1.Analysis of comparator selection strategies for pharmaceutical enterprises in the national reimbursement drug list access application
Qingwen WANG ; Qin AN ; Xiaoyan YUAN ; Yuzhi HAN ; Xi CHEN ; Hongyan WU
China Pharmacy 2026;37(8):985-990
OBJECTIVE To analyze the selection and rationales of comparators for pharmaceutical enterprises in their medical insurance access application, so as to provide a reference for promoting communication and consensus between enterprises and medical insurance authorities in this process. METHODS The application materials for drugs outside the catalogue that passed formal review published by the National Healthcare Security Administration from 2021 to 2025 were extracted, and then content analysis was used to systematically sort out relevant information of the declared drugs and comparators; the specific situations and rationales of pharmaceutical enterprises’ selection of comparators were analyzed. RESULTS A total of 1 341 declared drug documents were collected. Data analysis showed that 1 035 (77.18%) were submitted with positive comparators and 306 (22.82%) used blank comparators; 58 drugs (4.33%) took combination therapy as the reference, and 5 drugs (0.37%) referred to non-pharmacological (or non-single pharmacological) treatment regimens. Among competitive drugs declared by multiple enterprises, 50.00% of the enterprises submitted different comparators. A total of 4 basic conditions and 39 additional conditions were extracted as the rationales for selecting positive comparators. For blank comparators, 12 drug-related factors, 2 administrative factors, and 1 other factor were identified. More than 10% of the drugs did not state the rationale for comparator selection, and over 44% of drugs using blank comparators provided only one justification. CONCLUSIONS Pharmaceutical enterprises mainly select comparators based on their own interests in the medical insurance access application, and there are deficiencies in the adequacy and standardization of their selection basis and reasoning. It is recommended that enterprises follow the principled requirements of medical insurance authorities, and fully and normatively explain the reasons for selecting comparators in combination with the characteristics of their own products. Meanwhile, it is advisable to change the current open-ended statement form of selection reasons into a closed-ended answering mode, so as to highlight the priority of selection, standardize the declaration behavior of enterprises, and reduce communication divergences between the two parties.
2.Establishment and Evaluation of Diabetic Macrovascular Atherosclerosis Model with Qi and Yin Deficiency Syndrome
Ting LUO ; Qingzhi LIANG ; Xi PENG ; Yi SU ; Hongyan XIE ; Chunguang XIE
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(13):86-98
ObjectiveTo explore the establishment of a rat model of diabetic macrovascular atherosclerosis (DMA) with Qi and Yin deficiency syndrome induced by high-fat diet, streptozotocin (STZ), and Yin-depleting herbs, and to evaluate its biological characteristics. MethodsForty SD rats were randomly divided into a blank group (n=10) and a modeling group (n=30). Except for the blank group, rats in the model group were fed a high-fat diet for 4 weeks, followed by intraperitoneal injection of STZ (30 mg·kg-1) to establish a diabetic model. Twenty-four successfully modeled diabetic rats were randomly divided into a model group (n=7), a Qi and Yin deficiency syndrome group (n=8), and a counter-syndrome group (n=9). Except for the model group, rats received intragastric administration of Yin-depleting herbs (1.2 g·kg-1) for 8 weeks. The counter-syndrome group was further treated with Shenqi compound formula (1.69 g·kg-1) for an additional 8 weeks. General condition and body weight were recorded, and syndrome-related indicators were assessed, including precordial temperature, skin moisture content, grip strength, open-field test performance, and tongue appearance. Serum levels of vascular endothelial growth factor (VEGF), endothelin-1 (ET-1), vascular cell adhesion molecule-1 (VCAM-1), insulin-like growth factor-1 (IGF-1), and monocyte chemotactic protein-1 (MCP-1) were measured by enzyme-linked immunosorbent assay (ELISA). Fasting blood glucose, blood lipids, hemorheological parameters, and