1.Evaluation of the performance of the artificial intelligence - enabled snail identification system for recognition of Oncomelania hupensis robertsoni and Tricula
Jihua ZHOU ; Shaowen BAI ; Liang SHI ; Jianfeng ZHANG ; Chunhong DU ; Jing SONG ; Zongya ZHANG ; Jiaqi YAN ; Andong WU ; Yi DONG ; Kun YANG
Chinese Journal of Schistosomiasis Control 2025;37(1):55-60
Objective To evaluate the performance of the artificial intelligence (AI)-enabled snail identification system for recognition of Oncomelania hupensis robertsoni and Tricula in schistosomiasis-endemic areas of Yunnan Province. Methods Fifty O. hupensis robertsoni and 50 Tricula samples were collected from Yongbei Township, Yongsheng County, Lijiang City, a schistosomiasis-endemic area in Yunnan Province in May 2024. A total of 100 snail sample images were captured with smartphones, including front-view images of 25 O. hupensis robertsoni and 25 Tricula samples (upward shell opening) and back-view images of 25 O. hupensis robertsoni and 25 Tricula samples (downward shell opening). Snail samples were identified as O. hupensis robertsoni or Tricula by schistosomiasis control experts with a deputy senior professional title and above according to image quality and morphological characteristics. A standard dataset for snail image classification was created, and served as a gold standard for recognition of snail samples. A total of 100 snail sample images were recognized with the AI-enabled intelligent snail identification system based on a WeChat mini program in smartphones. Schistosomiasis control professionals were randomly sampled from stations of schistosomisis prevention and control and centers for disease control and prevention in 18 schistosomiasis-endemic counties (districts, cities) of Yunnan Province, for artificial identification of 100 snail sample images. All professionals are assigned to two groups according the median years of snail survey experiences, and the effect of years of snail survey experiences on O. hupensis robertsoni sample image recognition was evaluated. A receiver operating characteristic (ROC) curve was plotted, and the sensitivity, specificity, accuracy, Youden’s index and the area under the curve (AUC) of the AI-enabled intelligent snail identification system and artificial identification were calculated for recognition of snail sample images. The snail sample image recognition results of AI-enabled intelligent snail identification system and artificial identification were compared with the gold standard, and the internal consistency of artificial identification results was evaluated with the Cronbach’s coefficient alpha. Results A total of 54 schistosomiasis control professionals were sampled for artificial identification of snail sample image recognition, with a response rate of 100% (54/54), and the accuracy, sensitivity, specificity, Youden’s index, and AUC of artificial identification were 90%, 86%, 94%, 0.80 and 0.90 for recognition of snail sample images, respectively. The overall Cronbach’s coefficient alpha of artificial identification was 0.768 for recognition of snail sample images, and the Cronbach’s coefficient alpha was 0.916 for recognition of O. hupensis robertsoni snail sample images and 0.925 for recognition of Tricula snail sample images. The overall accuracy of artificial identification was 90% for recognition of snail sample images, and there was no significant difference in the accuracy of artificial identification for recognition of O. hupensis robertsoni (86%) and Tricula snail sample images (94%) (χ2 = 1.778, P > 0.05). There was no significant difference in the accuracy of artificial identification for recognition of snail sample images with upward (88%) and downward shell openings (92%) (χ2 = 0.444, P > 0.05), and there was a significant difference in the accuracy of artificial identification for recognition of snail sample images between schistosomiasis control professionals with snail survey experiences of 6 years and less (75%) and more than 6 years (90%) (χ2 = 7.792, P < 0.05). The accuracy, sensitivity, specificity and AUC of the AI-enabled intelligent snail identification system were 88%, 100%, 76% and 0.88 for recognition of O. hupensis robertsoni snail sample images, and there was no significant difference in the accuracy of recognition of O. hupensis robertsoni snail sample images between the AI-enabled intelligent snail identification system and artificial identification (χ2 = 0.204, P > 0.05). In addition, there was no significant difference in the accuracy of artificial identification for recognition of snail sample images with upward (90%) and downward shell openings (86%) (χ2 = 0.379, P > 0.05), and there was a significant difference in the accuracy of artificial identification for recognition of snail sample images between schistosomiasis control professionals with snail survey experiences of 6 years and less and more than 6 years (χ2 = 5.604, Padjusted < 0.025). Conclusions The accuracy of recognition of snail sample images is comparable between the AI-enabled intelligent snail identification system and artificial identification by schistosomiasis control professionals, and the AI-enabled intelligent snail identification system is feasible for recognition of O. hupensis robertsoni and Tricula in Yunnan Province.
