抗肿瘤药物临床应用的管理.doc

抗肿瘤药物临床应用指导原则
（征求意见稿）
目 录
第一章  抗肿瘤药物临床应用的基本原则..............................................................................................4
一、权衡利弊，最大获益.................................................................................................................4
二、目的明确，治疗有序.................................................................................................................4
三、医患沟通，知情同意.................................................................................................................4
四、治疗适度，规范合理.................................................................................................................4
五、熟知病情，因人而异.................................................................................................................5
六、不良反应，谨慎处理.................................................................................................................5
七、临床试验，积极鼓励.................................................................................................................5
第二章  抗肿瘤药物临床应用的管理.............................................................................................. 6
一、抗肿瘤药物的管理.....................................................................................................................6
（一）分级管理...............................................................................................................................6
（二）使用管理...............................................................................................................................7
（三）配置管理...............................................................................................................................7
（四）人员资质管理.......................................................................................................................8
二、落实与督查.................................................................................................................................8
第三章 各类抗肿瘤药物的适应证和注意事项................................................................................ 9
一、细胞毒类药物.............................................................................................................................9
（一）作用于 DNA 化学结构的药物...............................................................................................9
（二）影响核酸合成的药物.........................................................................................................13
（三）作用于核酸转录的药物.....................................................................................................17
（四）作用于 DNA 复制的拓扑异构酶抑制剂.............................................................................18
（五）主要作用于有丝分裂 M 期干扰微管蛋白合成的药物.....................................................19
（六）其他细胞毒药物.................................................................................................................21
二、激素类药物...............................................................................................................................22
（一）芳香化酶抑制剂.................................................................................................................22
（二）雌激素和抗雌激素.............................................................................................................25
（三）雄激素与抗雄激素.............................................................................................................27
（四）孕激素.................................................................................................................................29
（五）RH-LH 激动剂/拮抗剂........................................................................................................30
三、肿瘤分子靶向和生物治疗.......................................................................................................31
（一）生物反应调节剂.................................................................................................................31
（二）单克隆抗体.........................................................................................................................34
（三）细胞分化诱导剂.................................................................................................................37
（四）细胞凋亡诱导剂.................................................................................................................37
（五）新生血管生成抑制剂.........................................................................................................38

（六）表皮生长因子受体抑制剂.................................................................................................39
（七）基因治疗.............................................................................................................................40
（八）多靶点小分子抑制剂.........................................................................................................40
四、肿瘤治疗辅助药物...................................................................................................................42
（一）造血生长因子.....................................................................................................................42
（二）止吐药.................................................................................................................................47
（三）镇痛药.................................................................................................................................49
（四）抑制破骨细胞药.................................................................................................................52
（五）神经精神用药.....................................................................................................................53
第四章 各类肿瘤的治疗原则........................................................................................................ 57
一、头颈部恶性肿瘤.......................................................................................................................57
（一）鼻咽癌.................................................................................................................................58
（二）鼻腔和鼻旁窦恶性肿瘤.....................................................................................................58
（三）喉癌.....................................................................................................................................59
（四）甲状腺癌.............................................................................................................................62
二、胸部肿瘤...................................................................................................................................63
（一）非小细胞肺癌.....................................................................................................................63
（二）小细胞肺癌.........................................................................................................................67
（三）胸腺肿瘤.............................................................................................................................69
（四）恶性胸膜间皮瘤.................................................................................................................70
三、消化系统肿瘤...........................................................................................................................71
（一）食管癌.................................................................................................................................71
（二）贲门癌.................................................................................................................................73
（三）胃癌.....................................................................................................................................73
（四）结直肠癌.............................................................................................................................75
（五）胆管癌 、胆囊癌...............................................................................................................78
（六）胰腺癌.................................................................................................................................79
（七）肝癌.....................................................................................................................................81
四、乳腺癌...................................................................................................................................... 82
（一）复发转移乳腺癌药物治疗.................................................................................................83
（二）可手术乳腺癌术后抗肿瘤药物治疗.................................................................................85
五、泌尿系统、男生殖系统肿瘤...................................................................................................87
（一）肾上腺肿瘤.........................................................................................................................87
（二）肾脏肿瘤.............................................................................................................................88
（三）尿路上皮癌.........................................................................................................................90
（四）前列腺癌.............................................................................................................................92
（五）阴茎肿瘤.............................................................................................................................96
（六）睾丸肿瘤.............................................................................................................................97
六、妇科肿瘤...................................................................................................................................99
（一）宫颈癌.................................................................................................................................99
（二）卵巢癌...............................................................................................................................100
（三）子宫内膜癌.......................................................................................................................104
（四）外阴癌...............................................................................................................................106

（五）阴道癌...............................................................................................................................107
（六）妊娠滋养细胞肿瘤...........................................................................................................109
七、血液淋巴系统肿瘤.................................................................................................................112
（一）白血病...............................................................................................................................112
（二）恶性淋巴瘤.......................................................................................................................116
（三）多发性骨髓瘤...................................................................................................................135
八、颅脑肿瘤.................................................................................................................................138
（一）胶质瘤...............................................................................................................................138
（二）髓母细胞瘤.......................................................................................................................141
（三）脑转移瘤...........................................................................................................................142
（四）中枢神经系统淋巴瘤.......................................................................................................145
（五）颅内生殖细胞瘤...............................................................................................................147
（六）颈静脉球瘤.......................................................................................................................149
（七）垂体腺瘤...........................................................................................................................151
九、原发恶性骨与软组织肿瘤.....................................................................................................155
（一）骨肉瘤...............................................................................................................................155
（二）尤文氏肉瘤.................................................................................................................160
（三）软组织肉瘤.......................................................................................................................162
《抗肿瘤药物临床应用指导原则》编审专家名单...........................................................................163