coagulation function were analyzed using an automatic biochemical analyzer. Vascular ultrasound and hematoxylin-eosin (HE) staining were used to evaluate vascular lesions. ResultsIn terms of syndrome manifestations, compared with the blank group, body weight increased rapidly during the first 5 weeks in the model, Qi and Yin deficiency, and counter-syndrome groups. After STZ injection combined with Yin-depleting herbal administration at week 5, body weight decreased significantly (P<0.01) and continued to decline until the end of the experiment. Rats exhibited decreased activity, irritability, coarse and yellowish fur with obvious shedding, polydipsia, polyphagia, frequent urination, and dry stools, which were most pronounced in the Qi and Yin deficiency group. Grip strength decreased, peak activity time occurred earlier, total distance in the open-field test was reduced, and residence time was prolonged. Precordial temperature decreased (P<0.01), while paw temperature increased (P<0.05), and skin moisture and oil content were reduced (P<0.05, P<0.01). In terms of disease-related indicators, compared with the blank group, fasting blood glucose was significantly increased (>16.7 mmol·L-1) in the model and Qi and Yin deficiency groups, and blood lipid levels were significantly elevated (P<0.05). Vascular-related factors ET-1, MCP-1, VCAM-1, and VEGF were significantly increased (P<0.05,P<0.01), while IGF-1 was significantly decreased (P<0.01). Pathological examination of the aortic valve showed valvular thickening and structural disorganization. Carotid artery examination revealed discontinuity of the intima, foam cell accumulation beneath the intima, disordered smooth muscle arrangement, and widened intercellular spaces. Compared with the model group, ET-1, MCP-1, and VEGF levels were significantly decreased in both the Qi and Yin deficiency group and the counter-syndrome group. The reductions in ET-1 and MCP-1 were more pronounced in the Qi and Yin deficiency group (P<0.01), while the decrease in VCAM-1 was more significant in the counter-syndrome group (P<0.05). Compared with the blank group, the Qi and Yin deficiency group showed significantly prolonged activated partial thromboplastin time (APTT), thrombin time (TT), and prothrombin time (PT) (P<0.01). The erythrocyte deformability index (TK), erythrocyte sedimentation rate, erythrocyte electrophoresis index, and whole blood low-shear viscosity all showed increasing trends. Vascular ultrasound revealed reduced arterial blood flow velocity, increased vascular resistance, and intimal thickening without plaque formation. The aortic intima showed no obvious overall thickening, with only occasional localized thickening and foam cell presence, and carotid artery injury was observed. ConclusionA rat model of DMA with Qi and Yin deficiency syndrome was successfully established using high-fat diet feeding combined with STZ injection and Yin-depleting herbal administration. Shenqi compound formula effectively alleviated Qi and Yin deficiency syndrome, regulated glucose and lipid metabolism, improved hemorheological and coagulation function, reduced vascular lesion severity, and demonstrated potential for early prevention and treatment of DMA.
3.Research status and development trends of dental pulpitis biomarkers
Hongyan LIU ; Yanling CAI ; Xi WEI
Chinese Journal of Stomatology 2025;60(11):1217-1224
Pulpitis is an inflammatory response of dental pulp tissue triggered by external stimuli such as bacterial infection, mechanical trauma, and iatrogenic injury. Accurate diagnosis of pulpitis is essential for the success of minimally invasive endodontic treatments. However, the current diagnostic framework lacks objective indicators capable of precisely assessing the severity of pulp inflammation. Recent studies have revealed that biomarkers such as matrix metalloproteinases, cytokines, chemokines, non-coding RNAs, growth factors, and signaling molecules are closely associated with the degree of pulp inflammation. These findings suggested that biomarker-based molecular diagnostics held significant promise for advancing precision and minimally invasive approaches in endodontics. This review systematically discusses the current research progress, challenges, and future directions of biomarkers in the diagnosis and treatment of pulpitis.
