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中华结直肠疾病电子杂志

中华结直肠疾病电子杂志 ›› 2018, Vol. 07 ›› Issue (05) : 420 -430. doi: 10.3877/cma.j.issn.2095-3224.2018.05.004

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青年专家论坛

伴有合并症的结直肠癌治疗的药物选择
房文通1, 顾艳宏2,†()   
  1. 1. 210029　南京医科大学第一附属医院药学部
    2. 210029　南京医科大学第一附属医院肿瘤科
  • 收稿日期:2017-07-27 出版日期:2018-10-25
  • 通信作者: 顾艳宏
  • 基金资助:
    江苏省药学会Shire生物药学基金(No.S201602); 促进海峡两岸科技合作联合基金(No.U1505229)

Medication options for colorectal cancer with complications

Wentong Fang1, Yanhong Gu2,†()   

  1. 1. Department of Pharmacy, First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China
    2. Department of Oncology, First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China
  • Received:2017-07-27 Published:2018-10-25
  • Corresponding author: Yanhong Gu
  • About author:
    Corresponding author: Gu Yanhong, Email:
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房文通, 顾艳宏. 伴有合并症的结直肠癌治疗的药物选择[J/OL]. 中华结直肠疾病电子杂志, 2018, 07(05): 420-430.

Wentong Fang, Yanhong Gu. Medication options for colorectal cancer with complications[J/OL]. Chinese Journal of Colorectal Diseases(Electronic Edition), 2018, 07(05): 420-430.

结直肠癌是我国及世界范围内最常见的肿瘤之一，结直肠癌合并特殊功能状态或疾病如肝肾功能不全、肝炎、心血管疾病、老年、体弱等的患者并不少见。合并特殊功能状态或疾病的结直肠癌患者的治疗，既要考虑伴随疾病对结直肠癌治疗选择的影响，又要考虑结直肠癌治疗对既有疾病的影响。本文将主要从伴随疾病对结直肠癌治疗药物药动学和药效学的影响方面，系统回顾现有资料，探讨伴有合并症的结直肠癌的治疗选择。

关键词: 结直肠肿瘤, 肾功能不全, 肝功能不全, 心脏毒性, 老年患者

Colorectal cancer (CRC) is one of the most commonly diagnosed cancers in China and worldwide. CRC accompany with other system diseases or insufficiency, such as kidney insufficiency, liver insufficiency, hepatitis, cardiovascular disease, agedness or weakness is not uncommon. Complications may affect the treatment choices of CRC, while CRC therapies also have an effect the complications. We overviewed the effect of complications on pharmacokinetics and pharmacodynamics of drug therapy, and discussed the optimal medication for these patients.

