1.Rapid health technology assessment of efficacy,safety and cost-effectiveness of vonoprazan in the treatment of gastroesophageal reflux disease
Shuan WANG ; Can HUANG ; Lamei QI
China Pharmacy 2025;36(7):794-800
OBJECTIVE To evaluate the efficacy, safety and cost-effectiveness of vonoprazan (VPZ) in the treatment of gastroesophageal reflux disease (GERD) by rapid health technology assessment, and provide evidence for clinical decision-making. METHODS English and Chinese databases including PubMed, Medline, Cochrane Library, CNKI, VIP, and Wanfang data as well as the official websites of domestic and international health technology assessment agencies were searched by computer from the database establishment to August 2024. After literature screening, data extraction and quality evaluation of included studies were conducted by two researchers, the results were described and analyzed qualitatively. RESULTS A total of 21 pieces of literature were included, involving 15 systematic reviews/meta-analyses and 6 pharmacoeconomic studies. In terms of efficacy, compared with the control regimen (different doses of VPZ, placebo, other positive controls or combination therapy), VPZ (mainly 20 mg/d VPZ) significantly improved the total response rate, mucosal healing rate at 2nd week, symptom remission rate, and maintenance rate at 12th and 24th week after mucosal healing (P<0.05); when the endoscopic Los Angeles classification was C/D, the effective rate of VPZ was significantly higher than that of the control regimen (P<0.05). In terms of safety, there was no significant difference in the incidence of adverse events between VPZ and the control regimen for GERD treatment (P>0.05), but the risk of elevated serum gastrin and abnormal liver function caused by long-term use of VPZ was higher than that of the control regimen (P<0.05). In terms of cost-effectiveness, compared with rabeprazole, lansoprazole and esomeprazole, VPZ had a cost- effectiveness/cost-utility advantage. CONCLUSIONS VPZ is effective, safe and cost-effective in the treatment of GERD.
2.Stratified mucin-producing epithelial neoplastic lesions of the cervix: clinicohistologic and molecular pathological characteristics
LIU Yaling ; HUANG Xian ; WANG Fei ; HU Quanquan ; XUAN Lanlan
Chinese Journal of Cancer Biotherapy 2025;32(3):301-308
[摘 要] 目的:探究浸润性复层产生黏液的复层上皮癌(ISMC)的临床组织及分子病理特征。方法: 回顾性分析2018年1月至2024年4月间安徽医科大学安庆医学中心/安庆市立医院及皖南医学院第一附属医院/弋矶山医院的病理数据库的11例ISMC和4例产生黏液的复层上皮内病变(SMILE)的临床病理资料、免疫组化、阿利新蓝(AB)/过碘酸雪夫(PAS)染色、分子学检测及PD-L1表达情况。结果:ISMC患者多表现为阴道不规则流血。细胞质内含有黏液的细胞呈复层排列,周围呈栅栏状,肿瘤细胞可呈印戒样或胞质透明。ISMC不仅存在单纯型,也可呈混合型。ISMC具有高侵袭性的生物学特性。CK7、p16,p40和(或)p63表达呈癌巢周栅栏状阳性或局灶表达。AB/PAS染色阳性。人乳头状病毒(HPV)检测结果:ISMC中HPV16/18阳性(1/4),术前检测出HPV16/18阳性(4/6);SMILE组织中HPV阴性。ISMC均表达PD-L1。成功随访8例ISMC患者,时间4~39个月(平均20.50月),4例SMILE患者,时间1~25个月(平均8.25月),随访患者均存活,1例ISMC术后出现多脏器转移。结论:ISMC具有独特的形态学特征及免疫表型,表现为高侵袭性和不良预后。所有ISMC均呈PD-L1阳性,提示所有患者均可从PD-L1免疫治疗中获益。
3.Construction and application of the criteria for drug utilization evaluation of low-dose rivaroxaban in atherosclerotic cardiovascular disease
Liang WU ; Wei WANG ; Yanghui XU ; Bo ZHU ; Yijun KE
China Pharmacy 2025;36(17):2176-2181
