Fechner J, Albrecht S, Ihmsen H, Knoll R, Schwilden H, Schüttler J
Klinik für Anästhesiologie der Friedrich-Alexander-Universität Erlangen-Nürnberg.
Anaesthesist. 1998 Aug;47(8):663-8. doi: 10.1007/s001010050611.
In Germany a TCI-system for propofol (Disoprifusor-TCI) has been commercially available since spring 1997. We investigated the prediction error and precision of this TCI system as part of a multicentre study. Bias, precision, blood concentrations and dosage of propofol were compared with patients receiving propofol via a manually controlled infusion device.
After approval by the local Ethics Committee and written informed consent, 21 patients of ASA-classification I to III scheduled for major abdominal surgery received either a target controlled infusion (group T, Disoprifusor-TCI) or a manually controlled infusion (group M) of propofol. The propofol plasma concentrations were measured by HPLC. The prediction error for each measurement, the median prediction error (MDPE) or bias, the median absolute prediction error (MDAPE) or precision and the divergence (change of the prediction error over infusion time) were calculated for both groups.
For all patients in group T (n = 12) the bias of the TCI system was 6.7% and the precision 27.5%. For 70% of all measured plasma concentrations the absolute prediction error was < or = 37%. The divergence was -5.4% per hour. For all patients in group M (n = 9) the bias was 44.2% and the precision 50%. The mean amount of propofol infused per kilogram body weight and hour was significant higher in T (9.0 +/- 1.2 mg/kg/h) than in M (6.6 +/- 1.2 mg/kg/h, p < 0.005).
With a precision of 27.5% the investigated TCI system (Diprifusor-TCI) showed an acceptable inaccuracy, as for TCI-systems a median prediction error of +/- 30% has to be expected due to the inherent variability of pharmacokinetic parameters. Further studies will be necessary to find out whether the investigated TCI system for propofol may offer substantial advantages.
在德国,自1997年春季起丙泊酚靶控输注系统(Disoprifusor-TCI)已投入商业使用。作为一项多中心研究的一部分,我们对该靶控输注系统的预测误差和精确度进行了调查。将丙泊酚的偏差、精确度、血药浓度和剂量与通过手动控制输注装置接受丙泊酚治疗的患者进行了比较。
经当地伦理委员会批准并获得书面知情同意后,21例计划接受腹部大手术的ASA分级为I至III级的患者,分别接受丙泊酚靶控输注(T组,Disoprifusor-TCI)或手动控制输注(M组)。采用高效液相色谱法测定丙泊酚血浆浓度。计算两组每次测量的预测误差、中位预测误差(MDPE)或偏差、中位绝对预测误差(MDAPE)或精确度以及离散度(预测误差随输注时间的变化)。
T组所有患者(n = 12)中,靶控输注系统的偏差为6.7%,精确度为27.5%。在所有测量的血浆浓度中,70%的绝对预测误差≤37%。离散度为每小时-5.4%。M组所有患者(n = 9)中,偏差为44.2%,精确度为50%。T组每千克体重每小时输注的丙泊酚平均量(9.0±1.2 mg/kg/h)显著高于M组(6.6±1.2 mg/kg/h,p < 0.005)。
所研究的靶控输注系统(Diprifusor-TCI)精确度为27.5%,显示出可接受的不准确性,因为对于靶控输注系统,由于药代动力学参数的固有变异性,预期中位预测误差为±30%。有必要进行进一步研究以确定所研究的丙泊酚靶控输注系统是否可能具有显著优势。