Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

Objective:To study the effect of Compound Duzhong Jiangu Granules on joint function, quality of life and inflammatory factors in patients with Kashin-Beck disease.Methods:By group design, 135 patients with Kashin-Beck disease in Chongxin County, Pingliang City, Gansu Province, were selected and divided into intervention group (100 cases treated with Compound Duzhong Jiangu Granules, 12 g/bag, 1 bag/time, 3 times/day, treatment for 1 month) and control group (35 cases treated with ibuprofen, 0.3 g/capsule, 1 capsule/time, 2 times/day, treatment for 2 weeks) according to the randomized, single-blind principle. The changes of joint dysfunction index score, joint function improvement rate, total scores of Kashin-Beck disease quality of life (KBDQOL) and scores of each dimension were analyzed before treatment, 1 month and 3 months after treatment. The serum levels of interleukin-6 (IL-6), nuclear factor κB (NFκB)-p65, inducible nitric oxide synthase (NOS2), nitric oxide (NO), and prostaglandin E2 (PGE2) were detected by enzyme-linked immunosorbent assay before treatment and 1 month after treatment.Results:The total scores of joint dysfunction index of the intervention group and the control group 1 month after treatment and 3 months after treatment were lower than those before treatment, but 3 months after treatment was higher than 1 month after treatment ( P < 0.001). One month after treatment, the total effective rates of joint function improvement in the intervention group and the control group were 68.00% (68/100) and 54.55% (18/33), respectively; 3 months after treatment, the total effective rates of the intervention group and the control group were 36.00% (36/100) and 39.39%(13/33), respectively. The total scores and scores of each dimension of KBDQOL were not significant for the main effect of the group ( P > 0.05), but significant for the main effect at the time point ( P < 0.05), and there was no interactive effect ( P > 0.05). There were significant differences in the scores of social support and mental status dimensions in the intervention group at different time points ( P < 0.001). And in the intervention group, the total score, the scores of physical function, activity limitation, economy and overall health dimensions were statistically significant between before treatment and 1 month after treatment, 1 month after treatment and 3 months after treatment( P < 0.05); however, there was no significant difference between before treatment and 3 months after treatment ( P > 0.05). One month after treatment, the serum PGE2 levels of both groups were decreased ( P < 0.05), and there was no difference in other inflammatory factors at different groups and time points ( P > 0.05). Conclusion:Compound Duzhong Jiangu Granules can effectively inhibit the inflammatory reaction of patients with Kashin-Beck disease, promote the improvement of joint function and improve the quality of life in various aspects.

Objective:To analyze the epidemic situation of plague among animals in the foci of Meriones unguiculatus in Inner Mongolia Plateau, and to find out key influencing factors affecting the epidemic of the plague, and to provide theoretical basis for the prediction, early warning and risk assessment of the plague. Methods:The monitoring data including gerbils density, gerbils body flea index, plague epidemic intensity, etc., as well as environmental data including temperature, precipitation and El Ni?o activity (Southern Oscillation Index, SOI) from 19 banners (counties, cities and districts) in Ulanqab Plateau area, the foci of Meriones unguiculatus in Inner Mongolia Plateau were selected. The methods of correlation analysis, structural equation model and rank correlation were used to analyze the epidemic and key influencing factors of plague among animals in the foci. Results:The plague epidemic cycle in the foci of Meriones unguiculatus in Inner Mongolia Plateau was 5 to 10 years. The correlation analysis results showed that all the factors had influence on each other. Structural equation model screened out that the main influencing factors of plague epidemic were SOI, gerbils density and temperature. SOI had a negative effect on plague epidemic intensity (-0.022) and temperature (-0.029), while gerbils density had a positive effect on plague epidemic intensity (0.014), and temperature had a negative effect on plague epidemic intensity (-0.065). In rank correlation, when the gerbils density was at a high value, the probability of high plague epidemic intensity in that year was 4/9; when SOI was at a low value, the probability was 5/9; when the temperature was at a low value, the probability was 5/9. When the plague epidemic intensity was at a high value in that year, the probability of the plague epidemic intensity being high in the following year was 5/8; when the gerbils density was at a high value in that year, the probability was 4/9; when SOI was at a low value in that year, the probability was 4/9. Conclusion:Climate and biological factors can affect prevalence of plague, and countermeasures should be taken in advance to prevent plague outbreaks when El Ni?o phenomenon, low temperature, high density of gerbils, and high previous-year prevalence of plague appear.

