1.Development and validation of a risk prediction model for tumor recurrence after breast-conserving surgery based on admission clinical data
Qinxiang WU ; Hengyi DING ; Yufei LI
Chinese Journal of General Surgery 2025;34(5):988-995
Background and Aims:Breast-conserving surgery,which balances tumor excision with preservation of breast tissue,has become a widely adopted surgical approach for breast cancer.However,postoperative tumor recurrence remains a major factor affecting patient prognosis.Accurate risk prediction tools are urgently needed to guide personalized treatment strategies.This study aimed to develop a risk prediction model for tumor recurrence after BCS based on admission clinical data and to evaluate its predictive performance to provide a scientific and practical tool for clinical decision-making.Methods:A total of 224 breast cancer patients who underwent breast-conserving surgery between May 2017 and May 2019 were enrolled.Postoperative recurrence was recorded during follow-up.Multivariate Logistic regression analysis was used to identify independent risk factors for recurrence and to construct a risk prediction model.The model's discriminative ability was assessed using the receiver operating characteristic(ROC)curve,and its calibration was evaluated using a calibration curve.Results:208 patients completed follow-up,ranging from 32 to 84 months,with a mean duration of(58.41±7.33)months.The recurrence rate was 17.79%.Multivariate Logistic regression analysis revealed that TNM stage Ⅲ(OR=2.029),tumor diameter≥4 cm(OR=1.782),≥4 lymph node metastases(OR=1.958),lymphovascular invasion(OR=1.984),and HER2 positivity(OR=1.774)were independent risk factors for recurrence(all P<0.05).The Logistic regression model was established as follows:Y=-12.788+0.707X?+0.578X?+0.672X?+0.685X?+0.573X?.The model yielded an area under the ROC curve(AUC)of 0.934(95%CI=0.891-0.963),with a sensitivity of 86.49%and specificity of 96.49%.The calibration curve demonstrated good agreement between predicted and observed outcomes(χ2=0.501,P=0.392).Conclusion:TNM stage Ⅲ,tumor diameter≥4 cm,≥4 lymph node metastases,lymphovascular invasion,and HER2 positivity are independent risk factors for tumor recurrence after breast-conserving surgery.The risk prediction model based on these factors demonstrates favorable discrimination and calibration,offering valuable guidance for postoperative risk assessment and clinical intervention.
2.Development and validation of a risk prediction model for tumor recurrence after breast-conserving surgery based on admission clinical data
Qinxiang WU ; Hengyi DING ; Yufei LI
Chinese Journal of General Surgery 2025;34(5):988-995
Background and Aims:Breast-conserving surgery,which balances tumor excision with preservation of breast tissue,has become a widely adopted surgical approach for breast cancer.However,postoperative tumor recurrence remains a major factor affecting patient prognosis.Accurate risk prediction tools are urgently needed to guide personalized treatment strategies.This study aimed to develop a risk prediction model for tumor recurrence after BCS based on admission clinical data and to evaluate its predictive performance to provide a scientific and practical tool for clinical decision-making.Methods:A total of 224 breast cancer patients who underwent breast-conserving surgery between May 2017 and May 2019 were enrolled.Postoperative recurrence was recorded during follow-up.Multivariate Logistic regression analysis was used to identify independent risk factors for recurrence and to construct a risk prediction model.The model's discriminative ability was assessed using the receiver operating characteristic(ROC)curve,and its calibration was evaluated using a calibration curve.Results:208 patients completed follow-up,ranging from 32 to 84 months,with a mean duration of(58.41±7.33)months.The recurrence rate was 17.79%.Multivariate Logistic regression analysis revealed that TNM stage Ⅲ(OR=2.029),tumor diameter≥4 cm(OR=1.782),≥4 lymph node metastases(OR=1.958),lymphovascular invasion(OR=1.984),and HER2 positivity(OR=1.774)were independent risk factors for recurrence(all P<0.05).The Logistic regression model was established as follows:Y=-12.788+0.707X?+0.578X?+0.672X?+0.685X?+0.573X?.The model yielded an area under the ROC curve(AUC)of 0.934(95%CI=0.891-0.963),with a sensitivity of 86.49%and specificity of 96.49%.The calibration curve demonstrated good agreement between predicted and observed outcomes(χ2=0.501,P=0.392).Conclusion:TNM stage Ⅲ,tumor diameter≥4 cm,≥4 lymph node metastases,lymphovascular invasion,and HER2 positivity are independent risk factors for tumor recurrence after breast-conserving surgery.The risk prediction model based on these factors demonstrates favorable discrimination and calibration,offering valuable guidance for postoperative risk assessment and clinical intervention.
