50．香菇多糖
出处：按学科分类—医药、卫生 军事医学科学出版社《临床常用进口药物手册》第279页（7552字）
【中文释文】：
抗恶性肿瘤药物
香菇多糖是从香菇子实体中提取的经提纯后得到的一种以β-(1→3)结合为主链的高分子葡聚糖，是一种抗肿瘤性多糖体。
在动物实验中证实：香菇多糖和化疗药物合用时，对同系肿瘤及自体肿瘤具有抑制肿瘤增殖作用及延长动物生存期的效果。单独使用时，也有抑制肿瘤增殖作用及延长动物生存期的效果。
临床试验中，与口服呋喃氟尿嘧啶合用时，主要可延长不能手术或复发的胃癌病人的生存期。有关香菇多糖单独用药是否有效这一点迄今为止尚未明确证实。
〔组成〕
香菇多糖1mg系小瓶中含有1mg香菇多糖的冷冻干燥品。
〔作用与效果〕
与口服呋喃氟尿嘧啶合用，主要对不能手术或复发的胃癌病人具有延长生存期的效果。
〔用法与用量〕
通常，成人与口服呋喃氟尿嘧啶600mg／d合用时，香菇多糖每周2mg(1mg每周2次或2mg每周1次)静脉注射或静滴。
注射液的配制法：小瓶中加入日本药典注射用蒸馏水、日本药典生理盐水，日本药典5%或20%葡萄糖注射液2～5ml，用力振荡后使之完全溶解。
〔性状〕
制剂的性状：每一小瓶中含有香菇多糖1mg的白色多孔性固体，经溶解后供注射用。
本剂溶解在注射用蒸馏水、生理盐水、葡萄糖注射液时的pH及其渗透压，如下所示：
表16 香菇多糖溶解于不同溶剂时的pH值及渗透压
有效成分的理化性质
一般名：香菇多糖
分子式：(C6H10O5)n
香菇多糖为白色～淡黄灰白色粉末，无臭或略有特殊气味，无味。
几乎不溶于水、甲醇、乙醇或丙酮中，可溶于0．5mol／L氢氧化钠溶液，具有吸湿性。
〔使用时的注意事项〕
注意：应根据医生的处方或医嘱使用。
贮藏方法：室温保存。
使用期限：应在包装上标记的使用期限内使用。
〔包装〕
香菇多糖1mg：10小瓶
〔使用上的注意事项〕
1．副作用
(1)休克：偶尔会发生休克症状，应密切注意观察，一经发现有口腔内异常感、恶寒、脉搏异常、血压降低、呼吸困难等症状时，应立即停药，并给予适当的处置。
(2)皮肤：有时会出现皮疹或潮红等症状，这时应立即停药并给予适当的处理。
(3)呼吸：有时会产生胸部压迫感、咽狭窄感等症状，应密切注意观察。一旦出现这些症状时，应改用静滴或减慢用药速度以给予适当的处理(在人工呼吸的麻醉狗上，有时会出现轻度的呼吸道阻力上升现象)。
(4)消化道：会出现恶心、呕吐及食欲不振等症状。
(5)中枢神经系统：有时会出现头痛、头重及眩晕等症状。
(6)血液：有时会发生白细胞减少，红细胞减少、血红蛋白减少。
(7)其他：有时会出现发汗、发热、面部潮红及热感等症状。
2．有关小儿用药 对早产儿、新生儿、乳儿及幼儿用药的安全性尚未得到证实(无使用经验)。
3．用药时的注意事项
(1)用药时，注入溶解液后用力振荡，使之完全溶解。溶解后，应立即使用。
(2)本剂溶解在2ml注射用蒸馏水中后，渗透压比在1左右，因此，当使用的溶剂量超过2ml时，考虑到渗透压的关系，应尽量使用生理盐水液或5%的葡萄糖注射液。
(3)由于和维生素A剂混合注射时会产生混浊，原则上应避免合用。
〔生产厂家〕
日本国味之素株式会社
(附本品别名：瘤停能，香菇糖)
【外文释文】：
Anticancer Drug
Introduction
Lentinan is an antitumor polysaccharide that is extracted and purified from the fruit body of Lentinus edodes．Lentinan is a macromolecular glucan，β-1，3-glucan．Experimental studies have demonstrated that against various experimental tumors，lentinan prolongs life and reduces tumor size．Its mode of action is characterized not by direct cytotoxic effect but by host-mediated activation of host defense factors．Clinical studies have shown that lentinan in combination with oral tegafur enhances the reduction of tumor size，and prolongs life in patients with inoperable or recurrent gastric cancers．The incidence of side effects considered attributable to lentinan was 6．8%(32／469 patients)．
Indications
Lentinan，in combination with oral tegafur，is indicated in the treatment of patients with inoperable or recurrent gastric cancer to prolong survival．
Preparation of injection use
To each vial of lentinan，add 2ml to 5ml of distilled water for injection JP，isotonic sodium chloride solution JP，or 5%or 20%glucose injection，and shake vigorously to dissolve well．
Dosage and adminisiration
The usual adult dosage of lentinan is 2 mg per week(1 mg twice weekly or 2 mg once weekly)administered by intravenous injection or intravenous drip infusion．It is given in combination with oral tegafur 600mg／day(400mg／m2／day)．
Composition and description
Lentinan(Ajinomoto)1mg is a white porous solid，and in each vial contains 1mg of lentinan．It is a preparation for injection，which is dissolved before use．When it is dissolved in distilled water for injection，isotonic sodium chloride solution，and glucose injection，lentinan gives the following pH and osmotic pressure ratios．
