1.A prospective randomized controlled study on 3D-printed porous bioceramic artificial bone and artificial bone substitutes in the treatment of limb bone defect
Taoran WANG ; Zhuojing LUO ; Long BI ; Jiakai GAO ; Xiang HE ; Jingdi CHEN ; Jingzhuo JIA ; Hui ZHANG ; Yu WANG
Chinese Journal of Orthopaedics 2025;45(20):1298-1304
Objective:To compare the safety and efficacy of 3D-printed porous bioceramic artificial bone and artificial bone substitutes in the treatment of limb bone defects.Methods:A total of 220 patients with post-traumatic limb bone defects admitted to Xijing Hospital Affiliated to Air Force Medical University of the Chinese People's Liberation Army (34 cases), the Third Hospital of Hebei Medical University (60 cases), Xi'an Honghui Hospital (28 cases), the Third Hospital of Southern Medical University (18 cases), Changsha Third Hospital (28 cases), Foshan Traditional Chinese Medicine Hospital (16 cases), Foshan Fuxing Chancheng Hospital (12 cases), and Henan Provincial Orthopaedic Hospital (24 cases) from May 2022 to October 2023 were included as research subjects. According to the manufacturing method of the bone graft material, the subjects were randomly divided into the 3D printed porous bioceramic artificial bone group (3D printing group) and the artificial bone substitute group (non-3D printing group) at a ratio of 1:1 by the envelope method. Adverse events that might be related to the surgery were selected through correlation evaluation and classified as abnormal laboratory indicators, systemic or other site symptoms and abnormalities, and local symptoms and abnormalities of the affected limb. The safety of the two groups was compared. The bone graft fusion rate, bone defect repair and healing rate, and short form 12 (SF-12) score of the two groups were calculated to evaluate the postoperative recovery.Results:Thirty-two cases were excluded (4 cases refused to use their data after reconsideration, 7 cases were not used after preoperative assessment, and 21 cases exceeded the standard for body mass index and laboratory indicators upon re-examination). A total of 188 cases were randomly divided into the 3D printing group and the non-3D printing group according to the random method, with 94 cases in each group. Among them, 11 cases in the 3D printing group and 9 cases in the non-3D printing group dropped out due to loss to follow-up. Finally, 168 cases completed the follow-up, including 83 cases in the 3D printing group and 85 cases in the non-3D printing group. In the 3D printing group, there were 53 males and 30 females, with an average age of 47.9±12.7 years; in the non-3D printing group, there were 53 males and 32 females, with an average age of 48.6±12.9 years. A total of 51 cases in the two groups experienced adverse events related to the surgery, including 13 cases of abnormal laboratory indicators (5 cases in the 3D printing group and 8 cases in the non-3D printing group), 15 cases of systemic or other site symptoms and abnormalities (9 cases in the 3D printing group and 6 cases in the non-3D printing group), and 23 cases of local symptoms and abnormalities of the affected limb (13 cases in the 3D printing group and 10 cases in the non-3D printing group). There was no statistically significant difference in the incidence of adverse events between the two groups ( P>0.05). The bone graft fusion rates of the 3D printing group and the non-3D printing group at 6 months after surgery were 99%(82/83) and 99%(84/85), respectively, and the bone defect repair and healing rates were 89%(74/83) and 89%(76/85), respectively. At the time of 12 months after surgery, the bone graft fusion rates were 99%(82/83) and 99%(84/85), respectively, and the bone defect repair and healing rates were 94%(78/83) and 92%(78/85), respectively. There was no statistically significant difference in the bone graft fusion rate and bone defect repair and healing rate between the two groups ( P>0.05). The SF-12 scores during the screening period were 27.82±2.96 points and 27.22±4.23 points in the 3D printing group and the non-3D printing group, respectively, and at 3 months after surgery were 28.08±3.13 points and 27.64±3.16 points, at 6 months after surgery were 29.42±3.10 points and 28.55±3.45 points, and at 12 months after surgery were 29.78±2.80 points and 29.58±2.94 points, respectively. There was no statistically significant difference between the groups ( P>0.05). Both groups of surgeries were successfully completed without any serious surgical or bone graft-related complications. Conclusion:The safety and efficacy of 3D-printed porous bioceramic artificial bone in the treatment of limb bone defects are not significantly different from those of currently clinically applied artificial bone substitutes.
