1.Comparative efficacy of O-arm navigation-assisted versus C-arm-guided percutaneous vertebroplasty for postoperative recurrent vertebral fractures following Kümmell′s disease
Kun WANG ; Wei MEI ; Zhenhui ZHANG ; Yaojun DAI ; Shuang CHEN ; Xiaopan CHANG ; Yili LI ; Jinlu WANG ; Yong YANG
Chinese Journal of Trauma 2025;41(8):732-739
Objective:To compare the clinical efficacy of O-arm navigation-assisted percutaneous vertebroplasty (PVP) versus C-arm-guided PVP in the treatment of postoperative recurrent vertebral fractures following Kümmell′s disease.Methods:A retrospective cohort study was conducted to analyze the clinical data of 48 patients with postoperative recurrent vertebral fractures following Kümmell′s disease who were admitted to Zhengzhou Orthopedic Hospital from January 2021 to September 2024, including 16 males and 32 females, aged 51-85 years [(69.8±6.6)years]. Among them, 21 patients had stage I Kümmell′s disease and 27 stage II. Fractured vertebrae involved T 8-T 10 in 4 patients, T 11-L 2 in 29, and L 3-L 5 in 15. Twenty-five patients underwent O-arm navigation-assisted PVP (O-arm-assisted group) and 23 underwent C-arm-guided PVP (C-arm-guided group). The two groups were compared in terms of the operative time, intraoperative blood loss, bone cement volume, and bone cement filling saturation rate in the injured vertebral body. The visual analogue scale (VAS) scores and Oswestry disability index (ODI) values were also compared before operation, at 1 day, 1 month, 6 months after operation, and at the last follow-up. The excellent-good rate based on the MacNab criteria at the last follow-up and incidence of postoperative complications were detected. Results:All the patients were followed up for 6-24 months [(13.3±3.5)months]. There were no significant differences in the operative time, operative blood loss or bone cement volume between the two groups ( P>0.05). The O-arm-assisted group demonstrated a bone cement filling saturation rate of 96% (24/25) in the fractured vertebrae, significantly higher than 65% (15/23) in the C-arm-guided group ( P<0.05). The VAS scores before operation, at 1 day, and 1 month after operation were (8.4±1.0)points, (1.9±0.7)points, and (1.8±0.6)points, respectively in the O-arm-assisted group, while they were (8.3±0.8)points, (2.0±0.6)points, and (1.9±0.5)points, respectively in the C-arm-guided group ( P>0.05). The ODI values before operation, at 1 day, and 1 month after operation were 76.6±8.2, 20.4±4.5, and 19.8±4.1, respectively in the O-arm-assisted group, and 74.9±9.1, 21.3±3.6, and 20.9±3.2, respectively in the O-arm-assisted group ( P>0.05). At 6 months after operation and at the last follow-up, the VAS scores were (1.4±0.5)points and (1.5±0.5)points in the O-arm-assisted group, with significant improvement compared to (1.8±0.4)points and (1.9±0.3)points in the C-arm-guided group ( P<0.01); the ODI values were 17.8±3.2 and 18.2±3.5 in the O-arm-assisted group, with significant improvement compared to 19.9±3.1 and 21.3±4.0 in the C-arm-guided group ( P<0.05). Both groups demonstrated significant improvements in VAS scores and ODI values at 1 day, 1 month, 6 months after operation, and at the last follow-up, compared to those preoperatively ( P<0.05), while no statistically significant differences were found in VAS scores or ODI values at any postoperative timepoints ( P>0.05). According to the MacNab criteria, the O-arm-assisted group had a 100% (25/25) excellent-good rate, compared to 74% (17/23) in the C-arm-guided group ( P<0.05). The complication rate was 4% (1/25) in the O-arm-assisted group, significantly lower than 35% (8/23) in the C-arm-guided group ( P<0.05). Conclusion:O-arm navigation-assisted PVP for postoperative recurrent vertebral fractures following Kümmell′s disease offers advantages in precise cement delivery with sufficient dispersion, enhanced pain relief, functional recovery, improved quality of life, and reduced complication rates when compared to C-arm navigation-assisted PVP.
