Carrara Fabiola, Gaspari Flavio, Trillini Matias, Peracchi Tobia, Fidone Diego, Stucchi Nadia, Ferrari Silvia, Cugini Daniela, Perico Norberto, Parvanova Aneliya, Remuzzi Giuseppe, Ruggenenti Piero
Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Clinical Research Center for Rare Diseases "Aldo e Cele Daccò", Bergamo, Italy.
Unit of Nephrology, Azienda Socio-Sanitaria Territoriale (ASST) Papa Giovanni XXIII, Bergamo, Italy.
PLoS One. 2024 Jul 17;19(7):e0306935. doi: 10.1371/journal.pone.0306935. eCollection 2024.
Implementing shortened one-compartment iohexol plasma clearance models for GFR measurement is crucial since the gold standard inulin renal clearance technique and the reference two-compartment, 10-hour, 16-samplings iohexol plasma clearance method are clinically unfeasible. Inulin may precipitate anaphylactic shock. Four-hour and 8-hour one-compartment iohexol plasma clearance models with Bröchner-Mortensen correction provide accurate GFR measurements in patients with estimated GFR (eGFR) > or ≤40 mL/min/1.73m2, respectively. We compared the performance of the simplified 5-hour, 4-samplings, two-compartment population pharmacokinetic model (popPK) with the performance of the reference two-compartment 10-hour iohexol method in 16 patients with GFR 15.2 to 56.5 mL/min/1.73 m2. We also compared the performance of shortened (5, 6 and 7-hour) one-compartment models with the performance of the standard 8-hour one-compartment model in 101 patients with eGFR ≤40 mL/min/1.73 m2. The performance of popPK and shortened methods versus reference methods was evaluated by total deviation index (TDI), concordance correlation coefficient (CCC) and coverage probability (CP). TDI <10%, CCC ≥0.9 and CP >90% indicated adequate performance. TDI, CCC and CP of popPK were 11.11%, 0.809 and 54.10%, respectively. All shortened, one-compartment models overestimated the GFR (p <0.0001 for all) as compared to the 8-hour model. TDI, CCC and CP were 7.02%, 0.815, and 75.80% for the 7-hour model, 7.26%, 0.803, and 74.20% for the 6-hour model, and 8.85%, 0.729 and 64.70% for the 5-hour model. The agreement of popPK model was comparable to that obtained with the Chronic-Kidney-Disease-Collaboration-Epidemiology (CKD-Epi) and the Modification-of-Diet-in-Renal-Disease (MDRD) serum-creatinine based equations for GFR estimation. PopPK model is remarkably unreliable for GFR measurement in stage III-IV CKD patients. In patients with eGFR ≤40 mL/min/1.73m2, shortened one-compartment models, in particular the 5-hour model, are less performant than the reference 8-hour model. For accurate GFR measurements, the iohexol plasma clearance should be measured with appropriate protocols. Over-simplified procedures should be avoided.
由于金标准菊粉肾清除技术以及参考的两室、10小时、16次采样的碘海醇血浆清除方法在临床上不可行,因此实施缩短的单室碘海醇血浆清除模型用于肾小球滤过率(GFR)测量至关重要。菊粉可能会引发过敏性休克。采用布罗克纳 - 莫特森校正的4小时和8小时单室碘海醇血浆清除模型分别能为估算肾小球滤过率(eGFR)>或≤40 mL/min/1.73m²的患者提供准确的GFR测量值。我们比较了简化的5小时、4次采样的两室群体药代动力学模型(popPK)与参考的两室10小时碘海醇方法在16例GFR为15.2至56.5 mL/min/1.73 m²患者中的性能。我们还比较了缩短的(5、6和7小时)单室模型与标准8小时单室模型在101例eGFR≤40 mL/min/1.73 m²患者中的性能。通过总偏差指数(TDI)、一致性相关系数(CCC)和覆盖概率(CP)评估popPK和缩短方法相对于参考方法的性能。TDI<10%、CCC≥0.9且CP>90%表明性能良好。popPK的TDI、CCC和CP分别为11.11%、0.809和54.10%。与8小时模型相比,所有缩短的单室模型均高估了GFR(所有p<0.0001)。7小时模型的TDI、CCC和CP分别为7.02%、0.815和75.80%,6小时模型分别为7.26%、0.803和74.20%,5小时模型分别为8.85%、0.729和64.70%。popPK模型的一致性与基于血清肌酐的慢性肾脏病协作流行病学(CKD - Epi)和肾脏疾病饮食改良(MDRD)方程估算GFR时所获得的一致性相当。PopPK模型在III - IV期慢性肾脏病患者的GFR测量中明显不可靠。在eGFR≤40 mL/min/1.73m²的患者中,缩短的单室模型,尤其是5小时模型,性能不如参考的8小时模型。为了准确测量GFR,应采用适当的方案测量碘海醇血浆清除率。应避免过度简化的程序。