1.Local irritation study of repeated lumbar intrathecal injection of Ziconotide Acetate
Ying SONG ; Xinlu FU ; Tianlong LAN ; Xuemin YANG ; Huandi MAI ; Tao NIE ; Zhiying HUANG ; Yuwen QIU
Drug Evaluation Research 2017;40(1):54-58
Objective To study the local irritation of repeated intrathecal injection of Ziconotide Acetate,and to provide reference for irritancy evaluation ofintrathecal injection.Methods Sixteen New Zealand rabbits were assigned into two groupsat random:Control group and Ziconotide Acetate group,eight animals each group.Totally 50 μL saline or Ziconotide Acetate (100 μg/mL) were administrated by repeated lumbar intrathecal injection once daily for 7 d.Animal behavior was observed every day,and four animals in each group were sacrificed 2 d later after the last injection,the lumbar spinal cord was removed for histopathological examination and irritancy evaluation.The remaining animals were sacrificed for initancy evaluation 14 d later after the last injection.Results Only one animal died after anesthesia on day three in saline group,while no obvious adverse reactions were observed in other rabbits during the entire study,and no intrathecal irritant reactions of histopathological examination were found in both groups.The reversible minor mechanical damage was observed at the injection point,2 d after the last administration.Conclusion For 7 d repeated lumbar intrathecal injection in rabbits,no intrathecal irritant reactions observed in Ziconotide group,and the New Zealand rabbit could be used as a local irritation evaluation model.
2.Under microscope bilateral decompression via unilateral approach for the treatment of lumbar stenosis
Sheng YANG ; Jianmin LU ; Dewei ZHAO ; Peicheng XIN ; Xinlu LI ; Haoyi LIAN ; Xing QIU ; Dapeng FU
Chinese Journal of Microsurgery 2011;34(3):179-181,后插1
Objective To evaluate the characteristics and efficacy of microscope-assisted bilateral decompression via unilateral approach for the treatment of lumbar stenosis. Methods From June 2007 to June 2010, Sixty case lumbar stenosis with bilateral decompression were treated via unilateral approach under microscopy. Patients were followed up from 6 to 24 months, average (12 ± 4.7) months. Results The pain level of each patient was assessed both before and after the opeartion, using a visual analogue scale (VAS). Intermittent claudication was completely relieved in 57 out of 60 cases, moderately relieved in 3 cases. VAS score decreased from pre-operational 9.08 ± 0.76 to post-operational 2.33 ± 1.43, and there was significantly difference between them. There was no recurrent case during the whole follow-up. Conclusion Bilateral decompression via unilateral approach under microscope is proved to be an effective and safe procedure for the treatment of lumbar stenosis, and have the advantages of minimal invasion, less pain, quick recovery, better effect, little influence on the spinal stability.
3.Hemolysis rates of three red blood cell components at the end of storage: a 5-year retrospective study
Zhenping LU ; Fufa LIU ; Meiyan KANG ; Xianbin WU ; Yanting WANG ; Xing LONG ; Xinlu QIU ; Jin LI
Chinese Journal of Blood Transfusion 2025;38(6):828-832
Objective: To evaluate the suitability of the existing hemolysis rate standards for locally processed red blood cell components by retrospectively analyzing 5-year hemolysis rate data at the end of storage. Methods: A total of 720 blood samples of three types of red blood cell components from our blood station from January 2019 to December 2023 were collected. Parameters included hemoglobin concentration (Hb), hematocrit (Hct), and free hemoglobin concentration (fHb). Hemolysis rate were taken as the control standard of 0.8% in accordance with the national standard. The hemolysis rates were compared against the national standard threshold of 0.8% (GB18469-2012), and annual trends of the detection parameters were observed. Results: The hemolysis rates (x-+s,%) of leukocyte-depleted whole blood at the end of storage were (0.038±0.023 8) in 2019, (0.049±0.039 5) in 2020, (0.043±0.040 7) in 2021, (0.049±0.030 7) in 2022, and (0.058±0.054 8) in 2023, respectively; The hemolysis rates (x-+s" />,%) of leukocyte-depleted suspended red blood cells at the end of storage were (0.093±0.050 2) in 2019, (0.086±0.049 5) in 2020, (0.123±0.072 3) in 2021, (0.122±0.052 1) in 2022, and (0.106±0.058 6) in 2023, respectively; The hemolysis rates (x-+s,%) of washed red blood cells at the end of storage were (0.127±0.038 2) in 2019, (0.150±0.066 5) in 2020, (0.121±0.052 2) in 2021, (0.124±0.038 9) in 2022, and (0.128±0.044 3) in 2023, respectively. Conclusion: Hemolysis rates at the end of blood storage of three red blood cell components were significantly lower than the limits specified in Quality Requirements for Whole Blood and Components (GB18469-2012), as well as standards from the EU, AABB and the United States. The results demonstrate excellent product quality control. A regional internal control standard of <0.2% is proposed for hemolysis rates at the end of storage.