2.Causal relationship between periodontal disease and prostate cancer:A two-sample bidirectional Mendelian randomization analysis in two races
Xiaoxu JIN ; Jing LIU ; Xiaodong ZHAO ; Wenyi HUANG ; Ning DONG ; Shihao WANG ; Mengfei MA ; Yulin ZHOU ; Yuhao CHEN ; Jinlu SUN ; Jie DONG ; Jun HU ; Song XU
National Journal of Andrology 2025;31(10):885-890
Objective The aim of this study is to discuss the causal relationship between periodontal disease(PD)and prostate cancer(PCa).Methods A two-sample bidirectional Mendelian randomization(MR)analysis based on publicly statistical data from genome-wide association studies(GWAS)was conducted.MR Egger,weighted medium,simple mode and weighted mode were supplemented,while inverse variance weighted analysis(IVW)was the main method of analysis.Heterogeneity testing,pleiotropy testing and leave-one-out testing were used to assess the sensitivity and stabili-ty.Results The results of MR analysis showed that PD had no significant impact on the occurrence of PCa:East Asian(IVW,PD:OR=1.07,P=0.48);European(IVW,PD:OR=1.00,P=0.37,periodontitis:OR=1.03,P=0.14,chronic gingivitis:OR=0.99,P=0.37,chronic periodontitis:OR=1.03,P=0.22).The reverse MR analysis also did not show a causal relationship between PCa and PD:East Asian(IVW,PD:OR=0.97,P=0.22);European(IVW,PD:OR=0.84,P=0.44,periodontitis:OR=1.01,P=0.75,chronic gingivitis:OR=0.93,P=0.23,chronic periodontitis:OR=0.99,P=0.80).The results of other analysis were consistent with those of IVW analysis.Conclusions The results of our two-sample bidirectional MR analysis do not support a causal relationship between PD and PCa.
3.Causal relationship between periodontal disease and prostate cancer:A two-sample bidirectional Mendelian randomization analysis in two races
Xiaoxu JIN ; Jing LIU ; Xiaodong ZHAO ; Wenyi HUANG ; Ning DONG ; Shihao WANG ; Mengfei MA ; Yulin ZHOU ; Yuhao CHEN ; Jinlu SUN ; Jie DONG ; Jun HU ; Song XU
National Journal of Andrology 2025;31(10):885-890
Objective The aim of this study is to discuss the causal relationship between periodontal disease(PD)and prostate cancer(PCa).Methods A two-sample bidirectional Mendelian randomization(MR)analysis based on publicly statistical data from genome-wide association studies(GWAS)was conducted.MR Egger,weighted medium,simple mode and weighted mode were supplemented,while inverse variance weighted analysis(IVW)was the main method of analysis.Heterogeneity testing,pleiotropy testing and leave-one-out testing were used to assess the sensitivity and stabili-ty.Results The results of MR analysis showed that PD had no significant impact on the occurrence of PCa:East Asian(IVW,PD:OR=1.07,P=0.48);European(IVW,PD:OR=1.00,P=0.37,periodontitis:OR=1.03,P=0.14,chronic gingivitis:OR=0.99,P=0.37,chronic periodontitis:OR=1.03,P=0.22).The reverse MR analysis also did not show a causal relationship between PCa and PD:East Asian(IVW,PD:OR=0.97,P=0.22);European(IVW,PD:OR=0.84,P=0.44,periodontitis:OR=1.01,P=0.75,chronic gingivitis:OR=0.93,P=0.23,chronic periodontitis:OR=0.99,P=0.80).The results of other analysis were consistent with those of IVW analysis.Conclusions The results of our two-sample bidirectional MR analysis do not support a causal relationship between PD and PCa.
