1.Effects of Jiaohong Pills and Its Prescription on Scopolamine-induced Alzheimer's Disease Mice
Lijinchan DONG ; Weiyan CAI ; Li FENG ; Qing YANG ; Mengting LI ; Yanli WANG ; Hong ZHANG ; Qi LI ; Xiaogang WENG ; Yajie WANG ; Xiaoxin ZHU ; Xiaoru HU ; Ying CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(2):37-45
ObjectiveTo investigate the effects of Jiaohong pills (JHP) and its prescription, Pericarpium Zanthoxyli (PZ) and Rehmanniae Radix (RR) cognitive dysfunction in scopolamine-induced Alzheimer's disease (AD) mice and its mechanism through pharmacodynamic and metabolomics study. MethodThe animal model of AD induced by scopolamine was established and treated with PZ, RG and JHP, respectively. The effects of JHP and its formulations were investigated by open field test, water maze test, object recognition test, avoidance test, cholinergic system and oxidative stress related biochemical test. Untargeted metabolomics analysis of cerebral cortex was performed by ultra-performance liquid chromatography-Quadrupole/Orbitrap high resolution mass spectrometry (UPLC Q-Exactive Orbitrap MS). ResultThe behavioral data showed that, compared with the model group, the discrimination indexes of the high dose of JHP, PZ and RR groups was significantly increased (P<0.05). The staging rate of Morris water maze test in the PZ, RR, high and low dose groups of JHP was significantly increased (P<0.05, P<0.01), the crossing numbers in the PZ, JHP high and low dose groups were significantly increased (P<0.05, P<0.01); the number of errors in the avoidance test were significantly reduced in the PZ and high-dose JHP groups (P<0.01), and the error latencies were significantly increased in the JHP and its prescription drug groups (P<0.01). Compared with the model group, the activities of acetylcholinesterase in the cerebral cortex of the two doses of JHP group and the PZ group were significantly increased (P<0.05, P<0.01), and the activity of acetylcholinesterase in the high-dose JHP group was significantly decreased (P<0.05), and the level of acetylcholine was significantly increased (P<0.01). At the same time, the contents of malondialdehyde in the serum of the two dose groups of JHP decreased significantly (P<0.05, P<0.01). The results of metabolomics study of cerebral cortex showed that 149 differential metabolites were identified between the JHP group and the model group, which were involved in neurotransmitter metabolism, energy metabolism, oxidative stress and amino acid metabolism. ConclusionJHP and its prescription can antagonize scopolamine-induced cognitive dysfunction, regulate cholinergic system, and reduce oxidative stress damage. The mechanism of its therapeutic effect on AD is related to the regulation of neurotransmitter, energy, amino acid metabolism, and improvement of oxidative stress.
2.Immune responses in the microenvironment after spinal cord injury:a bibliometric analysis
Huayong DU ; Zehui LI ; Xiaoxin WANG ; Yingli JING ; Feng GAO ; Degang YANG ; Jianjun LI
Chinese Journal of Rehabilitation Theory and Practice 2024;30(11):1322-1333
Objective To analyze the current status,research hotspots and development trends in the field of immune responses in the microenvironment after spinal cord injury(SCI). Methods Literatrues about immune responses in the microenvironment after SCI were searched from CNKI and the Web of Science Core Collection,from inception to March,2024.VOSviewer and CiteSpace were used to conduct a vi-sual analysis of authors,countries,institutions,journals,co-cited references and keywords. Results A total of 152 Chinese and 455 English studies were included.The number of publications increased annually,and China and the United States were leading research efforts in this field.In the Chinese literature,Zhu Yue was the most prolific author,and China Medical University was the leading institution.In the English literature,Phil-lip Popovich was the most prolific and highly cited author,and Ohio State University was the leading institution.Journal of Neuroscience and Experimental Neurology were identified as key journals.The research hotspots in both languages focused on immune activation,inflammatory response and functional recovery.Researches on stem cell transplantation,macrophage and traditional Chinese medicine were particularly prominent in the regu-lation of immune responses after SCI. Conclusion Immune responses in the microenvironment have emerged as a central focus in SCI research.The emphasis of current researches is shifting from mechanistic exploration to the investigation of immunomodulatory strate-gies,with several cutting-edge technologies showing significant potential in this regard.Moving forward,increas-ing collaboration across regions and institutions are essential to promote information sharing,accelerate scientific progress,and facilitate clinical translation,ultimately enhance patient rehabilitation outcomes.