4.National clinical three-tiered surveillance and stratified precision detection report on respiratory infectious pathogens in 2024
Jingwen AI ; Jikui DENG ; Min DONG ; Xiaohong GAO ; Jiawei GENG ; Xiaoli HU ; Zhu JIN ; Hongyan LIU ; Yongzhong LI ; Xi LIU ; Yuanwang QIU ; Lihong QU ; Binhuang SUN ; Wei SONG ; Hongyu WANG ; Junping WANG ; Sen WANG ; Xiaoming XIONG ; Daokun YANG ; Liaoyun ZHANG ; Yanliang ZHANG ; Xianghong ZHOU ; Wenhong ZHANG
Chinese Journal of Infectious Diseases 2025;43(2):79-89
Objective:To analyze the epidemiological and clinical characteristics of respiratory pathogens in China.Methods:This study was a cross-sectional study, which encompassed 19 core units of the clinical pathogen network and established a three-tiered clinical pathogen surveillance system. Thirty respiratory samples were collected every two weeks from various units from January to December 2024, and the clinical and pathogen diagnostic information were gathered. A total of 11 864 samples were tested using this system. The tier-1 clinical pathogen surveillance system covered influenza A virus (Flu-A), influenza B virus (Flu-B), respiratory syncytial virus (RSV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The tier-2 clinical pathogen surveillance system focused on 18 key respiratory pathogens. The tier-3 clinical pathogen surveillance system further clarified whether any emerging infectious diseases had occurred.Results:The tier-1 clinical pathogen surveillance system showed Flu-A predominated in December, Flu-B predominated in January, SARS-CoV-2 peaked in March and August, whereas RSV circulated sporadically throughout the year. Geographic trends were broadly consistent across the seven major regions, although Flu-A detection in December was notably higher in Northeast China (48.1%(111/231)) and East China (36.2%(148/409)), and RSV detection was concentrated in the Northwest and South China from January to March. Data from the tier-2 clinical pathogen surveillance system indicated that Streptococcus pneumoniae, Mycoplasma pneumoniae, rhinovirus, and adenovirus were detected year-round, of these, Streptococcus pneumoniae and rhinovirus showed elevated positive detection rates from August to September, while adenovirus peaked in January. Legionella pneumophila was not detected throughout the year, and other pathogens fluctuated throughout the year without a consistent pattern. The predominant etiologic agents of pediatric pneumonia were Mycoplasma pneumoniae (35.0%(105/300)), rhinovirus (25.7%(77/300)), and adenovirus (17.3%(52/300)), whereas adult pneumonia was mainly caused by Streptococcus pneumoniae (10.5%(29/277)), Staphylococcus aureus (6.9%(19/277)), Mycoplasma pneumoniae (6.9%(19/277)), and Flu-A (6.1%(17/277)). The tier-3 clinical pathogen surveillance system did not identify any emerging respiratory pathogens. Conclusion:Respiratory pathogens in China in 2024 exhibit distinct temporal and spatial distribution patterns and vary among different populations.
5.Research status and development trends of dental pulpitis biomarkers
Hongyan LIU ; Yanling CAI ; Xi WEI
Chinese Journal of Stomatology 2025;60(11):1217-1224
Pulpitis is an inflammatory response of dental pulp tissue triggered by external stimuli such as bacterial infection, mechanical trauma, and iatrogenic injury. Accurate diagnosis of pulpitis is essential for the success of minimally invasive endodontic treatments. However, the current diagnostic framework lacks objective indicators capable of precisely assessing the severity of pulp inflammation. Recent studies have revealed that biomarkers such as matrix metalloproteinases, cytokines, chemokines, non-coding RNAs, growth factors, and signaling molecules are closely associated with the degree of pulp inflammation. These findings suggested that biomarker-based molecular diagnostics held significant promise for advancing precision and minimally invasive approaches in endodontics. This review systematically discusses the current research progress, challenges, and future directions of biomarkers in the diagnosis and treatment of pulpitis.