4.Comparative efficacy of O-arm navigation-assisted versus C-arm-guided percutaneous vertebroplasty for postoperative recurrent vertebral fractures following Kümmell′s disease
Kun WANG ; Wei MEI ; Zhenhui ZHANG ; Yaojun DAI ; Shuang CHEN ; Xiaopan CHANG ; Yili LI ; Jinlu WANG ; Yong YANG
Chinese Journal of Trauma 2025;41(8):732-739
Objective:To compare the clinical efficacy of O-arm navigation-assisted percutaneous vertebroplasty (PVP) versus C-arm-guided PVP in the treatment of postoperative recurrent vertebral fractures following Kümmell′s disease.Methods:A retrospective cohort study was conducted to analyze the clinical data of 48 patients with postoperative recurrent vertebral fractures following Kümmell′s disease who were admitted to Zhengzhou Orthopedic Hospital from January 2021 to September 2024, including 16 males and 32 females, aged 51-85 years [(69.8±6.6)years]. Among them, 21 patients had stage I Kümmell′s disease and 27 stage II. Fractured vertebrae involved T 8-T 10 in 4 patients, T 11-L 2 in 29, and L 3-L 5 in 15. Twenty-five patients underwent O-arm navigation-assisted PVP (O-arm-assisted group) and 23 underwent C-arm-guided PVP (C-arm-guided group). The two groups were compared in terms of the operative time, intraoperative blood loss, bone cement volume, and bone cement filling saturation rate in the injured vertebral body. The visual analogue scale (VAS) scores and Oswestry disability index (ODI) values were also compared before operation, at 1 day, 1 month, 6 months after operation, and at the last follow-up. The excellent-good rate based on the MacNab criteria at the last follow-up and incidence of postoperative complications were detected. Results:All the patients were followed up for 6-24 months [(13.3±3.5)months]. There were no significant differences in the operative time, operative blood loss or bone cement volume between the two groups ( P>0.05). The O-arm-assisted group demonstrated a bone cement filling saturation rate of 96% (24/25) in the fractured vertebrae, significantly higher than 65% (15/23) in the C-arm-guided group ( P<0.05). The VAS scores before operation, at 1 day, and 1 month after operation were (8.4±1.0)points, (1.9±0.7)points, and (1.8±0.6)points, respectively in the O-arm-assisted group, while they were (8.3±0.8)points, (2.0±0.6)points, and (1.9±0.5)points, respectively in the C-arm-guided group ( P>0.05). The ODI values before operation, at 1 day, and 1 month after operation were 76.6±8.2, 20.4±4.5, and 19.8±4.1, respectively in the O-arm-assisted group, and 74.9±9.1, 21.3±3.6, and 20.9±3.2, respectively in the O-arm-assisted group ( P>0.05). At 6 months after operation and at the last follow-up, the VAS scores were (1.4±0.5)points and (1.5±0.5)points in the O-arm-assisted group, with significant improvement compared to (1.8±0.4)points and (1.9±0.3)points in the C-arm-guided group ( P<0.01); the ODI values were 17.8±3.2 and 18.2±3.5 in the O-arm-assisted group, with significant improvement compared to 19.9±3.1 and 21.3±4.0 in the C-arm-guided group ( P<0.05). Both groups demonstrated significant improvements in VAS scores and ODI values at 1 day, 1 month, 6 months after operation, and at the last follow-up, compared to those preoperatively ( P<0.05), while no statistically significant differences were found in VAS scores or ODI values at any postoperative timepoints ( P>0.05). According to the MacNab criteria, the O-arm-assisted group had a 100% (25/25) excellent-good rate, compared to 74% (17/23) in the C-arm-guided group ( P<0.05). The complication rate was 4% (1/25) in the O-arm-assisted group, significantly lower than 35% (8/23) in the C-arm-guided group ( P<0.05). Conclusion:O-arm navigation-assisted PVP for postoperative recurrent vertebral fractures following Kümmell′s disease offers advantages in precise cement delivery with sufficient dispersion, enhanced pain relief, functional recovery, improved quality of life, and reduced complication rates when compared to C-arm navigation-assisted PVP.
