Alimentary Pharmacology & Therapeutics ( IF 6.6 ) Pub Date : 2024-12-09 , DOI: 10.1111/apt.18388
Arkenbosch JHC, van Ruler O, Dwarkasing RS, Fuhler GM, Schouten WR, van Oud-Alblas MB, et al. Stromal vascular fraction with platelet-rich plasma injection during surgery is feasible and safe in treatment-refractory perianal fistulising Crohn's disease: A pilot study. Aliment Pharmacol Ther. 2023;57(7):783–791. https://doi.org/10.1111/apt.17347
In the Result section ‘3.1 Study Population’, the baseline characteristics were incorrect. We, therefore, corrected the section to the following:
In total, 25 consecutive CD patients with treatment-refractory perianal fistulas were included. Fourteen (56%) patients were female, median age was 35 (interquartile range [IQR] 25–40) years. The median time of follow-up was 12 (IQR 6–18) months. One patient was diagnosed with Crohn's disease after LIFT procedure with additional injection of SVF combined with PRP. This patient was also included in this study. Four (16%) patients were active smokers. All patients were tertiary referral patients, with a median duration of fistulising disease of 4 (range 2–8) years and a median CD duration of 11 (range 3–19) years (Table 1). Fistula had infralevatoric extensions in 10 (40%) patients, horseshoe configuration in 9 (38%) patients and supralevatoric extensions in 6 (25%) patients at baseline MRI. All patients had persistent treatment-refractory fistula. Twenty-three (92%) patients had previously been exposed to antibiotics, 15 (60%) patients to corticosteroids, 21 (84%) patients to thiopurines and 23 (92%) patients to biologicals. At time of surgery, 1 (4%) patient used an immunomodulator for CD treatment and 15 (60%) patients used biological therapy (4 (16%) adalimumab, 8 (32%) infliximab, 1 (4%) vedolizumab, 2 (8%) ustekinumab and 6 (24%) patients used immunomodulatory and anti-tumour necrosis factor combination therapy). Almost all patients underwent previous fistula surgery (24 [96%] patients), with a median number of prior procedures of 3 (range 1–12). One patient had been diverted by a colostomy prior to enrolment.
In addition, Table 1 is revised:
Study population N = 25 | |
---|---|
Age, years | 35 [25–40] |
Female | 14 (66) |
Smoking status at time of surgery | |
Active | 4 (16) |
Previous | 8 (32) |
Never | 13 (52) |
CD duration years | 11 [3–19] |
Fistulising disease duration, year | 4 [2–8] |
Active luminal CD | |
None | 21 (84) |
Ileum | 1 (4) |
Proximal colon | 1 (4) |
Sigmoid | 2 (8) |
Disease phenotype (montreal) | |
Luminal (B1) | 18 (72) |
Stricturing (B2) | 4 (16) |
Penetrating (B3) | 3 (12) |
Disease localisation (montreal) | |
Ileum (L1) | 2 (8) |
Colon (L2) | 4 (16) |
Ileocolonic (L3) | 19 (76) |
Previous fistula surgery | 23 (92) |
Number of previous fistula operations | 3 [0–11] |
Types of previous fistula surgery | |
Fistulotomy | 2 (8) |
Drainage of abscess with seton or drain placement | 9 (38) |
Drainage of abscess without drain placement | 16 (64) |
Seton placement alone | 17 (68) |
Laser treatment | 1 (4) |
Diverting colostomy at time of surgery | 1 (8) |
Concomitant IBD medication at baseline | |
Thiopurine | 1 (4) |
Anti-TNFα treatmentA | 12 (48) |
Combination therapyB | 6 (24) |
Ustekinumab | 2 (8) |
Vedolizumab | 1 (4) |
None | 3 (12) |
In Section ‘3.4.2. Clinical outcome after SVF with PRP injection’ of the Results section, the partial and total clinical closure rates were incorrect. This is due to the fact a proportion of patients developed new-onset fistula after index treatment or that not all external openings were treated at time of the index treatment. In the original manuscript, these fistulas were not excluded from the analysis. Thus, the effect of our studied treatment was underrated. Therefore, we have revised our data and the text as the following:
Three months after the first SVF with PRP procedure, 17 (68%) patients showed clinical response (≥ 1 external opening closed), of which 7 (28%) had complete clinical closure. In all patients, clinical response and complete clinical closure were sustained until the end of follow-up at 12 months. Subsequently, 3 patients without clinical response at 3 months postoperatively achieved clinical response within 12 months. Thus, clinical response was observed in 20 (80%) patients. In addition, 6 other patients without complete clinical closure at 3 months postoperatively reached complete clinical closure within 12 months after the first SVF with procedure. The overall complete clinical closure rate was 52% (13/25). Due to fistula healing, restoration of bowel continuity was performed in one patient with a diverting colostomy prior to inclusion.
The authors apologise for these errors.