Objective:To evaluate the reliability and validity of Chinese version of Minnesota Living with Heart Failure Questionnaire (MLHFQ) scale among patients with chronic Keshan disease.Methods:The patients with chronic Keshan disease diagnosed in Keshan disease area of Gansu Province from August 2018 to April 2020 were selected as the survey subjects to analyze the reliability and validity of the Chinese version of MLHFQ scale in evaluating the quality of life of patients with chronic Keshan disease. To evaluate the reliability of MLHFQ scale, the Cronbach's α coefficient was used, and when the Cronbach's α coefficient > 0.8 indicated that the consistency reliability of the scale was good. Kaider-Meyer-Olkin(KMO) statistic and Barlett's sphericity test were used to evaluate whether the scale was suitable for factor analysis (applicable when KMO > 0.6 and Barlett's sphericity test P < 0.05). The principal component analysis and maximum variance method of exploratory factor analysis were used to extract common factors, and the structural validity of the scale was evaluated. The discrimination validity of the scale was evaluated by New York Heart Association (NYHA) cardiac function classification and analysis of variance. Pearson correlation analysis was used to evaluate the content validity of the scale. Results:A total of 333 questionnaires were collected, of which 329 were valid. There were 180 males and 149 females, aged (59.52 ± 9.26) years. The Cronbach's α coefficient of the Chinese version of MLHFQ scale was 0.95 ( > 0.8). Among them, the Cronbach's α coefficients in the physical domain, emotional domain and other domains were 0.93, 0.91 and 0.86, respectively ( > 0.8). The KMO value of the Chinese version of MLHFQ scale was 0.95 ( > 0.6), and Barlett's sphericity test rejected the hypothesis (χ 2 = 5 222.01, P < 0.05). Principal component analysis and maximum variance method were used to extract 3 common factors, which were named kinetic energy of life, physical condition and emotional condition, respectively. The cumulative contribution rate of principal components was 66.22% ( > 50%). Compared with patients with NYHA cardiac function grade Ⅱ and patients with grade Ⅲ and Ⅳ, there were significant differences in the physical domain, other domain and total score ( P < 0.001). The Pearson correlation coefficients between the physical, emotional, and other domains and their respective items ranged from 0.74 to 0.88, 0.78 to 0.90, and 0.56 to 0.80, respectively, and the correlation coefficients between each item and its domain were all > 0.5 ( P < 0.001). Conclusion:The Chinese version of MLHFQ scale has good reliability and validity in patients with chronic Keshan disease in Gansu Province, and can be used to evaluate the quality of life of patients with chronic Keshan disease.

Objective:To investigate the clinical characteristics and causes of death of chronic Keshan disease cases.Methods:A retrospective analysis was conducted on the last clinical data of 39 death cases of chronic Keshan disease who were repeatedly hospitalized in Jingchuan County People's Hospital from March 2016 to August 2020 before their death, including gender, age, course of disease, clinical symptoms and signs, chest X-ray, electrocardiogram, cardiac echocardiography, causes of death, etc., and analysis was made on the clinical characteristics related to the death of chronic Keshan disease cases.Results:Among the 39 death cases of chronic Keshan disease, 27 cases (69.2%) were male and 12 cases (30.8%) were female. The age was (62.64 ± 8.63) years old, and the median course of disease was 5 years. Dyspnea [37 cases (94.9%)] and edema [33 cases (84.6%)] were the main clinical symptoms. All cases had varying degrees of cardiac enlargement, pulmonary congestion signs, and abnormal changes in electrocardiogram. Among the causes of death, 18 cases (46.2%) were sudden cardiac death, 11 cases (28.2%) were heart failure, 5 cases (12.8%) were cardiogenic shock, and 3 cases (7.7%) were heart failure combined with cardiogenic shock, and 2 cases (5.1%) had other causes.Conclusion:Dyspnea and edema are the main clinical characteristics of death cases of chronic Keshan disease, sudden cardiac death, heart failure and cardiogenic shock are the three common causes of death.

Objective:To evaluate the reliability and validity of the Chinese version of concise health status questionnaire (SF-36 scale) in evaluating the quality of life of patients with chronic Keshan disease, and to provide a scientific basis for studying the quality of life and the evaluation of treatment and rehabilitation of this population.Methods:In the August 2017, using cluster random sampling method, 175 patients with chronic Keshan disease treated by self-management of family beds in Pingliang City, Gansu Province in 2017 were selected as survey subjects, and demographic and disease data were collected. The Chinese version of SF-36 scale was used to investigate the quality of life. Split-half reliability and Cronbach's α coefficient were used to evaluate the reliability of the SF-36 scale; the factor analysis, correlation and differences between groups were used to evaluate the validity of the SF-36 scale.Results:The split-half reliability value of SF-36 scale was 0.916, and the Cronbach's α coefficient was 0.869. Factor analysis extracted 3 common factors from 8 dimensions of SF-36 scale, and the cumulative contribution rate of the 3 common factors to the total variance was 72.08%. In addition to the correlation coefficient ( r) between Role-Emotional and Bodily Pain dimension, the r value between total score and the scores of each dimension, and the scores of each dimension of SF-36 scale were 0.140 - 0.769. Except for the Bodily Pain dimension, there were statistically significant differences in the scores of Physiological Functioning, Role-Physical, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health dimension of the quality of life of patients with different grades of cardiac function ( F = 4.66, 10.73, 6.77, 14.61, 5.58, 9.57, 7.10, P < 0.05). Conclusion:The Chinese version of SF-36 scale has good reliability and validity in evaluating the quality of life of patients with chronic Keshan disease, and can be used to evaluate the quality of life of the patients.