2.A prospective randomized controlled study on 3D-printed porous bioceramic artificial bone and artificial bone substitutes in the treatment of limb bone defect
Taoran WANG ; Zhuojing LUO ; Long BI ; Jiakai GAO ; Xiang HE ; Jingdi CHEN ; Jingzhuo JIA ; Hui ZHANG ; Yu WANG
Chinese Journal of Orthopaedics 2025;45(20):1298-1304
Objective:To compare the safety and efficacy of 3D-printed porous bioceramic artificial bone and artificial bone substitutes in the treatment of limb bone defects.Methods:A total of 220 patients with post-traumatic limb bone defects admitted to Xijing Hospital Affiliated to Air Force Medical University of the Chinese People's Liberation Army (34 cases), the Third Hospital of Hebei Medical University (60 cases), Xi'an Honghui Hospital (28 cases), the Third Hospital of Southern Medical University (18 cases), Changsha Third Hospital (28 cases), Foshan Traditional Chinese Medicine Hospital (16 cases), Foshan Fuxing Chancheng Hospital (12 cases), and Henan Provincial Orthopaedic Hospital (24 cases) from May 2022 to October 2023 were included as research subjects. According to the manufacturing method of the bone graft material, the subjects were randomly divided into the 3D printed porous bioceramic artificial bone group (3D printing group) and the artificial bone substitute group (non-3D printing group) at a ratio of 1:1 by the envelope method. Adverse events that might be related to the surgery were selected through correlation evaluation and classified as abnormal laboratory indicators, systemic or other site symptoms and abnormalities, and local symptoms and abnormalities of the affected limb. The safety of the two groups was compared. The bone graft fusion rate, bone defect repair and healing rate, and short form 12 (SF-12) score of the two groups were calculated to evaluate the postoperative recovery.Results:Thirty-two cases were excluded (4 cases refused to use their data after reconsideration, 7 cases were not used after preoperative assessment, and 21 cases exceeded the standard for body mass index and laboratory indicators upon re-examination). A total of 188 cases were randomly divided into the 3D printing group and the non-3D printing group according to the random method, with 94 cases in each group. Among them, 11 cases in the 3D printing group and 9 cases in the non-3D printing group dropped out due to loss to follow-up. Finally, 168 cases completed the follow-up, including 83 cases in the 3D printing group and 85 cases in the non-3D printing group. In the 3D printing group, there were 53 males and 30 females, with an average age of 47.9±12.7 years; in the non-3D printing group, there were 53 males and 32 females, with an average age of 48.6±12.9 years. A total of 51 cases in the two groups experienced adverse events related to the surgery, including 13 cases of abnormal laboratory indicators (5 cases in the 3D printing group and 8 cases in the non-3D printing group), 15 cases of systemic or other site symptoms and abnormalities (9 cases in the 3D printing group and 6 cases in the non-3D printing group), and 23 cases of local symptoms and abnormalities of the affected limb (13 cases in the 3D printing group and 10 cases in the non-3D printing group). There was no statistically significant difference in the incidence of adverse events between the two groups ( P>0.05). The bone graft fusion rates of the 3D printing group and the non-3D printing group at 6 months after surgery were 99%(82/83) and 99%(84/85), respectively, and the bone defect repair and healing rates were 89%(74/83) and 89%(76/85), respectively. At the time of 12 months after surgery, the bone graft fusion rates were 99%(82/83) and 99%(84/85), respectively, and the bone defect repair and healing rates were 94%(78/83) and 92%(78/85), respectively. There was no statistically significant difference in the bone graft fusion rate and bone defect repair and healing rate between the two groups ( P>0.05). The SF-12 scores during the screening period were 27.82±2.96 points and 27.22±4.23 points in the 3D printing group and the non-3D printing group, respectively, and at 3 months after surgery were 28.08±3.13 points and 27.64±3.16 points, at 6 months after surgery were 29.42±3.10 points and 28.55±3.45 points, and at 12 months after surgery were 29.78±2.80 points and 29.58±2.94 points, respectively. There was no statistically significant difference between the groups ( P>0.05). Both groups of surgeries were successfully completed without any serious surgical or bone graft-related complications. Conclusion:The safety and efficacy of 3D-printed porous bioceramic artificial bone in the treatment of limb bone defects are not significantly different from those of currently clinically applied artificial bone substitutes.
