1.Atmospheric fine particles induce oxidatives stress and inflammatory reaction in respiratory systems: research progress
Kuikui LU ; Min LING ; Qian BIAN
Chinese Journal of Pharmacology and Toxicology 2017;31(6):682-688
Fine particles,less than 2.5 micrometer in diameter (PM2.5),are the main components of inhalable particles.Because of their relatively small size and large surface area,PM2.5 can absorb and retain chemicals,bacteria,viruses and other toxic substances,penetrate deeply into the respiratory tract and easily reach the alveolar ducts,exerting adverse effects on the lungs.PM2.5 can also be absorbed into the bloodstream through alveolar capillaries,causing serious damage to human health.The biological effects produced by PM2.5 are frequently attributed to the oxidative stress induced by intracellular reactive oxygen species alterations and abnormal release of inflammatory mediators closely involved in the development of lung diseases.This review discusses the research advances in relationships between PM2.5 exposure and inflammatory responses and oxidative stress based on experimental researches,in vivo and in vitro studies.Recent epidemiologic investigations have shown associations between increased incidence of respiratory diseases and lung cancer from exposure to low levels of various forms of respirable fibers and particulate matter.In vivo experiments have disclosed the association between PM2.5 exposure and the exacerbation of asthma,bronchitis,chronic obstructive pulmonary disease,and other lung damages.Cell damage mechanisms mainly include alterations of cell signaling pathways,DNA damage,immune injury,autophagy and apoptosis.
2.In vitro release and antibacterial property of minocycline-hydroxyapatite/chitosan complex
Haochen GAO ; Pei WANG ; Zhizhong CAO ; Kuikui GE ; Yihan WANG ; Min LU
Chinese Journal of Tissue Engineering Research 2016;20(8):1118-1125
BACKGROUND: Hydroxyapatite/chitosan (HA/CS) complex may act as a drug carrier for drug release, but little is reported about the release amount and antibacterial effect of minocycline-HA/CS (Mino-HA/CS) complex. OBJECTIVE: To investigate the in vitro release and antibacterial property of Mino-HA/CS complex. METHODS: HA/CS and Mino-HA/CS were prepared using co-precipitation method. The surface and cross-section features of the complexes were observed under scanning electron microscopy. The porosities were measured according to Archimedes Principle. The release of minocycline hydrochloride was measured by high performance liquid chromatography with the simulated saliva as drug release media. In vitro antibacterial effect on Porphyromonas gingivalis and Staphylococcus aureus were measured by bacteria-inhibiting ring method. Biological toxicities were evaluated via cel counting kit-8cel proliferation assay. RESULTS AND CONCLUSION: The porosity of Mino-HA/CS was larger than that of HA/CS, with the average porosity of 53.99%. Single-day release amount of Mino-HA/CS could maintain at the level of 0.5-1 μg per day for a long-term. Bacteriostatic rings of Porphyromonas gingivalis and Staphylococcus aureus stil existed clearly after 7 days. Cel proliferation assays showed that Mino-HA/CS extract had the significant effect on promoting cel proliferation. These findings indicate that the Mino-HA/CS sustains the release of minocycline at a relatively stable level within a longer period, shows good inhibitory effect on Porphyromonas gingivalis and Staphylococcus aureus and promotes the proliferation of periodontal ligament cel s.
3.Analysis of water iodine content in Jiangsu rural water factory
Yuting XIA ; Kuikui LU ; Li SHANG ; Yunjie YE ; Peihua WANG ; Yang WANG ; Mao LIU ; Yan XU ; Ran LIU
Chinese Journal of Endemiology 2019;38(10):818-822
Objective To further understand and master the distribution and influencing factors of water iodine in Jiangsu Province.Methods From 2012 to 2014,half of the water plants in rural centralized water supply monitoring plants in 63 counties (cities,districts) of Jiangsu Province were selected as survey sites,and the types of monitoring,types of water plants,types of water sources,self-inspection ability,disinfection situation,water treatment methods were investigated and analyzed.One sample of peripheral water was collected from each survey site to determine the water iodine content.Results From 2012-2014,there were 938 samples of river water were monitored,and the median water iodine was 5.9 μg/L.There were 57 samples of lake water were monitored,the median water iodine was 6.8 μg/L.There were 228 samples of reservoir water were monitored,and the median water iodine was 7.1 μg/L.There were 43 samples of gully pond water were monitored,and the median water iodine was 6.9 μg/L.There were 5 474 samples of deep well water were monitored,and the median water iodine was 28.2 μg/L.There were 162 samples of shallow well water were monitored,and the median water iodine was 30.9 μg/L.There was a statistically significant difference in the median iodine content of water samples from different water sources (x2 =844.9,P < 0.05).The differences of median iodine of lake water,reservoir water,gully pond water,deep well water and shallow well water among different monitoring types were significant (x2 =9.6,6.3,9.7,121.2,38.1,P < 0.05).The differences of median iodine of river water,reservoir water,deep well water and shallow well water among different types of water plants were significant (x2 =109.5,39.0,153.3,7.6,P < 0.05).The iodine contents of fiver water,lake water,deep well water and shallow well water had significant difference in selfinspection ability of different water plants (x2 =62.5,5.1,29.9,10.1,P < 0.05).The iodine content of reservoir water,deep well water and shallow well water were significandy different in different disinfection situation (x2 =12.1,12.4,35.7,P < 0.05).The medians iodine of river water,reservoir water,deep well water and shallow well water had significant difference in different water treatment methods (x2 =9.5,21.2,102.4,46.9,P < 0.05).Conclusions The water iodine contents of water samples in different types of water sources in rural area of Jiangsu Province are different.The level of water iodine is affected by factors such as monitoring type,type of water plant,self-inspection ability,disinfection situation and water treatment method.