中文翻译:
纠正“手术期间富血小板血浆注射基质血管分数在难治性难治性肛周瘘管性克罗恩病中是可行且安全的:一项初步研究”
Arkenbosch JHC、van Ruler O、Dwarkasing RS、Fuhler GM、Schouten WR、van Oud-Alblas MB 等人。手术期间注射富含血小板的血浆基质血管部分在难治性难治性肛周瘘管性克罗恩病中是可行且安全的:一项初步研究。食品药理学 Ther.2023;57(7):783–791.https://doi.org/10.1111/apt.17347
在结果部分 '3.1 研究人群'中,基线特征不正确。因此,我们将该部分更正为以下内容:
总共纳入 25 例连续患有难治性肛周瘘的 CD 患者。14 例 (56%) 患者为女性,中位年龄为 35 岁 (四分位距 [IQR] 25-40) 岁。中位随访时间为 12 (IQR 6-18) 个月。1 例患者在 LIFT 手术后额外注射 SVF 联合 PRP 后被诊断为克罗恩病。该患者也被纳入本研究。4 例 (16%) 患者是主动吸烟者。所有患者均为三级转诊患者,瘘管病变的中位病程为 4 (范围 2-8) 年,中位 CD 病程为 11 (范围 3-19) 年(表 1)。基线 MRI 时,10 例 (40%) 患者瘘管呈股下延伸,9 例 (38%) 患者出现马蹄形,6 例 (25%) 患者呈上扩张。所有患者均患有持续性难治性瘘管。23 例 (92%) 患者既往接受过抗生素治疗,15 例 (60%) 患者接受过皮质类固醇治疗,21 例 (84%) 患者接受过硫嘌呤治疗,23 例 (92%) 患者接受过生物制剂治疗。手术时,1 名 (4%) 患者使用免疫调节剂进行 CD 治疗,15 名 (60%) 患者使用生物疗法 (4 名 (16%) 阿达木单抗,8 名 (32%) 英夫利昔单抗,1 名 (4%) 维得利珠单抗,2 名 (8%) 乌司奴单抗和 6 名 (24%) 患者使用免疫调节和抗肿瘤坏死因子联合治疗)。几乎所有患者既往接受过瘘管手术 (24 [96%] 患者),既往手术的中位数为 3 次 (范围 1-12)。一名患者在入组前曾因结肠造口术而分流。
此外,还修订了表 1:
研究人群 N = 25 |
|
---|---|
年龄、年 | 35 [25–40] |
女性 | 14 (66) |
手术时的吸烟状况 |
|
积极 | 4 (16) |
以前 | 8 (32) |
从不 | 13 (52) |
CD 持续时间年 | 11 [3–19] |
瘘管病程、年 |
4 [2–8] |
活动性管腔 CD | |
没有 | 21 (84) |
回肠 | 1 (4) |
近端结肠 | 1 (4) |
乙状结肠 | 2 (8) |
疾病表型(蒙特利尔) |
|
管腔 (B1) | 18 (72) |
狭窄 (B2) | 4 (16) |
渗透 (B3) | 3 (12) |
疾病定位(蒙特利尔) |
|
回肠 (L1) | 2 (8) |
结肠 (L2) | 4 (16) |
回结肠 (L3) | 19 (76) |
既往瘘管手术史 | 23 (92) |
既往瘘管手术次数 |
3 [0–11] |
既往瘘管手术的类型 |
|
瘘管切开术 | 2 (8) |
脓肿引流伴挂线或引流管 |
9 (38) |
脓肿引流而不放置引流管 |
16 (64) |
仅放置 Seton | 17 (68) |
激光治疗 | 1 (4) |
手术时结肠造口术分流术 |
1 (8) |
基线时伴随的 IBD 药物治疗 |
|
硫嘌呤 | 1 (4) |
抗 TNFα 治疗A |
12 (48) |
联合疗法B |
6 (24) |
乌司奴单抗 | 2 (8) |
维多珠单抗 | 1 (4) |
没有 | 3 (12) |
在第 3.4.2 节中。结果部分 SVF 加 PRP 注射后的临床结局,部分和全部临床闭合率不正确。这是因为一部分患者在指数治疗后出现新发瘘管,或者在指数治疗时并非所有外部开口都得到治疗。在原始手稿中,这些瘘管并未被排除在分析之外。因此,我们研究的治疗效果被低估了。因此,我们将数据和文本修改如下:
第一次 SVF 与 PRP 手术后 3 个月,17 例 (68%) 患者出现临床反应 (≥ 1 个外部开口闭合),其中 7 例 (28%) 临床完全闭合。在所有患者中,临床反应和完全临床闭合持续到 12 个月随访结束。随后,3 例术后 3 个月无临床反应的患者在 12 个月内达到临床反应。因此,在 20 例 (80%) 患者中观察到临床反应。此外,其他 6 例术后 3 个月未完全临床闭合的患者在第一次 SVF 手术后 12 个月内达到完全临床闭合。总体临床完全闭合率为 52% (13/25)。由于瘘管愈合,在纳入前对一名接受分流结肠造口术的患者进行了肠道连续性的恢复。
作者对这些错误表示歉意。