1.Post-marketing clinical safety assessment of Shenmai injection based on active monitoring and passive monitoring in large data background.
Lian-xin WANG ; Yan-ming XIE ; Qing-hua AI ; Nian-bin SONG
China Journal of Chinese Materia Medica 2015;40(24):4752-4756
This paper adopted a series of related analysis methods to comprehensively analyze post-marketing clinical safety data of Shenmai injection from 4,220 cases of SRS and 32,358 cases of multicenter, prospective, registered hospital centralized monitoring in large data background, calculated ADR incidence rate was 0.93 per 1,000, main symptoms of ADR includes chest pain, chills, skin itching, palpitations, fever, nausea, dizziness, vomiting, flushing, numbness, allergic reaction, cyanosis, rash, low back pain, and "breath", "anaphylactoid reaction" and "flush" were the safety warning signals of Shenmai injection. Primary disease for chronic pulmonary heart disease, thyroid disease, and combined with cerebral vascular disease, prior to the injection and continuous use of alprostadil, cyclic adenosine monophosphate, combined with quinolones, penicillins were suspicious influence factors of ADR of Shenmai injection, these promot the clinical safety.
Drug Combinations
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Drugs, Chinese Herbal
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adverse effects
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Humans
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Injections
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Product Surveillance, Postmarketing
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Prospective Studies
2.Protein array technology applied in high throughput monoclonal antibody generation.
Kai SONG ; Sai YE ; Jia-Jing ZHOU ; Hai-Lin PENG ; Sheng-Nian WANG ; Ling WEI ; Hua-Sheng XIAO ; Guo-Ping ZHAO ; Qing-Hua ZHANG
Chinese Journal of Biotechnology 2007;23(6):1116-1120
UNLABELLEDTo reduce the huge labor-cost in the screening in traditional monoclonal antibody generation, We established a new system for monoclonal antibody generation integrating with protein array. BALB/c mice were immunized by eight recombinant proteins respectively, and the positive hybridoma cells were obtained by cell fusion and ELISA screening. All the eight kinds of positive hybridoma cells were mixed, cloned, screened by protein array, and definite dilution cloned.
RESULTS175 single cell clones were obtained by complex cloning, and 119 of those were positive clones. Then 8 positive cell lines were generated by the following 2 rounds definite dilution cloning. By comparing with the traditional method, we got 8 monoclonal antibodies using the combined protein array screening and multiplex cloning method in 1 cycle, and fewer amounts of antigens were used. As a result, the combined protein array and multiplex cloning method could be used as an economical, rapid and simple tool applying in high throughput monoclonal antibody generation.
Animals ; Antibodies, Monoclonal ; biosynthesis ; immunology ; isolation & purification ; Female ; Humans ; Hybridomas ; metabolism ; Mice ; Mice, Inbred BALB C ; Protein Array Analysis
3.Observation on marrow-derived mesenchymal stem cells differentiating into functional cells in rabbit with smoke inhalation injury.
Feng ZHU ; Guang-hua GUO ; Ren-sheng CHEN ; Ke-han YU ; Song HUANG ; Nian-yun WANG ; Juan-juan XING
Chinese Journal of Burns 2011;27(2):150-155
OBJECTIVETo observe the homing and differentiation of marrow-derived mesenchymal stem cells (MSC) transplanted intravenously in smoke inhalation injured rabbits.
METHODSThirty-two New Zealand big ear rabbits were divided into normal control group (NC), inhalation injury group (II), normal control + MSC treatment group (NM), and MSC treatment group (MT) according to the random number table, with 8 rabbits in each group. Rabbits in NC group were injected with 10 mL phosphate buffered saline (PBS) via ear marginal vein. Rabbits in NM group were injected with 10 mL PBS containing the third generation MSC labeled by BrdU (1 × 10(7) per 10 mL PBS) via ear marginal vein. Severe smoke inhalation injury model was reproduced in the other two groups, among them rabbits in II group were treated as rabbits in NC group, rabbits in MT group treated as rabbits in NM group. On the 7th and 28th day post treatment (PTD), lung tissue and trachea tissue were harvested from four groups for observation on injury with HE staining. Homing of MSC in injured tissue was observed with immunohistochemistry staining. The differentiation of MSC into functional cells was observed with immunohistochemical double staining of combining nuclear marker BrdU with lung (trachea) membrane-specific marker aquaporin-5 (AQP-5), alkaline phosphatase (AKP), CD34, and cytokeratin respectively.
