A RANDOMIZED, GROUP-PARALLEL COMPARATIVE TRIAL OF THE SUPPRESSIVE EFFECT OF CHINESE TRADITIONAL MEDICINE, SHEN-MI-TANG (SHIN-PI-TO), COMPARED TO SODIUM ORAMOYLYCATE INHALATION IN IMPROVING SUBJECTIVE AND OBJECTIVE SYMPTOMS IN BRONCHIAL ASTHMATICS
Shen-mi-tang (Shin-pi-to, SBT) is a well-known suppressor of 5-lypoxygenase as reported by Hamazaki's et al. SBT also has many other antiallergic and antiinflammatory effects. If we can use SBT tropically on bronchoallergic portions, we see the same phenomena occurring in in vivo and in vitro e...
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| Published in | JIBI INKOKA TEMBO Vol. 47; no. Supplement1; pp. 20 - 27 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article |
| Language | Japanese |
| Published |
Society of Oto-rhino-laryngology Tokyo
2004
耳鼻咽喉科展望会 |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0386-9687 1883-6429 |
| DOI | 10.11453/orltokyo1958.47.Supplement1_20 |
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| Abstract | Shen-mi-tang (Shin-pi-to, SBT) is a well-known suppressor of 5-lypoxygenase as reported by Hamazaki's et al. SBT also has many other antiallergic and antiinflammatory effects. If we can use SBT tropically on bronchoallergic portions, we see the same phenomena occurring in in vivo and in vitro experiments.To obtain a high SBT concentration on the bronchoalligopathological portion, we sutudied kampo herb medicine, i.e., SBT inhalation therapy. After informed consent was obtained, 161 patients were divided into two groups (Group A, n = 81) (Group B, n = 80). Under the same conditions for different drugs, patients in group A inhaled SBT (500 μg/1 capsule, 4 times/day) for 3 years. Patients in group B inhaled sodium cromoglicate (CSCG) (20 mg/1 capsule) in the same administraton using DSCG-spinhela. The difference between DSCG and SBT in capsules was not recognized because these capsules were identical capsule using for DSCG, i.e., baseline clinical characteristics did not significantly differ between groups. At the end point, subjective symptoms such as asthmatic score, PEF titer, and resqure time of β 2 agonist use decreased significantly. Therapeutic drugs also decreased significantly in group A (p < 0.001). In group B, these parameters increased significantly. (p< 0.05). (p< 0.001 vs Group B) Adverse side effects and the appearance of abnormal laboratory data during this trial was lower in group A. In global improvement, group A showed 61.9%, but group B only 5.6% (p< 0.001). These reasons are discussed in this paper. |
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| AbstractList | Shen-mi-tang (Shin-pi-to, SBT) is a well-known suppressor of 5-lypoxygenase as reported by Hamazaki's et al. SBT also has many other antiallergic and antiinflammatory effects. If we can use SBT tropically on bronchoallergic portions, we see the same phenomena occurring in in vivo and in vitro experiments.To obtain a high SBT concentration on the bronchoalligopathological portion, we sutudied kampo herb medicine, i.e., SBT inhalation therapy. After informed consent was obtained, 161 patients were divided into two groups (Group A, n = 81) (Group B, n = 80). Under the same conditions for different drugs, patients in group A inhaled SBT (500 μg/1 capsule, 4 times/day) for 3 years. Patients in group B inhaled sodium cromoglicate (CSCG) (20 mg/1 capsule) in the same administraton using