1.Immune checkpoint inhibitors combined with neoadjuvant chemotherapy and adjuvant chemotherapy in the treatment of early-stage triple-negative breast cancer:a meta-analysis
Chunyan YANG ; Shaohua ZHANG ; Rongkang LI ; Lei PENG ; Li ZHAO ; Jun BIE
China Pharmacy 2025;36(18):2322-2327
OBJECTIVE To evaluate the efficacy and safety of immune checkpoint inhibitors combined with neoadjuvant chemotherapy and adjuvant chemotherapy in the treatment of early-stage triple-negative breast cancer (TNBC). METHODS A systematic search was conducted in PubMed, Embase, Cochrane Library, CNKI, and Wanfang Data to collect randomized controlled trials (RCT) on the use of immune checkpoint inhibitors combined with neoadjuvant chemotherapy and adjuvant chemotherapy (experimental group) versus neoadjuvant chemotherapy and adjuvant chemotherapy (control group) in the treatment of TNBC. After literature screening, data extraction and literature quality evaluation, meta-analysis was performed using Stata 17.0. RESULTS A total of 5 RCT involving 1 498 patients were included. The meta-analysis results showed that the pathological complete response rate (pCR) [RR=1.34, 95%CI (1.09, 1.63), P=0.03], pCR in patients with positive programmed death-1 (PD-1) and its ligand (PD-L1) [RR=1.33, 95%CI (1.16, 1.51), P=0.01], pCR in patients with positive lymph nodes [RR= 1.56, 95%CI (1.27, 1.93), P=0.01], the incidence of grade 3-4 adverse events (AEs) [RR=1.07, 95%CI (1.01, 1.14), P= 0.04], the incidence of serious AEs [RR=1.57, 95%CI (1.31, 1.87), P=0.03], and the incidence of treatment discontinuation due to AEs [RR=1.45, 95%CI (1.19, 1.76), P=0.01] were significantly higher in the experimental group than control group. There were no statistically significant difference in pCR in patients with negative PD-1/PD-L1[RR= E-mail:biejun23@126.com 1.26, 95%CI (0.98, 1.62), P=0.08] and pCR in patients with negative lymph nodes [RR=1.14, 95%CI (0.97, 1.33), P=0.17] between the two groups. CONCLUSIONS Immune checkpoint inhibitors combined with neoadjuvant chemotherapy and adjuvant chemotherapy demonstrates significant efficacy in early-stage TNBC patients, with more pronounced benefits observed in those who are PD-1/PD-L1 positive and lymph node- positive. However, the incidence of AEs is relatively high.
2.Pharmacoeconomic evaluation of glucagon-like peptide-1 receptor agonist combined with metformin in the treatment of type 2 diabetes mellitus
Tian YU ; Shaohua LIU ; Anhua WEI ; Jieru GUO ; Chengliang ZHANG ; Dong LIU ; Zhelong LIU
Chinese Journal of Pharmacoepidemiology 2024;33(4):388-401
Objective To evaluate the economic value of using glucagon-like peptide-1 receptor agonist(GLP-1RA)in combination with metformin for the treatment of type 2 diabetes mellitus(T2DM).Methods Based on 7 randomized controlled clinical trials(RCTs),Markov model was built to simulate the dynamic changes of metformin alone or combined with GLP-1RA in the treatment of T2DM patients without or with complications and death from the perspective of China's health system.Quality-adjusted life years(QALYs)was used as a health output indicator and 3 times China's per capita gross domestic product(GDP)in 2023 was set as the willingness-to-pay(WTP)threshold.The cycle was at the rate of 1 year and a total of 20 years cohort simulation in Markov model was applied to obtain long-term cost and effect of each treatment strategy.The incremental cost-utility ratio(ICUR)was analyzed as the primary evaluation indicator and the sensitivity of cost,utility and discount was performed to test the stability of the results.Results Compared with metformin alone,the ICUR of GLP-1RA including liraglutide,dulaglutide,exenatide,loxenatide,semaglutide combined with metformin were all below the WTP threshold,and the increased cost was acceptable.Extending the simulation time to 30 years or 50 years had no effect on results.The results of probability sensitivity analysis showed that the cost effect of semaglutide 0.5 mg combined with metformin had the highest probability of a cost-utility advantage of 99.7%among all the treatment strategies when WTP threshold was 3 times China's per capita GDP in 2023(268 074 yuan).Conclusion GLP-1RA,including liraglutide,dulaglutide,exenatide,lixisenatide,and semaglutide,at the regular recommended dose combined with metformin,would present higher cost-utility compared to metformin monotherapy.
