1.Pharmacoeconomic evaluation of finerenone combined with standard regimen in the treatment of heart failure with preserved or mildly reduced ejection fraction
Runan XIA ; Xu WANG ; Huijuan CHEN ; Mengyu JIANG ; Panpan DI ; Mengmeng ZHAO ; Li LIU ; Hai LIANG
China Pharmacy 2025;36(14):1770-1774
OBJECTIVE To evaluate the cost-effectiveness of finerenone combined with standard of care (SoC) in the treatment of heart failure with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF). METHODS Based on a phase Ⅲ clinical trial, a Markov model was constructed from the perspective of China’s healthcare system to compare the treatment outcomes of finerenone combined with SoC regimen versus SoC regimen alone in the treatment of different cardiac functional statuses of HFmrEF/HFpEF. Using quality-adjusted life year (QALY) as the health output index, 3 times China’s per capita GDP in 2023 as the willingness-to-pay (WTP) threshold, a simulation was conducted with a 3-month cycle length and a 10- year time horizon, incorporating an annual discount rate of 5%. The dynamic changes across various stages of HFmrEF/HFpEF treated with finerenone combined with SoC versus SoC alone were simulated to evaluate the long-term effectiveness and costs of the two treatment strategies. Additionally, one-way sensitivity analysis and probabilistic sensitivity analysis were performed, to test the robustness of the results. RESULTS The incremental cost-effectiveness ratio (ICER) of the finerenone combined with SoC regimen versus SoC regimen alone was 179 504.75 yuan/QALY, which was below the WTP threshold set in this study, indicating that the finerenone combined with SoC regimen possessed certain economic advantages. The results of one-way sensitivity analysis showed that the utility value of NYHA Ⅱ status, the drug price of finerenone, the discount rate, and the probability of hospital transfer for both groups had a great influence on ICER, but did not affect the robustness of the model. The probabilistic sensitivity analysis also confirmed the robustness of the model. CONCLUSIONS Under the WTP threshold set in this study, finerenone combined with SoC is cost-effective in the treatment of HFmrEF/HFpEF, compared with the SoC regimen.
2.Study on the nutritional value of human protein synthesized from six balanced compound amino acid injections
Hai-Ling DI ; Ling-Zhi FANG ; Yao LI ; Ze-Fang YU ; Yu-Pei WU ; Ying-Qin SHI
Parenteral & Enteral Nutrition 2024;31(3):143-146,153
Objective:To provide reference for hospital drug selection and clinical rational drug selection,through evaluating the nutritional value of six commonly used balanced compound amino acid injection (BCAA) in clinical practice,including 18AA (250 mL:12.5 g),18AA-I (250 mL:17.5 g),18AA-Ⅱ(250 mL:21.25 g),18AA-IV (250 mL:8.7 g),18AA-V (250 mL:8.06 g),and 18AA-V-SF (250 mL:8.06 g). Methods:Based on the whole egg protein model,the nutritional value of six varieties of BCAA from two aspects were evaluated,including the first limiting amino acid chemical score (CS),value of essential amino acid (EAA) and the comprehensive quality of total EAA (both essential amino acid index and closeness to standard protein). Results:The first limiting amino acid CS value from high to low was 18AA-Ⅱ>18AA>18AA-V=18AA-V-SF>18AA-I=18AA-Ⅳ. Total EAA comprehensive quality:the essential amino acid index from high to low was 18AA-Ⅱ>18AA>18AA-I>18AA-Ⅳ>18AA-V=18AA-V-SF. The closeness to whole egg protein from high to low was 18AA-Ⅱ=18AA=18AA-I>18AA-Ⅳ>18AA-V=18AA-V-SF. Ultimately,the nutritional value of the 6 varieties of BCAA decreased from high to low:18AA-Ⅱ>18AA>18AA-I>18AA-Ⅳ>18AA-V=18AA-V-SF. Conclusions:Among the six varieties of BCAA,18AA-Ⅱ has the highest nutritional value and the highest amino acid content in the same liquid volume,making it the preferred drug for patients with normal liver and kidney function.
