1.Atezolizumab therapy in Chinese patients with locally advanced or metastatic solid tumors: An open-label, phase Ⅰ study.
Li ZHANG ; Ji Fang GONG ; Hong Ming PAN ; Yu Xian BAI ; Tian Shu LIU ; Ying CHENG ; Ya Chi CHEN ; Jia Ying HUANG ; Ting Ting XU ; Fei Jiao GE ; Wan Ling HSU ; Jia SHI ; Xi Chun HU ; Lin SHEN
Journal of Peking University(Health Sciences) 2022;54(5):971-980
OBJECTIVE:
To evaluate pharmacokinetics (PK), efficacy, and safety of atezolizumab (anti-PD-L1) in high interest cancers in China, including esophageal cancer (EC), gastric cancer (GC), hepatocellular carcinoma (HCC), nasopharyngeal cancer (NPC), and non-small cell lung can-cer (NSCLC).
METHODS:
This phase I, open-label study was conducted at 6 Chinese sites from August 4, 2016 to April 15, 2019. The patients were ≥18 years old with a histologically documented incurable or metastatic solid tumor that was advanced or recurrent and had progressed since the last anti-tumor the-rapy. The PK phase characterized PK and safety of atezolizumab following multiple-dose administration when atezolizumab was administered as a single agent. The extension phase studied safety and efficacy of atezolizumab, as monotherapy (EC, GC, HCC, NPC) and with chemotherapy (NSCLC).
RESULTS:
This study enrolled 120 patients (PK phase: n=20; extension phase: n=20/cohort). Fourty-two patients (42.0%) were PD-L1 positive in atezolizumab monotherapy group (100 patients), of the 9 patients (9.0%) with microsatellite instability-high (MSI-H) tumors. Atezolizumab clearance was 0.219 L/d, and steady state was reached after 6 to 9 weeks (2-3 cycles) of repeated dosing. Objective response rates (ORRs) in EC, GC, HCC, NPC, and NSCLC were 10.0%, 15.0%, 10.0%, 5.0%, and 40.0%, respectively. In the patients with PD-L1 positive tumors, ORR was 11.9% with atezolizumab and 46.2% with atezolizumab plus gemcitabine and cisplatin. Two GC patients achieved durable response after pseudo-progression. The most common treatment-related adverse events in the atezolizumab monotherapy group were fatigue, anemia, fever, and decreased white blood cell count. The most common treatment-related adverse events in the combination group were anemia, decreased white blood cell count, and decreased appetite. No new safety signals were identified.
CONCLUSION
Atezolizumab's PK, efficacy, and safety were similar in Chinese patients vs. global patients in previous studies.
Adolescent
;
Antibodies, Monoclonal, Humanized
;
Antineoplastic Agents/therapeutic use*
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
;
Carcinoma, Hepatocellular/drug therapy*
;
Cisplatin/therapeutic use*
;
Humans
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Liver Neoplasms/drug therapy*
;
Lung Neoplasms/pathology*
;
Nasopharyngeal Neoplasms/drug therapy*
2.Application of Relative Quality Constant in Grade Evaluation of Codonopsis Radix Slices
Rui-ming ZHANG ; Sha-sha ZHANG ; Jing HOU ; Xiao-ting ZHANG ; Yun-e BAI ; Jian-ping GAO ; Zhen-hong LEI ; Yu-long WANG ; Shu-xian XIAO
Chinese Journal of Experimental Traditional Medical Formulae 2021;27(1):162-171
Objective:To establish the grade evaluation method for Codonopsis Radix slices based relative quality constants, in order to provide scientific theoretical basis for grading of Codonopsis Radix slices. Method:Through literature and market research,the main production areas of Codonopsis Radix slices were determined,and 67 batches of Ludangshen slices(52 batches) and Baitiaodang slices (15 batches) were collected. The appearance traits (average quality and average thickness of Codonopsis Radix slices) were observed and measured. According to
3.Associations of Sedentary Time and Physical Activity with Metabolic Syndrome among Chinese Adults: Results from the China Health and Nutrition Survey.
Jing BAI ; Yun WANG ; Xian Fan ZHANG ; Yi Fei OUYANG ; Bing ZHANG ; Zhi Hong WANG ; Shu Fa DU ; Hui Jun WANG
Biomedical and Environmental Sciences 2021;34(12):963-975
Objective:
This study aimed to determine the independent and joint associations of sedentary time (ST) and physical activity (PA) with metabolic syndrome (MetS) and its components among Chinese adults.