Key words: Colorectal neoplasms, Renal insufficiency, Liver insufficiency, Cardiac toxicity, Elderly patients
表1 不同肾功能状态时卡培他滨及其代谢产物的药动学参数
Ccr 组I 组II 组III 组IV
>80 mL/min 51~80 mL/min 30~50 mL/min <30 mL/min
检测时间 第1天（n=6） 第14天（n=6） 第1天（n=8） 第14天（n=7） 第1天（n=6） 第14天（n=6） 第1天（n=4） 第14天（n=2）
卡培他滨 ? ? ? ? ? ? ? ?
Cmax（μg/mL） 4.63 5.05 3.47 3.80 4.10 3.32 5.07 2.25/2.61
tmax（h） 1.00 1.50 2.03 1.00 2.51 2.00 1.23 2.00/0.48
AUC0-∞（μg.h/mL） 5.95 6.46 5.40 6.13 6.73 7.23 7.06 3.88/3.98
t1/2（h） 0.56 0.37 0.46 0.48 0.48 0.56 0.50 0.50/0.58
5′-DFCR ? ? ? ? ? ? ? ?
Cmax（μg/mL） 5.20 6.26 5.15 5.38 4.65 2.71 6.23 3.37/3.95
tmax（h） 1.03 1.51 2.03 1.07 2.51 2.13 1.54 3.00/1.02
AUC0-∞（μg.h/mL） 11.00 11.40 12.20 12.00 11.40 7.26 11.90 7.40/9.74
t1/2（h） 0.79 0.72 0.80 0.78 0.71 0.74 0.83 0.59/0.92
5′-DFUR ? ? ? ? ? ? ? ?
Cmax（μg/mL） 6.55 11.20 6.22 7.91 7.74 9.02 12.50 12.3/9.79
tmax（h） 1.03 1.51 2.05 2.00 2.98 2.63 1.54 3.00/1.02
AUC0-∞（μg.h/mL） 13.50 18.80 13.40 15.40 18.20 23.20 23.00 22.5/22.7
t1/2（h） 0.72 0.56 0.61 0.58 0.62 0.67 0.68 0.54/0.70
5-FU ? ? ? ? ? ? ? ?
Cmax（μg/mL） 0.42 0.96 0.26 0.58 0.31 0.47 0.54 0.754/0.390
tmax（h） 1.03 1.51 2.03 1.07 2.98 2.63 1.54 3.00/1.02
AUC0-∞（μg.h/mL） 0.80 1.53 0.55 1.09 0.72 1.18 1.01 1.456/0.966
t1/2（h） 0.78 0.60 0.64 0.69 0.65 0.75 0.71 0.58/0.72
FBAL ? ? ? ? ? ? ? ?
Cmax（μg/mL） 7.34 6.55 6.39 7.80 7.76 8.93 11.20 19.6/17.1
tmax（h） 2.57 3.00 3.00 2.00 5.01 4.02 3.50 5.00/3.12
AUC0-∞（μg.h/mL） 37.50 36.50 35.20 44.80 69.50 63.90 133.00 163/NC
t1/2（h） 3.07 3.88 3.38 3.25 4.42 5.45 7.29 8.85/NC
表2 不同肾功能状态时奥沙利铂的药动学参数
Ccr 组I 组II 组III 组IV
≥60 mL/min 40~59 mL/min 20~39 mL/min <20 mL/min
剂量（患者数） 130 mg/m2（n=11） 105 mg/m2（n=3） 130 mg/m2（n=6） 80 mg/m2（n=1） 105 mg/m2（n=2） 130 mg/m2（n=5） 60 mg/m2（n=1）
Cmax（μg/mL） 1.31 0.84 1.31 0.63 1.45 1.39 0.72
AUC0-∞（μg.h/mL） 16.40 32.70 39.70 29.50 42 44.60 32.20
Vss，L/m2 361 224 136 100 99 144 135
CL（L/h/m2） 4.20 1.80 1.74 1.33 1.22 1.61 0.91
0~24小时尿排泄量（%） 36.60 19.90 24.20 18.10 15.60 19 7.13
表3 个案报道中HD患者应用奥沙利铂的药动学参数
? Katsumata等，2008[11] Watayo等，2010[12] Horimatsu等，2011[13] Gori S等，2014[14]
性别 男性 男性 男性 男性
年龄（y） 65 58 50 55
治疗方案 mFOLFOX6 mFOLFOX6 mFOLFOX6 FLOX
剂量（mg/m2） 40 40~50 60~85 42.5
总剂量（mg） 68 68~85 — 85
透析开始时间 用药后30 min 用药后立即 用药后立即 用药后1.5 h
透析时间（h） 3 4 4 3.5
透析流速（mL/min） 200 200 200 220
不同剂量 1 3 3 1
