1.Association between chronic disease comorbidity patterns and activities of daily living among permanent elderly residents in Xuhui District of Shanghai
Qian XU ; Xiaohong ZHANG ; Xiaolin QIAN ; Jing ZHU ; Yun CHEN ; Fei YAN ; Chaowei FU ; Haiyan GU
Shanghai Journal of Preventive Medicine 2026;38(7):527-535
ObjectiveTo investigate the patterns of chronic disease comorbidity among permanent elderly residents in Xuhui District of Shanghai, and to analyze the impact of different comorbidity patterns on the elderly’s ability to perform activities of daily living. MethodsBased on data from the 2015 and 2021 Surveys on Health Status and Health Service Utilization among Permanent Residents in Xuhui District of Shanghai, the study included permanent residents who fully participated in both surveys, were aged 60 years or older at the 2015 survey, self-reported having a chronic disease, and reported no significant changes in their chronic disease status between the two surveys. A prospective cohort study design was adopted, using the 2015 data as the baseline and the 2021 survey data as follow-up data. Physical examinations and questionnaire surveys were conducted by the Shanghai Xuhui District Center for Disease Control and Prevention in the subdistricts and towns within the jurisdiction from April to July in both 2015 and 2021. Latent class analysis (LCA) was used to classify comorbidity patterns across 11 types of chronic diseases. The smaller the values of the Akaike information criterion (AIC), the Bayesian information criterion (BIC), and the sample-corrected Bayesian information criterion (aBIC), the better the model fits. The Barthel index (BI) and the Lawton and Brody Instrumental Activities of Daily Living Scale (LB-IADL) were used to assess the participants’ activities of daily living (ADL) and instrumental activities of daily living (IADL). Multiple linear regression and multivariate logistic regression models were used to analyze the association between different comorbidity patterns and ADL and IADL. ResultsA total of 1 608 study participants were enrolled. Among them, 671 (41.73%) self-reported having no chronic diseases. The prevalence of 11 types of chronic diseases was as follows: hypertension in 743 participants (46.21%), heart disease in 148 participants (9.20%), cerebrovascular disease in 37 participants (2.30%), diabetes or abnormal blood glucose in 310 participants (19.28%), other endocrine system diseases (non-diabetic) in 39 participants (2.43%), malignant tumors in 37 participants (2.30%), chronic lung disease in 16 participants (1.00%), gout in 8 participants (0.50%), musculoskeletal disorders in 34 participants (2.11%), gastric or digestive system diseases in 27 participants (1.68%), and dyslipidemia in 15 participants (0.93%). LCA was used to classify comorbidity patterns of chronic diseases among older adults into 1 to 9 latent category combinations. Model 5 (i.e., 5 latent categories) had the lowest BIC (7 112.69) and aBIC (6 909.38), with a relatively low AIC (6 768.20), indicating the best model fit; thus, five latent categories represented the optimal combination in this study. The five latent categories (and their respective proportions of study participants) were the healthy control group (41.73%), the hypertension group (31.28%), the diabetes-hypertension group (19.28%), the severe illness group (5.29%), and the other metabolic diseases group (2.43%). According to multiple linear regression analyses, compared with the healthy control group, the diabetes-hypertension group had significantly lower BI-20 scores (b=-0.952, 95%CI: -1.317‒ -0.587, P<0.001) and lower IADL scores (b=-0.744, 95%CI: -0.999‒ -0.489, P<0.001); the severe illness group (b=-0.644, 95%CI: -1.072‒ -0.217, P=0.003) and the hypertension group (b=-0.344, 95%CI: -0.562‒ -0.125, P=0.002) had lower IADL scores. According to multivariate logistic regression analyses, compared with the healthy control group, older adults in the diabetes-hypertension group had a higher risk of disability (OR=2.835, 95%CI: 1.392‒5.774), impaired ADL function (OR=2.470, 95%CI: 1.637‒3.726), and impaired IADL function (OR=1.739, 95%CI: 1.264‒2.392); older adults in the severe illness group had a higher risk of impaired ADL function (OR=2.206, 95%CI: 1.171‒4.155). ConclusionAmong the elderly participating in the Survey on Health Status and Health Service Utilization of Permanent Residents in Xuhui District of Shanghai, diabetes-hypertension is one of the key chronic disease comorbidity combinations and has adverse effects on both ADL and IADL. Community health management should prioritize the elderly with diabetes-hypertension comorbidity, and strengthen early screening and comprehensive interventions to slow the decline in ADL and IADL.