3.Research progress of multi-source information fusion technology in quality evaluation of traditional Chinese medicine
Han LI ; Meng-di XIE ; Xin-jing GUI ; Fu-guo HOU ; Xue-hua FAN ; Hai-yang LI ; Yan-li WANG ; Xue-lin LI ; Rui-xin LIU
Acta Pharmaceutica Sinica 2023;58(10):2835-2852
The quality evaluation of traditional Chinese medicine is one of the key issues related to the modernization of traditional Chinese medicine. The quality evaluation technology system of traditional Chinese medicine mainly includes traditional evaluation (traits, microscopic and physicochemical identification), chemical evaluation and biological evaluation. Due to the complex composition of traditional Chinese medicine, the single detection method in the above evaluation technology system usually cannot obtain sufficient quality information. The multi-source information fusion strategy can organically integrate data from multiple analysis and detection technologies to obtain more comprehensive information of samples and improve the quality evaluation effect. At present, multi-source information fusion strategy has been widely used in the fields of military, industrial and food, and it is still in its infancy in the field of quality evaluation of traditional Chinese medicine. This research introduces the definition, structure, method (algorithm) and fusion level of multi-source information fusion, summarizes its research progress in the origin traceability, variety identification and pharmaceutical analysis of traditional Chinese medicine, and sorts out the specific methods of data fusion in each literature. Finally, we summarized, prospected and discussed the application, development and existing problems of information fusion technology and its application in the quality evaluation of traditional Chinese medicine, in order to provide reference for broadening the application of this technology in the field of traditional Chinese medicine.
4.Evaluation of Renal Impairment in Patients with Diabetic Kidney Disease by Integrated Chinese and Western Medicine.
Yi-Lun QU ; Zhe-Yi DONG ; Hai-Mei CHENG ; Qian LIU ; Qian WANG ; Hong-Tao YANG ; Yong-Hui MAO ; Ji-Jun LI ; Hong-Fang LIU ; Yan-Qiu GENG ; Wen HUANG ; Wen-Hu LIU ; Hui-di XIE ; Fei PENG ; Shuang LI ; Shuang-Shuang JIANG ; Wei-Zhen LI ; Shu-Wei DUAN ; Zhe FENG ; Wei-Guang ZHANG ; Yu-Ning LIU ; Jin-Zhou TIAN ; Xiang-Mei CHEN
Chinese journal of integrative medicine 2023;29(4):308-315
OBJECTIVE:
To investigate the factors related to renal impairment in patients with diabetic kidney disease (DKD) from the perspective of integrated Chinese and Western medicine.
METHODS:
Totally 492 patients with DKD in 8 Chinese hospitals from October 2017 to July 2019 were included. According to Kidney Disease Improving Global Outcomes (KDIGO) staging guidelines, patients were divided into a chronic kidney disease (CKD) 1-3 group and a CKD 4-5 group. Clinical data were collected, and logistic regression was used to analyze the factors related to different CKD stages in DKD patients.
RESULTS:
Demographically, male was a factor related to increased CKD staging in patients with DKD (OR=3.100, P=0.002). In clinical characteristics, course of diabetes >60 months (OR=3.562, P=0.010), anemia (OR=4.176, P<0.001), hyperuricemia (OR=3.352, P<0.001), massive albuminuria (OR=4.058, P=0.002), atherosclerosis (OR=2.153, P=0.007) and blood deficiency syndrome (OR=1.945, P=0.020) were factors related to increased CKD staging in patients with DKD.
CONCLUSIONS
Male, course of diabetes >60 months, anemia, hyperuricemia, massive proteinuria, atherosclerosis, and blood deficiency syndrome might indicate more severe degree of renal function damage in patients with DKD. (Registration No. NCT03865914).
Humans
;
Male
;
Diabetes Mellitus, Type 2
;
Diabetic Nephropathies
;
Hyperuricemia
;
Kidney
;
Proteinuria
;
Renal Insufficiency, Chronic/complications*
5.Efficacy of decitabine combined with low dose chemotherapy on children with acute myeloid leukemia.
Li Yan FAN ; Li GAO ; Di Xin HU ; Jing LING ; Pei Fang XIAO ; Hai Long HE ; Yi WANG ; Jie LI ; Jun LU ; Jian PAN ; Shao Yan HU
Chinese Journal of Pediatrics 2023;61(6):550-555
Objective: To evaluate the efficacy of decitabine combined with low dose chemotherapy (LDC) in the treatment of high-risk, refractory and relapsed pediatric acute myeloid leukemia (AML). Methods: Clinical data of 19 AML children treated with decitabine combined with LDC in the Department of Hematology, Children's Hospital of Soochow University from April 2017 to November 2019 were analyzed retrospectively. The therapeutic response, adverse effects and survival status were analyzed,and the outcomes of patients were followed up. Results: Among 19 AML cases, there were 10 males and 9 females. Five cases were high-risk AML, 7 cases were refractory AML, and 7 cases were relapsed AML. After one course of decitabine+LDC treatment, 15 cases achieved complete remission, 3 cases got partial remission, and only 1 case didn't get remission. All patients received allogeneic hematopoietic stem cell transplantation as consolidation therapy. The follow-up time of all cases was 46 (37, 58) months, 14 children had survived. The cumulative three-year overall survival rate was (79±9) %, events free survival rates was (68±11) %, and recurrence free survival rate was (81±10) %. The most common adverse effects related to the induction treatment were cytopenia (19 cases) and infection (16 cases).There were no treatment-related death during the therapy. Conclusion: Decitabine combined with LDC is a safe and effective option for high-risk, refractory and relapsed AML children, which provides an opportunity for HSCT.