Objective:By investigating the cognitive level and influencing factors of heart failure knowledge in patients with chronic Keshan disease, so as to provide reference for improving the cognitive level of disease-related knowledge of the patients with Keshan disease in the targeted manner.Methods:In 2019, 100 patients with chronic Keshan disease were selected in Jingchuan County, Gansu Province. A questionnaire survey was conducted using the heart failure knowledge questionnaire to conduct correlation and regression analysis on the cognitive level of patients' heart failure knowledge and influencing factors.Results:Patients' average score of the heart failure knowledge level was (6.18 ± 2.72) points, and the scoring accuracy rate was 41.20%. The Spearman correlation analysis indicated that heart failure knowledge level was associated with annual family income ( r = 0.363, P < 0.01), the hospitalization times due to heart failure ( r = 0.304, P < 0.01), and the number of family members ( r = 0.240, P < 0.05). The results of multiple linear regression showed that the cognitive level of heart failure knowledge in male patients was higher than that in female patients ( P < 0.05). The more hospitalization times ( P < 0.05) and the more family members ( P < 0.05) were, the higher the cognitive level of heart failure knowledge was. Conclusions:The cognitive level of heart failure knowledge of patients with chronic Keshan disease is generally low. Medical staff should actively make use of the patient's hospitalization time for health education, and pay attention to the health education of family members of the patients.

Objective:To evaluate the effect of self-management treatment for patients with chronic Keshan disease in Gansu Province.Methods:From March to June 2018, 243 patients with chronic Keshan disease who were treated by self-management treatment outside the hospital in 7 Keshan disease counties in Gansu Province were selected as the survey subjects, and their general demographic and clinical data were collected. At the same time, the survey subjects were given a 6-month self-management treatment, and the self-management scale was used to evaluate the patients' self-management behavior before treatment and 6 months after treatment. The higher the score, the better the patients' self-management behavior. The influencing factors of self-management scale were analyzed by multiple linear regression analysis.Results:Excluding incomplete data, a total of 158 patients with chronic Keshan disease were included in this survey, including 96 males and 62 females. Compared with patients before self-management treatment, the patients' cardiac function classification and work ability improved significantly after 6 months of self-management treatment ( Z = - 4.685, - 5.934, P < 0.05); cardiothoracic ratio decreased (0.61 ± 0.08 vs 0.63 ± 0.09, t = 5.175, P < 0.05); in the cardiac color Doppler ultrasound indexes, left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) were increased (0.41 ± 0.11 vs 0.36 ± 0.07, 0.21 ± 0.07 vs 0.18 ± 0.05, t = - 6.504, - 5.391, P < 0.05); the total score of the self-management scale was increased [(53.86 ± 9.29) scores vs (51.46 ± 10.50) scores, t = - 3.696, P < 0.05]. Further analysis of the efficacy of the patients' cardiac function classification showed that the patients' medication compliance was positively correlated with the efficacy of the cardiac function classification ( r = 0.243, P < 0.05). The result of multiple linear regression analysis showed that education level and efficacy of the cardiac function classification were influencing factors of the self-management scale for patients with chronic Keshan disease ( t = 2.466, 2.635, P < 0.05). Conclusion:The self-management treatment for patients with chronic Keshan disease can effectively improve heart function and improve self-management behavior.

Objective:Analyze the monitoring results of drinking water-type endemic fluorosis in Gansu Province, understand the epidemic situation of endemic fluorosis and the operation of water improvement projects, combined with the comprehensive evaluation of water improvement measures, to provide data support and scientific suggestions for making prevention and control measures and strategies of endemic fluorosis.Methods:A simple random sampling method was adopted; six surveillance cites in Gansu Province were selected from 2014 to 2017, including Zhangye, Wuwei, Linxia, Tianshui, Pingliang and Qingyang. In addition, three epidemic villages were selected as fixed monitoring villages in each city. The operation situation of water improvement projects and the fluoride content in drinking water were determined, and the dental fluorosis of children aged 8 to 12 was diagnosed.Results:There was no significant difference in water fluoride from 2014 to 2017 ( H = 1.397, P > 0.05), the normal operation rates of water improvement projects were 84.63% - 100.00%, and the water fluoride of all the water improvement projects in villages with water changed was up to the standard in 2017. In 2017, the average value of water fluoride in 3 of the 4 villages without water improvement exceeded the standard. A total of 4 901 children aged 8 to 12 were investigated, the dental fluorosis prevalence rate of whole children was 38.93% (1 908/4 901), and the dental fluorosis index was 0.64, showing a mild prevalence of dental fluorosis. In 2014 - 2017, the dental fluorosis prevalence rates of children were 29.47% (262/889), 47.24% (735/1 556), 46.60% (700/1 502) and 22.12% (211/954), respectively. Conclusions:The water improvement projects in Gansu Province run well, and the water fluoride exceeds the standard in some areas without water improvement. The detection rate of dental fluorosis of children shows a downward trend year by year, and the condition of fluorosis is effectively controlled. It is suggested to strengthen the operation monitoring and later maintenance of the water improvement projects, implement the water improvement projects in the villages without water improvement as soon as possible, and solve the problem of excessive fluoride content in drinking water of residents in the villages without water improvement.