Objective: To investigate the mid-term efficacy of sacral nerve stimulation (SNS) for chronic constipation. Methods: A descriptive case series study was conducted. Patients with chronic constipation were treated in Xijing Hospital of Digestive Disease from February 2013 to December 2018 were retrospectively enrolled. The types of constipation were confirmed based on colon slow transit test, anorectal manometry and defecography in Xi'an Mayinglong Coloproctological Hospital. This study has been registered in China clinical trial registry (Registration No.: ChiCTR-ROC-16008945). Case inclusion criteria: (1) constipation was diagnosed according to Rome III criteria; (2) traditional treatment, including education, diet adjustment, laxative, biofeedback treatment, failed for at least 1 year; (3) there were no constipation-related organic diseases. After excluding neurogenic diseases, including spinal cord injury and multiple sclerosis, 21 patients were included in this study. There were 10 males and 11 females, with an average age of 50.9 (14-76) years. After the relevant examination and evaluation of patients, they underwent percutaneous nerve evaluation (PNE). If patient experienced a good response to PNE after 2 or 3 weeks (≥50%), permanent SNS implantation was performed. The improvement of clinical symptoms and quality of life between the baseline, PNE, and latest follow-up time points were compared. Improvement of clinical symptoms, including autonomic stool frequency per week, autonomic stool days per week, defecation time, visual analogue scale (VAS, lower score indicates more serious symptoms) score and Cleveland clinic constipation score (CCCS, higher score indacates more serious symptoms) criteria. The change of quality of life was scored by SF-36 questionnaires (the higher score indicates better quality of life). Results: Of 21 patients, 18 (85.7%) experienced significant improvement in symptoms with PNE, and 2 patients discontinued treatment due to their dissatisfaction. Sixteen patients (76.2%) received permanent SNS implantation, two of whom underwent bilateral PNE implantation. These patients were followed-up for mean 56 (34-72) months. The treatment was continuously effective in 13 patients (61.9%), including 3 of ODS, 1 of STC and 9 of mixed constipation. Compared with baseline, the score of constipation patients receiving permanent SNS implantation at latest follow-up was shown. The median autonomic stool frequency per week increased from 1.0 (0-7) to 7.5 (0-10) (P<0.001), the median autonomic stool days per week increased from 1.0 (0-7) d to 4.5 (0-7) d (P<0.001), the median defecation time decreased from 19.0 (8-40) minutes to 4.0 (3-31) minutes (P<0.001), the median CCCS decreased from 20.0 (13-30) to 9.0 (6-30) (P<0.001), and the median VAS score increased from 9.0 (7-40) to 80.0 (15-90) (P<0.001). The values of the 8 parts of the SF-36 questionnaire increased (all P<0.05). Conclusion: SNS implantation is safe and has obvious effects on severe constipation with stable mid-term efficacy.
目的： 探讨骶神经调节术治疗便秘的疗效。 方法： 采用描述性病例系列研究的方法。回顾性收集自2013年2月至2018年12月期间，在空军军医大学西京医院消化病医院就诊、并在西安马应龙肛肠医院完善结肠慢传输试验、直肠肛管测压以及排粪造影确认便秘类型的便秘患者的临床资料。本研究已于中国临床试验注册中心注册（注册号ChiCTR-ROC-16008945）。纳入标准：（1）根据罗马Ⅲ标准诊断便秘；（2）传统治疗（包括教育、饮食调整、泻药、生物反馈治疗）失败至少1年；（3）没有便秘相关的器质性疾病。排除患有神经源性疾病，包括脊髓损伤和多发性硬化症后，共21例患者纳入本研究，女性11例（52.4%），平均年龄50.9（14~76）岁。对本组患者进行相关检查和评估后，先进行体验治疗，如果2~3周后便秘症状改善≥50%，就接受永久性骶神经调节术治疗。比较治疗前、体验治疗完成后2~3周和完成永久治疗后患者的临床症状和生活质量改善的情况。临床症状的改善情况，包括每周自主排粪频率、每周自主排粪天数、排粪时间、视觉模拟量表（VAS，分数越低表示便秘症状越严重）评分和克利夫兰诊所便秘评分（CCCS，分数越高表示便秘症状越严重）；生活质量变化采用SF-36问卷评分（分数越高表示生活质量越好）。 结果： 21例患者中有18例（85.7%）在体验治疗后症状有显著改善，其中2例并不满意治疗效果而停止治疗。16例（76.2%）接受了永久性骶神经调节术治疗，其中2例患者接受了双侧体验治疗植入。接受永久性骶神经调节术治疗后，16例患者平均随访56（34~72）个月，13例（61.9%）治疗持续有效（包括3例出口梗阻型便秘，1例慢传输型便秘，9例混合型便秘）。与接受骶神经调节术治疗前相比，接受永久性置入后末次随访时，每周自主排粪中位次数从1.0（0~7）次增加到7.5（0~10）次，每周自主排粪中位天数从1.0（0~7）次增加到4.5（0~7）次，中位排粪时间从19.0（8~40） min下降到4.0（3~31） min，CCCS中位数从20.0（13~30）分下降到9.0（6~30）分，中位VAS评分从9.0（7~40）分提高到80.0（15~90）分（均P<0.001）。SF-36问卷各领域评分均上升（均P<0.05）。 结论： 骶神经调节术治疗顽固性便秘安全可行，中期疗效稳定。.
Keywords: Bilateral implantation; Constipation; Sacral nerve stimulation.