OBJECTIVE To construct and apply drug utilization evaluation (DUE) criteria for low-dose rivaroxaban in atherosclerotic cardiovascular disease (ASCVD) based on the dual pathway inhibition (DPI) antithrombotic therapy scheme, to promote clinical rational drug use. METHODS Based on the instructions and relevant guidelines of low-dose rivaroxaban (2.5 mg, bid), the Delphi method was used to establish the DUE criteria for low-dose rivaroxaban used in ASCVD. Weighted technique for order preference by similarity to an ideal solution method was used to determine the relative weights of each evaluation index, and the rationality of the filing medical records of discharged patients using low-dose rivaroxaban for ASCVD at Anqing Municipal Hospital from February 2024 to January 2025 was evaluated. RESULTS The established DUE criteria included 3 primary indicators (medication indications, medication process, medication results) and 11 secondary indicators (such as indications, contraindications, etc.). The higher weighted secondary indicators being contraindications (0.117 9) and indications (0.112 1). A total of 265 medical records were included for evaluation. The evaluation results showed that 192 cases (72.45%) had reasonable medical records, 69 cases (26.04%) had basic reasonable medical records, and 4 cases (1.51%) had unreasonable medical records; unreasonable types mainly included inappropriate combination therapy, inappropriate usage and dosage, inappropriate post- medication monitoring, and inappropriate drug switching, etc. CONCLUSIONS This study establishes a DUE criteria for low-dose rivaroxaban in ASCVD based on the DPI antithrombotic treatment regimen, and the evaluation results are intuitive, reliable, and quantifiable. The use of low-dose rivaroxaban in ASCVD patients in our hospital is relatively reasonable, but further management needs to be strengthened.
4.Rapid health technology assessment of the efficacy,safety and cost-effectiveness of vericiguat in the treatment of heart failure
Yijun KE ; Wei WANG ; Can HUANG ; Yong JIN ; Lamei QI
China Pharmacy 2024;35(15):1818-1824
OBJECTIVE To evaluate the efficacy, safety and cost-effectiveness of vericiguat in the treatment of heart failure (HF) by rapid health technology evaluation method, and provide reference for the selection and decision-making of clinical treatment plans. METHODS Chinese and foreign databases such as CNKI, PubMed and related health technology evaluation websites were searched by computer. Relevant researchers independently screened literature, extracted data, and comprehensively analyzed the results of the included literature based on literature quality evaluation. RESULTS A total of 17 pieces of literature were included, involving 12 systematic reviews/meta-analyses and 5 pharmacoeconomic studies. The effectiveness analysis showed: for HF patients, compared with placebo, vericiguat (10 mg/d) significantly improved the EuroQol five dimensions questionnaire (EQ-5D) index and decreased the rate of hospitalization due to HF (P<0.05). For heart failure with reduced ejection fraction (HFrEF) patients, vericiguat reduced the incidence of hospitalization due to HF compared with sodium-glucose cotransporter 2 inhibitor (SGLT2i)(P<0.05); compared with angiotensin-converting enzyme inhibitor, vericiguat significantly reduced the occurrence risk of composite endpoints of cardiovascular death or hospitalization due to HF(P<0.05). For HFrEF patients with chronic kidney disease, vericiguat had a tendency to reduce the occurrence risk of composite endpoints of cardiovascular death or hospitalization due to HF compared with neurohormone inhibitors. Safety analysis showed: vericiguat did not increase drug-related adverse reactions compared to placebo (P>0.05). Economic analysis showed: domestic studies indicated that vericiguat had a higher incremental cost-effectiveness ratio. CONCLUSIONS Vericiguat has good safety and efficacy in the treatment of HF but does not possess an economic advantage in the Chinese population.
