Supplementary Material for: Intralesional corticosteroid administration in the treatment of keloids: a scoping review on injection methods

Background
Intralesional corticosteroid administration (ICA) is a first-line treatment for keloids. However, its clinical results are still highly variable and often suboptimal. Treatment results may strongly be influenced by various operator dependent factors. The aim of this study is to map the details of ICA in keloids described in randomized controlled trials (RCTs), hence presenting the scientific practice of a first-line treatment for keloids in the best available evidence.
Summary
A systematic search was performed on PubMed, Ovid MEDLINE, Ovid EMBASE and CENTRAL. Eligible studies were RCTs including patients with keloids treated with intralesional corticosteroids. Treatment and study design related data were charted on a predefined form. Thirty-eight RCTs were included for data extraction. Triamcinolone acetonide was used in 37 (97.4%) studies. Dosing per cm2 could only be compared among ten (26%) studies, and varied from 1 to 20 mg. The maximum dose per session varied from 20 to 80 mg. Anesthetics were administered locally and orally in seven and one RCT(s). Treatment intervals varied from weekly to monthly, with four weeks most frequently (50%) used. Needle size was reported in eleven (29%) studies and varied from 26 to 30-gauge. Syringe size was specified in four (11%) studies, being 1 mL. The injection level was described in eleven (29%) studies. Blanching as endpoint was reported in ten (26%) studies. Outcome measures varied widely, from height, surface area or volume, to Vancouver Scar Scale, Patient and Observer Scar Assessment Scale, pain and itch scores, patient satisfaction and different efficacy rates. Only six studies had a follow-up of ≥6 months. Recurrence was identified in two studies with 18 weeks and 1 year of follow-up. Adverse events were reported in 25 (66%) studies.
Key messages
There is incomplete reporting and substantial heterogeneity in many aspects of ICA and study design among RCTs. This scoping review underscores the urgent need for standardization of treatment protocol and study design to enhance and uniform research conduct among keloid studies.

背景
皮损内皮质类固醇注射（ICA）是治疗瘢痕疙瘩的一线治疗方案。然而，其临床效果仍然存在较大差异，且往往不尽如人意。治疗方案的效果可能受到多种操作者依赖因素的影响。本研究旨在梳理随机对照试验（RCTs）中关于ICA在瘢痕疙瘩治疗中的详细情况，从而以最佳可用证据展示治疗瘢痕疙瘩一线治疗方案的科学研究实践。
摘要
本研究对PubMed、Ovid MEDLINE、Ovid EMBASE和CENTRAL数据库进行了系统检索。纳入符合条件的研究为包含使用皮损内皮质类固醇治疗的瘢痕疙瘩患者的RCTs。治疗和研究设计相关数据被记录在预定义的表格上。共纳入了38项RCTs进行数据提取。37项（97.4%）研究中使用了醋酸曲安奈德。每平方厘米的剂量只能在10项（26%）研究中进行比较，剂量范围为1至20毫克。单次最大剂量范围为20至80毫克。在7项和1项RCTs中，分别采用局部和口服麻醉。治疗间隔从每周到每月不等，其中以四周最为常见（50%）。11项（29%）研究中报告了针头大小，范围在26至30号。4项（11%）研究中指定了注射器大小，为1毫升。11项（29%）研究中描述了注射层次。10项（26%）研究中报告了以皮肤发白作为终点。结局指标差异较大，包括高度、表面积或体积、温哥华瘢痕量表、患者及观察者瘢痕评估量表、疼痛和瘙痒评分、患者满意度以及不同的疗效率。只有6项研究进行了≥6个月的随访。两项研究在18周和1年的随访中发现了复发。25项（66%）研究中报告了不良事件。
关键信息
在许多ICA和RCTs研究设计中，存在报告不完整和显著异质性的问题。本次范围综述强调了统一治疗方案和研究设计，以增强并统一瘢痕疙瘩研究中的研究实践的紧迫需求。