[评论]经肛门灌洗治疗低位前切除综合征:一项国际多中心随机临床试验OA
Transanal irrigation for low anterior resection syndrome treatment:in-ternational multicentre randomized clinical trial
背景 低位直肠前切除术后,很大一部分患者会受到长期肠道功能障碍的困扰.本研究旨在评估经肛门灌洗治疗低位前切除综合征的疗效.方法 本研究在欧洲4家中心开展,纳入低位直肠前切除术后至少12个月、患有重度低位前切除综合征(评分＞30分)的成年(≥18岁)患者.采用区组随机化方法,将符合条件的患者按1∶1比例随机分配至经肛门灌洗组或最佳支持治疗组.主要终点为通过治疗依从性或治疗转换来衡量的经肛门灌洗可行性.次要终点包括肠道功能、生活质量以及研究特定的患者满意度问题.结局评估者和统计团队对分组情况设盲,而受试者和护理人员不设盲.结果 41例患者被随机分组,其中40例(经肛门灌洗组19例;最佳支持治疗组21例)完成了随访;经肛门灌洗组中有1例患者因接受瘘管手术而被排除.随访12个月时,经肛门灌洗组的低位前切除综合征评分(中位数为3分,范围0～39分)、Wexner失禁评分(中位数为0分,范围0～15分)均显著低于最佳支持治疗组(低位前切除综合征评分中位数为36分,范围2～42分;Wexner失禁评分中位数为13分,范围4～20分),比较差异有统计学意义(P＜0.001).治疗3个月后,经肛门灌洗组自我医疗结局量表评分更低[2(0～11)vs.11(7～12);P＜0.001].此外,治疗12个月后,经肛门灌洗组的纪念斯隆凯特琳癌症中心肠道功能量表评分更高[89(37～90)vs.39(28～61);P＜0.001].经肛门灌洗组治疗依从性良好,15例(75%)患者坚持每日灌洗,且患者满意度指标均倾向于经肛门灌洗治疗.研究中报告了2例轻度与操作相关的不良事件(里急后重、头晕).结论 本随机临床可行性研究证实,经肛门灌洗是可行的且患者接受度高.与最佳支持治疗相比,经肛门灌洗可显著改善低位前切除综合征患者的肠道功能结局,并提高其生活质量.
Background Long-term bowel dysfunction can impact a significant proportion of patients following anterior re-section.The aim of this study was to assess the efficacy of transanal irrigation(TAI)to treat low anterior resection syndrome.Methods Adults(≥18 years)with major low anterior resection syndrome(score＞30)at least 12 months after low anterior resection were enrolled at four European centres.Eligible patients were randomized 1∶1 using block randomization to the TAI group or best supportive care group.The primary endpoint was the feasibility of TAI measured by treatment adherence or switch of therapy.Secondary endpoints included bowel function,quality of life and study-specific patient satisfaction questions.Outcome evaluators and the statistical team were blinded to allocation,whereas participants and caregivers were unblinded.Results Forty-one patients were randomized,of which 40(19 TAI;21 best supportive care)completed follow-up;1 patient in the TAI group was excluded due to fistula surgery.At 12 months,low anterior resection syndrome(median 3[range 0-39]versus 36[2-42];P＜0.001)and Wexner scores(median 0[0-15]versus 13[4-20];P＜0.001)were significantly lower in the TAI group compared with the control group.The Measure Yourself Medical Outcome Profile score was lower in the TAI group after 3 months(median 2[0-11]versus 11[7-12];P＜0.001).In addition,patients in the TAI group achieved higher Memorial Sloan Kettering Cancer Center Bowel Function Instrument scores after 12 months(median 89[37-90]versus 39[28-61];P＜0.001).Adherence was high,with 15(75%)maintaining daily irrigation,and patient satisfaction measures favoured TAI.Two mild procedure-related adverse events(tenesmus,dizziness)were reported.Conclusions This randomized clinical feasibility study confirms that TAI is feasible and has high acceptability for patients.It leads to better functional outcomes and improvements in quality of life compared with the best supportive care for patients with low anterior resection syndrome.
Civilka I;Klimovskij M;Aleinikov A;黄鉴
昆明医科大学第一附属医院肿瘤外科 云南 昆明 650032
医药卫生
低位前切除综合征经肛门灌洗可行性研究肠道功能生活质量
low anterior resection syndrometransanal irrigationfeasibility studybowel functionquality of life
《结直肠肛门外科》 2026 (4)
404-406,3
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