3.Real-world study on the efficacy and safety of vedolizumab in the maintenance treatment of ulcerative colitis
Qiao YU ; Jiakai LUO ; Yuting WANG ; Xiaoying WANG ; Dingting XU ; Hanyun ZHANG ; Minfang LYU ; Yan MA ; Shuyan LI ; Xiaoxu HUANG ; Miaoyan CHEN ; Xiujun LIAO ; Dong XU ; Yan CHEN
Chinese Journal of Inflammatory Bowel Diseases 2024;08(2):144-148
Objective:To evaluate the efficacy and safety of vedolizumab (VDZ) monoclonal antibody in maintenance therapy for ulcerative colitis (UC) .Methods:A retrospective case control study was conducted, including 84 patients with active UC undergoing VDZ therapy for an average of (22±8) weeks in the Department of Gastroenterology, the Second Affiliated Hospital of Zhejiang University School of Medicine from December 2020 to September 2023. These patients achieved a response or remission by (22±8) weeks and continued follow-up until (54±8) weeks. They were divided into effective and ineffective groups based on whether they achieved clinical remission by (54±8) weeks after using VDZ; those who required optimized treatment with shortened injection intervals were included in the ineffective group. Baseline clinical data, medication history and endoscopic imaging data were recorded. The clinically modified Mayo score, Mayo endoscopic score, and other assessments were used to evaluate UC disease activity. Adverse reactions related to treatment were also recorded to assess the efficacy of VDZ treatment up to (54±8) weeks was assessed and key factors affecting clinical remission of the disease were analyzed.Results:Among the 84 UC patients with followed up to (54±8) weeks, 47 cases (55.95%) achieved clinical remission and were classified as the effective group, while 37 cases (44.05%) did not achieve clinical remission and were classified as the ineffective group. The endoscopic remission rate in the effective group was 68.09% (32/47), and the mucosal healing rate was 36.17% (17/47). Joint pain occurred in 2.38% of patients, hepatic dysfunction in 3.57%, and one patient died from leukemia following a COVID-19 infection during the maintenance therapy period.Conclusion:VDZ has a certain efficacy in the continuous treatment of UC patients and in maintaining clinical and endoscopic remission, with generally high overall safety and a low incidence of adverse reactions.
4.Real-world study on the efficacy and safety of vedolizumab in the maintenance treatment of ulcerative colitis
Qiao YU ; Jiakai LUO ; Yuting WANG ; Xiaoying WANG ; Dingting XU ; Hanyun ZHANG ; Minfang LYU ; Yan MA ; Shuyan LI ; Xiaoxu HUANG ; Miaoyan CHEN ; Xiujun LIAO ; Dong XU ; Yan CHEN
Chinese Journal of Inflammatory Bowel Diseases 2024;08(2):144-148
Objective:To evaluate the efficacy and safety of vedolizumab (VDZ) monoclonal antibody in maintenance therapy for ulcerative colitis (UC) .Methods:A retrospective case control study was conducted, including 84 patients with active UC undergoing VDZ therapy for an average of (22±8) weeks in the Department of Gastroenterology, the Second Affiliated Hospital of Zhejiang University School of Medicine from December 2020 to September 2023. These patients achieved a response or remission by (22±8) weeks and continued follow-up until (54±8) weeks. They were divided into effective and ineffective groups based on whether they achieved clinical remission by (54±8) weeks after using VDZ; those who required optimized treatment with shortened injection intervals were included in the ineffective group. Baseline clinical data, medication history and endoscopic imaging data were recorded. The clinically modified Mayo score, Mayo endoscopic score, and other assessments were used to evaluate UC disease activity. Adverse reactions related to treatment were also recorded to assess the efficacy of VDZ treatment up to (54±8) weeks was assessed and key factors affecting clinical remission of the disease were analyzed.Results:Among the 84 UC patients with followed up to (54±8) weeks, 47 cases (55.95%) achieved clinical remission and were classified as the effective group, while 37 cases (44.05%) did not achieve clinical remission and were classified as the ineffective group. The endoscopic remission rate in the effective group was 68.09% (32/47), and the mucosal healing rate was 36.17% (17/47). Joint pain occurred in 2.38% of patients, hepatic dysfunction in 3.57%, and one patient died from leukemia following a COVID-19 infection during the maintenance therapy period.Conclusion:VDZ has a certain efficacy in the continuous treatment of UC patients and in maintaining clinical and endoscopic remission, with generally high overall safety and a low incidence of adverse reactions.
