追踪评价新型抗肿瘤药物用药的适宜性、有效性和安全性

Follow-up Evaluation of the Suitability, Efficacy and Safety of New Antineoplastic Drugs

关键词:  新型抗肿瘤药物  追踪评价  合理用药  不良反应

Key words:  new antineoplastic drugs  follow-up evaluation  rational drug use  adverse reactions

摘要:

目的 追踪评价新型抗肿瘤药物用药的适宜性、有效性和安全性，完善药品供应，保障患者用药的可及性和连续性，促进临床合理用药经验的积累。方法 参考药品使用说明书建立新型抗肿瘤药物用前适应证审核标准；参考《新型抗肿瘤药物临床应用指导原则》和药品说明书建立追踪评价标准；采用追踪方法学评价实施新型抗肿瘤药物用前审核制度以来通过审核的患者用药的适宜性、有效性和安全性。结果 2018年度共审核通过41例新型抗肿瘤药物用药患者，适宜性评价结果为3例不符合用药指征，2例不符合给药方法。有效性评价结果为客观有效率53.7%（22/41），疾病控制率80.5%（33/41）；追踪时间截至2020年5月，24例无进展生存期>12个月，占比58.5%（24/41），14例患者死亡，占比34.1%（14/41）。安全性评价结果为7例使用贝伐珠单抗未检测尿常规，4例使用曲妥珠单抗未检查心脏超声；可能由新型抗肿瘤药物引起的不良反应，包括4例使用曲妥珠单抗发生心脏不良反应，2例使用索拉菲尼或奥西替尼发生皮肤及皮下组织不良反应，1例使用贝伐珠单抗发生出血不良反应，不良反应发生率17.1%（7/41）。结论 实施新型抗肿瘤药物用前审核制度可以保障患者用药的可及性和连续性，临床药师应积极实施新型抗肿瘤药物的药物重整、药学监护和用药教育，提高患者用药的适宜性、有效性和安全性。

Abstract:

OBJECTIVE To follow up and evaluate the suitability, effectiveness and safety of new antineoplastic drugs, so as to accumulate experience for improving drug supply, ensuring patient access and continuity of drug use, and promoting clinical rational drug use. METHODS Established the examination standards of pre-use indication of new antineoplastic drugs with reference to the instructions for the use of drugs. With reference to the Guiding Principles for Clinical Application of New Antineoplastic Drugs and Drug Instructions, a follow-up evaluation standard was established. The follow-up methodology was used to evaluate the suitability, effectiveness and safety of patients who had passed the review since the implementation of the pre-use review system of new antineoplastic drugs. RESULTS A total of 41 patients with new antineoplastic drugs were approved in 2018, and the results of suitability evaluation showed that 3 cases did not meet the indication of drug use and 2 cases did not meet the method of administration. The results of effectiveness evaluation showed that the objective response rate was 53.7%(22/41), and the disease control rate was 80.5%(33/41). As of May 2020, 24 patients had a progression-free survival period of more than 12 months, accounting for 58.5%(24/41), and 14 patients died, accounting for 34.1%(14/41). The results of safety evaluation showed that 7 cases did not test urine routine with bevacizumab and 4 cases did not check cardiac ultrasound with trastuzumab. Adverse reactions that may be caused by new antineoplastic drugs include:cardiac adverse reactions in 4 cases with trastuzumab, skin and subcutaneous tissue adverse reactions in 2 cases with sorafenib or oxetinib, and bleeding adverse reactions in 1 case with bevacizumab. The incidence of adverse reactions was 17.1%(7/41). CONCLUSION The implementation of the pre-use review system of new antineoplastic drugs can ensure the accessibility and continuity of drug use for patients. Clinical pharmacists should actively implement drug reorganization, pharmaceutical care and drug use education of new antineoplastic drugs to improve the suitability, effectiveness and safety of drug use for patients.