1.Dupilumab for the treatment of severe asthma:a rapid health technology assessment
Huayu WANG ; Shichao DONG ; Wei SUN ; Ying WANG
China Pharmacy 2025;36(6):648-654
OBJECTIVE To evaluate the efficacy, safety and cost-effectiveness of dupilumab in the treatment of severe asthma with rapid health technology assessment (HTA), and to provide evidence-based evidence for clinical treatment. METHODS Retrieved from PubMed,Cochrane Library,CNKI,Wanfang, VIP database, and other related websites of HTA. HTA reports, systematic review/meta-analysis, and economic studies of dupilumab in the treatment of severe asthma were collected. Researchers independently identified literature, extracted data, and assessed the quality of included studies. Qualitative description was performed. RESULTS A total of 15 pieces of literature were included, involving 9 systematic reviews/meta-analyses and 6 economic studies. In terms of effectiveness, dupilumab was significantly better than placebo. Compared with other biological drugs, in the patients with severe asthma aged 12 years and above, for those with eosinophil (EOS) ≥300 cells/μL, dupilumab ranked first in improving forced expiratory volume in one second (FEV1), outperforming tezepelumab, benralizumab, and mepolizumab. It ranked second in reducing acute exacerbations, surpassed only by tezepelumab, while its effect on improving asthma control questionnaire score was relatively lower, being better only than benralizumab. For those with 150 cells/μL ≤EOS<300 cells/μL, dupilumab was superior to mepolizumab in reducing asthma exacerbation, while the effect on FEV1 was weaker than benralizumab and mepolizumab. In terms of safety, there was no significant difference in the incidence of adverse events and serious adverse events between dupilumab and placebo or other biological drugs, while the incidence of injection site reactions of dupilumab was significantly higher than placebo. In terms of cost-effectiveness, the research results of different countries were not consistent, and there was a lack of research data from China. CONCLUSIONS Dupilumab is an effective and safe choice in the treatment of severe asthma, and its cost-effectiveness requires further research based on China’s medical environment to be determined.
2.Apixaban for the prevention and treatment of cancer-associated venous thromboembolism:a rapid health technology assessment
Huayu WANG ; Keke SHANGGUAN ; Ying WANG ; Yankui LI
China Pharmacy 2025;36(10):1260-1265
OBJECTIVE To evaluate the efficacy, safety and cost-effectiveness of apixaban in the prevention and treatment of cancer-associated venous thromboembolism (CA-VTE), and provide evidence-based reference for clinical treatment. METHODS Retrieved from PubMed, the Cochrane Library, CNKI, Wanfang, VIP database and other websites of health technology assessment (HTA), systematic review/meta-analysis, pharmacoeconomic studies and HTA reports of apixaban in the prevention and treatment of CA-VTE were collected. After data extraction and quality evaluation, the results of the included study were analyzed descriptively. RESULTS A total of 23 literatures were included, involving 16 systematic review/meta-analysis and 7 pharmacoeconomic studies. In terms of efficacy, compared with placebo, prophylactic use of apixaban could significantly reduce the incidence of venous thromboembolism (VTE) in outpatient adult cancer patients receiving chemotherapy (P<0.05). Compared with low-molecular weight heparin (LMWH), rivaroxaban and warfarin, there were no statistically significant differences in the incidence of VTE for apixaban (P>0.05); nevertheless, apixaban was ranked as the most preferable choice. For the treatment of patients with CA-VTE, compared with warfarin, apixaban could significantly reduce the recurrence rate of VTE (P<0.05). While compared with patients treated with LMWH, rivaroxaban, edoxaban and dabigatran, there were no statistically significant differences in the recurrence rates of VTE, deep venous thrombosis and pulmonary embolism among patients using apixaban (P>0.05). In terms of safety, compared with placebo, prophylactic use of apixaban showed a higher occurrence of major bleeding in outpatient adult cancer patients receiving chemotherapy (P<0.05), while compared withpatients treated with LMWH, rivaroxaban, and warfarin, there were no statistically significant differences in the incidence of major bleeding among patients using apixaban (P>0.05); despite this, apixaban was ranked as the most favorable option. For the treatment of patients with CA-VTE, compared with dalteparin, the incidence of major bleeding and all-cause mortality of apixaban were similar (P>0.05), while the incidence of clinically relevant non-major bleeding (CRNMB) was higher (P<0.05). Compared with edoxaban, the incidence of major bleeding of apixaban was reduced significantly (P<0.05), while there was no significant difference in the incidence of CRNMB, the incidence of clinically relevant bleeding and all-cause mortality (P>0.05). Compared with rivaroxaban, warfarin and dabigatran, there were no significant differences in the incidence of major bleeding, the incidence of CRNMB, the incidence of clinically relevant bleeding and all-cause mortality (P>0.05). In terms of cost-effectiveness, the researches in China showed that apixaban was cost-effective in preventing CA-VTE; foreign studies showed that apixaban was cost-effective in preventing and treating CA-VTE. CONCLUSIONS Apixaban is effective, safe and cost- effective in the prevention and treatment of CA-VTE.
