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 详细处方信息以本药内容附件PDF文件（20122117333828.PDF,20122117332913.pdf）的“原文Priscribing Information”为准
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部分中文伏格列波处方资料（仅供参考）

英文药名: Basen (Voglibose Tablets)

中文药名: 伏格列波糖片

药品类别: 胰岛素及其他影响血糖药

药理毒理
本品为口服降血糖药，其降血糖作用的机理是抑制小肠壁细胞a －葡萄糖苷酶的活性，延缓摄入的碳水化合物的降解，从而使餐后血糖水平降低。

药代动力学
据国外研究资料报道，健康成人男子，1次0.2mg，1日3次，连续服药7天，血浆及尿中没有检测出伏格列波糖。健康成人男子，单次服用2mg时，血浆及尿中没有检测出伏格列波糖。

适应症
改善糖尿病餐后高血糖。(本品适用于患者接受饮食疗法·运动疗法没有得到明显效果时，或者患者除饮食疗法·运动疗法外还用口服降血糖药物或胰岛素制剂而没有得到明显效果时。)

用法用量
通常成人1次0.2mg(1次1片)，1日3次餐前口服。疗效不明显时，经充分观察可以将每次用量增至0.3mg(1次1.5片)。

不良反应
据国外文献资料，在服用1日0.6mg或0.9mg的965例中有154例(16.0%)、上市后的使用结果调查（1997年8月为止）的2,855例中有316例（11.1%）出现了包括临床检查异常值在内的副作用。
以下的副作用是上述调查或自发报告等可看到的。
1.严重的副作用
1)与其它糖尿病药物并用时有时出现低血糖(不到0.1～ 5%)。另外，也有报告不并用其它糖尿病药物也偶见低血糖(不到0.1%)。本品可延迟双糖类的消化·吸收，如出现低血糖症状时不应给予蔗糖而应给予葡萄糖进行适当处理。
2)有时出现腹部胀满、肠排气增加(不到0.1～ 5%)等，由于肠内气体等的增加，偶尔出现肠梗阻样症状(不到0.1%)，应充分进行观察，出现症状应进行停药等适当处理。
3)偶尔出现伴随黄疸、GOT、GPT上升等的严重肝功能障碍（不到0.1%），另外，有报导，因同类药物（阿卡波糖）有过暴发性肝炎(不到0.1%)，故应充分观察，出现异常时应进行停止给药等适当处理。
4)严重肝硬化病例给药时，因伴随以便秘等为契机的高氨血症恶化、意识障碍（频率不明），所以应充分观察排便等状况，发现异常应立即进行停止给药等适当处理。
2.其它副作用
1）消化系统：腹泻、软便、腹鸣、腹痛、便秘、食欲不振、恶心、呕吐、烧心(发生率在0.1～ 5%以下)口腔炎、口渴、味觉异常(0.1%以下)
2）过敏症注1)：皮疹、瘙痒(发生率在0.1%以下)
3）肝 脏：GOT、GPT、LDH、g -GTP、ALP上升(发生率在0.1～ 5%以下)
4）精神神经系统：头痛、眩晕、蹒跚、困倦(发生率在0.1%以下)
5）其 它：麻痹、颜面等浮肿、朦胧眼、发热感、倦怠感、乏力感、高钾血症、血清淀粉酶上升、高密度脂蛋白降低、发汗、脱毛(发生率在0.1～ 5%以下) 注1)出现这些情况时，应停止用药.

禁忌症
下述患者禁止用药
1．严重酮体症、糖尿病昏迷或昏迷前的患者。因必须用输液及胰岛素迅速调节高血糖，所以不适于服用本品。
2．严重感染的患者、手术前后的患者或严重创伤的患者。因有必要通过注射胰岛素调节血糖，所以不适于服用本品。
3．对本品的成分有过敏史的患者。

