英文商品名: GLYSET

英文药品名: MIGLITOL

中文参考药品译名: 米格列醇

规格

GLYSET 50MG/TAB 100TABS/BOTTLE 、GLYSET 25MG/TAB 100TABS/BOTTLE 、GLYSET 100MG/TAB 100TABS/BOTTLE

分类名称

一级分类：内分泌系统药物 二级分类：糖尿病及胰岛疾病用药物

药品英文名

Miglitol

药品别名

德赛天、米格尼醇、Glyset

药物剂型

米格列醇片：25mg/片；50mg/片；100mg/片。15～30℃保存。

药理作用

本品为第二代糖苷酶抑制药。本品为小分子化合物，其结构与葡萄糖相似。在食物的消化过程中，α-葡萄糖苷酶(包括麦芽糖酶、异麦芽糖酶、蔗糖酶、葡萄糖淀粉酶等)可以将食物中的多糖及低聚糖水解为单糖(包括葡萄糖)。α-糖苷酶抑制药可延缓葡萄糖的生成及吸收，从而缓解糖尿病患者餐后高血糖及其后血糖的急剧变化。本品主要作用于小肠，对结肠内碳水化合物水解影响较小，由未吸收的糖类发酵继发的胃肠道不良反应较阿卡波糖少见。

药动学

本品较阿卡波糖更易在小肠吸收，口服给药的吸收程度随剂量增加而降低。口服25mg药物的生物利用度为100%，口服100mg药物的生物利用度约50%～70%，在更高剂量时吸收可达饱和。其蛋白结合率低于4%，分布容积为0.18L/kg。较少在体内代谢，超过95%以原形自尿液排泄，剂量超过25mg时，由于吸收不完全，可有少量药物经尿液重吸收。本品半衰期为2h。

适应证

用于治疗成人2型糖尿病。

禁忌证

以下患者禁用。
1.对本品过敏者。
2.糖尿病酮症酸中毒者。
3.消化或吸收不良的慢性肠道疾病患者。
4.炎性肠病或其他使肠道产气增加的疾病。
5.肠梗阻。
6.本品不宜用于儿童。

注意事项

1.本品宜在每次正餐开始时服用。
2.发生低血糖时，宜口服葡萄糖，不宜服用蔗糖，因本品可延迟蔗糖吸收。
3.在创伤、发热、感染、手术等应激情况下，本品可能对降低血糖无效，必要时应使用胰岛素。
4.本品妊娠安全性分级为B级。
5.本品排泄至乳汁的浓度很低，对新生儿几乎没有影响的可能，但仍建议哺乳期妇女停止用药。
6.用药期间定期监测血糖，在开始治疗时，应监测餐后1h血糖水平。定期监测HbAlc。
7.慎用：血清肌酸酐浓度高于2mg/dl患者慎用。

不良反应

1.代谢/内分泌系统：本品可影响糖原代谢，可能抑制肝糖原分解，空腹用药过量可能发生低血糖。根据本品的作用机制，空腹或餐后单独使用时都不应引起低血糖，但与磺酰脲类药物或胰岛素联用，可能导致血糖浓度进一步降低，增加了发生低血糖症的可能。2.消化系统：常见胃肠道反应，腹痛、腹泻、胃肠胀气的发生率可能与剂量正相关，继续治疗时，腹痛、腹泻多可缓解。3.血液：有血清铁浓度降低、贫血的报道。4.皮肤：皮疹多为一过性。

用法用量

口服给药，用于2型糖尿病，可单用或与磺酰脲类降糖药合用。起始剂量为每次25mg，3次/d，个别患者起始时需从1次/d逐渐增加至3次/d。4～8周后可增量至每次50mg，3次/d，服用3个月。在此期间，应测定糖化血红蛋白(HbAlc)以确定是否需加量至每次100mg，3次/d(最大推荐量)。有研究认为，在25～200mg范围内，疗效随剂量相应增加，但胃肠道不良反应也相应增加。单独使用本品的最佳剂量范围为每次50～100mg，3次/d。

药物相应作用

1.与活性炭等肠道吸附剂合用，本品疗效降低，两者应避免合用。
2.与含淀粉酶、胰酶等可分解糖类的助消化酶剂合用，本品疗效降低，应避免合用。
3.本品可能使地高辛的血药浓度降低，两者合用时应注意监测地高辛血药浓度。
4.本品可使格列本脲的血药浓度峰值及药时曲线下面积轻微降低，但该变化无显著临床意义。此外，本品与磺酰脲类降糖药合用，发生低血糖的风险增加，应引起注意。
5.本品可使雷尼替丁的生物利用度降低约60%，两者合用时应注意观察雷尼替丁疗效。未见本品与抗酸药、华法林、硝苯地平有明显相互作用。

Generic Name: miglitol (Oral route)

USES:

Miglitol is used along with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes (non-insulin-dependent diabetes). Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Miglitol works by slowing the absorption of carbohydrates from your diet, so that your blood sugar does not rise as much after a meal.

HOW TO USE:

Take this medication by mouth, usually 3 times daily with the first bite of a meal, or as directed by your doctor. The dosage is based on your medical condition and response to therapy.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day.

SIDE EFFECTS:

Diarrhea, gas, upset stomach, or stomach pain may occur in the first few weeks of treatment as your body adjusts to this medication but usually improve with time. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Miglitol does not cause low blood sugar (hypoglycemia). However, this effect can occur if you also take other anti-diabetic drugs (e.g., sulfonylureas, insulin) and if you do not consume enough calories (from food, juices, fruit, etc.). The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, rapid heart rate, weakness, headache, fainting, tingling of the hands or feet, or hunger. Do not use table sugar or drink non-diet soda to relieve these symptoms because miglitol delays the breakdown of table sugar. Carry glucose tablets or gel with you to treat low blood sugar. If you are in a situation where you don't have these reliable forms of glucose, eat some honey or drink a glass of orange juice to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule and do not skip meals.

Check with your doctor or pharmacist about what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your medication dosage may need to be increased or you may need other drugs.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.