5.Cocktail hepatocarcinoma therapy by a super-assembled nano-pill targeting XPO1 and ATR synergistically
Liuyun GONG ; Yinliang LU ; Jing WANG ; Xinyue LI ; Jing ZHAO ; Yuetong CHEN ; Rongze MA ; Jinlu MA ; Tianya LIU ; Suxia HAN
Journal of Pharmaceutical Analysis 2023;13(6):603-615
Intensive cancer treatment with drug combination is widely exploited in the clinic but suffers from inconsistent pharmacokinetics among different therapeutic agents.To overcome it,the emerging nanomedicine offers an unparalleled opportunity for encapsulating multiple drugs in a nano-carrier.Herein,a two-step super-assembled strategy was performed to unify the pharmacokinetics of a pep-tide and a small molecular compound.In this proof-of-concept study,the bioinformatics analysis firstly revealed the potential synergies towards hepatoma therapy for the associative inhibition of exportin 1(XPO1)and ataxia telangiectasia mutated-Rad3-related(ATR),and then a super-assembled nano-pill(gold nano drug carrier loaded AZD6738 and 97-110 amino acids of apoptin(AP)(AA@G))was con-structed through camouflaging AZD6738(ATR small-molecule inhibitor)-binding human serum albumin onto the AP-Au supramolecular nanoparticle.As expected,both in vitro and in vivo experiment results verified that the AA@G possessed extraordinary biocompatibility and enhanced therapeutic effect through inducing cell cycle arrest,promoting DNA damage and inhibiting DNA repair of hepatoma cell.This work not only provides a co-delivery strategy for intensive liver cancer treatment with the clinical translational potential,but develops a common approach to unify the pharmacokinetics of peptide and small-molecular compounds,thereby extending the scope of drugs for developing the advanced com-bination therapy.
6.Analysis on efficacy and safety of ustekinumab in Crohn′s disease patients
Juntao LU ; Xitao XU ; Tianrong WANG ; Wenmei YU ; Qi FENG ; Yunqi YAN ; Mingming ZHU ; Zhihua RAN ; Jinlu TONG
Chinese Journal of Inflammatory Bowel Diseases 2023;07(1):37-42
Objective:To evaluate the efficacy and safety of ustekinumab (UST) for Crohn′s disease (CD) .Methods:A retrospective cohort study was conducted to collect clinical data of CD patients with active lesions in colonoscopy before the treatment of UST in Renji Hospital of Shanghai Jiaotong University School of Medicine from May 2020 to September 2021. Primary endpoint was the endoscopic response and remission rates at the 24th/32th week after the treatment of UST.Results:A total of 36 CD patients who were endoscopically active at baseline [25 men, 11 women; mean age, 29.8±8.7 years; disease duration, 38.0 (15.5, 66.1) months] were included. According to Montreal classification, 4 patients (11.1%) were L1 type (terminal ileum) , 4 (11.1%) were L2 type (colon) , 28 (77.8%) belonged to L3 type (ileocolon) , and upper digestive tract involvement occurred in 4 (11.1%) . As for disease behavior, 28 patients (77.8%) had non-structuring and non-penetrating lesions; 5 (13.9%) had structuring lesions and 3 (8.3%) had penetrating lesions. (1) Endoscopic activity: At the 24th/32th week, the endoscopic remission rate and response rate were 33.3% (12/36) and 63.9% (23/36) , respectively. There was no statistically significant difference in endoscopic remission rate and response rate between first-line and second-line usages of UST (all P>0.05) . (2) Clinical activity: Among the 36 patients, 16 were in the clinical active phase, and 20 patients were in the clinical remission phase at baseline. The clinical remission rate and clinical response rate of 16 clinical active patients at the 24th/32th week were 81.2% and 93.8% respectively. (3) Radiological activity: Twenty-seven patients completed the radiological evaluation at the 24th/32th week. In 3 patients with L1 lesions, 2 achieved response or partial response and no response in 1. In 24 patients with L3 lesions, radiological response occurred in 5 patients (20.8%) , partial response in 19 (79.2%) , and no response in 5 (20.8%) . In 19 patients with active perianal fistula at baseline, 6 achieved healing fistule at the 24th/32th week, 2 had partial response, 6 remained stable, while progress were seen in the other 5. (4) Serological and nutritive index: Compared with baseline values, the body mass index, hemoglobin and serum albumin levels of patients were significantly improved at the 24th/32th week (all P<0.05) , but the level of C-reactive protein and erythrocyte sedimentation rate at the 24th/32th week showed no significant difference (all P>0.05) . (5) Safety: No serious adverse events and infusion reactions were observed, and adverse events occurred in 2 patients. Conclusion:UST can effectively improve the endoscopic manifestations, clinical symptoms, imaging and nutritive index of CD patients with good safety.