2.Incidence and mortality of lung cancer in Beilun District of Ningbo City in Zhejiang Province from 2020 to 2024
Pan ZHU ; Zuquan ZOU ; Nian ZHU ; Feng GU ; Yubin WO ; Xuhui XU
Shanghai Journal of Preventive Medicine 2026;38(8):586-590
ObjectiveTo analyze the incidence and mortality of lung cancer in Beilun District of Ningbo City in Zhejiang Province from 2020 to 2024, and to provide a scientific basis for the prevention and control strategies of lung cancer. MethodsThis study was based on the tumor incidence and mortality surveillance data of registered residents in Beilun District from 2020 to 2024. The crude incidence rate, crude mortality rate, age-standardized incidence rate and age-standardized mortality rate of lung cancer were calculated by gender and age. The Joinpoint software was used to analyze the temporal trends of lung cancer incidence and mortality, and the average annual percent change (AAPC) of lung cancer incidence and mortality was calculated. ResultsFrom 2020 to 2024, a total of 3 496 cases of lung cancer were reported in Beilun District (crude incidence rate: 157.15/100 000, age-standardized incidence rate: 106.28/100 000), and 1 077 deaths were recorded (crude mortality rate: 48.42/100 000, age-standardized mortality rate: 26.00/100 000). The crude incidence rate (164.83/100 000) and crude mortality rate (73.97/100 000) for males were both higher than those for females (150.06/100 000 and 24.70/100 000, respectively). The average ages of lung cancer at diagnosis and death showed upward trends (AAPC=1.53%, 0.46%; t=10.23, 3.27; P=0.002, 0.047). The incidence and mortality rates increased with age, peaking in the 70‒74 age group (452.62/100 000) and the 80‒84 age group (402.63/100 000), respectively. Age-group analysis showed that only the incidence rate in the 50‒54 age group and the mortality rates in the 60‒64 and 70‒74 age groups exhibited downward trends over time (AAPC=-13.03%, -11.12%, -4.46%, P=0.038, 0.048, 0.031), while no significant trends were observed in other age groups. ConclusionThe incidence level of lung cancer among residents in Beilun District is relatively high, with a heavy disease burden and no obvious annual downward trend, posing significant challenges to prevention and control. The government should implement measures including strengthening tobacco control and occupational protection for men, formulating personalized diagnosis and treatment plans for elderly patients, launching kitchen health campaigns and passive smoking intervention for women, and improving the tumor registration and follow-up system to achieve precise gender-and age-specific prevention and control of lung cancer.
3.Prevalence of central obesity among the elderly with different body mass indexes in Xuhui District, Shanghai
Zhanyu JIANG ; Xiaolin QIAN ; Xiaohong ZHANG ; Zhenmei PU ; Jing ZHU ; Weiqi XU ; Chaowei FU ; Haiyan GU
Shanghai Journal of Preventive Medicine 2024;36(3):289-296
ObjectiveTo investigate the prevalence and influencing factors of overweight, obesity and central obesity among elderly residents in Xuhui District, and to analyze the epidemiological status of central obesity in elderly people with different body mass indexes. MethodsThe third round of health status and health service utilization monitoring data in Xuhui District was used. The information collected from questionnaire survey and physical examination were analyzed. SPSS 20.0 software was used for χ2 test, trend χ2 test and multinominal logistic regression analysis. Results5 096 survey subjects were included. The prevalence of overweight, general obesity, and central obesity in the residents aged 60 and above in Xuhui District were 34.3%, 6.5%, and 29.2%, respectively. There was gender difference in the rates of overweight, obesity, and central obesity among the residents. The overweight and central obesity rates in males were higher than those in females, while the obesity rate was lower than that in females (P<0.05). Multinominal logistic regression analysis showed that in comparison with the normal weight non-central obesity group drinking only at party (OR=1.729, 95%CI: 1.184‒2.525), and hypertension (OR=1.637, 95%CI: 1.305‒2.053), were highly associated with normal weight with central obesity. Aged 60‒ years (OR=1.589, 95%CI: 1.190‒2.120), aged 70‒ years (OR=1.763, 95%CI: 1.327‒2.342), male (OR=1.379, 95%CI: 1.134‒1.676), hypertension (OR=2.231, 95%CI: 1.878‒2.649), former smokers (OR=1.437, 95%CI: 1.027‒2.011), drinking at party only (OR=1.491, 95%CI: 1.107‒2.006), and drinking ≥3 times per week (OR=1.611, 95%CI: 1.116‒2.325), were highly associated with overweight combined with central obesity. Aged 60‒ years (OR=3.817, 95%CI: 2.251‒6.474), aged 70‒ years (OR=3.084, 95%CI: 1.838‒5.175), hypertension (OR=3.683, 95%CI: 2.753‒4.929), diabetes (OR=2.085, 95%CI: 1.511‒2.878), former smokers (OR=1.835, 95%CI: 1.043‒3.226), were highly associated with compound obesity. Central obesity was found in the elderly residents with different BMI categories, and the rate of central obesity increased with the increase of BMI grade. ConclusionThe prevalence of overweight, obesity and central obesity among the elderly aged 60 years and above in Xuhui District is not optimistic. Attention should be paid to the elderly under 80 years old who are with hypertension and/or diabetes, alcohol consumption, low educational level and not doing physical exercise. Especially for the central obesity population with normal BMI, measures should be taken to prevent and intervene the occurrence of obesity and related diseases.
