1.A randomized,double-blind,placebo-controlled,multicenter clinical study of Shengxuebao Mixture in treating cancer-related anemia
Zhu LIU ; Xiangrong LI ; Xiaojun DAI ; Yanjun WANG ; Xiao LI ; Keqiong WANG ; Tao WU ; Miaowen ZHONG ; Hongjiang YU ; Ji FENG ; Zuowei HU ; Kainan LI ; Shaowei CHEN ; Chunhua LI ; Zhengchuan FU ; Rui ZHANG ; Yongfa CHEN ; Hongyu XU ; Tao REN ; Yibo YAO ; Jianxu JIN ; Pengyin WANG ; Zhijiang HE ; Jian SHEN ; Lei WANG ; Min LI ; Wenming CHANG ; Xinyi CHEN ; Li HOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(10):1447-1459
Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.
2.Neuropsychological characteristics and related factors in patients with congestive heart failure complicated by mild cognitive impairment
Pan FENG ; Tao LIU ; Yibo WANG ; Ting ZHANG ; Kai XU
Chinese Journal of Primary Medicine and Pharmacy 2025;32(3):382-386
Objective:To analyze the neuropsychological characteristics of patients with chronic heart failure (CHF) complicated by mild cognitive impairment (MCI) and investigate the factors that influence the development of CHF complicated by MCI.Methods:A case-control study was conducted to retrospectively analyze the clinical data of 98 patients with CHF admitted to Baoji Hospital of Traditional Chinese Medicine from January 2019 to October 2020. Based on the Petersen MCI screening criteria, the patients were divided into the MCI group ( n = 48) and the normal cognitive group (NC group, n = 50). The neuropsychological characteristics were analyzed using the Mini-Mental State Examination and the Montreal Cognitive Assessment. The cognitive domain scores of the two groups were tested and compared. Logistic regression analysis was performed to identify the factors influencing the development of CHF complicated by MCI. Results:The total scores of the Mini-Mental State Examination and the Montreal Cognitive Assessment in the NC group were 28.45 ± 1.10 and 27.90 ± 1.35, respectively, which were significantly higher than those in the MCI group (23.50 ± 2.25, 22.95 ± 1.35, t = 13.92, 18.15, both P < 0.001). In addition, the NC group outperformed the MCI group in terms of the number of correct readings, time taken, attention, visuospatial function, memory, and language function ( t = 2.94, 7.29, 3.15, 9.90, 14.69, 4.87, all P < 0.01). The MCI group had a greater proportion of patients who were aged ≥ 65 years, had an education level of junior high school or below, experienced sleep disorders, and were classified as New York Heart Association (NYHA) functional class Ⅲ, compared with the NC group ( χ2 = 4.18, 4.08, 6.88, 4.70, all P < 0.05). Additionally, the cardiac output was lower in the MCI group than in the NC group ( t = 4.70, P < 0.05). Logistic regression analysis revealed that age ≥ 65 years ( OR = 3.904, 95% CI: 1.530-9.963), education level of junior high school or below ( OR = 2.565, 95% CI: 1.571-4.187), sleep disorders ( OR = 3.080, 95% CI: 1.445-6.564), and low cardiac output ( OR = 1.784, 95% CI: 1.168-2.725) were independent risk factors for CHF complicated by MCI ( P < 0.05). Conclusions:Patients with CHF complicated by MCI are more likely to experience impairments in visuospatial function, executive function, attention, language function, and memory. Independent risk factors for CHF complicated by MCI include age ≥ 65 years, education level of junior high school or below, sleep disorders, and low cardiac output.
3.Structural Optimization Design of Chiral-Like Honeycomb Sandwich Vertebral Implants Using Finite Element Methods
Wenbin NIE ; Yuan GUO ; Xushu ZHANG ; Yibo ZHAO ; Bin ZHAO ; Zhikang XU ; Haibo KE
Journal of Medical Biomechanics 2025;40(2):421-427
Objective To enhance the mechanical properties of trichiral honeycomb sandwich structures and satisfy the design criteria for vertebral implant structures.Methods A chiral-like honeycomb sandwich structure with an auxiliary support structure was constructed for optimal design.The finite element method was used to study the influence of the auxiliary support structure on the chiral-like honeycomb sandwich structure and the relationship between the support position and mechanical property parameters.Furthermore,the influence of the deformation mechanism of different structures on mechanical properties was discussed.Results All chiral-like honeycomb sandwich structures exhibited enhanced mechanical properties in comparison to trichiral honeycomb sandwich structures.The mechanical properties of the chiral-like dCW honeycomb sandwich structure with the auxiliary support structure positioned perpendicular to the ligament were optimal,and this position represented the optimal support position.When the volume was used as a control variable,the compressive stiffness,stiffness-to-mass ratio,and transverse strain of the chiral-like honeycomb sandwich structure in the x1 direction were significantly correlated with the change of the support position,and all of them were positively correlated.Conclusions As a novel chiral-like honeycomb structure,it provides a biomechanical basis for the optimal design and clinical application of honeycomb sandwich structures as vertebral implant structures.
