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目的调查淋巴瘤患者同意或拒绝参加临床试验的原因,制定干预对策,以提高参与率。方法结合文献自制淋巴瘤患者对临床试验同意及拒绝调查问卷,于2014年12月—2015年8月在中山大学肿瘤防治中心内科住院部患者展开调查。结果共有331例淋巴瘤患者完整回答问卷,177例受访者表示愿意参加临床试验,排前5位的理由包括:希望尝试新药,更早接受新的治疗方法(100%);对医院信任(96.6%);对医生信任,相信医生的建议(96.0%);临床试验的效果可能比常规治疗更好(76.3%);想得到更精细的管理和监测(72.3%)。154例不愿意参加临床试验,其排前5位理由是:对临床试验缺乏了解,不愿尝试(94.2%);担心临床试验药物不良反应、安全性(93.5%);担心药物的有效性(81.8%);认为相关法律法规不完善,权利得不到保障(76.6%);认为自己的病情不需要临床试验治疗(60.4%)。结论淋巴瘤患者拒绝参加临床试验的主要原因是不了解、不敢轻易尝试,担心药物不良反应、安全性,故有必要制定护理对策,提高大众对临床试验知识的普及,提高患者对临床试验的参与率。
Objective To investigate the reasons why patients with lymphoma agree or refuse to participate in clinical trials and formulate intervention strategies to increase the participation rate. Methods Patients with self-made lymphomas in the literature were informed about the clinical trial and rejected the questionnaire. From December 2014 to August 2015, patients with in-patient inpatient department of Sun Yat-sen University Cancer Center were investigated. Results A total of 331 lymphoma patients answered the questionnaire completely. 177 respondents indicated their willingness to participate in the clinical trials. The top 5 reasons include: hoping to try new drugs and accept new treatment earlier (100%); trust in the hospital 96.6%); trusting doctors, believing in doctor’s advice (96.0%); clinical trials may be better than conventional treatment (76.3%); and finer management and monitoring (72.3%). 154 were unwilling to participate in clinical trials, the top five reasons are: lack of understanding of clinical trials, reluctant to try (94.2%); fear of adverse drug reactions to clinical trials, safety (93.5%); concerned about the effectiveness of the drug 81.8%). They found that the relevant laws and regulations are imperfect and their rights are not protected (76.6%). They think that their condition does not require clinical trial treatment (60.4%). Conclusion The main reason for patients refusing to participate in clinical trials of lymphoma is that they do not understand and can not easily try and worry about adverse drug reactions and safety. Therefore, it is necessary to formulate nursing countermeasures to improve the popularization of clinical trial knowledge and to improve the clinical trial of patients Participation Rate.