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Objective. To evaluate the clinical therapeutic efficacy and safety of JieDuTongLuoShengJin granules + HCQ in patients with pSS. Methods. 40 patients with low-activity-level pSS and without visceral involvement participated in this study and were randomized to receive either JieDuTongLuoShengJin granules with HCQ or placebo with HCQ. Patients and investigators were blinded to treatment allocation. The primary endpoint was week 12 ESSPRI score, while secondary endpoints included ESSDAI, salivary and lacrimal gland function, and some laboratory variables. Safety-related data were also assessed. Results. Comparing with the placebo group, the treatment group experienced statistically significant improvement in the mean change from baseline for the primary endpoint of ESSPRI score and also in PGA. Moreover, in comparison with baseline values, the treatment group had significantly improved ESSDAI score, unstimulated saliva flow rate, and several laboratory variables. However, upon comparison of the two groups, there were no significant differences for them. The incidence of AEs was 10.0%, one in treatment group and three in placebo group. Conclusion. Treatment with a combination of JieDuTongLuoShengJin granules with HCQ is effective in improving patients’ subjective symptoms and some objective indicators of pSS. These results indicate that JieDuTongLuoShengJin is promising as a safe and effective treatment of pSS.

本稿では、自由記述型談話完成テストにより収集した改善要求発話を「切り出し部」「用件内容部」「終了部」の３つの部分に分け、ビリヤードボール･モデルを援用し、改善要求発話の談話構造を分析した上、「因果連鎖」と「事態把握」という二つの認知的アプローチから、日中間の類型論的特性を考察した。さらに、その考察結果に基づき、これまで着目されてこなかった認知とポライトネスの接点から、日中間の配慮の仕方の相違と認知レベルでの営みとの関連性を検討した。その結果、改善要求発話の各部分に用いる配慮の仕方が、日中両言語とも一見異なる表現形式で表しているようであるが、その深層において、日本語は話者自身の感情活動を事態に注ぎ込んだ｢主観的把握｣、中国語は事態そのものを重視した「客観的把握」、といった認知レベルでの共通性があることが明らかになった。, The present paper discusses the typological characteristics of Japanese and Chinese “making demands” from the viewpoint of ‘causal chain’ and ‘construal’. We collected the data through a test called the ‘Discourse Completion Test’. The discourse then could be divided into the following parts, namely, ‘the beginning part’, ‘the key part’ and ‘the finishing part’. From the viewpoint of ‘the relevance of politeness and cognition’, which has not been noted heretofore, we found that in both Japanese and Chinese, the expressions and the ways of consideration in one part are different from that in another. That is, they are connected by the ‘construal’ which works at the cognitive level. The Japanese speakers would like to use the ‘subjective construal’ while the Chinese speakers prefer the ‘objective construal’. In this way, we can get some insight into the differences in cognitive level resulting in individual ways of making politeness between Japanese and Chinese.