【目的】 基于倾向性评分匹配（PSM）方法分析宫颈癌免疫治疗疗效相关的中医证候特征，为筛选免疫治疗优势人群提供 依据。【方法】 回顾性研究 2020年 1月～2024年 10月中国中医科学院广安门医院收治的 253例接受程序性死亡受体 1（PD-1） 抑制剂治疗的宫颈癌患者，收集所有患者的临床资料和中医四诊资料。通过PSM（1∶1匹配）平衡混杂因素后，以治疗效果为 因变量，采用多因素Logistic回归分析免疫治疗有效组的中医证候特征，并构建预测模型。【结果】（1）PSM匹配情况：匹配成 功后进入统计分析的病例共 198例，其中有效组 99例，无效组 99例。（2）中医证素分布情况：2组患者的病性证素气虚、气 滞、血瘀、热、痰差异有统计学意义（P＜0.05或 P＜0.01），而病位证素胞宫、肾、肺、脾、肝、心以及病性证素血虚、阴 虚、阳虚、寒、湿差异无统计学意义（P＞0.05）。其中，有效组的主要病性证素为气虚、血虚和热，无效组的主要病性证素 为气滞、热、痰。（3）单因素回归分析结果显示：靶向治疗（P = 0.040）、细胞程序性死亡-配体 1（PD-L1）表达水平（P＜ 0.001）、气虚（P = 0.009）、血虚（P＜0.001）、阳虚（P＜0.001）、阴虚（P＜0.001）、气滞（P = 0.003）、血瘀（P＜0.001）、寒 （P＜0.001）、热（P＜0.001）、痰（P＜0.001）、湿（P＜0.001）为 PD-1抑制剂疗效相关的因素。（4）多因素 Logistic回归分析结果 显示：既往靶向治疗（OR=0.36，95%CI：0.16～0.83），病性证素气滞（OR=0.23，95%CI：0.10 ~ 0.49）、痰（OR=0.28， 95%CI：0.13 ~ 0.61）是宫颈癌 PD-1抑制剂疗效相关的危险因素，PD-L1表达水平（OR=15.27，95%CI：2.60 ~ 89.63），病性 证素气虚（OR=2.90，95%CI：1.42～5.89）是宫颈癌PD-1抑制剂疗效相关的保护因素。（5）预测模型的预测价值：经受试者工 作特征（ROC）曲线分析，预测模型对预测PD-1抑制剂治疗宫颈癌疗效的曲线下面积（AUC）为0.78（0.71 ~ 0.84），具有一定的预测 价值。【结论】PD-L1表达水平以及病性证素气虚、气滞和痰等中医证素是宫颈癌免疫治疗疗效的独立影响因素，可为中西医 结合优化诊疗策略提供参考。

Objective To investigate traditional Chinese medicine （TCM） syndrome characteristics associated with immunotherapy efficacy in cervical cancer using propensity score matching （PSM）， aiming to identify the population benefiting from immunotherapy. Methods A retrospective analysis was conducted in 253 cervical cancer patients， who received the treatment with programmed death receptor 1（PD-1） inhibitors at Guang’anmen Hospital，China Academy of Chinese Medical Sciences from January 2020 to October 2024. Clinical data and TCM four-examination data were collected. After balancing the confounders via PSM（1∶1 matching） and with therapeutic efficacy as the dependent variable，multivariate logistic regression was performed to analyze the characteristics of TCM syndrome in the immunotherapy-response group and then a predictive model was constructed. Results （1）After matching with PSM，198 cases were included，99 cases in response group and 99 cases in non-response group. （2）Analysis of the distribution of TCM syndrome elements showed that the differences in the pathogenic syndrome elements of qi deficiency，qi stagnation，blood stasis，heat and phlegm between the two groups were statistically significant （P＜0.05 or P＜0.01），while there were no statistically significant differences in the disease-location syndrome elements of uterus，kidneys，lungs，spleen，liver，and heart，as well as in the pathogenic syndrome elements of blood deficiency， yin deficiency， yang deficiency， cold， and dampness （P＞0.05）. The main pathogenic syndrome elements in the response group were qi deficiency，blood deficiency and heat，while those in the non-response group were qi stagnation， heat and phlegm.（3） The results of univariate regression analysis showed that targeted therapy （P = 0.040）， programmed cell death-ligand 1（PD-L1） expression level （P＜ 0.001），qi deficiency （P = 0.009），blood deficiency （P＜0.001），yang deficiency （P＜0.001），yin deficiency （P＜0.001），qi stagnation （P = 0.003），blood stasis （P＜0.001），cold （P＜0.001），cold （P＜0.001），heat （P＜0.001），phlegm （P＜0.001），and dampness （P＜0.001） were the factors associated with the efficacy of PD-1 inhibitors. （4） The results of multivariate logistic regression analysis showed that previous targeted therapy （OR= 0.36，95% CI：0.16-0.83） and pathogenic syndrome elements of qi stagnation （OR=0.23，95%CI：0.10- 0.49）， phlegm （OR=0.28，95%CI：0.13-0.61） were the risk factors of associated with the efficacy of PD-1 inhibitors， while PD-L1 expression level （OR=15.27， 95%CI： 2.60-89.63）， and pathogenic syndrome element qi deficiency （OR=2.90， 95%CI： 1.42-5.89） were the protective factors associated with the efficacy of PD-1 inhibitors in cervical cancer.（5） Receiver operating characteristic （ROC） curve analysis demonstrated that the area under the ROC curve （AUC） of the predictive model for evaluating PD-1 inhibitor efficacy in cervical cancer was 0.78（95%CI：0.71-0.84），indicating certain predictive value. Conclusion PD-L1 expression level and TCM pathogenic syndrome elements such as qi deficiency，qi stagnation， and phlegm are the independent factors influencing PD-1 inhibitor efficacy in cervical cancer，providing insights for optimizing integrated TCM-western medicine treatment strategies.

R273.733

国家自然科学基金资助项目（编号：82474354）