Background: Lac color, a natural red dye derived from the larvae of laccifer lacca kerr, is one of the most commonly used substances in food. To date, no studies have reported on the antigenicity of lac color and the other biomarkers that can determine anaphylactic reactions. To address this, we evaluated the antigenicity of lac color through active systemic anaphylaxis (ASA) in addition to identifying potential biomarkers performing exploratory studies. For ASA test, Guinea pigs (n = 5) were sensitized with 0(negative control), 4 mg/kg of lac color, 4 mg/kg of lac color + FCA, and 5 mg/kg of ovalbumin + FCA (positive control) 3 times a week for three weeks. Fourteen days after the last sensi‑ tization, animals were challenged intravenously weekly for two weeks. Hematological and histopathological analyses were performed and compared to control groups. Results: In the ASA test, all lac color groups showed mild symptoms such as nose rubbing, urination, and evacuation, which are insufficient indicators of anaphylaxis. Exploratory studies identified several biomarkers: decreased platelet count, and increased basophil count; distention in the lung, and redness on the inner wall of trachea; mononuclear inflammatory cell infiltration (MICI) in the ear, and heart hemorrhage. When these biomarkers were applied to the ASA test of lac color, in comparison to the negative control group, the positive control group (ovalbumin + FCA) showed a significant over 60-fold reduction in platelet count and nearly threefold higher basophil count compared to other groups. Furthermore, only positive control group exhibited full lung distention and severe redness on the inner wall of the trachea. Mononuclear inflammatory cell infiltration (MICI) in the ear was about three times higher, and heart hemorrhage was only present in the positive control group compared to others. None of the lac color groups were different from the negative control group (p > 0.05), whereas the positive control group was significantly different (p < 0.05). Conclusions Our study concludes that lac color, at the tested concentrations, does not induce antigenicity in the guinea pig model, providing valuable safety data. Furthermore, the biomarkers identified in this study offer a supportive approach to evaluating the immunogenicity of substances in future research.

Background: Lac color, a natural red dye derived from the larvae of laccifer lacca kerr, is one of the most commonly used substances in food. To date, no studies have reported on the antigenicity of lac color and the other biomarkers that can determine anaphylactic reactions. To address this, we evaluated the antigenicity of lac color through active systemic anaphylaxis (ASA) in addition to identifying potential biomarkers performing exploratory studies. For ASA test, Guinea pigs (n = 5) were sensitized with 0(negative control), 4 mg/kg of lac color, 4 mg/kg of lac color + FCA, and 5 mg/kg of ovalbumin + FCA (positive control) 3 times a week for three weeks. Fourteen days after the last sensi‑ tization, animals were challenged intravenously weekly for two weeks. Hematological and histopathological analyses were performed and compared to control groups. Results: In the ASA test, all lac color groups showed mild symptoms such as nose rubbing, urination, and evacuation, which are insufficient indicators of anaphylaxis. Exploratory studies identified several biomarkers: decreased platelet count, and increased basophil count; distention in the lung, and redness on the inner wall of trachea; mononuclear inflammatory cell infiltration (MICI) in the ear, and heart hemorrhage. When these biomarkers were applied to the ASA test of lac color, in comparison to the negative control group, the positive control group (ovalbumin + FCA) showed a significant over 60-fold reduction in platelet count and nearly threefold higher basophil count compared to other groups. Furthermore, only positive control group exhibited full lung distention and severe redness on the inner wall of the trachea. Mononuclear inflammatory cell infiltration (MICI) in the ear was about three times higher, and heart hemorrhage was only present in the positive control group compared to others. None of the lac color groups were different from the negative control group (p > 0.05), whereas the positive control group was significantly different (p < 0.05). Conclusions Our study concludes that lac color, at the tested concentrations, does not induce antigenicity in the guinea pig model, providing valuable safety data. Furthermore, the biomarkers identified in this study offer a supportive approach to evaluating the immunogenicity of substances in future research.