5.Palliative surgery versus simple medication therapy for secondary non-ischemic mitral regurgitation: A retrospective cohort study
Yiwei XU ; Mi ZHOU ; Jiaxi ZHU ; Lei KANG ; Xiaofeng YE ; Jiapei QIU ; Haiqing LI ; Zhe WANG ; Anqing CHEN ; Qiang ZHAO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(07):1000-1006
Objective To compare the effect of palliative mitral valve surgeries and medication therapies for secondary non-ischemic mitral regurgitation. Methods The clinical data of patients with non-ischemic functional mitral regurgitation treated in our hospital between 2009 and 2019 were retrospectively analyzed. Patients with a left ventricular ejection fraction (LVEF)<40% underwent a dobutamine stress test, and a positive result was determined when the LVEF improved by more than 15% compared to the baseline value. Positive patients were divided into a surgery group and a medication group. The surgery group underwent surgical mitral valve repair or replacement, while the medication group received simple medication treatment. Follow-up on survival and cardiac function status through outpatient or telephone visits every six months after surgery, and patients underwent cardiac ultrasound examination one year after surgery. The main research endpoint was a composite endpoint of all-cause death, heart failure readmission, and heart transplantation, and the differences in cardiac function and cardiac ultrasound parameters between the two groups were compared. Results Ultimately 41 patients were collected, including 28 males and 13 females with an average age of 55.5±11.1 years. Twenty-five patients were in the surgery group and sixteen patients in the medication group. The median follow-up time was 16 months, ranging 1-96 months. The occurrence of all-cause death in the surgery group was lower than that in the medication group (HR=0.124, 95%CI 0.024-0.641, P=0.034). The difference between the two groups was not statistically significant in the composite endpoint (HR=0.499, 95%CI 0.523-1.631, P=0.229). The New York Heart Association (NYHA) grade of the surgery group was better (NYHA Ⅰ-Ⅱ accounted for 68.0% in the surgury group and 18.8% in the medication group, P<0.01) as well as the grade of mitral valve regurgitation (87.5% of the patients in the medication group had moderate or above regurgitation at follow-up, while all the patients in the surgery group had moderate below regurgitation, P<0.01). There was no statistical difference in preoperative and follow-up changes in echocardiograph parameters between the two groups (P>0.05). Conclusion For non-ischemic functional mitral regurgitation, if the cardiac systolic function is well reserved, mitral valve surgery can improve survival and quality of life compare to simple medication therapy.
6.Study on the chemical constituents of triterpenoids in Patrinia villosa Juss.
Qi-guo WU ; Le-yi HUANG ; Zhi CHEN ; Dong-feng LIU ; Yong-li WANG ; Gui-xin CHOU
Acta Pharmaceutica Sinica 2024;59(4):1005-1009
Seven triterpenoids were isolated and purified from the 95% aqueous EtOH extract whole plants of
7.Study on the influencing factors and risk prediction model for proteinuria in patients with malignant tumors induced by apatinib
Can HUANG ; Shuan WANG ; Jun MA ; Yan GUO ; Lamei QI
China Pharmacy 2024;35(22):2779-2783
OBJECTIVE To study the influencing factors for proteinuria in patients with malignant tumors treated with apatinib, then establish and evaluate a risk prediction model based on it. METHODS A total of 120 patients with malignant tumors treated with apatinib in our hospital from January 2020 to December 2022 were selected as the training set, and the clinical data was collected. Univariate analysis and multivariate Logistic regression analysis were used to identify independent risk factors for proteinuria associated with apatinib and then construct a risk prediction model. The predictive value of the model was evaluated by using the receiver operator characteristic (ROC) curve. A total of 34 patients with malignant tumors treated with apatinib from January to December 2023 in our hospital were selected as the validation set, and their clinical data were obtained to cross-validate the accuracy of the prediction