1.A real world study of anti-IgE monoclonal antibody in the treatment of allergic united airway disease.
Hai Jing SUI ; Zhen ZHEN ; Quan Gui WANG ; Tie Chuan CONG ; Jun Jun HUANG ; Yan HU
Chinese Journal of Preventive Medicine 2023;57(2):273-280
Objective: To investigate the clinical efficacy and safety of anti-IgE monoclonal antibody (omazumab) in the treatment of allergic united airway disease (UAD) in the real-wold. Methods: Retrospective cohort study summarizes the case data of patients with allergic united airway disease who were treated with anti IgE monoclonal antibody (omalizumab) for more than 16 weeks from March 1, 2018 to June 30, 2022 in the Peking University First Hospital.The allergic UAD is defined as allergic asthma combined with allergic rhinitis (AA+AR) or allergic asthma combined with chronic sinusitis with nasal polyps (AA+CRSwNP) or allergic asthma combined with allergic rhinitis and nasal polyps (AA+AR+CRSwNP). The control of asthma was evaluated by asthma control test (ACT), lung function test and fractional exhaled nitric oxide (FeNO). The AR was assessed by total nasal symptom score (TNSS). The CRSwNP was evaluated by nasal visual analogue scale (n-VAS), sino-nasal outcome test-22 (SNOT-22), nasal polyps score (TPS) and Lund-Mackay sinus CT grading system. The global evaluation of omalizumab for the treatment of allergic UADwas performed by Global Evaluation of Treatment Effectiveness(GETE).The drug-related side effects were also recorded. Matched t test and Wilcoxon signed-rank test were used to compare the score changes of IgE monoclonal antibody (omazumab) before and after treatment, and multivariate logistic regression analysis was used to determine the influencing factors of IgE monoclonal antibody (omazumab) response. Results: A total of 117 patients with UAD were enrolled, ranging in age from 19 to 77 years; The median age of patients was 48.7 years; Among them, 60 were male, ranging from 19 to 77 years old, with a median age of 49.9 years; There were 57 females, ranging from 19 to 68 years old, with a median age of 47.2 years. There were 32 cases in AA+AR subgroup, 59 cases in AA+CRSwNP subgroup, and 26 cases in AA+AR+CRSwNP subgroup. The total serum IgE level was 190.5 (103.8,391.3) IU/ml. The treatment course of anti IgE monoclonal antibody was 24 (16, 32) weeks. Compared with pre-treatment, omalizumab increased ACT from 20.0 (19.5,22.0) to 24.0 (23.0,25.0) (Z=-8.537, P<0.001), increased pre-bronchodilator FEV1 from 90.2 (74.8,103.0)% predicted value to 95.4 (83.2,106.0)% predicted value (Z=-5.315,P<0.001), increased FEV1/FVC from 80.20 (66.83,88.38)% to 82.72 (71.26,92.25)% (Z=-4.483,P<0.001), decreased FeNO from(49.1±24.8) ppb to (32.8±24.4) ppb (t=5.235, P<0.001), decreased TNSS from (6.5±2.6)to (2.4±1.9) (t=14.171, P<0.001), decreased n-VAS from (6.8±1.2) to (3.4±2.0)(t=14.448, P<0.001), decreased SNOT-22 from (40.0±7.9) to (21.3±10.2)(t=15.360, P<0.001), decreased TPS from (4.1±0.8) to (2.4±1.0)(t=14.718, P<0.001) and decreased Lund-Mackay CT score from (6.0±1.3) to (3.1±1.6)(t=17.012, P<0.001). The global response rate to omalizumab was 67.5%(79/117). The response rate in AA+AR (90.6%,29/32) was significantly higher than that in AA+CRSwNP (61.0%,36/59) and AA+AR+CRSwNP (53.8%,14/26) subgroups (χ2=11.144,P=0.004). Only 4 patients (3.4%,4/117) had mild side effects. Conclusion: The real-world study showed favorable effectiveness and safety of anti-IgE monoclonal antibody for treatment of allergic UAD. To provide basis for preventing the progress and precise treatment of allergic UAD.