Objective: To identify risk factors and establish radiographic criteria for distal junctional failure (DJF) in patients with adult spinal deformity (ASD), who underwent fusion surgery stopping at L5. Methods: This retrospective study was undertaken from January 2016 to December 2020. Patients with ASD who underwent fusion surgery (≥5 levels) stopping at L5 were analyzed. DJF was defined as symptomatic adjacent segment pathology at the lumbosacral junction necessitating consideration for revision surgery. Demographic data and radiographic measurements were compared between the DJF and non-DJF groups. Receiver operating characteristic curve analysis was performed to identify the radiographic cutoff value for DJF. Results: Among 76 patients, 16 (21.1%) experienced DJF. DJF was associated with older age, antidepressant/anxiolytic medication, longer level of fusions, and worse preoperative sagittal alignment. Antidepressant/anxiolytic medication (odds ratio, 5.60) and preoperative pelvic incidence (PI)–lumbar lordosis (LL) mismatch>40° (odds ratio, 5.87) were independent risk factors for DJF. Without both factors, the incidence of DJF has been greatly reduced (9.1%). Two radiographic criteria were determined for DJF: last distal junctional angle (DJA)>-5° and Δ last DJA–post DJA>5°. When both criteria were met, the sensitivity and specificity of the DJF were 93.3% and 91.7%, respectively. Conclusion Use of antidepressant/anxiolytic medication and preoperative PI–LL mismatch >40° were independent risk factors for DJF. DJF could be diagnosed using postoperative changes in the DJA. If both criteria were met, DJF could be strongly suggested.

Background: Lac color, a natural red dye derived from the larvae of laccifer lacca kerr, is one of the most commonly used substances in food. To date, no studies have reported on the antigenicity of lac color and the other biomarkers that can determine anaphylactic reactions. To address this, we evaluated the antigenicity of lac color through active systemic anaphylaxis (ASA) in addition to identifying potential biomarkers performing exploratory studies. For ASA test, Guinea pigs (n = 5) were sensitized with 0(negative control), 4 mg/kg of lac color, 4 mg/kg of lac color + FCA, and 5 mg/kg of ovalbumin + FCA (positive control) 3 times a week for three weeks. Fourteen days after the last sensi‑ tization, animals were challenged intravenously weekly for two weeks. Hematological and histopathological analyses were performed and compared to control groups. Results: In the ASA test, all lac color groups showed mild symptoms such as nose rubbing, urination, and evacuation, which are insufficient indicators of anaphylaxis. Exploratory studies identified several biomarkers: decreased platelet count, and increased basophil count; distention in the lung, and redness on the inner wall of trachea; mononuclear inflammatory cell infiltration (MICI) in the ear, and heart hemorrhage. When these biomarkers were applied to the ASA test of lac color, in comparison to the negative control group, the positive control group (ovalbumin + FCA) showed a significant over 60-fold reduction in platelet count and nearly threefold higher basophil count compared to other groups. Furthermore, only positive control group exhibited full lung distention and severe redness on the inner wall of the trachea. Mononuclear inflammatory cell infiltration (MICI) in the ear was about three times higher, and heart hemorrhage was only present in the positive control group compared to others. None of the lac color groups were different from the negative control group (p > 0.05), whereas the positive control group was significantly different (p < 0.05). Conclusions Our study concludes that lac color, at the tested concentrations, does not induce antigenicity in the guinea pig model, providing valuable safety data. Furthermore, the biomarkers identified in this study offer a supportive approach to evaluating the immunogenicity of substances in future research.

Objective: To identify risk factors and establish radiographic criteria for distal junctional failure (DJF) in patients with adult spinal deformity (ASD), who underwent fusion surgery stopping at L5. Methods: This retrospective study was undertaken from January 2016 to December 2020. Patients with ASD who underwent fusion surgery (≥5 levels) stopping at L5 were analyzed. DJF was defined as symptomatic adjacent segment pathology at the lumbosacral junction necessitating consideration for revision surgery. Demographic data and radiographic measurements were compared between the DJF and non-DJF groups. Receiver operating characteristic curve analysis was performed to identify the radiographic cutoff value for DJF. Results: Among 76 patients, 16 (21.1%) experienced DJF. DJF was associated with older age, antidepressant/anxiolytic medication, longer level of fusions, and worse preoperative sagittal alignment. Antidepressant/anxiolytic medication (odds ratio, 5.60) and preoperative pelvic incidence (PI)–lumbar lordosis (LL) mismatch>40° (odds ratio, 5.87) were independent risk factors for DJF. Without both factors, the incidence of DJF has been greatly reduced (9.1%). Two radiographic criteria were determined for DJF: last distal junctional angle (DJA)>-5° and Δ last DJA–post DJA>5°. When both criteria were met, the sensitivity and specificity of the DJF were 93.3% and 91.7%, respectively. Conclusion Use of antidepressant/anxiolytic medication and preoperative PI–LL mismatch >40° were independent risk factors for DJF. DJF could be diagnosed using postoperative changes in the DJA. If both criteria were met, DJF could be strongly suggested.

