Vidal-Taboada Jose M, Cucala Mercedes, Mas Herrero Sergio, Lafuente Amalia, Cobos Albert
Pharmacogenomic Unit, RDES SL, Barcelona, Spain.
BMC Med Genet. 2006 May 8;7:45. doi: 10.1186/1471-2350-7-45.
Pharmacogenetic studies are essential in understanding the interindividual variability of drug responses. DNA sample collection for genotyping is a critical step in genetic studies. A method using dried blood samples from finger-puncture, collected on DNA-cards, has been described as an alternative to the usual venepuncture technique. The purpose of this study is to evaluate the implementation of the DNA cards method in a multicentre clinical trial, and to assess the degree of investigators' satisfaction and the acceptance of the patients perceived by the investigators.
Blood samples were collected on DNA-cards. The quality and quantity of DNA recovered were analyzed. Investigators were questioned regarding their general interest, previous experience, safety issues, preferences and perceived patient satisfaction.
151 patients' blood samples were collected. Genotyping of GST polymorphisms was achieved in all samples (100%). 28 investigators completed the survey. Investigators perceived patient satisfaction as very good (60.7%) or good (39.3%), without reluctance to finger puncture. Investigators preferred this method, which was considered safer and better than the usual methods. All investigators would recommend using it in future genetic studies.
Within the clinical trial setting, the DNA-cards method was very well accepted by investigators and patients (in perception of investigators), and was preferred to conventional methods due to its ease of use and safety.
药物遗传学研究对于理解个体间药物反应的变异性至关重要。用于基因分型的DNA样本采集是遗传学研究中的关键步骤。一种使用在DNA卡上采集的手指穿刺干血样的方法已被描述为常规静脉穿刺技术的替代方法。本研究的目的是评估DNA卡方法在多中心临床试验中的实施情况,并评估研究者的满意度以及研究者所感知到的患者接受度。
在DNA卡上采集血样。对回收的DNA的质量和数量进行分析。就研究者的总体兴趣、既往经验、安全问题、偏好以及所感知到的患者满意度对研究者进行询问。
采集了151例患者的血样。所有样本(100%)均成功进行了谷胱甘肽S-转移酶(GST)基因多态性的基因分型。28名研究者完成了调查。研究者认为患者满意度非常好(60.7%)或良好(39.3%),患者对手指穿刺没有抵触情绪。研究者更喜欢这种方法,认为它比常规方法更安全、更好。所有研究者均会推荐在未来的遗传学研究中使用该方法。
在临床试验环境中,DNA卡方法受到研究者和患者(基于研究者的感知)的广泛接受,并且由于其易用性和安全性而优于传统方法。