4.Epidemiological characteristics of high-risk population for cardiovascular disease of Shanghai residents
Yuzhuo WANG ; Yang ZHENG ; Yingquan WANG ; Cui WU ; Haiyan GU ; Yiying ZHANG ; Yan XU ; Sen WANG ; Xin ZHANG ; Yu JIANG ; Jia ZHAO ; Yan SHI
Shanghai Journal of Preventive Medicine 2024;36(1):64-71
ObjectiveTo investigate the high-risk detection rate and aggregation of cardiovascular diseases(CVD) in 8 districts of Shanghai and influencing factors, and to provide scientific references for prevention and control of CVD. MethodsBased on the Cardiovascular Disease Screening and Management Program in Shanghai from 2016 to 2021, 104 685 participants aged 35 to 75 in 8 districts of Shanghai were selected for analysis. χ2 test and multivariate logistic regression were used for statistical analysis of the influencing factors of CVD and aggregation of CVD. ResultsThe proportion of high-risk CVD individuals in the population was 19.17%, including the high-risk individuals with hypertension (8.65%), dyslipidemia (6.33%), CVD history (5.58%), and WHO assessed risk ≥20% types (2.69%), respectively. Old age, overweight and obesity, central obesity, smoking, drinking, farmers, unmarried, and low family income were the risk factors of CVD, while high education level was the protective factor. In the participants, 16 323 people (81.34%) were classified as CVD high-risk groups; The number of aggregation of 1, 2 and ≥3 high risk types of CVD were 16 323(81.34%), 3 236(16.13%), 509(2.54%), respectively. Old age, low education level, low annual family income, farmers, unmarried, smoking, drinking, overweight, obesity and central obesity were associated with the risk of aggregation of high risk types of CVD, and the correlation strength increased with the increase of aggregation types. ConclusionThe prevention and control of CVD in Shanghai should focus on the hypertension, elderly, overweight, obesity, central obesity, smoking, drinking, low educated, low family income, farmers and unmarried people, and targeted intervention measures should be taken to reduce the risk of CVD among residents.