4.Cost-effectiveness of primary prophylaxis with PEG-rhG-CSF in early-stage breast cancer patients receiving chemotherapy in China
Wen XIA ; Shusen WANG ; Hao HU ; Feili ZHAO ; Fei XU ; Ruoxi HONG ; Kuikui JIANG ; Zhongyu YUAN ; Yanxia SHI ; Kun ZHAO ; Jiajia HUANG ; Cong XUE ; Xiwen BI ; Qianyi LU ; Xin AN ; Jingmin ZHANG
Chinese Journal of Oncology 2020;42(10):861-867
Objective:To evaluate the cost effectiveness of primary prophylaxis (PP) with pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF), PP with recombinant human granulocyte colony stimulating factor (rhG-CSF) and no prophylaxis in women with early-stage breast cancer in China.Methods:Two phase Markov models were constructed for a hypothetical cohort of patients aged 45 with stage Ⅱ breast cancer. The first phase modelled costs and outcomes of 4 cycles docetaxel combined with cyclophosphamide [TC×4, febrile neutropenia (FN) risk>20%] chemotherapy, which assumptions based on literature reviews, including FN rates [base-case (deterministic sensitivity analysis range), 0.29 (0.24-0.35)] and related events [FN case-fatality, 3.4 (2.7-4.1)]. Second phase modelled the long term survival which was link with the relative dose intensity (RDI) [mortality hazard ratio ( HR) of RDI < 85% vs ≥85%, 1.45 (1.00-2.32)]. Clinical effectiveness, therapeutic costs, and economic utilities were estimated from peer-reviewed publications and expert opinions in case of unavailability of published evidences. Results:Compared to rhG-CSF PP and no prophylaxis, the cost of PEG-rhG-CSF PP increased to 5 208.19 RMB and 5 222.73 RMB, respectively. The quality-adjusted life-years (QALYs) enhanced to 0.066 and 0.297, respectively. Accordingly, the incremental cost effectiveness ratios (ICERs) are 79 146.3 RMB and 17 558.77 RMB per QALY, which were both below the willingness to pay (WTP) threshold of three times GDP per capita (18, 000 RMB) recommended by the WHO. Sensitivity analysis suggested that the more clinically effective the primary prophylaxis with PEG-rhG-CSF is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. And the lower the mortality HR of RDI<85% vs ≥85% is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. Conclusion:Although the cost of PP PEG-rhG-CSF is higher, considering the additional benefits, the administrating of PP PEG-rhG-CSF is likely to be a cost-effective alternative to PP rhG-CSF and no prophylaxis in patients with early stage breast cancer whose FN risks are more than 20% in China.
5.Cost-effectiveness of primary prophylaxis with PEG-rhG-CSF in early-stage breast cancer patients receiving chemotherapy in China
Wen XIA ; Shusen WANG ; Hao HU ; Feili ZHAO ; Fei XU ; Ruoxi HONG ; Kuikui JIANG ; Zhongyu YUAN ; Yanxia SHI ; Kun ZHAO ; Jiajia HUANG ; Cong XUE ; Xiwen BI ; Qianyi LU ; Xin AN ; Jingmin ZHANG
Chinese Journal of Oncology 2020;42(10):861-867
Objective:To evaluate the cost effectiveness of primary prophylaxis (PP) with pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF), PP with recombinant human granulocyte colony stimulating factor (rhG-CSF) and no prophylaxis in women with early-stage breast cancer in China.Methods:Two phase Markov models were constructed for a hypothetical cohort of patients aged 45 with stage Ⅱ breast cancer. The first phase modelled costs and outcomes of 4 cycles docetaxel combined with cyclophosphamide [TC×4, febrile neutropenia (FN) risk>20%] chemotherapy, which assumptions based on literature reviews, including FN rates [base-case (deterministic sensitivity analysis range), 0.29 (0.24-0.35)] and related events [FN case-fatality, 3.4 (2.7-4.1)]. Second phase modelled the long term survival which was link with the relative dose intensity (RDI) [mortality hazard ratio ( HR) of RDI < 85% vs ≥85%, 1.45 (1.00-2.32)]. Clinical effectiveness, therapeutic costs, and economic utilities were estimated from peer-reviewed publications and expert opinions in case of unavailability of published evidences. Results:Compared to rhG-CSF PP and no prophylaxis, the cost of PEG-rhG-CSF PP increased to 5 208.19 RMB and 5 222.73 RMB, respectively. The quality-adjusted life-years (QALYs) enhanced to 0.066 and 0.297, respectively. Accordingly, the incremental cost effectiveness ratios (ICERs) are 79 146.3 RMB and 17 558.77 RMB per QALY, which were both below the willingness to pay (WTP) threshold of three times GDP per capita (18, 000 RMB) recommended by the WHO. Sensitivity analysis suggested that the more clinically effective the primary prophylaxis with PEG-rhG-CSF is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. And the lower the mortality HR of RDI<85% vs ≥85% is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. Conclusion:Although the cost of PP PEG-rhG-CSF is higher, considering the additional benefits, the administrating of PP PEG-rhG-CSF is likely to be a cost-effective alternative to PP rhG-CSF and no prophylaxis in patients with early stage breast cancer whose FN risks are more than 20% in China.