Female
;
Male
;
Humans
;
Child
;
Decitabine
;
Retrospective Studies
;
Leukemia, Myeloid, Acute/drug therapy*
;
Drug-Related Side Effects and Adverse Reactions
;
Hematopoietic Stem Cell Transplantation
6.Clinical, genetic characteristics and follow-up in 14 patients with transthyretin familial amyloid polyneuropathy
Haoran LIU ; Yanan SUN ; Min XU ; Hai CHEN ; Li DI ; Jianying DUO ; Yuwei DA
Chinese Journal of Neurology 2023;56(6):673-678
Objective:To summarize the clinical and genetic characteristics in patients with transthyretin familial amyloid polyneuropathy (TTR-FAP).Methods:Fourteen unrelated TTR-FAP patients diagnosed at Xuanwu Hospital, Capital Medical University from September 2014 to February 2022 were retrospectively reviewed. The clinical manifestation, electrophysiology, cardiac function, biopsy and gene mutation were analyzed.Results:In the 14 patients (13 males, 1 female) diagnosed as TTR-FAP, the mean age at onset was 53.9 years (range: 33.0-71.0 years), with a mean course from symptom-onset to diagnosis of 4.1 years. The late-onset type occurred in 9 cases. Seven patients had a family history of TTR-FAP. Distal paresthesia of lower limbs was the commonest initial symptom (8 cases), with sensorimotor neuropathy and autonomic dysfunction seen initially in 4 and 2 cases, respectively. Cardiac involvement occurred in 6/8 of the patients. Nerve conduction studies indicated extremely axonal impairment with demyelinating features. Sural nerve biopsies showed moderate to severe axonal loss of myelinated fibers and the positive rate of Congo red staining was 8/14. Of 8 different TTR mutations detected, V50M was the most common (appearing in 5 cases). No obvious neuropathy progression was seen in the 5 patients who received tafamidis and 2 patients died of dyscrasia. Conclusions:TTR-FAP is more common in males, with sensorimotor axonal polyneuropathy, autonomic dysfunction and cardiac subclinical damage as the predominant symptoms. V50M is the commonest mutation. Tafamidis can delay the progression of disability.
7.Diagnosis and Treatment of Klebsiella Pneumoniae Combined with Enterobacter Cloacae in Lumbar Intervertebral Space Infection
Han-wen CHENG ; Zhao-juan WU ; Zhuo-jie LIU ; Hao-yu WU ; Di ZHANG ; Ning WANG ; Chun-hai LI
Journal of Sun Yat-sen University(Medical Sciences) 2023;44(3):485-489
ObjectiveTo explore the clinical diagnosis and treatment of rare primary lumbar intervertebral space infection with Klebsiella pneumoniae and Enterobacter cloacae, and provide clinical experience for the diagnosis and treatment of this rare spinal infection. MethodsAn elderly male patient with low back pain and numbness in the left lower extremity for more than 7 months, which aggravated for more than 1 week, was diagnosed with lumbar disc herniation after laboratory and imaging examinations. After admission, the symptoms became acutely aggravated, and re-examination of lumbar enhanced MRI showed local enhancement at the posterior edge of the L3/4 intervertebral space. The VAS score was 9 points, and the lumbar JOA score was 6 points. A posterior lumbar interbody fusion of L3-L5 was performed, and L3/4 intervertebral disc specimens were collected during the operation for bacterial culture. ResultsBacterial culture results showed Klebsiella pneumoniae and Enterobacter cloacae infection. The patient was treated with sensitive antibiotics for 6 weeks after the operation, and the patient was cured during the follow-up of half a year after the operation. ConclusionFor middle-aged and elderly patients with clinical manifestations of acute severe low back pain or lower extremity pain, the possibility of spinal infection should be considered when routine laboratory and imaging examinations suggest lumbar degenerative diseases.
8.Analysis on the secondary attack rates of SARS-CoV-2 Omicron variant and the associated factors.