7.Analysis on efficacy and safety of ustekinumab in Crohn′s disease patients
Juntao LU ; Xitao XU ; Tianrong WANG ; Wenmei YU ; Qi FENG ; Yunqi YAN ; Mingming ZHU ; Zhihua RAN ; Jinlu TONG
Chinese Journal of Inflammatory Bowel Diseases 2023;07(1):37-42
Objective:To evaluate the efficacy and safety of ustekinumab (UST) for Crohn′s disease (CD) .Methods:A retrospective cohort study was conducted to collect clinical data of CD patients with active lesions in colonoscopy before the treatment of UST in Renji Hospital of Shanghai Jiaotong University School of Medicine from May 2020 to September 2021. Primary endpoint was the endoscopic response and remission rates at the 24th/32th week after the treatment of UST.Results:A total of 36 CD patients who were endoscopically active at baseline [25 men, 11 women; mean age, 29.8±8.7 years; disease duration, 38.0 (15.5, 66.1) months] were included. According to Montreal classification, 4 patients (11.1%) were L1 type (terminal ileum) , 4 (11.1%) were L2 type (colon) , 28 (77.8%) belonged to L3 type (ileocolon) , and upper digestive tract involvement occurred in 4 (11.1%) . As for disease behavior, 28 patients (77.8%) had non-structuring and non-penetrating lesions; 5 (13.9%) had structuring lesions and 3 (8.3%) had penetrating lesions. (1) Endoscopic activity: At the 24th/32th week, the endoscopic remission rate and response rate were 33.3% (12/36) and 63.9% (23/36) , respectively. There was no statistically significant difference in endoscopic remission rate and response rate between first-line and second-line usages of UST (all P>0.05) . (2) Clinical activity: Among the 36 patients, 16 were in the clinical active phase, and 20 patients were in the clinical remission phase at baseline. The clinical remission rate and clinical response rate of 16 clinical active patients at the 24th/32th week were 81.2% and 93.8% respectively. (3) Radiological activity: Twenty-seven patients completed the radiological evaluation at the 24th/32th week. In 3 patients with L1 lesions, 2 achieved response or partial response and no response in 1. In 24 patients with L3 lesions, radiological response occurred in 5 patients (20.8%) , partial response in 19 (79.2%) , and no response in 5 (20.8%) . In 19 patients with active perianal fistula at baseline, 6 achieved healing fistule at the 24th/32th week, 2 had partial response, 6 remained stable, while progress were seen in the other 5. (4) Serological and nutritive index: Compared with baseline values, the body mass index, hemoglobin and serum albumin levels of patients were significantly improved at the 24th/32th week (all P<0.05) , but the level of C-reactive protein and erythrocyte sedimentation rate at the 24th/32th week showed no significant difference (all P>0.05) . (5) Safety: No serious adverse events and infusion reactions were observed, and adverse events occurred in 2 patients. Conclusion:UST can effectively improve the endoscopic manifestations, clinical symptoms, imaging and nutritive index of CD patients with good safety.
8.Design and Experimental Research of Portable Extracorporeal Circulation Pipeline Performance Testing System.
Song LIU ; Ganying WANG ; Yihan WANG ; Ling PENG ; Jinlu ZHENG
Chinese Journal of Medical Instrumentation 2022;46(2):164-167
Aiming at the current situation of performance testing of hemodialysis extracorporeal circulation tubing, which has slow efficiency, inaccurate measurement, and inconvenient testing, a portable detection system for testing the performance of hemodialysis extracorporeal circulation tubing is designed. The system mainly includes a hardware system and a software system. The hardware system uses STM32F407 single-chip microcomputer as the core to design the driving control of the roller pump; the software system uses the C++ real-time operating system, and the flow detection data is transmitted to the upper computer through RS485 communication and displayed. Experimental showed that the system detects the accuracy and the stability of the flow rate. It has the characteristics of stability and high precision. The relative error of the experimental measurement is within the range of ±10%. The weight of the whole machine is 2 kg, which improves the efficiency by 50% compared with the traditional detection method.