model. RESULTS The incidence of proteinuria in the training set of 120 patients was 26.67%. The proportions of patients with smoking history, combined hypertension, apatinib daily dose of ≥500 mg, and alanine aminotransferase level were significantly higher in proteinuria group than those in non-proteinuria group. At the same time,the neutrophilic granulocyte count was significantly lower than that in non-proteinuria group (P<0.05). Patients with smoking history and combined hypertension were the independent risk factors for apatinib-induced proteinuria (odds ratios were 5.005 and 5.342, respectively; with 95% confidence intervals of 1.806- 13.872 and 1.227-9.602, respectively; P<0.05). The binary Logistic regression model equation for the probability (P) of apatinib- induced proteinuria is expressed as LogitP=1.610XMH+1.233XSH-1.483 (MH for combined hypertension, SH for the smoking history), with a model accuracy of 80.0%. ROC curve analysis demonstrated the area under the ROC curve of 0.771, the maximum Youden’s index of 0.474, and the optimal cut-off value for LogitP was 0.159 9, with a sensitivity of 90.6% and specificity of 56.8%. Cross-validation results indicated an overall prediction accuracy of 88.24% for the 34 patients. CONCLUSIONS Combined hypertension and smoking history are independent risk factors for apatinib-induced proteinuria. The constructed risk prediction model has moderate predictive value and can be used to predict the risk of proteinuria in patients with malignant tumors induced by apatinib.
8.Effects of Compound Danshen Dripping Pills on Ventricular Remodeling and Cardiac Function after Acute Anterior Wall ST-Segment Elevation Myocardial Infarction (CODE-AAMI): Protocol for a Randomized Placebo-Controlled Trial.
Yu-Jie WU ; Bo DENG ; Si-Bo WANG ; Rui QIAO ; Xi-Wen ZHANG ; Yuan LU ; Li WANG ; Shun-Zhong GU ; Yu-Qing ZHANG ; Kai-Qiao LI ; Zong-Liang YU ; Li-Xing WU ; Sheng-Biao ZHAO ; Shuang-Lin ZHOU ; Yang YANG ; Lian-Sheng WANG
Chinese journal of integrative medicine 2023;29(12):1059-1065
BACKGROUND:
Ventricular remodeling after acute anterior wall ST-segment elevation myocardial infarction (AAMI) is an important factor in occurrence of heart failure which additionally results in poor prognosis. Therefore, the treatment of ventricular remodeling needs to be further optimized. Compound Danshen Dripping Pills (CDDP), a traditional Chinese medicine, exerts a protective effect on microcirculatory disturbance caused by ischemia-reperfusion injury and attenuates ventricular remodeling after myocardial infarction.
OBJECTIVE:
This study is designed to evaluate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function after AAMI on a larger scale.
METHODS:
This study is a multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The total of 268 patients with AAMI after primary percutaneous coronary intervention (pPCI) will be randomly assigned 1:1 to the CDDP group (n=134) and control group (n=134) with a follow-up of 48 weeks. Both groups will be treated with standard therapy of ST-segment elevation myocardial infarction (STEMI), with the CDDP group administrating 20 tablets of CDDP before pPCI and 10 tablets 3 times daily after pPCI, and the control group treated with a placebo simultaneously. The primary endpoint is 48-week echocardiographic outcomes including left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume index (LVEDVI), and left ventricular end-systolic volume index (LVESVI). The secondary endpoint includes the change in N terminal pro-B-type natriuretic peptide (NT-proBNP) level, arrhythmias, and cardiovascular events (death, cardiac arrest, or cardiopulmonary resuscitation, rehospitalization due to heart failure or angina pectoris, deterioration of cardiac function, and stroke). Investigators and patients are both blinded to the allocated treatment.
DISCUSSION
This prospective study will investigate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function in patients undergoing pPCI for a first AAMI. Patients in the CDDP group will be compared with those in the control group. If certified to be effective, CDDP treatment in AAMI will probably be advised on a larger scale. (Trial registration No. NCT05000411).