5.Probability of premature death from 4 major chronic diseases among the registered residents in Xuhui District, Shanghai from 2007 to 2021
Jingshu XU ; Deng NIU ; Haiyan GU ; Xiaolin QIAN ; Lu LU ; Jianhua SHI
Shanghai Journal of Preventive Medicine 2024;36(8):802-806
ObjectiveTo understand the death status of major chronic diseases among the registered residents in Xuhui District, Shanghai from 2007 to 2021, and to analyze the probability and trend of premature death, so as to provide an evidence for the policy-making of disease control and prevention. MethodsBased on the data from the death registration system of the registered residents in Xuhui District, Shanghai from 2007 to 2021, the mortality rate of major chronic diseases, life expectancy without cause of death, potential years of life lost (PYLL), average years of life lost (AYLL), and premature death rate were calculated. Joinpoint 4.8 software was used to calculate the annual percentage change (APC) of premature death rate and its trend. ResultsIn 2021, the mortality rate and standardized mortality rate of four major chronic diseases, namely cardiovascular and cerebrovascular diseases, malignant tumors, diabetes mellitus and chronic lower respiratory diseases among the registered residents in Xuhui District, Shanghai was 767.75/100 000 and 234.69/100 000, respectively, accounting for 85.63% of the total causes of death among the residents in Xuhui District, Shanghai. The PYLL, AYLL and PYLL rate were 10 710.00 person-years, 1.49 years per person, and 11.43‰, respectively. Life expectancy increased by 14.91 years after removing the four major chronic diseases. From 2007 to 2021, the premature death rate of chronic diseases among the registered residents in Xuhui District decreased from 9.38% to 7.91% (APC=-1.09%,P<0.05). Malignant tumors had the highest rate in premature death, and the premature death rate was higher in males than that in females, with a slower rate of decline than in females. Cardiovascular and cerebrovascular diseases, malignant tumors and chronic lower respiratory diseases showed a significant decreasing trend in premature death rate (APC=-1.30%, -1.20%, -5.42%, P<0.05), while diabetes mellitus showed a significant increasing trend in premature death rate (APC=3.20%, P<0.05). There was a significant increasing trend in the rate of premature death from diabetes mellitus in males (APC=5.15%, P<0.05) and a decreasing trend in the rate of premature death from diabetes mellitus in females (APC=-0.76%, P<0.05). ConclusionCardiovascular and cerebrovascular diseases, malignant tumors, diabetes mellitus and chronic lower respiratory diseases are the main causes of death among the registered residents in Xuhui District. The probability of premature death of the residents in Xuhui District from major chronic diseases is at a low level, indicating that the prevention and control of chronic diseases in Xuhui District has achieved some success, but it is still difficult to realize the goals of the Outline of the "Healthy China 2030" Plan. Therefore, it is necessary to comprehensively carry out the control of risk factors such as tobacco use, harmful alcohol consumption, salt intake, hypertension, hyperglycemia and obesity, especially to strengthen the control of risk factors for male residents, as well as early diagnosis and treatment of malignant tumors, cardiovascular and cerebral vascular diseases and diabetes mellitus, and to implement the disease management mechanism to reduce premature death.
6.Study on the Evolution Principles of Traditional Chinese Medicine syndromes and fNIRS Cerebral Hemodynamic Characteristics in Patients with Alzheimer's Disease
Mengxue ZHANG ; Yanjie QU ; Qian LI ; Chao GU ; Limin ZHANG ; Minrui DING ; Tong ZHANG ; Rongrong ZHEN ; Hongmei AN
Journal of Traditional Chinese Medicine 2024;65(6):600-608
ObjectiveTo explore the evolution principles of symptoms including deficiency, phlegm and blood stasis, and of the functional near-infrared spectroscopy (fNIRS) cerebral hemodynamic characteristics at various stages in patients of Alzheimer's disease. MethodsA total of 497 patients with complaint of memory loss were included, and were divided into subjective cognitive decline (SCD) group (198 participants), mild cognitive impairment (MCI) group (228 participants) and dementia (AD) group (71 participants). Neuropsychological evaluation, traditional Chinese medicine (TCM) syndrome investigation, and fNIRS data collection of prefrontal cortex were performed in each group. Descriptive statistics were used to analyze the distribution of TCM syndromes and the difference of TCM syndrome scores in each group; logistic regression was used to analyze the influence of TCM syndromes on the incidence of the patients; association rules were used to analyze the TCM syndromes of the patients; the hemodynamic characteristics of fNIRS in the prefrontal cortex of each group were compared. ResultsKidney essence deficiency syndrome was the dominant syndrome in all stages of AD. There were statistically significant differences in the distribution frequency of kidney essence deficiency, phlegm turbidity obstructing orifices, blood stasis obstructing collaterals, qi and blood deficiency, heat toxin in the interior, and fu-organ stagnation and turbidity retention syndromes among the three groups (P<0.01), and the scores of kidney essence deficiency syndrome among the three groups were statistically significant (P<0.01). Logistic regression analysis showed that kidney essence deficiency, and qi and blood deficiency syndromes were the main risk factors for the SCD group (P<0.05), phlegm turbidity obstructing orifices syndrome was the main risk factor for the MCI group (P<0.05), and heat toxin in the interior, and fu-organ stagnation and turbidity retention syndromes were the main risk factors for the AD group (P<0.05). The association rule analysis showed that the combination of kidney essence deficiency plus phlegm turbidity obstructing orifices had the highest support (33.33%) in the SCD group, and the combination of kidney essence deficiency plus blood stasis obstructing collaterals had the highest support (32.90% and 52.13%) in both the MCI and AD group. The prefrontal fNIRS results showed that the mean ∆HbO2 concentration in the left dorsolateral prefrontal cortex (LDLPFC) decreased sequentially among the three groups (P<0.05), and the mean ∆HbO2 concentration in the LDLPFC was negatively correlated with the MoCA score among the three groups (r = -0.142, P<0.05). Further analysis showed that the mean ∆HbO2 concentration in the LDLPFC of patients with kidney essence deficiency syndrome were statistically significant differences among the three groups (P<0.05). ConclusionKidney deficiency is the basis of the pathogenesis of AD, and the key brain area damaged is the LDLPFC. Turbid pathogens such as phlegm and blood stasis are the pathological factors that aggravate the disease, and the syndromes of AD show the evolution law of deficiency and excess as “kidney deficiency→phlegm turbidity→blood stasis→turbid toxin”. The changes in prefrontal hemodynamics based on fNIRS are consistent with the changes in the characteristics of symptoms, which can be used to assess the degree of cognitive impairment in AD patients.
