阿地白介素：Aldesleukin 
中文别名： 阿地白介素、阿地流津、白介素-2、重组人白介素-2
英文别名： Proleukin
生产企业：  
药品类别： 其它抗肿瘤药 
 
药理药动
本品的生物活性作用与天然的人体IL-2相似，能产生淋巴因子(淋巴激活素)，不但有助于调节细胞的正常生长，而且促进免疫系统细胞的分化。
IL-2与具专一性、高度亲合力的细胞表面受体结合，以活化的T细胞表达，此外它还存在于某些淋巴细胞内。IL-2使细胞毒淋巴细胞活化及活化的T细胞分化。IL-2激发免疫效应器细胞，产生各种继发的细胞因子，如γ-干扰素和肿瘤坏死因子(TNF)等。
动物模型实验表明IL-2的抗肿瘤作用与剂量及应用方案有关。对患轻度肿瘤的动物用本品治疗有效。致免疫性和宿主的免疫系统状况影响实验动物接受IL-2治疗的效果。
药动学
IL-2的药代动力学几乎呈线性关系。静脉输注后2h达到与剂量成正比的稳坪状态，一旦停止输注后血药浓度迅速下降。本品主要通过肾脏排泄。
适 应 症
治疗成人(18岁以上)转移性肾细胞癌。
用法用量
转移性肾细胞癌成人患者用本品治疗每个疗程为五天，间歇一段时间重复治疗五天。
成人剂量：每日静脉输注1mg／平方米(体表面积)，连续5天，停药2～6天，再每日静注1mg／平方米，连续5天。间歇3周后再重复。若肿瘤缩小不需重复下个疗程。若肿瘤继续生长，本品治疗最长可达12个月。出现不良反应，应停药而不是减少剂量。
维持量：每日静注1mg／平方米，连续5天。间歇4～5周再如前重复，至多4次。儿童不宜使用。
[制剂与规格]注射用冻于粉针剂。每瓶22或18MIU。
不良反应
最常见的不良反应可能由于血管血液渗漏综合征所引起的包括发热、寒战、体重增加和低血压，但由此引起的死亡率较小。
255例转移性肾细胞癌患者单用本品治疗的因药物引起的死亡率4％(11例／255例)。不良反应的发生率和严重程度一般与剂量及用药方案有关。多数不良反应是暂时和可逆性的，停用本品后2或3天内消除。常见不良反应有心肌梗塞、肠穿孔／梗阻，坏疽。最常见报道的严重不良反应包括低血压、肾功能障碍(尿少或无尿)、呼吸困难或肺充血、精神状态变化(如昏睡、磕睡、意识模糊和焦虑)。其它不良反应包括：心肌缺血、心肌炎、呼吸衰竭、胃肠道出血(需手术)、肠穿孔／肠梗阻、昏迷、癫痫发作、脓毒症和肾功能损害(需透析)。罕见关节痛、腹水、肌痛、甲状腺机能减退、高血糖、低血钙、高血钾。
禁忌症
禁用于孕期及哺乳妇女，严重心脏病、严重的感染、缺氧症、主要器官功能障碍，中枢神经系统转移瘤或癫痫症及自体免疫病患者。
对本品或本品制剂中任何组分发生过敏者、肺功能试验严重异常者、同种器官移植者禁用。
早期治疗使用本品曾发生不良反应者，如持续室性心动过速(＞5次)，心律紊乱不能控制或对处理无效，兼有FCG变化的反复胸痛、心绞痛或心肌梗塞，心包填塞，肾功能障碍需透析72h以上者；昏迷或毒性精神病持续48h以上者；反复发作或难以控制的癫痫者；肠缺血／穿孔，胃肠道出血需手术者禁用。
以下患者慎用：老年人，肾或肝功能不良者，毛细血管渗漏综合征者，严重贫血、白细胞或血小板减少者。
 
有 效 期  3年

Aldesleukin (Proleukin®)

This information is about the use of aldesleukin as a treatment for people with cancer. It's mainly used to treat people with a type of kidney cancer| known as renal cell carcinoma, but is sometimes used to treat other types of cancer.
What is aldesleukin?
Aldesleukin is a protein produced naturally in the body in very small amounts. It is produced by a type of white blood cell called a T-lymphocyte. It works as part of the body’s defence mechanism (immune system) in fighting illness. Aldesleukin can be made commercially as a drug and is used as a treatment for cancer.

It can be used to treat a few different types of cancer, including some kidney tumours and melanoma|. It can be given on its own or in combination with other treatments.

Aldesleukin used to be known as interleukin-2 or IL2.

What it looks like
Aldesleukin is a colourless fluid.

How it is given
Aldesleukin is usually given as an injection under the skin (subcutaneously). It may also be given into a vein (intravenous infusion).

The amount of aldesleukin that occurs naturally in the body is very small, and so aldesleukin treatment greatly increases the amount in the body.

How often it is given
The length of the course of treatment, how often the injections are given and the dosage will vary according to your general health and the type of cancer you have.

Most people have aldesleukin as an outpatient.

How it works
Aldesleukin is given to stimulate the body’s immune system to fight some types of cancer. The exact way in which it works is still not fully understood. However, it can stimulate white cells to recognise and destroy some cancer cells.