2.Comparision of aripiprazole and risperidone in improving psychiatric symptoms among chronic schizophrenia patients
Jianfeng WANG ; Bangwen LIU ; Yanyan ZHANG ; Yanping XUE ; Liang GUO ; Yanhai WU
Sichuan Mental Health 2025;38(2):108-114
BackgroundAtypical antipsychotics have been widely used in patients with chronic schizophrenia, and aripiprazole and risperidone are the most commonly used drugs. The mechanism of action of the two is different, while previous studies have provided insufficient credible evidence from multiple perspectives to support the comparative efficacy of the two drugs in improving symptoms in patients with chronic schizophrenia. ObjectiveTo compare the efficacy of aripiprazole and risperidone on the improvement of symptoms, prepulse inhibition (PPI), cognitive functioning and neurotrophic factors in patients with chronic schizophrenia, so as to provide effective treatment regimens for these patients. MethodsA total of 86 patients with chronic schizophrenia attending the psychiatry department of the Third People's Hospital of Fuyang from March 2021 to March 2023 and fulfilling the diagnostic criteria of International Classification of Diseases, tenth edition (ICD-10) were enrolled and grouped using random number table method, each with 43 cases. Aripiprazole group was given oral aripiprazole once daily at an initial dose of 5 mg for one week and then gradually increased to a maximum dose of 25 mg. Risperidone group received oral risperidone twice daily at an initial dose of 0.5 mg for one week and then gradually increased to a maximum dose of 3 mg. Treatment in both groups lasted 3 months. Before treatment and 3 months after treatment, Patients were required to complete Positive and Negative Symptom Scale (PANSS), detection of both strong and weak PPIs in a startle modification passive attention paradigm, Wisconsin Card Sorting Test (WCST) and the measurement of neurotrophic factors at baseline and after treatment. The adverse reactions were recorded. Analysis of covariance was used to test the difference between the PANSS score, PPI, WCST and neurotrophic factor levels of the groups, with the pretest used as the covariate. Results3 months after treatment, no statistical difference was found in the scores of PANSS general psychopathology subscale, positive symptom subscale, negative symptom subscale and total score between two groups after treatment (F=0.621, 0.815, 0.743, 0.752, P>0.05). There were no statistically significant differences between the two groups in PPI inhibition rate, single intense stimulus amplitude, single intense stimulus latency, prepulse inhibition amplitude, or prepulse inhibition latency (F=0.174, 0.001, 0.183, 0.171, 0.001, P>0.05). There was no statistically significant difference in the total number of WCST tests between two groups (F=0.512, P>0.05), whereas aripiprazole group reported significantly larger total numbers of categories completed and correct responses as well as smaller total numbers of random errors and perseverative errors compared to risperidone group (F=3.737, 4.621, 4.892, 5.130, P<0.05). A significant increase in brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF) along with a reduction in glial fibrillary acidic protein (GFAP) were documented in risperidone group when compared to risperidone group (F=4.414, 3.781, 6.319, P<0.05). No significant difference was demonstrated in the incidence of adverse reactions between the two groups (χ2=0.261, P>0.05). ConclusionAripiprazole may be more beneficial than risperidone in improving cognitive functioning and neurotrophic factor levels in patients with chronic schizophrenia. [Funded by Scientific Research Project of Fuyang Municipal Health Commission in 2021 (number, FY2021-147)]
3.Value of Head and Neck 4D-CTA Combined with SDF-1a/CXCR4 Signaling Pathway in Assessing the Risk of Ruptured Intracranial Posterior Communicating Aneurysms
Yiming XU ; Jianfeng ZHONG ; Bin LI ; Xinyan ZHOU ; Hongli ZHU ; Jing LIANG ; Chengde LIAO
Journal of Kunming Medical University 2024;45(3):59-64