Female
;
Humans
;
Male
;
Middle Aged
;
Young Adult
;
Adult
;
Aged
;
Nasal Polyps/drug therapy*
;
Omalizumab/therapeutic use*
;
Rhinitis/drug therapy*
;
Retrospective Studies
;
Asthma/diagnosis*
;
Rhinitis, Allergic/drug therapy*
;
Sinusitis/drug therapy*
;
Antibodies, Monoclonal/therapeutic use*
;
Chronic Disease
2.Vaccination status and immunization strategies of some non-immunization vaccines in China at domestic and overseas
Hai-tian SUI ; Zhong-nan YANG ; Jing-feng SU ; Xiang SHU ; Yang ZHANG ; Xiao-ming YANG
Journal of Public Health and Preventive Medicine 2022;33(5):7-12
The vaccination status of influenza, pneumococcus and other non-immunization planning vaccines at home and abroad and the related researches on effectively improving the vaccination rate were comprehensively reviewed. We found that the vaccination rates of influenza, pneumococci and other vaccines in some countries are at a high level, which is due to the fact that the country has included them in the immunization plan or given government financial support. In addition, a series of multimodal strategies integrating patient education, medical training, electronic information technology and compulsory vaccination have also effectively improved the vaccination coverage. At present, the vaccination rates of influenza, pneumococcus and other vaccines in China are generally low. We should actively learn from the advanced strategies and experience of various countries and take effective measures to improve the vaccination rate, so as to protect people's life and health better.
3.IL-6 Regulates the Chemosensitivity of Drug-Resistant Multiple Myeloma Cell Lines to Bortezomib through STAT3/Notch Signaling Pathway.
Ying LIU ; Jing-Zhe SUI ; Li-Hua ZHU ; Yi DAI ; Hai-Qun DONG ; Peng CHENG
Journal of Experimental Hematology 2022;30(5):1474-1481
OBJECTIVE:
To investigate the effect of interleukin-6 (IL-6) on the chemosensitivity of drug-resistant multiple myeloma (MM) cell lines to bortezomib (BTZ) and its mechanism.
METHODS:
Peripheral blood samples were collected from patients with BTZ-resistant MM before and after treatment. Human MM cell lines KM3 and KM3/BTZ were cultured in vitro. ELISA was used to detect the content of IL-6 in peripheral blood of MM patients, KM3 and KM3/BTZ cells. CCK-8 assay was used to detect the drug sensitivity of KM3 and KM3 / BTZ cells to BTZ. KM3 / BTZ cells were divided into KM3/BTZ control group (normal culture for 48 h), IL-6 neutralizing antibody Anti-IL-6 group (500 ng/ml Anti-IL-6 treated for 48 h), BTZ group (300 ng/ml BTZ treated for 48 h), BTZ + Anti-IL-6 group (300 ng/ml BTZ and 500 ng/ml Anti-IL-6 treated for 48 h). The proliferation activity of KM3 / BTZ cells was detected by CCK-8 assay. The cell cycle distribution of KM3/BTZ cells was detected by flow cytometry. The apoptosis of KM3/BTZ cells was detected by Annexin V-FITC/PI double staining. The mRNA expression levels of IL-6, Notch1, signal transducer and activator of transcription 3 (STAT3) in KM3/BTZ cells were detected by real-time fluorescent quantitative PCR (qRT-PCR), and the protein expression levels of IL-6, Notch1, STAT3 in KM3/BTZ cells were detected by Western blot.
RESULTS:
The level of IL-6 in peripheral blood of patients with BTZ-resistant MM after treatment was significantly higher than that before treatment (P<0.05). The level of IL-6 in KM3/BTZ cells was significantly higher than that in KM3 cells (P<0.05). The sensitivity of KM3/BTZ cells to BTZ was significantly lower than that of KM3 cells (P<0.05), and the resistance index (RI) was 19.62. Anti-IL-6 and BTZ could inhibit the proliferation of KM3 / BTZ cells, block cell cycle, and induce apoptosis (P<0.05). Compared with single drug treatment, the combined effect of Anti-IL-6 and BTZ was more obvious on KM3/BTZ cells (P<0.05), and significantly down regulated the mRNA and protein expression of IL-6, Notch1 and STAT3 in KM3/BTZ cells (P<0.05).
CONCLUSION
Antagonizing IL-6 can increase the chemosensitivity of MM cells to BTZ, and IL-6 may reduce the sensitivity of MM cells to BTZ through STAT3/Notch signaling pathway.