DSCG-spinhela. The difference between DSCG and SBT in capsules was not recognized because these capsules were identical capsule using for DSCG, i.e., baseline clinical characteristics did not significantly differ between groups. At the end point, subjective symptoms such as asthmatic score, PEF titer, and resqure time of β 2 agonist use decreased significantly. Therapeutic drugs also decreased significantly in group A (p < 0.001). In group B, these parameters increased significantly. (p< 0.05). (p< 0.001 vs Group B) Adverse side effects and the appearance of abnormal laboratory data during this trial was lower in group A. In global improvement, group A showed 61.9%, but group B only 5.6% (p< 0.001). These reasons are discussed in this paper. Shen-mi-tang (Shin-pi-to, SBT) is a well-known suppressor of 5-lypoxygenase as reported by Hamazaki's et al. SBT also has many other antiallergic and antiinflammatory effects. If we can use SBT tropically on bronchoallergic portions, we see the same phenomena occurring in in vivo and in vitro experiments.To obtain a high SBT concentration on the bronchoalligopathological portion, we sutudied kampo herb medicine, i.e., SBT inhalation therapy. After informed consent was obtained, 161 patients were divided into two groups (Group A, n = 81) (Group B, n = 80). Under the same conditions for different drugs, patients in group A inhaled SBT (500 μg/1 capsule, 4 times/day) for 3 years. Patients in group B inhaled sodium cromoglicate (CSCG) (20 mg/1 capsule) in the same administraton using DSCG-spinhela. The difference between DSCG and SBT in capsules was not recognized because these capsules were identical capsule using for DSCG, i.e., baseline clinical characteristics did not significantly differ between groups. At the end point, subjective symptoms such as asthmatic score, PEF titer, and resqure time of β 2 agonist use decreased significantly. Therapeutic drugs also decreased significantly in group A (p < 0.001). In group B, these parameters increased significantly. (p< 0.05). (p< 0.001 vs Group B) Adverse side effects and the appearance of abnormal laboratory data during this trial was lower in group A. In global improvement, group A showed 61.9%, but group B only 5.6% (p< 0.001). These reasons are discussed in this paper. 我々は先に神秘湯吸入療法時, 気道病変局所神秘湯濃度がin vivo, in vitro実験系と同等濃度になるため, 神秘湯が同所5-リポキシゲナーゼ活性を抑制し, アスピリン喘息予防に有効であることをソディウムクロモグリセート (sodium cromoglicate : DSCG) 吸入療法との前向き無作為多施設二重盲検試駈で報告した。本報告ではアスピリン喘息例を無作為に2群に割りつけ外見上識別不可のソディウムクロモグリセート用カプセルにA群 (n=81) に神秘湯 (500μ9/1カプセル), B群 (n=80) にソデイウムクロモグリセート20mg/1カプセルを1日4回, ソディウムクロモグリセート用スピンヘラーで現治療を変化することなく6時間おきに追加吸入させた。3年間にわたり併発気管支喘息症状がいかに改善するか検討した。その結果, A群がB群に比較し, (1) 喘息自他覚症状, (2) 併用薬剤減量を統計的に右意に改善し, かつ (3) 副作用, 臨床検査値異常も少なかった。以上の結果, 神秘湯吸入療法は気管支喘息治療薬としソディウムクロモグリセートより優れている可能性が示唆された。すなわち, 従来漢方薬の実験系使用濃度を臨床用量の病変局所濃度差を神秘湯吸入療法という手段を用い実験系同等濃度に達して, 実験系で示された多彩な神秘湯の抗アレルギー, 抗炎症反応がアレルギー反応を示す気道で直接発揮しえた結果と考えられた。 |
| Author | Goto, Gracy Hiroe Nishizawa, Yoshio Nishizawa, Yasuko Fushiki, Shinji Yoshioka, Fumi |
| Author_FL | 後藤 グレイシイ・広恵 Nishizawa Yoshio 西澤 恭子 伏木 信次 吉岡 二三 |
| Author_FL_xml | – sequence: 1 fullname: Nishizawa Yoshio – sequence: 2 fullname: 西澤 恭子 – sequence: 3 fullname: 後藤 グレイシイ・広恵 – sequence: 4 fullname: 吉岡 二三 – sequence: 14 fullname: 伏木 信次 |