RESULTS(1) MSC homing in lung and trachea tissue was observed in MT group on PTD 7, which was not observed in NM group. (2) AQP-5, AKP, and CD34 positive MSC were observed in lung tissue in MT group on PTD 28, while cytokeratin positive MSC was not observed in trachea tissue. No positively marked MSC was observed in NM group. (3) Injury in lung and trachea was less severe in MT group than in II group; and the proliferation of fibroblasts was less in MT group.
CONCLUSIONSIntravenous injection of MSC to rabbits with smoke inhalation injury can migrate to lung and trachea tissue at obviously inflammatory site, and differentiate into alveolar epithelial cells typeI and II, and pulmonary vascular endothelial cells, which may participate in the process of tissue repair in smoke inhalation injury.
Animals ; Bone Marrow Cells ; cytology ; Cell Differentiation ; Cells, Cultured ; Endothelial Cells ; cytology ; Epithelial Cells ; cytology ; Lung ; cytology ; Mesenchymal Stem Cell Transplantation ; Mesenchymal Stromal Cells ; cytology ; Pulmonary Alveoli ; cytology ; Rabbits ; Smoke Inhalation Injury ; pathology ; Trachea ; cytology
4.Infectious bovine rhinotracheitis viral gG expression and gG-ELISA development.
Bang-Fen YAN ; Zeng CHEN ; Shu-Huan ZHANG ; Xiang-Mei LIN ; Ying-Yu CHEN ; Yan-Jie CHAO ; De-Xue LI ; Nian-Hua SONG ; Huan-Chun CHEN ; Ai-Zhen GUO
Chinese Journal of Biotechnology 2007;23(5):806-811
Taking the genome DNA of Infectious Bovine Rhinotracheitis Virus (IBRV) as the template, the gG gene was amplified with PCR and cloned into the T cloning vector pMD18-T. After being identified by restriction digestion and DNA sequencing, the insert was subcloned into the expression vector pGEX-KG. Sodium docecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) and Western blot assay showed that this gene was expressed as both soluble form and inclusion body by the transformed E. coli BL21 strain (DE3). The fusion protein was purified and used as the coating antigen to develop the indirect Enzyme-Linked Immunosorbent Assay (ELISA). Comparison between this gG-ELISA and commercial IBRV gB-ELISA Kit (IDEXX) was made in the detection of 380 cow serum samples. The results demonstrated an agreement of 92%. By using this novel gG-ELISA, 1248 cow serum samples were tested and the average positive rate of IBRV antibodies for imported cows is 21.7%, while the positive rate ranged greatly from 0.0%-41.5% for Hubei local Chinese Black and White Dairy Cows.
Animals
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Antibodies, Viral
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blood
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immunology
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Antigens, Viral
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genetics
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immunology
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Cattle
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Cloning, Molecular
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Enzyme-Linked Immunosorbent Assay
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methods
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Escherichia coli
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genetics
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metabolism
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Female
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Herpesvirus 1, Bovine
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genetics
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immunology
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Male
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Recombinant Proteins
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biosynthesis
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genetics
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immunology
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Sensitivity and Specificity
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Viral Proteins
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biosynthesis
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genetics
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immunology
5.Efficacy of inactivated autologous porous bone flap and BAM bone-induced artificial bone for repairing skull defect in rats.
Chao-Min WANG ; Tie-Jian LIU ; Zhen-Hua SONG ; Xiao-Yu GUO ; Da-Nian WEI ; Cheng-Yong LIU
Journal of Southern Medical University 2018;38(6):748-754
OBJECTIVETo study the effect of BAM bone grafting combined with inactivated autologous porous bone flap in repairing skull defect in rats.
METHODSSeventy-two Wistar rats with skull defect were randomly divided into control group, inactivated autologous bone flap group (AB group), BAM bone-induced artificial bone material group (BAM group), and inactivated autologous bone flap with BAM bone-induced artificial bone group (BAM+AB group). The bone healing was evaluated with micro-CT and the new bone formation was assessed with histological staining at 1, 2, and 3 months after modeling.
