We used Saiko--to in an attempt to alleviate tinnitus of over 3 months' duration in 13 patients. Saiko--to was administered orally at 7.5 grams per day, divided into 3 doses, and a subjective evaluation for efficacy was performed 4 weeks thereafter. Of the 13 patients, one was rated as markedly improved,2 as improved and 2 as slightly improved. In 7 patients who had a favorable response to intravenous lidocaine,2 were rated as improved and 2 as slightly improved following Saiko--to administration.
Intravenous lidocaine is effective against tinnitus by blocking the hyperirritable auditory pathway. Saiko--to acts to suppress the bursts of neurons firing in an epileptic state. We presume that Saiko--to was more effective in those patients with a good response to lidocaine because of the similar actions of both of these therapies.

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著者名のうちYoshimitsu FUKUDA氏はHiromitsu FUKUDA氏の誤りでした
（誤）Takashi OHMORI¹⁾, ADACHI¹⁾, Yoshimitsu FUKUDA¹⁾, Satoshi TAMAHARA¹⁾, Naoaki MATSUKI¹⁾ and Kenichiro ONO¹⁾
（正）Takashi OHMORI¹⁾, ADACHI¹⁾, Hiromitsu FUKUDA¹⁾, Satoshi TAMAHARA¹⁾, Naoaki MATSUKI¹⁾ and Kenichiro ONO¹⁾

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The purpose of this study is to clarify the effects of 17β-estradiol and the Japanese herbal medicine

Keishi

-bukuryo-gan on the release and synthesis of calcitonin gene-related peptide (CGRP) in ovariectomized (OVX) rats. The effect of ovariectomy on the release or synthesis was evaluated by measuring CGRP concentration in plasma after capsaicin (1.0 mg/kg, i.p.) injection or by measuring CGRP concentration and its mRNA expression in dorsal root ganglia in OVX rats. Ovariectomy attenuated the capsaicin-evoked increase in plasma concentration of CGRP, which was restored by treatment with 17β-estradiol (0.010 mg/kg, s.c.) or

Keishi

-bukuryo-gan (1,000 mg/kg, p.o.) for 7 days after ovariectomy. However, no significant differences were observed in the CGRP concentration and the mRNA expression of dorsal root ganglia by treating the rats with ovariectomy, 17 β-estradiol, and

Keishi

-bukuryo-gan. These results suggest not only that estrogen deficiency attenuates CGRP release but also that 17β-estradiol or

Keishi

-bukuryo-gan normalizes the attenuated release process.

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The in vitro effect of one traditional Chinese herbal medicine (Japanese name: "-bukuryo-gan"), which has been empirically used in scleroderma patients in China and Japan, on collagen production in tibroblast cultures was studied. Fibroblasts from 3 scleroderma patients and 2 normal controls were incubated with various concentrations of "-bukuryo-gan" and collagen production was then determined by a radiochemical method. "-bukuryo-gan" significantly and selectively inhibited collagen synthesis in a dose-dependent manner, with a tendency of a stronger effect on scleroderma fibroblasts than control cells. The results may explain the clinical usefulness of this medicine, and it may become a promising new agent for the treatment of scleroderma.
(Internal Medicine 33: 466-471, 1994)

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The effects of preparations of Chinese medicinal prescriptions on the activities of digestive enzymes were investigated. The starch dextrinizing activity of pancreatin was inhibited by -bukuryo-gan, Sho-seiryu-to, Hachimi-jio-gan, Unsei-in and -ka-shakuyaku-to to below 40% of the control activity. Hachimi-jio-gan and Sho-seiryu-to, in particular, lowered the activity to 4% and 24% of the control activity, respectively. The protein digestive activity of pancreatin was lowered by -bukuryo-gan, Oren-gedoku-to, Ryutan-shakan-to, Tokaku-joki-to, Yokuinin-to and Hange-shashin-to, to 56 to 70% of the control activity.To investigate the effects of the preparations of Chinese medicinal prescriptions on digestive enzymes in vivo, 600 mg (185 kBq) of ¹²⁵I-egg white albumin were administered orally to rats 30 min before the administration of 100 mg of Tokaku-joki-to or Oren-gedoku-to. The radioactivity which transferred to the blood was less in the animals pre-fed these prescriptions than in the control animals, indicating that the digestion of egg white albumin was delayed in the presence of the prescriptions.