注意事项
1．下述患者应慎重用药
1)正在服用其它糖尿病药物的患者（同时服用本品有可能引起低血糖）
2)有腹部手术史或肠梗阻史的患者（因服用本品可能使肠内气体增加，易出现肠梗阻样症状。）
3)伴有消化和吸收障碍的慢性肠道疾病的患者（因本品有引起消化道副作用的可能性，有可能使病情恶化。）
4)勒姆里尔德(Roem-held)综合征、重度疝、大肠狭窄和溃疡等患者。（因服用本品可能使肠内气体增加，有可能使病情恶化。）
5)严重肝障碍的患者（因代谢状态的变化，有可能诱发血糖控制状况的显著变化，另外，在严重肝硬化病例中，有可能出现高血氨症恶化同时伴随意识障碍。）
6)严重肾障碍的患者（因代谢状态的变化，有可能诱发血糖控制状况的显著变化。）
2．一般注意事项
1)本品只用于已明确诊断为糖尿病的患者，必须注意除糖尿病外的葡萄糖耐量异常和尿糖阳性等也会出现糖尿病样症状（肾性糖尿、老年性糖代谢异常、甲状腺功能异常等）。
2)对只进行糖尿病基本治疗即饮食疗法运动疗法的患者，仅限于餐后2小时血糖值在200mg/dl（11.1mmol/L）以上。
3)除饮食疗法和运动疗法外，对并用口服降糖药或胰岛素制剂的患者，服用本品的指标为空腹时血糖值在140mg/dl(7.8mmol/L)以上。
4)服用本药期间必须定期监测血糖值并注意观察，充分注意持续用药的必要性。假如用药2～3月后，控制餐后血糖的效果不满意（餐后2小时静脉血浆的血糖值不能控制在200mg/dl（11.1mmol/L）以下），必须考虑换用其他更合适的治疗方法。 另外，餐后血糖得到充分控制（静脉血浆中餐后2小时血糖值降到160mg/dl（8.9mmol/L）以下）、饮食疗法和运动疗法或并用口服降糖药或胰岛素制剂就能够充分控制血糖时，应停止服用本品并注意观察。
5)在使用本品时，应向患者充分说明低血糖症状及其处理方法。

孕妇及哺乳期妇女用药
孕妇、产妇和哺乳期妇女应慎重用药，因有关妊娠期用药的安全性尚未确立，孕妇或有可能妊娠的妇女，只有在判定治疗上的有益性大于危险性时才可用药。虽然尽可能避免哺乳期妇女用药，但当不得不用药时应避免哺乳。

儿童用药
对儿童用药的安全性尚未确立。

老年患者用药
老年人通常生理机能下降，应从小剂量开始用药并留意观察血糖值及消化系统症状等的发生，同时应慎重用药。

药物相互作用
合并用药注意事项
1．并用糖尿病药物（如磺酰胺类及磺酰脲类药物、双胍类药物、胰岛素制剂、胰岛素增敏剂）时： 和胰岛素及磺酰脲类药物并用时，因有出现低血糖的报告，所以与上列的药物并用时，应考虑发生低血糖的可能性，慎重地从低剂量开始给药。
2．并用糖尿病药物及增强或降低其降糖作用的药物时：
1）增强糖尿病药物降血糖作用的药物(β-阻滞剂、水杨酸制剂、单胺氧化酶抑制剂、氯贝特(fibrate)类高脂血症治疗剂、华法林等。)
2）降低糖尿病药物降糖作用的药物(肾上腺素、肾上腺素皮质激素、甲状腺激素等。) 上列药物在与本品并用时，应留意并用糖尿病药物注意项记载的相互作用，同时也应充分注意由于本品糖吸收延迟作用的影响。 

Voglibose (BASEN®) for the prevention of type 2 diabetes mellitus:
A Randomized, Double-blind Trial in Japanese Subjects with Impaired Glucose Tolerance
--- Data Presented at The 51st Annual Meeting of the Japan Diabetes Society ---

May 26, 2008, Osaka, Japan --- Takeda Pharmaceutical Company Limited (“Takeda”) today announced that, on May 24 at the 51st Annual Meeting of the Japan Diabetes Society, the data from a phase 3 clinical study to evaluate the effects of BASEN® (generic name: voglibose) on prevention of onset of type 2 diabetes mellitus in subjects with impaired glucose tolerance (“IGT”) was presented. The data represents the first clinical evidence with Japanese subjects that showed preventive effects by medicinal treatment of type 2 diabetes, when being added on the dietary treatment and/or exercise therapy.

