部分中文丝裂霉素信息资料（仅供参考）
药品英文名
Mitomycin
药品别名
丝裂霉素C、自力霉素、嘧吡霉素、Mutamycin、Ametycine、MMC、MIT-C、Zilimyclnnm、NSC-26980
药物剂型
1.滴眼剂：0.04%；
2.注射剂(粉)：2mg，4mg，8mg。
药理作用
MMC的抗癌机制主要是烷化作用。它在体内经酶作用，还原为双功能基烷化剂，由两个烷化中心与DNA形成交叉连接，使细胞中DNA解聚，抑制DNA复制，还可以引起DNA的单链断裂。MMC低浓度时，使G1期细胞减少，S期及G2期细胞增加，说明G1期细胞对它最敏感。
药动学
静脉注射，10～20mg/m2，血浆半衰期分别为2～7min和30～45min，迅速进入细胞。动物实验证明，MMC分布以肺、皮肤、肾与肌肉中浓度较高，肿瘤组织次之，脾脏最低。在脑组织中未检出MMC成分。大部分在肝、肾中代谢，经肾小球过滤，由尿中排出，也可从胆汁排出，但浓度比尿中低。
适应证
1.胃肠道癌：如胃、肠、肝、胰腺等癌肿。
2.肺癌、乳腺癌、宫颈癌、绒毛膜上皮癌。
3.恶性淋巴瘤、慢性髓细胞白血病、黑色素瘤、复发性翼状胬肉和抑制新生血管等。
4.癌性胸腔、腹腔积液。
5.在抗青光眼滤过手术中，亦可作为预防术后增殖药物局部应用。
禁忌证
1.水痘或带状疱疹患者。
2.妊娠期及哺乳期妇女。
注意事项
1.老年患者及肾功能不全者慎用。
2.用药前后及用药时应当检查或监测：用药期间应密切随访血常规、血小板及肾功能。
3.本药不可肌内或皮下注射。
4.本药有迟发性、累积性骨髓抑制。
不良反应
1.骨髓抑制为剂量限制性毒性，表现为白细胞和血小板下降，如单用MMC20mg/m2后，白细胞降至最低点，平均为3.5周，持续1～2周；血小板降至最低点的平均时间为4周，持续2～3周，多数患者在8周内恢复。因MMC有蓄积性毒性，后续疗程的骨髓抑制将更明显和持久。可采取支持疗法，促进骨髓功能恢复。治疗中若白细胞低于3×109/L，血小板低于70×109/L时应停药。
2.胃肠反应：部分患者有食欲减退、恶心、呕吐、腹泻、口腔炎，但一般较轻。
3.局部反应：药液漏出血管外，有局部刺激作用，重者可产生组织坏死、静脉炎，因此，注射时可先用生理盐水注射，确认针头在血管内后再注入药液。另外，腔内给药可引起化学性胸膜炎，引起胸痛。可同时注入腔内适量地塞米松及利多卡因，以减轻症状。
4.其他：药疹、脱发、乏力、肝肾功能损害，但一般不严重。
用法用量
1.静脉注射：成人每次4～6mg，用注射用水或生理盐水10～20ml溶解，每周1～2次，40～60mg为1个疗程。还可采用10～30mg，每2～3周1次。也可将药物溶于0.9%氯化钠注射剂200ml静脉滴注(在1h内滴完)。
2.动脉注射：剂量同静脉注射。
3.腔内注射：尽量抽尽积液后注入4～10mg，每5～7天1次，4～6次为1个疗程。
4.也可做膀胱内灌注。
5.口服：每次2～6mg，每天1次，1个疗程80～120mg。
6.玻璃体内注射：每次2μg。
7.点眼：0.04%溶液，每天3或4次，疗程2周。
药物相应作用
1.丝裂霉素与氯喹合用，骨髓抑制作用加重，应注意血象变化。
2.丝裂霉素和利血平、降压灵、氯丙嗪3种药物之一合用，都可使后者作用加强或延长，应注意。
3.与维生素C、维生素B、维生素B6等配伍后静脉应用时，可使本品疗效显著下降
4.与他莫昔芬合用可增加溶血性尿毒症的发生危险。
5.与阿霉素合用可增加心脏毒性。
专家点评
对胃肠道癌，如胃、肠、肝、胰腺等癌肿疗效较好。对肺癌、乳腺癌、宫颈癌、绒毛膜上皮癌也有效。对恶性淋巴瘤、慢性粒细胞白血病也有作用，对骨髓瘤无效。对癌性胸腔、腹腔积液有明显疗效。本品抗瘤谱广，作用迅速，但化疗指数不高，对眼内结构毒性较大，应用时应慎重。
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*有効成分に関する理化学的知見

欧文商標名
MITOMYCIN Injection
一般名
マイトマイシンC　MitomycinC
化学名
（1aS, 8S, 8aR, 8bS）-6-Amino-4, 7-dioxo-8a-methoxy-5-methyl-1, 1a, 2, 8, 8a, 8b-hexahydroazirino［2′, 3′：3, 4］pyrrolo［1, 2-α］indol-8-ylmethyl carbamate
分子式
C15H18N4O5=334.33
化学構造式

 
性状
青紫色の結晶又は結晶性の粉末である。
溶解性
N,N-ジメチルアセトアミドに溶けやすく、水又はメタノールに溶けにくく、エタノール（99.5)に極めて溶けにくい。
安定性
結晶の状態では常温で安定である。
水溶液の状態ではpHによる影響を受けやすく、pH8.0では安定であるが、pH7.0以下ではpH値が低くなるにつれて、その安定性が低下する。
分配係数
logP′OCT=-0.53
（測定法：フラスコシェイキング法 n-オクタノール/pH7.4緩衝溶液）
包装
マイトマイシン注用10mg：10瓶