3.Efficacy and safety of glucagon-like peptide 1 receptor agonists in the treatment of overweight or obese patients with type 2 diabetes:a Meta-analysis
Tian YU ; Shaohua LIU ; Anhua WEI ; Jieru GUO ; Chengliang ZHANG ; Dong LIU ; Zhelong LIU
Chinese Journal of Pharmacoepidemiology 2024;33(5):519-538
Objective To evaluate the efficacy and safety of glucagon-like peptide 1 receptor agonists(GLP-1RA)in type 2 diabetes mellitus(T2DM)patients with overweight or obese.Methods PubMed,Embase,Cochrane Library,Ovid,ClinicalTrial.gov,SinoMed,CNKI,WanFang Data and VIP databases were electronically searched to collect randomized controlled trials(RCTs)on the efficacy of GLP-1RA in the treatment of T2DM patients with overweight or obese from January 1,2005 to November 1,2023.Two researchers independently screened the literature,extracted data and evaluated the risk of bias of the included studies.R software was then used for meta-analysis.The level of evidence was assessed by using the GRADE system.Results A total of 71 RCTs were included,including 29 476 patients.The results of Meta-analysis showed that compared with other hypoglycemic drugs,GLP-1RA showed superior effects in improving HbAlc status(WMD=-0.55,95%CI-0.65 to-0.45,P<0.001)and weight loss(WMD=-2.61,95%CI-3.25 to-1.97,P<0.001),while the effect on fasting plasm glucose was time-dependent(within 16 weeks:WMD=0.25,95%CI-0.17 to 0.66,P=0.250;16 to 52 weeks:WMD=-0.06,95%CI-0.32 to 0.20,P=0.650;over 52 to 104 weeks:WMD=-1.67,95%CI-1.91 to-1.43,P<0.001).In terms of safety,the incidence of GLP-1RA's adverse reactions was higher than other hypoglycemic drugs(RR=1.11,95%CI 1.07 to 1.15,P<0.001);the incidence of hypoglycemia was lower with GLP-1RA than with insulin(RR=0.58,95%CI 0.48 to 0.71,P<0.001)and similar to oral hypoglycemic drugs(RR=0.83,95%CI 0.58 to 1.19,P=0.310).According to the GRADE assessment,only the certainty of the evidence for the results of the incidence of hypoglycemia was moderate,and the certainty of the evidence for the other results was low.Conclusion Current evidence shows that for T2DM patients with overweight or obese,GLP-1RA especially semaglutide,was more effective in lowering blood glucose,controlling body weight and reducing the occurrence of hypoglycemia than placebo,insulin and oral hypoglycemic drugs.
4.Relationship between Vitamin D receptor gene polymorphism and genetic susceptibility in gestational diabetes mellitus
Chinese Journal of Diabetes 2024;32(6):427-431
Objective To explore the relationship between vitamin D receptor(VDR)gene polymorphisms and genetic susceptibility in gestational diabetes mellitus(GDM).Methods A total of 240 patients with GDM who were hospitalized in the Obstetrics and Gynecology Department of Wuhan Yaxin General Hospital were enrolled in this study from January 2019 to January 2022(GDM group),and another 240 healthy pregnant women matched were selected as normal control(NC)group during the same period.The general information,FPG,HbA1c,2 hour postprandial blood glucose(2 hPG),insulin resistance index(HOMA-IR),serum 25 hydroxyvitamin D[25(OH)D]level,and VDR gene polymorphisms were compared between the two groups.The correlation between HOMA-IR and 25(OH)D levels was evaluated by Pearson analysis.The influencing factors for GDM genetic susceptibility were analyzed by logistic regression model.The pregnancy outcomes of GDM patients were analyzed by follow-up to the end of pregnancy.Results The prevalence of DM family history,FPG,2 hPG,HbA1c and HOMA-IR were higher(P<0.05),whilethe serum 25(OH)D was lower in GDM group than in NC group(P<0.05).There was significant difference in the distribution of genotype and allele frequency of FokI locus of VDR gene between the two groups(P<0.05).Pearson correlation analysis showed that serum 25(OH)D was negatively correlated with FPG,2 hPG,HbA1c and HOMA-IR(P<0.05).Logistic regression analysis showed that DM family history,VDR gene FokI genotype GA and AA were the influencing factors for GDM genetic susceptibility.The incidence of adverse pregnancy outcome was higher in patients with FokI AA genotype than in patients with GA and GG genotypes(P<0.05).The incidence of adverse pregnancy outcome was higher in patients with GA genotype than in patients with GG genotype(P<0.05).Conclusions The VDR gene FokI locus gene polymorphism is associated with the genetic susceptibility to GDM,and its GA and AA genotypes both increase the risk of GDM susceptibility and the incidence of adverse pregnancy outcomes.