6.National clinical three-tiered surveillance and stratified precision detection report on respiratory infectious pathogens in 2024
Jingwen AI ; Jikui DENG ; Min DONG ; Xiaohong GAO ; Jiawei GENG ; Xiaoli HU ; Zhu JIN ; Hongyan LIU ; Yongzhong LI ; Xi LIU ; Yuanwang QIU ; Lihong QU ; Binhuang SUN ; Wei SONG ; Hongyu WANG ; Junping WANG ; Sen WANG ; Xiaoming XIONG ; Daokun YANG ; Liaoyun ZHANG ; Yanliang ZHANG ; Xianghong ZHOU ; Wenhong ZHANG
Chinese Journal of Infectious Diseases 2025;43(2):79-89
Objective:To analyze the epidemiological and clinical characteristics of respiratory pathogens in China.Methods:This study was a cross-sectional study, which encompassed 19 core units of the clinical pathogen network and established a three-tiered clinical pathogen surveillance system. Thirty respiratory samples were collected every two weeks from various units from January to December 2024, and the clinical and pathogen diagnostic information were gathered. A total of 11 864 samples were tested using this system. The tier-1 clinical pathogen surveillance system covered influenza A virus (Flu-A), influenza B virus (Flu-B), respiratory syncytial virus (RSV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The tier-2 clinical pathogen surveillance system focused on 18 key respiratory pathogens. The tier-3 clinical pathogen surveillance system further clarified whether any emerging infectious diseases had occurred.Results:The tier-1 clinical pathogen surveillance system showed Flu-A predominated in December, Flu-B predominated in January, SARS-CoV-2 peaked in March and August, whereas RSV circulated sporadically throughout the year. Geographic trends were broadly consistent across the seven major regions, although Flu-A detection in December was notably higher in Northeast China (48.1%(111/231)) and East China (36.2%(148/409)), and RSV detection was concentrated in the Northwest and South China from January to March. Data from the tier-2 clinical pathogen surveillance system indicated that Streptococcus pneumoniae, Mycoplasma pneumoniae, rhinovirus, and adenovirus were detected year-round, of these, Streptococcus pneumoniae and rhinovirus showed elevated positive detection rates from August to September, while adenovirus peaked in January. Legionella pneumophila was not detected throughout the year, and other pathogens fluctuated throughout the year without a consistent pattern. The predominant etiologic agents of pediatric pneumonia were Mycoplasma pneumoniae (35.0%(105/300)), rhinovirus (25.7%(77/300)), and adenovirus (17.3%(52/300)), whereas adult pneumonia was mainly caused by Streptococcus pneumoniae (10.5%(29/277)), Staphylococcus aureus (6.9%(19/277)), Mycoplasma pneumoniae (6.9%(19/277)), and Flu-A (6.1%(17/277)). The tier-3 clinical pathogen surveillance system did not identify any emerging respiratory pathogens. Conclusion:Respiratory pathogens in China in 2024 exhibit distinct temporal and spatial distribution patterns and vary among different populations.
7.A preliminary study of the effects of medication interval on the quality of split-dose bowel preparation before colonoscopy
Shuhuai XU ; Xiangyu SUI ; Miao WAN ; Song ZHANG ; Jiahui WEI ; Hongyan RU ; Fengxiang XI ; Zhaoshen LI ; Shengbing ZHAO ; Yu BAI
Chinese Journal of Digestive Endoscopy 2025;42(4):288-293
Objective:To explore the effects of medication interval on the quality of split-dose bowel preparation and analyze the independent risk factors affecting the quality of bowel preparation.Methods:This pilot study involved two centers. Adult outpatients who underwent screening, surveillance, and diagnostic colonoscopy in the First Affiliated Hospital of Naval Medical University ( n=46) and the Fifth Hospital of Zhangjiakou ( n=20) between April and June 2023 were enrolled. Bowel preparation was conducted based on the guideline. Patients were divided into the short-interval group (4-<10 hours, n=45) and the long-interval group (10-16 hours, n=21) based on the time between the two administrations of polyethylene glycol during bowel preparation. Differences in terms of patient-reported outcome measurements (patient-reported willingness to repeat the bowel preparation regimen, satisfaction with bowel preparation, satisfaction with sleep), defecation frequency, Boston bowel preparation scale scores, bowel preparation bubble scores, bowel preparation qualified rates, polyp detection rates and incidence of adverse events were compared. Relevant factors influencing bowel preparation quality were analyzed by univariate logistic regression. Results:There were no significant differences in patient-reported willingness to repeat the bowel preparation regimen [88.9% (40/45) VS 85.7% (18/21), χ2<0.001, P>0.999], the satisfaction with bowel preparation [65.9% (29/45) VS 57.1% (12/21), χ2=0.469, P=0.493], or the satisfaction with sleep quality [35.6% (16/45) VS 28.6% (6/21), χ2=0.314, P=0.575] between the short-interval and long-interval groups. Similarly, no significant differences were observed between the groups in defecation frequency (11.3±4.8 VS 10.2±4.4, t=0.861, P=0.395), Boston bowel preparation scale scores (8.2±1.4 scores VS 7.9±1.2 scores, t=1.024, P=0.311), bowel preparation bubble scores (8.6±1.0 scores VS 8.4±1.5 scores, t=0.672, P=0.506), bowel preparation qualified rates [88.9% (40/45) VS 90.5% (19/21), χ2<0.001, P>0.999], polyp detection rates [33.3% (15/45) VS 47.6% (10/21), χ2=1.242, P=0.265], or incidence of adverse events [24.4% (11/45) VS 14.3% (3/21), χ2=0.381, P=0.537]. Univariate logistic analysis suggested that a low-fiber diet ( OR=8.100, 95% CI:1.400-46.849, P=0.019) was an influencing factor for qualified bowel preparation. Conclusion:Medication interval of the two doses of polyethylene glycol in a split-dose bowel preparation regimen for colonoscopy has no significant impact on bowel preparation quality. Notably, preoperative low-fiber diet emerges as an independent protective factor for qualified bowel preparation.
