成，RoB2用于对包含的RCT进行质量评估，和综合证据质量等级。进行了额外的敏感性分析以探索单一草药和草药组合的潜在抗肿瘤作用。结果：纳入40项试验，涉及3,029名参与者。大多数纳入的随机对照试验被评估为偏倚风险的“一些担忧”。Meta分析显示，与单纯以奥沙利铂为基础的化疗相比，CHM联合以奥沙利铂为基础的化疗可使客观缓解率(ORR)增加35%[风险比(RR)=1.35,95%置信区间(CI)(1.25,1.45)],疾病控制率（DCR）为12%[RR=1.12，95%CI（1.08，1.16）]。亚组分析表明，与SOX相比，FOLFOX,只有XELOX方案，CHM加上SOX，CHM加上FOLFOX,CHM加XELOX可显着增加ORR和DCR。敏感性分析确定了7种黄芪药材，甘草,Poria,大头苍术,中国当归,党参,和橘皮有可能改善AGC中奥沙利铂为基础的化疗的肿瘤反应。结论：综合证据表明，CHM联合奥沙利铂为基础的化疗可促进AGC患者肿瘤反应的改善。CHM治疗对于AGC是安全的。由于纳入的随机对照试验质量差，样品尺寸小，合成证据质量不高。草药的特定组合似乎比草药单独对ORR产生更高的贡献。上述七种草药中的每一种都已在实验研究中显示出可能有助于改善肿瘤反应。为了支持这一结论,这七种草药值得进一步的临床研究。系统审查注册：[http://www。crd.约克。AC.uk/PROSPERO/display_record。php?RecordID=262595],标识符[CRD42022262595]。