4.Structural Optimization Design of Chiral-Like Honeycomb Sandwich Vertebral Implants Using Finite Element Methods
Wenbin NIE ; Yuan GUO ; Xushu ZHANG ; Yibo ZHAO ; Bin ZHAO ; Zhikang XU ; Haibo KE
Journal of Medical Biomechanics 2025;40(2):421-427
Objective To enhance the mechanical properties of trichiral honeycomb sandwich structures and satisfy the design criteria for vertebral implant structures.Methods A chiral-like honeycomb sandwich structure with an auxiliary support structure was constructed for optimal design.The finite element method was used to study the influence of the auxiliary support structure on the chiral-like honeycomb sandwich structure and the relationship between the support position and mechanical property parameters.Furthermore,the influence of the deformation mechanism of different structures on mechanical properties was discussed.Results All chiral-like honeycomb sandwich structures exhibited enhanced mechanical properties in comparison to trichiral honeycomb sandwich structures.The mechanical properties of the chiral-like dCW honeycomb sandwich structure with the auxiliary support structure positioned perpendicular to the ligament were optimal,and this position represented the optimal support position.When the volume was used as a control variable,the compressive stiffness,stiffness-to-mass ratio,and transverse strain of the chiral-like honeycomb sandwich structure in the x1 direction were significantly correlated with the change of the support position,and all of them were positively correlated.Conclusions As a novel chiral-like honeycomb structure,it provides a biomechanical basis for the optimal design and clinical application of honeycomb sandwich structures as vertebral implant structures.
5.Application of prostate health index and prostate health index density in the detection of intermediate-to high-risk prostate cancer
Chenchen CHEN ; Yinghao ZHOU ; Yaozong XU ; Yibo MENG ; Guowei SHI ; Jun ZHANG ; Wandong YU
Journal of Modern Urology 2025;30(8):642-647,700
Objective To evaluate the diagnostic value of prostate health index(PHI)and prostate health index density(PHID)in identifying intermediate-to high-risk prostate cancer(PCa).Methods Clinical data of 160 treatment-na?ve patients with highly suspected PCa,who underwent initial prostate biopsy in our hospital during Jul.2022 and Feb.2024,were retrospectively analyzed.Data included age,body mass index(BMI),prostate volume(PV),total prostate-specific antigen(tPSA),free PSA(fPSA),[-2]proPSA(p2PSA),PHI and PHID.Biopsy-positive results were stratified according to the EAU D'Amico risk criteria.Receiver operating characteristic(ROC)curve and multivariate logistic regression analysis were employed to assess the diagnostic performance of PHI and PHID in predicting PCa and identifying intermediate-to high-risk PCa.Results There were statistically significant differences in tPSA,p2PSA,PHI and PHID between the negative and positive groups,as well as among the low-,medium-and high-risk groups(P<0.01).Both PHI and PHID demonstrated good diagnostic performance in predicting PCa(AUC=0.820 8 and 0.875 7,respectively;all P<0.001),and in identifying intermediate-to high-risk PCa(AUC=0.838 0 and 0.878 3,respectively;all P<0.001).Compared to the baseline model,the incorporation of PHI and PHID individually into the multivariate model significantly improved the screening performance for PCa(AUC=0.910 and 0.898,respectively;all P<0.001).Conclusion PHI and PHID exhibit high diagnostic efficacy in screening PCa,particularly in identifying intermediate-to high-risk disease.
