Jørgensen Rasmus W, Jensen Claus H, Jørring Stig
From the Hand Clinic, Department of Orthopedics, Herlev-Gentofte University Hospital of Copenhagen.
Plast Reconstr Surg. 2023 Feb 1;151(2):365-371. doi: 10.1097/PRS.0000000000009847. Epub 2022 Nov 9.
In this randomized controlled trial, the authors compared the recurrence of Dupuytren disease at 3 years following needle fasciotomy or collagenase injection treatment for isolated metacarpophalangeal joint contractures.
The study was conducted between 2013 and 2015. The study design was a single-center, randomized controlled clinical trial with an independent blinded observer. Patients were randomized between collagenase clostridium histolyticum injections (Xiapex) and percutaneous needle fasciotomy (collagenase clostridium histolyticum versus percutaneous needle fasciotomy). A total of 36 patients were followed in the percutaneous needle fasciotomy group and 32 in the collagenase clostridium histolyticum group.
Patients who were treated with collagenase clostridium histolyticum had a significantly lower recurrence rate than patients treated with percutaneous needle fasciotomy during the 3-year period ( P = 0.007). Of the 36 patients who were followed in the percutaneous needle fasciotomy group, 17 (47%) had recurrence of extension deficit or progression of the disease leading to further treatment. Of the 32 patients who were followed in the collagenase clostridium histolyticum group, six (19%) had recurrence or progression. No serious adverse event was reported in any of the patients.
In this randomized controlled trial, we found less recurrence and progression of Dupuytren disease using collagenase injection as compared to percutaneous needle fasciotomy 3 years following treatment for isolated metacarpophalangeal joint contractures.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
在这项随机对照试验中,作者比较了针对孤立性掌指关节挛缩采用针刀筋膜切开术或胶原酶注射治疗后3年时Dupuytren病的复发情况。
该研究于2013年至2015年进行。研究设计为单中心、随机对照临床试验,有独立的盲法观察者。患者被随机分为注射溶组织梭状芽孢杆菌胶原酶(Xiapex)组和经皮针刀筋膜切开术组(溶组织梭状芽孢杆菌胶原酶与经皮针刀筋膜切开术对比)。经皮针刀筋膜切开术组共随访了36例患者,溶组织梭状芽孢杆菌胶原酶组随访了32例患者。
在3年期间,接受溶组织梭状芽孢杆菌胶原酶治疗的患者复发率显著低于接受经皮针刀筋膜切开术治疗的患者(P = 0.007)。在经皮针刀筋膜切开术组随访的36例患者中,17例(47%)出现伸展功能障碍复发或疾病进展,需要进一步治疗。在溶组织梭状芽孢杆菌胶原酶组随访的32例患者中,6例(19%)出现复发或疾病进展。所有患者均未报告严重不良事件。
在这项随机对照试验中,我们发现对于孤立性掌指关节挛缩,治疗后3年采用胶原酶注射治疗Dupuytren病的复发和进展情况少于经皮针刀筋膜切开术。
临床问题/证据级别:治疗性,I级