1.Relationship between self-management behaviors and time perspective among patients with comorbid diabetes
YU Dandan ; ZHANG Yaping ; XU Huilin ; HE Dandan ; LIANG Tongtong ; YANG Jiali ; LI Jun
Journal of Preventive Medicine 2025;37(2):130-134
Objective:
To examine the relationship between self-management behaviors and time perspective among patients with comorbid diabetes, so as to provide the evidence for improving self-management behaviors among patients with comorbid diabetes.
Methods:
The patients with comorbid diabetes who were registered in the chronic disease health management system of Minhang District, Shanghai Municipality in 2021, followed up regularly, and lived in Meilong Town were recruited. Demographic information and family history of diabetes were collected through questionnaire surveys. Time perspective and self-management behaviors were assessed using the Zimbardo Time Perspective Inventory and Diabetes Self-Management Behavior Scale, respectively. The relationship between self-management behaviors and time perspective was analyzed using a multivariable ordinal logistic regression model.
Results:
A total of 907 patients with comorbid diabetes were enrolled, including 472 males (52.04%) and 435 females (47.96%). There were 652 cases aged 65 years and above, accounting for 71.89%. In terms of the types of time perspective, 280 patients were future-oriented (30.87%), 236 were balanced (26.02%), 162 were sensation-seeking (17.86%), 123 were fatalistic (13.56%), and 106 were negative (11.69%). In terms of the self-management behaviors, 46 patients were good (5.07%), 643 were moderate (70.89%), and 218 were poor (24.04%). Multivariable ordinal logistic regression analysis showed that after adjusting for age, gender, educational level, marital status, occupation status, monthly income, and family history of diabetes, the patients with comorbid diabetes who had a future-oriented time perspective had better self-management behaviors (OR=1.874, 95%CI: 1.204-2.915).
Conclusion
The self-management behaviors among patients with comorbid diabetes are moderate to poor, and patients with a future-oriented time perspective can better engage in self-management behaviors.
2.Guideline for the diagnosis and treatment of vertebral refracture after percutaneous vertebral augmentation in elderly patients with osteoporotic thoracolumbar compression fractures (version 2025)
Yong YANG ; Xiaoguang ZHOU ; Qixin CHEN ; Jian CHEN ; Jian DONG ; Liangjie DU ; Shunwu FAN ; Jin FAN ; Zhong FANG ; Haoyu FENG ; Shiqing FENG ; Haishan GUAN ; Aiguo GAO ; Yanzheng GAO ; Yong HAI ; Da HE ; Dengwei HE ; Haiyi HE ; Dianming JIANG ; Xuewen KANG ; Bin LIN ; Baoge LIU ; Changqing LI ; Fang LI ; Li LI ; Fangcai LI ; Weishi LI ; Xiaoguang LIU ; Hongjian LIU ; Xinyu LIU ; Yong LIU ; Zhongjun LIU ; Shibao LU ; Xuhua LU ; Fei LUO ; Yuhai MA ; Keya MAO ; Xuexiao MA ; Bin MENG ; Xu NING ; Limin RONG ; Hongxun SANG ; Jun SHU ; Tiansheng SUN ; Dasheng TIAN ; Zheng WANG ; Bing WANG ; Linfeng WANG ; Qingde WANG ; Qinghe WANG ; Lan WEI ; Jigong WU ; Baoshan XU ; Youjia XU ; Guoyong YIN ; Jinglong YAN ; Feng YAN ; Cao YANG ; Huilin YANG ; Qiang YANG ; Bin ZHAO ; Jie ZHAO ; Yue ZHU ; Jianguo ZHANG ; Wenzhi ZHANG ; Zhongmin ZHANG ; Zhaomin ZHENG ; Yan ZENG ; Baorong HE ; Wei MEI
Chinese Journal of Trauma 2025;41(7):613-626
Vertebral refracture following percutaneous vertebral augmentation (PVA) is commonly seen in elderly patients with osteoporotic thoracolumbar compression fractures (OTLCF). It can lead to recurrent pain, loss of vertebral height, progression of kyphosis, and even neurological dysfunction, significantly impairing patients′ quality of life. Current diagnosis and treatment face multiple challenges, including high misdiagnosis rate, difficulty in choosing between surgical and non-surgical treatment options, lack of standardized surgical protocols, interference from intralesional bone cement during procedures, inadequate stability of internal fixation in osteoporotic bone, and suboptimal compliance of anti-osteoporotic therapy. Establishing a standardized diagnostic and therapeutic framework is urgently needed. To standardize the management process and improve outcomes for vertebral refractures after PVA in elderly OTLCF patients, Spinal Trauma Group of the Orthopedic Branch of Chinese Medical Doctor Association organized experts in the field to develop Guideline for the diagnosis and treatment of vertebral refracture after percutaneous vertebral augmentation in elderly patients with osteoporotic thoracolumbar compression fractures ( version 2025), based on current literature and clinical experience, and adhering to principles of scientific rigor and clinical applicability. A total of 11 recommendations were proposed, encompassing diagnosis, treatment, and rehabilitation of vertebral refracture after PVA in elderly patients with OTLCF, aiming to provide a foundation for a standardized management.
