Objective:To evaluate the therapeutic effectiveness of adult patients with Kashin-Beck disease (KBD) in Gansu Province, and provide guidance for rational and effective treatment of KBD patients.Methods:The KBD patients who participated in the "2021 Basic Public Health Service Subsidy Key Endemic Disease Prevention and Control Project" in Gansu Province were selected as the research subjects. Gender, age, clinical grading characteristics, and treatment plan selection of all subjects were analyzed, and the treatment effectiveness of KBD patients in different regions was evaluated.Results:A total of 6 711 KBD patients were included in the treatment program, including 3 139 males (46.8%) and 3 572 females (53.2%), 3 157 cases (47.0%) of patients aged 60 and 3 554 cases (53.0%) over 60 years old. There were 3 921, 2 166, and 624 patients with grades Ⅰ, Ⅱ, and Ⅲ, respectively, accounting for 58.4%, 32.3%, and 9.3%, respectively. The gender, age composition, and clinical grading among KBD patients included in different regions were compared, and the differences were statistically significant (χ 2 = 194.34, 47.44, 408.61, P < 0.001). In the distribution of treatment schemes, the number of patients who selected "drug treatment", "drug treatment combined with physical therapy", "drug treatment combined with acupuncture and moxibustion/massage", "drug treatment combined with acupuncture and moxibustion/massage combined with physical therapy", and "other treatment schemes" were 4 084 (60.9%), 726 (10.8%), 672 (10.0%), 443 (6.6%), and 786 (11.7%), respectively. The distribution of treatment plans in different regions was compared, and the difference was statistically significant (χ 2 = 1 088.38, P < 0.001). The total effective rate of KBD patients was 84.5% (5 668/6 711). The total effective rates of KBD patients with different clinical grades were ranked from high to low as grade Ⅲ (87.3%, 545/624), grade Ⅱ (86.4%, 1 871/2 166), and grade Ⅰ (82.9%, 3 252/3 921). The total effective rate of KBD patients with different treatment schemes from high to low was "drug treatment combined with acupuncture and moxibustion/massage combined with physical therapy" (91.0%, 403/443), "drug treatment combined with physical therapy" (87.1%, 632/726), "drug treatment" (86.7%, 3 539/4 084), "drug treatment combined with acupuncture and moxibustion/massage" (82.3%, 553/672), and "other treatment schemes" (68.8%, 541/786). The total effective rate of KBD patients in different regions, from high to low, was as follows: Linxia Hui Autonomous Prefecture (100%, 144/144), Qingyang City (88.7%, 3 562/4 017), Pingliang City (85.0%, 1 327/1 562), Gannan Tibetan Autonomous Prefecture (83.9%, 78/93), Dingxi City (70.9%, 151/213), Tianshui City (62.5%, 125/200), and Longnan City (58.3%, 281/482). The total effective rate of KBD patients in different clinical grades, treatment schemes, and regions was compared, and the differences were statistically significant (χ 2 = 16.95, 181.72, 435.80, P < 0.001). Conclusions:The overall effective rate of treatment for KBD patients in Gansu Province is relatively high, but there are significant differences in therapeutic outcomes among cities (prefectures); it is related to the treatment scheme and the clinical grading of patients. The scheme of "drug treatment combined with acupuncture and moxibustion/massage combined with physical therapy" has better efficacy.

