妇科患者药物临床试验参加意愿调查分析

Investigation of Participants’ Willingness on Gynecological Clinical Trials

摘要: 目的：对患者进行药物临床试验参与意愿及其影响因素调查，为药物临床试验更加合理有效开展提供依据。方法：采用自行设计的问卷，对妇科患者进行一对一问卷调查。结果：在106名研究对象中，对药物临床试验知晓率较高的前三位内容是“保护受试者的安全和权益”，知晓率为77.4% (82/106)；“保证试验数据及结果的科学性、准确性和可靠性”，知晓率为66.0% (70/106)；“签署知情同意书”，知晓率为64.2% (68/106)。知晓率最低的内容是“不良事件处理、记录、报告”，知晓率为37.7% (40/106)。药物临床试验的参加意愿情况，有20人表示愿意参加药物临床试验，占18.9% (20/106)；有86人表示不愿意参加药物临床试验，占81.1% (86/106)。不愿意参加的前三位原因是：70.9% (61/86)的患者担心有不良反应和副作用，37.2%的患者没有时间参加(32/86)，30.2%的患者担心没有效果(26/86)。在86名不愿意参加药物临床试验的患者中，有19人表示如果医护人员做了详尽的解释以及充分的知情后，愿意参加药物临床试验，占38.1% (19/86)。药物临床试验参加意愿的影响因素，药物临床试验参加意愿的单因素分析结果表明，在所有纳入分析的因素中，高文化程度、没有时间参加和担心有不良反应和副作用与不愿参加药物临床试验有关(P < 0.5)。以是否愿意参加药物为因变量，将单因素分析中P < 0.05的变量为自变量，使用后退法进行多因素logistic回归分析。多因素分析结果表明，没有时间参加、担心有不良反应和副作用是药物临床试验参加意愿的独立影响因素。结论：参加临床药物试验的医护人员，应该参加严格的GCP培训，有良好的科学严谨态度，详细向受试者讲述临床药物试验的各项细节，应该让患者充分理解可能获得的治疗和帮助，并让他们在临床试验中体会参与试验为医学做贡献的高尚感和幸福感而愿意参加临床药物试验。

Abstract: Objective: to investigate the will of participating drug clinical trials in subjects and possible in-fluencing factors, thus providing the basis of carrying out more reasonable clinical trials. Results: of all the 106 subjects who have participated in the trials, most persons are aware of the top three listing aspects, “Protecting the safety and rights of the subjects, accounting for 77.4% (82/106)”, ”Ensuring a scientific, accurate and reliable experimental data, accounting for 66% (70/106)”, ”Signing informed consent, accounting for 64.2% (68/106)”. The lowest awareness is “Adverse event handling, record and report” with the rate of 37.7% (40/106). Situation of participating wills: 20 of 106 subjects are willing to participate in the trials, accounting for 18.9% (20/106) whereas 86 subjects are not, accounting for 81.1% (86/106). The top three reasons of not willing to participate trials are: 70.9% (61/86) subjects worried about adverse reactions and side effects; 37.2% (32/86) had no time; 30.2% (26/86) feel anxious about the effect. Of all the 86 subjects, 19 of whom indicated their wishes if medical staff did a detailed explanation, accounting for 38.1% (19/86). The influencing factors of participating trials: in all the factors included, higher diplomas, less time and worries about side effects have statistically relation to no participating trials (P < 0.05). We have used regressive method of multi-factor logistic regression analysis and chosen “Participate the trial or not” as the dependent variable and “higher diplomas, less time and worries about side effects” as the independent variables. Multi-factor analysis results show that “less time” and “worries about side effects” are the independent factors affecting drug clinical trials. Conclusions: medical personal implemented in the trials should strictly attend the GCP training, have scientific and rigorous attitude, make all subjects aware of details of clinical drug trials and let them experience the noble sense and happiness contribution to medical science.