荷兰莱顿大学医学中心Féline P B Kroon小组近日取得一项新成果。他们探讨了为期6周的10毫克泼尼松治疗手部骨关节炎的效果。这一研究成果于2019年11月11日发表在国际顶尖学术期刊《柳叶刀》上。

手部骨性关节炎是一种常见的关节疾病，疾病负担较高，且未能有效治疗。由于手部骨关节炎多由局部炎症引起，因此研究组决定采用泼尼松进行治疗。

HOPE研究是一项双盲、随机、安慰剂对照试验。2015年12月3日至2018年5月31日，研究组从荷兰两个地点的风湿病门诊招募了92名症状性手部骨关节炎和远近端指间关节炎（DIP/PIP）的患者。将其按1：1随机分组，其中46名接受10mg泼尼松治疗，46名接受安慰剂治疗，每日一次，为期6周，之后再进行为期2周的逐渐减量治疗。采用100毫米视觉模拟评分量表（VAS）对患者的手指疼痛程度进行评分，分数越高越疼痛。

治疗6周后，泼尼松组患者的手指疼痛评分降低了21.5分，安慰剂组降低了5.2分，组间差异显著。两组间非严重不良事件的发生率相差不大。共有5例严重不良事件发生，其中泼尼松组1例心肌梗死，安慰剂组1例外伤性腿部感染需要手术，1例肠道手术，1例房颤需植入起搏器，1例子宫肌瘤需切除子宫。

总之，采用10mg泼尼松治疗手部疼痛性骨关节炎安全有效，该短期治疗方案值得临床推广。

附：英文原文

Title: Results of a 6-week treatment with 10 mg prednisolone in patients with hand osteoarthritis (HOPE): a double-blind, randomised, placebo-controlled trial

Author: Féline P B Kroon, Marion C Kortekaas, Annelies Boonen, Stefan Bhringer, Monique Reijnierse, Frits R Rosendaal, Naghmeh Riyazi, Mirian Starmans, Franktien Turkstra, Jende van Zeben, Cornelia F Allaart, Margreet Kloppenburg

Issue&Volume: November 11, 2019

Abstract:

Background

Hand osteoarthritis is a prevalent joint condition that has a high burden of disease and an unmet medical need for effective therapeutic options. Since local inflammation is recognised as contributing to osteoarthritic complaints, the Hand Osteoarthritis Prednisolone Efficacy (HOPE) study aimed to investigate the efficacy and safety of short-term prednisolone in patients with painful hand osteoarthritis and synovial inflammation.

Methods

The HOPE study is a double-blind, randomised, placebo-controlled trial. We recruited eligible adults from rheumatology outpatient clinics at two sites in the Netherlands. Patients were considered eligible if they had symptomatic hand osteoarthritis and signs of inflammation in their distal and proximal interphalangeal (DIP/PIP) joints. For inclusion, patients were required to have four or more DIP/PIP joints with osteoarthritic nodes; at least one DIP/PIP joint with soft swelling or erythema; at least one DIP/PIP joint with a positive power Doppler signal or synovial thickening of at least grade 2 on ultrasound; and finger pain of at least 30 mm on a 100-mm visual analogue scale (VAS) that flared up during a 48-h non-steroidal anti-inflammatory drug (NSAID) washout (defined as worsening of finger pain by at least 20 mm on the VAS). Eligible patients were randomly assigned (1:1) to receive 10 mg prednisolone or placebo orally once daily for 6 weeks, followed by a 2-week tapering scheme, and a 6-week follow-up without study medication. The patients and study team were masked to treatment assignment. The primary endpoint was finger pain, assessed on a VAS, at 6 weeks in participants who had been randomly assigned to groups and attended the baseline visit. This study is registered with the Netherlands Trial Registry, number NTR5263.

Findings

We screened patients for enrolment between Dec 3, 2015, and May 31, 2018. Patients completed baseline visits and started treatment between Dec 14, 2015, and July 2, 2018, and the last study visit of the last patient was Oct 4, 2018. Of 149 patients assessed for eligibility, 57 (38%) patients were excluded (predominantly because they did not meet one or several inclusion criteria, most often because of an absence of synovial inflammation or of flare-ups after NSAID washout) and 92 (62%) patients were eligible for inclusion. We randomly assigned 46 (50%) patients to receive prednisolone and 46 (50%) patients to receive placebo, all of whom were included in the modified intention-to-treat analysis of the primary endpoint. 42 (91%) patients in the prednisolone group and 42 (91%) in the placebo group completed the 14-week study. The mean change between baseline and week 6 on VAS-reported finger pain was 21·5 (SD 21·7) in the prednisolone group and 5·2 (24·3) in the placebo group, with a mean between-group difference (of prednisolone vs placebo) of 16·5 (95% CI 26·1 to 6·9; p=0·0007). The number of non-serious adverse events was similar between the groups. Five serious adverse events were reported during our study: one serious adverse event in the prednisolone group (a myocardial infarction) and four serious adverse events in the placebo group (an infected traumatic leg haematoma that required surgery, bowel surgery, atrial fibrillation that required a pacemaker implantation, and symptomatic uterine myomas that required a hysterectomy). Four (4%) patients discontinued the study because of an adverse event: one (2%) patient receiving prednisolone (for a myocardial infarction) and three (7%) patients receiving placebo (for surgery of the bowel and for an infected leg haematoma and for Lyme disease arthritis of the knee).

Interpretation

Treatment with 10 mg prednisolone for 6 weeks is efficacious and safe for the treatment of patients with painful hand osteoarthritis and signs of inflammation. The results of our study provide clinicians with a new short-term treatment option for patients with hand osteoarthritis who report a flare-up of their disease.

DOI: 10.1016/S0140-6736(19)32489-4

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32489-4/fulltext