Abstract

Introduction: Oral 5-aminolevulinic acid (5-ALA) is often used for photodynamic diagnosis-assisted glioma or bladder tumor surgery. 5-ALA affects blood pressure (BP). In fact, hypotension is a well-known adverse effect of 5-ALA in urology. However, information regarding 5-ALA-induced hemodynamic changes in neurosurgery remains limited. Furthermore, the duration of hypotension and how 5-ALA affects the heart rate (HR) are yet to be determined. Thus, in this study, we aimed to elucidate 5-ALA-induced perioperative hemodynamic changes in neurosurgery and urological surgery by examining real-world data. Methods: Consecutive patients who underwent neurosurgery (neurosurgery patients; 5-ALA-pretreated vs. non-pretreated [17 vs. 16], from January 2014 to March 2021) and urological surgery (urological surgery patients; 5-ALA-pretreated vs. non-pretreated [26 vs. 101], from August 2018 to September 2020) were enrolled. Differences in hemodynamics were evaluated using the linear mixed model. BP and HR in 5-ALA-pretreated patients were compared with those in non-pretreated patients. Differences in 5-ALA-induced preoperative BP changes were compared between the neurosurgery patients and urological surgery patients. Results: 5-ALA scarcely affected the hemodynamics in neurosurgery patients, whereas 5-ALA-induced hemodynamic changes were clearly observed in urological surgery patients. Hemodynamic parameters were found to be not significantly different between 5-ALA-pretreated and non-pretreated neurosurgery patients. The preoperative, intraoperative, and postoperative BP in 5-ALA-pretreated urological surgery patients were significantly lower than those in the non-pretreated patients. Preoperatively, two 5-ALA-pretreated urological surgery patients had severe postural hypotension (systolic BP <50 mmHg), and one of them did not continue with the surgery because of prolonged severe hypotension. The BP in 5-ALA-pretreated urological surgery patients tended to be persistently lower for 9 h after 5-ALA pretreatment. The preoperative and postoperative HR values were higher in 5-ALA-pretreated urological surgery patients. Cumulative incidences of BP reduction and HR elevation were significantly higher in 5-ALA-pretreated urological surgery patients. The preoperative BP reduction in 5-ALA-pretreated urological surgery patients was significantly larger than that in neurosurgery patients. Conclusions: 5-ALA-induced hemodynamics may differ between neurosurgery patients and urological surgery patients. 5-ALA may affect BP for at least 9 h.

Highlights

  • マ ウ ス へ の本 剤 の 静脈 内 投 与時 後 の紫 外 線 照射に お い て 光毒 性 が みと め ら れた た め (2.6.8.8.1 参照). 本 剤 投 与 によ り 肝機 能 検 査値 の 上 昇が 認 めら れる 可 能 性 があ る こと か ら 、国 内 試 験 (NPC-07-1 試験)では、肝機能検査値が CTCAE グレード 3 以上に上昇した場合に、重要な有害.

  • Council for International Organizations of Medical Science

  • MC-ALS.20/BV 試験及び MC-ALS.8-I/GLI 試験)における 5-ALA 及び PPIX の薬物動態パラメータ

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Summary

Introduction

マ ウ ス へ の本 剤 の 静脈 内 投 与時 後 の紫 外 線 照射に お い て 光毒 性 が みと め ら れた た め (2.6.8.8.1 参照). 本 剤 投 与 によ り 肝機 能 検 査値 の 上 昇が 認 めら れる 可 能 性 があ る こと か ら 、国 内 試 験 (NPC-07-1 試験)では、肝機能検査値が CTCAE グレード 3 以上に上昇した場合に、重要な有害. Council for International Organizations of Medical Science

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