3.Risk factors for changes of eggshell vertebral body after fixation of thoracolumbar fracture with posterior pedicle screws
Xiao SUN ; Qi YAN ; Tianyi WU ; Leyu ZHAO ; Jinning WANG ; Huilin YANG ; Jun ZOU
Chinese Journal of Orthopaedic Trauma 2025;27(7):612-619
Objective:To investigate the risk factors for the formation of eggshell vertebral body after open reduction and internal fixation with posterior screw-rod system for thoracolumbar spine fractures. Methods:A retrospective study was conducted to analyze the 118 patients with thoracolumbar single-segment fracture who had been treated at Department of Orthopaedic Surgery, The First Hospital Affiliated to Soochow University between January 2020 and January 2023. The patients were divided into a case group (47 cases) and a control group (71 cases) according to whether an eggshell vertebral body developed in the injured vertebra after internal fixation with posterior screw-rod system. The 2 groups were compared in terms of gender, age, follow-up time, body mass index, history of primary hypertension, history of diabetes mellitus, vertebral bone quality (VBQ) score, local Cobb angle correction, presence or absence of screwing at the injured vertebra, fracture site, fracture type, presence or absence of injury to the posterior ligamentous complex, presence or absence of injury to the upper and lower discs/endplate complex in the injured vertebrae, recovery rates of the anterior, middle, and posterior heights of the injured vertebra, and preoperative and postoperative visual analog scale (VAS) for pain. After positive indicators were screened by univariate analysis ( P<0.05), they were included in a multivariate logistic regression model and receiver operating characteristic curve (ROC) to analyze the risk factors for the formation of eggshell vertebral body after posterior screw-rod internal fixation of thoracolumbar spine fractures. Results:Of the 118 patients, 47 developed an eggshell vertebral body after surgery. Univariate analysis showed that VBQ score, presence or absence of screwing at the injured vertebra, burst fracture type, injury to the posterior ligamentous complex, injury to the upper and lower discs/endplate complex in the injured vertebrae, recovery rate of the anterior height of the injured vertebra, recovery rate of the middle height of the injured vertebra were statistically significant ( P<0.05). The multivariate logistic regression analysis and ROC curve analysis showed that a VBQ score ≥ 2.95 points( OR=6.216, 95% CI: 1.890 to 20.441, P=0.003), a recovery rate of the anterior height of the injured vertebra ≥ 25.26% ( OR=1.097, 95% CI: 1.046 to 1.149, P<0.001), a burst fracture type ( OR=6.397, 95% CI: 1.733 to 23.617, P=0.005), and injury to the upper and lower discs/endplate complex in the injured vertebrae ( OR=7.581, 95% CI: 1.827 to 31.461, P=0.005) were significantly associated with the formation of eggshell vertebral body after open reduction and internal fixation with posterior screw-rod system for thoracolumbar spine fractures ( P<0.05). Conclusion:A VBQ score ≥ 2.95 points, a recovery rate of the anterior height of the injured vertebra ≥ 25.26%, a burst fracture type, and injury to the disc/endplate complex in the injured vertebrae are the independent risk factors for the formation of eggshell vertebral body after open reduction and internal fixation with posterior screw-rod system for thoracolumbar spine fractures.
