Ishibashi Kohei, Eishi Yoshinobu, Tahara Nobuhiro, Asakura Masanori, Sakamoto Naka, Nakamura Kazufumi, Takaya Yoichi, Nakamura Tomohisa, Yazaki Yoshikazu, Yamaguchi Tetsuo, Asakura Koko, Anzai Toshihisa, Noguchi Teruo, Yasuda Satoshi, Terasaki Fumio, Hamasaki Toshimitsu, Kusano Kengo
Department of Cardiovascular Medicine National Cerebral and Cardiovascular Center Osaka Japan.
Department of Human Pathology Tokyo Medical and Dental University Tokyo Japan.
J Arrhythm. 2018 Aug 31;34(5):520-526. doi: 10.1002/joa3.12084. eCollection 2018 Oct.
Cardiac sarcoidosis (CS) is a noncaseating granulomatous disease of unknown etiology. Lifelong immunosuppressive therapy, most frequently using corticosteroids, is a standard therapy to control hypersensitivity of immune reactions and prevent inflammation. However, it sometimes causes various systemic adverse effects and requires dose escalation. Thus, additional therapy may be required for the treatment of this disease. Recently, () was reported as one of the etiologic agents of CS, indicating that antibacterial drugs (ABD) may be effective for the treatment of CS. The objective of this study was to investigate the effect of ABD treatment, in addition to standard corticosteroid therapy, in patients with CS.
The Japanese Antibacterial Drug Management for Cardiac Sarcoidosis (J-ACNES) trial was designed as a prospective, multicenter, randomized, open-label, controlled clinical trial. The patients will be randomized to receive either standard corticosteroid therapy plus ABD therapy (ABD group) or standard corticosteroid therapy (standard group). The primary endpoint is change in the total standardized uptake value at 6 months vs baseline using fluorine-18 fluorodeoxyglucose positron emission tomography and computed tomography. Secondary endpoints include efficacy, prognosis, and safety.
The results of this study are currently under investigation.
The J-ACNES trial will be the first prospective study assessing the clinical benefit and safety of ABD therapy, in addition to corticosteroid treatment, in patients with CS. Our findings may improve treatment of patients with CS, as additional ABD therapy reduces recurrence of inflammation and elucidates the mechanism of sarcoidosis.
心脏结节病（CS）是一种病因不明的非干酪样肉芽肿性疾病。终身免疫抑制治疗，最常用的是皮质类固醇，是控制免疫反应超敏反应和预防炎症的标准疗法。然而，它有时会引起各种全身不良反应，并且需要增加剂量。因此，可能需要额外的治疗来治疗这种疾病。最近，（）被报道为CS的病因之一，这表明抗菌药物（ABD）可能对CS的治疗有效。本研究的目的是调查在标准皮质类固醇治疗基础上，ABD治疗对CS患者的影响。
日本心脏结节病抗菌药物管理（J-ACNES）试验设计为一项前瞻性、多中心、随机、开放标签、对照临床试验。患者将被随机分为接受标准皮质类固醇治疗加ABD治疗（ABD组）或标准皮质类固醇治疗（标准组）。主要终点是使用氟-18氟脱氧葡萄糖正电子发射断层扫描和计算机断层扫描，6个月时与基线相比总标准化摄取值的变化。次要终点包括疗效、预后和安全性。
本研究结果目前正在调查中。
J-ACNES试验将是第一项评估在CS患者中，除皮质类固醇治疗外，ABD治疗的临床益处和安全性的前瞻性研究。我们的研究结果可能会改善CS患者的治疗，因为额外的ABD治疗可减少炎症复发并阐明结节病的机制。