Computers
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Equipment Design
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Extracorporeal Circulation
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Microcomputers
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Renal Dialysis
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Software
9.Value of dual energy CT parameters combined with serum procollagen Ⅰ N-terminal propeptide and beta C-terminal cross-linked telopeptide of type Ⅰ collagen in differential diagnosis of spinal bone metastasis from lung cancer and myeloma
Erfeng WU ; Jianping ZHANG ; Jinglong WU ; Xingwei WANG ; Jinlu GUO ; Ningning HAN
Chinese Journal of Postgraduates of Medicine 2022;45(3):257-262
Objective:To analyze the value of dual energy CT parameters combined with serum procollagen Ⅰ N-terminal propeptide (PⅠNP) and beta C-terminal cross-linked telopeptide of type Ⅰ collagen (β-CTX) in differential diagnosis of spinal bone metastasis from lung cancer and myeloma.Methods:The clinical data of 54 patients with spinal bone metastasis from lung cancer and 50 patients with myeloma in Jincheng People′s Hospital from October 2019 to March 2021 were analyzed retrospectively. All patients were examined by dual energy CT on the day of admission, and the CT values at the energy levels of 40 to 80 keV (energy interval of 10 keV) were recorded. The serum PⅠNP and β-CTX levels were detected by chemiluminescent assay before treatment. The pathological examination results were taken as gold standard, and the CT values at the energy levels of 40 to 80 keV by dual energy CT and serum PⅠNP and β-CTX levels were compared between 2 groups. Receiver operating characteristic (ROC) curve was used to analyze the differential diagnosis value of the CT values at the energy levels of 40 to 80 keV, serum PⅠNP and β-CTX levels alone and combination.Results:The CT values at the energy levels of 40 to 80 keV by dual energy CT and serum PⅠNP and β-CTX levels in patients with spinal bone metastasis from lung cancer were significantly higher than those in patients with myeloma: 79.86 (61.20, 116.32) HU vs. 58.29 (46.92, 64.03) HU, 64.48 (50.27, 90.08) HU vs. 45.78 (38.59, 56.75) HU, 57.35 (43.31, 78.04) HU vs. 43.62 (36.91, 54.06) HU, 52.05 (42.98, 75.79) HU vs. 41.26 (32.84, 51.76) HU, 45.52 (38.55, 63.59) HU vs. 36.68 (28.72, 49.83) HU, 66.35 (31.15, 81.97) μg/L vs. 31.38 (27.76, 34.50) μg/L and 0.61 (0.48, 0.67) μg/L vs. 0.49 (0.47, 0.52) μg/L, and there were statistical differences ( P<0.05 or <0.01). ROC curve analysis result showed that the sensitivity of the combination of the CT values at the energy levels of 40 to 80 keV by dual energy CT was higher than those alone (83.33% vs. 59.26%, 61.11%, 62.96%, 64.81% and 66.67), the area under the curve (AUC) was also higher than those alone (0.882 vs. 0.798, 0.811, 0.817, 0.801 and 0.773), and there were statistical differences ( P<0.01 or <0.05); the sensitivity of the combination of serum PⅠNP and β-CTX levels was higher than those alone (81.48% vs. 57.41% and 62.96%), the AUC was higher than those alone (0.829 vs. 0.753 and 0.729), and there were statistical differences ( P<0.01 or <0.05); the sensitivity of all indexes combined in the differential diagnosis of spinal bone metastasis from lung cancer and myeloma was higher than those of the combination of the CT values at the energy levels of 40 to 80 keV by dual energy CT, the combination of serum PⅠNP and β-CTX levels (98.15% vs. 83.33% and 81.48%), the same as AUC (0.976 vs. 0.882 and 0.829), and there were statistical differences ( P<0.01); there were no significant differences in the specificity of each index alone and combination ( P>0.05). Conclusions:Compared with myeloma, the CT values at the energy levels of 40 to 80 keV by dual energy CT, serum PⅠNP and β-CTX levels in patients with spinal bone metastasis from lung cancer are increased, and the combination of the above indexes has ideal value in differential diagnosis of the two diseases.
