肿瘤细胞治疗研究
英文原题：Efficacy and safety of thymosin combined with anticancer therapy for esophageal cancer: a systematic review and meta-analysis of randomized controlled trials.
现有证据提示，胸腺素联合抗肿瘤治疗用于食管癌可能增强抗肿瘤疗效、改善患者免疫功能，并减少传统治疗相关的毒性。
目的：本研究旨在全面评估胸腺肽联合抗癌治疗对食管癌（EC）患者的临床疗效、免疫功能影响及安全性。 方法：系统检索中英文数据库，纳入评估胸腺肽联合食管癌标准抗癌治疗的随机对照试验（RCT）。采用Review Manager 5.4进行荟萃分析，使用Stata 18.0开展敏感性分析和发表偏倚评估，并采用试验序贯分析（TSA）验证主要结局的可靠性。依据GRADE系统评估证据质量。 结果：共纳入18项RCT、1272例患者。荟萃分析显示，与单用标准抗癌治疗相比，联合胸腺肽显著提高客观缓解率（ORR）（RR=1.27，95% CI：1.17–1.39）和疾病控制率（DCR）（RR=1.13，95% CI：1.07–1.19），并改善1年（RR=1.36，95% CI：1.19–1.56）、2年（RR=1.47，95% CI：1.12–1.92）和3年生存率（RR=1.42，95% CI：1.07–1.90）。免疫功能方面，治疗组CD3⁺ T淋巴细胞比例（CD3⁺%）（MD=17.56，95% CI：13.63–21.50）、CD4⁺ T淋巴细胞比例（CD4⁺%）（MD=12.81，95% CI：10.76–14.87）、CD4⁺/CD8⁺比值（MD=0.71，95% CI：0.61–0.81）及NK细胞水平（MD=4.02，95% CI：3.06–4.97）均显著升高。安全性方面，联合治疗显著降低治疗相关不良反应发生率，包括胃肠道反应（恶心、呕吐）（RR=0.69，95% CI：0.60–0.79）、白细胞减少（RR=0.52，95% CI：0.43–0.63）、放射性食管炎（RR=0.63，95% CI：0.44–0.90）及放射性肺炎（RR=0.37，95% CI：0.22–0.62）。但纳入RCT的方法学质量有限，且缺少胸腺肽特异性副作用数据，限制了全面安全性评估。GRADE评估显示，多数结局的证据质量为“极低”至“低”。 结论：现有证据提示，胸腺肽联合抗癌治疗可能提高食管癌抗肿瘤疗效、改善患者免疫功能并降低常规治疗相关毒性。但鉴于RCT质量有限且存在发表偏倚，这些结论仍需更多大规模、高质量前瞻性研究验证。 系统综述注册：PROSPERO，CRD420261282381。
OBJECTIVE: This study aims to comprehensively evaluate the clinical efficacy, impact on immune function, and safety of thymosin combined with anticancer therapy for esophageal cancer (EC) patients. METHODS: We systematically searched Chinese and English databases to identify randomized controlled trials (RCTs) evaluating thymosin combined with standard anticancer therapy for EC. Meta-analysis was performed using Review Manager 5.4. Sensitivity analysis and publication bias assessment were conducted using Stata 18.0. TSA was further employed to validate the reliability of primary outcomes. Evidence quality was assessed using GRADE system. RESULTS: A total of 18 RCTs (1,272 patients) were included. Meta-analysis demonstrated that compared with standard anticancer therapy alone, combined thymosin therapy significantly improved Objective Response Rate (ORR) (RR = 1.27, 95% CI: 1.17-1.39) and Disease Control Rate (DCR) (RR = 1.13, 95% CI: 1.07-1.19), and improved 1-year survival rate (RR = 1.36, 95% CI: 1.19-1.56), 2-year survival rate (RR = 1.47, 95% CI: 1.12-1.92), and 3-year survival rate (RR = 1.42, 95% CI: 1.07-1.90). Regarding immune function, the treatment group exhibited a higher CD3 + T lymphocyte ratio (CD3 + %) (MD = 17.56, 95% CI: 13.63-21.50), CD4 + T lymphocyte ratio (CD4 + %) (MD = 12.81, 95% CI: 10.76-14.87), CD4 + /CD8 + ratio (MD = 0.71, 95% CI: 0.61 - 0.81), and natural killer (NK) cell level (MD = 4.02, 95% CI: 3.06-4.97) were significantly elevated. Regarding safety, combination therapy significantly reduced incidence of treatment-related adverse effects, including gastrointestinal reactions (nausea and vomiting) (RR = 0.69, 95% CI: 0.60-0.79), leukopenia (RR = 0.52, 95% CI: 0.43-0.63), radiation esophagitis (RR = 0.63, 95% CI: 0.44-0.90), and radiation pneumonitis (RR = 0.37, 95% CI: 0.22-0.62). However, methodological quality of included RCTs was limited, and a comprehensive safety assessment is limited by lack of data on thymosin-specific side effects. GRADE assessment indicates that the quality of evidence for most outcomes ranges from "very low" to "low." CONCLUSION: Current evidence suggests that combination of thymosin with anticancer therapy for EC may enhance antitumor efficacy, improve patients' immune function, and reduce toxicity associated with conventional treatments. However, given limited quality of RCTs and presence of publication bias, these conclusions require validation through additional large-scale, high-quality prospective research. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/prospero/, identifier PROSPERO CRD420261282381.
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