Qing Xiang SHANG ; Ke XU ; Qi Gang DAI ; Hao Di HUANG ; Jian Li HU ; Xin ZOU ; Li Ling CHEN ; Ye WEI ; Hai Peng LI ; Qian ZHEN ; Wei CAI ; Yin WANG ; Chang jun BAO
Chinese Journal of Preventive Medicine 2023;57(10):1550-1557
Objective: To evaluate the secondary attack rates of the SARS-CoV-2 Omicron variant and the associated factors. Methods: A total of 328 primary cases and 40 146 close contacts of the SARS-CoV-2 Omicron variant routinely detected in local areas of Jiangsu Province from February to April 2022 were selected in this study, and those with positive nucleic acid test results during 7 days of centralized isolation medical observation were defined as secondary cases. The demographic information and clinical characteristics were collected, and the secondary attack rate (SAR) and the associated factors were analyzed by using a multivariate logistic regression model. Results: A total of 1 285 secondary cases of close contacts were reported from 328 primary cases, with a SAR of 3.2% (95%CI: 3.0%-3.4%). Among the 328 primary cases, males accounted for 61.9% (203 cases), with the median age (Q1, Q3) of 38.5 (27, 51) years old. Among the 1 285 secondary cases, males accounted for 59.1% (759 cases), with the median age (Q1, Q3) of 34 (17, 52) years old. The multivariate logistic regression model showed that the higher SAR was observed in the primary male cases (OR=1.632, 95%CI: 1.418-1.877), younger than 20 years old (OR=1.766, 95%CI: 1.506-2.072),≥60 years old (OR=1.869, 95%CI: 1.476-2.365), infected with the BA.2 strain branch (OR=2.906, 95%CI: 2.388-3.537), the confirmed common cases (OR=2.572, 95%CI: 2.036-3.249), and confirmed mild cases (OR=1.717, 95%CI: 1.486-1.985). Meanwhile, the higher SAR was observed in the close contacts younger than 20 years old (OR=2.604, 95%CI: 2.250-3.015),≥60 years old (OR=1.287, 95%CI: 1.052-1.573) and exposure for co-residence (OR=27.854, 95%CI: 23.470-33.057). Conclusion: The sex and age of the primary case of the Omicron variant, the branch of the infected strain, case severity of the primary case, as well as the age and contact mode of close contacts are the associated factors of SAR.
Humans
;
Male
;
Middle Aged
;
Young Adult
;
Adult
;
COVID-19/epidemiology*
;
Incidence
;
SARS-CoV-2
;
Logistic Models
9.Analysis on the secondary attack rates of SARS-CoV-2 Omicron variant and the associated factors.
Qing Xiang SHANG ; Ke XU ; Qi Gang DAI ; Hao Di HUANG ; Jian Li HU ; Xin ZOU ; Li Ling CHEN ; Ye WEI ; Hai Peng LI ; Qian ZHEN ; Wei CAI ; Yin WANG ; Chang jun BAO
Chinese Journal of Preventive Medicine 2023;57(10):1550-1557
Objective: To evaluate the secondary attack rates of the SARS-CoV-2 Omicron variant and the associated factors. Methods: A total of 328 primary cases and 40 146 close contacts of the SARS-CoV-2 Omicron variant routinely detected in local areas of Jiangsu Province from February to April 2022 were selected in this study, and those with positive nucleic acid test results during 7 days of centralized isolation medical observation were defined as secondary cases. The demographic information and clinical characteristics were collected, and the secondary attack rate (SAR) and the associated factors were analyzed by using a multivariate logistic regression model. Results: A total of 1 285 secondary cases of close contacts were reported from 328 primary cases, with a SAR of 3.2% (95%CI: 3.0%-3.4%). Among the 328 primary cases, males accounted for 61.9% (203 cases), with the median age (Q1, Q3) of 38.5 (27, 51) years old. Among the 1 285 secondary cases, males accounted for 59.1% (759 cases), with the median age (Q1, Q3) of 34 (17, 52) years old. The multivariate logistic regression model showed that the higher SAR was observed in the primary male cases (OR=1.632, 95%CI: 1.418-1.877), younger than 20 years old (OR=1.766, 95%CI: 1.506-2.072),≥60 years old (OR=1.869, 95%CI: 1.476-2.365), infected with the BA.2 strain branch (OR=2.906, 95%CI: 2.388-3.537), the confirmed common cases (OR=2.572, 95%CI: 2.036-3.249), and confirmed mild cases (OR=1.717, 95%CI: 1.486-1.985). Meanwhile, the higher SAR was observed in the close contacts younger than 20 years old (OR=2.604, 95%CI: 2.250-3.015),≥60 years old (OR=1.287, 95%CI: 1.052-1.573) and exposure for co-residence (OR=27.854, 95%CI: 23.470-33.057). Conclusion: The sex and age of the primary case of the Omicron variant, the branch of the infected strain, case severity of the primary case, as well as the age and contact mode of close contacts are the associated factors of SAR.