4.Study on quality standard of wine-processed Coptidis Rhizoma standard decoction
Huilin YANG ; Kaiwei HUANG ; Yanghua LI ; Suqin CAI ; Shuping XU ; Jiabao WEI ; Hui ZHANG ; Weizhi ZHAO ; Pei TAN
International Journal of Traditional Chinese Medicine 2025;47(9):1285-1292
Objective:To establish the quality standard of the standard decoction of wine-processed Coptidis Rhizoma by studying the extraction rate, fingerprint and component quantitative analysis.Methods:ccording to the Technical Requirements for Quality Control and Standard Formulation of Chinese Medicine Formula Granules, 15 batches of the standard decoction of wine-processed Coptidis Rhizoma were prepared, and the paste rate was determined; HPLC fingerprints of 15 batches of standard decoction of wine-processed Coptidis Rhizoma were established, and evaluated by combining similarity evaluation, clustering analysis, principal component analysis and orthogonal partial least squares discriminant analysis; the contents of berberine, epiberberine, pamadine, and safranine in the samples of the 15 batches were determined and analyzed their transfer rates.Results:A total of 15 batches of standard decoction samples were calibrated with 11 common peaks, referring to the recognition of 8 components. The similarity between the samples and the control product was greater than 0.900; the clustering analysis could cluster the 15 batches of samples into 2 classes; the results of the principal component analysis showed that the cumulative variance contribution rate of the 3 principal component factors was 89.388%; the OPLS-DA screened out the 3 components of the quality difference; the 15 batches of samples out of the paste rate was 15.7% -20.8%, and the mass fractions of berberine, epiberberine, safranine, and palmatine were 18.47%-24.38%, 2.82%-3.49%, 5.08%-6.69%, and 4.84%-6.68%, respectively, with transfer rates of 41.7%-61.7%, 46.9%-68.7%, 39.8%-61.5%, and 43.8%-65.2%.Conclusion:The fingerprint and content determination method established in this study is accurate, stable, simple, and can be used for the quality control and evaluation of the standard decoction of wine-processed Coptidis Rhizoma.
5.Li Huilin's Experience in Treating Acne Through the Therapy of Unblocking Triple Energizer and Opening Xuanfu
Hongli WANG ; Yuxin YAN ; Xiaoxue YANG ; Shufang CHU ; Huilin LI
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(5):1250-1254
The triple energizer is the pathway for the transportation and metabolism of qi,blood and body fluid in the body,and the xuanfu(sweat pores)is the way for the ascending,descending,exiting,and entering of qi movement in the muscular striae and the exterior.Professor Li Huilin believes that the pathogenesis of acne is usually due to the dysfunction of triple energizer and the stagnation of depressed yang-heat,which result into the abnormal opening and closing of the xuanfu and the accumulation of heat-toxin in the muscular striae.For the treatment of acne with traditional Chinese medicine,it is necessary to pay attention to the regulation of triple energizer-xuanfu.The treatment should be based on unblocking therapy,and the therapeutic principle of unblocking triple energizer and opening xuanfu should be taken into account.In clinical practice,it is necessary to identify the syndromes of upper energizer,middle energizer and lower energizer.The syndrome of the upper energizer is often due to fire-heat,which results from the wind-heat in lung meridian or the exuberance of heart fire.The upper-energizer syndrome can be treated by the therapy of relieving and clearing the pathogens with light and mild drugs,expelling fire-heat to open sweat pores,and through the modified use of Mahuang Lianqiao Chixiaodou Decoction,Ma Xing Shi Gan Decoction,or Puji Xiaodu Decoction.The syndrome of the middle energizer is usually due to the qi stagnation,which results from intense stomach-heat,damp-heat in the spleen and stomach,liver depression and qi stagnation,or spleen deficiency with dampness accumulation.The middle-energizer syndrome can be treated by the therapy of regulating qi movement to relieve stagnation and open sweat pores,and through the modified use of Qingwei san,Sanren Decoction,Huanglian Wendan Decoction,Chaihu Shugan Powder,or Heqi Powder.The syndrome of the lower energizer is often due to healthy-qi deficiency,which results from yin deficiency of liver and kidney,or deficiency-cold in lower energizer.The lower-energizer syndrome can be treated by the therapy of cultivating the vital essence and consolidating vital base,supplementing deficiency to open sweat pores,and through the modified use of Liuwei Dihuang Pills or Yanghe Decoction.