マイトマイシン注用2mg  10瓶

*製造販売元
協和発酵キリン株式会社
原文处方资料附件：http://www.kegg.jp/medicus-bin/japic_med?japic_code=00049688

MITOMYCIN-C 2 mg POWDER FOR INJECTION
MITOMYCIN-C 10 mg POWDER FOR INJECTION
COMPOSITION:
Each vial of Mitomycin-C 2 mg contains 2 mg of crystalline Mitomycin-C and 48 mg of sodium chloride.
Each vial of Mitomycin-C 10 mg contains 10 mg of crystalline Mitomycin-C and 240 mg of sodium chloride.
PHARMACOLOGICAL CLASSIFICATION:
A 26 –Cytostatic Agents
PHARMACOLOGICAL ACTION:
Mitomycin-C acts as a bifunctional or trifunctional alkylating agent. It inhibits DNA synthesis and cross-links DNA to an extent proportional to its content of guanine and cytosine. Its action is most prominent during the late G1 and early S phases of the cell cycle.
INDICATIONS:
Mitomycin-C is a broad spectrum cytostatic. Used on its own Mitomycin-C may be effective in the treatment of a wide variety of malignant tumours such as breast cancer and gastro-intestinal cancer. It is, however, very often used in combination with other cytostatics particularly in the treatment of gastric and pancreatic cancers. Mitomycin-C has also been reported to have an effect in the treatment of bladder cancer, non-small cell lung cancer, head and neck squamous cell cancer, and colorectal cancer.
CONTRA-INDICATIONS:
Mitomycin-C should not be used in patients suffering from an active infection.
Mitomycin-C is contra-indicated in pregnancy. Safety during lactation has not been established. Patients with a history of hypersensitivity to Mitomycin-C. Use with caution in patients with hepatic disorder, renal disorder, bone marrow suppression or in patients with varicella (fatal systemic disorders may occur). Administration to children and reproducible patients should be carried out considering its potential effects to the gonads.
DOSAGE AND DIRECTIONS FOR USE:

There is limited but increasing evidence and concern that personnel involved in preparation and administration of parenteral antineoplastics may be at some risk because of the potential mutagenicity, teratogenicity, and/or carcinogenicity of these agents although the actual risk is unknown. Cautious handling both in the preparation and disposal of antineoplastic agents is recommended. Precautions include:
*	use of a biological containment cabinet during reconstitution and dilution of parenteral medications and wearing of disposable surgical gloves and masks
*	use of proper technique to prevent contamination of the medication, word area, and operator during transfer between containers (including proper training of personnel in this technique)
*	cautious and proper disposal of needles, syringes, vials, ampoules, and unused medication

As a single cytostatic:
12 - 14 mg/m² once a month or every 35 days by intravenous infusion.
The crystals are dissolved in 200 mL of a 5% glucose solution which is then administered over a period of 30 minutes, preferably with Vitamin B Compound.

In combination therapy:
Mitomycin-C is usually administered along with other agents (e.g. FOAM –5 FU plus oncovin plus adriamycin plus mitomycin; SMF –streptozotocin plus mitomycin plus 5 FU; AM – adriamycin plus mitomycin; FAM –5 FU plus adriamycin plus mitomycin) in a dosage of 10 mg/m² every 6 - 9 weeks. Higher doses have also been given.
Although Mitomycin-C is primarily administered intravenously other methods of administration have been used.
Intra-arterial injection:
Intra-arterial injection is used only when high concentrations of Mitomycin-C are required to attack the tumour. Water, saline or 5% dextrose/water may be used. The vehicle of choice is saline.
Intravesical infusion:
After catheterization with a Nelaton's catheter, 10 to 40 mg, dissolved in 20 - 40 mL of sterile distilled water, is injected for the treatment of bladder tumours.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Haematologic
Prolonged depression of the hemogram may occur. Leukocytopaenia, thrombocytopenia, haemorrhage, anaemia and microangiopathic haemolytic anaemia may occur. Regular full blood counts should be taken, paying special attention to the count of leucocytes and platelets. Treatment should not be repeated until these counts (leucocytes and platelets) return to normal.
Hepatic
Hepatic disorders may occur.
Renal
Since haemolytic uraemic syndrome and proteinuria, haematuria, oedema, and hypertension may occur, monitor the patients carefully by periodical examinations. If any abnormal findings are observed, discontinue administration, or adequate measures should be taken.
Gastrointestinal
Anorexia, nausea and vomiting, and stomatitis may occur.
Hypersensitivity
Hypersensitivity reactions such as rash may occur.
Urinary
Cystitis, haematuria, or atrophy of the bladder caused by bladder instillation therapy may occur.
Respiratory
Interstitial pneumonia and pulmonary fibrosis may occur.
Others
Fever, malaise and alopecia may occur.
Special precautions
To avoid necrosis, phlebitis and thrombosis, intravenous administration should be carried out as slowly as possible, paying careful attention to the injection site and method, lest extravasation occur.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects. Treatment is symptomatic.
IDENTIFICATION:
Bluish-purple crystals.
PRESENTATION:
Individual vials each containing 2 mg or 10 mg.
STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light. The product reconstituted with water, saline or 5% glucose solution is stable at room temperature for 6 hours.
KEEP OUT OF REACH OF CHILDREN.