Methods:
The study analyzed data from 4,865 adults aged ≥ 18 years who participated in the 2009 and 2015 China Health and Nutrition Surveys (CHNS). Four types of leisure ST and three types of PA self-reported at baseline were collected. Multivariable logistic regressions were used to determine the independent and joint associations of ST and PA with the odds of MetS or its components.
Results:
For independent effects, higher levels of television time and total leisure ST was associated with higher MetS risk [odds ratio (
Conclusions
MVPA and total PA have independent preventive effects, and sedentary behavior (mainly watching TV) has an unsafe effect on MetS and its components. Strengthening the participation of MVPA and combining the LPA to replace the TV-based ST to increase the total PA may be necessary to reduce the prevalence of MetS in Chinese adults.
Adult
;
Aged
;
Aged, 80 and over
;
China/epidemiology*
;
Exercise/statistics & numerical data*
;
Female
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Humans
;
Male
;
Metabolic Syndrome/etiology*
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Middle Aged
;
Nutrition Surveys
;
Risk Factors
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Sedentary Behavior
;
Young Adult
4.Association of Overlapped and Un-overlapped Comorbidities with COVID-19 Severity and Treatment Outcomes: A Retrospective Cohort Study from Nine Provinces in China.
Yan MA ; Dong Shan ZHU ; Ren Bo CHEN ; Nan Nan SHI ; Si Hong LIU ; Yi Pin FAN ; Gui Hui WU ; Pu Ye YANG ; Jiang Feng BAI ; Hong CHEN ; Li Ying CHEN ; Qiao FENG ; Tuan Mao GUO ; Yong HOU ; Gui Fen HU ; Xiao Mei HU ; Yun Hong HU ; Jin HUANG ; Qiu Hua HUANG ; Shao Zhen HUANG ; Liang JI ; Hai Hao JIN ; Xiao LEI ; Chun Yan LI ; Min Qing LI ; Qun Tang LI ; Xian Yong LI ; Hong De LIU ; Jin Ping LIU ; Zhang LIU ; Yu Ting MA ; Ya MAO ; Liu Fen MO ; Hui NA ; Jing Wei WANG ; Fang Li SONG ; Sheng SUN ; Dong Ting WANG ; Ming Xuan WANG ; Xiao Yan WANG ; Yin Zhen WANG ; Yu Dong WANG ; Wei WU ; Lan Ping WU ; Yan Hua XIAO ; Hai Jun XIE ; Hong Ming XU ; Shou Fang XU ; Rui Xia XUE ; Chun YANG ; Kai Jun YANG ; Sheng Li YUAN ; Gong Qi ZHANG ; Jin Bo ZHANG ; Lin Song ZHANG ; Shu Sen ZHAO ; Wan Ying ZHAO ; Kai ZHENG ; Ying Chun ZHOU ; Jun Teng ZHU ; Tian Qing ZHU ; Hua Min ZHANG ; Yan Ping WANG ; Yong Yan WANG
Biomedical and Environmental Sciences 2020;33(12):893-905
Objective:
Several COVID-19 patients have overlapping comorbidities. The independent role of each component contributing to the risk of COVID-19 is unknown, and how some non-cardiometabolic comorbidities affect the risk of COVID-19 remains unclear.
Methods:
A retrospective follow-up design was adopted. A total of 1,160 laboratory-confirmed patients were enrolled from nine provinces in China. Data on comorbidities were obtained from the patients' medical records. Multivariable logistic regression models were used to estimate the odds ratio (
Results:
Overall, 158 (13.6%) patients were diagnosed with severe illness and 32 (2.7%) had unfavorable outcomes. Hypertension (2.87, 1.30-6.32), type 2 diabetes (T2DM) (3.57, 2.32-5.49), cardiovascular disease (CVD) (3.78, 1.81-7.89), fatty liver disease (7.53, 1.96-28.96), hyperlipidemia (2.15, 1.26-3.67), other lung diseases (6.00, 3.01-11.96), and electrolyte imbalance (10.40, 3.00-26.10) were independently linked to increased odds of being severely ill. T2DM (6.07, 2.89-12.75), CVD (8.47, 6.03-11.89), and electrolyte imbalance (19.44, 11.47-32.96) were also strong predictors of unfavorable outcomes. Women with comorbidities were more likely to have severe disease on admission (5.46, 3.25-9.19), while men with comorbidities were more likely to have unfavorable treatment outcomes (6.58, 1.46-29.64) within two weeks.