Objective:To evaluate the therapeutic effectiveness of adult patients with Kashin-Beck disease (KBD) in Gansu Province, and provide guidance for rational and effective treatment of KBD patients.Methods:The KBD patients who participated in the "2021 Basic Public Health Service Subsidy Key Endemic Disease Prevention and Control Project" in Gansu Province were selected as the research subjects. Gender, age, clinical grading characteristics, and treatment plan selection of all subjects were analyzed, and the treatment effectiveness of KBD patients in different regions was evaluated.Results:A total of 6 711 KBD patients were included in the treatment program, including 3 139 males (46.8%) and 3 572 females (53.2%), 3 157 cases (47.0%) of patients aged 60 and 3 554 cases (53.0%) over 60 years old. There were 3 921, 2 166, and 624 patients with grades Ⅰ, Ⅱ, and Ⅲ, respectively, accounting for 58.4%, 32.3%, and 9.3%, respectively. The gender, age composition, and clinical grading among KBD patients included in different regions were compared, and the differences were statistically significant (χ 2 = 194.34, 47.44, 408.61, P < 0.001). In the distribution of treatment schemes, the number of patients who selected "drug treatment", "drug treatment combined with physical therapy", "drug treatment combined with acupuncture and moxibustion/massage", "drug treatment combined with acupuncture and moxibustion/massage combined with physical therapy", and "other treatment schemes" were 4 084 (60.9%), 726 (10.8%), 672 (10.0%), 443 (6.6%), and 786 (11.7%), respectively. The distribution of treatment plans in different regions was compared, and the difference was statistically significant (χ 2 = 1 088.38, P < 0.001). The total effective rate of KBD patients was 84.5% (5 668/6 711). The total effective rates of KBD patients with different clinical grades were ranked from high to low as grade Ⅲ (87.3%, 545/624), grade Ⅱ (86.4%, 1 871/2 166), and grade Ⅰ (82.9%, 3 252/3 921). The total effective rate of KBD patients with different treatment schemes from high to low was "drug treatment combined with acupuncture and moxibustion/massage combined with physical therapy" (91.0%, 403/443), "drug treatment combined with physical therapy" (87.1%, 632/726), "drug treatment" (86.7%, 3 539/4 084), "drug treatment combined with acupuncture and moxibustion/massage" (82.3%, 553/672), and "other treatment schemes" (68.8%, 541/786). The total effective rate of KBD patients in different regions, from high to low, was as follows: Linxia Hui Autonomous Prefecture (100%, 144/144), Qingyang City (88.7%, 3 562/4 017), Pingliang City (85.0%, 1 327/1 562), Gannan Tibetan Autonomous Prefecture (83.9%, 78/93), Dingxi City (70.9%, 151/213), Tianshui City (62.5%, 125/200), and Longnan City (58.3%, 281/482). The total effective rate of KBD patients in different clinical grades, treatment schemes, and regions was compared, and the differences were statistically significant (χ 2 = 16.95, 181.72, 435.80, P < 0.001). Conclusions:The overall effective rate of treatment for KBD patients in Gansu Province is relatively high, but there are significant differences in therapeutic outcomes among cities (prefectures); it is related to the treatment scheme and the clinical grading of patients. The scheme of "drug treatment combined with acupuncture and moxibustion/massage combined with physical therapy" has better efficacy.

Objective:To compare the application effect among Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scale, Medical Outcomes Study 36-item Short Form (SF-36) scale and "Assessment for Therapeutic Efficacy on Kashin-Beck Disease" (WS/T 79-2011) standard in the evaluation of therapeutic effect of patients with Kashin-Beck disease, which could provide basis for the treatment evaluation of patients with Kashin-Beck disease.Methods:A total of 213 patients with Kashin-Beck disease in Gansu Province were investigated. WOMAC scale, SF-36 scale and standard of WS/T 79-2011 were used to analyze the quality of life of patients before and after treatment. The reliability, construct validity, content validity, discriminant validity of WOMAC and SF-36 scales were compared. Correlation between WOMAC, SF-36 scales and standard of WS/T 79-2011 were evaluated.Results:Both WOMAC and SF-36 scales had good construct validity and content validity (construct validity showed WOMAC and SF-36 scales contained 1 and 2 common factors, respectively; content validity showed WOMAC and SF-36 scales contained 3 and 8 common factors, respectively). The reliability and discriminant validity of WOMAC scale were better than those of SF-36 seale (reliability showed WOMAC reliability coefficient ≥0.934, the reliability coefficient of SF-36 scale was ranged from 0.386 to 0.999. Discriminant validity showed there were differences in 3 dimensions of the WOMAC scale before and after treatment, while there were differences in 6 out of 8 dimensions of the SF-36 scale). The correlation coefficients between WOMAC scale and standard of WS/T 79-2011 ranged from 0.175 to 0.437, the correlation coefficients between SF-36 scale and standard of WS/T 79-2011 ranged from - 0.434 to - 0.099 ( P < 0.05). Conclusion:The reliability, discriminant validity and correlation with the standard of WS/T 79-2011 of WOMAC scale are better than those of SF-36 scale in efficacy evaluation of patients with Kashin-Beck disease.