Objective To investigate the value of 4D-CTA combined with SDF-1a/CXCR4 signaling pathway in evaluating the risk of intracranial aneurysm rupture.Methods Fifty patients with unruptured intracranial posterior communicating aneurysms and 50 patients with ruptured intracranial posterior communicating aneurysms were divided into unruptured group 1 and ruptured group 1.All patients underwent 4D-CTA examination and serumSDF-1alevel was detected.Non-ruptured group 1 was followed up for 12 months(After conservative treatment),on this basis,patients with ruptured posterior communicating aneurysms were included in ruptured group 2,and patients with unruptured posterior communicating aneurysms were included in non-ruptured group 2.Results The AUC values of Wn,AR,L,SR,SDF-1a and their combinations in diagnosing ruptured intracranial posterior communicating aneurysms were all greater than 0.70.The AUC values of Wn,AR,L,SR,SDF-1a and their combinations in predicting ruptured intracranial posterior communicating aneurysms in ruptured group 2 were all greater than 0.70.Conclusion 4D-CTA combined with SDF-1acan effectively distinguish ruptured intracranial posterior communicating aneurysms and predict the risk of rupture.
4.The Chinese guideline for management of snakebites
Lai RONGDE ; Yan SHIJIAO ; Wang SHIJUN ; Yang SHUQING ; Yan ZHANGREN ; Lan PIN ; Wang YONGGAO ; Li QI ; Wang JINLONG ; Wang WEI ; Ma YUEFENG ; Liang ZIJING ; Zhang JIANFENG ; Zhou NING ; Han XIAOTONG ; Zhang XINCHAO ; Zhang MAO ; Zhao XIAODONG ; Zhang GUOQIANG ; Zhu HUADONG ; Yu XUEZHONG ; Lyu CHUANZHU
World Journal of Emergency Medicine 2024;15(5):333-355
In 2009,the World Health Organization included snakebite on the list of neglected tropical diseases,acknowledging it as a common occupational hazard for farmers,plantation workers,and others,causing tens of thousands of deaths and chronic physical disabilities every year.This guideline aims to provide practical information to help clinical professionals evaluate and treat snakebite victims.These recommendations are based on clinical experience and clinical research evidence.This guideline focuses on the following topics:snake venom,clinical manifestations,auxiliary examination,diagnosis,treatments,and prevention.
5.Efficacy of flexible negative pressure ureteral access sheath plus disposable flexible ureteroscope versus SMP in the treatment of 2-3 cm renal calculi
Jianfeng LIN ; Zhibin YE ; Liren HU ; Fulyu LIANG ; Jianping TU ; Chaohao MIAO ; Xianming FAN
Journal of Modern Urology 2024;29(7):617-621,626
Objective To explore the efficacy of negative pressure ureteral access sheath combined with disposable flexible ureteroscope(UAS+FRUS)in the treatment of renal calculi of 2-3 cm,so as to provide reference for the treatment.Methods A retrospective analysis was conducted on 130 cases of renal calculi of 2-3 cm treated with surgery in Xiamen Third Hospital during Sep.2021 and Sep.2023,including 68 cases with UAS+FRUS and 62 cases with super-mini percutaneous nephrolithotripsy(SMP).The perioperative indexes and stone-clearance rate(SFR)were compared between the two groups.Results All operations were successful.There were no statistically significant differences in the total SFR and incidence of complications(5.88%vs.9.67%)between the two groups 3 days(88.24%vs.90.32%)and 1 month(91.18%vs.93.55%)after surgery(P>0.05).For patients with lower calyceal calculi with infundibulopelvic angle(IPA)<45°,the SFR of the UAS+FRUS group was significantly lower than that of the SMP group(57.14%vs.100%,P<0.05).The UAS+FRUS group had a longer operation time than the SMP group[(104.94±8.79)minutes vs.(77.98±6.60)minutes,P<0.001],higher hospitalization costs[(23 112.82±1152.34)yuan vs.(21 975.84±1512.24)yuan,P<0.001],less postoperative decrease in hemoglobin[(6.71±2.07)g/L vs.(9.81±4.80)g/L,P<0.001],and shorter postoperative hospitalization time[(3.28±0.51)d vs.(5.58±0.71)d,P<0.001].The UAS+FRUS group had lower postoperative VAS score at 6,24,and 48 hours than the SMP group[(6.38±0.69)vs.(7.87±0.88);(3.62±0.73)vs.(5.81±0.83)and(3.12±0.33)vs.(3.81±0.60)],with statistical significance(P<0.05).Conclusion Both surgical methods have a high SFR in the treatment of renal calculi of 2-3 cm.SMP has the advantages of short operation time,low hospitalization costs,and high SFR for lower calyx calculi,while UAS+FURS has the advantages of little bleeding,minimal trauma,and short hospital stay.Surgeons can make reasonable choices based on the patients'condition and willingness,combined with their own surgical experience.