Conclusion
Besides hypertension, diabetes, and CVD, fatty liver disease, hyperlipidemia, other lung diseases, and electrolyte imbalance were independent risk factors for COVID-19 severity and poor treatment outcome. Women with comorbidities were more likely to have severe disease, while men with comorbidities were more likely to have unfavorable treatment outcomes.
Adult
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Aged
;
COVID-19/virology*
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China/epidemiology*
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Comorbidity
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Female
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Humans
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Male
;
Middle Aged
;
Retrospective Studies
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Severity of Illness Index
;
Treatment Outcome
5.Efficient Detection of Environmental Estrogens Bisphenol A and Estradiol By Sensing System Based on AuNP-AuNP-UCNP Triple Structure
Qiao-Feng LI ; Shu-Yue REN ; Yu WANG ; Jia-Lei BAI ; Yuan PENG ; Bao-An NING ; Quan-Jun LYU ; Zhi-Xian GAO
Chinese Journal of Analytical Chemistry 2018;46(4):486-492
A sensing system based on AuNP-AuNP-UCNP triple structure for efficient detection of dual targets was constructed. In the preparation of triple structure, the gold nanoparticles (AuNPs) and upconversion nanoparticles (NaYF4: Yb, Er, Gd, UCNPs) were synthesized and surface modified. Then the two nanoparticles and their aptamers were connected to form two kinds of optical fluorescent probes. A nucleic acid sequence that matches with two aptamers was designed, rendering the probes to get close based on the principle of complementary base pairing. On the basis of this, a sensing system with a triple structure was prepared,and its connecting effect was characterized by TEM. With this system, dual targets of bisphenol A and estradiol were efficiently and conveniently detected through quantitative determination by fluorescence and UV spectrophotometer. At reaction temperature of 30℃ and pH=7.8,this method exhibited good linear range for determination of bisphenol A and estradiol from 2 ng/mL to 200 ng/mL and from 10 ng/mL to 150 ng/mL, with limits of detection of 0.2 ng/mL and 0.5 ng/mL, respectively. This sensing system with the triple structure owned better specificity to structural and functional analogues, and showed good repeatability and stability. What's more,this sensing system was applied in actual water detection,with the recoveries between 86.1% and 107. 4%, and the relative standard deviation below 6. 8%. This method showed promising applications in other environmental estrogens in water samples.
6.Effect of Kuanxiong Aerosol () on Patients with Angina Pectoris: A Non-inferiority Multi-center Randomized Controlled Trial.
Qiao-Ning YANG ; Rui-Na BAI ; Guo-Ju DONG ; Chang-Jiang GE ; Jing-Min ZHOU ; Li HUANG ; Yan HE ; Jun WANG ; Ai-Hua REN ; Zhan-Quan HUANG ; Guang-Li ZHU ; Shu LU ; Shang-Quan XIONG ; Shao-Xiang XIAN ; Zhi-Jun ZHU ; Da-Zhuo SHI ; Shu-Zheng LU ; Li-Zhi LI ; Ke-Ji CHEN
Chinese journal of integrative medicine 2018;24(5):336-342
OBJECTIVETo evaluate the effect and safety of Kuanxiong Aerosol (, KA) on patients with angina pectoris.
METHODSBlock randomization was performed to randomly allocate 750 patients into KA (376 cases) and control groups (374 cases). During an angina attack, the KA group received 3 consecutive sublingual sprays of KA (0.6 mL per spray). The control group received 1 sublingual nitroglycerin tablet (NT, 0.5 mg/tablet). Log-rank tests and Kaplan-Meier estimations were used to estimate the angina remission rates at 6 time-points after treatment (1, 2, 3, 4, 5, and >5 min). Logistic regression analysis was performed to observe the factors inflfluencing the rate of effective angina remission, and the remission rates and incidences of adverse reactions were compared for different Canadian Cardiovascular Society (CCS) classes of angina.
RESULTSThe 5-min remission rates in the KA and control groups were not signifificantly different (94.41% vs. 90.64%, P>0.05). The angina CCS class signifificantly inflfluenced the rate of remission (95% confidence interval = 0.483-0.740, P<0.01). In the CCS subgroup analysis, the 3-and 5-min remission rates for KA and NT were similar in the CCSII and III subgroups (P>0.05), while they were signifificantly better for KA in the CCSI and II subgroups (P<0.05 or P<0.01). Furthermore, the incidence of adverse reactions was signifificantly lower in the KA group than in the control group for the CCSII and III subgroups (9.29% vs. 26.22%, 10.13% vs. 20.88%, P<0.05 or P<0.01).