8.A preliminary study of the effects of medication interval on the quality of split-dose bowel preparation before colonoscopy
Shuhuai XU ; Xiangyu SUI ; Miao WAN ; Song ZHANG ; Jiahui WEI ; Hongyan RU ; Fengxiang XI ; Zhaoshen LI ; Shengbing ZHAO ; Yu BAI
Chinese Journal of Digestive Endoscopy 2025;42(4):288-293
Objective:To explore the effects of medication interval on the quality of split-dose bowel preparation and analyze the independent risk factors affecting the quality of bowel preparation.Methods:This pilot study involved two centers. Adult outpatients who underwent screening, surveillance, and diagnostic colonoscopy in the First Affiliated Hospital of Naval Medical University ( n=46) and the Fifth Hospital of Zhangjiakou ( n=20) between April and June 2023 were enrolled. Bowel preparation was conducted based on the guideline. Patients were divided into the short-interval group (4-<10 hours, n=45) and the long-interval group (10-16 hours, n=21) based on the time between the two administrations of polyethylene glycol during bowel preparation. Differences in terms of patient-reported outcome measurements (patient-reported willingness to repeat the bowel preparation regimen, satisfaction with bowel preparation, satisfaction with sleep), defecation frequency, Boston bowel preparation scale scores, bowel preparation bubble scores, bowel preparation qualified rates, polyp detection rates and incidence of adverse events were compared. Relevant factors influencing bowel preparation quality were analyzed by univariate logistic regression. Results:There were no significant differences in patient-reported willingness to repeat the bowel preparation regimen [88.9% (40/45) VS 85.7% (18/21), χ2<0.001, P>0.999], the satisfaction with bowel preparation [65.9% (29/45) VS 57.1% (12/21), χ2=0.469, P=0.493], or the satisfaction with sleep quality [35.6% (16/45) VS 28.6% (6/21), χ2=0.314, P=0.575] between the short-interval and long-interval groups. Similarly, no significant differences were observed between the groups in defecation frequency (11.3±4.8 VS 10.2±4.4, t=0.861, P=0.395), Boston bowel preparation scale scores (8.2±1.4 scores VS 7.9±1.2 scores, t=1.024, P=0.311), bowel preparation bubble scores (8.6±1.0 scores VS 8.4±1.5 scores, t=0.672, P=0.506), bowel preparation qualified rates [88.9% (40/45) VS 90.5% (19/21), χ2<0.001, P>0.999], polyp detection rates [33.3% (15/45) VS 47.6% (10/21), χ2=1.242, P=0.265], or incidence of adverse events [24.4% (11/45) VS 14.3% (3/21), χ2=0.381, P=0.537]. Univariate logistic analysis suggested that a low-fiber diet ( OR=8.100, 95% CI:1.400-46.849, P=0.019) was an influencing factor for qualified bowel preparation. Conclusion:Medication interval of the two doses of polyethylene glycol in a split-dose bowel preparation regimen for colonoscopy has no significant impact on bowel preparation quality. Notably, preoperative low-fiber diet emerges as an independent protective factor for qualified bowel preparation.