Objective:To master the epidemic trend of Kashin-Beck disease (KBD) in Gansu Province and provide a scientific basis for prevention and treatment of KBD.Methods:All children aged 7 - 12 or 16 years old were selected as the survey subjects in 37 KBD districts and counties in Gansu Province, clinical and X-ray monitoring results of KBD in children from 2004 to 2018 were collected to analyze the epidemic trend of the disease.Results:From 2004 to 2018, a total of 97 190 children were examined clinically and 94 180 X-ray films were taken in Gansu Province. Four hundred and twenty-eight clinical positive cases were detected, with a detection rate of 0.44%. There were 649 X-ray positive cases, and the detection rate was 0.69%. There were 435 metaphyseal positive cases, the detection rate was 0.46%. There were 214 positive cases of bone end, and the detection rate was 0.23%. The clinical positive rate was the highest (7.17%, 58/809) in 2004, followed by 2007 (4.60%, 51/1 109) and 2005 (4.48%, 187/4 173), and the positive rate in other years was less than 3%. The positive rate of X-ray was the highest (9.59%, 58/605) in 2004, followed by 2005 (5.10%, 213/4 173), 2008 (3.66%, 45/1 228) and 2006 (3.04%, 125/4 107), the positive rate of other years was less than 3%.Conclusions:The clinical positive rate and X-ray positive rate of KBD in children in Gansu Province are decreased rapidly and then maintain a low fluctuation. The effect of comprehensive prevention and control measures is remarkable.

Background::Erythropoietin is a glycoprotein that mainly regulates erythropoiesis. In patients with chronic renal failure with anemia, darbepoetin alfa can stimulate erythropoiesis, correct anemia, and maintain hemoglobin levels. This study was designed to demonstrate the efficacy and safety of darbepoetin alfa injections as being not inferior to epoetin alfa injections (Recombinant Human Erythropoietin injection, rHuEPO) when maintaining hemoglobin (Hb) levels within the target range (10.0-12.0 g/dL) for the treatment of renal anemia.Methods::Ninety-five patients were enrolled in this study from April 15, 2013 to April 10, 2014 at 25 sites. In this study, patients ( n = 95) aged 18-70 years were randomized into a once per week intravenous darbepoetin alfa group ( n = 56) and a twice or three times per week intravenous epoetin alfa group ( n = 39) for 28 weeks, who had anemia with hemoglobin levels between 6 g/dL and 10 g/dL due to chronic kidney disease (CKD) and were undergoing hemodialysis or hemofiltration with ESA-naive (erythropoiesis stimulating agent-naive). The primary efficacy profile was the mean Hb level (the non-inferiority margin was -1.0 g/dL, week 21-28); the secondary efficacy profiles were the Hb increase rate (week 0-4), the target Hb achievement cumulative rate and time, the change trends of the Hb levels, and the target Hb maintenance ratio. Adverse events (AEs) were observed and compared, and the efficacy and safety were analyzed between the two treatment groups. Additionally, the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment period. SAS? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::The mean Hb level was 11.3 g/dL in the darbepoetin alfa group and 10.7 g/dL in the epoetin alfa group, respectively; the difference of the lower limits of the 95% confidence intervals (CI) between the two groups was 0.1 g/dL (>-1.0 g/dL), and non-inferiority was proven; the Hb levels started to increase in the first four weeks at a similar increase rate; no obvious differences were observed between the groups in the target Hb achievement cumulative rates, and the Hb levels as well as the target Hb level maintenance rate changed over time. The incidence of AEs was 62.5% in the darbepoetin alfa group and 76.9% in the epoetin alfa group. All the adverse events observed in the study were those commonly associated with hemodialysis.Conclusion::Darbepoetin alfa intravenously once per week can effectively increase Hb levels and maintain the target Hb levels well, which makes it not inferior to epoetin alfa intravenously twice or three times per week. Darbepoetin alfa shows an efficacy and safety comparable to epoetin alfa for the treatment of renal anemia.