3.Quality control status and the prediction analysis of quality markers in Curculigo orchioides
Shicong WANG ; Huayu WANG ; Bo SHI ; Mingsan MIAO
China Pharmacy 2025;36(20):2604-2608
Curculigo orchioides refers to the dried rhizome of a plant from Amaryllidaceae family and exhibits a variety of pharmacological activities such as anti-osteoporosis, anti-inflammatory, anti-oxidation and immune regulation. However, the current quality control of C. orchioides mainly relies on the determination of a single indicator component (curculigoside), which makes it difficult to reflect its quality fully. At the same time, factors such as processing methods, harvesting times, and place of origins can also lead to variations in the types and contents of chemical constituents in C. orchioides. Based on the theory of quality markers (Q-markers) for traditional Chinese medicine, a predictive analysis of the Q-markers of C. orchioides was conducted from seven perspectives: plant phylogeny and specificity of chemical constituents, traditional medicinal properties, efficacy, place of origin and harvesting period, processing methods, measurability of chemical constituents, and blood-entry constituents. It is preliminarily speculated that curculigoside, sakakin, orcinol gentiobioside, curculigoside B, curlignan, β-sitosterol, actinidioionoside, 2,6-dimethoxybenzoic acid, curculigoside C, glucosyringic acid, orcinol and stigmasterol are Q-markers of C. orchioides, providing a scientific basis for establishing a comprehensive and systematic quality evaluation system for C. orchioides.
4.STAR Recommendations: A novel framework for generating recommendations.
Xu WANG ; Janne ESTILL ; Hui LIU ; Qianling SHI ; Jie ZHANG ; Shilin TANG ; Huayu ZHANG ; Xueping LI ; Zhewei LI ; Yaxuan REN ; Bingyi WANG ; Fan WANG ; Juan JUAN ; Huixia YANG ; Xiuyuan HAO ; Junmin WEI ; Yaolong CHEN
Chinese Medical Journal 2025;138(14):1643-1646
5.USP51/GRP78/ABCB1 axis confers chemoresistance through decreasing doxorubicin accumulation in triple-negative breast cancer cells.
