1.Pharmacoeconomics Evaluation of Utidelone Combined with Capecitabine in the Second-line Treatment of Metastatic Breast Cancer
ZHANG Sen ; JIA Caifeng ; XU Hao ; LI Sainan ; KANG Shuo
Chinese Journal of Modern Applied Pharmacy 2023;40(19):2732-2737
OBJECTIVE To evaluate the economics of utidelone combined with capecitabine compared with capecitabine in the second-line treatment of metastatic breast cancer from the perspective of Chinese health-care system. METHODS A partitioned survival model was established using clinical trial data and relevant literature data, with the cycle of 3 weeks and the time horizon of 15 years. Cost and utility data were discounted using a discount rate of 5%. The model output was the incremental cost-effectiveness ratio(ICER), and the willingness-to-pay threshold(WTP) was set to 1-3 times per capita gross domestic product(GDP) in China in 2021(80 976 yuan/QALY-242 928 yuan/QALY). One-way sensitivity analyses and probabilistic sensitivity analyses were performed to evaluate the stability of model results when the model parameters were changed. RESULTS The results of base-case analysis showed that utidelone combined with capecitabine was a high-cost and high-health benefit regimen, and the ICER was 393 949.83 yuan/QALY. One-way sensitivity analyses showed that the price of utidelone was the most influential factor of the ICER, and the probabilistic sensitivity analyses showed that the model results were robustness. CONCLUSION Utidelone combined with capecitabine has no economic advantage compared with capecitabine alone in the second-line treatment of metastatic breast cancer, but in areas with per capita GDP of more than 131 316 yuan, utidelone combined with capecitabine can be considered the cost-effective regimen.
2.Diagnosis, treatment and prevention of severe acute respiratory syndrome coronavirus 2 infection in children: experts′ consensus statement (Fifth Edition)updated for the Omicron variant
Rongmeng JIANG ; Zhengde XIE ; Yi JIANG ; Xiaoxia LU ; Runming JIN ; Yuejie ZHENG ; Yunxiao SHANG ; Baoping XU ; Zhisheng LIU ; Gen LU ; Jikui DENG ; Guanghua LIU ; Xiaochuan WANG ; Jianshe WANG ; Luzhao FENG ; Wei LIU ; Yi ZHENG ; Sainan SHU ; Min LU ; Wanjun LUO ; Miao LIU ; Yuxia CUI ; Leping YE ; Adong SHEN ; Gang LIU ; Liwei GAO ; Lijuan XIONG ; Yan BAI ; Likai LIN ; Zhuang WEI ; Fengxia XUE ; Tianyou WANG ; Dongchi ZHAO ; Zhengyan ZHAO ; Jianbo SHAO ; Wong Wing-kin GARY ; Yanxia HE ; Xingwang LI ; Yonghong YANG ; Kunling SHEN
Chinese Journal of Applied Clinical Pediatrics 2023;38(1):20-30
China has classified the Corona Virus Disease 2019(COVID-19) as a statutory category B infectious disease and managed it according to Category B since January 8, 2023.In view that Omicron variant is currently the main epidemic strain in China, in order to guide the treatment of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) infection in children with the times, refer to the Diagnosis and Treatment Protocol for Novel Coronavirus Infection (Trial 10 th Edition), Expert Consensus on Diagnosis, Treatment and Prevention of Novel Coronavirus Infection in Children (Fourth Edition) and the Diagnosis and Treatment Strategy for Pediatric Related Viral Infections.The Expert Consensus on the Diagnosis, Treatment and Prevention of Novel Coronavirus Infection in Children (Fifth Edition) has been formulated and updated accordingly on related etiology, epidemiology, pathogenic mechanism, clinical manifestations, auxiliary examination, diagnosis and treatment, and added key points for the treatment of COVID-19 related encephalopathy, fulminating myocarditis and other serious complications for clinical reference.
