新辅助治疗模式下局部进展期直肠癌患者保肛术后生活质量的调查研究

Quality of life of patients with locally advanced rectal cancer after neoadjuvant therapy and sphincter-preserving surgery

目的对新辅助治疗模式下行根治性低位前切除联合保护性造口的局部进展期直肠癌患者进行调查, 探讨新辅助治疗前至造口还纳后12个月患者的生活质量。方法本研究采用描述性病例系列研究方法。回顾性收集2017年12月至2020年1月期间, 于北京协和医院接受完整新辅助长程放化疗并行根治性低位前切除(LAR)联合保护性造口的中低位局部进展期直肠癌患者。纳入标准:(1)新辅助治疗前行直肠MRI评估为mT3~4b或mN1~2而无远处转移(M0)的患者, 同时肿瘤下缘距肛缘<12 cm;(2)新辅助治疗前活检病理确诊直肠腺癌;(3)行完整周期的新辅助治疗;(4)接受根治性保肛手术治疗, 术式均为LAR联合保护性造口, 已经完成造口还纳, 同时随访12个月以上。排除美国麻醉医师协会分级Ⅳ~Ⅴ级、合并多原发结直肠癌者、过去5年内有其他恶性肿瘤病史、需要急诊手术的患者、怀孕或哺乳期女性、有严重精神疾病史者、行核磁共振检查、放化疗或手术治疗禁忌者后, 共纳入83例患者, 男性51例(61.4%), 中位年龄59岁, 体质指数(24.4±3.1)kg/m2。采用欧洲癌症研究与治疗机构生活质量问卷的结直肠癌模块(EORTC QLQ-CR29)、国际勃起功能指数(IIEF)、Wexner便秘评分和低位前切除综合征(LARS)量表, 分别调查了解患者新辅助治疗前、术前、造口还纳后3个月、造口还纳后12个月的生活质量变化情况, 包括直肠肛门功能、性功能等方面。量表的各项分值采用M(P25, P75)表示。结果 (1)EORTC QLQ-CR29评分显示, 新辅助治疗前、术前、造口还纳后3个月、造口还纳后12个月, 患者焦虑[分别为64.4(52.0, 82.5)分、75.3(66.0, 89.5)分、82.6(78.0, 90.0)分、83.6(78.0, 91.0)分]和担心身体形象[分别为76.8(66.0, 92.0)分、81.1(76.5, 91.5)分、85.5(82.5, 94.0)分、86.1(82.0, 92.0)分]均有所改善(均P<0.01);盆腔痛[分别为5.4(2.0, 8.0)分、5.0(2.0, 7.8)分、3.9(1.0, 5.0)分、3.0(1.0, 5.0)分]、尿失禁[分别为15.7(7.0, 22.0)分、11.1(0, 17.5)分、10.0(0, 17.0)分、9.9(0, 16.0)分]、阳痿[分别为14.3(4.2, 19.0)分、12.2(0, 16.8)分、5.6(0, 10.0)分、5.2(0.2, 8.0)分]、尿频[分别为26.4(13.0, 38.5)分、13.9(0, 20.0)分、13.4(2.5, 21.5)分、13.2(2.0, 20.0)分]和黏液血便[分别为4.7(3.0, 6.0)分、2.6(0, 5.0)分、2.2(0, 5.0)分、1.9(0, 4.0)分]等症状均有改善(均P<0.01)。在改善男性性功能、腹痛、口干、担心体质量改变、皮肤疼痛和性交困难方面, 评分存在波动, 但造口回纳后较新辅助治疗前症状均有改善(均P<0.05)。在女性性功能、排尿困难、味觉障碍和排粪失禁方面, 造口回纳后较新辅助治疗前差异未见统计学意义(均P>0.05)。(2)IIEF量表显示:新辅助治疗模式前后, 各项评分均接近, 差异无统计学意义(均P>0.05)。(3)直肠肛门功能量表显示:新辅助治疗前、术前、造口还纳后3个月、造口还纳后12个月, 患者的排气失禁[分别为3.1(0, 4.0)分、2.3(0, 4.0)分、1.8(0, 4.0)分、1.2(0, 3.0)分]和急迫排粪[分别为7.2(0, 11.0)分、5.2(0, 11.0)分、2.9(0, 9.0)分、1.7(0, 0)分]症状均有改善(均P<0.01);在改善不完全排空感方面, 患者症状存在波动, 但造口回纳后较新辅助治疗前症状有改善(均P<0.05);在需要协助排粪[分别为0(0, 0)分、0.7(0, 1.0)分、0.6(0, 1.0)分、0.7(0, 1.0)分]和排粪失败[分别为0.2(0, 0)分、1(0, 2.0)分、0.8(0, 1.5)分、0.8(0, 1.0)分]方面, 患者症状呈现恶化趋势(均P<0.01)。对新辅助治疗效果不同的患者进行分层分析, 比较术前与新辅助治疗前的生活质量改变情况。新辅助治疗较不敏感与较敏感的患者在功能、症状方面改变大致相同, 区别在于, 较不敏感的患者在排尿困难、尿失禁、皮肤疼痛和性交困难方面症状显著改善(均P<0.05), 而较敏感患者在便频方面症状改善(P<0.05)。结论对于局部进展期直肠癌患者, 新辅助放化疗后行根治性低位前切除联合保护性造口的治疗模式可以从许多方面改善患者生活质量。但需注意患者在需要协助排粪及排粪失败方面, 呈现恶化趋势。