6.Construction of a visual intelligent identification model for Oncomelania hupensis robertsoni in Yunnan Province based on the EfficientNet-B4 model
Shaowen BAI ; Jihua ZHOU ; Yi DONG ; Jianfeng ZHANG ; Liang SHI ; Kun YANG
Chinese Journal of Schistosomiasis Control 2024;36(6):555-561
Objective To construct a visual intelligent recognition model for Oncomelania hupensis robertsoni in Yunnan Province based on the EfficientNet-B4 model, and to evaluate the impact of data augmentation methods and model hyperparameters on the recognition of O. hupensis robertsoni. Methods A total of 400 O. hupensis robertsoni and 400 Tricula snails were collected from Yongsheng County, Yunnan Province in June 2024, and snail images were captured following identification and classification of 300 O. hupensis robertsoni and 300 Tricula snails. A total of 925 O. hupensis robertsoni images and 1 062 Tricula snail images were collected as a dataset and divided into a training set and a validation set at a ratio of 8:2, while 352 images captured from the remaining 100 O. hupensis robertsoni and 354 images from the remaining 100 Tricula snails served as an external test set. All acquired images were subjected to preprocessing, including cropping and resizing. Three data augmentation approaches were employed, including baseline, Mixup and Gaussian blurring, and model hyperparameters included two optimization algorithms of adaptive moment estimation (Adam) and stochastic gradient descent (SGD), two loss functions of focal loss and cross entropy loss, and two learning rate decay strategies of cosine annealing and multi-step. The intelligent recognition models of O. hupensis robertsoni and Tricula snails were constructed based on the EfficientNet-B4 model, and 7 training strategy groups were generated by combinations of different data augmentation approaches and hyperparameters. The performance of intelligent recognition models was tested with external test sets, and evaluated with accuracy, precision, recall, F1 score, loss, Youden’s index, and the area under the receiver operating characteristic curve (AUC) under different training strategies. Results The variation of loss values was comparable among intelligent recognition models with different data augmentation approaches. The Group 4 model constructed with Mixup and Gaussian blurring data augmentation approaches showed the optimal performance, with an accuracy of 90.38%, precision of 90.07%, F1 score of 89.44%, Youden’s index of 0.81 and AUC of 0.961 in the external test set. The accuracy of models using the SGD optimizer reduced by 29.16% as compared to those using the Adam optimizer (χ2 = 81.325, P < 0.001), and the accuracy of models using the cross entropy loss function reduced by 0.80% as compared to the Group 4 model (χ2 = 3.147, P > 0.05), while the accuracy of models using the multi-step learning rate decay strategy increased by 0.65% as compared to the Group 4 model (χ2 = 0.208, P > 0.05). In addition, the model with the baseline + Mixup + Gaussianblurring data augmentation approach and hyperparameters of Adam optimizer, focal loss function and multi-step learning rate decay strategy showed the highest performance, with an accuracy of 91.03%, precision of 91.97%, recall of 88.11%, F1 score of 90.00%, Youden’s index of 0.82 and AUC values of 0.969 in external test set, respectively. Conclusions The intelligent recognition model of O. hupensis robertsoni based on EfficientNet-B4 model is accurate for identification of O. hupensis robertsoni and Tricula snails in Yunnan Province.