6.Data Mining in the Medication Rules of Li Huilin in Treating Hashimoto's Thyroiditis Complicated with Hypothyroidism
Xiaoxue YANG ; Chenyang WANG ; Mengru YAN ; Hongli WANG ; Xueqi HU ; Shufang CHU ; Huilin LI
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(7):1779-1785
Objective To explore the medication rules of Professor Li Huilin in treating Hashimoto's thyroiditis(HT)complicated with hypothyroidism using data mining techniques based on the R language.Methods Prescription data of the patients with HT complicated with hypothyroidism treated by Professor Li Huilin in outpatient clinics from March 2023 to March 2024 were collected.A database was established using Microsoft Excel 2021,and R language was employed to analyze the frequency,efficacy,properties and flavors,and meridian tropism of the medicinals from Chinese herbal prescriptions.Additionally,correlation analysis,association rule analysis,and cluster analysis were performed on the medicines from Chinese herbal prescriptions.Results A total of 57 Chinese herbal prescriptions involving 125 medicinals with 782 medication frequencies were included.The top 10 frequently-used medicinals were Glycyrrhizae Radix et Rhizoma Praeparata cum Melle(Zhigancao),Angelicae Sinensis Radix(Danggui),Atractylodis Macrocephalae Rhizoma(Baizhu),Astragali Radix(Huangqi),Bupleuri Radix(Chaihu),Cinnamomi Ramulus(Guizhi),Leonuri Herba(Yimucao),Paeoniae Radix Alba(Baishao),Poria(Fuling),and Fici Simplicissimae Radix(Wuzhimaotao).Most of the medicinals had therapeutic action of tonifying deficiency.The analysis of properties and flavors showed that the majority of medicinals were mild or warm in nature,and sweet in flavor.The top three meridians having the tropism of medicinals were the liver,lung,and spleen meridians.Correlation analysis identified five strongly-correlated herbal combinations.Association rule mining revealed a core herbal combination consisting of seven medicinals of Zhigancao,Huangqi,Danggui,Chaihu,Codonopsis Radix(Dangshen),Baizhu,and Cyperi Rhizoma(Xiangfu).Cluster analysis of medicinals with a frequency of≥5 yielded five groups of herbal combination.Conclusion For the treatment of HT complicated with hypothyroidism,Professor Li Huilin follows the principle of addressing the root cause of the disease,and focuses on strengthening the spleen and replenishing qi.Moreover,attention is given to soothing the liver and regulating qi,harmonizing qi and blood simultaneously,and treating symptoms and root cause simultaneously.
7.Observation of therapeutic effect of different exercise methods on senile sarcopenia
Huilin JIN ; Beiren SHEN ; Mingyao YANG ; Wei PAN
Chinese Journal of Geriatrics 2025;44(4):472-476
Objective:To observe the effect of different exercise methods on the prevention and treatment of senile sarcopenia.Methods:A cross-sectional investigation was carried out to select the elderly who visited the First Affiliated Hospital of Zhejiang University School of Medicine and Tongxiang Hospital of Traditional Chinese Medicine from October 2016 to December 2023 for medical check-ups at the geriatrics department and physical examination center.General information was collected, and the Hologic Discovery-Wi bone density scanner(Hologic, USA)was used to measure appendicular lean mass(ALM).Walking speed over 6 meters and grip strength were measured, and the appendicular skeletal muscle index(ASMI=limb muscle mass/height 2)was calculated.The subjects were divided into three groups aged 60-69, 70-79, and 80-89 years and the relevant information was obtained through standard questionnaires.Based on the exercise methods and time, each age group was categorized into three groups: non-exercise, aerobic exercise, and resistance exercise.Differences in related indicators of sarcopenia among the elderly in different age groups with different exercise methods were analyzed. Results:In all three age groups, the ASMI of the resistance exercise group was higher compared to the aerobic exercise and non-exercise groups: In the 60-69 years old group, (7.50±0.31)kg/m 2vs.(6.93±0.37)kg/m 2 and (6.81±0.27)kg/m 2, F=38.146, P<0.001; In the 70-79 years old group, (7.26±0.30)kg/m 2vs.(6.82±0.38)kg/m 2 and (6.50±0.36)kg/m 2, F=35.784, P<0.001; In the 80-89 years old group, (7.00±0.59)kg/m 2vs.