| Author_xml | – sequence: 1 fullname: Goto, Gracy Hiroe organization: Department of Clinical and Experimental Pathophysiology, Graduate School of Pharmaceutical Sciences, Osaka University – sequence: 1 fullname: Nishizawa, Yasuko organization: Department of Clinical and Experimental Pathophysiology, Graduate School of Pharmaceutical Sciences, Osaka University – sequence: 1 fullname: Fushiki, Shinji organization: Department of Pathology and Applied Neurobiology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine – sequence: 1 fullname: Yoshioka, Fumi organization: The Department of Internal Medicine, Yoshioka Clinic – sequence: 1 fullname: Nishizawa, Yoshio organization: The Department of Anesthesiology, Shiga University of Medical Science |
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| References | 7) Hirai K, Asada Y, Takaishi T, Nakajima T, Morita Y, et al : Saiboku-to, a kampo herbal medicine, inhibits LTC, release from eosinophils. Allergy Int 47 : 279-283, 1998. 20) Nishizawa Y, Nishizawa Y, Yoshioka F, Amakata Y, Fushiki S : Thyroxine-induced production of superoxide anion by human alveoliar neutrophils and macrophages : a possible mechanism with the development of hyperthyroidism. In vivo 12 : 253-258, 1998. 10) 西澤芳男, 西澤恭子, 吉岡二三, 後藤・グレイシィ・広恵, 竹村光一, 他 : ベクロメタゾン吸入量半減時の柴朴湯吸入療法とクロモグリセート吸入療法の代替療法比較試験.耳展45 (補1) : 8-15, 2002 6) 西澤芳男, 西澤恭子, 雨森保憲, 野坂修一, 天方義邦, 他 : 柴朴湯のヒト肺胞洗浄液中肥満細胞のLeukotriene産生への影響.漢方と最新治療7 : 63-74, 1998 16) Nishizawa Y, Nishizawa Y, Yoshioka F, Amakata Y, Nosaka S, et al : Effect of Shen-bi-tang on activity of 5-lipoxy-genase in human alveoral mast cells. Jpn Med J 3 : 14-22, 2002. 12) Nishizawa Y, Nishizawa Y, Yoshioka F, NosakaS, Amenomori Y, et al Suppressive effect of kampo medicine, Choi-po-tang (Japanese name : Saiboku-to, TJ-96) on bronchospsms in aspirin-induced bronchial asthmatic patients and decreases of chronic pain, especially psychological pain. Pain Kampo Med 11 : 14-20, 2001. 8) Nishizawa Y, Nishizawa Y, Fushiki S : Effect of inhalation of Saiboku-to on patients with bronchial asthma. J Trad Med 16 (Suppl 1) : 81, 1999. 14) Nishizawa Y, Fushiki S, Nishizawa S : Preventive effect of Saiboku-to inhalation on aspirin inotolerant attack. J Trad Med 17 (Suppl 1) : 46, 2000. 1) Nakajima S, Tohda Y, Ohkawa K, Chihara J, Nagasaka Y : Effect of Saiboku-to (TJ-96) on bronchial asthma. Ann N Y Acad Sci 685 : 549-560, 1993. 9) Nishizawa Y, Nishizawa Y, Yoshioka F, Nosaka S, Amenomori Y, et al : Multicenter, randomized, double-blind trial of roxithromycin to protect asthma attacks in patients with aspirinintolerant asthma. Jpn Med J 1 : 24-32, 2002. 2) Egashira Y, Nagano H : A multicenter clinical trial of TJ-96 in patients with steroid dependent bronchial asthma. Ann N Y Acad Sci 685 : 580-583, 1993. 4) Nishizawa Y, Nishizawa Y, Fushiki S : The inhibitory effect of Saiboku-to on 5-lipoxygenase activity in human alveolar mast cells. J Trad Med 14 : 382-383, 1997. 13) Nishizawa Y, Nishizawa Y, Yoshioka F, Nosaka S, Amakata Y, et al : A Kampo herbal medicine, Chi-po-tang inhibits LTC4 release from human bronchialveolar eosinophil. Jpn Med J 2 : 140-145, 2002. 18) Yamamoto H, Nagata M, Kuramitsu K, Tabe K, Kiuchi H, et al : Inhivition of analgesic-induced asthma by leukotriene receptor antagonist ONO-1078. Am J Respir Crit 150 : 254-257, 1994. 3) Kobayashi I, Hamasaki Y, Sato R, Zaitu M, Muro E, et al : Saiboku-to, a herbal extract mixture, selectively inhibitory 5-lipoxygenase activity on leukotriene syntheses in rat basophilic leukemial cell. J Ethnophar 48 : 32-41, 1995. 