RESULTSInactivated porous bone flap combined with BAM bone-induced artificial bone effectively induced vascular and fibrous tissue regeneration and osteogenesis in the cranial defects. With the inactivated porous bone flap as the scaffold, BAM bone-induced artificial bone obviously promoted the restoration of the skull appearance in the rats with cranial defects.
CONCLUSIONInactivated autologous bone flap group and BAM bone-induced artificial bone material can promote skull healing and restoration of the original skull appearance, and can be used for reconstruction of the local anatomy of the skull surface.
6.An investigation on satisfaction of occupational health examination and diagnosis of occupational diseases in Zhejiang Province
Zhao-Qiang JIANG ; Song LIN ; Xin-Nian GUO ; Ling-Fang FENG ; Min ZHANG ; Min YU ; Yan-Hua WANG ; Ming-Qiang MA ; Jian-Lin LOU
Journal of Preventive Medicine 2017;29(7):649-652,659
Objective To investigate the employers' and employees' satisfaction of Zhejiang Province on occupation health examination and diagnosis of occupational diseases, and to guide and to standardize the occupation health examination and occupational disease diagnosis. Methods A random sample of 953 employers, 1791 workers with health examination and 135 workers with diagnosis of occupational diseases were selected in the survey, and the questionnaire about the Satisfuction on occupation health examination and occupation disease diagnosis were used in this survey. Results A total of 2879 questionnaires were sent out, in which 2841 valid questionnaires were returned, and the effective recovery rate was 98.68%. The recognition rates on comfortable environment, clear instructions process, workflow notification, and attention notification were all above 98%. The satisfaction rates for all items were above 86%, and the total satisfaction rate was 89.27% . The total satisfaction rates of workers with health examination, workers with diagnosis of occupational diseases and employers were 89.28%, 82.03%, and 90.22%, respectively. The recognition rates on clear instructions process and attention notification, and the satisfaction rates on service attitude, result information and overall satisfaction were significantly different between different types of respondents (P<0.05) . The results of pair wise comparison showed that the satisfaction rates of workers with diseases diagnosis on service attitude, results information and overall satisfaction were significantly lower than those of employers (P<0.05) . The overall satisfaction rate of workers with diagnosis of occupational diseases was lower than that of workers with health examination (P=0.011) . The recognition rates of workers with health examination on clear instructions process and attentions notification were lower than those of employers (P<0.016) . There was a significant difference in the overall satisfaction between respondents in different regions (P<0.01) . Conclusion The service of occupational health examination and occupational disease diagnosis services should be further improved. We should better learn the demands of employees and employers, improve service attitude, optimize service processes, shorten service time, and improve service quality and satisfaction.
7.Evaluate the safety and effi cacy of the CARTO3-based total three-dimensional mapping technique in radiofrequency catheter ablation of elderly patients with atrial fibrillation
cai Yu HU ; 河南郑州,河南中医药大学第一附属医院心内科 ; Rong BAI ; qiang Feng XU ; nan Song LI ; yuan Xue GUO ; Nian LIU ; hua Cai SANG ; yong De LONG ; bo Ri TANG
Chinese Journal of Interventional Cardiology 2017;25(11):622-627
Objective To evaluate the safety and efficacy of the CARTO3-based total three-dimensional(T3D,total three-dimensional)zero X-ray mapping technique in radiofrequency catheter ablation of elderly patients with atrial fibrillation. Methods A total of 60 patients diagnosed with paroxysmal atrial fibrillation underwent radiofrequency catheter ablation at the Beijing Anzhen Hospital Arrhythmia Center from December 2015 to April 2017 were included. All patients were randomly divided into the study group(30 cases) and the control group(30 cases). T3D technique was utilized in the study group, and patients in the control group received conventional AF ablation. The procedure parameters success rate of circumferential pulmonary vein isolation(CPVI), rates of atrial fibrillation recurrence complication were compared between the two groups. Results All the 60 patients with paroxysmal atrial fibrillation had successful atrial fibrillation ablation and finished follow-up. Compared with the control group, the time of atrium three-dimensional reconstruction in the study group was longer [study group vs control group:(57.7±11.0)min vs.(10.4±3.5)min,P<0.001)];X-ray exposure time was significantly shorter in the study group[study group vs control group:0 min vs.(15.73±3.91)min,(P<0.001)]. The diff erence in circumferential pulmonary vein ablation time between the two groups was not of statistical significance[study group vs. control group:(49.9 ± 11.3)min vs.(51.1 ± 12.6)min,P=0.699].CPVI was successful in all patients in both groups. There was no signifi cant diff erence in the early and late recurrence rate and the incidence of complications between the two groups(P>0.05). Conclusions The application of T3D technique in radiofrequency ablation for elderly patients with paroxysmal atrial fi brillation is safe and eff ective, which can reduce the time of X-ray exposure and has important clinical value.