7.Study on the correlation between spontaneous cerebrospinal fluid rhinorrhea and increased intracranial pressure
Erpeng ZHANG ; Xuhui LIANG ; Mingqiang HE ; Hongbo GU ; Lei SHI ; Bing LI ; Ming LIU ; Guanggang SHI
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2024;59(11):1165-1172
Objective:To study the correlation between spontaneous cerebrospinal fluid rhinorrhea and increased intracranial pressure.Methods:Clinical data of patients with spontaneous cerebrospinal fluid rhinorrhea treated in the Department of Otorhinolaryngology of the Provincial Hospital of Shandong First Medical University from January 2019 to December 2023 and their epidemiology, clinical symptoms and signs, preoperative cerebrospinal fluid pressure, imaging data, leakage site, repair method and the presence or absebce of increased intracranial pressure were analysed. SPSS 23.0 software was used for statistical analysis.Results:Of the 57 patients with cerebrospinal fluid nasolacrimal leakage, 84.2%(48/57) were females and 15.8%(9/57) were males; 80.7%(46/57) were between 40 and 60 years old; and overweight and obese patients accounted for 75.4%(43/57). Of 57 patients, 35 patients received cranial MRI+magnetic resonance venography, and among them, 12(34.3%) patients were clinically with headache symptoms; the incidences of empty pterygoid and venous sinus stenosis were 40.0%(14/35) and 51.4%(18/35), respectively; and 33 patients underwent preoperative lumbar puncture examination, of whom 25(75.8%) patients had the increased cerebrospinal fluid pressure and 1 patient had idiopathic intracranial hypertension. All 57 patients underwent dural repair of the skull base, the postoperative follow-up period ranged from 3 to 60 months, and the success rate of surgery was 94.7%. The success rate was 100% in female patients and 33.3%(3/9) in male patients, including one with surgical failure receiving reoperation and two with postoperative recurrence in other areas of the skull base, with significant difference in the success rate of surgery between males and females (χ 2=16.890, P<0.001). Conclusions:Most patients with spontaneous cerebrospinal fluid rhinorrhea have the increased cerebrospinal fluid pressures, but very few fulfil the diagnosis of idiopathic intracranial hypertension. The success rate of surgical repair alone is high, but some recurrences still exist, especially in male patients.