Humans
;
Male
;
Middle Aged
;
Young Adult
;
Adult
;
COVID-19/epidemiology*
;
Incidence
;
SARS-CoV-2
;
Logistic Models
10.Relationship between body mass index and sexual development in Chinese children.
Xiao Qin XU ; Jian Wei ZHANG ; Rui Min CHEN ; Jing Si LUO ; Shao Ke CHEN ; Rong Xiu ZHENG ; Di WU ; Min ZHU ; Chun Lin WANG ; Yan LIANG ; Hui YAO ; Hai Yan WEI ; Zhe SU ; Mireguli MAIMAITI ; Hong Wei DU ; Fei Hong LUO ; Pin LI ; Shu Ting SI ; Wei WU ; Ke HUANG ; Guan Ping DONG ; Yun Xian YU ; Jun Fen FU
Chinese Journal of Pediatrics 2022;60(4):311-316
Objective: To investigate the relationship between body mass index (BMI) and sexual development in Chinese children. Methods: A nationwide multicenter and population-based large cross-sectional study was conducted in 13 provinces, autonomous regions and municipalities of China from January 2017 to December 2018. Data on sex, age, height, weight were collected, BMI was calculated and sexual characteristics were analyzed. The subjects were divided into four groups based on age, including ages 3-<6 years, 6-<10 years, 10-<15 years and 15-<18 years. Multiple Logistic regression models were used for evaluating the associations of BMI with sexual development in children. Dichotomous Logistic regression was used to compare the differences in the distribution of early and non-early puberty among normal weight, overweight and obese groups. Curves were drawn to analyze the relationship between the percentage of early puberty and BMI distribution in girls and boys at different Tanner stages. Results: A total of 208 179 healthy children (96 471 girls and 111 708 boys) were enrolled in this study. The OR values of B2, B3 and B4+ in overweight girls were 1.72 (95%CI: 1.56-1.89), 3.19 (95%CI: 2.86-3.57), 7.14 (95%CI: 6.33-8.05) and in obese girls were 2.05 (95%CI: 1.88-2.24), 4.98 (95%CI: 4.49-5.53), 11.21 (95%CI: 9.98-12.59), respectively; while the OR values of G2, G3, G4+ in overweight boys were 1.27 (95%CI: 1.17-1.38), 1.52 (95%CI: 1.36-1.70), 1.88 (95%CI: 1.66-2.14) and in obese boys were 1.27 (95%CI: 1.17-1.37), 1.59 (95%CI: 1.43-1.78), and 1.93 (95%CI: 1.70-2.18) (compared with normal weight Tanner 1 group,all P<0.01). Analysis in different age groups found that OR values of obese girls at B2 stage and boys at G2 stage were 2.02 (95%CI: 1.06-3.86) and 2.32 (95%CI:1.05-5.12) in preschool children aged 3-<6 years, respectively (both P<0.05). And in the age group of 6-10 years, overweight girls had a 5.45-fold risk and obese girls had a 12.54-fold risk of B3 stage compared to girls with normal BMI. Compared with normal weight children, the risk of early puberty was 2.67 times higher in overweight girls, 3.63 times higher in obese girls, and 1.22 times higher in overweight boys, 1.35 times higher in obese boys (all P<0.01). Among the children at each Tanner stages, the percentage of early puberty increased with the increase of BMI, from 5.7% (80/1 397), 16.1% (48/299), 13.8% (27/195) to 25.7% (198/769), 65.1% (209/321), 65.4% (157/240) in girls aged 8-<9, 10-<11 and 11-<12 years, and 6.6% (34/513), 18.7% (51/273), 21.6% (57/264) to 13.3% (96/722), 46.4% (140/302), 47.5% (105/221) in boys aged 9-<10, 12-<13 and 13-<14 years, respectively. Conclusions: BMI is positively correlated with sexual development in both Chinese boys and girls, and the correlation is stronger in girls. Obesity is a risk factor for precocious puberty in preschool children aged 3-<6 years, and 6-<10 years of age is a high risk period for early development in obese girls.
Adolescent
;
Body Mass Index
;
Child
;
Child, Preschool
;
China/epidemiology*
;
Cross-Sectional Studies
;
Female
;
Humans
;
Male
;
Obesity/epidemiology*
;
Overweight/epidemiology*
;
Puberty
;
Puberty, Precocious
;
Sexual Development

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