晚期卵巢癌常规治疗后中医维持治疗的疗效分析

TCM therapy maintenance in patients with advanced epithelial ovarian cancer

目的 评价中医维持治疗对晚期卵巢癌患者生存和免疫的影响.方法 研究回顾了初次诊断为IIIC/IV期上皮型卵巢癌,在接受常规治疗后病灶完全消失,或其后在广安门医院进行至少两个月以上辨证中医药干预治疗的患者,采集患者原发病时的数据,CA125基线值,CA125最低值,无复发生存时间及免疫功能.用Kaplan-Meier 法和Cox 回归分析影响生存期的危险因素,用student＇s t检验来评估免疫功能.结果 共161例患者满足入组条件,中医组86例（53.4%）,其中正气亏虚、气滞血瘀型50例（58.1%）,脾肾亏虚、痰湿内阻型36例（41.9%）;观察组75例（46.6%）.中医组中位复发时间为18个月,观察组为16个月.Kaplan-Meier曲线显示中药维持治疗可延长中位无复发生存期（log rank：P＝0.008）.Cox 回归分析显示,中医维持治疗、FIGO分期、分级、年龄及CA125最低值等是影响无复发生存期的独立预后因素（P＜0.01）,Cox模型中的校正风险比例（HR）分别是0.423、9.327、2.212、0.315和3.421.免疫功能结果显示,中医组调节性T细胞低于观察组[CD4＋ T调节细胞两组分别为（4.62±0.8）%、（5.92±1.2）%,CD8＋ T调节细胞两组分别为（12.87±2.1）%、（16.29±1.9）%,P＜0.01];中医组总CD4 T淋巴细胞高于观察组[分别为（44.57±5.4）%、（40.44±4.9）%,P＜0.01];总CD8 T淋巴细胞两组比较,差异无统计学意义（P＞0.05）.结论 中医辨证论治作为常规一线治疗后的维持疗法延长了肿瘤复发时间,调控了调节性T细胞的免疫抑制功能.

Objective To evaluate the effects of TCM maintenance on the survival and immune suppression of the patients with advanced EOC. Methods The records of patients with initial diagnosis of III/IV epithelial ovarian cancer who were treated with conventional therapy in tertiary hospital and received subsequent TCM differentiation maintenance treatment for at least two months post-conventional-therapy in Guang＇anmen hospital were reviewed. Data of the baseline CA125 when diagnosed, nadir CA125 during conventional therapy, time-to-relapse （TTR） and the immunity in these records were collected. Kaplan-Meier method and Cox regression method were used to analyze risk factors, and the student＇s t test was to estimate the immunity. Results 161 patients met all inclusion criteria. 86 patients （53.4%） were in TCM group and 75 patients （46.6%） were in observation group. Of 86 patients in the TCM group, 50 patients had syndrome of deficiency of spleen and kidney deficiency, 36 patients had the syndrome of phlegm retention. The median relapse time was 18 months and 16 months in the TCM group and the observation group respectively. Kaplan-Meier curves demonstrated that TCM maintenance therapy could prolong relapse-flee duration （log rank： P=0.008 ）. Cox analysis revealed that TCM maintenance, FIGO stage, grading, age and nadir CA125 level were independent prognostic factors for TTR. The Cox model adjusted hazard ratio for them were 0.423, 9.327, 2.212, 0.315 and 3.421 respectively. For T regulatory cells,TCM group had lower level than the observation group （CD4＋ T regulatory cells were （4.62± 0.8） % and （5.92 ± 1.2） %, CD8＋ T regulatory cells were （12.87±2.1）%, （16.29±1.9）%, P〈0.01）. The level of CD4＋T lymphocyte in the TCM group （44.57±5.4） % was higher than the observation group （40.44± 4.9） %, P〈 0.01. There was no significant difference in the total amount of CD8＋lymphocyte between the two groups. Conclusion TCM maintenance therapy by syndrome differentiation prolong the relapse duration of advanced EOC and regulate the T regulatory cells