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桂枝茯苓丸の糖尿病性腎症に対する作用を，2種類のモデルラット（腎摘＋STZ,自然発症糖尿病 WBN/Kob ラット）を用い検討した。いずれのモデルにおいても桂枝茯苓丸投与により，腎機能（尿蛋白排泄量）と病理所見の改善作用が認められ，桂枝茯苓丸が糖尿病性腎症の発症・進展を遅延することが実験的に明らかとなった。一方，慢性的な高血糖状態では酸化ストレス，ポリオール経路，糖化反応の亢進をひき起こし，腎症の進展に関与しているが，これら指標の脂質過酸化，ソルビトール，advanced glycation endproducts（AGEs）を測定した結果，桂枝茯苓丸は脂質過酸化とAGEsに好影響を及ぼしていた。さらに，桂枝茯苓丸の作用を，aminoguanidine（AGEs 阻害薬），butylated hydroxytoluene（抗酸化剤），captopril（ACE阻害剤）と比較検討した結果，脂質過酸化とAGEsに対する抑制作用が認められた。また，桂枝茯苓丸の腎保護作用はcaptoprilよりは弱く，aminoguanidine と同程度であった。これらの結果より，桂枝茯苓丸による糖尿病性腎症治療の可能性が示唆された。

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To evaluate the usefulness of a traditional Chinese medicine (Kampo prescription), -bushi-to (KBT), which is composed of five medicinal plants derived from Kampo prescriptions used to treat rheumatoid arthritis, we investigated the effect of KBT on the development of arthritis induced by type II collagen (CII). Oral administration of KBT at a dose of 500 mg/kg from 7d before intradermal injection of CII significantly reduced the severity from 7d after the onset of arthritis. The reduction in body weight resulting from the development of arthritis was not seen in rats treated with KBT.Plasma IgG and IgM anti-CII antibody levels were lower in KBT-treated rats than control rats. In addition, the clearane of IgG anti-CII-antibody from circulating blood after intravenous injection was faster in KBT-treated rats than control rats. These results indicate that KBT is effective in suppressing collagen-induced arthritis and its effect is at least partly due to the suppression of humoral and cellular immunity.

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Keishibukuryogan is a traditional Japanese medicine widely administered to patients with menopausal symptoms. Because humans use it on a long-term basis, we believed that a carcinogenicity study was warranted. We orally administered keishibukuryogan (TJ-25) extract powder to 6-week-old Sprague-Dawley rats [Crl:CD(SD)], which were divided into four dosage groups-0 (water for injection), 100, 500 and 2,500 mg/kg/day for 24 months. We found that TJ-25 did not affect the survival rate of either sex. Furthermore, it did not affect the clinical condition of the rats, number of superficial tumors found by palpation, body weight, food consumption, hematology, or gross pathological findings. The severity of degeneration of muscle fiber in the femoral skeletal muscle increased slightly in males and females in the 2,500 mg/kg/day group, but TJ-25 did not increase the number of tumors found on histopathological examination. In our study, oral administration of TJ-25 extract powder in rats for 24 months was not associated with an increased incidence of tumors.

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Rosacea is an intractable skin disease and no effective treatment has been established, but there are cases of improvement with Kampo medicine. In this study, the efficacy of

-Bukukryo-gan-ka-Yokuinin (KBY) in ameliorating the symptoms of rosacea was investigated in a steroid-induced rosacea mouse model. The mice were fed a KBY-containing diet for 28 d, after application of clobetasol propionate for 10 d; thereafter, the velocity of capillary blood flow, area of the skin purpura, histopathologic features, and gut microbiota were analyzed. The KBY-fed mice showed remarkable recovery in the capillary blood flow velocity and purpura area, as well as restoration of the epidermis features. Furthermore, gut microbiome analysis showed the enhancement of Lactobacillus population in the KBY-fed mice. The KBY-induced improvement of circulatory disturbances in skin might contribute to the alleviation of telangiectasia and erythema. Lactobacillus may be involved in alleviating the rosacea-like symptoms in association with KBY; however, this association should be investigated further by using other analysis methods. Our results provide evidence of the effectiveness of KBY in improving the pathology of rosacea.