Yang OU ; Kun ZHANG ; Qiuying SHUAI ; Chenyang WANG ; Huayu HU ; Lixia CAO ; Chunchun QI ; Min GUO ; Zhaoxian LI ; Jie SHI ; Yuxin LIU ; Siyu ZUO ; Xiao CHEN ; Yanjing WANG ; Mengdan FENG ; Hang WANG ; Peiqing SUN ; Yi SHI ; Guang YANG ; Shuang YANG
Acta Pharmaceutica Sinica B 2025;15(5):2593-2611
Recent studies have indicated that the expression of ubiquitin-specific protease 51 (USP51), a novel deubiquitinating enzyme (DUB) that mediates protein degradation as part of the ubiquitin‒proteasome system (UPS), is associated with tumor progression and therapeutic resistance in multiple malignancies. However, the underlying mechanisms and signaling networks involved in USP51-mediated regulation of malignant phenotypes remain largely unknown. The present study provides evidence of USP51's functions as the prominent DUB in chemoresistant triple-negative breast cancer (TNBC) cells. At the molecular level, ectopic expression of USP51 stabilized the 78 kDa Glucose-Regulated Protein (GRP78) protein through deubiquitination, thereby increasing its expression and localization on the cell surface. Furthermore, the upregulation of cell surface GRP78 increased the activity of ATP binding cassette subfamily B member 1 (ABCB1), the main efflux pump of doxorubicin (DOX), ultimately decreasing its accumulation in TNBC cells and promoting the development of drug resistance both in vitro and in vivo. Clinically, we found significant correlations among USP51, GRP78, and ABCB1 expression in TNBC patients with chemoresistance. Elevated USP51, GRP78, and ABCB1 levels were also strongly associated with a poor patient prognosis. Importantly, we revealed an alternative intervention for specific pharmacological targeting of USP51 for TNBC cell chemosensitization. In conclusion, these findings collectively indicate that the USP51/GRP78/ABCB1 network is a key contributor to the malignant progression and chemotherapeutic resistance of TNBC cells, underscoring the pivotal role of USP51 as a novel therapeutic target for cancer management.
6.A Standardized Approach to Recommending Diagnostic Criteria in Chinese Clinical Practice Guidelines
Qi ZHOU ; Qinyuan LI ; Hongfeng HE ; Dongrui PENG ; Huayu ZHANG ; Ye WANG ; Kehu YANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2024;15(6):1432-1438
Diagnostic criteria, as a critical component of clinical practice guidelines, play a direct role in guiding clinicians' diagnostic and treatment decisions. Although China has increasingly emphasized the development and updating of clinical guidelines in recent years, research focusing on the diagnostic criteria within these guidelines remains limited. This paper aims to explore the types of diagnostic criteria, the issues they present, and the processes involved in their formulation. Based on this analysis, suggestions are proposed to improve the recommendation and application of diagnostic criteria in Chinese guidelines.
7.Analysis of the Current Status of China's Adaptation Guidelines
Ling WANG ; Yaxuan REN ; Xufei LUO ; Di ZHU ; Zhewei LI ; Ye WANG ; Bingyi WANG ; Huayu ZHANG ; Shu YANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2024;15(1):192-201
8.Improvement and application of culture method for hemorrhagic amniotic fluid cells
Daoqi HUANG ; Huayu TU ; Keting TONG ; Chaohong WANG ; Jiansheng ZHU
Chinese Journal of Clinical Laboratory Science 2024;42(2):90-92
Objective To compare the success rates of different culture methods for hemorrhagic amniotic fluid.Methods Thirty-one hemorrhagic amniotic fluid samples from pregnant women who were subjected to chromosomal examination at Anhui Maternal and Child Health Hospital were collected from January 2021 to December 2022.Two culture methods,the slide in situ culture box method(re-ferred to as the slide method)and the plastic bottle culture combined with slide in situ culture box method(referred to as the combined culture method),were used for cell cultivation.All the cells were harvested and stained with Giemsa staining,then the number of eligi-ble karyotype was counted and the success rates were compared between the two methods.Results Among the 31 cases of the slide method,21 were successfully cultured with a success rate of 67.7%.For the combined culture method,all the 31 cases were success-fully cultured with a success rate of 100%.The success rate of the combined culture method was significantly higher than that of the slide method(P<0.05).Of 31 bloody amniotic fluid samples,three cases were fresh bleeding,and an average number of eligible kary-otype was 8 in the slide method and 32 in the combined culture method.Twenty-eight cases were old bleeding,and an average number of eligible karyotype was 13 in the slide method and 53 in the combined culture method.The number of eligible karyotype in the com-bined culture method was significantly higher than that of the slide method(P<0.05).Conclusion The combined culture method is suitable for the cultivation of hemorrhagic amniotic fluid samples,and should be worthy of promotion in the clinics.