3.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
4.Establishment and evaluation of a risk prediction model for severe obstructive sleep apnea
Yewen SHI ; Yushan XIE ; Lina MA ; Zine CAO ; Yitong ZHANG ; Yonglong SU ; Xiaoxin NIU ; Haiqin LIU ; Yani FENG ; Xiaoyong REN
Journal of Xi'an Jiaotong University(Medical Sciences) 2023;44(6):915-923
【Objective】 To construct a prediction model of severe obstructive sleep apnea (OSA) risk in the general population by using nomogram in order to explore the independent risk factors of severe OSA and guide the early diagnosis and treatment. 【Methods】 We retrospectively enrolled patients who had been diagnosed by polysomnography and divided them into training and validation sets at the ratio of 7∶3. Patients were divided into severe OSA group and non-severe OSA group according to apnea hypopnea index (AHI)>30. Variables entering the model were identified by least absolute shrinkage and selection operator regression model (Lasso), and logistic regression (LR) method. Then, multivariable logistic regression analysis was used to establish the nomogram, and the area under the receiver operating characteristic curve (AUC) was used to evaluate the discriminative properties of the nomogram model. Finally, we conducted decision curve analysis (DCA) of nomogram model, STOP-Bang questionnaire and Berlin questionnaire to assess clinical utility. 【Results】 Through single factor and multiple factor logistic regression analyses, the independent risk factors for severe OSA were screened out, including moderate and severe sleepiness, family history of hypertension, history of smoking, drinking, snoring, history of suffocation, sedentary lifestyle, male, age, body mass index (BMI), waist and neck circumference. Lasso logistic regression identified smoke, suffocation time, snoring time, waistline, Epworth sleepiness scale (ESS) and BMI as predictive factors for inclusion in the nomogram. The AUC of the model was 0.795 [95% confidence interval (CI): 0.769-0.820] . Hosmer-Lemeshow test indicated that the model was well calibrated (χ2=3.942, P=0.862). The DCA results on the visual basis confirmed that the nomogram had superior overall net benefits within a wide, practical threshold probability range which displayed the nomogram was higher than that of STOP-Bang questionnaire and Berlin questionnaire, which is clinically useful. The Clinical Impact Curve (CIC) analysis showed the clinical effectiveness of the prediction model when the threshold probability was greater than 82% of the predicted score probability value. The prediction model determined that the high-risk population with severe OSA was highly matched with the actual population with severe OSA, which confirmed the high clinical effectiveness of the prediction model. 【Conclusion】 The model performed better than STOP-Bang questionnaire and Berlin questionnaire in predicting severe OSA and can be applied to screening. And it can be helpful to the early diagnosis and treatment of OSA in order to reduce social burden.
5.Comparison of day surgical ward mode and traditional hospitalization mode for lung cancer patients
Ling GE ; Xiaoxin LIU ; Xinxing JU ; Jie YANG ; Jing FENG
Chinese Journal of Modern Nursing 2023;29(25):3375-3380
Objective:To explore the differences in postoperative recovery, economic effects, and discharge readiness between the day surgical ward mode and the traditional hospitalization mode for lung cancer patients based on propensity score matching analysis.Methods:From August to December 2022, 320 lung cancer patients who underwent thoracoscopy in the Department of Thoracic Surgery and Day Surgery Ward of the Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine were selected as the study subject by convenience sampling. The patients were surveyed using the General Information Questionnaire and the Readiness for Hospital Discharge Scale (RHDS) . The differences in postoperative recovery indicators, economic indicators, and discharge readiness between the day surgical ward mode and the traditional hospitalization mode for lung cancer patients were compared. A total of 320 questionnaires were distributed, and 308 valid questionnaires were collected, with an effective response rate of 96.25% (308/320) .Results:Among 308 lung cancer patients, there were 161 in the day surgical ward mode group and 147 in the traditional hospitalization mode group. Through propensity matching, a total of 160 cases were successfully matched, with 80 cases in each group. The first time out of bed, chest tube retention time, and postoperative hospitalization time in the day surgical ward mode group were all shorter than those in the traditional hospitalization mode group, with statistically significant differences ( P<0.05) . There was no statistically significant difference in the incidence of postoperative complications, adverse reactions, and pain scores between the two groups on the first and second postoperative days ( P>0.05) . The laboratory expenses, Western medicine expenses, and total postoperative hospitalization expenses of the day surgical ward mode group were all lower than those of the traditional hospitalization mode group, and the differences were statistically significant ( P<0.05) . The individual status, adaptability, and discharge readiness scores of the day surgical ward mode group were lower than those of the traditional hospitalization mode group, with statistically significant differences ( P<0.05) . Conclusions:The daytime surgical ward mode based on enhanced recovery after surgery for lung cancer can ensure the safety of patients during the perioperative period, promote early recovery, shorten hospitalization time, and improve economic effects. Compared to the traditional hospitalization mode, there is still room for improvement in the discharge readiness of the day surgical ward mode. It is necessary to strengthen the evaluation of patient discharge readiness and implement targeted interventions.