Antibodies, Neutralizing/therapeutic use*
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Apoptosis
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Bortezomib/therapeutic use*
;
Cell Line, Tumor
;
Cell Proliferation
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Humans
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Interleukin-6/metabolism*
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Multiple Myeloma/drug therapy*
;
RNA, Messenger
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STAT3 Transcription Factor/metabolism*
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Signal Transduction
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Sincalide/therapeutic use*
4.Chinese expert consensus on diagnosis, treatment and prevention of venous thrombus embolism associated with chest trauma (2022 version)
Kaibin LIU ; Yi YANG ; Hui LI ; Yonten TSRING ; Zhiming CHEN ; Hao CHEN ; Xinglong FAN ; Congrong GAO ; Chundong GU ; Yutong GU ; Guangwei GUO ; Zhanlin GUO ; Jian HU ; Ping HU ; Hai HUANG ; Lijun HUANG ; Weiwei HE ; Longyu JIN ; Baoli JING ; Zhigang LIANG ; Feng LIN ; Wenpan LIU ; Danqing LI ; Xiaoliang LI ; Zhenyu LI ; Haitao MA ; Guibin QIAO ; Zheng RUAN ; Gang SUI ; Dongbin WANG ; Mingsong WANG ; Lei XUE ; Fei XIA ; Enwu XU ; Quan XU ; Jun YI ; Yunfeng YI ; Jianguo ZHANG ; Dongsheng ZHANG ; Qiang ZHANG ; Zhiming ZHOU ; Zhiqiang ZOU
Chinese Journal of Trauma 2022;38(7):581-591
Chest trauma is one of the most common injuries. Venous thromboembolism (VTE) as a common complication of chest trauma seriously affects the quality of patients′ life and even leads to death. Although there are some consensus and guidelines on the prevention and treatment of VTE at home and abroad, the current literatures lack specificity considering the diagnosis, treatment and prevention of VTE in patients with chest trauma have their own characteristics, especially for those with blunt trauma. Accordingly, China Chest Injury Research Society and editorial board of Chinese Journal of Traumatology organized relevant domestic experts to jointly formulate the Chinese expert consensus on the diagnosis, treatment and prevention of chest trauma venous thromboembolism associated with chest trauma (2022 version). This consensus provides expert recommendations of different levels as academic guidance in terms of the characteristics, clinical manifestations, risk assessment, diagnosis, treatment, and prevention of chest trauma-related VTE, so as to offer a reference for clinical application.
6.Efficacy and safety of Shexiang Baoxin pill (MUSKARDIA) in patients with stable coronary artery disease: a multicenter, double-blind, placebo-controlled phase IV randomized clinical trial.
Jun-Bo GE ; Wei-Hu FAN ; Jing-Min ZHOU ; Hai-Ming SHI ; Fu-Sui JI ; Yang WU ; Yu-Lan ZHAO ; Jun QIAN ; Yuan-Zhe JIN ; Ying-Wu LIU ; Sheng-Huang WANG ; Sheng-Hu HE ; Ping YANG ; Jie WU ; Feng LU ; Zi-Shan HOU
Chinese Medical Journal 2020;134(2):185-192
BACKGROUND:
The Shexiang Baoxin Pill (MUSKARDIA) has been used for treating coronary artery disease (CAD) and angina for more than 30 years in China. Nevertheless, methodologically sound trials on the use of MUSKARDIA in CAD patients are scarce. The aim of the study is to determine the effects of MUSKARDIA as an add-on to optimal medical therapy (OMT) in patients with stable CAD.
METHODS:
A total of 2674 participants with stable CAD from 97 hospitals in China were randomized 1:1 to a MUSKARDIA or placebo group for 24 months. Both groups received OMT according to local tertiary hospital protocols. The primary outcome was the occurrence of a major adverse cardiovascular event (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal stroke. Secondary outcomes included all-cause mortality, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or heart failure, peripheral revascularization, angina stability and angina frequency.
RESULTS:
In all, 99.7% of the patients were treated with aspirin and 93.0% with statin. After 2 years of treatment, the occurrence of MACEs was reduced by 26.9% in the MUSKARDIA group (MUSKARDIA: 1.9% vs. placebo: 2.6%; odds ratio = 0.80; 95% confidence interval: 0.45-1.07; P = 0.2869). Angina frequency was significantly reduced in the MUSKARDIA group at 18 months (P = 0.0362). Other secondary endpoints were similar between the two groups. The rates of adverse events were also similar between the two groups (MUSKARDIA: 17.7% vs. placebo: 17.4%, P = 0.8785).
CONCLUSIONS:
As an add-on to OMT, MUSKARDIA is safe and significantly reduces angina frequency in patients with stable CAD. Moreover, the use of MUSKARDIA is associated with a trend toward reduced MACEs in patients with stable CAD. The results suggest that MUSKARDIA can be used to manage patients with CAD.
