[摘 要] 目的：探讨组蛋白去乙酰化酶（HDAC）抑制剂西达苯胺联合CHOP方案治疗初诊外周T细胞淋巴瘤（PTCL）的临床 疗效，并分析其预后影响因素。方法：收集2012年4月至2022年8月期间在南通大学附属医院初诊为PTCL且未接受过放化疗 的患者的临床资料。根据患者接受的一线治疗方案，分为西达苯胺 + CHOP组（n = 20）和CHOP组（n = 24）。通过卡方检验或 Fisher确切检验比较两组间临床病理特征的差异，使用Kaplan-Meier法生成生存曲线，采用Log-Rank检验进行单因素生存分析。 进行亚组分析，评估西达苯胺 + CHOP组患者的生存结局，并通过相互作用测试 ，以评估影响两组生存预后差异的相关因素。 结果：两组患者基线（年龄、性别、肿瘤分期）基本均衡，但西达苯胺 + CHOP组血管免疫母细胞性T细胞淋巴瘤（AITL）患者较多 （70.8% vs 15%），PTCL-非特指型（NOS）患者较少（16.7% vs 30%）。疗效分析显示，西达苯胺 + CHOP治疗的患者中位无进展生 存期（PFS）显著延长（7个月 vs 3个月，P = 0.032），中位OS也显著延长（20个月 vs 6个月，P = 0.004）。单因素预后分析发现，与无 B症状PTCL患者相比，有B症状患者的PFS（P = 0.053）和OS（P = 0.065）均较差；且基线乳酸脱氢酶（LDH）较高的患者OS较差 （P = 0.056）。进一步亚组疗效分析显示，在基线血清铁蛋白水平正常的患者中，西达苯胺 + CHOP组患者的PFS显著优于CHOP 组[95% C（I 1.14, 43.58）]；血清铁蛋白水平和治疗方案之间的相互作用检验具有统计学意义（P = 0.042）。结论：西达苯胺联合 CHOP方案对初诊PTCL患者有生存获益，且基线血清铁蛋白水平可作为联合治疗的潜在预测标志物。

[Abstract] Objective: To investigate the clinical efficacy of histone deacetylase (HDAC) inhibitor chidamide combined with CHOP in the treatment of preliminarily diagnosed peripheral T-cell lymphoma (PTCL) and to analyze the factors influencing its prognosis. Methods: Clinical data were collected from patients who were preliminarily diagnosed with PTCL, but had not received radiotherapy or chemotherapy at the Affiliated Hospital of Nantong University between April 2012 and August 2022. The patients were divided into two groups, based on the frontline treatment regimen: the chidamide + CHOP group (n = 20) and the CHOP group (n = 24). The differences in clinicopathological characteristics between the two groups were compared by chi-square test or Fisher's exact test. Survival curves were generated by Kaplan-Meier method, and univariate survival analysis was conducted by Log-Rank test. Subgroup analysis was performed to assess the survival outcomes of patients in the chidamide + CHOP group, and interaction tests were conducted to assess the factors that might influence the difference in survival prognosis between the two groups. Results: The baseline levels of the two groups were comparable in age, gender, and tumor stage, but there were more AITL patients (70.8% vs 15%) and fewer PTCL-NOS patients (16.7% vs 30%) in the chidamide + CHOP group . Efficacy analysis revealed that the median PFS was significantly longer in patients treated with chidamide + CHOP (7 months vs 3 months, P = 0.032), and their median OS was also significantly longer (20 months vs 6 months, P = 0.004). Univariate prognostic analysis revealed that PTCL patients with B symptoms had significantly poorer PFS (P = 0.053) and OS (P = 0.065) than PTCL patients without B symptoms; and patients with elevated baseline LDH levels had a worse OS (P = 0.056). Further subgroup analysis of efficacy revealed that, among patients with normal baseline serum ferritin levels, those in the chidamide + CHOP group had significantly better PFS compared with those in the CHOP group (95% CI [1.14, 43.58]). The interaction test between serum ferritin levels and treatment regimens demonstrated statistical significance (P = 0.042). Conclusion: The combination of chidamide and CHOP has survival benefits for patients preliminarily diagnosed with PTCL, and baseline serum ferritin levels may serve as a potential predictor for combination therapy.

[基金项目] 2024年度省江苏基础研究计划（自然科学基金）面上项目（No. BK20241837）；江苏省研究型医院发展基金课题（No. YJXYY202204-XKB17）； 白求恩·肿瘤临床研究计划项目（No. BCF-XD-ZL-20220118-001）；2022 年度南通市基础科学研究和社会民生科技计划项目（No. MS22022111）； 南通市“十四五”科教强卫工程重点项目——肿瘤学临床医学中心（No. NTYXZX18）；江苏省“十四五”卫生健康科教能力提升 工程——医学重点学科（肿瘤学）（No. ZDXK202234）