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The subjective symptoms of varicose veins of the lower extremity often include malaise, numbness, coldness, pain, and pruritus of the lower extremity, and relieving these complaints is important in managing the quality of life of patients. We have examined the clinical efficacy of keishibukuryogan, a Kampo prescription for improving oketsu (impaired microcirculation, congestion), on non-specific complaints associated with varicose veins of the lower extremity. Keishibukuryogan was administered to 30 patients with non-specific complaints associated with varicose veins of the lower extremity for 12 weeks, resulting in improvements in the scores of subjective symptoms, severity of varicose veins, and oketsu as well as an increase in skin perfusion pressure. And especially the effect was remarkable in female. In addition, oketsu was shown to be involved in the subjective symptoms associated with varicose veins of the lower extremity, demonstrating efficacy of keishibukuryogan. No adverse drug reaction or abnormal laboratory result was observed in patients receiving keishibukuryogan, and the rate of general improvement and usefulness was 73.3%. It was suggested that keishibukuryogan was useful to improve the symptoms of patients with non-specific complaints associated with varicose veins of the lower extremity especially in female patients. (*English translation of Jpn J Phlebol 2013; 24: 303-310)

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静脈瘤50症例に高張食塩水の注入による硬化療法を行い, 著効 (腫瘤が平らになったもの) 105カ所 (85%), 有効 (同様に減少したが不十分なもの) 12カ所 (10%), 無効・増悪7 (5%), 合計124カ所注入部位であった。試みに, 硬化剤5ml 注入に漢方内服, 桂枝茯苓丸を併用したものと硬化剤4-5ml注入のものと比較したところ, 前者は20症例26注入カ所中, 著効19 (73%), 有効5 (19%), 無効・増悪2 (8%) で, 後者は14症例30カ所注入中, 著効19 (63%), 有効9 (30%), 無効・増悪2 (7%) であり, 前者は, 血栓を防止すると推定される。

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  Stagnation of peripheral blood flow is the cause of various diseases. Changes in peripheral blood flow after oral administration of Kampo medicines in mice with betamethasone-induced oketsu syndrome and normal mice were examined using a laser Doppler blood flow meter. The Kampo medicines used were: Toki-shakuyaku-san; Kami-shoyo-san; -bukuryo-gan; Daio-botanpi-to; Tokaku-joki-to; Goshuyu-to; and Hange-koboku-to. In the oketsu mice, blood flow was improved by single-dose administration of Toki-shakuyaku-san, Kami-shoyo-san, -bukuryo-gan, Daio-botanpi-to, Tokaku-joki-to, and Goshuyu-to, but only Toki-shakuyaku-san increased blood flow significantly in normal mice. In addition, blood flow decreased after single-dose administration of -bukuryo-gan, Daio-botanpi-to, and Tokaku-joki-to in normal mice.

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In view of the recent investigation, highly reactive oxygen-derived free radicals may play a role in cerebral ischemia and brain damage, free radical scavenging activity of kampo formulations (Oren-gedoku-to, -bukuryogan, Saiko-ka-ryukotsu-borei-to and Daio-botampi-to) and Kampo components (Ityou, Shini, Menamomi, Arinosudama and Denshiti), used for the attenuation of brain damage, was investigated in vitro. The used experimental system was a radical scavenging action against 1, 1-diphenyl-2-picrylhydrazyl (DPPH), superoxide anion radical (O₂^⨩) and hydroxyl radical (OH^·) by the electron spin resonance technique at room temperature. All kampo formulations and kampo components showed radical scavenging activity in a concentration-dependent manner. This result indicates that kampo formulations, treated for brain damage, were good radical scavenger that could possibly prevent ischemic complications such as formation of brain damage. The intensity of scavenging activity of kampo formulations for three types of radicals were as follows ; 1. DPPH : Daiobotampi-to > Saiko-ka-ryukotsu-borei-to=-bukuryo-gan > Oren-gedoku-to, 2. O₂^⨩ : Daio-botampi-to=-bukuryo-gan > Saiko-ka-ryukotsu-borei-to > Oren-gedoku-to, 3. OH^· : Daio-botampi-to=Saiko-ka-ryukotsu-borei-to > -bukuryo-gan=Oren-gedoku-to. Daio-botampi-to indicated the strongest scavenging activity against three types of radicals. Ischemic brain damage is thought to be an "oketsu" syndrome, which is correlated with abnormalities of the microcirculation. Therefore, Daio-botampi-to, which has been used for "oketsu"syndrome, showed superior free-radical scavenging activity.