(6.53±0.63)kg/m 2 and (5.89±0.66)kg/m 2, F=23.380, P<0.001.The resistance exercise group also had higher grip strength than the aerobic and non-exercise groups: In the 60-69 years old group, (39.23±1.78) kg vs.(26.21±4.79) kg and (24.68±3.55) kg, F=127.806, P<0.001; In the 70-79 years old group, (37.78±2.50) kg vs.(27.21±5.47) kg and (24.43±3.49) kg, F=75.265, P<0.001; In the 80-89 years old group, (28.75±4.71) kg vs.(21.37±5.57) kg and (17.08±4.50) kg, F=33.148, P<0.001; Both the resistance and aerobic exercise groups had a faster walking speed compared to the non-exercise group: 60-69 years old group (1.30±0.14) m/s and (1.31±0.15) m/s compared to (1.20±0.14) m/s, F=5.905, P=0.003; 70-79 years old group (1.26±0.13) m/s and (1.24±0.17) m/s compared to (1.16±0.16) m/s, F=4.931, P=0.009; and (1.00±0.20) m/s and (1.02±0.27) m/s over (0.84±0.24) m/s in the group of 80-89 years old, F=6.913, P=0.001.The results of two-by-two comparisons showed that among the older adults in the 70-79 and 80-89 age groups, ASMI was higher in the aerobic exercise group than in the non-exercise group ( t=0.070, 0.048, both P<0.001), and grip strength was higher in the aerobic exercise group than in the non-exercise group ( t=0.885, 0.976, P=0.002, <0.001); however, there was no difference in step speed between the resistance exercise group and the aerobic exercise group among older adults in the three age groups ( t=0.031, 0.035, 0.701, P=0.605, 0.593, 0.841). Conclusions:Compared with non-exercise and aerobic exercise, resistance exercise has a clear effect on the prevention and treatment of sarcopenia in the elderly.As age increases, aerobic exercise can also prevent and treat sarcopenia in the elderly aged 70-89 years.Both resistance exercise and aerobic exercise have obvious effect on maintaining the pace of the elderly.
8.Clinical guideline for diagnosis and treatment of nonunion of osteoporotic vertebral fractures (version 2025)
Haipeng SI ; Le LI ; Junjie NIU ; Wencan ZHANG ; Fuxin WEI ; Jinqiu YUAN ; Qiang YANG ; Hongli WANG ; Guangchao WANG ; Shihong CHEN ; Yunzhen CHEN ; Xiaoguang CHENG ; Jianwen DONG ; Shiqing FENG ; Rui GU ; Yong HAI ; Tianyong HOU ; Bo HUANG ; Xiaobing JIANG ; Lei ZANG ; Chunhai LI ; Nianhu LI ; Hua LIN ; Hongjian LIU ; Peng LIU ; Xinyu LIU ; Sheng LU ; Shibao LU ; Chunshan LUO ; Lvy CHAOLIANG ; Lvy WEIJIA ; Xuexiao MA ; Wei MEI ; Chunyang MENG ; Cailiang SHEN ; Chunli SONG ; Ruoxian SONG ; Jiacan SU ; Honglin TENG ; Hui SHENG ; Beiyu WANG ; Bingwu WANG ; Liang WANG ; Xiangyang WANG ; Nan WU ; Guohua XU ; Yayi XIA ; Jin XU ; Youjia XU ; Jianzhong XU ; Cao YANG ; Maowei YANG ; Zibin YANG ; Xiaojian YE ; Hailong YU ; Xijie YU ; Hua YUE ; Zhili ZENG ; Xinli ZHAN ; Hui ZHANG ; Peixun ZHANG ; Wei ZHANG ; Zhenlin ZHANG ; Jianguo ZHANG ; Tengyue ZHU ; Qiang LIU ; Huilin YANG
Chinese Journal of Trauma 2025;41(10):932-945
Nonunion of osteoporotic vertebral fractures (OVF), predominantly affecting the elderly, can lead to intractable pain, vertebral collapse, progressive kyphotic deformity, and neurological impairment, significantly compromising patients′ quality of life. There exists considerable debate on diagnosis and management of OVF, encompassing key issues such as clinical diagnosis and staging criteria for nonunion, surgical indications and procedure selection, and postoperative rehabilitation planning. Currently, there lacks standardized clinical guideline and expert consensus on the diagnosis and management of OVF nonunion in China. To address this gap, Minimally Invasive Surgery Group of Chinese Orthopedic Association, Osteoporosis Committee of Chinese Association of Orthopedic Surgeons, Prevention and Rehabilitation Committee for Osteoporosis of Chinese Association of Rehabilitation Medicine and Minimally Invasive Orthopedic Surgery Branch of China Association for Geriatric Care jointly organized domestic experts in spinal surgery, endocrinology, and rehabilitation to formulate the Clinical guideline for the diagnosis and treatment for nonunion of osteoporotic vertebral fractures ( version 2025), based on existing literature and clinical experience and adhering to principles of scientific rigor and practicality. The guideline provided 13 evidence-based recommendations encompassing diagnosis and treatment of OVF nonunion, aiming to standardize its clinical management.