3.Effects of 0.3% sodium hyaluronate ophthalmic solution in the treatment of mild-to-moderate dry eye patients:a multi-center clinical study
Caihong HUANG ; Zuguo LIU ; Wei LI ; Li ZHU ; Sisi ZHU ; Xiang LIN ; Weijie OUYANG ; Nan JIANG ; Jianjiang XU ; Dan WU ; Lingyi LIANG ; Xiaohui LUO ; Hua WANG ; Ting CHEN ; Wei CHEN ; Qinxiang ZHENG ; Xuguang SUN ; Shijing DENG
Chinese Journal of Experimental Ophthalmology 2019;36(12):936-941
Objective To evaluate the efficacy of 0.3% sodium hyaluronate ophthalmic solution in mild-to-moderate dry eye patients.Metbods A prospective,multicenter,and self-controlled clinical trial was performed on 200 patients who were diagnosed as mild-to-moderate dry eye from January 2015 to June 2017 in Eye Institute of Xiamen University,Eye & ENT Hospital of Fudan University,Zhongshan Ophthalmic Center,Xiangya Hospital Central South University,Eye Hospital of Wenzhou Medical University,and Beijing Tongren Hospital,Capital Medical University.The study protocol was approved by the Ethics Committees of Eye Institute of Xiamen University,written informed consent was obtained from each patient prior to any medical examination.All patients were treated with 0.3% sodium hyaluronate ophthalmic solution 6 times per day (one drop each time) for 28 days.Corneal fluorescein sodium staining,tear film break-up time (BUT),Schirmer Ⅰ test (S Ⅰ t),degree of conjunctival hyperemia,eyelid margin,meibomian gland secretion,secretory capacity of meibomian gland and subjective symptoms were assessed at baseline,on the 14th day and 28th day after treatment.Bulbar impression cytology was evaluated at baseline and on the 28th day after treatment.Irritation of 0.3% sodium hyaluronate ophthalmic solution was estimated on the 14th day and 28th day after treatment.Results The total score of subjective symptoms,BUT,S Ⅰ t,degree of conjunctival hyperemia were significantly different among different treatment time points (F =108.969,27.598,16.838,36.750;all at P<0.01).Compared with before treatment,the total score of subjective symptoms was significantly decreased,the degree of conjunctival hyperemia and the total corneal fluorescein sodium staining point number were significant decreased on the 14th day and 28th day after treatment.The total score of subjective symptoms,degree of conjunctival hyperemia and total corneal fluorescein sodium staining point number on the 28th day after treatment were significant lower than those on the 14th day after treatment.Compared with before treatment,the BUT was significantly longer and the S Ⅰ t scores were significantly increased on the 14th day and 28th day after treatment.The BUT on the 28th day after treatment was significantly longer than that on the 14th day after treatment;no significant difference in S Ⅰ t was observed between the 28th day and the 14th day after treatment.The scores of palpebral margin change,meibomian gland secretory ability and secretion characteristics were not significantly different among different treatment time points(H=0.255,2.356,0.294;all at P>0.05).The impression cytology grade on the 28th day after treatment was 1.08±0.74,which was significantly lower than 1.53±0.76 before treatment (t =5.979,P<0.01).The number of goblet cells on the 28th day after treatment was significantly higher than that before treatment (U =1 806.500,P< 0.01).On the 14th day after treatment,70% of the patients indicated that the drug was non-irritating,and no patient had intolerable irritation affecting daily lives.All patients had good tolerance to this drug.Conclusions The use of 0.3% sodium hyaluronate eye drops can improve the symptoms and signs of mild to moderate dry eye,which can be widely used for mild-to-moderate dry eye patients in clinic.
