1.Comparative study of different treatment methods for peroneus longus tendon stump in anterior cruciate ligament reconstruction.
Peng WANG ; Zhiwei LIU ; Zhonghua SHI ; Fan ZHAO ; Jiawen WANG ; Huan LI
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(12):1526-1531
OBJECTIVE:
To compare the impact of different peroneus longus tendon (PLT) stump management techniques on ankle function following arthroscopic anterior cruciate ligament (ACL) reconstruction with autologous PLT grafts.
METHODS:
A retrospective analysis was conducted on 60 patients with ACL rupture who met the inclusion criteria between August 2020 and July 2024. All patients underwent arthroscopic ACL reconstruction using the autologous PLT grafts. Patients were assigned to group A [PLT stump sutured to peroneus brevis tendon (PBT), n=30] or group B (no stump intervention, n=30). The two groups showed no significant difference ( P>0.05) in baseline data, including gender, age, body mass index, injury mechanism, affected side, preoperative American Orthopaedic Foot and Ankle Society (AOFAS) score, ankle muscle strength, ankle range of motion, and arch-related angles. Postoperative outcomes were assessed using the AOFAS score, ankle muscle strength (eversion and first-ray plantar flexion), arch-related angles (medial/lateral longitudinal and anterior/posterior arch), ankle range of motion (eversion, inversion, dorsiflexion, plantarflexion), and limb symmetry index (LSI). Change values in muscle strength, arch-related angles, and range of motion from preoperative to 12 months postoperatively were calculated for intergroup comparison.
RESULTS:
Groups A and B had comparable PLT graft lengths and diameters ( P>0.05). All patients were followed up 13-16 months (mean, 14.5 months). Postoperative complications included 1 case of incision infection, 1 case of deep vein thrombosis, and 1 case of knee stiffness in group A, 1 case of knee stiffness in group B. There was no significant difference in the overall complication incidences between groups ( P>0.05). No significant difference was found in the AOFAS scores between different time points and between groups ( P>0.05). At 12 months after operation, neither group showed significant changes from preoperative baseline in ankle strength, range of motion, or arch-related angles, and there was no significant difference in these change values between groups ( P>0.05). There was no significant difference in LSI between the two groups at 6 or 12 months postoperatively ( P>0.05).
CONCLUSION
Both suturing and leaving the PLT stump untreated during arthroscopic ACL reconstruction provided comparable ankle outcomes and well-preserved foot and ankle function.
Humans
;
Anterior Cruciate Ligament Reconstruction/methods*
;
Male
;
Retrospective Studies
;
Female
;
Adult
;
Anterior Cruciate Ligament Injuries/surgery*
;
Tendons/transplantation*
;
Range of Motion, Articular
;
Arthroscopy/methods*
;
Young Adult
;
Treatment Outcome
;
Muscle Strength
;
Transplantation, Autologous
;
Ankle Joint/surgery*
;
Middle Aged
;
Adolescent
2.Exploring local microbial communities in adenoids through 16S rRNA gene sequencing.
Luohua YUAN ; Haibing LIU ; Wenli LI ; Zhonghua PENG ; Yuling MA ; Jian ZOU
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(1):51-56
Objective:To explore the hypothesis of "pathogen storage pool" by analyzing the local microbial community of adenoids. Methods:Under the guidance of a 70° nasal endoscope, sterile swabs were used to collect secretions from the adenoid crypts of the subjects. The samples were sent to the laboratory for DNA extraction and standard bacterial 16S full-length sequencing analysis. Results:At the species level, the top three microbial communities in adenoid crypts were Bacillus subtilis(18.78%), Fusobacterium pyogenes(11.42%), and Streptococcus pneumoniae(9.38%). Conclusion:The local microbial community of adenoids exhibits a high degree of diversity, including microbial communities from the oral cavity and gastrointestinal tract. Our research results support the hypothesis that adenoids act as a " pathogen reservoir".