9.Clinical guideline for vertebral augmentation of acute symptomatic osteoporotic thoracolumbar compression fractures (version 2025)
Bolong ZHENG ; Wei MEI ; Yanzheng GAO ; Liming CHENG ; Jian CHEN ; Qixin CHEN ; Liang CHEN ; Xigao CHENG ; Jian DONG ; Jin FAN ; Shunwu FAN ; Xiangqian FANG ; Zhong FANG ; Shiqing FENG ; Haoyu FENG ; Haishan GUAN ; Yong HAI ; Baorong HE ; Lijun HE ; Yuan HE ; Hua HUI ; Weimin JIANG ; Junjie JIANG ; Dianming JIANG ; Xuewen KANG ; Hua GUO ; Jianjun LI ; Feng LI ; Li LI ; Weishi LI ; Chunde LI ; Qi LIAO ; Baoge LIU ; Xiaoguang LIU ; Xuhua LU ; Shibao LU ; Bin LIN ; Chao MA ; Xuexiao MA ; Renfu QUAN ; Limin RONG ; Honghui SUN ; Tiansheng SUN ; Yueming SONG ; Hongxun SANG ; Jun SHU ; Jiacan SU ; Jiwei TIAN ; Xinwei WANG ; Zhe WANG ; Zheng WANG ; Zhengwei XU ; Huilin YANG ; Jiancheng YANG ; Liang YAN ; Feng YAN ; Guoyong YIN ; Xuesong ZHANG ; Zhongmin ZHANG ; Jie ZHAO ; Yuhong ZENG ; Yue ZHU ; Rongqiang ZHANG
Chinese Journal of Trauma 2025;41(9):805-818
Acute symptomatic osteoporotic thoracolumbar compression fracture (ASOTLF) can lead to chronic low back pain, kyphosis deformity, pulmonary dysfunction, loss of mobility, and even life-threatening complications. Vertebral augmentation is currently the mainstream treatment method for this condition. In 2019, the Editorial Board of Chinese Journal of Trauma and the Spinal Trauma Group of Orthopedic Surgeons Branch of Chinese Medical Doctor Association collaboratively led the development of Clinical guideline for vertebral augmentation for acute symptomatic osteoporotic thoracolumbar compression fractures. Six years later, with advances in clinical diagnosis and treatment techniques as well as accumulating evidence in related fields, the 2019 guideline requires updating. To this end, the Spinal Trauma Group of Orthopedic Surgeons Branch of Chinese Medical Doctor Association, the Spinal Health Professional Committee of China Human Health Science and Technology Promotion Association, and the Minimally Invasive Orthopedics Professional Committee of Shaanxi Medical Doctor Association have organized experts in the field to develop the Clinical guideline for vertebral augmentation of acute symptomatic osteoporotic thoracolumbar compression fractures ( version 2025) , based on the latest evidence-based medical researches. This guideline incorporates 3 recommendations retained from the 2019 version with updated strength of evidence, along with 12 new recommendations. It provides recommendations from six aspects of diagnosis, pain management, treatment option selection, prevention of postoperative complications, anti-osteoporosis therapy, and postoperative rehabilitation, aiming to provide a reference for standard treatment of vertebral augmentation for ASOTLF in hospitals at all levels.
10.The application of sequential analysis for continuous post-market vaccine safety surveillance
Zixuan LU ; Musu LI ; Jiahe PAN ; Yiwen WU ; Huilin LI ; Er YU ; Hongmei WO ; Shaowen TANG ; Yang ZHAO ; Juncheng DAI ; Honggang YI
Chinese Journal of Epidemiology 2025;46(3):514-518
To explore the application of sequential analysis in post-market safety dynamic surveillance of vaccines. Under the dynamic monitoring data of vaccines post-market approval, this research introduces the fundamental principles of maximizing sequential probability ratio test (MaxSPRT) and Bayesian sequential analysis, employing R software. Through an example of dynamic safety monitoring data of vaccines post-market approval, we analyze using the MaxSPRT and Bayesian sequential analysis. The MaxSPRT identified a safety signal in week 4 ( P<0.05), while Bayesian sequential analysis indicated that the 95% highest density interval for the RR value at week 4 is 1.13-3.27, suggesting the first appearance of a safety signal at week 4. The MaxSPRT and Bayesian sequential analysis effectively leverage continuously accumulating dynamic monitoring data, thereby serving as a valuable method for post-market safety surveillance of vaccines.


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