Possible side effects
Each person’s reaction to any drug is different. Some people have very few side effects while others may experience more. The side effects described below will not affect everyone taking aldesleukin.

We have outlined the most common side effects but haven't included those that are rare and therefore unlikely to affect you. If you notice any effects that aren't listed here, discuss them with your doctor or nurse.

The side effects of aldesleukin usually disappear once the treatment has finished.

•Flu-like symptoms These can occur quite soon after the drug has been given and make some people feel quite unwell. You may have aching joints or muscles, a high temperature, a lack of energy (lethargy) and chills. If you have these symptoms, it's important to drink plenty of fluids and get plenty of rest. Paracetamol is often prescribed to help reduce these effects.
•Feeling sick (nausea) and being sick (vomiting) Your doctor can prescribe anti-sickness (anti-emetic) drugs to reduce or prevent these effects. If the sickness is not controlled, or if it continues, tell your doctor or nurse. There are other anti-sickness drugs that can be prescribed.
•Loss of appetite A dietitian or specialist nurse at your hospital can give advice.
•Skin changes Aldesleukin may cause your skin to darken or redden. It may become dry and itchy, and peel or blister. Your doctor can prescribe medicine and creams to help. If you already have a skin complaint such as psoriasis, aldesleukin may make it worse.
•Changes in mood or behaviour Let your doctor know if you feel anxious, agitated or confused.
•Tiredness and a general feeling of weakness It's important to allow yourself plenty of time to rest if this happens. Balancing rest periods with gentle exercise such as walking may also help.
•Your kidneys may be affected Your doctors will check how well your kidneys are working with a blood test before and during your course of treatment. In some hospitals you will be asked to measure and record everything you drink and the amount of urine that you pass. You may be given medicine to help you pass urine if you don't pass enough.
•Fluid retention You may put on weight and/or your face, ankles and legs may swell. This improves slowly once your treatment has finished. Sometimes drugs can be given to help to reduce the swelling.
•Anaemia (low number of red blood cells) You may become anaemic while having treatment with aldesleukin. Symptoms include having no energy (lethargy) and feeling tired. Tell your doctor or nurse if you have these symptoms.
•Changes in the way your heart works In some people, aldesleukin can affect how the heart works. The effect on the heart depends on the dose given. Tell your doctor if your heartbeat feels irregular or if you have any chest pain. 
•Low blood pressure The hospital team will check your blood pressure regularly during treatment. It is important to tell your doctor if you feel dizzy or faint.
Always let your doctor or nurse know about any side effects you have. There are usually ways in which they can be controlled or improved.

Additional information
Some patients having aldesleukin treatment have to stay in hospital for close monitoring. This may be necessary if treatment is given at higher doses, when side effects may be more severe.

Some patients give themselves aldesleukin injections at home. If this is the case, you must keep your aldesleukin in the refrigerator.

References
This information has been compiled using information from a number of reliable sources including:

•British National Formulary. 60th edition. 2010. British Medical Association and Royal Pharmaceutical Society of Great Britain.
•electronic Medicines Compendium (eMC). Proleukin. (accessed 30 September 2010).
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原产地英文商品名:
Proleukin
原产地英文药品名:
Aldesleukin
中文参考商品译名:
普诺肯
中文参考化合物名称:
阿地白介素
包装规格: 22000,000IU/瓶
生产厂家英文名:
Chiron Corp

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原产地英文商品名:
PROKINE
原产地英文药品名:
ALDESLEUKIN
中文参考商品译名:
普鲁肯
中文参考化合物名称:
阿地白介素

包装规格: 22兆IU/瓶
生产厂家英文名:
Chiron
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Aldesleukin (IL-2)普留淨注射劑
藥名：Aldesleukin (Human Recombinant Interleukin-2, IL-2)
商品名：Proleukin for Injection 18 x 10^6 IU/vial
中文名：普留淨注射劑
藥品作用：抗癌藥/ 免疫調節劑
給藥方式：僅能以5%葡萄糖溶液稀釋，靜脈輸注15分鐘。
注意事項：需冷藏 (2-8度C)。
粉劑溶解 (Reconstitution):
每小瓶 以 1.2mL 注射用水溶解，勿使用含保藏劑注射用水或 normal saline，可能造成凝集 (aggregation)。輕輕旋動瓶身使溶解，避免劇烈震搖產生過多泡沫產生。
溶解後每 mL含有18 x 106 IU ，可穩定 48小時，但建議於 24小時內用完。
懷孕分級： [C]
健保給付規定
9.13. aldesleukin (如 Proleukin for Injection)：(90/10/1、93/8/1)
限轉移性腎細胞癌及惡性黑色素癌病患使用。

健保藥品給付規定通則
四、注射藥品之使用原則：
(二) 因病情需要，經醫師指導使用方法由病人持回注射之藥品包括：
17. 患者初次使用 aldesleukin (如 Proleukin Inj) 治療期間 (第一療程)，應每週發藥，俾回診觀察是否有無嚴重之副作用發生。第一療程使用若未發生嚴重副作用，在第二療程以後可攜回兩週之處方量。(91/12/1)