TRIAL REGISTRATION
chictr.org.cn, No. ChiCTR-TRC-12003513.
Angina Pectoris
;
China
;
Coronary Artery Disease/drug therapy*
;
Double-Blind Method
;
Drugs, Chinese Herbal/adverse effects*
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Humans
7.Feasibility of balloon dilation with injectable calcium sulfate cement for tibial plateau fractures
Jin-Min CHEN ; Sui-Sheng CHEN ; Jing DING ; Bao-Quan XIA ; Xiao-Jia LUO ; Cheng-Hai LU ; Zhen-Keng YANG
Chinese Journal of Tissue Engineering Research 2018;22(18):2795-2799
BACKGROUND: The balloon dilatation technique plays an important role in the correction of kyphosis. A balloon catheter can enlarge the spinal cavity in kyphoplasty followed by injection of bone cement under low pressure to lay a foundation for the stability of the spine. OBJECTIVE: To explore the feasibility of balloon dilation with injectable calcium sulfate cement for tibial plateau fractures and to analyze its clinical effect. METHODS: Twenty-four upper tibia specimens of the adults were taken to make the Schatzker Ⅲ collapsed fracture model of the tibial plateau. Then, these specimens were randomized into three groups: the standard group was subjected to poking reduction with autologus bone grafting and screw internal fixation, the bone cement group was inflated with balloon dilatation followed by calcium sulfate cement injection, and the combined group was treated with fixation with cancellous bone screws and balloon dilatation followed by injection of calcium sulfate cement. The general situation of reduction and fixation was observed and the reduction effect was measured. RESULTS AND CONCLUSION: (1) Fixation effect in the model: All three models were well reset, and the average displacement of the standard group, the simple bone cement group and the bone cement screw group was (-0.22±0.62), (-0.23±0.67), and (-0.20±0.69) mm, respectively. There was no significant difference in the displacement between the three groups (P > 0.05). (2) Clinical application: One case of Schatzker type Ⅱ fracture of the left tibial plateau was treated with cancellous bone screw fixation and balloon dilatation followed by injection of calcium sulfate cement. X-ray results showed calcium sulfate cement was visible at 3 postoperative days. At 30 postoperative days, the patient presented with good joint range of motion, and the calcium sulfate was partially absorbed on the X-ray film. At 60 postoperative days, the patient appeared to have no joint extension disorder, and fracture healing and absorption of calcium sulfate as shown by X-rays. To conclude, the balloon dilation with injectable calcium sulfate cement for the treatment of tibial plateau fracture is feasible and has clinical value.
8.Clinical Observation of Shuanghuanglian Injection in the Treatment of Acute Exacerbation of Chronic Ob-structive Pulmonary Disease
Zhenhuan ZHAO ; Weili JING ; Yan JIANG ; Zhongguo SUI ; Hai DONG
China Pharmacy 2016;27(29):4096-4098
OBJECTIVE:To evaluate the clinical efficacy of Shuanghuanglian injection in the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD),and to observe its effects on the plasma levels of C-reactive protein (CRP),procalcitonin(PCT)and interleukin-6(IL-6). METHODS:A total of 100 AECOPD patients were randomly divided into observation group and control group,with 50 cases in each group. Control group received routine treatment,such as controlled oxygen therapy,intravenous dripping of moxifloxacin,bronchodilator for relieving asthma,mucolytic for eliminating phlegm,nu-tritional support. Observation group was additionally given Shuanghuanglian injection 1 ml/(kg·d)added into 5% Glucose injec-tion 250 ml intravenously,qd,on the basis of control group. Treatment course of 2 groups lasted for 10 d. Clinical efficacies of 2 groups were compared as well as the changes of serum levels of CRP,PCT and IL-6 before and after treatment and the occur-rence of ADR. RESULTS:After treatment,total effective rate of observation group was 96.0%,which was significantly higher than 82.0% of control group,with statistical significance(P<0.05). Before treatment,there was no statistical significance in se-rum levels of CRP,PCT and IL-6 between 2 groups (P>0.05). After treatment,serum levels of CRP,PCT and IL-6 were de-creased significantly in 2 groups,and those of observation group were significantly lower than those of control group,with statis-tical significance (P<0.05). There was no statistical significance in the incidence of ADR between 2 groups (P>0.05). CON-CLUSIONS:Shuanghuanglian injection can effectively improve serum inflammatory factors of AECOPD patients,and shows good clinical efficacy and safety.