Background::This study was to explore the clinical efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection (recombinant human erythropoietin injection, rHuEPO) for the treatment of anemia associated with chronic kidney failure in Chinese patients undergoing hemodialysis.Method::This study was a multicenter, randomized, open-label, intergroup parallel control phase III noninferiority trial from April 19, 2013 to September 9, 2014 at 25 sites. In this study, the members of the darbepoetin alfa group underwent intravenous administration once per week or once every two weeks. The members of the control drug epoetin alfa group underwent intravenous administration two or three times per week. All subjects underwent epoetin alfa administration during the 8-week baseline period. After that, subjects were randomly assigned to the darbepoetin alfa group or epoetin alfa group. The noninferiority in the changes of the average Hb concentrations from the baseline to the end of the evaluation period (noninferiority threshold: -1.0 g/dl) was tested between the two treatments. The time-dependent hemoglobin (Hb) concentration and the maintenance rate of the target Hb concentration (the proportion of subjects with Hb concentrations between 10.0 and 12.0 g/dl) were also evaluated. Iron metabolism, including changes in the serum iron, total iron-binding capacity, ferritin, transferrin saturation, and comparisons of the dose adjustments between the two groups during the treatment period were analyzed further. Adverse events (AEs) were also observed and compared, and the safety was analyzed between the two treatment groups. The conversion rate switching from epoetin alfa to darbepoetin alfa was also discussed. SAS ? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::Four hundred and sixty-six patients were enrolled in this study, and ultimately 384 cases were analyzed for safety, including 267 cases in the darbepoetin alfa group and 117 cases in the epoetin alfa group. There were 211 cases in the per-protocol set, including 152 cases in the darbepoetin alfa group and 59 cases in the epoetin alfa group. The changes in the average Hb concentrations from the baseline to the end of the evaluation period were -0.07 and -0.15 g/dl in the darbepoetin alfa group and epoetin alfa group respectively. The difference between the two groups was 0.08 g/dl (95% confidence interval [CI]: -0.22 to 0.39), and the lower limit of the 95% CI was -0.22 > -1.0 g/dl. The average Hb concentrations of the two groups were 10.88-11.43 g/dl (darbepoetin alfa) and 10.91-11.38 g/dl (epoetin alfa) during the study period of Weeks 0-28, with the maintenance rates of the target Hb concentration ranging within 71%-87% and 78%-95% in the darbepoetin alfa group and epoetin alfa group respectively. During the period of comparison between the two groups, the incidence of AEs in the darbepoetin alfa group was 61.42%, while in the epoetin alfa group it was 56.41%. All of the adverse events and reactions in the study were those commonly associated with hemodialysis.Conclusion::The overall efficacy and safety of darbepoetin alfa for the treatment of Chinese renal anemia patients undergoing hemodialysis are consistent with those of epoetin alfa.