Humans
;
Adenoids/microbiology*
;
RNA, Ribosomal, 16S/genetics*
;
Microbiota/genetics*
;
Streptococcus pneumoniae/isolation & purification*
;
Bacillus subtilis/genetics*
;
DNA, Bacterial/analysis*
3.Comparison of curative effects of NNS-guided MIP and CHE in traumatic intracerebral hemorrhage
Chen JIA ; Zhonghua XU ; Xue JIA ; Peng ZHANG
China Medical Equipment 2025;22(11):87-91
Objective:To investigate the differences of comprehensively curative effect of neuro navigation system(NNS)-guided minimally invasive puncture(MIP)and conventional craniotomy hematoma evacuation(CHE)in treatment for traumatic intracerebral hemorrhage,and analyze the mechanisms of affecting the differences of the trajectories postoperative neurologically functional recovery between two kinds of surgical methods.Methods:Based on the design of multicenter prospective cohort study,a total of 240 patients with traumatic intracerebral parenchymal hemorrhage,who admitted to the Neurosurgery Center of Rugao Hospital of Traditional Chinese Medicine between June 2021 and May 2024,were selected.They were randomized into the NNS group(n=120)and the CHE group(n=120)by using a stratified block randomization method.The NNS group underwent NNS-guided surgical intervention,while the CHE group received conventional craniotomy.The primary endpoint was hematoma evacuation rate at the postoperative 7th day.The secondary endpoints encompassed surgical parameters,complications,and the prognostic indicators of function.Microstructural assessment was performed by using three-dimensional image fusion technique[three-dimensional-T1weighted imaging magnetic resonance imaging(3D-T1WI MRI)combined with thin-slice computed tomography(CT)]and tract-based spatial statistics(TBSS).Results:At the dimension of hematoma evacuation,the average hematoma evacuation rate of NNS group was(88.37±6.52)%at the postoperative 7th day,which was significantly higher than(76.15±10.32)%of CHE group,and the residual hematoma volume of NNS group was(5.23±2.15)mL at the postoperative 7th day,which was less than(11.49±4.78)ml,and the differences of them between two groups were significant(t=9.843,7.015,P<0.05),respectively.The surgical trauma parameters appeared polarization:the mean incision length in the NNS group was(3.15±0.73)cm,which reduced 76.3%of(13.24±2.15)cm of the CHE group,with statistically significant difference(Z=15.327,P<0.05).The operative duration of NNS group was(68.34±15.32)min,which was shorter than(142.56±23.48)min,and the difference was significant(t=29.846,P<0.05).The radiation dose of NNS group was(312.45±85.32)cGy·cm2,which was significantly higher than(45.23±12.15)cGy·cm2 of CHE group,and the difference was significant(Z=24.156,P<0.05).The volume of intraoperative blood transfusion of NNS group was(50.34±25.36)ml,which was significantly less than(325.67±158.32)ml,and the difference was significant(Z=18.943,P<0.05),The result of complication genealogy analysis indicated that the re-bleeding incidence of the NNS group was 6.67%,which decreased by 9.16%than 15.83%of the CHE group,and the difference of that between two groups was statistical significance(x2=5.627,P<0.05).However,there was not significant difference in infection rates and incidences of deep vein thrombosis between the two groups(P>0.05).For functional recovery,the proportion of patients whose modified Rankin Scale(mRS)scores was≤2 at the postoperative 90th day was 52.50%in the NNS group,which increased 13.33%than 39.17%in the CHE group,and the difference of that between two groups was statistical significance(x2=4.302,P<0.05).Additionally,the improvement value of National Institutes of Health Stroke Scale(NIHSS)was(9.34±4.156)in the NNS group,which existed marginal advantage of 2.19 points than(7.15±5.327)of the CHE group,and the difference was significant between two groups(Z=3.842,P<0.05).Conclusion:NNS-guided MIP appears notable advantages in enhancing hematoma evacuation efficiency and improving prognosis of neurological function.However,its increased amount of radiation exposure,and risks of specific complication should be considered.The craniotomy approach remains indispensable for complex hematoma morphologies.
