目的 采用WHO推荐的HTA方法评价尼妥珠单抗(nimotuzumab,NTZ)治疗晚期鼻咽癌患者的有效性、安全性和经济性,为其临床合理应用提供循证参考。方法 系统检索PubMed、Embase、Cochrane Library、中国知网(CNKI)、万方和中国生物医学文献数据库等,同时检索卫生技术评估(HTA)相关网站与数据库,纳入评价NTZ的Meta分析/系统评价、经济学研究和HTA报告。由2位研究者分别依照纳入和排除标准对文献进行筛选、数据提取与汇总,并交叉核对,最终采用定性描述的方法对结果进行汇总分析。结果 共纳入5篇Meta分析,未检索到药物经济学研究和相关HTA报告。汇总结果显示,与对照组比较,使用NTZ可治疗晚期鼻咽癌,能有效控制疾病发展,延长患者生存时间,改善预后,效果良好,且无严重不良反应。结论 NTZ治疗晚期鼻咽癌具有良好的有效性和安全性,未来可考虑对其开展药物经济学研究, 补充其治疗鼻咽癌的经济性评价证据。
Abstract
OBJECTIVE To evaluate rapidly the effectiveness, safety and economics of nimotuzumab(NTZ)in the treatment of nasopharyngeal carcinoma using the HTA method recommended by WHO and provide evidence-based support for clinical drug use. METHODS Retrieved from PubMed, Embase, Cochrane Library, CNKI, Wanfang database and CBM, etc., health technology assessment(HTA)related website and database were searched systematically to select HTA report, Meta-analysis/systemic evaluation and pharmacoeconomic study about NTZ. According to the inclusion and exclusion criteria, two researchers independently screened the literatures, extracted and summarized the data, then performed qualitative description of results. RESULTS Totally 5 Meta-analysis were retrieved. No pharmacoeconomic studies and related HTA reports were retrieved. RESULTS of the study showed that compared with the control group, NTZ can be used to treat advanced nasopharyngeal carcinoma, effectively control the development of the disease, prolong the survival time of patients, improve the prognosis, with good effect and no serious adverse reactions. CONCLUSION NTZ has favorable efficacy and safety in the treatment of advanced nasopharyngeal carcinoma.In the future, pharmacoeconomic research on NTZ can be considered to supplement the evidence of economic evaluation.
关键词
尼妥珠单抗 /
鼻咽癌 /
有效性 /
安全性 /
经济性 /
快速卫生技术评估
{{custom_keyword}} /
Key words
nimotuzumab /
nasopharyngeal carcinoma /
efficacy /
safety /
economics /
rapid health technology assessment
{{custom_keyword}} /
中图分类号：
R95
{{custom_clc.code}}
({{custom_clc.text}})
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] WANG W Y, TWU C W, CHEN H H, et al.Long-term survival analysis of nasopharyngeal carcinoma by plasma Epstein-Barr virus DNA levels[J]. Cancer, 2013, 119(5): 963-970.
[2] CHEN J, WANG W H, GU J. Systematic review of effectiveness and safety of nedaplatin and cisplatininthe in treatment of advanced nasopharyngeal carcinoma[J]. Chin Pharm J(中国药学杂志), 2016, 51(2): 144-150.
[3] FERLAY J, SOERJOMATARAM I, DIKSHIT R, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012[J]. Int J Cancer, 2015, 136(5):359-386.
[4] CHUA M L, WEE J T, HUI E P, et al. Nasopharyngeal carcinoma[J]. Lancet, 2016, 387:1012-1024.
[5] BRAY F, FERLAY J, SOERJOMATARAM I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA Cancer J Clin, 2018, 68(6): 394-424.
[6] CHEN W, ZHENG R, BAADE P D, et al. Cancer statistics in China, 2015[J]. CA Cancer J Clin, 2016, 66(2):115-132.
[7] YANG Q T. The application of Bayesian meta analysis on the evalution of therapeutic effect of monoclonal anti-EGFR in the treatment of nasopharyngeal carcinoma [D]. Hunan: University of South China, 2016.