6.Efficacy and the influence on anal function of surgery combined with ustekinumab in active Crohn's disease patients with perianal fistula
Simin XU ; Yibo YAO ; Yikun LI ; Tingting ZHANG ; Yang LIU ; Yingxin FU ; Chen WANG
Chinese Journal of Inflammatory Bowel Diseases 2025;09(1):59-66
Objective:To evaluate the long-term clinical efficacy and the influence on anal function of surgery combined with ustekinumab (UST) in active Crohn's disease (CD) patients with perianal fistula.Methods:A retrospective cohort study was conducted. Clinical data of active CD patients with perianal fistula undergoing surgery combined with UST at Longhua Hospital of Shanghai University of Traditional Chinese Medicine from August 2020 to December 2022 were collected. The primary endpoints were clinical healing rate, Wexner score, and anorectal manometry values at week 52 of treatment. Secondary endpoints included the Crohn's disease activity index (CDAI), perianal Crohn's disease activity index (PDAI), laboratory indicators [C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), fecal calprotectin (FC) ], endoscopic remission rate, Van Assche score, and radiographic healing rate at week 52 of treatment.Results:A total of 28 patients were included, with 22 males (78.6%) and 6 females (21.4%) ; age (25.2 ± 7.7) (16.0-52.0) years. There was 1 patient (3.6%) of simple anal fistula. There were 27 patients (96.4%) of complex anal fistulas, including 12 of high intersphincteric type, 15 of high transsphincteric type, in which 15 with branched tracts (or ≥2 fistula tracts). The pre-treatment CDAI was 187.0 (156.0, 245.0), and the PDAI was 10.0 (9.0, 12.0). Among the 28 patients, 23 (82.1%) underwent fistulotomy, 1 (3.6%) underwent transanal opening of intersphincteric space (TROPIS), and 4 (14.3%) underwent video-assisted anal fistula treatment (VAAFT) combined with fistula-tract laser closure (FiLaC). All the patients received UST treatment postoperatively, without concurrent use of immunosuppressants or corticosteroid therapy. At week 52 of treatment, 28 (100%) patients achieved clinical healing. Compared to pre-treatment, Wexner score of patients at week 52 of treatment was significantly lower [0 (0, 0) vs. 1.0 (0, 3.0), P < 0.001], maximum anal sphincter pressure increased [ (137.6±40.9) mmHg vs. (105.1±29.2) mmHg, P < 0.001], maximum anal sphincter contraction time extended [9.0 (5.0, 15.0) s vs. 4.0 (2.0, 6.0) s, P < 0.001], and there was no significant decrease in anal resting pressure ( P > 0.05). Compared to pre-treatment, CDAI, PDAI, Van Assche scores, and simple endoscopic score for Crohn's disease (SES-CD) of patients at week 52 of treatment all significantly decreased (all P < 0.001), and CRP, ESR, and FC all decreased (all P < 0.05), with statistically significant differences. The radiographic healing rate at week 52 of treatment was 75.0% (21/28), and the radiographic remission rate was 92.9% (26/28). The endoscopic remission rate was 57.1% (16/28), and the endoscopic response rate was 82.1% (23/28) . Conclusion:The long-term clinical healing rate of active CD patients with perianal fistula receiving surgery combined with UST is high, and the anal function can be improved significantly.
7.Effects of different volumes of ropivacaine for iliopsoas muscle plane block on quadriceps strength in patients undergoing hip arthroplasty
Jin HUANG ; Yanan HAN ; Shengyu WANG ; Yanhui BAI ; Xu CHEN ; Yibo LIU ; Kefei ZHAO ; Chunguang WANG
Chinese Journal of Anesthesiology 2025;45(3):320-324
Objective:To evaluate the effects of different volumes of ropivacaine for iliopsoas muscle plane block on quadriceps strength in patients undergoing hip arthroplasty.Methods:In this prospective study, 75 patients of either sex, aged 40-80 yr, with a body mass index of 18.5-30.0 kg/m 2, of American Society of Anesthesiologists Physical Status classification Ⅰ-Ⅲ, undergoing elective hip arthroplasty from June to December 2023 at Baoding First Central Hospital, were randomized into 3 groups ( n=25 each) by using a computer-generated randomization sequence: ropivacaine 5 ml group (group Ⅰ), ropivacaine 10 ml group (group Ⅱ), and ropivacaine 15 ml group (group Ⅲ). Before induction of anesthesia, iliopsoas muscle plane block was performed with 0.5% ropivacaine 5, 10 and 15 ml in Ⅰ, Ⅱ and Ⅲ groups, respectively. The lateral femoral cutaneous nerve block was carried out using 0.5% ropivacaine 5 ml in all the three groups. The quadriceps muscle strength and status of quadriceps motor block in the affected limb were assessed on admission to postanesthesia care unit (PACU) and at 2, 4, 6, 24 and 48 h after surgery. The consumption of dezocine, score for patient′s satisfaction with analgesia, and occurrence of complications were recorded. Results:Compared with group Ⅰ, the quadriceps muscle strength scores were significantly decreased on admission to PACU and at 2, 4 and 6 h postoperatively in group Ⅲ, the rate of quadriceps motor block was significantly increased on admission to PACU in group Ⅱ, and the rate of quadriceps motor block was significantly increased on admission to PACU and at 2 and 4 h postoperatively in group Ⅲ ( P<0.05), and the consumption of dezocine was significantly decreased in group Ⅱ and group Ⅲ ( P<0.05). Conclusions:The recommended volume of ropivacaine for iliopsoas plane block is 10 ml in patients undergoing hip arthroplasty.