4.Mechanism of stachydrine-induced autophagy in improving atherosclerosis in high-fat-fed mice
Jun YANG ; Peng YIN ; Zhonghua ZHENG
Chinese Journal of Tissue Engineering Research 2025;29(24):5140-5147
BACKGROUND:Stachydrine has anti-inflammatory,antioxidant,and antiplatelet properties that promote angiogenesis and has potential benefits on the cardiovascular system and central nervous system.Recently,it has been found that stachydrine effectively reverses homocysteine-induced endothelial dysfunction and ameliorates endothelial dysfunction by increasing the expression of guanosine triphosphate cyclase hydrolase and dihydrofolate reductase,but the role of stachydrine in atherosclerosis is yet unclear.OBJECTIVE:To explore the effect and molecular mechanism of stachydrine on atherosclerosis induced by a high-fat diet in ApoE mice.METHODS:A total of 48 ApoE-/-mice were randomly divided into blank control group,model group,stachydrine group and atorvastatin group,with 12 mice in each group.Mice in the latter three groups were fed with high-fat diet for 12 weeks to establish animal models of atherosclerosis.After successful modeling,the stachydrine group was treated with stachydrine(30 mg/kg)by gavage,the atorvastatin group was treated with atorvastatin(2.6 mg/kg)by gavage,and the blank control group and the model group were treated with the same volume of sodium carboxymethyl cellulose by gavage once a day for 30 days.After administration,hematoxylin-eosin staining was used to observe the pathological changes of the aortic root.Oil red O staining was used to detect lipid deposition in aortic plaques and the aortic root.Real-time fluorescent quantitative PCR was used to detect mRNA expression of adhesion molecules(intercellular adhesion molecule 1,vascular cell adhesion molecule 1,and selectin E)and chemokines(CXCL1,CXCL4,and monocyte chemotactic protein 1)in the aorta.RNA sequencing was used to analyze differential expression of genes between groups of aortic tissues and enrich for significantly upregulated signaling pathways.Western blot was used to detect the expression levels of autophagy marker proteins,autophagy microtubule-associated protein light chain β3 antibody(LC3BⅡ/LC3BⅠ),SQSTM1,phosphorylated AMp-activated protein kinase α and silent information regulator.Autophagy-lysosome changes were observed under transmission electron microscope.RESULTS AND CONCLUSION:Compared with the blank control group,the model group had increased aortic plaques and lipid deposition,and increased mRNA expression of adhesion molecules and chemokines(P<0.05).Compared with the model group,the stachydrine group or atorvastatin group had reduced aortic plaques and lipid deposition,and decreased mRNA expression of adhesion molecules and chemokines(P<0.05).RNA sequencing analysis showed that 972 genes were up-regulated and 781 genes were down-regulated in the stachydrine group compared with the model group.KEGG enrichment analysis of the up-regulated genes showed that autophagy signaling pathway and AMPK signaling pathway were significantly up-regulated.Western blot results showed that compared with the model group,the stachydrine group had a significantly increased LC3BⅡ/LC3BⅠ ratio and protein expression of phosphorylated AMp-activated protein kinase α and silent information regulator(P<0.05),and a significantly decreased protein level of SQSTM1.Transmission electron microscope analysis of mouse aorta showed that the stachydrine group had a significantly increased number of autophagolysosomes compared with the model group.To conclude,stachydrine may activate autophagy by up-regulating AMp-activated protein kinase/silent information regulator signaling pathway,thereby alleviating vascular endothelial inflammation and plaque deposition in atherosclerosis mice.