7.Shuxuetong Inhibits Bim-dependent Apoptosis of Cerebellar Granule Neurons
Shenhao PAN ; Dongfang CAO ; Fanyi ZHAO ; Sijie ZHAO ; Chenghao ZHANG ; Jianfeng LIANG ; Jianwei WU ; Zhongmin YUAN
Journal of Sun Yat-sen University(Medical Sciences) 2024;45(4):549-556
[Objective]To investigate the effect and mechanism of Shuxuetong and its main component hirudin on the apoptosis of cerebellar granule neurons(CGNs)in Sprague-Dawley(SD)rats.[Methods]CGNs incubated in vitro for 7 days were divided into survival control group or 25 K group(cultured in medium containing 25 mmol/L KCL)and apopto-sis group or 5 K group(cultured in medium containing 5 mmol/L KCL).CGNs were separately treated with proportionally diluted and different concentrations of Shuxuetong(1/50,1/40,1/30,1/20 and 1/10)and the corresponding different con-centrations of hirudin(2,2.5,3.34,5 and 10 U/mL).Hoechst staining was performed to analyze the apoptosis.Western blot was used to detect the expression levels of Cleaved Caspase-3,Bim and VEGF.[Results]Hoechst staining showed that 5 K group had a higher apoptosis rate than 25 K group.In 25 K group,there was no significant change in the apoptosis rate between neurons treated with different concentrations of Shuxuetong and hirudin,but significant changes was found in 5 K group and the higher the concentration,the lower the apoptosis rate.Western blot results revealed that,compared with control neurons in 5 K group,Shuxuetong injection and hirudin treatments resulted in a decrease of Cleaved Caspase-3 and Bim expression,but an increase of VEGF protein.[Conclusions]Shuxuetong and its main component hirudin inhibits the apoptosis of CGNs through suppressing proapoptotic BH3-only protein Bim.
8.Sagittal splitting osteotomy of the mandibular outer cortex and autologous bone grafting for the treatment of hemifacial microsomia
Lai GUI ; Feng NIU ; Bing YU ; Jianfeng LIU ; Ying CHEN ; Xi FU ; Shixing XU ; Jia QIAO ; Qi JIN ; Yu HE ; Xuebing LIANG ; Lei CUI ; Fuhuan CHEN ; Qi CHEN
Chinese Journal of Plastic Surgery 2024;40(3):249-257
Objective:To investigate a new method for the reconstruction of hemifacial microsomia by sagittal osteotomy of the affected mandibular outer cortex combined with bone graft of mandibular outer cortex from healthy side.Methods:From March 2006 to March 2023, the clinical data of patients with hemifacial microsomia admitted to the Department of Craniomaxillofacial Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences were analyzed retrospectively. Preoperative diagnosis and surgical design were performed based on clinical manifestations and imaging findings. All cases were operated under general anesthesia. The affected mandibular outer cortex was previously split by an intraoral approach, and then the mandibular outer cortex of appropriate shape and size on the healthy side was harvested and grafted into the split bone space according to the preoperative design, following by internal rigid fixation. Complications, facial appearance improvement, and patient satisfaction were followed up. Photographs were taken preoperative, immediately postoperative and at the long-term(last) postoperative follow-up, and the severity of the deformity was analyzed. CT data from preoperative, immediate postoperative, and long-term follow-up visits were imported into Surgicase Proplan medical three-dimensional image workstation in Dicom format. The mandible was reconstructed using Segmentation, and the thickness of the mandible was measured during pre-operative, immediate post-operative and long-term follow-up visits. Anova with repeated measurement design was used to compare measurements and LSD test was used for multiple comparisons. The Kruskal-Wallis rank sum test were used to statistically analyze malformation severity. P< 0.05 is considered statistically significant. Results:A total of 39 patients were included in this study, including 13 females and 26 males, with an average age of (22.21±4.57) years (15-27 years). All patients were followed up for an average of (45.56±39.41) months (6-153 months) after surgery. The grafted mandibular outer cortex grows well with the adjacent bone tissue, and