早期胃癌内镜黏膜下剥离术与外科手术临床效果及生存质量的回顾性对比研究

Comparative analysis for clinical efficacy and life quality between endoscopic submucosal dissection and surgical treatment of patients with early gastric cancer

目的比较内镜黏膜下剥离术（ESD）与外科手术治疗早期胃癌的有效性、安全性及术后生存质量。方法收集自2009年10月至2015年1月于中国医学科学院肿瘤医院就诊并接受内镜治疗或外科治疗的460例早期胃癌患者的临床资料进行回顾性分析，对比评价早期胃癌ESD治疗与外科治疗临床效果及生存质量。结果最终共434例患者纳入本研究，其中ESD组208例（229个早期胃癌病灶），外科组226例。从短期临床效果来看，ESD组较外科组平均住院时间短[（7．85±3．18）d比（16．68±5．89）d，P〈0．001）]、平均住院费用少[（3782．30±1898．84）元比（9685．60±3643．97）元，P〈0．001）]，出院后并发症发生率低[0（0／208）比6．2％（14／226），P〈0．001]。从长期临床效果来看，两组复发率差异无统计学意义[0．4％（1／229）比0．9％（2／226），P=0．622]。累积多原发风险概率对比曲线提示，相同随访时间内ESD组多原发风险高于外科组（P=0．004）。应用COX回归模型控制年龄等其他因素，两组多原发风险差异亦有统计学意义（P=0．013）。ESD组较外科组自我健康评分以及生存质量各领域评分差异均具有统计学意义（P〈0．001）。结论对于早期胃癌术后短期临床效果ESD组优于外科组。对于长期临床效果，ESD组术后多原发风险高于外科组，但大多数多原发病例可行二次ESD成功治疗。ESD组患者术后自我健康评分以及生存质量评分均优于外科组患者。

Objective To compare the efficacy, safety, and the life quality of patients with early gastric cancer （EGC） between endoscopic submucosal dissection （ESD） and surgical treatment. Methods A total of 460 cases with EGC receiving endoscopic therapy or surgical treatment were collected from October 2009 to January 2015 in the Cancer Hospital, Chinese Academy of Medical Sciences. The clinical efficacy and life quality of ESD and surgical treatment for EGC patients were retrospectively analyzed. Results There were 434 cases collected in the study, including 208 cases （229 lesions） in the ESD group and 226 cases in the surgery group. For the short-term clinical outcomes of the ESD group, the hospitalization time （7.85±3. 18 d VS 16. 68±5.89 d, P〈0. 001）, hospitalization cost （3 782. 30±1 898.84 CNY VS 9 685.60±3643.97 CNY, P〈0.001） and complications[0（0/208） VS 6. 2% （14/226）, P〈0.001] were statistically different compared with those of the surgery group. For the long-term clinical outcomes, there was no statistical significance on recurrence rate [ 0.4% （1/229） VS 0. 9% （2/226）, P = 0. 622 ] between the two groups. The cumulative multiple hazard probability curve showed that the ESD group had a significantly higher risk of multiple primary lesions than the surgery group （P = 0. 004） after the same follow-up period. In order to exclude the influence of confounding factors, COX regression model was used to control the age and other factors, and multiple primary risks of the two groups were also statistically significant （P= 0. 013）. The health score of self-evaluation and life quality between the two groups were statistically significant （P 〈 0. 001）. Conclusion For the short-term clinical outcomes, the ESD group was better than the surgery group. For the long-term clinical outcomes, multiple primary risks were higher in the ESD group than those in the surgery group, but most of the multiple primary cases were successfully treated with a second ESD. The health score of self-evaluation and life quality were better in the ESD group than those in the surgery group.