9.Application of health belief model in blood pressure management in patients with moyamoya disease after cerebral vascular reconstruction surgery
Na LI ; Hongyan CHEN ; Xi REN ; Xinxin DONG ; Qinglin LIU ; Donghong ZHAO
Journal of Clinical Medicine in Practice 2025;29(12):120-124
Objective To explore the application effect of blood pressure management based on the health belief model in patients with moyamoya disease after cerebral vascular reconstruction sur-gery.Methods From February to July 2024,210 patients with moyamoya disease who underwent cerebral vascular reconstruction surgery in our hospital were selected as study subjects.They were randomly divided into control group and intervention group,with 105 cases in each group.The control group received routine nursing care,while the intervention group applied blood pressure management based on the health belief model on the basis of routine nursing care.The postoperative cerebral hy-perperfusion syndrome and blood pressure control status of the two groups were compared,and the Health Belief Scale and the Mishel Uncertainty in Illness Scale were used to evaluate the effects before and after intervention.Results A total of 203 patients completed the study,including 100 cases in the control group and 103 cases in the intervention group.There were statistically significant differ-ences in the incidence of cerebral hyperperfusion syndrome and the proportion of patients with blood pressure higher than baseline data between the two groups(P<0.05).After the intervention,there were statistically significant differences in the postoperative cerebral hyperperfusion syndrome status and blood pressure control status between the two groups(P<0.05).After intervention,there were statistically significant differences in the scores of susceptibility and health motivation dimensions as well as the total score in the Health Belief Scale between the intervention group and the control group(P<0.05).After the intervention,there were statistically significant differences in the scores of ambiguity and unpredictability dimensions as well as the total score in the Mishel Uncertainty in Ill-ness Scale between the intervention group and the control group(P<0.05).Conclusion Blood pressure management based on the health belief model can effectively control blood pressure,reduce the incidence of cerebral hyperperfusion,improve health beliefs,and reduce the sense of uncertainty about the disease.
10.Effects of Zigui yichong formula on premature ovarian insufficiency in mice through glycolytic metabolic pathway
Xinmiao ZHANG ; Xueping LIU ; Hongyan XI ; Siling TANG ; Rongxia LI ; Zhongyu WU ; Yancang DUAN
China Pharmacy 2024;35(20):2460-2465
OBJECTIVE To study the effects of Zigui yichong formula on premature ovarian insufficiency (POI) in mice through glycolysis metabolic pathway. METHODS Eighty SPF C57BL/6N female mice were divided into normal group, model group, Zigui yichong formula group (14.175 g/kg), Zigui yichong formula+2-deoxy-D-arabino-hexose (2-DG) group (Zigui yichong formula 14.175 g/kg + glycolysis inhibitor 2-DG 100 mg/kg), with 20 mice in each group. Except for the normal group, POI model mice were induced by intraperitoneal administration of cyclophosphamide in the other groups. After the model was successfully established, each group was given corresponding drugs. HE staining was employed to observe the pathomorphological changes in ovarian tissue and to count follicles at all developmental stages; radioimmunoassay was conducted to measure the serum levels of estradiol (E2), anti-Müllerian hormone (AMH), and follicle-stimulating hormone (FSH); TUNEL assay was employed to detect apoptosis in ovarian granulosa cells of mice; the activities of hexokinase (HK), pyruvate kinase (PK) and lactate dehydrogenase (LDH) were detected by colorimetry; Western blot and real-time fluorescence quantitative PCR were employed to analyze the protein and mRNA expressions of B-cell lymphoma-2 (Bcl-2), Bcl-2 associated X protein (Bax), caspase-3, HK2, pyruvate kinase M2 (PKM2), and lactate dehydrogenase A (LDHA). RESULTS Compared with model group, the number of primordial follicles, growing follicles, antral follicles and granulosa cells were increased significantly(P<0.05), and granulosa cells arranged neatly, but the number of atretic follicles and granulosa cells apoptosis were decreased significantly in Zigui yichong formula group (P<0.05); the serum levels of E2 and AMH, the activities of HK, PK and LDH, protein and mRNA expressions of Bcl-2, HK2, PKM2 and LDHA were increased significantly (P<0.05); the serum levels of FSH, the protein and mRNA expressions of Bax and caspase-3, Bax/Bcl-2 ratio were decreased significantly (P<0.05). 2-DG could reverse the improvement effects of Zigui yichong formula on the above indexes of POI model mice. CONCLUSIONS Zigui yichong formula may inhibit the apoptosis of ovarian granulosa cells, reduce follicle atresia and improve ovarian reserve function by promoting glycolysis levels in POI model mice.

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