8.New 9, 19-cycloartane triterpenoid from the root of Cimicifuga foetida.
Di-Fan ZHU ; Yin NIAN ; Hai-Yan WANG ; Zhi-Run ZHANG ; Yan-Bo SONG ; Rong-Tao LI ; Ming-Hua QIU
Chinese Journal of Natural Medicines (English Ed.) 2014;12(4):294-296
AIM:
To study the 9, 19-cycloartane triterpenes from the roots of Cimicifuga foetida.
METHOD:
Chromatographic separations by silica gel, C18 reversed phase silica gel, and high-performance liquid chromatography (HPLC) were used. All of the structures were elucidated on the basis of spectroscopic analysis and chemical methods.
RESULTS:
Five 9, 19-cycloartane triterpenes, (3β, 12β, 15α, 24R)-12, 2'-diacetoxy-24, 25-epoxy-15-hydroxy-16, 23-dione-3-O-α-L-arabinopyranoside (1), actein (2), 23-epi-26-deoxyactein (3), asiaticoside B (4), and 12β-hydroxycimigenol (5) were isolated from the roots of Cimicifuga foetida.
CONCLUSION
Compound 1 is a new triterpene with two acetoxy groups at C-2' and C-12.
Cimicifuga
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chemistry
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Drugs, Chinese Herbal
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chemistry
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isolation & purification
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Molecular Structure
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Plant Roots
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chemistry
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Triterpenes
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chemistry
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isolation & purification
9.Prevalence, awareness, treatment, and control of hypertension in the non-dialysis chronic kidney disease patients.
Ying ZHENG ; Guang-Yan CAI ; Xiang-Mei CHEN ; Ping FU ; Jiang-Hua CHEN ; Xiao-Qiang DING ; Xue-Qing YU ; Hong-Li LIN ; Jian LIU ; Ru-Juan XIE ; Li-Ning WANG ; Zhao-Hui NI ; Fu-You LIU ; Ai-Ping YIN ; Chang-Ying XING ; Li WANG ; Wei SHI ; Jian-She LIU ; Ya-Ni HE ; Guo-Hua DING ; Wen-Ge LI ; Guang-Li WU ; Li-Ning MIAO ; Nan CHEN ; Zhen SU ; Chang-Lin MEI ; Jiu-Yang ZHAO ; Yong GU ; Yun-Kai BAI ; Hui-Min LUO ; Shan LIN ; Meng-Hua CHEN ; Li GONG ; Yi-Bin YANG ; Xiao-Ping YANG ; Ying LI ; Jian-Xin WAN ; Nian-Song WANG ; Hai-Ying LI ; Chun-Sheng XI ; Li HAO ; Yan XU ; Jing-Ai FANG ; Bi-Cheng LIU ; Rong-Shan LI ; Rong WANG ; Jing-Hong ZHANG ; Jian-Qin WANG ; Tan-Qi LOU ; Feng-Min SHAO ; Feng MEI ; Zhi-Hong LIU ; Wei-Jie YUAN ; Shi-Ren SUN ; Ling ZHANG ; Chun-Hua ZHOU ; Qin-Kai CHEN ; Shun-Lian JIA ; Zhi-Feng GONG ; Guang-Ju GUAN ; Tian XIA ; Liang-Bao ZHONG ; null
Chinese Medical Journal 2013;126(12):2276-2280
BACKGROUNDData on the epidemiology of hypertension in Chinese non-dialysis chronic kidney disease (CKD) patients are limited. The aim of the present study was to investigate the prevalence, awareness, treatment, and control of hypertension in the non-dialysis CKD patients through a nationwide, multicenter study in China.