3.Latent tuberculosis infection and screening method among close contacts in schools in Xuhui District,Shanghai from 2020 to 2022
Sainan ZHANG ; Meixia YANG ; Xiaofeng CAI ; Xiang XU ; Yi ZHANG
Shanghai Journal of Preventive Medicine 2023;35(12):1223-1226
ObjectiveTo investigate the latent tuberculosis infection (LTBI) of close contacts in schools of Xuhui District, and to explore the tuberculin skin test (TST)- interferon-γ release assay (IGRA) two-step method in order to discover the screening strategy of tuberculosis in Xuhui District. MethodsClose contacts of tuberculosis in schools of Xuhui District from 2020 to 2022 were selected as research subjects. Screening was conducted using symptom questionnaire, TST, chest X-rays, IGRA, and the information including the etiological results and grade of the index cases, as well as gender, age, and relationship with the index cases of the research subjects were collected. ResultsTotally 615 close contacts of 32 tuberculosis cases occurred in the schools were finally included. Of the 609 close contacts who completed tuberculosis infection screening and underwent TST testing, 153 TST(+) individuals underwent IGRA testing. The final LTBI rate was 4.6%, and the pulmonary tuberculosis detection rate was 163 per 100 000. The relationship with the index cases was an influencing factor for LTBI. The IGRA positivity rate was higher among close contacts with TST ≥15 mm than among those with 10 mm≤ TST <15 mm (χ2=14.41, P<0.05). ConclusionThe latent tuberculosis infection among close contacts of school tuberculosis cases in Xuhui District remains serious. TST-IGRA two-step method can assist in the accurate diagnosis of LTBI and pulmonary tuberculosis cases.
4.Cost-utility analysis of pertuzumab combined with trastuzumab and docetaxel in first-line treatment of HER 2- positive metastatic breast cancer
Caifeng JIA ; Sen ZHANG ; Hao XU ; Sainan LI ; Mingxia WANG
China Pharmacy 2022;33(4):481-486
OBJECTIVE To study the metabolites of four diterpenoids of Euphorbia fischeriana in liver microsomes of rats and to investigate its metabolic regularity. METHODS In vitro incubation system of liver microsomes of rats was built. The jolkinolide A,jolkinolide B ,17-hydroxyl jolkinolide A and 17-hydroxyl jolkinolide B were added into incubation system of liver microsomes in rats activated by reduced nicotinamide adenine dinucleotide phosphate ,incubated at 37 ℃ for 30 min,and then terminated the reaction with acetonitrile. Taking the negative group (adding acetonitrile firstly and then starting incubation for 30 min)as the reference,the ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry was used ;Anaylyst®TF 1.7.1、PeakView® 2.2,MetabolitePilot 1.5 and MasterView 1.2 software were used to speculate and identify the fragmentation law of mass spectrometry and metabolites. RESULTS Four diterpenoids were easy to lose neutral fragments such as H 2O and CO in secondary mass spectrometry. Jolkinolide A and 17-hydroxyl jolkinolide A showed similar metabolism pathway ,including dihydroxylation,dehydrogenation,and monohydroxylation ;six and five metabolites were identified respectively. Jolkinolide B and 17-hydroxyl jolkinolide B showed similar metabolism pathway ,including monohydroxylation ,hydration and isomerization. Five metabolites were identified. CONCLUSIONS Both jolkinolide A and 17-hydroxyl jolkinolide A produce the metabolites of hydroxylation and dehydrogenation in liver microsomes of rats ;both jolkinolide B and 17-hydroxyl jolkinolide B produce the metabolites of hydroxylation ,hydration and isomerization in liver microsomes of rats. The metabolites of four diterpenoids are phase Ⅰ metabolites.
5.A multicenter epidemiological study of acute bacterial meningitis in children.