4.Effects of 0. 3% sodium hyaluronate ophthalmic solution in the treatment of mild-to-moderate dry eye patients:a multi-center clinical study
Caihong HUANG ; Zuguo LIU ; Wei LI ; Li ZHU ; Sisi ZHU ; Xiang LIN ; Weijie OUYANG ; Nan JIANG ; Jianjiang XU ; Dan WU ; Lingyi LIANG ; Xiaohui LUO ; Hua WANG ; Ting CHEN ; Wei CHEN ; Qinxiang ZHENG ; Xuguang SUN ; Shijing DENG
Chinese Journal of Experimental Ophthalmology 2018;36(12):936-941
Objective To evaluate the efficacy of 0. 3% sodium hyaluronate ophthalmic solution in mild.to. moderate dry eye patients. Methods A prospective,multicenter,and self.controlled clinical trial was performed on 200 patients who were diagnosed as mild.to.moderate dry eye from January 2015 to June 2017 in Eye Institute of Xiamen University,Eye &ENT Hospital of Fudan University,Zhongshan Ophthalmic Center,Xiangya Hospital Central South University, Eye Hospital of Wenzhou Medical University, and Beijing Tongren Hospital, Capital Medical University. The study protocol was approved by the Ethics Committees of Eye Institute of Xiamen University,written informed consent was obtained from each patient prior to any medical examination. All patients were treated with 0. 3% sodium hyaluronate ophthalmic solution 6 times per day ( one drop each time) for 28 days. Corneal fluorescein sodium staining,tear film break.up time (BUT),SchirmerⅠtest (SⅠt),degree of conjunctival hyperemia,eyelid margin,meibomian gland secretion,secretory capacity of meibomian gland and subjective symptoms were assessed at baseline,on the 14th day and 28th day after treatment. Bulbar impression cytology was evaluated at baseline and on the 28th day after treatment. Irritation of 0. 3% sodium hyaluronate ophthalmic solution was estimated on the 14th day and 28th day after treatment. Results The total score of subjective symptoms,BUT,SⅠt,degree of conjunctival hyperemia were significantly different among different treatment time points( F=108. 969,27. 598,16. 838,36. 750;all at P<0. 01). Compared with before treatment,the total score of subjective symptoms was significantly decreased, the degree of conjunctival hyperemia and the total corneal fluorescein sodium staining point number were significant decreased on the 14th day and 28th day after treatment. The total score of subjective symptoms,degree of conjunctival hyperemia and total corneal fluorescein sodium staining point number on the 28th day after treatment were significant lower than those on the 14th day after treatment. Compared with before treatment,the BUT was significantly longer and the SⅠt scores were significantly increased on the 14th day and 28th day after treatment. The BUT on the 28th day after treatment was significantly longer than that on the 14th day after treatment;no significant difference in SⅠt was observed between the 28th day and the 14th day after treatment. The scores of palpebral margin change,meibomian gland secretory ability and secretion characteristics were not significantly different among different treatment time points(H=0. 255,2. 356,0. 294;all at P>0. 05). The impression cytology grade on the 28th day after treatment was 1. 08±0. 74,which was significantly lower than 1. 53±0. 76 before treatment (t=5. 979, P<0. 01). The number of goblet cells on the 28th day after treatment was significantly higher than that before treatment(U=1806. 500,P<0. 01). On the 14th day after treatment,70% of the patients indicated that the drug was non.irritating,and no patient had intolerable irritation affecting daily lives. All patients had good tolerance to this drug. Conclusions The use of 0. 3% sodium hyaluronate eye drops can improve the symptoms and signs of mild to moderate dry eye,which can be widely used for mild.to.moderate dry eye patients in clinic.
5.The research status of preclinical animal experiments of gene therapy for Leber congenital amaurosis
Chinese Journal of Experimental Ophthalmology 2014;32(8):764-768
Leber congenital amaurosis (LCA) is extremely severe hereditary retinal dystrophy,because it leads to congenital bilateral blindness in early childhood.With the development of molecular genetics and the therapeutic gene replacement technology,gene therapy clinical trials have obtained exciting results on the basis of relatively satisfied with preliminary clinical experimental results by adeno-associated virus (AAV) vector-mediated gene therapy in the past decade.These researching methods include intravitreal injection and subretinal space injection of gene vector,and the investigating indexes include evaluations of visual function and safety,such as immune reaction of the animals,ocular histopathological change,complications and bio-distribution of gene sequence.The preliminary success of the LCAⅡ Ⅱ gene therapy will give some clues to the other inherited retinal diseases.This review focuses on the present status of pre-clinical animal experiments of its gene therapy.

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