Objective To investigate quality of life(QoL)of patients with locally advanced rectal cancer(LARC)who underwent low anterior resection with protective stoma under neoadjuvant therapy mode,and to explore the changes of QoL of patients from before neoadjuvant therapy to 12 months after stoma reversal.Methods A descriptive case series study was carried out.A retrospective study was performed on patients with mid and low LARC who received complete neoadjuvant long course radiotherapy and chemotherapy,followed by radical low anterior resection(LAR)combined with protective stoma at Peking Union Medical College Hospital from December 2017 to January 2020.Inclusion criteria:(1)patients with rectal MRI assessment of mT3-4b or mN1-2 without distant metastasis(M0)before neoadjuvant therapy;(2)distance from tumor lower margin to the anal verge<12 cm;(3)rectal adenocarcinoma confirmed by biopsy before neoadjuvant therapy;(4)complete cycle of neoadjuvant therapy;(5)patients undergoing radical LAR with sphincter preservation and protective ostomy;(6)patients receiving follow-up for more than 12 months after stoma reversal.Exclusion criteria:(1)patients as gradeⅣtoⅤclassified by the American Society of Anesthesiologists(ASA);(2)patients with multiple primary colorectal cancer;(3)patients with history of other malignant tumors in the past 5 years;(4)patients of emergency surgery;(5)pregnant or lactating women;(6)patients with history of severe mental illness;(7)patients with contraindication of MRI,radiotherapy,chemotherapy,or surgical treatment.A total of 83 patients were enrolled,including 51 males and 28 females with median age of 59 years and mean BMI of(24.4±3.1)kg/m2.EORTC QLQ-CR29,international erectile function index(IIEF),Wexner constipation score and low anterior resection syndrome(LARS)score were applied to investigate the QoL of the patients before neoadjuvant therapy,3 and 12 months after ostomy reversal,including rectal anal function and sexual function.M(P25,P75)was used for the scores of the scale.Results(1)EORTC QLQ-CR29 score showed that before neoadjuvant therapy,before surgery,3 months and 12 months after ostomy reversal,anxiety[64.4(52,0,82.5),75.3(66.0,89.5),82.6(78.5,90.0),83.6(78.0,91.0)]and concern about body image[76.8(66.0,92.0),81.1(76.5,91.5),85.5(82.5,94.0),86.1(82.0,92.0)]were improved(all P<0.01);pelvic pain[5.4(2.0,8.0),5,0(2.0,7.8),3.9(1.0,5.0),3.0(1.0,5.0)],urinary incontinence[15.7(7.0,22.0),11.1(0,17.5),10.0(0,17.0),9.9(0,16.0)],impotence[14.3(4.2,19.0),12.2(0,16.8),5.6(0,10.0),5.2(0.2,8.0)],urinate[26.4(13.0,38.5),13.9(0,20.0),13.4(2.5,21.5),13.2(2.0,20.0)]and mucous bloody stool[4.7(3.0,6.0),2.6(0,5.0),2.2(0,5.0),1.9(0,4.0)]were improved as well(all P<0.01).The scores fluctuated in the improvement of male sexual function,abdominal pain,dry mouth,worry about body mass change,skin pain and dyspareunia,but the symptoms were significantly improved after ostomy reversal compared with before neoadjuvant therapy(all P<0.05).There were no significant changes in female sexual function,dysuria,dysgeusia and fecal incontinence after ostomy reversal compared with before neoadjuvant therapy(all P>0.05).(2)IIEF scale showed that all scores were similar before and after neoadjuvant therapy(all P>0.05).(3)Rectal and anal function scale revealed that before neoadjuvant therapy,before operation,3 months and 12 months after stoma reversal,gas incontinence[3.1(0,4.0),2.3(0,4.0),1.8(0,4.0),1.2(0,3.0)]and urgent defecation[7.2(0,11.0),5.2(0,11.0),2.9(0,9.0),1.7(0,0)]were improved(all P<0.001).In terms of improving incomplete emptying sensation,the symptoms fluctuated,but the symptoms improved significantly after ostomy reversal compared with before neoadjuvant therapy(all P<0.05).While the symptoms of assistance with defecation[0(0,0),0.7(0,1.0),0.6(0,1.0),0.7(0,1.0)]and defecation failure[0.2(0,0),1.0(0,2.0),0.8(0,1.5),0.8(0,1.0)]showed a worsening trend(all P<0.001).Stratified analysis was performed on patients with different efficacy of neoadjuvant therapy to compare the changes in QoL before and after neoadjuvant therapy.Patients with less sensitive and more sensitive neoadjuvant therapy showed similar changes in function and symptoms.Patients with less sensitive therapy showed significant improvement in dysuria,urinary incontinence,skin pain and dyspareunia(all P<0.05),and the symptom of defecation frequency in more sensitive patients was significantly improved(P<0.05).Conclusions For patients with LARC,neoadjuvant radiochemotherapy combined with radical LAR and protective stoma can improve QoL in many aspects.It is noted that patients show a worsening trend in the need for assistance with defecation and in defecation failure.