the mandibular angle and mandibular body are significantly wider. Of the 39 cases, 1 developed an infection 1 year after surgery, the titanium plate was exposed, and the patient healed after debridement and removal of the immobilizing splint. The facial appearance of the other patients improved significantly. Preoperative, immediate postoperative and long term follow up of mandibular thickness measurements were compared in pairs, and the differences were statistically significant (all P<0.05). The patient’s appearance satisfaction score: the preoperative score was [2.0(1.5, 2.0)] points, the immediate postoperative score was [4.0(4.0, 4.0)] points, the score of the last postoperative follow up was [4.0(4.0, 4.0)] points. There was statistical difference in satisfaction among the three groups ( P<0.01). The preoperative scores were compared with the scores of the immediate postoperative and the last postoperative follow-up respectively, and the differences were statistically significant( P<0.01). There was no statistical significance in satisfaction between the immediate postoperative score and the score of the last postoperative follow up ( P>0.05). Conclusion:The sagittal splitting osteotomy of the mandibular outer cortex is consistent with the features of mandibular anatomy, and provides a good condition for the grafting and healing of autogenous bone. Removing the outer cortex of the mandible on the healthy side not only increases the thickness of the affected side, but also decreases the width of the angle of the mandible on the healthy side, so as to effectively correct the asymmetric deformity of the mandible. The method is simple, with few complications and good results, and is one of the ideal treatments to correct hemofacial microsomia.
9.Sagittal splitting osteotomy of the mandibular outer cortex and autologous bone grafting for the treatment of hemifacial microsomia
Lai GUI ; Feng NIU ; Bing YU ; Jianfeng LIU ; Ying CHEN ; Xi FU ; Shixing XU ; Jia QIAO ; Qi JIN ; Yu HE ; Xuebing LIANG ; Lei CUI ; Fuhuan CHEN ; Qi CHEN
Chinese Journal of Plastic Surgery 2024;40(3):249-257
Objective:To investigate a new method for the reconstruction of hemifacial microsomia by sagittal osteotomy of the affected mandibular outer cortex combined with bone graft of mandibular outer cortex from healthy side.Methods:From March 2006 to March 2023, the clinical data of patients with hemifacial microsomia admitted to the Department of Craniomaxillofacial Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences were analyzed retrospectively. Preoperative diagnosis and surgical design were performed based on clinical manifestations and imaging findings. All cases were operated under general anesthesia. The affected mandibular outer cortex was previously split by an intraoral approach, and then the mandibular outer cortex of appropriate shape and size on the healthy side was harvested and grafted into the split bone space according to the preoperative design, following by internal rigid fixation. Complications, facial appearance improvement, and patient satisfaction were followed up. Photographs were taken preoperative, immediately postoperative and at the long-term(last) postoperative follow-up, and the severity of the deformity was analyzed. CT data from preoperative, immediate postoperative, and long-term follow-up visits were imported into Surgicase Proplan medical three-dimensional image workstation in Dicom format. The mandible was reconstructed using Segmentation, and the thickness of the mandible was measured during pre-operative, immediate post-operative and long-term follow-up visits. Anova with repeated measurement design was used to compare measurements and LSD test was used for multiple comparisons. The Kruskal-Wallis rank sum test were used to statistically analyze malformation severity. P< 0.05 is considered statistically significant. Results:A total of 39 patients were included in this study, including 13 females and 26 males, with an average age of (22.21±4.57) years (15-27 years). All patients were followed up for an average of (45.56±39.41) months (6-153 months) after surgery. The grafted mandibular outer