CONCLUSIONSKA is not inferior to NT in the remission of angina. Furthermore, in CCSII and III patients, KA is superior to NT, with a lower incidence of adverse reactions. (Registration No. ChiCTRIPR-15007204).
Aerosols ; adverse effects ; therapeutic use ; Angina Pectoris ; drug therapy ; Case-Control Studies ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Female ; Humans ; Kaplan-Meier Estimate ; Logistic Models ; Male ; Middle Aged ; Remission Induction ; Treatment Outcome
7.Clinicopathological Characteristics and Prognosis Analysis of the Patients with Plasmablastic Lymphoma.
Juan FENG ; Li XU ; Hong-Juan DONG ; Na ZHANG ; Qing-Xian BAI ; Rong LIANG ; Mi-Mi SHU ; Lan YANG ; Xie-Qun CHEN ; Hong-Tao GU ; Guang-Xun GAO
Journal of Experimental Hematology 2018;26(5):1350-1354
OBJECTIVETo evaluate the clinicopathological characteristics, treatment and prognosis of the patients with plasmablastic lymphoma(PBL).
METHODSThe clinical and pathological data of 21 patients with PBL diagnosed and treated in our center between January 2009 and September 2017 were retrospectively analyzed. The clinical and pathological features, treatment and therapentic outcome were summarized and the high risk factors affecting the prognosis of patients were investigated.
RESULTSThe 21 PBL patients included 12 males and 9 females, and their median age was 52 years old. The human immunodeficiency virus (HIV) was negative in all patients. The primary involved sites of 16 patients were extranodal, and the patients staged in III-IV accounted for 81%; 18 patients receved first-line chemotherapy with standard CHOP(E) (cyclophosphamide +epirubicin +vincristine +prednisone±etoposide). After treatment, only 1 patient achieved complete response (CR), and 8 patients achieved partial response (PR). The median overall survival time was 6.3 months. Multivariate analysis showed the America Eastern Cooperative Oncology Group (ECOG) physical score and bone marrow infiltration were significant prognostic factors (P<0.01).
CONCLUSIONPlasmablastic lymphoma frequently occurrs in the middle-old aged persons with all HIV negative. Primary extranodal lesions are frequent. Most patients were in advanced stage with poor treatment response. ECOG score≥2 and bone marrow infiltration are independent prognostic factors related with worse prognosis.
8.Effects of cultivated Cordyceps sinensis on proliferation and apoptosis of human leukemia K562 cells.
Xue-Lian BAI ; Shu-Xian YANG ; Yu SHAN ; Wen-Jia LI ; Jing LI ; Ying XIAO ; Xue-Feng HU ; Li CAO
China Journal of Chinese Materia Medica 2018;43(10):2134-2139
The present study was designed to investigate the effect of cultivated Cordyceps sinensis (CCS) on leukemia-derived K562 cells, and further explore the underlying mechanisms. After routine culture of K562 cells, MTT assay was used to detect the effect of CCS on survivel of human leukemia cell lines K562;DAPI staining was used to observe the morphological changes of the nucleus and AO/EB staining was used to observe cell apoptosis. JC-1 staining was employed to detect the changes in mitochondrial membrane potential. Flow cytometry (FCM) was used to detect cell cycle distribution, and Western blot analysis was used to detect the expression levels of Bax, Bcl-2, caspase 3, caspase 8, cyclin D1, CDK2, and CDK4 in K562 cells. The results showed that CCS (0.345-5.524 g·L⁻¹) substantially suppressed proliferation of K562 cells and induced G₁/S phase arrest in a dose-dependent manner. DAPI and AO/EB staining indicated that cell apoptosis was significantly induced by CCS treatment, accompanied by decreased mitochondrial membrane potential demonstrated by JC-1 staining. Western blot results showed that CCS significantly increased the expression of Bax and, meanwhile, decreased the expression levels of Bcl-2, cyclin D1, CDK2, CDK4, caspase 3 and caspase 8. Collectively, our data demonstrated that CCS dose-dependently suppressed cell proliferation and induced cell apoptosis in K562 cells, and the mechanism might be associated with inducing cell cycle arrest, regulating Bcl-2/Bax ratio and activating the mitochondrial apoptosis pathway.