5.A Meta-analysis of the Efficacy of Transcatheter Versus Surgical Aortic Valve Replacement Combined With Coronary Artery Revascularization in Patients With Intermediate or High Risk Severe Aortic Stenosis and Coronary Artery Disease
Xiangyu ZHANG ; Wei GENG ; Mengyu LI ; Shaohua YAN ; Qiumei LIU ; Chenfeng ZHANG
Chinese Circulation Journal 2024;39(5):464-469
Objectives:To compare the efficacy of transcatheter aortic valve replacement(TAVR)combined with percutaneous coronary intervention(PCI)versus surgical aortic valve replacement(SAVR)combined with coronary artery bypass grafting(CABG)in patients with intermediate or high risk severe aortic stenosis(AS)and coronary artery disease(CAD). Methods:Embase,Medline,the Cochrane Library,PubMed,VIP,Wanfang Database,CNKI were searched for studies comparing the efficacy of TAVR combined with PCI and SAVR combined with CABG in patients with intermediate or high risk severe aortic stenosis complicated with CAD,from the establishment of the database to July 4,2023. Results:Six studies were included,including one randomized controlled study and five observational cohort studies.A total of 2 137 patients were enrolled,including 833 in the TAVR+PCI group and 1 304 in the SAVR+CABG group.The results of the meta-analysis showed that compared with SAVR+CABG,TAVR+PCI did not significantly increase the risk of myocardial infarction(OR=0.65,95%CI:0.28-1.46,P=0.29),stroke(OR=0.81,95%CI:0.45-1.48,P=0.50)within 30 days and the risk of acute kidney injury(OR=0.38,95%CI:0.14-1.02,P=0.05),major bleeding(OR=0.66,95%CI:0.22-2.00,P=0.47)during follow-up,and significantly reduced all-cause mortality within 30 days(OR=0.66,95%CI:0.44-0.99,P=0.04),but significantly increased all-cause mortality(OR=1.47,95%CI:1.12-1.93,P=0.005)and vascular complications(OR=11.48,95%CI:2.69-48.94,P=0.001),pacemaker implantation(OR=3.09,95%CI:1.68-5.68,P<0.001)during long-term(≥2 years)follow-up. Conclusions:In patients with intermediate or high risk severe AS and CAD,compared with SAVR+CABG,TAVR+PCI significantly reduced the risk of all-cause mortality within 30 days,but significantly increased the risk of all-cause mortality,vascular complications,and pacemaker implantation during long-term follow-up.
6.Development and validation of an Assessment Scale of Proactive Health Behavior Ability for the Disabled Elderly in Nursing Homes
Yangli OU ; Xiaoyan LIAO ; Ying PENG ; Hong ZHANG ; Shaohua YIN ; Liyu CHEN ; Xue XIONG ; Xiuli YU ; Lifang TONG ; Yan XIE ; Dan HUO ; Jun SHEN
Chinese Journal of Nursing 2024;59(21):2579-2586
Objective To develop the assessment scale of proactive health behavior ability for the disabled elderly in nursing homes and to test its reliability and validity.Methods The first draft of the scale was formed by literature review,qualitative interviews and Delphi method.From December 2023 to March 2024,525 disabled elderly people from 9 nursing homes in Sichuan Province and Chongqing City were selected as the survey subjects,and item analysis and reliability and validity test were carried out on the scale.30 disabled elderly people were re-investigated after 2 weeks to calculate the retest reliability of the scale.Results The scale consisted of 4 dimensions and 27 items.Exploratory factor analysis extracted 4 common factors,with the cumulative vanance contribution rate of 65.992%,and confirmatory factor analysis showed that the modified model fitting index was within acceptable range.The content validity index at item level was 0.917-1.000,and that at scale level was 0.997.The Cronbach's α coefficient,test-retest reliability and split-half reliability of the total scale were 0.944,0.997 and 0.882,respectively.Conclusion The scale has good reliability and validity,and it can be used to evaluate the proactive health behavior ability of the disabled elderly in nursing homes.