cortex grows well with the adjacent bone tissue, and the mandibular angle and mandibular body are significantly wider. Of the 39 cases, 1 developed an infection 1 year after surgery, the titanium plate was exposed, and the patient healed after debridement and removal of the immobilizing splint. The facial appearance of the other patients improved significantly. Preoperative, immediate postoperative and long term follow up of mandibular thickness measurements were compared in pairs, and the differences were statistically significant (all P<0.05). The patient’s appearance satisfaction score: the preoperative score was [2.0(1.5, 2.0)] points, the immediate postoperative score was [4.0(4.0, 4.0)] points, the score of the last postoperative follow up was [4.0(4.0, 4.0)] points. There was statistical difference in satisfaction among the three groups ( P<0.01). The preoperative scores were compared with the scores of the immediate postoperative and the last postoperative follow-up respectively, and the differences were statistically significant( P<0.01). There was no statistical significance in satisfaction between the immediate postoperative score and the score of the last postoperative follow up ( P>0.05). Conclusion:The sagittal splitting osteotomy of the mandibular outer cortex is consistent with the features of mandibular anatomy, and provides a good condition for the grafting and healing of autogenous bone. Removing the outer cortex of the mandible on the healthy side not only increases the thickness of the affected side, but also decreases the width of the angle of the mandible on the healthy side, so as to effectively correct the asymmetric deformity of the mandible. The method is simple, with few complications and good results, and is one of the ideal treatments to correct hemofacial microsomia.
10.Chidamide plus prednisone, cyclophosphamide, and thalidomide for relapsed or refractory peripheral T-cell lymphoma: A multicenter phase II trial
Jinhua LIANG ; Li WANG ; Xiaodong WANG ; Guohui CUI ; Jianfeng ZHOU ; Tongyao XING ; Kaixin DU ; Jingyan XU ; Luqun WANG ; Rong LIANG ; Biyun CHEN ; Jian CHENG ; Haorui SHEN ; Jianyong LI ; Wei XU
Chinese Medical Journal 2024;137(13):1576-1582
Background::Although the treatment of peripheral T-cell lymphoma (PTCL) has undergone advancements during the past several years, the response rate and long-term effects with respect to patients with PTCL remain unsatisfactory—particularly for relapsed or refractory (R/R) patients. This phase II trial was designed to explore the efficacy and safety of an all-oral regimen of chidamide plus prednisone, cyclophosphamide, and thalidomide (CPCT) for R/R PTCL patients who could not tolerate the standard chemotherapy for a variety of reasons.Methods::We conducted a multicenter phase II clinical trial in which we combined chidamide (30 mg twice weekly) with prednisone (20 mg daily after breakfast), cyclophosphamide (50 mg daily after lunch), and thalidomide (100 mg daily at bedtime) (the CPCT regimen) for a total of fewer than 12 cycles as an induction-combined treatment period, and then applied chidamide as single-drug maintenance. Forty-five patients were ultimately enrolled from August 2016 to April 2021 with respect to Chinese patients at nine centers. Our primary objective was to assess the overall response rate (ORR) after the treatment with CPCT.Results::Of the 45 enrolled patients, the optimal ORR and complete response (CR)/CR unconfirmed (CRu) were 71.1% (32/45) and 28.9% (13/45), respectively, and after a median follow-up period of 56 months, the median progression-free survival (PFS) and overall survival (OS) were 8.5 months and 17.2 months, respectively. The five-year PFS and OS rates were 21.2% (95% confidence interval [CI], 7.9-34.5%) and 43.8% (95% CI, 28.3-59.3%), respectively. The most common adverse event was neutropenia (20/45, 44.4%), but we observed no treatment-related death.Conclusion::The all-oral CPCT regimen was an effective and safe regimen for R/R PTCL patients who could not tolerate standard chemotherapy for various reasons.Trial Registration::ClinicalTrials.gov, NCT02879526.

Result Analysis
Print
Save
E-mail