6.Evidence-based practice of perioperative enhanced recovery nursing for lung cancer patients based on the Stetler model of research utilization
Tingting LIU ; Jing FENG ; Shiying ZENG ; Ling GE ; Fengxia JIN ; Xiaoxin LIU
Chinese Journal of Modern Nursing 2022;28(14):1908-1913
Objective:To apply the best evidence of perioperative enhanced recovery nursing for lung cancer patients to clinical practice, and to evaluate the effect of practice.Methods:Following the 5 steps of the Stetler model of research utilization, an evidence-based protocol was formed through literature search, quality assessment, evidence synthesis and revision by expert group meetings. From January to July 2021, convenience sampling was used to select 160 lung cancer patients admitted to the Thoracic Surgery of Shanghai Chest Hospital as the research object. Patients admitted from January to April 2021 were set as the control group ( n=80) for baseline review. Patients admitted from May to July 2021 were set as the intervention group ( n=80) , and an evidence-based protocol was applied. Results:Finally, one guideline and 7 consensus articles were included. The evidence-based protocol covered 10 modules of preoperative nursing assessment, nutritional management, dietary preparation, health education, postoperative dietary management, functional exercise, pipeline management, pain management, venous thrombosis management and symptom management, with a total of 22 recommendations. There were significant differences in the time of first ambulation, the completion of ambulation on the day of operation, the pain score of first ambulation, the time for the first eating, and the time for the first exhausting between the two groups ( P<0.05) . There were no complications and venous thrombosis in the two groups during hospitalization. Conclusions:The development of the evidence-based practice project is beneficial to accelerate the postoperative recovery of lung cancer patients, and is conducive to standardizing the nursing path, thereby promoting the improvement of nursing quality.
7.Investigation of dental caries and periodontal conditions in maintenance hemodialysis patients
WU Hongyu ; MA Xiaoxin ; LU Haixia ; FENG Xiping ; GU Qin ; YE Wei ; XIE Yingxin ; XIE Danshu ; WANG Wenji
Journal of Prevention and Treatment for Stomatological Diseases 2020;28(5):313-317
Objective:
To compare the prevalence of dental caries and periodontal disease in patients with end-stage renal disease treated with maintenance hemodialysis with that in healthy controls and to investigate the relationship between end-stage renal disease, dental caries and periodontal disease.
Methods :
A total of 82 maintenance hemodialysis patients who met the inclusion criteria were selected as the case group, and 86 healthy persons who underwent oral examination in the physical examination center were selected as the control group. Dental caries and periodontal conditions were examined in the two groups. The dental caries examination was conducted by determining the number of decayed-missing-filled teeth, which was recorded as recommended by the World Health Organization. The periodontal condition parameters included the plaque index, calculus index, bleeding on probing, periodontal pocket depth and clinical attachment loss.
Results:
The prevalence of dental caries in the case group and healthy control group was 87.8% and 81.4%, respectively, and there was no statistically significant difference between the two groups (P > 0.05). The periodontal indexes, including the plaque index, calculus index, probe bleeding index, periodontal pocket depth and clinical attachment level, in the case group were significantly higher than those in the control group (P < 0.05), and the prevalence of periodontitis in the case group was significantly higher than that in the control group (97.6% vs 88.4%, P < 0.05).