5.Comparison of curative effects of NNS-guided MIP and CHE in traumatic intracerebral hemorrhage
Chen JIA ; Zhonghua XU ; Xue JIA ; Peng ZHANG
China Medical Equipment 2025;22(11):87-91
Objective:To investigate the differences of comprehensively curative effect of neuro navigation system(NNS)-guided minimally invasive puncture(MIP)and conventional craniotomy hematoma evacuation(CHE)in treatment for traumatic intracerebral hemorrhage,and analyze the mechanisms of affecting the differences of the trajectories postoperative neurologically functional recovery between two kinds of surgical methods.Methods:Based on the design of multicenter prospective cohort study,a total of 240 patients with traumatic intracerebral parenchymal hemorrhage,who admitted to the Neurosurgery Center of Rugao Hospital of Traditional Chinese Medicine between June 2021 and May 2024,were selected.They were randomized into the NNS group(n=120)and the CHE group(n=120)by using a stratified block randomization method.The NNS group underwent NNS-guided surgical intervention,while the CHE group received conventional craniotomy.The primary endpoint was hematoma evacuation rate at the postoperative 7th day.The secondary endpoints encompassed surgical parameters,complications,and the prognostic indicators of function.Microstructural assessment was performed by using three-dimensional image fusion technique[three-dimensional-T1weighted imaging magnetic resonance imaging(3D-T1WI MRI)combined with thin-slice computed tomography(CT)]and tract-based spatial statistics(TBSS).Results:At the dimension of hematoma evacuation,the average hematoma evacuation rate of NNS group was(88.37±6.52)%at the postoperative 7th day,which was significantly higher than(76.15±10.32)%of CHE group,and the residual hematoma volume of NNS group was(5.23±2.15)mL at the postoperative 7th day,which was less than(11.49±4.78)ml,and the differences of them between two groups were significant(t=9.843,7.015,P<0.05),respectively.The surgical trauma parameters appeared polarization:the mean incision length in the NNS group was(3.15±0.73)cm,which reduced 76.3%of(13.24±2.15)cm of the CHE group,with statistically significant difference(Z=15.327,P<0.05).The operative duration of NNS group was(68.34±15.32)min,which was shorter than(142.56±23.48)min,and the difference was significant(t=29.846,P<0.05).The radiation dose of NNS group was(312.45±85.32)cGy·cm2,which was significantly higher than(45.23±12.15)cGy·cm2 of CHE group,and the difference was significant(Z=24.156,P<0.05).The volume of intraoperative blood transfusion of NNS group was(50.34±25.36)ml,which was significantly less than(325.67±158.32)ml,and the difference was significant(Z=18.943,P<0.05),The result of complication genealogy analysis indicated that the re-bleeding incidence of the NNS group was 6.67%,which decreased by 9.16%than 15.83%of the CHE group,and the difference of that between two groups was statistical significance(x2=5.627,P<0.05).However,there was not significant difference in infection rates and incidences of deep vein thrombosis between the two groups(P>0.05).For functional recovery,the proportion of patients whose modified Rankin Scale(mRS)scores was≤2 at the postoperative 90th day was 52.50%in the NNS group,which increased 13.33%than 39.17%in the CHE group,and the difference of that between two groups was statistical significance(x2=4.302,P<0.05).Additionally,the improvement value of National Institutes of Health Stroke Scale(NIHSS)was(9.34±4.156)in the NNS group,which existed marginal advantage of 2.19 points than(7.15±5.327)of the CHE group,and the difference was significant between two groups(Z=3.842,P<0.05).Conclusion:NNS-guided MIP appears notable advantages in enhancing hematoma evacuation efficiency and improving prognosis of neurological function.However,its increased amount of radiation exposure,and risks of specific complication should be considered.The craniotomy approach remains indispensable for complex hematoma morphologies.