6.Pyrotinib Combined with Vinorelbine in Patients with Previously Treated HER2-Positive Metastatic Breast Cancer: A Multicenter, Single-Arm, Prospective Study
Kuikui JIANG ; Ruoxi HONG ; Wen XIA ; Qianyi LU ; Liang LI ; Jianhao HUANG ; Yanxia SHI ; Zhongyu YUAN ; Qiufan ZHENG ; Xin AN ; Cong XUE ; Jiajia HUANG ; Xiwen BI ; Meiting CHEN ; Jingmin ZHANG ; Fei XU ; Shusen WANG
Cancer Research and Treatment 2024;56(2):513-521
Purpose:
This study aims to evaluate the efficacy and safety of a new combination treatment of vinorelbine and pyrotinib in human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer (MBC) and provide higher level evidence for clinical practice.
Materials and Methods:
This was a prospective, single-arm, phase 2 trial conducted at three institutions in China. Patients with HER2-positive MBC, who had previously been treated with trastuzumab plus a taxane or trastuzumab plus pertuzumab combined with a chemotherapeutic agent, were enrolled between March 2020 and December 2021. All patients received pyrotinib 400 mg orally once daily plus vinorelbine 25 mg/m2 intravenously or 60-80 mg/m2 orally on day 1 and day 8 of 21-day cycle. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included the objective response rate (ORR), disease control rate (DCR), overall survival, and safety.
Results:
A total of 39 patients were enrolled. All patients had been pretreated with trastuzumab and 23.1% (n=9) of them had accepted trastuzumab plus pertuzumab. The median follow-up time was 16.3 months (95% confidence interval [CI], 5.3 to 27.2), and the median PFS was 6.4 months (95% CI, 4.0 to 8.8). The ORR was 43.6% (95% CI, 27.8% to 60.4%) and the DCR was 84.6% (95% CI, 69.5% to 94.1%). The median PFS of patients with versus without prior pertuzumab treatment was 4.6 and 8.3 months (p=0.017). The most common grade 3/4 adverse events were diarrhea (28.2%), neutrophil count decreased (15.4%), white blood cell count decreased (7.7%), vomiting (5.1%), and anemia (2.6%).
Conclusion
Pyrotinib plus vinorelbine showed promising efficacy and tolerable toxicity as second-line treatment in patients with HER2-positive MBC.
7.Development and Analysis of Standards for Drugs Under Special Management
Kuikui GENG ; Ling JIANG ; Jiancun ZHEN ; Tianlu SHI ; Wei ZHANG ; Jin LU ; Jianqing WANG ; Xiaoyang LU ; Qianzhou LYU ; Zhiqing ZHANG ; Ying CHEN ; Hong XIA ; Qin GUANG ; Hongpeng BI
Herald of Medicine 2024;43(8):1217-1221
Drugs under special management include narcotic drugs,psychotropic drugs,toxic drugs for medical use,radiopharmaceuticals,and pharmaceutical precursor chemicals.Supervising and guiding the clinical use of drugs under special management is one of the important responsibilities of the Pharmaceutical Management and Drug Therapy Committee(Group)of medical institutions.The standard for drugs under special management is led by the Pharmaceutical Professional Committee of the China Hospital Association,which standardizes 16 key elements of organizational management,process management,and quality control management drugs under special management in medical institutions.It can guide the standardized implementation of Pharmaceuticals under special control work in various levels and types of medical institutions.This article elaborates on the methods and contents of formulating standards for Pharmaceuticals under special management,to provide reference and inspiration for medical institutions to carry out special drug drug management and daily related work.