23) Nishizawa Y, Amakata Y, Matsushita Y, Nosaka F, Fushiki S : Urinary aracidonic acid cascade in hepatorenal syndrome : evidence for increased vasodilator and decreased vasoconstrictive foctor in experimental disease model rat with hepatorenal syndrome. Biotrans Tox Anesth 9 : 1-8, 1988. 17) 西澤芳男, 西澤恭子, 吉岡二三, 山田まゆみ, 安田理絵, 他 : 神秘湯 (Shen-bi-tang) SBT吸入療法とsodiumcromoglicate吸入療法とのアスピリン喘息への多施設無作為効果比較検討.耳展46 (補1) : 3-14, 2003 24) 西澤芳男, 西澤恭子, 吉岡二三, 野坂修一, 雨森保憲, 他 : 柴朴湯の抗不安効果に基づく抗気管支喘息治療効果 : 抗不安薬との多施設無作為前向き比較検討試験.東洋心身医学17 : 20-27, 2002. 22) Nishizawa Y : Role of the eosinophil in the type I allergic bronchial asthma 1 prostaglandine relased from eosinophils acts the central role in homeostasis to asthma attacks induced with the house dust. J Med Uneni Hop 1 : 167-175, 1980. 25) 西澤芳男, 西澤恭子, 吉岡二三, 野坂修一, 天方義邦, 他 : 漢方薬の抗不安作用に基づく気管支喘息患者の症状悪化の改善効果 : 柴朴湯と小青竜湯の無作為比較試験.東洋心身医学18 : 1-7, 2003. 11) 西澤芳男, 西澤恭子, 吉岡二三, 永野富美代, 谷垣由美子, 他 : 柴朴湯吸入の高アスピリン喘息効果.耳展44 (補1) : 5-13, 2001. 21) Nishizawa Y, Nishii K, Nishizawa Y : Effect of estrogen cell proliferation and increase formation in transformed mouse leydig cells cultured under serumfree condition. Cancer Res 50 : 3866-3871, 1990. 5) Nishizawa Y, Nishizawa Y, Fushiki S : Effect of herbal medicine, Saiboku-to, on LTC4 synthase in human alveolar eosinophils. J Trad Med 15 : 290-291, 1998. 19) 美濃口健治, 足立 満 : 抗ロイコトリエン薬.日本臨床59 : 1979-1985, 2001 15) Hamasaki Y, Kobayashi I, Miyazaki M : Analysis of the mechanism where by Simpi-to blocks leukotriene C4 (LTC4) production. Kamp Inmunoallergy 10 : 36-42, 1996. |
| References_xml | – reference: 19) 美濃口健治, 足立 満 : 抗ロイコトリエン薬.日本臨床59 : 1979-1985, 2001 – reference: 17) 西澤芳男, 西澤恭子, 吉岡二三, 山田まゆみ, 安田理絵, 他 : 神秘湯 (Shen-bi-tang) SBT吸入療法とsodiumcromoglicate吸入療法とのアスピリン喘息への多施設無作為効果比較検討.耳展46 (補1) : 3-14, 2003 – reference: 5) Nishizawa Y, Nishizawa Y, Fushiki S : Effect of herbal medicine, Saiboku-to, on LTC4 synthase in human alveolar eosinophils. J Trad Med 15 : 290-291, 1998. – reference: 10) 西澤芳男, 西澤恭子, 吉岡二三, 後藤・グレイシィ・広恵, 竹村光一, 他 : ベクロメタゾン吸入量半減時の柴朴湯吸入療法とクロモグリセート吸入療法の代替療法比較試験.耳展45 (補1) : 8-15, 2002 – reference: 21) Nishizawa Y, Nishii K, Nishizawa Y : Effect of estrogen cell proliferation and increase formation in transformed mouse leydig cells cultured under serumfree condition. Cancer Res 50 : 3866-3871, 1990. – reference: 18) Yamamoto H, Nagata M, Kuramitsu K, Tabe K, Kiuchi H, et al : Inhivition of analgesic-induced asthma by leukotriene receptor antagonist ONO-1078. Am J Respir Crit 150 : 254-257, 1994. – reference: 20) Nishizawa Y, Nishizawa Y, Yoshioka F, Amakata Y, Fushiki S : Thyroxine-induced production of superoxide anion by human alveoliar neutrophils and macrophages : a possible mechanism with the development of hyperthyroidism. In vivo 12 : 253-258, 1998. – reference: 8) Nishizawa Y, Nishizawa Y, Fushiki S : Effect of inhalation of Saiboku-to on patients with bronchial asthma. J Trad Med 16 (Suppl 1) : 81, 1999. – reference: 12) Nishizawa Y, Nishizawa Y, Yoshioka F, NosakaS, Amenomori Y, et al Suppressive effect of kampo medicine, Choi-po-tang (Japanese name : Saiboku-to, TJ-96) on bronchospsms in aspirin-induced bronchial asthmatic patients and decreases of chronic pain, especially psychological pain. Pain Kampo Med 11 : 14-20, 2001. – reference: 3) Kobayashi I, Hamasaki Y, Sato R, Zaitu M, Muro E, et al : Saiboku-to, a herbal extract mixture, selectively inhibitory 5-lipoxygenase activity on leukotriene syntheses in rat basophilic leukemial cell. J Ethnophar 48 : 32-41, 1995. – reference: 1) Nakajima S, Tohda Y, Ohkawa K, Chihara J, Nagasaka Y : Effect of Saiboku-to (TJ-96) on bronchial asthma. Ann N Y Acad Sci 685 : 549-560, 1993. – reference: 24) 西澤芳男, 西澤恭子, 吉岡二三, 野坂修一, 雨森保憲, 他 : 柴朴湯の抗不安効果に基づく抗気管支喘息治療効果 : 抗不安薬との多施設無作為前向き比較検討試験.