6.Mechanism of stachydrine-induced autophagy in improving atherosclerosis in high-fat-fed mice
Jun YANG ; Peng YIN ; Zhonghua ZHENG
Chinese Journal of Tissue Engineering Research 2025;29(24):5140-5147
BACKGROUND:Stachydrine has anti-inflammatory,antioxidant,and antiplatelet properties that promote angiogenesis and has potential benefits on the cardiovascular system and central nervous system.Recently,it has been found that stachydrine effectively reverses homocysteine-induced endothelial dysfunction and ameliorates endothelial dysfunction by increasing the expression of guanosine triphosphate cyclase hydrolase and dihydrofolate reductase,but the role of stachydrine in atherosclerosis is yet unclear.OBJECTIVE:To explore the effect and molecular mechanism of stachydrine on atherosclerosis induced by a high-fat diet in ApoE mice.METHODS:A total of 48 ApoE-/-mice were randomly divided into blank control group,model group,stachydrine group and atorvastatin group,with 12 mice in each group.Mice in the latter three groups were fed with high-fat diet for 12 weeks to establish animal models of atherosclerosis.After successful modeling,the stachydrine group was treated with stachydrine(30 mg/kg)by gavage,the atorvastatin group was treated with atorvastatin(2.6 mg/kg)by gavage,and the blank control group and the model group were treated with the same volume of sodium carboxymethyl cellulose by gavage once a day for 30 days.After administration,hematoxylin-eosin staining was used to observe the pathological changes of the aortic root.Oil red O staining was used to detect lipid deposition in aortic plaques and the aortic root.Real-time fluorescent quantitative PCR was used to detect mRNA expression of adhesion molecules(intercellular adhesion molecule 1,vascular cell adhesion molecule 1,and selectin E)and chemokines(CXCL1,CXCL4,and monocyte chemotactic protein 1)in the aorta.RNA sequencing was used to analyze differential expression of genes between groups of aortic tissues and enrich for significantly upregulated signaling pathways.Western blot was used to detect the expression levels of autophagy marker proteins,autophagy microtubule-associated protein light chain β3 antibody(LC3BⅡ/LC3BⅠ),SQSTM1,phosphorylated AMp-activated protein kinase α and silent information regulator.Autophagy-lysosome changes were observed under transmission electron microscope.RESULTS AND CONCLUSION:Compared with the blank control group,the model group had increased aortic plaques and lipid deposition,and increased mRNA expression of adhesion molecules and chemokines(P<0.05).Compared with the model group,the stachydrine group or atorvastatin group had reduced aortic plaques and lipid deposition,and decreased mRNA expression of adhesion molecules and chemokines(P<0.05).RNA sequencing analysis showed that 972 genes were up-regulated and 781 genes were down-regulated in the stachydrine group compared with the model group.KEGG enrichment analysis of the up-regulated genes showed that autophagy signaling pathway and AMPK signaling pathway were significantly up-regulated.Western blot results showed that compared with the model group,the stachydrine group had a significantly increased LC3BⅡ/LC3BⅠ ratio and protein expression of phosphorylated AMp-activated protein kinase α and silent information regulator(P<0.05),and a significantly decreased protein level of SQSTM1.Transmission electron microscope analysis of mouse aorta showed that the stachydrine group had a significantly increased number of autophagolysosomes compared with the model group.To conclude,stachydrine may activate autophagy by up-regulating AMp-activated protein kinase/silent information regulator signaling pathway,thereby alleviating vascular endothelial inflammation and plaque deposition in atherosclerosis mice.
7.Construction of a risk prediction model for failure of proximal femoral nail antirotation fixation in intertrochanteric fractures
Zesong TU ; Daxing XU ; Hongbin LUO ; Yusheng WANG ; Xinglun FENG ; Zhonghua PENG ; Shaolong DU
Chinese Journal of Tissue Engineering Research 2025;29(27):5845-5853
BACKGROUND:Intertrochanteric femoral fractures are the main type of fragility fracture in the elderly,and proximal femoral nail antirotation is the preferred surgical option,but the factors associated with postoperative internal fixation failure are controversial.OBJECTIVE:A new"three-column"classification of intertrochanteric femoral fractures was proposed by evaluating patients'imaging data preoperatively and analyzing its interaction with postoperative internal fixation failure.A risk prediction model was developed and validated by using numerical algorithms,which facilitates clinicians to identify and intervene in high-risk patients preoperatively.METHODS:Patients with intertrochanteric femur fractures in Sanshui Branch of Foshan Hospital of Traditional Chinese Medicine between June 2012 and June 2022 were selected.The patients were divided into the internal fixation failure group and the internal fixation maintenance group according to whether they had internal fixation failure after surgery.According to the preoperative radiographs,the proximal femur was divided into three columns:the medial column,the lateral column,and the middle column.Each column had different subgroups.The relationship between the morphological characteristics of the"three columns"and the failure of proximal femoral nail antirotation internal fixation was analyzed,and the independent risk factors for internal fixation failure were screened out by single and then multifactorial logistic regression analyses.A risk prediction model was constructed according to the independent risk factors using R language software.The Bootstrap method was used to resample 1 000 times.The area under the curve,calibration curve,and