Objective: To identify risk factors and establish radiographic criteria for distal junctional failure (DJF) in patients with adult spinal deformity (ASD), who underwent fusion surgery stopping at L5. Methods: This retrospective study was undertaken from January 2016 to December 2020. Patients with ASD who underwent fusion surgery (≥5 levels) stopping at L5 were analyzed. DJF was defined as symptomatic adjacent segment pathology at the lumbosacral junction necessitating consideration for revision surgery. Demographic data and radiographic measurements were compared between the DJF and non-DJF groups. Receiver operating characteristic curve analysis was performed to identify the radiographic cutoff value for DJF. Results: Among 76 patients, 16 (21.1%) experienced DJF. DJF was associated with older age, antidepressant/anxiolytic medication, longer level of fusions, and worse preoperative sagittal alignment. Antidepressant/anxiolytic medication (odds ratio, 5.60) and preoperative pelvic incidence (PI)–lumbar lordosis (LL) mismatch>40° (odds ratio, 5.87) were independent risk factors for DJF. Without both factors, the incidence of DJF has been greatly reduced (9.1%). Two radiographic criteria were determined for DJF: last distal junctional angle (DJA)>-5° and Δ last DJA–post DJA>5°. When both criteria were met, the sensitivity and specificity of the DJF were 93.3% and 91.7%, respectively. Conclusion Use of antidepressant/anxiolytic medication and preoperative PI–LL mismatch >40° were independent risk factors for DJF. DJF could be diagnosed using postoperative changes in the DJA. If both criteria were met, DJF could be strongly suggested.

Background: Lac color, a natural red dye derived from the larvae of laccifer lacca kerr, is one of the most commonly used substances in food. To date, no studies have reported on the antigenicity of lac color and the other biomarkers that can determine anaphylactic reactions. To address this, we evaluated the antigenicity of lac color through active systemic anaphylaxis (ASA) in addition to identifying potential biomarkers performing exploratory studies. For ASA test, Guinea pigs (n = 5) were sensitized with 0(negative control), 4 mg/kg of lac color, 4 mg/kg of lac color + FCA, and 5 mg/kg of ovalbumin + FCA (positive control) 3 times a week for three weeks. Fourteen days after the last sensi‑ tization, animals were challenged intravenously weekly for two weeks. Hematological and histopathological analyses were performed and compared to control groups. Results: In the ASA test, all lac color groups showed mild symptoms such as nose rubbing, urination, and evacuation, which are insufficient indicators of anaphylaxis. Exploratory studies identified several biomarkers: decreased platelet count, and increased basophil count; distention in the lung, and redness on the inner wall of trachea; mononuclear inflammatory cell infiltration (MICI) in the ear, and heart hemorrhage. When these biomarkers were applied to the ASA test of lac color, in comparison to the negative control group, the positive control group (ovalbumin + FCA) showed a significant over 60-fold reduction in platelet count and nearly threefold higher basophil count compared to other groups. Furthermore, only positive control group exhibited full lung distention and severe redness on the inner wall of the trachea. Mononuclear inflammatory cell infiltration (MICI) in the ear was about three times higher, and heart hemorrhage was only present in the positive control group compared to others. None of the lac color groups were different from the negative control group (p > 0.05), whereas the positive control group was significantly different (p < 0.05). Conclusions Our study concludes that lac color, at the tested concentrations, does not induce antigenicity in the guinea pig model, providing valuable safety data. Furthermore, the biomarkers identified in this study offer a supportive approach to evaluating the immunogenicity of substances in future research.