Humans
;
ST Elevation Myocardial Infarction/therapy*
;
Stroke Volume
;
Ventricular Remodeling
;
Prospective Studies
;
Microcirculation
;
Ventricular Function, Left
;
Myocardial Infarction/etiology*
;
Treatment Outcome
;
Percutaneous Coronary Intervention/adverse effects*
;
Heart Failure/drug therapy*
;
Drugs, Chinese Herbal/therapeutic use*
;
Randomized Controlled Trials as Topic
;
Multicenter Studies as Topic
9. Treatment advice of small molecule antiviral drugs for elderly COVID-19
Min PAN ; Shuang CHANG ; Xiao-Xia FENG ; Guang-He FEI ; Jia-Bin LI ; Hua WANG ; Du-Juan XU ; Chang-Hui WANG ; Yan SUN ; Xiao-Yun FAN ; Tian-Jing ZHANG ; Wei WEI ; Ling-Ling ZHANG ; Jim LI ; Fei-Hu CHEN ; Xiao-Ming MENG ; Hong-Mei ZHAO ; Min DAI ; Yi XIANG ; Meng-Shu CAO ; Xiao-Yang CHEN ; Xian-Wei YE ; Xiao-Wen HU ; Ling JIANG ; Yong-Zhong WANG ; Hao LIU ; Hai-Tang XIE ; Ping FANG ; Zhen-Dong QIAN ; Chao TANG ; Gang YANG ; Xiao-Bao TENG ; Chao-Xia QIAN ; Guo-Zheng DING
Chinese Pharmacological Bulletin 2023;39(3):425-430
COVID-19 has been prevalent for three years. The virulence of SARS-CoV-2 is weaken as it mutates continuously. However, elderly patients, especially those with underlying diseases, are still at high risk of developing severe infections. With the continuous study of the molecular structure and pathogenic mechanism of SARS-CoV-2, antiviral drugs for COVID-19 have been successively marketed, and these anti-SARS-CoV-2 drugs can effectively reduce the severe rate and mortality of elderly patients. This article reviews the mechanism, clinical medication regimens, drug interactions and adverse reactions of five small molecule antiviral drugs currently approved for marketing in China, so as to provide advice for the clinical rational use of anti-SARS-CoV-2 in the elderly.
10.Surveillance and analysis of avian influenza viruses in the external environment of poultry in Anqing City, Anhui Province
Zhaochun WU ; Xu HUANG ; Jinsheng WANG ; Yezhong QIAN ; Jin WANG ; Jiwen CHEN ; Yuxin LI
Shanghai Journal of Preventive Medicine 2023;35(11):1058-1062
ObjectiveTo determine the prevalence of avian influenza viruses in the external environment of poultry in Anqing City, Anhui Province, and provide scientific evidence for prevention and control of animal-derived influenza in humans. MethodsA total of 28 farmers’ markets/farms in 10 counties (cities, districts) of Anqing City, Anhui Province, were selected as surveillance sites by simple random sampling strategy. Poultry faeces and other related samples were collected for 6 consecutive weeks. Real-time fluorescence quantitative PCR was used to examine the nucleic acids of influenza A virus. Subtypes H5, H7, and H9 of avian influenza virus were further tested in the positive samples. ResultsA total of 426 specimens were collected, among which 113 tested positive with a positive rate of 26.53%. Among the positive specimens, 104 were determined to be subtype H9, accounting for 92.04%. It did not significantly differ in the positive rate between the main and non-main urban areas (χ2<0.01, P>0.05) or among the specimens collected in different weeks (χ2=7.57, P>0.05). However, it significantly differed in the positive rate among the specimens collected in the third week and other weeks (χ2=6.89, P<0.05). Furthermore, among the different sampling sites, farms had the highest positive rate of 46.67%. Among the specimens from different sources, the surface-coated specimens from poultry cages had the highest positive rate of 34.78%. ConclusionAvian influenza viruses are prevalent in the external environment of poultry in Anqing City. It warrants strengthening the surveillance and risk assessment to reduce the virus transmission in the external environment and risk of human infection with animal-derived influenza.

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