clinical decision curve were used to evaluate the differentiation,calibration ability,and clinical application value of the model.The Youden index was used to determine the optimal risk cut-off value of the prediction model,according to which the patients were divided into high and low risk groups.The stability and extensibility of the model were evaluated according to the accuracy of its risk prediction ability.RESULTS AND CONCLUSION:(1)The four independent risk factors for postoperative internal fixation failure after surgery were predicted using the"three-column"typing system:medial column(comminuted fracture of the lesser trochanter and femoral talar)[odds ratio=5.385,95%CI(1.961,14.782),P=0.001],medial column(chimney type)[odds ratio=2.893,95%CI(1.167,7.173),P=0.022],lateral column(lateral wall thickness<20.5 mm)[odds ratio=2.804,95%CI(1.078,7.297),P=0.035]and lateral column(lateral wall fracture)[odds ratio=4.278,95%CI(1.670,10.959),P=0.012].(2)The constructed risk prediction model showed good discrimination and accuracy[area under the receiver operating characteristic curve=0.852,95%CI(0.837,0.922)].The calibration curve showed good agreement between the model-predicted risk and the actual risk of occurrence.(3)The clinical decision curve suggested that the model had good clinical applicability when the risk threshold probability was in the range of 0.2-0.82.The risk probability of 28%was the optimal threshold for risk stratification of the model,and the predictive performance of the model was better in patients with different risk groups.(4)The"three-column"typing system constructs a predictive model to calculate the risk probability of postoperative internal fixation failure in patients with intertrochanteric femoral fractures.This method is accurate,simple,and easy to apply clinically,and can be used as a digital tool to guide personalized clinical treatment.
8.Construction of a risk prediction model for failure of proximal femoral nail antirotation fixation in intertrochanteric fractures
Zesong TU ; Daxing XU ; Hongbin LUO ; Yusheng WANG ; Xinglun FENG ; Zhonghua PENG ; Shaolong DU
Chinese Journal of Tissue Engineering Research 2025;29(27):5845-5853
BACKGROUND:Intertrochanteric femoral fractures are the main type of fragility fracture in the elderly,and proximal femoral nail antirotation is the preferred surgical option,but the factors associated with postoperative internal fixation failure are controversial.OBJECTIVE:A new"three-column"classification of intertrochanteric femoral fractures was proposed by evaluating patients'imaging data preoperatively and analyzing its interaction with postoperative internal fixation failure.A risk prediction model was developed and validated by using numerical algorithms,which facilitates clinicians to identify and intervene in high-risk patients preoperatively.METHODS:Patients with intertrochanteric femur fractures in Sanshui Branch of Foshan Hospital of Traditional Chinese Medicine between June 2012 and June 2022 were selected.The patients were divided into the internal fixation failure group and the internal fixation maintenance group according to whether they had internal fixation failure after surgery.According to the preoperative radiographs,the proximal femur was divided into three columns:the medial column,the lateral column,and the middle column.Each column had different subgroups.The relationship between the morphological characteristics of the"three columns"and the failure of proximal femoral nail antirotation internal fixation was analyzed,and the independent risk factors for internal fixation failure were screened out by single and then multifactorial logistic regression analyses.A risk prediction model was constructed according to the independent risk factors using R language software.The Bootstrap method was used to resample 1 000 times.The area under the curve,calibration curve,and clinical decision curve were used to evaluate the differentiation,calibration ability,and clinical application value of the model.The Youden index was used to determine the optimal risk cut-off value of the prediction model,according to which the patients were divided into high and low risk groups.The stability and extensibility of the model were evaluated according to the accuracy of its risk prediction ability.RESULTS AND CONCLUSION:(1)The four independent risk factors for postoperative internal fixation failure after surgery were predicted using the"three-column"typing system:medial column(comminuted fracture of the lesser trochanter and femoral talar)[odds ratio=5.385,95%CI(1.961,14.782),P=0.001],medial column(chimney type)[odds ratio=2.893,95%CI(1.167,7.173),P=0.022],lateral column(lateral wall thickness<20.5 mm)[odds ratio=2.804,95%CI(1.078,7.297),P=0.035]and lateral column(lateral wall fracture)[odds ratio=4.278,95%CI(1.670,10.959),P=0.012].(2)The constructed risk prediction model showed good discrimination and accuracy[area under the receiver operating characteristic curve=0.852,95%CI(0.837,0.922)].The calibration curve showed good agreement between the model-predicted risk and the actual risk of occurrence.(3)The clinical decision curve suggested that the model had good clinical applicability when the risk threshold probability was in the range of 0.2-0.82.The risk probability of 28%was the optimal threshold for risk stratification of the model,and the predictive performance of the model was better in patients with different risk groups.(4)The"three-column"typing system constructs a predictive model to calculate the risk probability of postoperative internal fixation failure in patients with intertrochanteric femoral fractures.This method is accurate,simple,and easy to apply clinically,and can be used as a digital tool to guide personalized clinical treatment.