BASEN was launched in 1994 in Japan as an improving agent for postprandial hyperglycemia in diabetes mellitus. Based on the data presented this time, Takeda submitted on December 18, 2007 an application to the Ministry of Health, Labour and Welfare in Japan for an additional indication of “BASEN® Tablets 0.2” and “BASEN® OD Tablets 0.2” for prevention of onset of type 2 diabetes in patients with IGT.

IGT is defined by WHO (World Health Organization) as “a state of higher than normal blood (or plasma) glucose concentration; fasting plasma glucose < 126 mg/dL and 2 hour post 75g oral glucose tolerance test of <6.9 mmol/L and 2-h OGTT 7.8 to 11.0mmol/L”. In the subjects with IGT, the risk of both the onset of type 2 diabetes and cardiovascular diseases is increased, and the dietary treatment and/or exercise therapy is conducted, however, there are cases in which sufficient effect has not been obtained. This phase 3 study conducted with BASEN was the first one with Japanese subjects to evaluate the preventive effect of the medicinal therapy for onset of type 2 diabetes though such clinical studies have been conducted with Western subjects.

“The number of patients with diabetes is notably increasing in Japan, and the necessity of managing diabetic complications is becoming an important social issue,” said Dr. Ryuzo Kawamori, Professor, Juntendo University Graduate School, who presented this data at the 51st Annual Meeting of the Japan Diabetes Society. “IGT increases a risk for onset of diabetes and cardiovascular diseases, and this data includes the first clinical evidence with Japanese subjects with IGT with risk factors such as hypertension and dyslipidemia, and showed preventive effects by medicinal treatment of type 2 diabetes, when being added on the dietary treatment and/or exercise therapy. It is meaningful to obtain this clinical evidence since BASEN, as an improving agent for postprandial hyperglycemia, is suitable for Japanese people whose IGT onset is mainly due to early stage insulin secretory deficiency.”

• A randomized, multi-centric (103 medical institutions), double-blind study
• Population: subjects with IGT as defined by the WHO, who had at least one of the following risk factors;
  1. hypertension
  2. dyslipidemia
  3. obesity (BMI>=25)
  4. a family history of diabetes
• Number of subjects: 1,778 consisting of two arms, one with voglibose (0.6mg, t.i.d.) and another with placebo (t.i.d.). Duration of treatment: medium 337 days under dietary treatment and/or exercise therapy 

Primary endpoint (Onset of type 2 diabetes)
placebo arm: 106 among 881 cases
voglibose arm: 50 among 897 cases 
  (40.5% decrease, statistically significant difference, p=0.0014)

Secondary endpoint (Achivement of normalization of oral glucose tolerance test)
placebo arm: 454 among 881 cases
voglibose arm: 599 among 897 cases 
  (53.9% increase, statistically significant difference, p<0.0001)

Safety
Adverse events such as diarrhea and flatulence were seen more frequently in voglibose arm than place arm. However, the overall safety profile shown in voglibose arm is comparable to the results which have been obtained with patients with diabetes, and no severe cases were found.

INDICATIONS
Improvement of postprandial hyperglycemia in diabetes mellitus. (However, BASEN® Tablets should be used only when sufficient effect has not been obtained in patients already undergoing dietary treatment and/or exercise therapy, or when sufficient effect has not been obtained in patients who have been using oral hypoglycemic drugs or insulin preparations, in addition to dietary treatment and/or exercise therapy.)

DOSAGE AND ADMINISTRATION
Usually, for adults, BASEN® Tablets are orally administered in a single dose of 0.2 mg as voglibose, three times a day, just before each meal. If the effect is not sufficient enough, the single dose may be increased up to 0.3 mg, under close observation of the course of disease.

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 详细处方信息以本药内容附件PDF文件（20122117333828.PDF,20122117332913.pdf）的“原文Priscribing Information”为准
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