使用Imipenem/Cilastatin動脈注射治療退化性手指關節炎引起之指間關節疼痛的成效及安全性分析

研究目的：隨著年齡的增長，退化性手指關節炎的發病率逐漸升高，女性患者尤為常見。該疾病主要累及指間關節和腕掌關節，可導致手指疼痛、僵硬、變形，嚴重時甚至會造成手指功能喪失，給患者帶來沉重的個人和社會負擔。目前，手指退化性關節炎的治療方法主要包括非侵入性的運動、物理治療、局部/口服藥物以及侵入性的指尖關節注射和外科手術。然而，並非所有患者都能對現有的治療方式獲得良好的療效或滿足適應症。經動脈注射imipenem/cilastatin sodium (IPM/CS) 是一種透過暫時性的微血管栓塞藥物來調控局部異常微血管增生，進而抑制慢性發炎和疼痛的療法，已被廣泛應用於各種慢性骨骼肌肉疼痛的治療。然而，目前尚缺乏針對手指退化性關節炎引起的指間關節疼痛的療效證據。本研究旨在探討經動脈注射IPM/CS 治療手指退化性關節炎引起的指間關節疼痛的有效性和安全性，以期為該疾病的治療提供新的選擇。研究方法及資料：本研究為回溯性研究，收集了 2020 年 5 月至 2021 年 10 月之間 58 位接受動脈注射 IPM/CS 治療手指指間退化性關節炎的患者的臨床資訊。患者平均年齡為 56.6 歲，其中女性患者 53 位，平均病程為 37.5 個月。所有患者均透過手腕動脈穿刺進行兩次的經動脈IPM/CS注射治療，在治療後 1、3、6、12 和 18 個月分?使用疼痛數字評定量表 (numerical rating scale, NRS) 、手指退化性關節炎功能指標 (functional index of hand osteoarthritis, FIHOA) 和病患整體治療印象評分 (patient global impression of change, PGIC) 進行評估。臨床成功率則根據 PGIC評估。研究結果：本研究中，所有患者均接受了至少 6 個月的治療後追蹤，其中 30 位和 6 位患者分別接受了 12 個月和 18 個月的追蹤。研究過程中未發生任何嚴重或危及生命的不良反應。治療前，患者的平均NRS評分為 6.0 ± 1.4。治療後第 1、3 和 6 個月，NRS 評分分?顯著下降至 2.8 ± 1.4、2.2 ± 1.9 和 2.4 ± 1.9 (所有 p 值 < 0.001)。在持續追蹤的患者中，第 12 和 18 個月的平均 NRS 評分分?為 2.8 ± 1.7 和 2.9 ± 1.9，提示經動脈注射 IPM/CS 對治療手指退化性關節炎引起的指間關節疼痛具有顯著的緩解效果。治療前，患者的平均FIHOA評分為 9.8 ± 5.0。治療後 3 個月，FIHOA 評分顯著下降至 4.1 ± 3.5 (p < 0.001)。在餘下 30 位12 個月後追蹤的患者中，第 12 個月的平均 FIHOA 評分為 4.5 ± 3.3，表明患者的手指功能在治療後 3 個月即有改善，且 12 個月後仍保持改善狀態。根據病患整體治療印象評分 (PGIC) 評估，經動脈注射IPM/CS 治療後 1、3、6、12 和 18 個月的臨床成功率分?為 62.1%、77.6%、70.7%、63.4% 和 50.0%。結論與建議：本研究顯示，經動脈IPM/CS注射治療對手指退化性關節炎引起的指間關節疼痛具有顯著的緩解效果，且能改善患者的手指功能，從而提高患者的生活品質。此外，我們在治療及追蹤過程中未在病患身上觀察到任何嚴重或危及生命的不良反應，顯示出良好的安全性。然而，本研究仍存在一些局限性，例如本研究為回溯性研究，因此存在一定的偏倚風險，且本研究的樣本量有限，且患者的異質性較大。因此，本研究的結果需要在更大規模、前瞻性、隨機對照試驗中進一步驗證。

Objective: Osteoarthritis (OA) of the hand is a common and debilitating condition that affects millions of people worldwide. It is characterized by pain, stiffness, and deformity of the joints, which can significantly impact hand function and quality of life. Current treatment options for hand OA include non-invasive measures such as exercise, physiotherapy, and oral medications, as well as invasive procedures such as intra-articular joint injections and surgery. However, not all patients respond adequately to these treatments. Intra-arterial injection of imipenem/cilastatin sodium (IPM/CS) is a novel therapeutic approach that has shown promise in the treatment of chronic musculoskeletal pain. Intra-arterial IPM/CS infusion is a temporary microvascular embolization therapy that reduces abnormal microvascular proliferation (angiogenesis) and inflammation. The objective of this study was to investigate the efficacy and safety of intra-arterial IPM/CS infusion for the treatment of interphalangeal joint pain in patients with hand OA.Methods and Materials: This retrospective study included 58 patients with hand OA who underwent intra-arterial IPM/CS infusion between May 2020 and October 2021. The mean patient age was 56.6 years, and 53 patients were female. The mean disease duration was 37.5 months. All patients received two courses of intra-arterial IPM/CS infusion via wrist puncture. Pain was assessed using the numerical rating scale (NRS) at 1, 3, 6, 12, and 18 months after treatment. Hand function was assessed using the functional index of hand osteoarthritis (FIHOA) at the same time points. Patient global impression of change (PGIC) was also assessed at each follow-up visit. Clinical success was defined as a PGIC score of "much improved" or " very much improved."Results: All patients were followed up for at least 6 months, and 30 and 6 patients were followed up for 12 and 18 months, respectively. No serious or life-threatening adverse events were reported. The mean NRS score at baseline was 6.0 ± 1.4. The NRS scores decreased significantly to 2.8 ± 1.4, 2.2 ± 1.9, and 2.4 ± 1.9 at 1, 3, and 6 months after treatment, respectively (all p values < 0.001). In patients with continued follow-up, the mean NRS scores at 12 and 18 months were 2.8 ± 1.7 and 2.9 ± 1.9, respectively, demonstrating sustained pain relief. The mean FIHOA score at baseline was 9.8 ± 5.0. The FIHOA score decreased significantly to 4.1 ± 3.5 at 3 months after treatment (p < 0.001). In the 30 patients with 12-month follow-up, the mean FIHOA score at 12 months was 4.5 ± 3.3, indicating improvement in hand function that persisted at 12 months. The clinical success rates based on PGIC were 62.1%, 77.6%, 70.7%, 63.4%, and 50.0% at 1, 3, 6, 12, and 18 months after treatment, respectively.Conclusions and Suggestion: Intra-arterial IPM/CS infusion was found to be an effective and safe treatment for interphalangeal joint pain in patients with hand OA. It significantly reduced pain, improved hand function, and had a good safety profile. Further studies with randomized controlled, larger sample sizes with longer follow-up duration are warranted to confirm these findings.