Background::Erythropoietin is a glycoprotein that mainly regulates erythropoiesis. In patients with chronic renal failure with anemia, darbepoetin alfa can stimulate erythropoiesis, correct anemia, and maintain hemoglobin levels. This study was designed to demonstrate the efficacy and safety of darbepoetin alfa injections as being not inferior to epoetin alfa injections (Recombinant Human Erythropoietin injection, rHuEPO) when maintaining hemoglobin (Hb) levels within the target range (10.0-12.0 g/dL) for the treatment of renal anemia.Methods::Ninety-five patients were enrolled in this study from April 15, 2013 to April 10, 2014 at 25 sites. In this study, patients ( n = 95) aged 18-70 years were randomized into a once per week intravenous darbepoetin alfa group ( n = 56) and a twice or three times per week intravenous epoetin alfa group ( n = 39) for 28 weeks, who had anemia with hemoglobin levels between 6 g/dL and 10 g/dL due to chronic kidney disease (CKD) and were undergoing hemodialysis or hemofiltration with ESA-naive (erythropoiesis stimulating agent-naive). The primary efficacy profile was the mean Hb level (the non-inferiority margin was -1.0 g/dL, week 21-28); the secondary efficacy profiles were the Hb increase rate (week 0-4), the target Hb achievement cumulative rate and time, the change trends of the Hb levels, and the target Hb maintenance ratio. Adverse events (AEs) were observed and compared, and the efficacy and safety were analyzed between the two treatment groups. Additionally, the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment period. SAS? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::The mean Hb level was 11.3 g/dL in the darbepoetin alfa group and 10.7 g/dL in the epoetin alfa group, respectively; the difference of the lower limits of the 95% confidence intervals (CI) between the two groups was 0.1 g/dL (>-1.0 g/dL), and non-inferiority was proven; the Hb levels started to increase in the first four weeks at a similar increase rate; no obvious differences were observed between the groups in the target Hb achievement cumulative rates, and the Hb levels as well as the target Hb level maintenance rate changed over time. The incidence of AEs was 62.5% in the darbepoetin alfa group and 76.9% in the epoetin alfa group. All the adverse events observed in the study were those commonly associated with hemodialysis.Conclusion::Darbepoetin alfa intravenously once per week can effectively increase Hb levels and maintain the target Hb levels well, which makes it not inferior to epoetin alfa intravenously twice or three times per week. Darbepoetin alfa shows an efficacy and safety comparable to epoetin alfa for the treatment of renal anemia.

Background::This study was to explore the clinical efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection (recombinant human erythropoietin injection, rHuEPO) for the treatment of anemia associated with chronic kidney failure in Chinese patients undergoing hemodialysis.Method::This study was a multicenter, randomized, open-label, intergroup parallel control phase III noninferiority trial from April 19, 2013 to September 9, 2014 at 25 sites. In this study, the members of the darbepoetin alfa group underwent intravenous administration once per week or once every two weeks. The members of the control drug epoetin alfa group underwent intravenous administration two or three times per week. All subjects underwent epoetin alfa administration during the 8-week baseline period. After that, subjects were randomly assigned to the darbepoetin alfa group or epoetin alfa group. The noninferiority in the changes of the average Hb concentrations from the baseline to the end of the evaluation period (noninferiority threshold: -1.0 g/dl) was tested between the two treatments. The time-dependent hemoglobin (Hb) concentration and the maintenance rate of the target Hb concentration (the proportion of subjects with Hb concentrations between 10.0 and 12.0 g/dl) were also evaluated. Iron metabolism, including changes in the serum iron, total iron-binding capacity, ferritin, transferrin saturation, and comparisons of the dose adjustments between the two groups during the treatment period were analyzed further. Adverse events (AEs) were also observed and compared, and the safety was analyzed between the two treatment groups. The conversion rate switching from epoetin alfa to darbepoetin alfa was also discussed. SAS ? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::Four hundred and sixty-six patients were enrolled in this study, and ultimately 384 cases were analyzed for safety, including 267 cases in the darbepoetin alfa group and 117 cases in the epoetin alfa group. There were 211 cases in the per-protocol set, including 152 cases in the darbepoetin alfa group and 59 cases in the epoetin alfa group. The changes in the average Hb concentrations from the baseline to the end of the evaluation period were -0.07 and -0.15 g/dl in the darbepoetin alfa group and epoetin alfa group respectively. The difference between the two groups was 0.08 g/dl (95% confidence interval [CI]: -0.22 to 0.39), and the lower limit of the 95% CI was -0.22 > -1.0 g/dl. The average Hb concentrations of the two groups were 10.88-11.43 g/dl (darbepoetin alfa) and 10.91-11.38 g/dl (epoetin alfa) during the study period of Weeks 0-28, with the maintenance rates of the target Hb concentration ranging within 71%-87% and 78%-95% in the darbepoetin alfa group and epoetin alfa group respectively. During the period of comparison between the two groups, the incidence of AEs in the darbepoetin alfa group was 61.42%, while in the epoetin alfa group it was 56.41%. All of the adverse events and reactions in the study were those commonly associated with hemodialysis.Conclusion::The overall efficacy and safety of darbepoetin alfa for the treatment of Chinese renal anemia patients undergoing hemodialysis are consistent with those of epoetin alfa.