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無症候性脳梗塞患者に対する桂枝茯苓丸を主体とした漢方薬の効果を3年間にわたり前向き研究により検討した。対象は富山大学附属病院ならびに関連病院を受診した無症候性脳梗塞患者93名で男性24名，女性69名，平均年齢70.0±0.8才である。桂枝茯苓丸エキスを1年あたり6カ月以上内服した51名をSK群，漢方薬を内服せずに経過を観察した42名をSC群とし，MRI上明らかな無症候性脳梗塞を認めない高齢者44名，平均年齢70.7±0.7才をNS群とした。3群間において，開始時と3年経過後の改訂版長谷川式痴呆スケール，やる気スコア（apathy scale），自己評価式うつ状態スコア（self-rating depression scale）を比較した。また，SK群とSC群においては自覚症状（頭重感，頭痛，めまい，肩凝り）の経過も比較検討した。その結果，3群間の比較では，自己評価式うつ状態スコアにおいて開始時のSK群とSC群は，NS群に比べて有意にスコアが高かった。しかし，3年経過後にはNS群は開始時に比較し有意に上昇したが，SK群は有意に減少した。さらに無症候性脳梗塞にしばしば合併する自覚症状の頭重感において桂枝茯苓丸は有効であった。以上の結果から，無症候性脳梗塞患者の精神症状と自覚症状に対して桂枝茯苓丸が有効である可能性が示唆された。

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The effects of decoctions of four Kanpo-prescriptions (-Ni-Eppi-Ittoh-Ka-Ryoh-Jutsu-Bu, -Ka-Jutsu-Bu-Toh, -Shakuyaku-Tchimo-Toh, and Yokuinin-Toh), which are widely used in Japan for the therapy of rheumatoid arthritis, on macrophage procoagulant activity was investigated. Peritoneal exudate cell of guinea pig was used as a macrophage source. These four decoctions were added to the macrophage suspensions in vitro, and each suspension was incubated for 14 h at 37°C. Macrophage procoagulant activity was measured by the method similar to that of determination of the recalcification time of the plasma. It was found that the decoctions of these four Kanpoprescriptions potentiated remarkably the macrophage procoagulant activity. In addition, we examined similarly the effect on the macrophage procoagulant activity of 18 kinds of crude drug including the constituents of these four prescriptions, and the decoctions of three kinds of crude drug, Byakujutsu, Sohjutsu, and Maoh, had apparent enhancing effect on it. Since every four Kanpo-prescription described above includes Byakujutsu or Maoh, their potentiating activity on macrophage procoagulant activity was dependent on the active substances of Byakujutsu and Maoh.

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漢方薬(柴胡桂枝湯, 十全大補湯, それらに共通する主要構成成分である甘草, 芍薬, 桂皮)の膵におよぼす影響につき検討した. コラゲナーゼを使用して作成したラット遊離膵腺細胞を正常カルシウム(1.8mM)ならびに高カルシウム(6mM)状況下の199培地に培養し, 上記漢方薬を160～320μg/mlの濃度で添加した. 培養1週間後における細胞内DNA量, 蛋白量, LDH量を測定した. これら測定値は高カルシウム状況下で有意に減少したが, 柴胡桂枝湯, 十全大補湯や甘草を添加しておくと有意な減少がなかった. 一方, 正常カルシウム状況下では柴胡桂枝湯十全大補湯, 芍薬や桂皮の添加により上記測定値は減少した. 以上より, 柴胡桂枝湯, 十全大補湯の膵障害におよぼす効果を確認できたが, 正常膵腺細胞に対する影響が認められた点を念頭に置くべきと思われる.

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Chinese medicinal prescriptions were screened for their effects on α-amylase activity in mouse plasma. Daio-kanzo-to, Hange-koboku-to, Saiko-ka-ryukotsu-borei-to, Saiko--kankyo-to and Mao-to changed the activity in isolated mouse plasma greatly and concentration dependently. However, no prescription influenced the elevation of postprandial blood glucose.

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In the present study, the effects on drug oxidations in rat liver microsomes in vitro using 126 Kampo extracts were investigated. Although the effects of inhibition on drug oxidations were dependent on the Kampo extracts and probe reactions studied, most of the Kampo extracts showed inhibitory effects on both N-demethylations of aminopyrine and erythromycin in rat liver microsomes. Among the Kampo extracts studied herein, Daio-kanzo-to exhibited the most remarkable inhibitory effect on both reactions. The Rhei Rhizoma extract inhibited not only aminopyrine and erythromycin N-demethylations, but also phenacetin O-deethylation, 7-ethoxycoumarin O-deethylation, ethanol oxidation and tolbutamide 4-hydroxylation in rat liver microsomes. The Glycyrrhizae Radix extract also showed a remarkable inhibitory effect on phenacetin O-deethylation as well as aminopyrine and erythromycin N-demethylations. In contrast, the Glycyrrhizae Radix extract virtually showed no effect on ethanol oxidation.

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