東洋心身医学17 : 20-27, 2002. – reference: 25) 西澤芳男, 西澤恭子, 吉岡二三, 野坂修一, 天方義邦, 他 : 漢方薬の抗不安作用に基づく気管支喘息患者の症状悪化の改善効果 : 柴朴湯と小青竜湯の無作為比較試験.東洋心身医学18 : 1-7, 2003. – reference: 7) Hirai K, Asada Y, Takaishi T, Nakajima T, Morita Y, et al : Saiboku-to, a kampo herbal medicine, inhibits LTC, release from eosinophils. Allergy Int 47 : 279-283, 1998. – reference: 9) Nishizawa Y, Nishizawa Y, Yoshioka F, Nosaka S, Amenomori Y, et al : Multicenter, randomized, double-blind trial of roxithromycin to protect asthma attacks in patients with aspirinintolerant asthma. Jpn Med J 1 : 24-32, 2002. – reference: 4) Nishizawa Y, Nishizawa Y, Fushiki S : The inhibitory effect of Saiboku-to on 5-lipoxygenase activity in human alveolar mast cells. J Trad Med 14 : 382-383, 1997. – reference: 23) Nishizawa Y, Amakata Y, Matsushita Y, Nosaka F, Fushiki S : Urinary aracidonic acid cascade in hepatorenal syndrome : evidence for increased vasodilator and decreased vasoconstrictive foctor in experimental disease model rat with hepatorenal syndrome. Biotrans Tox Anesth 9 : 1-8, 1988. – reference: 11) 西澤芳男, 西澤恭子, 吉岡二三, 永野富美代, 谷垣由美子, 他 : 柴朴湯吸入の高アスピリン喘息効果.耳展44 (補1) : 5-13, 2001. – reference: 22) Nishizawa Y : Role of the eosinophil in the type I allergic bronchial asthma 1 prostaglandine relased from eosinophils acts the central role in homeostasis to asthma attacks induced with the house dust. J Med Uneni Hop 1 : 167-175, 1980. – reference: 16) Nishizawa Y, Nishizawa Y, Yoshioka F, Amakata Y, Nosaka S, et al : Effect of Shen-bi-tang on activity of 5-lipoxy-genase in human alveoral mast cells. Jpn Med J 3 : 14-22, 2002. – reference: 15) Hamasaki Y, Kobayashi I, Miyazaki M : Analysis of the mechanism where by Simpi-to blocks leukotriene C4 (LTC4) production. Kamp Inmunoallergy 10 : 36-42, 1996. – reference: 14) Nishizawa Y, Fushiki S, Nishizawa S : Preventive effect of Saiboku-to inhalation on aspirin inotolerant attack. J Trad Med 17 (Suppl 1) : 46, 2000. – reference: 2) Egashira Y, Nagano H : A multicenter clinical trial of TJ-96 in patients with steroid dependent bronchial asthma. Ann N Y Acad Sci 685 : 580-583, 1993. – reference: 13) Nishizawa Y, Nishizawa Y, Yoshioka F, Nosaka S, Amakata Y, et al : A Kampo herbal medicine, Chi-po-tang inhibits LTC4 release from human bronchialveolar eosinophil. Jpn Med J 2 : 140-145, 2002. – reference: 6) 西澤芳男, 西澤恭子, 雨森保憲, 野坂修一, 天方義邦, 他 : 柴朴湯のヒト肺胞洗浄液中肥満細胞のLeukotriene産生への影響.漢方と最新治療7 : 63-74, 1998 |
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| Snippet | Shen-mi-tang (Shin-pi-to, SBT) is a well-known suppressor of 5-lypoxygenase as reported by Hamazaki's et al. SBT also has many other antiallergic and... |
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| SubjectTerms | bronchial asthma inhalated therapy 5-lipoxygenase Shen-mi-tang sodium cromoglicate 吸入療法 気管支喘息 神秘湯 |
| Title | A RANDOMIZED, GROUP-PARALLEL COMPARATIVE TRIAL OF THE SUPPRESSIVE EFFECT OF CHINESE TRADITIONAL MEDICINE, SHEN-MI-TANG (SHIN-PI-TO), COMPARED TO SODIUM ORAMOYLYCATE INHALATION IN IMPROVING SUBJECTIVE AND OBJECTIVE SYMPTOMS IN BRONCHIAL ASTHMATICS |
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