Table 16
Physicochemical properties of the active ingredient
Generic name：lentinan
Molecular formula：(C6H10O5)n
Description：lentinan is a white to yellow-grayish white powder．It has no odor or slightly peculiar odor，and it is tasteless．
Lentinan is practically insoluble in water，methanol，ethanol，or acetone，but it dissolves in 0．5 mol／L sodium hydroxide solution．It is hygroscopic．
Precautions in use
The drug should be used according to prescription or instruction from physicians．
Storage：Store at room temperature．
Expiration date：The drug is to be used before the expiration date labeled on the package．
Package
lentinan(Ajinomoto)1mg 10 vials
Precautions
1．Adverse reactions
(1)Shock：Patients should be closely observed，since shock may occur rarely．Whensymptoms or signs including abnormalities in puse or oral cavity，chill，lowered blood pressure and dyspnea develop，drug administration should be immediately discontinued，and appropriate measures should be taken．
(2)Skin：Eruption and erythema may cocur occasionally．When these symptons develop，appropriate measures，such as discontinuation of drug administration，should be taken．
(3)Respiraory system：Since symptons，such as a feeling of pressure in the chest or a feeling of squeezing on the pharynx，may occur occasionally，patients should be closely observed，When such symptoms devbelop，oppropriate measures，such as changing the administration method to an intravenous drip infusion of reducing the injection rate，should be taken．(Dogs under artificial respiration may reveal a slight increase in airway resistance．)
(4)Gastrointestinal tract：Symptoms，such as mausea and vomiting and anorexia，may occur．
(5)Central nervous system：Headache，feeling of heaviness in the head and dizziness may occur occasionally．
(6)Blood：Leukopenia，oligocythemia，and oligochromemia may occur occasionally．
(7)Miscellaneous：Symptoms，such as sweating，fever，facial flushing of hot sensation，may occur occasionally and symptoms，such as transient backache or lower backache may occur rarely．
2．Administration to children
Safety in immature infants，newborns，infants，and young children has not been established，as the drug has not been administered to these groups．
3．Dosage instructions
(1)Each vial that has been injected with dissolvent should be shaken vigorously before use to dissolve the drug completely．The solution should be used as soon as possible after preparation．
(2)A solution made with 2 ml of distilled water for injection has an osmotic pressure of approsimately 1．Therefore，if the volume of the dissolvent is greater than 2 ml，isotonic sodium chloride solution or 5%glucose injection is preferable to obtain an appropriate osmotic pressure．
(3)In principle，mixing LENTUNAN injection with vitamin A preparations should be avoided because of turbidity．
Manufacturer
Ajinomoto Co．，Inc．
14-1 Kyobashil-chome，Chuo-ku，Tokyo，Japan，