加味启膈散对食管癌根治术后患者复发转移及生存质量的影响

摘要

Objective To evaluate the effect of modified Qigesan on the recurrence and metastasis rate and quality of life among patients after radical resection of esophageal carcinoma.Methods We enrolled 332 cases undergoing radical resection of esophageal squamous-cell carcinoma (ESC) from Department of Chest Surgery,and Department of Traditional Chinese Medicine,Fourth Hospital of Hebei Medical University from December 2011 to December 2014.Based on patient's own selection of therapy,204 and 128 were assigned to the control group and TCM group,respectively.Regular followups were given to the controls after completing the postoperative adjuvant chemotherapy,and for the TCM group,treatment with modified Qigesan was given to stage Ⅰ ESC cases at 3 weeks after the surgery,and to stage Ⅱ and Ⅲ ESC cases after completing the postoperative adjuvant chemotherapy.The treatment with modified Qigesan lasted for 1 year or was stopped at the timing of recurrence and metastasis of ESC within 2 years.The follow-up (observation) period for all the patients was 2 years or was stopped at the timing of postoperative recurrence and metastasis of ESC within this period.The outcome indicators include disease-free survival time (DFS),1-and 2-year recurrence and metastasis rate,score evaluated by Chinese version of EORTC Quality of Life Questionnaire Core 30 (QLQ-C30),score assessed by EORTC Quality of Life QuestionnaireOesophageal Cancer Module (QLQ-OES18),Karnofsky performance score (KPS) and weight change.Results Compared with the control group,TCM group showed a longer DFS and lower 1-year recurrence/metastasis rate (P＜0.05),but similar 2-year recurrence/metastasis rate (P＞0.05).Before intervention,two groups demonstrated no significant differences in the scores of general health status,physical,role,cognitive,emotional and social functioning,nausea and vomiting,pain,fatigue,dyspnoea,insomnia,constipation,diarrhea,financial difficulties,eating,trouble swallowing saliva,choked when swallowing,appetite loss,trouble with coughing,trouble talking (P＞0.05),but the TCM group showed higher scores of reflux and lower score of dysphagia;score of trouble with taste constipation and dry mouth between the two group (P＜0.05).After 3 months of intervention,the scores of role,cognitive,emotional and social functioning,pain,appetite loss,dyspnoea,insomnia,constipation,diarrhea,financial difficulties,dysphagia,eating,trouble swallowing saliva,dry mouth,trouble with taste,trouble with coughing,and trouble talking were similar in both groups (P＞0.05),but TCM group exhibited higher scores of general health status and physical functioning as well as lower scores of nausea and vomiting,fatigue,reflux and choked when swallowing (P＜0.05).Moreover,TCM group had better KPS (P＜0.05).However,there was no significant difference in weight change between the two groups (P＜0.05).Conclusion The modified Qigesan can reduce the recurrence and metastasis rate,prolong the DFS and improve the quality of life of patients after radical surgery for ESC.%目的 探讨加味启膈散对食管癌根治术后患者复发转移及生存质量的影响.方法 选取2011年12月-2014年12月河北医科大学第四医院胸外科与中医科收治的食管鳞状细胞癌根治术后患者332例.根据患者治疗意愿,分为对照组204例和中药组128例.对照组根治术后辅助化疗完成后不施加中药干预措施,只定期随访;中药组Ⅰ期患者于食管癌根治术后3周,Ⅱ～Ⅲ期患者于完成辅助化疗后3周开始服用加味启膈散.比较两组患者的无病生存时间(DFS),1、2年复发转移率,生存质量核心调查量表(QLQ-C30)、食管癌子量表(QLQ-OES18)评分,卡氏评分(KPS)、体质量变化.结果 中药组DFS长于对照组,1年复发转移率低于对照组,差异有统计学意义(P＜0.05);两组患者2年复发转移率比较,差异无统计学意义(P＞0.05).治疗前两组患者总体健康状态、躯体功能、角色功能、认知功能、情绪功能、社会功能、恶心呕吐、疼痛、疲倦、气促、失眠、便秘、腹泻、经济困难、进食、吞咽唾液、梗阻、食欲减退、咳嗽、言语功能评分比较,差异无统计学意义(P＞0.05);中药组反流评分高于对照组,吞咽困难评分低于对照组,两组患者食欲丧失、口干评分比较,差异有统计学意义(P＜0.05).治疗3个月后两组患者角色功能、认知功能、情绪功能、社会功能、疼痛、食欲丧失、气促、失眠、便秘、腹泻、经济困难、吞咽困难、进食、吞咽唾液、口干、食欲减退、咳嗽、言语功能评分比较,差异无统计学意义(P＞0.05);中药组总体健康状态、躯体功能评分高于对照组,恶心呕吐、疲倦、反流、梗阻评分低于对照组,差异有统计学意义(P＜0.05).中药组KPS分级优于对照组,差异有统计学意义(P＜0.05).两组患者体质量变化比较,差异无统计学意义(P＞0.05).结论 加味启膈散可降低食管癌根治术后患者的复发转移率,延长DFS,提高生存质量.