9.A Standardized Approach to Recommending Diagnostic Criteria in Chinese Clinical Practice Guidelines
Qi ZHOU ; Qinyuan LI ; Hongfeng HE ; Dongrui PENG ; Huayu ZHANG ; Ye WANG ; Kehu YANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2024;15(6):1432-1438
Diagnostic criteria, as a critical component of clinical practice guidelines, play a direct role in guiding clinicians' diagnostic and treatment decisions. Although China has increasingly emphasized the development and updating of clinical guidelines in recent years, research focusing on the diagnostic criteria within these guidelines remains limited. This paper aims to explore the types of diagnostic criteria, the issues they present, and the processes involved in their formulation. Based on this analysis, suggestions are proposed to improve the recommendation and application of diagnostic criteria in Chinese guidelines.
10.Establishment and efficiency test of a clinical prediction model of bronchopulmonary dysplasia associated pulmonary hypertension in very premature infants
Jingke CAO ; Haoqin FAN ; Yunbin XIAO ; Dan WANG ; Changgen LIU ; Xiaoming PENG ; Xirong GAO ; Shanghong TANG ; Tao HAN ; Yabo MEI ; Huayu LIANG ; Shumei WANG ; Feng WANG ; Qiuping LI
Chinese Journal of Pediatrics 2024;62(2):129-137
Objective:To develop a risk prediction model for identifying bronchopulmonary dysplasia (BPD) associated pulmonary hypertension (PH) in very premature infants.Methods:This was a retrospective cohort study. The clinical data of 626 very premature infants whose gestational age <32 weeks and who suffered from BPD were collected from October 1 st, 2015 to December 31 st, 2021 of the Seventh Medical Center of the People′s Liberation Army General Hospital as a modeling set. The clinical data of 229 very premature infants with BPD of Hunan Children′s Hospital from January 1 st, 2020 to December 31 st, 2021 were collected as a validation set for external verification. The very premature infants with BPD were divided into PH group and non PH group based on the echocardiogram after 36 weeks′ corrected age in the modeling set and validation set, respectively. Univariate analysis was used to compare the basic clinical characteristics between groups, and collinearity exclusion was carried out between variables. The risk factors of BPD associated PH were further screened out by multivariate Logistic regression, and the risk assessment model was established based on these variables. The receiver operating characteristic (ROC) area under curve (AUC) and Hosmer-Lemeshow goodness-of-fit test were used to evaluate the model′s discrimination and calibration power, respectively. And the calibration curve was used to evaluate the accuracy of the model and draw the nomogram. The bootstrap repeated sampling method was used for internal verification. Finally, decision curve analysis (DCA) to evaluate the clinical practicability of the model was used. Results:A total of 626 very premature infants with BPD were included for modeling set, including 85 very premature infants in the PH group and 541 very premature infants in the non PH group. A total of 229 very premature infants with BPD were included for validation set, including 24 very premature infants in the PH group and 205 very premature infants in the non PH group. Univariate analysis of the modeling set found that 22 variables, such as artificial conception, fetal distress, gestational age, birth weight, small for gestational age, 1 minute Apgar score ≤7, antenatal corticosteroids, placental abruption, oligohydramnios, multiple pulmonary surfactant, neonatal respiratory distress syndrome (NRDS)>stage Ⅱ, early pulmonary hypertension, moderate-severe BPD, and hemodynamically significant patent ductus arteriosus (hsPDA) all had statistically significant influence between the PH group and the non PH group (all P<0.05). Antenatal corticosteroids, fetal distress, NRDS >stage Ⅱ, hsPDA, pneumonia and days of invasive mechanical ventilation were identified as predictive variables and finally included to establish the Logistic regression model. The AUC of this model was 0.86 (95% CI 0.82-0.90), the cut-off value was 0.17, the sensitivity was 0.77, and the specificity was 0.84. Hosmer-Lemeshow goodness-of-fit test showed that P>0.05. The AUC for external validation was 0.88, and the Hosmer-Lemeshow goodness-of-fit test suggested P>0.05. Conclusions:A high sensitivity and specificity risk prediction model of PBD associated PH in very premature infants was established. This predictive model is useful for early clinical identification of infants at high risk of BPD associated PH.

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