PMID- 36357252
OWN - NLM
STAT- MEDLINE
DCOM- 20221227
LR  - 20230320
IS  - 1879-291X (Electronic)
IS  - 0301-5629 (Linking)
VI  - 49
IP  - 2
DP  - 2023 Feb
TI  - Safety Analysis of Adverse Events of Ultrasound Contrast Agent Lumason/SonoVue in 
      49,100 Patients.
PG  - 454-459
LID - S0301-5629(22)00575-0 [pii]
LID - 10.1016/j.ultrasmedbio.2022.09.014 [doi]
AB  - This study assessed the incidence of mild, moderate and severe adverse events 
      (AEs) and examined their association with age, sex, body region examined, time to 
      event and duration of the AE(s) in a large cohort of patients who underwent 
      contrast-enhanced ultrasound (CEUS) with Lumason/SonoVue. In this retrospective 
      observational study, 49,100 patients who underwent CEUS were analyzed. 
      Forty-three (0.088%) patients experienced AEs, with 23 (0.047%) patients 
      experiencing mild AEs, 13 (0.026%) experiencing moderate AEs and 7 (0.014%) 
      experiencing severe AEs. No fatal event occurred. There was no age- or 
      sex-related difference in the incidence of the AE(s) (p = 0.158 and p = 0.474). 
      Inpatients (0.17%) more often experienced AEs than outpatients (0.06%, 
      p = 0.003). The mean time to event for mild and moderate AEs was 14.50 +/- 6.96 and 
      15.75 +/- 10.40 min, respectively, whereas that for severe AEs was 1.89 +/- 1.21 min 
      after the injection. The remission time for mild and moderate AEs was 
      approximately 30-40 min, and all patients with severe AEs recovered within 12 h. 
      Twenty-one (48.8%) patients received medical treatment. In summary, 
      Lumason/SonoVue has a good safety profile with a low incidence of AEs, most of 
      which are mild with a short time to event and duration.
CI  - Copyright (c) 2022. Published by Elsevier Inc.
FAU - Li, Qiuyang
AU  - Li Q
AD  - Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, 
      Beijing, China.
FAU - Yang, Kaixiu
AU  - Yang K
AD  - Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, 
      Beijing, China.
FAU - Ji, Yongjiao
AU  - Ji Y
AD  - Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, 
      Beijing, China.
FAU - Liu, Hongrui
AU  - Liu H
AD  - Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, 
      Beijing, China.
FAU - Fei, Xiang
AU  - Fei X
AD  - Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, 
      Beijing, China.
FAU - Zhang, Yan
AU  - Zhang Y
AD  - Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, 
      Beijing, China.
FAU - Li, Jingbo
AU  - Li J
AD  - Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, 
      Beijing, China; Medical School of Chinese PLA, Beijing, China.
FAU - Luo, Yukun
AU  - Luo Y
AD  - Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, 
      Beijing, China. Electronic address: lyk301@163.com.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20221107
PL  - England
TA  - Ultrasound Med Biol
JT  - Ultrasound in medicine & biology
JID - 0410553
RN  - 0 (Contrast Media)
RN  - 0 (contrast agent BR1)
RN  - WS7LR3I1D6 (Sulfur Hexafluoride)
RN  - 0 (Phospholipids)
SB  - IM
MH  - Humans
MH  - *Contrast Media/adverse effects
MH  - *Sulfur Hexafluoride/adverse effects
MH  - Ultrasonography/adverse effects
MH  - Phospholipids/adverse effects
OTO - NOTNLM
OT  - Adverse event
OT  - Contrast-enhanced ultrasound
OT  - Lumason
OT  - Ultrasound
OT  - Ultrasound contrast agent
COIS- Conflict of interest disclosure The authors declare that they have no competing 
      interests that could be perceived as prejudicing the impartiality of the research 
      reported in this study.
EDAT- 2022/11/11 06:00
MHDA- 2022/12/28 06:00
CRDT- 2022/11/10 22:04
PHST- 2022/05/22 00:00 [received]
PHST- 2022/09/13 00:00 [revised]
PHST- 2022/09/25 00:00 [accepted]
PHST- 2022/11/11 06:00 [pubmed]
PHST- 2022/12/28 06:00 [medline]
PHST- 2022/11/10 22:04 [entrez]
AID - S0301-5629(22)00575-0 [pii]
AID - 10.1016/j.ultrasmedbio.2022.09.014 [doi]
PST - ppublish
SO  - Ultrasound Med Biol. 2023 Feb;49(2):454-459. doi: 
      10.1016/j.ultrasmedbio.2022.09.014. Epub 2022 Nov 7.