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Matsuno Y, Umeno J, Hirano A, Fuyuno Y, Nagasue T, Fujioka S, Kawasaki K, Moriyama T, Kitazono T, Torisu T, Maintenance Efficacy of Oral Indigo Naturalis for Ulcerative Colitis: a single-center, open-label, randomized, controlled study, Crohn's & Colitis Congress, 2024.01. |
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Yuichi Matsuno, Atsushi Hirano, Takehiro Torisu, Yuta Fuyuno, Yasuharu Okamoto, Tomohiro Nagasue, Keizo Zeze, Shin Fujioka, Tomohiko Moriyama, Junji Umeno, Yoichiro Hirakawa, Motohiro Esaki, and Takanari Kitazono, The clinical efficacy and safety of indigo naturalis in induction & maintenance therapy for moderate-to-severe ulcerative colitis.: A single-center prospective uncontrolled open-label study., 15th Congress of European Crohn’s and Colitis Organisation, 2020.02, Background: Recently, several studies have shown the high efficacy of Indigo naturalis (IN) in the induction therapy for ulcerative colitis (UC). However, the efficacy and safety in the maintenance therapy remain unclear. Thus, we performed this prospective study to investigate the efficacy and safety of IN for induction and maintenance therapy in patients with moderate to severe active UC.
Method: We conducted a prospective uncontrolled open-label study at Kyushu university hospital. A total of 33 patients with moderate to severe active UC (Clinical activity index (CAI) ≧ 8) received 2g per day of IN for 52 weeks. We assessed CAI at week 0, 4, 8, 52, and Mayo endoscopic score (MES) was evaluated at week 0, 4, 52. We calculated the clinical remission (CAI ≦ 4) rate and mucosal healing (MES ≦ 1) rate at each point. Overall adverse events (AEs) during the follow-up were also estimated.
Result: Clinical remission rates at week 4, 8, and 52 were 67%, 76%, and 73%, respectively. Mucosal healing rates at week 4 and 52 were 48% and 70%. Seventeen patients experienced adverse events (AEs) during the follow-up. Seven severe AEs, including intussusception, acute severe colitis, infectious colitis, portal thrombosis, appendicitis, were observed in 4 patients.
Conclusion:
Our prospective study indicated that IN was a promising option for induction and maintenance therapy in UC. However, possible AEs of IN should be paid attention.
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Yuichi Matsuno, Takehiro Torisu, Yuta Fuyuno, Yasuharu Okamoto, Shin Fujioka, Atsushi Hirano, Junji Umeno, Tomohiko Moriyama, Takanari Kitazono, and Motohiro Esaki, Long-term outcome of watch and wait strategy for gastric antibiotic-resistant mucosa-associated lymphoid tissue lymphoma, United European Gastroenterology Week 2019, 2019.10, Introduction: Although Helicobacter pylori (HP) eradication therapy (antibiotic therapy) has been established as the first line therapy for gastric mucosa-associated lymphoid tissue (MALT) lymphoma regardless of their HP infection status, therapeutic strategy for superficial gastric MALT lymphoma in patients not responding to antibiotic therapy (non-responders) has been an important issue to be solved. Watch & wait strategy has been assumed to be a choice after antibiotic therapy, however, the malignant potential of the disease remains uncertain.
Aims &Method: We analyzed the long-term outcome of watch & wait strategy for non-responders. During the period between January 1995 and January 2017, 119 patients received antibiotic therapy as the first-line therapy for superficial gastric MALT lymphoma. Among them, we selected 45 patients who met the inclusion criteria; a) the first-line therapy of antibiotic therapy could not lead complete response of the disease, b) watch & wait strategy was subsequently applied for at least a year in case no disease progression, c) the disease confined to either mucosal layer or submucosal layer under endoscopic ultrasonography. Clinical data were collected by reviewing electrical medical records, and long-term outcome of superficial gastric MALT lymphoma occurring in HP-negative patients (HP-negative disease) was analyzed by comparing the outcome occurring in HP-positive patients (HP-positive disease). Overall survival rate (OSR) and progression free survival rate (PFSR) were calculated by the Kaplan-Meier method and the values were compared using the log-rank test. We also compared clinicopathological features between HP-negative and HP-positive diseases.
Results: The study subjects comprised 25 HP-negative disease and 20 HP-positive disease, and the mean follow-up period was 56 months [range; 9-224 months]. OSR of the study subjects at 5 and 10 years after HP eradication were 100% and 92%, and PFSR at 5 years was 53%. PFSR was significantly higher in HP-negative disease than in HP-positive disease (PFSR at 5 years; 73% vs 27%, p=0.0026). Age ≤ 60 years (16/25 vs 5/20), the disease confined to the mucosal layer (20/25 vs 8/20), and superficially spreading type in morphology (22/25, 11/20) were significantly more frequent in HP-negative disease than in HP-positive disease. Eleven patients (55%) in HP-positive disease and 4 patients (16%) in HP-negative disease experienced disease progression. Interestingly, the progression pattern was obviously different between HP-positive disease and HP-negative disease (enlargement of gastric leision/extra-gastric leision, 10/1 vs 0/4, p=0.0027).
Conclusion: Careful follow-up by EGD seems appropriate to monitor disease progression of superficial gastric MALT lymphoma in non-responders. In HP-negative patients with MALT lymphoma, watch & wait strategy can be reasonable after antibiotic therapy, however, careful follow-up using systemic imaging modalities should be necessary.
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松野 雄一、梅野 淳嗣、鳥巣 剛弘、平川 洋一郎、冬野 雄太、岡本 康治、安川 重義、平井 郁仁、渡辺 憲治、細江 直樹、河内 修司、藏原 晃一、八尾 恒良、北園 孝成、松本 主之、江﨑 幹宏, CEASとCrohn病の鑑別における尿中プロスタグランジンE主要代謝産物濃度測定の有用性に関する検討, 第9回日本炎症性腸疾患学会, 2018.11, 【背景】Chronic enteropathy associated with SLCO2A1 gene（CEAS）は多発する小腸潰瘍による慢性的な貧血と低蛋白血症を特徴とするまれな難治性疾患である。近年、我々は本症の原因遺伝子としてプロスタグランジン輸送体をコードするSLCO2A1 遺伝子を同定した。CEASとCrohn病（CD）はともに小腸に多発潰瘍や狭窄を認めるため、実臨床において鑑別が困難な場合がある。我々の過去の検討では、CEAS患者における尿中プロスタグランジンE主要代謝産物（PGE-MUM）濃度は健常人と比較して有意に高値であった。今回、CEASとCDとの鑑別におけるPGE-MUM濃度測定の有用性を検討した。【方法】2012- 2017年の期間中に研究協力施設に通院中でSLCO2A1遺伝子変異陽性であることが確認されたCEAS 17例と九州大学病院消化管内科に通院中のCD 97例より文書による同意を得た上で尿検体を採取した。PGE-MUM濃度は放射性免疫測定法で測定した。交絡因子の同定のため単回帰分析を行い、オッズ比の算出のため、ロジスティック回帰分析を行った。ROC解析により、適切なカットオフ値を求めた。【結果】CEAS群におけるPGE-MUM濃度はCD群と比較して有意に高値であった（中央値 121 vs 28 μg/g×Cre, p |