9.Effect of yangxinkang tablets on chronic heart failure: A multi-center randomized double-blind placebo-controlled trial.
Shao-xiang XIAN ; Zhong-qi YANG ; Pei-hua REN ; Xiao-han YE ; Sui-lin YE ; Qing-hai WANG ; Zhao-hui WANG ; Shu-jing SHEN ; Xi-wen HUANG
Chinese journal of integrative medicine 2015;21(10):733-742
OBJECTIVESTo investigate the safety and efficacy of yangxinkang tablets in patients with chronic heart failure (CHF) and syndrome of qi and yin deficiency, blood stasis, and water retention.
METHODSIn a double-blinded, randomized, placebo-controlled, multicenter clinical trail, 228 patients with CHF New York Heart Association (NYHA) class II or III in stage C were assigned by randomized block method to two groups in a 1:1 ratio to undergo either conventional Western treatment or conventional treatment plus yangxinkang tablets for 4 weeks. The outcome measure were effect of cardiac function, Chinese medicine (CM) syndromes, scores of symptoms, signs, and quality of life measured by Minnesota Living with heart failure questionnaire (MLHFQ) before and after the treatment.
RESULTSTotally 112 patients were analyzed in the treatment group and 109 in the control group. They were comparable in NYHA functional class, basic parameters and primary diseases before treatment. Cardiac function and CM syndromes were greatly ameliorated in both groups after treatment. Total effective rates of cardiac function and CM syndrome in the treatment group were significantly higher than those in the control group (P<0.05). Total symptom score and sign score in the treatment group decreased significantly after treatment (P<0.01), which were significantly lower than those in the control group (P<0.05). There were statistically significant differences in post-treatment scores of gasp, cough with phlegm, pulmonary rales and jugular vein engorgement between the two groups (P<0.05 or P<0.01). Three MLHFQ scores decreased significantly in both groups after treatment (P<0.01). Post-treatment total scale score and physical subscale score in the treatment group and the reduction of them showed statistically significant differences (P<0.05) as compared with the control group. There was no significant difference between the two groups in emotional subscale score and the reduction after treatment (P>0.05). There was no obvious adverse reaction in either group noted during the study.
CONCLUSIONSYangxinkang tablets were safe and efficacious in improving cardiac function, CM syndromes, symptoms, signs, and quality of life in patients with CHF class II or III in stage C on the base of conventional treatment.
Aged ; Chronic Disease ; Double-Blind Method ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Heart Failure ; drug therapy ; physiopathology ; Humans ; Male ; Quality of Life ; Surveys and Questionnaires ; Tablets
10.Expression of CD133 in the bone marrow of patients with myelodysplastic syndrome and its clinical significance.
Li-ye ZHONG ; Xin DU ; Su-xia GENG ; Jian-yu WENG ; Hai-tao ZHENG ; Sui-jing WU ; Yang-qiu LI
Journal of Southern Medical University 2011;31(5):854-855
OBJECTIVETo investigate the expression of CD133 in the bone marrow of patients with myelodysplastic syndrome (MDS) and explore its clinical significance.
METHODSThe expression of CD133 and CD34/CD38 in the bone marrow was detected using flow cytometry in 31 cases of refractory anemia with excess blasts (RAEB), 10 cases of refractory cytopenia with multilineage dysplasia (RCMD) and 11 cases of aplastic anemia (AA).
RESULTSThe percentage of CD133-expressing cells was 6.75% in patients with RAEB, significantly higher than that in patients with RCMD (1.41%) and AA (2.70%) (P<0.05); the percentage of CD133-positive cells were similar between the latter two patient groups (P>0.05). The percentage of CD34(+)/CD38- cells was similar in the 3 groups (P>0.05), all lower than 1%.
CONCLUSIONSAdvanced MDS patients are characterized by an increase of CD133-expressing cells, suggesting the value of CD133 in the diagnosis of RAEB. CD34(+)/CD38- cells do not show a significant value in the diagnosis of MDS.
AC133 Antigen ; Anemia, Aplastic ; metabolism ; Antigens, CD ; metabolism ; Antigens, CD34 ; metabolism ; Female ; Flow Cytometry ; Glycoproteins ; metabolism ; Humans ; Male ; Middle Aged ; Myelodysplastic Syndromes ; diagnosis ; metabolism ; Peptides ; metabolism


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