7.Progress of nuclide targeted α-particle therapy for blood tumors
Shanqi HUO ; Jin WANG ; Bei ZHANG ; Kai CAO ; Shaohua SUN ; Cheng CHEN ; Chunyan LIU ; Shicang SU
Chinese Journal of Nuclear Medicine and Molecular Imaging 2024;44(9):564-568
The incidence of blood tumors is getting higher and higher. In addition to traditional chemoradiotherapy, in recent years, with the development of nuclear medicine technology and nuclide, nuclide therapy is playing an increasingly important role in the treatment of blood tumors. At present, the main research on the treatment of blood tumors focuses on acute myeloid leukemia (AML), but progress has also been made in other blood tumors. 213Bi and 225Ac-labeled monoclonal antibodies have achieved good results in blood tumors. 225Ac has overcome the short half-life of 213Bi and the problems of transportation and preservation. However, there are still many problems to be solved in the clinical use of α particles. This article reviews the progress of α-particle therapy in blood system, in order to provide a broader idea for the treatment of blood tumors.
8.Clinical characterization of smoking and nonsmoking patients with chronic obstructive pulmonary disease combined with cardiovascular disease based on propensity score matching
Haijie CHEN ; Shaohua XU ; Jing ZHANG
Chinese Journal of Health Management 2024;18(5):333-338
Objective:To compare the clinical characteristics of patients with chronic obstructive pulmonary disease (COPD) and cardiovascular diseases between smokers and non-smokers.Methods:In this retrospective cross-sectional study, a total of 735 patients with COPD and comorbid cardiovascular disease who were hospitalized in the Department of Respiratory and Critical Care Medicine of Peking University Third Hospital from January 1, 2017 to August 1, 2022 were enrolled, and were divided into a smoking group (603 cases) and a non-smoking group (132 cases) according to whether or not they had ever smoked. Clinical data, blood counts, C-reactive protein, procalcitonin, echocardiography, comorbidities, hospitalization costs and outcomes were compared between the two groups. Propensity score matching method was used to balance the baseline information between smoking patients and non-smoking patients for further paired analysis. Data were statistically analyzed using t-test, chi-square test, and rank sum test. Results:The percentage of females was significantly higher in patients in the nonsmoking group than in those in the smoking group (65.9% vs 13.6%, P<0.001), and body mass index (BMI) was also significantly higher than in those in the smoking group [(24.4±4.7) vs (23.5±4.4) kg/m 2, P=0.022]. Inflammation indicators neutrophil-to-lymphocyte ratio (NLR) [3.8 (2.2, 8.1) vs 4.9 (2.9, 8.3), P=0.018], C-reactive protein [1.3(0.5, 8.1) vs 7.9(1.1, 35.1) mg/L, P=0.001] were lower in the non-smoking group than in the smoking group. The ratio of early transmitral flow velocity to early mitral annular velocity (E/Em) values were significantly higher in the smoking group than in the nonsmoking group [10(7, 12) vs 8(7, 10) P=0.030]. The cardiovascular disease composition was dominated by hypertension with a lower percentage of combined coronary heart disease in the nonsmoking group than in the smoking group (22.0% vs 35.0%, P=0.034). The two groups were similar in terms of cost during hospitalization and mortality indicators. Conclusions:Among patients with COPD, smokers exhibit higher levels of systemic inflammation, greater cardiac involvement, and an increased risk of ICU admission than non-smokers. Therefore, they require enhanced daily health management and management during hospitalization.
