Maeda Nobuki, Yamaji Ken, Kimura Kei, Kim Youngjoon, Tsuda Hiroshi, Hirose Shunichi, Hashimoto Hiroshi
Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine.
Nihon Rinsho Meneki Gakkai Kaishi. 2005 Dec;28(6):398-406. doi: 10.2177/jsci.28.398.
Sjögren's syndrome is not one of the forty-five diseases included in the incurable disease treatment research project funded by the government. However, it is approved as a designated incurable disease for government funded treatment in Tokyo. The criteria of approval are based on diagnostic criteria revised in 1999. Complications and other factors are taken into consideration in the recognition standard established independently in Tokyo. In this study we examined the recognition standard of approval and their significance by analyzing the clinical questionnaires of patients with Sjögren's syndrome in Tokyo through 2003. The major objective of the recognition standard (2003) appears to have been the approval of subjects with severe Sjögren's syndrome with such conditions as advanced glandular involvement xerosis affecting their daily lives and visceral complications. However, examinations using biopsy, salivary gland scintigraphy, and contrast sialography can only be performed at an institution with appropriate facilities. For an approval process that is impartial and accomplished with ease, we believe that combinations of simple multiple tests should be considered as auxiliary items which could be substituted for the aforementioned examinations. In addition, future investigation is necessary to examine the high cost incurred in requiring findings within six months for an approval application, performing of annual invasive tests, and the validity of the process for determining the approved or unapproved status using the present clinical questionnaire profiles.
干燥综合征并非政府资助的不治之症治疗研究项目所涵盖的45种疾病之一。然而,在东京,它被批准为政府资助治疗的指定不治之症。批准标准基于1999年修订的诊断标准。东京独立制定的认定标准中考虑了并发症及其他因素。在本研究中,我们通过分析2003年东京干燥综合征患者的临床调查问卷,研究了批准的认定标准及其意义。认定标准(2003年)的主要目的似乎是批准患有严重干燥综合征的患者,这些患者存在如腺体受累严重、口干影响日常生活以及内脏并发症等情况。然而,活检、唾液腺闪烁扫描和唾液腺造影检查只能在具备适当设施的机构进行。为了实现公正且轻松完成的批准流程,我们认为应将简单的多项检查组合作为辅助项目,以替代上述检查。此外,未来有必要调查批准申请要求在六个月内得出结果、每年进行侵入性检查所产生的高昂成本,以及使用当前临床调查问卷概况来确定批准或不批准状态这一流程的有效性。