Conclusion
The dental caries conditions were comparable between the case group and the control group, but the prevalence and severity of periodontitis were significantly higher in the case group than in the control group.
8.Application of health management mode based on symptom group management in nursing care of lung cancer patients after minimally invasive surgery
Jing FENG ; Ling GE ; Fengxia JIN ; Xiaoxin LIU
Chinese Journal of Health Management 2020;14(4):345-349
Objective:To explore the application effect of the health management mode based on symptom group management in the nursing of lung cancer patients after minimally invasive surgery.Methods:The lung cancer patients underwent minimally invasive surgery and were discharged from Shanghai Chest Hospital from April to August 2019 were selected as the study subjects. The patients were divided into control group and experimental group, with the intervention time of 1 month. Routine follow-up was carried out in the control group. The health management mode based on symptom group management was adopted in experimental group. According to the exploratory factor analysis method, three factors with characteristic value>1were extracted, and the symptoms with factor load≥0.5 were included in the symptom group, and post discharge nursing was carried out based on the symptom group, including establish health management archives, distribute symptom group manual, centralized teaching, WeChat communication, etc. Before and after nursing care, Anderson symptom evaluation form (Chinese version) was used to evaluate the symptom group score of patients and compare the interference of symptom group on daily life and the influence on quality of life.Results:A total of 40 cases (47.1%) in the control group and 45 cases (52.9%) in the experimental group were included. In the control group, 28 cases (70.0%) were male, 12 cases (30.0%) were female, the average age was (60.2±6.5) years, the average time of cancer was (8.0±2.0) months, and 21 cases (52.5%) had a history of smoking. In the experimental group, there were 30 (66.7%) males, 15 (33.3%) females, age (60.6±6.8), mean time of cancer (7.9±2.1) months, and 22 (48.9%) smokers. There was no significant difference in gender, age, average time of cancer and smoking history between the two groups (all P>0.05).There was no significant difference in factor load of those symptoms between the two groups before nursing, and there was no significant difference before and after nursing in the control group. After the intervention, the symptoms in the experimental group were less than before the intervention. The total scores of symptom group and disturbance of daily life in the experimental group were (32.4±10.3), (15.20±5.3), lower than those in the control group (44.3±11.5), (28.8±8.1), the quality of life score was (88.3±18.5), higher than that in the control group (64.2±16.5) (all P<0.05). Conclusion:The health management model based on symptom group management can improve the symptoms of patients with lung cancer after minimally invasive surgery, reduce the impact of symptom group on daily life and improve the quality of life.
9.Evaluation of immediate implant in patients with limited buccal bone wall dehiscence in single upper anterior tooth
Xiaoxin ZHANG ; Xinyu WU ; Ting XIA ; Shi FENG ; Qing HU ; Qi YAN ; Bin SHI
Chinese Journal of Stomatology 2020;55(11):831-837
Objective:To compare and evaluate the clinical outcome of immediate implant therapy in patients with limited buccal bone wall dehiscence and in patients with intact buccal bone wall.Methods:This prospective cohort study included patients intended to receive immediate implant treatment in upper anterior esthetic region in the Department of Implantology, Hospital of Stomatology, Wuhan University from August to December, 2018. Patients with buccal bone wall dehiscence limited to the coronal half were attributed to experimental group to conduct flap implant surgery (indicating to less than coronal half of the buccal bone wall length from the alveolar bone crest to the implant tip), whereas patients with intact buccal bone wall were attributed to control group to conduct flapless implant surgery. Buccal bone wall resorptions in height and thickness were evaluated 6 months after implant placement. Implant survival rate, pink/white esthetic score and post-operation complications were also analyzed 12 months after implant placement. Paired t-test and two-sample t-test were adopted to analyze the differences of different points within one group and differences between groups, respectively. Results:A