Objective: To identify risk factors and establish radiographic criteria for distal junctional failure (DJF) in patients with adult spinal deformity (ASD), who underwent fusion surgery stopping at L5. Methods: This retrospective study was undertaken from January 2016 to December 2020. Patients with ASD who underwent fusion surgery (≥5 levels) stopping at L5 were analyzed. DJF was defined as symptomatic adjacent segment pathology at the lumbosacral junction necessitating consideration for revision surgery. Demographic data and radiographic measurements were compared between the DJF and non-DJF groups. Receiver operating characteristic curve analysis was performed to identify the radiographic cutoff value for DJF. Results: Among 76 patients, 16 (21.1%) experienced DJF. DJF was associated with older age, antidepressant/anxiolytic medication, longer level of fusions, and worse preoperative sagittal alignment. Antidepressant/anxiolytic medication (odds ratio, 5.60) and preoperative pelvic incidence (PI)–lumbar lordosis (LL) mismatch>40° (odds ratio, 5.87) were independent risk factors for DJF. Without both factors, the incidence of DJF has been greatly reduced (9.1%). Two radiographic criteria were determined for DJF: last distal junctional angle (DJA)>-5° and Δ last DJA–post DJA>5°. When both criteria were met, the sensitivity and specificity of the DJF were 93.3% and 91.7%, respectively. Conclusion Use of antidepressant/anxiolytic medication and preoperative PI–LL mismatch >40° were independent risk factors for DJF. DJF could be diagnosed using postoperative changes in the DJA. If both criteria were met, DJF could be strongly suggested.

Background: Lac color, a natural red dye derived from the larvae of laccifer lacca kerr, is one of the most commonly used substances in food. To date, no studies have reported on the antigenicity of lac color and the other biomarkers that can determine anaphylactic reactions. To address this, we evaluated the antigenicity of lac color through active systemic anaphylaxis (ASA) in addition to identifying potential biomarkers performing exploratory studies. For ASA test, Guinea pigs (n = 5) were sensitized with 0(negative control), 4 mg/kg of lac color, 4 mg/kg of lac color + FCA, and 5 mg/kg of ovalbumin + FCA (positive control) 3 times a week for three weeks. Fourteen days after the last sensi‑ tization, animals were challenged intravenously weekly for two weeks. Hematological and histopathological analyses were performed and compared to control groups. Results: In the ASA test, all lac color groups showed mild symptoms such as nose rubbing, urination, and evacuation, which are insufficient indicators of anaphylaxis. Exploratory studies identified several biomarkers: decreased platelet count, and increased basophil count; distention in the lung, and redness on the inner wall of trachea; mononuclear inflammatory cell infiltration (MICI) in the ear, and heart hemorrhage. When these biomarkers were applied to the ASA test of lac color, in comparison to the negative control group, the positive control group (ovalbumin + FCA) showed a significant over 60-fold reduction in platelet count and nearly threefold higher basophil count compared to other groups. Furthermore, only positive control group exhibited full lung distention and severe redness on the inner wall of the trachea. Mononuclear inflammatory cell infiltration (MICI) in the ear was about three times higher, and heart hemorrhage was only present in the positive control group compared to others. None of the lac color groups were different from the negative control group (p > 0.05), whereas the positive control group was significantly different (p < 0.05). Conclusions Our study concludes that lac color, at the tested concentrations, does not induce antigenicity in the guinea pig model, providing valuable safety data. Furthermore, the biomarkers identified in this study offer a supportive approach to evaluating the immunogenicity of substances in future research.

Objective: To identify risk factors and establish radiographic criteria for distal junctional failure (DJF) in patients with adult spinal deformity (ASD), who underwent fusion surgery stopping at L5. Methods: This retrospective study was undertaken from January 2016 to December 2020. Patients with ASD who underwent fusion surgery (≥5 levels) stopping at L5 were analyzed. DJF was defined as symptomatic adjacent segment pathology at the lumbosacral junction necessitating consideration for revision surgery. Demographic data and radiographic measurements were compared between the DJF and non-DJF groups. Receiver operating characteristic curve analysis was performed to identify the radiographic cutoff value for DJF. Results: Among 76 patients, 16 (21.1%) experienced DJF. DJF was associated with older age, antidepressant/anxiolytic medication, longer level of fusions, and worse preoperative sagittal alignment. Antidepressant/anxiolytic medication (odds ratio, 5.60) and preoperative pelvic incidence (PI)–lumbar lordosis (LL) mismatch>40° (odds ratio, 5.87) were independent risk factors for DJF. Without both factors, the incidence of DJF has been greatly reduced (9.1%). Two radiographic criteria were determined for DJF: last distal junctional angle (DJA)>-5° and Δ last DJA–post DJA>5°. When both criteria were met, the sensitivity and specificity of the DJF were 93.3% and 91.7%, respectively. Conclusion Use of antidepressant/anxiolytic medication and preoperative PI–LL mismatch >40° were independent risk factors for DJF. DJF could be diagnosed using postoperative changes in the DJA. If both criteria were met, DJF could be strongly suggested.