10.Analysis of the short-term efficacy of tacrolimus in the treatment of refractory Crohn′s disease
Xitao XU ; Biyu WU ; Zhanghan DAI ; Mingming ZHU ; Tianrong WANG ; Jinlu TONG ; Zhihua RAN
Chinese Journal of Inflammatory Bowel Diseases 2022;06(2):115-121
Objective:To assess the short-term efficacy and safety of tacrolimus in patients with refractory Crohn′s disease (CD) , and analyze the influencing factors of clinical response.Methods:A single center restrospective cohort study was conducted. The clinical data of patients with refractory CD in Renji Hospital of Shanghai Jiaotong University School of Medicine from March 2014 to June 2019 were analyzed retrospectively. The patients received tacrolimus treatment for at least 3 months. Clinical response, clinical remission and relapse after tacrolimus treatment were evaluated by Crohn′s disease activity index (CDAI) . According to the existence of clinical response after 3 months of tacrolimus treatment, the patients were divided into clinical response group and non-clinical response group. The differences in clinical data between the 2 groups were assessed by univariate analysis. The variables with P<0.1 in univariate analysis and having clinical significance were further analyzed by multivariate Logistic regression to determine the independent risk factors of clinical response. The receiver operating characteristic (ROC) curve analysis was performed to evaluate the value of risk factors in predicting the clinical response of tacrolimus for the treatment of refractory CD. Results:A total of 45 patients with refractory CD were included, including 31 males and 14 females with the age of 32 (27, 39) years old. The disease duration was 61.0 (28.0, 97.5) months. The CDAI was 203 (175, 229) points before the treatment of tacrolimus while it decreased to 137 (117, 175) points after the treatment of tacrolimus for 3 months, and the difference was significant ( Z = -5.512, P<0.01) . After the treatment of tacrolimus for 3 months, 13 patients (28.9%) with clinical response were set as clinical response group and 32 (71.1%) without clinical response were set as non-clinical response group. Univariate analysis showed that the differences in gender, CDAI before the treatment of tacrolimus and neutrophil-to-lymphocyte ratio (NLR) between the clinical response group and non-clinical response group were statistically significant (all P<0.05) . Gender, CDAI before the treatment of tacrolimus and NLR were included for the multivariate Logistic regression analysis. The results showed that CDAI ( OR = 1.026, 95% CI: 1.006-1.046, P = 0.012) and NLR ( OR = 2.605, 95% CI: 1.290-5.258, P = 0.008) were the independent risk factors for predicting clinical response. The areas under ROC curve of CDAI, NLR and NLR combined with CDAI in predicting clinical response of tacrolimus in patients with refractory CD were 0.786 (95% CI : 0.648-0.924) , 0.764 (95% CI: 0.595-0.934) and 0.861 (95% CI : 0.729-0.992) , the optimal cut-off values were 189.15, 2.82 and 0.31, sensitivities were 100%, 84.6% and 84.6%, and specificities were 53.1%, 71.9% and 84.4%, respectively. Twenty-six patients continued to receive tacrolimus for 12 months, and the clinical remission rate was 73.1% (19/26) and the recurrence rate was 26.9% (7/26) . Forty-five patients were followed up for 1 year, adverse effects occurred in 6 and there was no severe adverse effects during the treatment of tacrolimus. Conclusions:Tacrolimus can be used as an immunosuppressant to induce the remission and maintenance in refractory CD patients. CDAI and NLR can be used as independent indicators to predict the clinical response of tacrolimus in the treatment of patients with refractory CD, and the combination of CDAI and NLR has higher prediction efficiency.

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