Cai Yun WANG ; Hong Mei XU ; Jiao TIAN ; Si Qi HONG ; Gang LIU ; Si Xuan WANG ; Feng GAO ; Jing LIU ; Fu Rong LIU ; Hui YU ; Xia WU ; Bi Quan CHEN ; Fang Fang SHEN ; Guo ZHENG ; Jie YU ; Min SHU ; Lu LIU ; Li Jun DU ; Pei LI ; Zhi Wei XU ; Meng Quan ZHU ; Li Su HUANG ; He Yu HUANG ; Hai Bo LI ; Yuan Yuan HUANG ; Dong WANG ; Fang WU ; Song Ting BAI ; Jing Jing TANG ; Qing Wen SHAN ; Lian Cheng LAN ; Chun Hui ZHU ; Yan XIONG ; Jian Mei TIAN ; Jia Hui WU ; Jian Hua HAO ; Hui Ya ZHAO ; Ai Wei LIN ; Shuang Shuang SONG ; Dao Jiong LIN ; Qiong Hua ZHOU ; Yu Ping GUO ; Jin Zhun WU ; Xiao Qing YANG ; Xin Hua ZHANG ; Ying GUO ; Qing CAO ; Li Juan LUO ; Zhong Bin TAO ; Wen Kai YANG ; Yong Kang ZHOU ; Yuan CHEN ; Li Jie FENG ; Guo Long ZHU ; Yan Hong ZHANG ; Ping XUE ; Xiao Qin LI ; Zheng Zhen TANG ; De Hui ZHANG ; Xue Wen SU ; Zheng Hai QU ; Ying ZHANG ; Shi Yong ZHAO ; Zheng Hong QI ; Lin PANG ; Cai Ying WANG ; Hui Ling DENG ; Xing Lou LIU ; Ying Hu CHEN ; Sainan SHU
Chinese Journal of Pediatrics 2022;60(10):1045-1053
Objective: To analyze the clinical epidemiological characteristics including composition of pathogens , clinical characteristics, and disease prognosis acute bacterial meningitis (ABM) in Chinese children. Methods: A retrospective analysis was performed on the clinical and laboratory data of 1 610 children <15 years of age with ABM in 33 tertiary hospitals in China from January 2019 to December 2020. Patients were divided into different groups according to age,<28 days group, 28 days to <3 months group, 3 months to <1 year group, 1-<5 years of age group, 5-<15 years of age group; etiology confirmed group and clinically diagnosed group according to etiology diagnosis. Non-numeric variables were analyzed with the Chi-square test or Fisher's exact test, while non-normal distrituction numeric variables were compared with nonparametric test. Results: Among 1 610 children with ABM, 955 were male and 650 were female (5 cases were not provided with gender information), and the age of onset was 1.5 (0.5, 5.5) months. There were 588 cases age from <28 days, 462 cases age from 28 days to <3 months, 302 cases age from 3 months to <1 year of age group, 156 cases in the 1-<5 years of age and 101 cases in the 5-<15 years of age. The detection rates were 38.8% (95/245) and 31.5% (70/222) of Escherichia coli and 27.8% (68/245) and 35.1% (78/222) of Streptococcus agalactiae in infants younger than 28 days of age and 28 days to 3 months of age; the detection rates of Streptococcus pneumonia, Escherichia coli, and Streptococcus agalactiae were 34.3% (61/178), 14.0% (25/178) and 13.5% (24/178) in the 3 months of age to <1 year of age group; the dominant pathogens were Streptococcus pneumoniae and the detection rate were 67.9% (74/109) and 44.4% (16/36) in the 1-<5 years of age and 5-<15 years of age . There were 9.7% (19/195) strains of Escherichia coli producing ultra-broad-spectrum β-lactamases. The positive rates of cerebrospinal fluid (CSF) culture and blood culture were 32.2% (515/1 598) and 25.0% (400/1 598), while 38.2% (126/330)and 25.3% (21/83) in CSF metagenomics next generation sequencing and Streptococcus pneumoniae antigen detection. There were 4.3% (32/790) cases of which CSF white blood cell counts were normal in etiology confirmed group. Among 1 610 children with ABM, main intracranial imaging complications were subdural effusion and (or) empyema in 349 cases (21.7%), hydrocephalus in 233 cases (14.5%), brain abscess in 178 cases (11.1%), and other cerebrovascular diseases, including encephalomalacia, cerebral infarction, and encephalatrophy, in 174 cases (10.8%). Among the 166 cases (10.3%) with unfavorable outcome, 32 cases (2.0%) died among whom 24 cases died before 1 year of age, and 37 cases (2.3%) had recurrence among whom 25 cases had recurrence within 3 weeks. The incidences of subdural effusion and (or) empyema, brain abscess and ependymitis in the etiology confirmed group were significantly higher than those in the clinically diagnosed group (26.2% (207/790) vs. 17.3% (142/820), 13.0% (103/790) vs. 9.1% (75/820), 4.6% (36/790) vs. 2.7% (22/820), χ2=18.71, 6.20, 4.07, all P<0.05), but there was no significant difference in the unfavorable outcomes, mortility, and recurrence between these 2 groups (all P>0.05). Conclusions: The onset age of ABM in children is usually within 1 year of age, especially <3 months. The common pathogens in infants <3 months of age are Escherichia coli and Streptococcus agalactiae, and the dominant pathogen in infant ≥3 months is Streptococcus pneumoniae. Subdural effusion and (or) empyema and hydrocephalus are common complications. ABM should not be excluded even if CSF white blood cell counts is within normal range. Standardized bacteriological examination should be paid more attention to increase the pathogenic detection rate. Non-culture CSF detection methods may facilitate the pathogenic diagnosis.