Objective:To investigate the application and problems existing in the implementation of the standard of "Assessment for Therapeutic Efficacy of Kashin-Beck Disease" (WS/T 79-2011, referred to as new standard), and to provide technical basis and suggestions for further improving the standard.Methods:In 2019, a questionnaire survey was conducted and analyzed in Sichuan, Shaanxi, Qinghai and Gansu provinces and Tibet Autonomous Region on basic information, standard implementation, publicity, training and application of scoring method of joint dysfunction index of Kashin-Beck disease prevention and control technicians.Results:One hundred and thirty-four questionnaires were distributed in this survey and 132 valid questionnaires were recovered, of which 88.64% (117/132) of Kashin-Beck disease prevention and control technicians received training in the new standard and 89.39% (118/132) used the new standard; 78.03% (103/132) thought that the standard terms were clear and easy to master; 71.97% (95/132) thought it was simple, convenient and easy to operate; 49.24% (65/132) thought that the standard evaluation results were consistent with the actual improvement of patients, and 50.75% (67/132) thought that it was generally consistent; 72.73% (96/132) thought that the design was scientific, reasonable and feasible. When using the scoring method of joint dysfunction index, more than 90% of the technicians thought that the five index terms of "joint rest pain", "joint movement pain", "morning stiffness", "maximum walking distance" and "limb activity ability" were easy to understand and ask questions. When patients with Kashin-Beck disease were investigated, the constituent ratios of easy to understand the five index terms were 96.21% (127/132), 83.33% (110/132), 90.15% (119/132), 78.79%(104/132), 90.15%(119/132) and the constituent ratios of easy to answer were 95.45% (126/132), 83.33% (110/132), 89.39% (118/132), 75.00% (99/132) and 89.39% (118/132), respectively.Conclusions:The new standard terms are clear, the design is scientific and reasonable, the operation is convenient and the feasibility is strong. The evaluation results are basically consistent with the actual improvement of patients. It is suggested to add objective evaluation indexes to the scoring method of joint dysfunction index.

This study aimed to evaluate the efficacy of Chinese herbal medicine (CHM) in patients with severe/critical coronavirus disease 2019 (COVID-19). In this retrospective study, data were collected from 662 patients with severe/critical COVID-19 who were admitted to a designated hospital to treat patients with severe COVID-19 in Wuhan before March 20, 2020. All patients were divided into an exposed group (CHM users) and a control group (non-users). After propensity score matching in a 1:1 ratio, 156 CHM users were matched by propensity score to 156 non-users. No significant differences in seven baseline clinical variables were found between the two groups of patients. All-cause mortality was reported in 13 CHM users who died and 36 non-users who died. After multivariate adjustment, the mortality risk of CHM users was reduced by 82.2% (odds ratio 0.178, 95% CI 0.076-0.418; P < 0.001) compared with the non-users. Secondly, age (odds ratio 1.053, 95% CI 1.023-1.084; P < 0.001) and the proportion of severe/critical patients (odds ratio 0.063, 95% CI 0.028-0.143; P < 0.001) were the risk factors of mortality. These results show that the use of CHM may reduce the mortality of patients with severe/critical COVID-19.
Age Factors ; Aged ; COVID-19/therapy* ; China ; Drugs, Chinese Herbal/therapeutic use* ; Female ; Humans ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Odds Ratio ; Propensity Score ; Retrospective Studies ; Survival Rate