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331例淋巴瘤患者参加临床试验意愿分析及对策

         

摘要

Objective To analyze the reasons for intention to participate in clinical trial or not in lymphoma patients and to provide reference for interventions to improve participation rate. Methods A self-designed questionnaire of intention for clinical trial of lymphoma patients was developed and used among 331 lymphoma hospitalized patients from December 2014 to Auguest 2015. Results Of the total, 177 patients showed the intention to participate in clinical trial and the top five reasons for it were desire for new medication and treatment (100%), having confidence in hospital (96.6%), having confidence in doctor (96.0%), hoping for better treatment in clinical trial (76.3%) and fine management and monitoring (72.3%). Another 154 patients had no intention and reasons for it included inadequate understanding for clinical trial (94.2%), adverse reaction and safety of clinical trial (93.5%), the efficiency of medication (81.8%), imperfect laws and regulations (76.6%) and with no need for clinical trial (60.4%). Conclusion The main reasons for refusal for clinical trial include insufficient understanding and anxiety for the adverse reaction and safety of medications. It is necessary to take corresponding measures to promote patients ’ knowledge of clinical trial so as to improve the participation rate of clinical trial.%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。

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