Adolescent
;
Brain Abscess
;
Child
;
Child, Preschool
;
Escherichia coli
;
Female
;
Humans
;
Hydrocephalus
;
Infant
;
Infant, Newborn
;
Male
;
Meningitis, Bacterial/epidemiology*
;
Retrospective Studies
;
Streptococcus agalactiae
;
Streptococcus pneumoniae
;
Subdural Effusion
;
beta-Lactamases
6.Expert consensus on the diagnosis, treatment and prevention of monkeypox in children
Rongmeng JIANG ; Yuejie ZHENG ; Lei ZHOU ; Luzhao FENG ; Lin MA ; Baoping XU ; Hongmei XU ; Wei LIU ; Zhengde XIE ; Jikui DENG ; Lijuan XIONG ; Wanjun LUO ; Zhisheng LIU ; Sainan SHU ; Jianshe WANG ; Yi JIANG ; Yunxiao SHANG ; Miao LIU ; Liwei GAO ; Zhuang WEI ; Guanghua LIU ; Gang LIU ; Wei XIANG ; Yuxia CUI ; Gen LU ; Min LU ; Xiaoxia LU ; Runming JIN ; Yan BAI ; Leping YE ; Dongchi ZHAO ; Adong SHEN ; Xiang MA ; Qinghua LU ; Fengxia XUE ; Jianbo SHAO ; Tianyou WANG ; Zhengyan ZHAO ; Xingwang LI ; Yonghong YANG ; Kunling SHEN
Chinese Journal of Applied Clinical Pediatrics 2022;37(13):964-973
Monkeypox is a zoonotic disease.Previous studies have shown that children are vulnerable to monkeypox and are also at high risk for severe disease or complications.In order to improve pediatricians′ understanding of monkeypox and achieve early detection, early diagnosis, early treatment and early disposal, the committee composed of more than 40 experts in the related fields of infectious diseases, pediatrics, infection control and public health formulate this expert consensus, on the basis of the latest clinical management and infection prevention and control for monkeypox released by the World Health Organization (WHO), the guidelines for diagnosis and treatment of monkeypox (version 2022) issued by National Health Commission of the People′s Republic of China and other relevant documents.During the development of this consensus, multidisciplinary experts have repeatedly demonstrated the etiology, epidemiology, transmission, clinical manifestations, laboratory examinations, diagnosis and differential diagnosis, treatment, discharge criteria, prevention, case management process and key points of prevention and control about monkeypox.
7.Diagnosis, treatment and prevention of severe acute respiratory syndrome coronavirus 2 infection in children: experts′ consensus statement (Fourth Edition)
Rongmeng JIANG ; Zhengde XIE ; Yi JIANG ; Xiaoxia LU ; Runming JIN ; Yuejie ZHENG ; Yunxiao SHANG ; Baoping XU ; Zhisheng LIU ; Gen LU ; Jikui DENG ; Guanghua LIU ; Xiaochuan WANG ; Jianshe WANG ; Luzhao FENG ; Wei LIU ; Yi ZHENG ; Sainan SHU ; Min LU ; Wanjun LUO ; Miao LIU ; Yuxia CUI ; Leping YE ; Adong SHEN ; Gang LIU ; Liwei GAO ; Lijuan XIONG ; Yan BAI ; Likai LIN ; Zhuang WEI ; Fengxia XUE ; Tianyou WANG ; Dongchi ZHAO ; Zhengyan ZHAO ; Jianbo SHAO ; Kwok-keung Daniel NG ; Wing-kin Gary WONG ; Xingwang LI ; Yonghong YANG ; Kunling SHEN
Chinese Journal of Applied Clinical Pediatrics 2022;37(14):1053-1065
Since December 2019, severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) infections have raged globally for more than 2 years.China has always adopted scientific and effective prevention and control measures to achieved some success.However, with the continuous variation of SARS-CoV-2 cases and imported cases from abroad, the prevention and control work has become more difficult and complex.With the variation of the mutant strain, the number of cases in children changed, and some new special symptoms and complications were found, which proposed a new topic for the prevention and treatment of SARS-CoV-2 infection in children in China.Based on the third edition, the present consensus according to the characteristics of the new strain, expounded the etiology, pathology, pathogenesis, and according to the clinical characteristics and experience of children′s cases, and puts forward recommendations on the diagnostic criteria, laboratory examination, treatment, prevention and control of children′s cases for providing reference for further guidance of effective prevention and treatment of SARS-CoV-2 infection in children in China.
