The efficacy, safety and cost-minimization analysis of different doses of pegylated recombinant human granulocyte-colony stimulating factor
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摘要:
目的 探讨不同剂量聚乙二醇化重组人粒细胞刺激因子（pegylated recombinant human granulocyte-colony stimulating factor，PEG-rhG-CSF）的临床疗效、安全性与经济性，为临床用药提供参考。 方法 收集2017年1月―2018年12月在中国科学技术大学附属第一医院（安徽省立医院）化疗后发生IV度骨髓抑制的恶性肿瘤患者106例。按给药剂量不同分为两组，A组（PEG-rhG-CSF 3 mg）64例，B组（PEG-rhG-CSF 6 mg）42例，比较用药前后的临床疗效、不良反应，计算治疗成本，对两组治疗方案进行药物经济学最小成本分析。 结果 A组（PEG-rhG-CSF 3 mg）和B组（PEG-rhG-CSF 6 mg）的临床疗效和不良反应比较，差异无统计学意义（均有P>0.05）。A组和B组治疗方案的成本分别为1 705元和3 410元，A组（PEG-rhG-CSF 3 mg）治疗方案更经济。 结论 考虑到药物的有效性和经济学，A组（PEG-rhG-CSF 3 mg）治疗方案是治疗IV度骨髓抑制的最佳治疗方案。 -
关键词:
- 聚乙二醇化重组人粒细胞刺激因子 /
- 骨髓抑制 /
- 安全性 /
- 有效性 /
- 最小成本分析
Abstract:Objective To evaluate the efficacy, safety and economics of myelosuppression treated by different doses of pegylated recombinant human granulocyte-colony stimulating factor(PEG-rhG-CSF), so as to provide reference for clinical use. Methods 106 patients with grade IV myelosuppression after chemotherapy from January 2017 to December 2018 were collected. According to different doses, patients were divided into two groups: 64 cases in group A (PEG-rhG-CSF 3 mg) and 42 cases in group B (PEG-rhG-CSF 6 mg). Clinical efficacy and adverse reactions were compared, and treatment cost was calculated so that cost-minimization analysis in pharmacoeconomic was compared between the two groups. Results There was no significant difference in clinical efficacy and adverse reactions between group A and group B (all P>0.05). The cost of these two regimens was RMB 1 705 for group A and RMB 3 410 for group B. The regimen in group A was more economical. Conclusions The regimen in group A(PEG-rhG-CSF 3 mg)is the proper option for grade IV myelosuppression in China, considering the efficacy, safety, and cost-minimization analysis of the drug. -
Key words:
- PEG-rhG-CSF /
- Myelosuppression /
- Safety /
- Efficacy /
- Cost-minimization analysis
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表 1 两种不同剂量给药方案的病例资料
[n (%)] Table 1. Patient characteristics in two different dosing regimens
[n (%)] 项目 PEG-rhG-CSF χ2值 P值 A组 B组 年龄(岁) 0.389 0.533 ≤60 39(60.9) 21(50.0) > 60 25(39.1) 21(50.0) ECOG评分(分) -a 0.878 0 43(67.2) 30(71.4) 1 18(28.1) 10(23.8) 2 3(4.7) 2(4.8) 肿瘤类型 8.284 0.082 淋巴瘤 13(20.3) 10(23.8) 肺癌 19(29.7) 11(26.2) 消化道肿瘤 17(26.5) 10(23.8) 妇科肿瘤 4(6.3) 9(21.4) 乳腺癌 11(17.2) 2(4.8) 合计 64 42 注：a表示Fisher's确切概率法 
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表 2 两种不同剂量给药方案的临床疗效
[n (%)] Table 2. The recovery of WBC and ANC in two different dosing regimens
[n (%)] 类别 PEG-rhG-CSF PEG-rhG-CSF A组 B组 A组 B组 正常 42(65.6) 35(83.3) 57(89.1) 40(95.2) 1度 18(28.1) 2(4.8) 2(3.1) 1(2.4) 2度 2(3.1) 4(9.5) 3(4.6) 0(0.0) 3度 1(1.6) 1(2.4) 1(1.6) 1(2.4) 4度 1(1.6) 0(0.0) 1(1.6) 0(0.0) 合计 64(100.0) 42(100.0) 64(100.0) 42(100.0) Z值 -1.658 -1.116 P值 0.097 0.265
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表 3 两种不同剂量给药方案的不良反应发生情况
Table 3. Adverse reactions in two different dosing regimens
组别 总例数(例) 不良反应发生例数(例) 发生率(%) χ2值 P值 A组 64 10 15.63 1.110 0.292 B组 42 10 23.80
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表 4 两种不同剂量给药方案最小成本分析结果
Table 4. Cost-minimization analysis in two different dosing regimens
组别 例数(例) 成本(元/人) A组 64 1 705 B组 42 3 410
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表 5 两种不同剂量给药方案敏感度分析结果
Table 5. Sensitivity analysis in two different dosing regimens
组别 例数(例) 成本(元/人) A组 64 1 534.5 B组 42 3 069.0
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