Riedel M, Strassnig M, Müller N, Zwack P, Möller H-J
Ludwig-Maximilians-University Munich, Dept. of Psychiatry and Psychotherapy, Nussbaumstrasse 7, 80336 Munich, Germany.
Eur Arch Psychiatry Clin Neurosci. 2005 Apr;255(2):143-8. doi: 10.1007/s00406-004-0547-5. Epub 2004 Nov 19.
There has been considerable discussion whether clinical trials accurately depict everyday practice. Restrictive inclusion/exclusion criteria, ethical considerations, differences in the severity of psychopathology between clinical and trial patients, or safety issues may bias results, which in turn may rather represent outcome for the "ideal" than for the "average"patient. Therefore, translation into psychiatric practice may be difficult.
A retrospective case-control study was performed. Schizophrenia inpatients at the LMU Department of Psychiatry, Munich, Germany, who had participated in clinical trials were compared to regular patients serving as controls. Probands and controls were matched by DSM-IV diagnosis, gender and age. The AMDP module, CGI and GAF were used to compare psychopathology. In addition, charts were reviewed for medication dosages, concurrent medical and neurological illness, and clinical history such as age of onset or family history.
A total of 200 probands (100/100) were enrolled in the study. With respect to psychopathology, formally thought disordered or suicidal patients were significantly less likely to be study participants (n = 3) than controls (n = 22; p < or = 0.05). Similarly, negative schizophrenia symptoms were significantly less often present in study participants (n = 17) than in controls (n = 38; p < or = 0.05). Study participants were also medically and neurologically healthier than controls. (p = 0.05 respectively). No differences in overall illness severity as depicted by CGI and GAF were observed.
We found the patients included in our clinical trials representative of the patient encountered in routine clinical practice. Adherence to inclusion and exclusion criteria prevents inclusion of severely ill (e. g. suicidal) patients requiring a more intensive treatment setting. Illness severity was found to be similar in trial participants and controls, and indicates an overall comparably severe psychopathology. The more chronic, rather treatment refractory patients were also not reflected in the trial participant pool; this population may arguably not represent the average clinical patient either. A more careful administration of antipsychotic medication was found in trial participants and may effectively be considered "good clinical practice".
关于临床试验是否准确反映日常医疗实践一直存在大量讨论。严格的纳入/排除标准、伦理考量、临床患者与试验患者之间精神病理学严重程度的差异或安全问题可能会使结果产生偏差，这反过来可能更多地代表“理想”患者而非“普通”患者的结局。因此，将其转化为精神科实践可能会很困难。
进行了一项回顾性病例对照研究。将德国慕尼黑路德维希 - 马克西米利安大学精神病学系参与过临床试验的精神分裂症住院患者与作为对照的普通患者进行比较。先证者和对照按照《精神疾病诊断与统计手册》第四版（DSM - IV）诊断、性别和年龄进行匹配。使用AMDP模块、临床总体印象量表（CGI）和大体功能评定量表（GAF）来比较精神病理学情况。此外，查阅病历以了解药物剂量、并发的内科和神经疾病以及临床病史，如发病年龄或家族史。
总共200名先证者（100/100）被纳入研究。在精神病理学方面，存在形式思维障碍或有自杀倾向的患者作为研究参与者的可能性（n = 3）显著低于对照组（n = 22；p≤0.05）。同样，研究参与者中出现精神分裂症阴性症状的情况（n = 17）明显少于对照组（n = 38；p≤0.05）。研究参与者在内科和神经方面也比对照组更健康（分别为p = 0.05）。未观察到CGI和GAF所描述总体疾病严重程度的差异。
我们发现纳入我们临床试验的患者代表了常规临床实践中遇到的患者。坚持纳入和排除标准可防止纳入需要更强化治疗环境的重症（如自杀倾向）患者。发现试验参与者和对照组的疾病严重程度相似，表明总体精神病理学严重程度相当。试验参与者群体中也未体现出更多慢性、难治性患者；这一群体可能也不代表普通临床患者。在试验参与者中发现了更谨慎的抗精神病药物使用情况，可有效地将其视为“良好临床实践”。