9.Treatment of 30 elderly patients with advanced myeloid neoplasm by allogeneic hematopoietic stem cell transplantation.
Jun YANG ; Yu CAI ; Jie Ling JIANG ; Li Ping WAN ; Hai Tao BAI ; Jun ZHU ; Shu LI ; Xian Min SONG ; Chun WANG
Chinese Journal of Hematology 2018;39(8):629-633
Objective: To evaluate the efficacy of allogeneic hematopoietic stem cell transplantation (allo-HSCT) for elderly patients with advanced myeloid neoplasm. Methods: From September 2014 to September 2017, 30 consecutive hospitalized 50-plus-year-old myeloid neoplasm patients were retrospectively analyzed. At the time of transplantation, 6 patients reached complete remission and the others remained no remission after treatment. The donors were identical sibling (12), matched unrelated (6) and haploidentical family member (12), respectively. 18 patients received RIC while 12 patients received MAC conditioning regiments consisted of Busulfan, cytarabine, fludarabine or clarithromycin±TBI, respectively. Results: Five patients died early in the conditioning stage, 24 patients successfully engrafted. The median time of neutrophil engraftment was 14(10-18) d, whereas platelet engraftment was 15(10-19) d. Six cases (25%) experienced aGVHD grades Ⅱ, 8 cases (32%) cGVHD, including moderate to severe cGVHD in 2 cases (8%). Seven, 7 and 5 cases developed CMV viremia, pneumonia and herpeszoster, respectively after transplantation, but no patients died of infections. The median follow-up time of the patients was 7(0.5-38) months. Twenty-one patients were still alive. The estimated 2 years OS and LFS were 62.5% (95% CI 39.2%-85.8%) and 59.2% (95% CI 26.9%-91.5%), respectively. Univariate analysis showed that HCT-CI was the only factor influencing OS. Conclusion: Allogeneic hematopoietic stem cell transplantation could improve the survival of elderly patients with myeloid neoplasm.
Aged
;
Busulfan
;
Graft vs Host Disease
;
Hematopoietic Stem Cell Transplantation
;
Humans
;
Leukemia, Myeloid, Acute
;
Middle Aged
;
Retrospective Studies
;
Transplantation Conditioning
10.Influence of CD117 Expression on Response of Multiple Myeloma Patients to Chemotherapy.
Hai-Long TANG ; Mi-Mi SHU ; Bao-Xia DONG ; Hong-Tao GU ; Rong LIANG ; Qing-Xian BAI ; Lan YANG ; Tao ZHANG ; Guang-Xun GAO ; Xie-Qun CHEN
Journal of Experimental Hematology 2015;23(5):1346-1351
OBJECTIVETo investigate the influence of CD117 expression on response of multiple myeloma patients to chemo-therapy.
METHODSA total of 65 cases of newly diagnosed multiple myeloma in our hospital from 2011 to 2013 were enrolled in this study. Cytogenetic abnormalities and immunophenotype were detected by using fluorescence in situ hybridization and flow cytometry before chemotherapy. The therapeutic efficacy of patients was evaluated after 4 cycles of PAD or TAD regimen.
RESULTSThe positive rates of 1q21 amplification, RB1: 13q14 deletion, D13S319: 13q14.3 deletion, IgH: 14q32 rearrangement and p53: 17p13 deletion were 32.2%, 40%, 40%, 20% and 3.1% respectively; the positive rates of CD38, CD138, CD56, CD117, CD20 were respectively 100%, 100%, 60%, 20%, 10.8%; the positive rates of CD19 and CD10 were 4.6% and 4.6% respectively; the positive CD22, CD7, CD5, CD103 did not found in any patients. The therapeutic efficacy of CD117⁻ patients was better than that of CD117⁺ patients (P < 0.05), there was no correlation of the remaining indicators with efficacy; the proportion of CD117⁺ patients with β2-microglobulin ≥ 5.5 mg/L was significantly higher than that of CD117⁻ patients (P < 0.05); the rest of baseline data had no significant difference (P > 0.05).
CONCLUSIONCD117 can be used as an indicator for evaluating efficacy of patients with newly diagnosed multiple myeloma.
Chromosome Aberrations ; Chromosome Deletion ; Flow Cytometry ; Humans ; Immunophenotyping ; In Situ Hybridization, Fluorescence ; Multiple Myeloma ; drug therapy ; metabolism ; Proto-Oncogene Proteins c-kit ; metabolism

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