自体脂肪干细胞移植治疗复杂性肛瘘的临床观察

目的评估自体脂肪干细胞移植治疗复杂性肛瘘的有效性和安全性。 方法纳入2018年1月到2018年10月间南京市中医院肛肠中心收治的复杂性肛瘘23例，年龄12~51岁，其中克罗恩病肛瘘11例，腺源性肛瘘12例，应用自体脂肪干细胞移植治疗，随访3~12个月，并收集患者的临床资料。通过临床评估及MRI结果评价瘘管闭合情况，统计瘘管外口完全上皮化的时间，采用SF-36量表和VAS量表评估患者术前、术后的生活质量变化及疼痛评分变化，运用Wexner失禁评分量表评估患者术前术后的肛门失禁情况，对于克罗恩病肛瘘患者需记录其治疗前后的肛周病变活动指数（PDAI），并记录研究中的所有不良事件。 结果瘘管的总愈合率为69.57%（16/23），其中克罗恩病肛瘘的愈合率为90.91%（10/11），腺源性肛瘘为50%（6/12）；16名瘘管愈合患者的外口平均闭合时间为（17.06±4.54）天，其中克罗恩病肛瘘为（17.90±4.53）天，腺源性肛瘘为（15.67±4.59）天。患者的生活质量评分与疼痛评分在术后7天可恢复至术前水平，而肛门失禁评分则保持不变或降低。克罗恩病肛瘘患者治疗前和治疗后90天的PDAI评分为（8.55±1.37）分和（1.27±1.10）分，二者之间差异有统计学意义（t=12.033，P<0.05）。研究中未出现与ADSCs注射相关的不良事件。 结论自体脂肪干细胞移植是治疗复杂性肛瘘特别是克罗恩病肛瘘的一种安全有效的方法，可以保护患者肛门功能，减轻术后疼痛，改善围手术期生活质量。

Clinical research of autologous adipose-derived stem cell transplantation in the treatment of complex anal fistulas

ObjectiveTo evaluate the safety and efficacy of autologous adipose-derived stem cells (ADSCs) in the treatment of complex anal fistulas. MethodsTwenty-three patients whose age ranged from 12 to 51 years old with complex anal fistula were treated with ADSCs in Colorectal Disease Center of Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine from January 2018 to October 2018. They included 11 patients with Crohn′s disease anal fistulas(CDAF) and 12 patients with cryptoglandular anal fistulas (CPAF). And their clinical data during the follow-up period of 3~12 months were collected. The closure of fistulas were evaluated by clinical evaluation and MRI scan. And the time of complete epithelialization of fistulas were also counted. It shouldn′t be forgotten that Perianal Disease Activity Index (PDAI) should be recorded for patients with CDAF before and after treatment. In addition, anal incontinence score(Wexner score), visual analogue scale score, quality of life score(SF-36) and adverse events were recorded. ResultsThe total healing rate of fistulas was 69.57%(16/23). The healing rate of CDAF was 90.91% (10/11) and CPAF was 50%(6/12). The average external closure time of 16 patients with fistulas healing was (17.06±4.54) days, of which (17.90±4.53) days was CDAF and (15.67±4.59) days was CPAF. The quality of life score and visual analogue scale come back to preoperative levels in 7 days postoperation, while the anal incontinence score unchanged or decreased. The PDAI of patients with CDAF was (8.55+ 1.37) points before treatment, and (1.27+ 1.10) points 90 days after treatment (t=12.033, P<0.05). No adverse events associated with ADSCs injection were observed in the study. ConclusionADSCs is a safe and effective treatment for complex anal fistula, especially for CDAF. It can protect the anal function of patients, relieve pain and improve the quality of life during perioperative period.