8.Diagnosis, treatment and prevention of 2019 novel coronavirus infection in children: experts′ consensus statement (Third Edition)
Rongmeng JIANG ; Zhengde XIE ; Yi JIANG ; Xiaoxia LU ; Runming JIN ; Yuejie ZHENG ; Baoping XU ; Zhisheng LIU ; Likai LIN ; Yunxiao SHANG ; Sainan SHU ; Yan BAI ; Min LU ; Gen LU ; Jikui DENG ; Wanjun LUO ; Lijuan XIONG ; Miao LIU ; Yuxia CUI ; Leping YE ; Liwei GAO ; Yongyan WANG ; Xuefeng WANG ; Jiafu LI ; Tianyou WANG ; Dongchi ZHAO ; Jianbo SHAO ; Xingwang LI ; Yonghong YANG ; Kunling SHEN
Chinese Journal of Applied Clinical Pediatrics 2021;36(10):721-732
2019 novel coronavirus(2019-nCoV) outbreak is one of the public health emergency of international concern.Since the 2019-nCoV outbreak, China has been adopting strict prevention and control measures, and has achieved remarkable results in the initial stage of prevention and control.However, some imported cases and sporadic regional cases have been found, and even short-term regional epidemics have occurred, indicating that the preventing and control against the epidemic remains grim.With the change of the incidence proportion and the number of cases in children under 18 years old, some new special symptoms and complications have appeared in children patients.In addition, with the occurrence of virus mutation, it has not only attracted attention from all parties, but also proposed a new topic for the prevention and treatment of 2019-nCoV infection in children of China.Based on the second edition, the present consensus further summarizes the clinical characteristics and experience of children′s cases, and puts forward recommendations on the diagnostic criteria, laboratory examination, treatment, prevention and control of children′s cases for providing reference for further guidance of treatment of 2019-nCoV infection in children.
9.The characteristics and change of aeroallergens in children from 2015 to 2020 in a hospital of pediatric in Beijing
Chong PANG ; Sainan BIAN ; Chuanhe LIU ; Linlin GUO ; Ying CUI ; Feng LIN ; Xu YIN ; Chang LIU ; Kai GUAN
Chinese Journal of Preventive Medicine 2021;55(7):840-846
Objective:To analyze the characteristics of clinical distribution and change of aeroallergens in children with allergic diseases from 2015 to 2020.Methods:Children who visited Capital Institute of Pediatrics affiliated Children′s Hospital, suspected of allergic diseases and received serum aeroallergens specific immunoglobulin E (sIgE) test were retrospectively enrolled (1 to 14 years old). sIgE was detected by Phadia1000 system with radioallergosorbent test fluorescent enzyme-linked immunoassay. The characteristics and change of the aeroallergens among the 6 years was analyzed. Enumeration data were expressed by percentage and categorical variables were compared by the independent samples t-test and Pearson χ 2 test. Results:In total 4 608 tests (4 575 patients) of children were enrolled, the average age was (5.4±2.9) years old, with the median age of 5.0 years old. 3 176 were boys (68.9%), and 1 432 were girls (31.1%). 4 294 children were from the north of China (93.2%), 295 children were from the south of China (6.4%), and 19 children were from unknown regions (0.4%). In total the most common aeroallergen was mold mixture (1 956/4 457 tests, 43.9%) and Alternaria alternata (276/630 tests, 43.8%), followed by Artemisia (300/889 tests, 33.7%), Humulus scandens (12/38 tests, 31.6%) and grass mixture (909/2 874 tests, 31.6%). Among the 6 years, mold, grass pollen and tree pollen sensitization increased, and mold [38/130 (29.2%) vs 1 574/3 233 (48.7%)], grass