9.Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
Chengyuan GU ; Zengjun WANG ; Tianxin LIN ; Zhiyu LIU ; Weiqing HAN ; Xuhui ZHANG ; Chao LIANG ; Hao LIU ; Yang YU ; Zhenzhou XU ; Shuang LIU ; Jingen WANG ; Linghua JIA ; Xin YAO ; Wenfeng LIAO ; Cheng FU ; Zhaohui TAN ; Guohua HE ; Guoxi ZHU ; Rui FAN ; Wenzeng YANG ; Xin CHEN ; Zhizhong LIU ; Liqiang ZHONG ; Benkang SHI ; Degang DING ; Shubo CHEN ; Junli WEI ; Xudong YAO ; Ming CHEN ; Zhanpeng LU ; Qun XIE ; Zhiquan HU ; Yinhuai WANG ; Hongqian GUO ; Tiwu FAN ; Zhaozhao LIANG ; Peng CHEN ; Wei WANG ; Tao XU ; Chunsheng LI ; Jinchun XING ; Hong LIAO ; Dalin HE ; Zhibin WU ; Jiandi YU ; Zhongwen FENG ; Mengxiang YANG ; Qifeng DOU ; Quan ZENG ; Yuanwei LI ; Xin GOU ; Guangchen ZHOU ; Xiaofeng WANG ; Rujian ZHU ; Zhonghua ZHANG ; Bo ZHANG ; Wanlong TAN ; Xueling QU ; Hongliang SUN ; Tianyi GAN ; Dingwei YE
Chinese Medical Journal 2023;136(10):1207-1215
BACKGROUND:
LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.
METHODS:
We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.
RESULTS:
On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).
CONCLUSION:
LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04563936.
Humans
;
Male
;
Antineoplastic Agents, Hormonal/therapeutic use*
;
East Asian People
;
Gonadotropin-Releasing Hormone/agonists*
;
Goserelin/therapeutic use*
;
Prostate-Specific Antigen
;
Prostatic Neoplasms/drug therapy*
;
Testosterone
10.Retrospective review of airway obstruction in 19 infants with pharyngeal cysts.
Yuling MA ; Yan HU ; Haibing LIU ; Zhonghua PENG ; Luohua YUAN
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2023;37(12):958-959
Objective:To discuss the clinical characteristic and treatment of laryngeal cysts in infants. Methods:The clinical data of 19 patients diagnosed with laryngeal cysts in Department of Otolaryngology, Sichuan Provincial Maternity and Child Health Care Hospital from November 2017 to April 2023 were retrospectively analyzed. Results:All of the 19 patients were diagnosed as laryngeal cysts, with clinical manifestations included respiratory distress, inspiratory dyspnea, difficulty in feeding and low and weak crying, etc. All of them were cured after surgical treatment. Conclusion:Misdiagnosis and missed diagnosis of laryngeal cysts are prone to occur in infants and young children. After diagnosis, patients should undergo early surgical treatment to remove airway obstruction and improve ventilation.
Pregnancy
;
Infant
;
Child
;
Humans
;
Female
;
Child, Preschool
;
Retrospective Studies
;
Laryngeal Diseases/surgery*
;
Airway Obstruction/surgery*
;
Laryngoscopy
;
Cysts/surgery*
;
Dyspnea/surgery*

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