9.Establishment and validation of a fluorescence PCR with internal positive control for Mycoplasma detection
Yu LIU ; Yunyi WU ; Xiaoxiao WANG ; Shaohua LIU ; Shanru LIU ; Lei CHEN ; Long TIAN ; Zhongyang ZHANG
Chinese Journal of Microbiology and Immunology 2024;44(9):792-800
Objective:To establish and validate a fluorescence PCR with internal positive control for rapid Mycoplasma detection. Methods:A fluorescence PCR with internal positive control for Mycoplasma detection was developed and verified for its specificity, limit of detection, and robustness. A sample of fever with thrombocytopenia syndrome (SFTSV) virus strains was tested with this method, and the result was compared with those of culture method and indicator cell culture method. Results:The established fluorescence PCR had good specificity and could amplify 11 kinds of plasmids containing Mycoplasma 16S rRNA gene with high efficiency. There was no cross reaction with the genomic DNAs of Clostridium sporogenes, Clostridium acetobutylicum, Lactobacillus acidophilus, Streptococcus pneumoniae, Bacillus subtilis, Staphylococcus aureus, Salmonella enteritidis, Escherichia coli, Pseudomonas aeruginosa, Aspergillus niger, Candida albicans, Vero cells, RD cells, and SF9 cells. The amplification efficiency of the internal positive control was basically consistent with that of the target gene of Mycoplasma, suggesting that the internal positive control could be used to detect the presence of PCR inhibitors. The sensitivity of the established method was high, and the detection limit was 10 colony-forming unit (CFU)/ml for Mycoplasma fermentans, 5 CFU/ml for Mycoplasma arginine, 5 CFU/ml for Mycoplasma gallisepticum, 5 CFU/ml for Mycoplasma hyorhinis, 5 CFU/ml for Acholeplasma laidlawii, 5 CFU/ml for Mycoplasma orale, 5 CFU/ml for Mycoplasma pneumoniae, 5 CFU/ml for Mycoplasma synoviae, and 1 CFU/ml for Spiroplasma citri by 7500 Fast real-time PCR system. At the detection limit of each species, there was no significant difference in the positive detection rate using different thermal cycler types. The established fluorescence PCR, culture method, and indicator cell culture were performed to detect Mycoplasma in the sample of SFTSV virus strains, and the results all showed Mycoplasma contamination. Conclusions:The established fluorescence PCR has high specificity, sensitivity, and robustness, and can be used as an alternative method for rapid detection of Mycoplasma.
10.Comparison of en-bloc direct vertebrae rotation and non-direct vertebrae rotation for the correction of adolescent idiopathic scoliosis Lenke 5C: a retrospective study in Changsha, China
Emmanuel ALONGE ; HongQi ZHANG ; Shaohua LIU ; Yuxiang WANG
Asian Spine Journal 2024;18(6):803-812
Methods:
A retrospective study was conducted with a minimum follow-up of four years involving 95 patients (ED group, n=45; non-DVR [ND] group, n=50). Radiographic measurements included thoracic kyphosis, lumbar lordosis, sagittal vertical axis, coronal balance, and Cobb angles preoperatively and postoperatively. Flexibility curves and axial vertebral rotation were assessed using computed tomography before and after surgery. Clinical outcomes were evaluated using the Scoliosis Research Society-22 (SRS-22) questionnaire.
Results:
The preoperative major Cobb angles were comparable between the ED group (52.2°±2°) and the ND group (52.8°±3°), with no significant difference (p=0.327). At the last follow-up, the average Cobb angle was significantly lower in the ED group (4.6°±2°) compared to the ND group (6.1°±3°), indicating a significant difference (p=0.005). The postoperative radiographic shoulder height showed no significant difference at the last follow-up. The axial vertebral rotation was significantly greater in the ED group (8.4°±0°) than in the ND group (11.1°±1°) (p=0.001). Additionally, the ED group demonstrated substantial preservation of fusion levels with an average of 5.6 fused segments compared to 6.3 in the ND group.
Conclusions
A significantly higher incidence of satisfactory outcomes was observed at the final follow-up, with the correction rate of the ED group superior to that of the ND group for adolescent idiopathic scoliosis Lenke 5C. Moreover, patients in the ED group reported better outcomes on the SRS-22 questionnaire and had a shorter hospital stay than those in the ND group.

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