total of 38 patients with the age of (39.2±5.8) years (range 19-45 years) and 38 upper anterior single tooth implants were included,in which 19 patients were attributed to experimental group [12 male and 7 female, the age was (37.6±5.3) years], and 19 patients were attributed to control group [9 male and 10 female, the age was (40.8±6.7) years]. Over the 12 months′ observation after implant placement, the overall implant survival rate was 97% (37/38), and 18/19 in control group and 19/19 in experimental group. Only one implant lost in control group and no other complications were reported. Buccal bone resorption in thickness and height occurred in both groups within 6 months after implant placement. The thickness and height of buccal bone decreased significantly in both groups within 6 months after implant placement ( P<0.05). Thickness decreases in experimental group were (1.32±0.74), (0.53±0.89) and (0.36±0.70) mm in coronal, middle and apical part of implant in experimental, and (1.24±0.57), (0.83±0.46) and (0.38±0.72) mm in coronal, middle and apical part of implant in control group. While the buccal bone height decreases were (0.24±0.15) mm in experimental group and (0.25±0.23) mm in control group. There were no statistical differences between the corresponding spots in the two groups ( P>0.05). Upon the final restoration, both group got ideal pink esthetic scores [experimental group (10.92±1.13),control group (10.92±1.26)] and white esthetic scores [experimental group (7.61±0.78), control group (7.40±0.71)], the differences in both groups were not statistically significant ( P>0.05). Conclusions:Clinical results of immediate implant to patients with buccal bone wall dehiscence limited to the coronal half are comparable to the results of patients with intact buccal bone wall.
10.Intravitreal aflibercept versus photodynamic therapy in Chinese patients with neovascular age-related macular degeneration: outcomes of the SIGHT study
Xiaoxin LI ; Youxin CHEN ; Junjun ZHANG ; Xun XU ; Feng ZHANG ; Chui Ming Gemmy Cheung ; Yu RUI ; Kazmi HUSAIN ; Sowade OLAF ; Oliver Zeitz on behalf of the SIGHT study group
Chinese Journal of Ocular Fundus Diseases 2019;35(2):156-165
Objective To assess the efficacy and safety ofintravitreal aflibercept injection (IAI) compared with photodynamic therapy (PDT) in the treatment of Chinese patients with predominantly classic subfoveal choroidal neovascularization (CNV) lesions secondary to neovascular age-related macular degeneration (nAMD).Methods A randomized,double-blind,multi-center phase-3 clinical trial lasting for 52weeks (from December 2011 to August 2014).Subjects were randomized in a 3:1 ratio to either IAI group or PDT-to-IAI group.Subjects in the IAI group received 2 mg IAI at baseline and at week 4,8,16,24,32,40,48,with sham injection at week 28,36.Subjects in the PDT-to-IAI group were forced to receive PDT once at baseline and more time at week 12,24 if PDT retreatment conditions were met.Sham injections were given in PDT-to-IAI group at baseline and at week 4,8,16 and 24,followed by 2 mg IAI at week 28,32,36,40,48.The primary outcome of efficacy were the change in mean Best Corrected Visual Acuity (BCVA) from baseline to week 28,and that of week 52.Safety evaluation included the percentage of subjects who suffered treatment emergent adverse events (TEAEs).Results Among the 304 subjects enrolled,there were 228 and 76 cases in IAI group and PDT-to-IAI group respectively.At week 28,the changes of mean BCVA in IAI group,PDT-to-IAI group compared to baseline were +14.0,+3.9 letters,respectively.At week 52,the changes of mean BCVA in two groups were + 15.2,+8.9 letters respectively with the difference of +6.2 letters (95%CI 2.6-9.9,P=0.000 9).At week 52,the mean foveal retinal thickness in the two groups decreased by-189.6,-170.0 μm,respectively.Subjects with the most BCVA increase in IAI group were those aged <65,and those with active CNV lesion area <50% of total lesion area.The most common TEAEs in IAI group and PDT-to-IAI group are macular fibrosis [11.8% (27/228),6.6% (5/76)] and BCVA decline [6.6% (15/228),21.1% (16/76)].There were 3 cases of arterial thromboembolic events defined in the antiplatelet experimental collaboration group,but all were considered unrelated to interventions.Conclusions The efficacy of aflibercept is superior to that of PDT in nAMD patients in China.The therapeutic effect of aflibercept persisted to week 52 in all subjects.The rate of adverse events was consistent with the safety data of aflibercept known before.


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