游离铂Cmax（μg/mL） 0.42（40） 0.27（40） 0.50（60） 0.53（42.5）
0.22（40） 0.60（70）
0.39（50） 0.86（85）
游离铂AUC0~48 h（μg/h/mL） Not evaluated 15.6（40） 17.6（60） 19.5（42.5）
12.5（40） 23.6（70）
21.5（50） 32.6（85）
表4 伊立替康在透析患者中的药动学参数
Dose（mg/m2） 透析患者（n=15） 正常患者（n=10） P值
50 60 70 50 60 70 ?
AUC（μg.h/mL） SN-38 0.22±0.07 0.19±0.03 0.17±0.03 0.26±0.11 0.18±0.02 0.22±0.08 NS
SN-38G 3.64±1.21 3.42±0.98 2.73±0.88 0.74±0.53 0.64±0.29 0.62±0.25 <0.01
CPT-11 3.55±1.00 3.74±1.28 2.94±1.11 3.47±1.21 3.28±1.33 3.86±2.00 NS
表5 不同肝功能状态时卡培他滨及其代谢产物的药动学参数
? 肝功能正常患者（n=14） 肝功能不全患者（n=13）
肝功能情况 ? ?
肝功能评分 0~2.0 5.0~9.0
总胆红素（μmol/L） 12.0±5.9 112.0±153.0
AST（IU/L） 39.5±41.9 107.0±34.1
ALT（IU/L） 27.1±15.4 112.0±94.0
AP（IU/L） 231.0±150.0 1 816.0±1 096.0
AUC0-∞ ? ?
Capecitabine 7.25 10.70
5′-DFCR 14.10 9.16
5′-DFUR 11.70 14.00
5-FU 0.53 0.61
FBAL 51.10 63.20
Cmax ? ?
Capecitabine 3.95 5.91
5′-DFCR 5.02 3.53
5′-DFUR 4.64 6.19
5-FU 0.22 0.28
FBAL 6.22 6.74
表6 不同肝功能状态时伊立替康及其代谢产物的药动学参数
? 组I 组II 组III 组IV
胆红素（*ULN） ≤1.0 1.10~1.50 1.51~3.00 ≥3.10
剂量（mg/m2） 350 350 175 200 240 100
患者数 7 3 8 3 5 3
伊立替康 ? ? ? ? ? ?
Cmax（μg/mL） 7.12 6.68 4.59 3.85 4.41 3.14
AUC（μg/h/mL） 25.60 34.20 23.00 24.70 30.10 16.40
Cl（L/h/m2） 12.10 9.80 7.20 7.80 7.20 5.50
Vss（L/m2） 78 83 71 91 71 57
t1/2（h） 6.9 9.0 9.3 10.7 8.9 9.3
尿排泄率（%） 15.7 14.4 12.3 10.2 15.2 13.4
SN-38 ? ? ? ? ? ?
Cmax（μg/mL） 0.041 0.068 0.054 0.063 0.060 0.036
AUC（μg/h/mL） 0.435 0.825 0.609 0.709 0.624 0.358
t1/2（h） 14.0 9.7 15.4 21.7 15.8 16.3
尿排泄率（%） 0.14 0.25 0.16 0.12 0.34 0.25
SN-38G ? ? ? ? ? ?
AUC（μg/h/mL） 2.60 3.29 2.95 2.68 2.70 2.12
t1/2（h） 10.3 16.1 18.5 21.4 17.4 17.1
APC ? ? ? ? ? ?
AUC（μg/h/mL） 8.1 17.0 7.4 6.8 7.1 9.8
t1/2（h） 7.2 10.9 11.4 18.6 10.3 14.5
代谢物比例 ? ? ? ? ? ?
AUC SN-38伊立替康 0.018 0.024 0.027 0.030 0.021 0.023
AUC SN-38-G/SN-38 7.5 3.7 6.9 4.7 6.8 5.6
AUC APC/伊立替康 0.32 0.52 0.34 0.28 0.23 0.65
表7 不同肝功能状态时奥沙利铂的药动学参数
参数 组I 组II 组III 组IV 组V（肝移植组）
胆红素 ≤ULN ≤ULN 1.0~3.0 mg/dL >3.0 mg/dL 任意
AST ≤ULN 1~2.5 ULN >2.5 ULN 任意 任意
AP ≤ULN 1~5 ULN >5 ULN 任意 任意
剂量（mg/m2） 130 130 130 130 60
患者数 11 9 6 3 1
Cmax,（μg.Pt/ml） 1.52 1.32 1.13 1.00 1.17
AUC0-∞（μg.h/ml） 12.4 12.4 11.3 35.2 17.1
Vss（L） 567 406 793 574 217
CL（L/h） 20.7 19.8 22.7 17.2 4.6
初始t1/2（h） 0.22 0.28 0.26 0.26 0.2
终末t1/2（h） 22.8 18.5 24.9 31.7 36.1
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