8.Three-dimensional analysis of force distribution on maxillary dentition while distalization of first and second molars simultaneously with clear aligners
Xuhui HE ; Zexuan YANG ; Xiayu ZHANG ; Yajie FAN ; Yirong HU ; Zexu GU
Chinese Journal of Stomatology 2024;59(10):1037-1043
Objective:To explore the force distribution on the maxillary dentition when the first and second molars distalized simultaneously with different step sizes using clear aligners in vitro in order to provide a theoretical basis for the rational design of molar distalization. Methods:Clear aligners were designed to simultaneously distalize the maxillary first and second molars bilaterally, with rectangular attachments placed on the buccal surfaces of the first and second premolars, as well as the second molars. Based on different step sizes, the aligners were divided into three groups: Group A (0.15 mm per step), Group B (0.20 mm per step), and Group C (0.25 mm per step). Ten aligners were fabricated for each group using 0.76 mm thick polyethylene terephthalate glycol (PET-G) sheets. A three-dimensional force measurement system was used to measure the forces exerted on each tooth by the aligners, the first and second molars served as the target teeth and the remaining teeth as anchorage teeth. The three-dimensional force data were compared among the three groups.Results:In the mesiodistal direction, the forces on the central and lateral incisors were relatively small among all three groups, with no statistically significant differences ( P>0.05). However, significant differences were observed in the forces on the canines, first premolars, second premolars, first molars, and second molars ( P<0.05). The distal forces on the second molars in Groups B and C were (6.13±1.45) N and (6.83±1.58) N, respectively, significantly higher than that in Group A [(3.51±1.01) N] ( P<0.05). The distal force on the first molars in Group C [(6.62±0.89) N] was significantly higher than that in Groups A and B ( P<0.05). The mesial reactive forces on the first and second premolars in Groups B and C were significantly higher than those in Group A ( P<0.05). The mesial reactive force on the canines in Group C [(-2.98±1.33) N] was significantly higher than that in Group A [(-1.69±0.68) N] ( P<0.05), while there were no significant differences between Groups B and C in the forces on the canines, first premolars, and second premolars ( P>0.05). In the buccolingual direction, there were no statistically significant differences in the forces on the central and lateral incisors among three groups ( P>0.05), but significant differences were observed in the forces on the canines, second premolars, and second molars ( P<0.05). The buccolingual forces on the canines, second premolars, and second molars in Group B were (-0.56±0.54), (-2.07±0.95), (1.13±0.55) N, respectively, significantly higher than those in Group A ( P<0.05), but there were no significant differences compared to Group C ( P>0.05). Compared to the mesiodistal and buccolingual forces, the vertical forces on the target and anchorage teeth were relatively small in all three groups. Conclusions:When using 0.76 mm thick PET-G sheets to fabricate clear aligners for simultaneous molar distalization, a step size of 0.20 mm per step is recommended. To prevent buccal tipping of the molars during distalization, it is advisable to design lingual displacement for the molars and buccal displacement for the adjacent anchorage teeth to counteract the unfavorable forces, with attachments placed on the primary anchorage teeth.
9.Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
Chengyuan GU ; Zengjun WANG ; Tianxin LIN ; Zhiyu LIU ; Weiqing HAN ; Xuhui ZHANG ; Chao LIANG ; Hao LIU ; Yang YU ; Zhenzhou XU ; Shuang LIU ; Jingen WANG ; Linghua JIA ; Xin YAO ; Wenfeng LIAO ; Cheng FU ; Zhaohui TAN ; Guohua HE ; Guoxi ZHU ; Rui FAN ; Wenzeng YANG ; Xin CHEN ; Zhizhong LIU ; Liqiang ZHONG ; Benkang SHI ; Degang DING ; Shubo CHEN ; Junli WEI ; Xudong YAO ; Ming CHEN ; Zhanpeng LU ; Qun XIE ; Zhiquan HU ; Yinhuai WANG ; Hongqian GUO ; Tiwu FAN ; Zhaozhao LIANG ; Peng CHEN ; Wei WANG ; Tao XU ; Chunsheng LI ; Jinchun XING ; Hong LIAO ; Dalin HE ; Zhibin WU ; Jiandi YU ; Zhongwen FENG ; Mengxiang YANG ; Qifeng DOU ; Quan ZENG ; Yuanwei LI ; Xin GOU ; Guangchen ZHOU ; Xiaofeng WANG ; Rujian ZHU ; Zhonghua ZHANG ; Bo ZHANG ; Wanlong TAN ; Xueling QU ; Hongliang SUN ; Tianyi GAN ; Dingwei YE
Chinese Medical Journal 2023;136(10):1207-1215
BACKGROUND:
LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.
METHODS:
We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.
RESULTS:
On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).
CONCLUSION:
LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04563936.
Humans
;
Male
;
Antineoplastic Agents, Hormonal/therapeutic use*
;
East Asian People
;
Gonadotropin-Releasing Hormone/agonists*
;
Goserelin/therapeutic use*
;
Prostate-Specific Antigen
;
Prostatic Neoplasms/drug therapy*
;
Testosterone
10.Asthma treatment adherence and related factors in Shanghai, China.
Juan DU ; Yu-Heng SHI ; Yu-Xiang DUAN ; Xiao-Ru WANG ; Min ZHOU ; Wen-Chao GU ; Chi-Jun WEN ; Yi GONG ; Chun-Ling DU ; Bo PENG ; Lin SUN ; Wei TANG
Chinese Medical Journal 2021;134(20):2506-2508

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