METHODSThe survey was performed in 61 tertiary hospitals in 31 provinces, municipalities, and autonomous regions in China (except Hong Kong, Macao, and Taiwan). Trained physicians collected demographic and clinical data and measured blood pressure (BP) using a standardized protocol. Hypertension was defined as systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg, and/or use of antihypertensive medications. BP < 140/90 mmHg and < 130/80 mmHg were used as the 2 thresholds of hypertension control. In multivariate logistic regression with adjustment for sex and age, we analyzed the association between CKD stages and uncontrolled hypertension in non-dialysis CKD patients.
RESULTSThe analysis included 8927 non-dialysis CKD patients. The prevalence, awareness, and treatment of hypertension in non-dialysis CKD patients were 67.3%, 85.8%, and 81.0%, respectively. Of hypertensive CKD patients, 33.1% and 14.1% had controlled BP to < 140/90 mmHg and < 130/80 mmHg, respectively. With successive CKD stages, the prevalence of hypertension in non-dialysis CKD patients increased, but the control of hypertension decreased (P < 0.001). When the threshold of BP < 130/80 mmHg was considered, the risk of uncontrolled hypertension in CKD 2, 3a, 3b, 4, and 5 stages increased 1.3, 1.4, 1.4, 2.5, and 4.0 times compared with CKD 1 stage, respectively (P < 0.05). Using the threshold of < 140/90 mmHg, the risk of uncontrolled hypertension increased in advanced stages (P < 0.05).
CONCLUSIONSThe prevalence of hypertension Chinese non-dialysis CKD patients was high, and the hypertension control was suboptimal. With successive CKD stages, the risk of uncontrolled hypertension increased.
Adult ; Aged ; Awareness ; Female ; Humans ; Hypertension ; complications ; epidemiology ; therapy ; Male ; Middle Aged ; Prevalence ; Renal Insufficiency, Chronic ; complications
10.Efficacy and safety of catheter ablation in patients with new-onset atrial arrhythmia after surgical excision of left atrial myxoma.
Xin ZHAO ; Xin SU ; De Yong LONG ; Cai Hua SANG ; Rong Hui YU ; Ri Bo TANG ; Nian LIU ; Rong BAI ; Chen Xi JIANG ; Song Nan LI ; Xue Yuan GUO ; Wei WANG ; Rong HU ; Jian Zeng DONG ; Chang Sheng MA
Chinese Journal of Cardiology 2021;49(1):60-65
Objective: To evaluate the safety and efficacy of catheter ablation in patients with new-onset atrial arrhythmia after surgical excision of left atrial myxoma. Methods: Nine patients with new onset atrial arrhythmia and a prior history of left atrial myxoma, who received surgical myxoma excision and catheter ablation between September 2014 and November 2019, were included in the present study. Baseline characteristics, procedural parameters during catheter ablation, severe perioperative adverse events, recurrence rate of arrhythmia and clinical prognosis were analyzed. Kaplan Meier survival analysis was used to define the maintenance rate of sinus rhythm after catheter ablation in this patient cohort. Results: Nine patients were included. The average age was (55.8 ± 9.1) years old (3 male), there were 3 patients (3/9) with paroxysmal atrial fibrillation (PAF) and 6 patients (6/9) with atrial flutter or atrial tachycardia (AFL or AT). Ablation was successful in all patients, there were no perioperative complications such as stroke, pericardial effusion, cardiac tamponade, vascular complications or massive hemorrhage. During a mean follow-up time of 40.0 (27.5, 55.5) months, sinus rhythm was maintained in six patients (6/9) after the initial catheter ablation. The overall sinus rhythm maintenance rate was 2/3. In addition, 1 out of the 3 AF patients (1/3) developed recurrence of AF at 3 month after ablation, and 2 out of the 6 AFL or AT patients (2/6) developed late recurrence of AF or AFL (19 months and 29 months after ablation), two out of three patients with recurrent AFs or AFL received repeated catheter ablation and one patient remained sinus rhythm post repeat ablation. Meanwhile, there was no recurrence of atrial myxoma, no death, stroke, acute myocardial infarction and other events during the entire follow-up period. Conclusions: Catheter ablation is a safe and feasible therapeutic option for patients with new-onset atrial arrhythmia after surgical excision of left atrial myxoma.