中医药辨证论治对Ⅱ~Ⅲ期结直肠癌术后早期复发转移的影响研究

Effects of individualized dialectical treatment with traditional Chinese medicine on postoperative early recurrence and metastasis of stageⅡ-Ⅲcolorectal cancer

目的:探讨Ⅱ~Ⅲ期结直肠癌(colorectal cancer,CRC)根治术后服用≥6个月的个体化辨证论治汤药在预防早期复发转移方面是否优于未服用中药(traditional Chinese medicine,TCM)者。方法:回顾性分析河南中医药大学第一附属医院及河南大学第一附属487例Ⅱ~Ⅲ期接受CRC根治术的患者,以是否服用≥6个月的个体化辨证论治汤药(TCM vs.Non-TCM)后早期(2年)复发转移的发生率为主要结局,采用多因素修正泊松回归评估是否服用中药与主要结局之间的关联。利用倾向评分匹配(propensity score matching,PSM)方法进行敏感性分析。结果:纳入分析TCM组103例,Non-TCM组384例。多因素修正泊松回归分析显示,TCM组发生早期复发转移的风险较低10.7%(12/103)vs.21.4%(82/384),相对危险度(relative risk,RR)为0.448,95%CI:0.261~0.769。经过1∶2比例的PSM,敏感性分析结果与多因素修正泊松回归分析的结果一致,TCM组仍显示出较低的早期复发转移风险11.1%(11/99)vs.21.2%(42/198),RR为0.464,95%CI:0.227~0.948。亚组分析显示在男性、N2(有4枚或以上区域淋巴结转移)、中-高分化的患者中,Non-TCM组和TCM组之间主要结局的差异较大(P<0.05)。生存分析显示TCM组无早期复发转移生存期显著高于Non-TCM组(P<0.05)。结论:对于Ⅱ~Ⅲ期CRC根治术后的患者,接受≥6个月的个体化辨证论治汤药后早期(2年)复发转移的风险低于未服用中药者,表明中医药辨证论治可作为CRC患者有效的选择。

Objective:To evaluate whether individualized dialectical treatment decoction taken for≥6 months after radical surgery for stageⅡ-Ⅲcolorectal cancer(CRC)is superior to surgery alone at preventing early(within 2 years)recurrence and metastasis.Methods:Patients with CRC who underwent radical surgery were enrolled consecutively in The First Affiliated Hospital of Henan University of CM and The First Affiliated Hospital of Henan University.The primary outcome was defined as early recurrence and metastasis for patients who underwent≥6 months of traditional Chinese medicine(TCM)treatment versus those who did not after surgery(Non-TCM).Multivariable modified Poisson regression was used to model the primary outcome,and propensity score matching(PSM)was included in the regression-based sensitivity analysis.Results:A total of 103 patients received TCM treatment and 384 did not.In the entire cohort,the multivariable modified Poisson regression model showed that the adjusted risk for early recurrence and metastasis was lower in the TCM group10.7%(12/103)vs.21.4%(82/384),relative risk(RR):0.448,95%confidence interval[CI]:(0.261-0.769).PSM analysis was used at a 1:2 ratio,resulting in 99 patients in the TCM group and 198 patients in the Non-TCM group.The TCM group still showed a lower risk for early recurrence and metastasis 11.1%(11/99)vs.21.2%(42/198),RR:0.464,95%CI:0.227-0.948.The results of sensitivity analysis were consistent with multivariable analysis.In this prespecified subgroup analysis,the difference in the rate of the primary outcome between the TCM and the Non-TCM groups was greater among males and those with N2 and moderately-highly differentiated tumors.Kaplan-Meier survival analysis showed that the incidence of early-recurrence-and metastasis-free survival was significantly higher in the TCM group than the Non-TCM groups.Conclusions:For patients with stageⅡ-Ⅲcolorectal cancer after radical surgery,individualized dialectical treatment with TCM was associated with a lower risk of early recurrence and metastasis.