[8] WANG H Y, HE D, WANG X J, et al. Progress and recommendations for international and domestic application of health technology assessments [J]. Chin J Health Policy(中国卫生政策研究), 2014, 7(8): 19-23.
[9] TANG H L, MEN P, ZHAI S D. Introducing and exploring the method of rapid review on drugs [J]. Clin Med J(临床药物治疗杂志), 2016, 14(2): 1-4.
[10] SHEA B J, REEVES B C, WELLS G, et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both[J]. BMJ, 2017, 358(8122):440.
[11] HOU Y Y, YANG Y H, FENG B,et al.A systematic review of the effectiveness and safety of nimotuzumab combined with chemotherapy and radiotherapy in the treatment of advanced nasopharyngeal carcinoma [J]. Guid J Health(Med Ed)(健康导报:医学版), 2014, 10(19):10-11.
[12] WANG B, XUE B Q, LIU W, et al. Nimotuzumab plus radiotherapy combined with chemotherapy in the treatment of advanced nasopharyngeal cancer: a Meta analysis [J]. Chin J Pharmacoepidemiol(药物流行病学杂志), 2018, 27(7): 433-441.
[13] LIANG P, ZE L L, CHENG X, et al. The efficacy and safety of anti-epidermal growth factor receptor monoclonal antibodies in nasopharyngeal carcinoma: literature-based Meta-analyses[J]. J Cancer, 2018, 9(23): 4510-4520.
[14] CHENG Y, XIN H X, LU X, et al. Cetuximab versus nimotuzumab for the treatment of advanced nasopharyngeal carcinoma: a network Meta-analysis[J]. J Balk Union Oncol, 2017, 22(4): 1004-1010.
[15] HAN Y R, YU H J. Research progress of nimotuzumab [J]. World Latest Med Inf(世界最新医学信息文摘), 2017, 7(101): 19-31.
[16] YOU R, SUN R, HUA Y J, et al. Cetuximab or nimotuzumab plus intensity-modulated radiotherapy versus cisplatin plus intensity-modulated radiotherapy for stage Ⅱ-Ⅳb nasopharyngeal carcinoma[J]. Int J Cancer, 2017, 141(6): 1265-1276.
[17] WANG F, SUN Q, JIANG C, et al. Additional induction chemotherapy to concurrent chemotherapy and intensity-modulated radiotherapy with or without nimotuzumab in first-line treatment for locoregionally advanced nasopharyngeal carcinoma: a propensity score matched analysis[J]. J Cancer, 2018, 9(3): 594-603.
[18] YOU R, HUA Y J, LIU Y P, et al. Concurrent chemoradiotherapy with or without anti-EGFR-targeted treatment for stage Ⅱ-Ⅳb nasopharyngeal carcinoma: retrospective analysis with a large cohort and long follow-up[J]. Theranostics, 2017, 7(8): 2314-2324.
[19] ZHANG B, TANG P Z. Introduction to "NCCN Clinical Practice Guidelines in Head and Neck Cancer (2009 Chinese Version)" [J]. Chin J Otorhinolaryngol Head Neck Surge(中华耳鼻咽喉头颈外科杂志), 2009, 44(9): 707-709.
[20] CHEN X Z, LI J G, LIN S J, et al. Expert consensus on the treatment of metastasis nasopharyngeal carcinoma [J]. Chin J Radiat Oncol(中华放射肿瘤学杂志), 2018, 27(1): 23-28.
[21] LIU Q H. Clinical Observation of nimotuzumab combined with chemotherapy for advanced malignant tumor[D]. Taian: Taishan Medical University, 2014.
[22] WATTA, CAMERONA, STURML, et al. Rapid reviews versus full systematic reviews:an inventory of current methods and practice in health technology assessment[J]. Int J Technol Assess Health Care, 2008, 24(2): 133-139.
{{custom_fnGroup.title_cn}}
脚注
{{custom_fn.content}}
基金
国家重大新药创制科技重大专项资助(2017zx09101001002002)
{{custom_fund}}
PDF(1312 KB)