pollen [11/77 (14.3%) vs 1 069/3 072 (34.8%)] increased significantly (χ 2 was 18.953 and 49.559, respectively, P=0.000). Positive rate of tree pollen increased [1/10 (10.0%) vs 516/2 122 (24.3%)], but did not have statistical significance (χ2=1.111, P=0.292). Dust mite [36/146 (24.7%) vs 321/1 408 (22.8%)] and hair of pets [7/33 (21.2%) vs 321/1 408 (17.1%)] sensitization didn′t change greatly (χ 2 =0.258, P =0.611; χ 2 =0.379, P =0.538). In 2015, the most common aeroallergens was mold (38/130, 29.2%), followed by dust mite (36/146, 24.7%), while in 2020, the most common aeroallergens was still mold (1 574/3 233, 48.7%), with grass pollen (1 069/3 072, 34.8%) and tree pollen (516/2 122, 24.3%) ranked after. Conclusion:Mold might be the most common aeroallergens in allergic children in Beijing area. With time went on, dust mite was gradually exceeded by grass pollen and tree pollen.
10.The characteristics and change of aeroallergens in children from 2015 to 2020 in a hospital of pediatric in Beijing
Chong PANG ; Sainan BIAN ; Chuanhe LIU ; Linlin GUO ; Ying CUI ; Feng LIN ; Xu YIN ; Chang LIU ; Kai GUAN
Chinese Journal of Preventive Medicine 2021;55(7):840-846
Objective:To analyze the characteristics of clinical distribution and change of aeroallergens in children with allergic diseases from 2015 to 2020.Methods:Children who visited Capital Institute of Pediatrics affiliated Children′s Hospital, suspected of allergic diseases and received serum aeroallergens specific immunoglobulin E (sIgE) test were retrospectively enrolled (1 to 14 years old). sIgE was detected by Phadia1000 system with radioallergosorbent test fluorescent enzyme-linked immunoassay. The characteristics and change of the aeroallergens among the 6 years was analyzed. Enumeration data were expressed by percentage and categorical variables were compared by the independent samples t-test and Pearson χ 2 test. Results:In total 4 608 tests (4 575 patients) of children were enrolled, the average age was (5.4±2.9) years old, with the median age of 5.0 years old. 3 176 were boys (68.9%), and 1 432 were girls (31.1%). 4 294 children were from the north of China (93.2%), 295 children were from the south of China (6.4%), and 19 children were from unknown regions (0.4%). In total the most common aeroallergen was mold mixture (1 956/4 457 tests, 43.9%) and Alternaria alternata (276/630 tests, 43.8%), followed by Artemisia (300/889 tests, 33.7%), Humulus scandens (12/38 tests, 31.6%) and grass mixture (909/2 874 tests, 31.6%). Among the 6 years, mold, grass pollen and tree pollen sensitization increased, and mold [38/130 (29.2%) vs 1 574/3 233 (48.7%)], grass pollen [11/77 (14.3%) vs 1 069/3 072 (34.8%)] increased significantly (χ 2 was 18.953 and 49.559, respectively, P=0.000). Positive rate of tree pollen increased [1/10 (10.0%) vs 516/2 122 (24.3%)], but did not have statistical significance (χ2=1.111, P=0.292). Dust mite [36/146 (24.7%) vs 321/1 408 (22.8%)] and hair of pets [7/33 (21.2%) vs 321/1 408 (17.1%)] sensitization didn′t change greatly (χ 2 =0.258, P =0.611; χ 2 =0.379, P =0.538). In 2015, the most common aeroallergens was mold (38/130, 29.2%), followed by dust mite (36/146, 24.7%), while in 2020, the most common aeroallergens was still mold (1 574/3 233, 48.7%), with grass pollen (1 069/3 072, 34.8%) and tree pollen (516/2 122, 24.3%) ranked after. Conclusion:Mold might be the most common aeroallergens in allergic children in Beijing area. With time went on, dust mite was gradually exceeded by grass pollen and tree pollen.


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