5.Correlation between aryl hydrocarbon receptor gene polymorphisms and haplotypes and ulcerative colitis
Limin WU ; Chaoqun WU ; Xiaochun HUANG ; Jiakai LUO ; Zixuan YE ; Weijun HONG ; Zijian LIN ; Yi JIANG
Chinese Journal of Digestion 2018;38(8):548-553
Objective To investigate the correlation between aryl hydrocarbon receptor (A hR) gene polymorphisms and haplotypes and susceptibility of ulcerative colitis (UC) .Methods From January 2010 to October 2017 ,at the Second Affiliated Hospital of Wenzhou Medical University ,the First Affiliated Hospital of Wenzhou Medical University , Central Hospital of Wenzhou City and Wenzhou People Hospital ,a total of 396 UC patients were recruited as the UC group .In the same period ,573 age-and gender-matched healthy individuals were taken as the healthy control group . Three single nucleotide polymorphisms (SNP) of A hR (rs10249788 ,rs2066853 ,rs2158041) were examined by modified multiple ligase detection reaction technique .The correlation between the differences in the frequency of each SNP mutant alleles ,genotypes and clinical pathological features of UC was analyzed by unconditional logistic regression analysis .Haploview 4 .2 software was applied to analyze the linkage disequilibrium (LD) . Results The frequency of mutant allele C and genotype TC+CC of AhR (rs10249788) of UC group were higher than those of the healthy control group (75 .00% ,594/792 vs .69 .98% ,802/1146 ;95 .45% , 378/396 vs .91 .10% ,522/573) ,the differences were statistically significant (odds ratio (OR)=1 .287 , 95% confidence interval (CI) 1 .049 to 1 .579 , P=0 .016 ;OR=2 .052 ,95% CI 1 .180 to 3 .568 , P=0 .011) .Compared with the patients with distal colitis ,the frequencies of mutant allele C and genotype TC +CC of AhR (rs10249788) were higher in the patients with extensive colitis (71 .34% ,341/478 vs . 80 .57% ,253/314;93 .31% ,223/239 vs .98 .73% ,155/157) ,and the differences were statistically significant (OR=1 .666 ,95% CI 1 .183 to 2 .347 ,P=0 .003 ;OR=5 .561 ,95% CI 1 .260 to 24 .530 ,P=0 .023) .The results of LD analysis indicated that rs10249788 and rs2066853 ,rs10249788 and rs2158041 , rs2066853 and rs2158041 were linked to each other (D′=0 .636 ,0 .430 and 0 .980 ;r2 =0 .270 ,0 .023 and 0 .177 ) . Compared with the healthy control group , the frequency of haplotype TAC of UC group decreased (20 .20% ,231 .5/1146 .0 vs .16 .24% ,128 .6/792 .0) ,however the frequency of haplotype CAC increased (14 .43% , 165 .4/1146 .0 vs . 20 .47% , 162 .1/792 .0 ) , and the differences were statistically significant (OR=0 .767 ,95% CI 0 .605 to 0 .973 , P=0 .029 ;OR=1 .529 ,95% CI 1 .204 to 1 .941 ,P<0 .01) .The results of further analysis demonstrated that the frequency of haplotype CGC was higher in patients with extensive colitis than that of patients with distal colitis (38 .69% ,121 .5/314 .0 vs . 29 .48% ,140 .9/478 .0) ,and the difference was statistically significant (OR=1 .511 ,95% CI 1 .119 to 2 .040 ,P= 0 .007) ,while the frequency of haplotype TAC in patients with extensive colitis was lower than that of patients with distal colitis (12 .10% , 38/314 .0 vs . 17 .55% , 83 .9/478 .0 ) , and the difference was statistically significant (OR= 0 .646 ,95% CI 0 .483 to 0 .983 , P= 0 .037) .Conclusion A hR (rs10249788) may be a potential locus affecting susceptibility to UC ,and synergistically influence the risk and the location of UC .

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