Statistics.

BackgroundSystemic Sclerosis in the hand is characteristically evidenced by Raynaud’s phenomenon, fibrosis of the skin, tendons, ligaments, and joints as well as digital ulcers with prolonged healing. Current medical treatment does not always cure these complications. Local adipose-derived stromal vascular fraction administration into the hands has been proposed as an emerging treatment due to its regenerative properties. The objective of this randomized controlled clinical trial was to evaluate the safety and clinical effects of fat micrografts plus adipose derived-stromal vascular fraction administration into the hands of patients with systemic sclerosis.MethodsThis was an open-label, monocentric, randomized controlled study. Twenty patients diagnosed with systemic sclerosis were assigned to the experimental or control group. Fat micrografts plus the adipose derived-stromal vascular fraction were injected into the right hand of experimental group patients. The control group continued to receive only medical treatment. Demographic, serologic data and disease severity were recorded. Digital oximetry, pain, Raynaud phenomenon, digital ulcers number, mobility, thumb opposition, vascular density of the nail bed, skin affection of the hand, serologic antibodies, hand function, and quality of life scores were evaluated in both groups.ResultsThe results of the intervention were analyzed with the Wilcoxon rank test, and the differences between the control and experimental groups at 0 days and 168 days were analyzed with the Mann–Whitney U test. Adverse events were not observed in both groups. At the end of the study, statistically significant improvements were observed in pain levels (pConclusionThe injection of adipose derived-stromal vascular fraction plus fat micrografts is a reproducible, and safe technique. Pain and digital ulcers in the hands of patients with systemic sclerosis can be treated with this technique plus conventional medical treatment.背景 手部系统性硬化症（Systemic Sclerosis）的典型临床表现为雷诺现象（Raynaud’s phenomenon）、皮肤、肌腱、韧带及关节纤维化，以及愈合迁延的指端溃疡。当前的内科治疗并非总能完全治愈此类并发症。鉴于其再生特性，局部注射脂肪来源基质血管组分（adipose-derived stromal vascular fraction）已被提出作为一种新兴治疗方案。本随机对照临床试验旨在评估脂肪微移植（fat micrografts）联合脂肪来源基质血管组分注射用于系统性硬化症患者手部治疗的安全性与临床疗效。方法 本研究为开放标签（open-label）、单中心（monocentric）随机对照研究。共纳入20例确诊系统性硬化症的患者，按随机分配原则分为试验组与对照组。试验组患者接受右侧手部脂肪微移植联合脂肪来源基质血管组分注射治疗；对照组仅继续接受常规内科治疗。记录受试者的人口学资料、血清学数据及疾病严重程度。对两组患者均开展以下指标评估：指尖血氧饱和度、疼痛程度、雷诺现象、指端溃疡数量、手部活动度、拇指对掌功能、甲床血管密度、手部皮肤受累情况、血清抗体水平、手部功能及生活质量评分。结果 本研究采用Wilcoxon秩和检验（Wilcoxon rank test）分析干预后的疗效数据，采用Mann-Whitney U检验（Mann–Whitney U test）比较对照组与试验组在基线（0天）及168天时的组间差异。两组均未观察到不良事件。研究终点时，疼痛程度出现具有统计学意义的改善（原文此处p值标注缺失）。结论 脂肪来源基质血管组分联合脂肪微移植是一项可重复且安全的治疗技术。联合常规内科治疗，该方案可用于改善系统性硬化症患者的手部疼痛及指端溃疡症状。