8.A randomized,double-blind,placebo-controlled,multicenter clinical study of Shengxuebao Mixture in treating cancer-related anemia
Zhu LIU ; Xiangrong LI ; Xiaojun DAI ; Yanjun WANG ; Xiao LI ; Keqiong WANG ; Tao WU ; Miaowen ZHONG ; Hongjiang YU ; Ji FENG ; Zuowei HU ; Kainan LI ; Shaowei CHEN ; Chunhua LI ; Zhengchuan FU ; Rui ZHANG ; Yongfa CHEN ; Hongyu XU ; Tao REN ; Yibo YAO ; Jianxu JIN ; Pengyin WANG ; Zhijiang HE ; Jian SHEN ; Lei WANG ; Min LI ; Wenming CHANG ; Xinyi CHEN ; Li HOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(10):1447-1459
Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.
9.Application of prostate health index and prostate health index density in the detection of intermediate-to high-risk prostate cancer
Chenchen CHEN ; Yinghao ZHOU ; Yaozong XU ; Yibo MENG ; Guowei SHI ; Jun ZHANG ; Wandong YU
Journal of Modern Urology 2025;30(8):642-647,700
Objective To evaluate the diagnostic value of prostate health index(PHI)and prostate health index density(PHID)in identifying intermediate-to high-risk prostate cancer(PCa).Methods Clinical data of 160 treatment-na?ve patients with highly suspected PCa,who underwent initial prostate biopsy in our hospital during Jul.2022 and Feb.2024,were retrospectively analyzed.Data included age,body mass index(BMI),prostate volume(PV),total prostate-specific antigen(tPSA),free PSA(fPSA),[-2]proPSA(p2PSA),PHI and PHID.Biopsy-positive results were stratified according to the EAU D'Amico risk criteria.Receiver operating characteristic(ROC)curve and multivariate logistic regression analysis were employed to assess the diagnostic performance of PHI and PHID in predicting PCa and identifying intermediate-to high-risk PCa.Results There were statistically significant differences in tPSA,p2PSA,PHI and PHID between the negative and positive groups,as well as among the low-,medium-and high-risk groups(P<0.01).Both PHI and PHID demonstrated good diagnostic performance in predicting PCa(AUC=0.820 8 and 0.875 7,respectively;all P<0.001),and in identifying intermediate-to high-risk PCa(AUC=0.838 0 and 0.878 3,respectively;all P<0.001).Compared to the baseline model,the incorporation of PHI and PHID individually into the multivariate model significantly improved the screening performance for PCa(AUC=0.910 and 0.898,respectively;all P<0.001).Conclusion PHI and PHID exhibit high diagnostic efficacy in screening PCa,particularly in identifying intermediate-to high-risk disease.
10.Interleukin-33 Knockout Promotes High Mobility Group Box 1 Release from Astrocytes by Acetylation Mediated by P300/CBP-Associated Factor in Experimental Autoimmune Encephalomyelitis.
Yifan XIAO ; Liyan HAO ; Xinyi CAO ; Yibo ZHANG ; Qingqing XU ; Luyao QIN ; Yixuan ZHANG ; Yangxingzi WU ; Hongyan ZHOU ; Mengjuan WU ; Mingshan PI ; Qi XIONG ; Youhua YANG ; Yuran GUI ; Wei LIU ; Fang ZHENG ; Xiji SHU ; Yiyuan XIA
Neuroscience Bulletin 2025;41(7):1181-1197
High mobility group box 1 (HMGB1), when released extracellularly, plays a pivotal role in the development of spinal cord synapses and exacerbates autoimmune diseases within the central nervous system. In experimental autoimmune encephalomyelitis (EAE), a condition that models multiple sclerosis, the levels of extracellular HMGB1 and interleukin-33 (IL-33) have been found to be inversely correlated. However, the mechanism by which IL-33 deficiency enhances HMGB1 release during EAE remains elusive. Our study elucidates a potential signaling pathway whereby the absence of IL-33 leads to increased binding of P300/CBP-associated factor with HMGB1 in the nuclei of astrocytes, upregulating HMGB1 acetylation and promoting its release from astrocyte nuclei in the spinal cord of EAE mice. Conversely, the addition of IL-33 counteracts the TNF-α-induced increase in HMGB1 and acetylated HMGB1 levels in primary astrocytes. These findings underscore the potential of IL-33-associated signaling pathways as a therapeutic target for EAE treatment.
Animals
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Encephalomyelitis, Autoimmune, Experimental/metabolism*
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Astrocytes/metabolism*
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Interleukin-33/metabolism*
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HMGB1 Protein/metabolism*
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Acetylation
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Mice, Knockout
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Mice, Inbred C57BL
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p300-CBP Transcription Factors/metabolism*
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Mice
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Spinal Cord/metabolism*
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Cells, Cultured
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Female
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Signal Transduction

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