1.Evaluation of metoprolol standard dosing pathway in Chinese patients with acute coronary syndrome: a prospective multicenter single-arm interventional study.
Xiao-Yun YIN ; Yun-Mei ZHANG ; Ai-Dong SHEN ; Jing-Ping WANG ; Zhe-Xun LIAN ; Yi-Bing SHAO ; Wen-Qi ZHANG ; Shu-Ying ZHANG ; Yang ZHENG ; Kang CHENG ; Biao XU ; Cheng-Xing SHEN ; Rong-Chong HUANG ; Jin-Cheng GUO ; Guo-Sheng FU ; Dong-Kai SHAN ; Dan-Dan LI ; Yun-Dai CHEN
Journal of Geriatric Cardiology 2023;20(4):256-267
OBJECTIVE:
To evaluate the feasibility and tolerability of metoprolol standard dosing pathway (MSDP) in Chinese patients with acute coronary syndrome (ACS).
METHODS:
In this multicenter, prospective, open label, single-arm and interventional study that was conducted from February 2018 to April 2019 in fifteen Chinese hospitals. A total of 998 hospitalized patients aged ≥ 18 years and diagnosed with ACS were included. The MSDP was applied to all eligible ACS patients based on the standard treatment recommended by international guidelines. The primary endpoint was the percentage of patients achieving the target dose at discharge (V2). The secondary endpoints included the heart rate and blood pressure at V2 and four weeks after discharge (V4), and percentage of patients experiencing bradycardia (heart rate < 50 beats/min), hypotension (blood pressure < 90/60 mmHg) and transient cardiac dysfunction at V2 and V4.
RESULTS:
Of the 998 patients, 29.46% of patients achieved the target dose (≥ 95 mg/d) at V2. The total population was divided into two groups: target group (patients achieving the target dose at V2) and non-target group (patients not achieving the target dose at V2). There was significant difference in the reduction of heart rate from baseline to discharge in the two groups (-4.97 ± 11.90 beats/min vs. -2.70 ± 9.47 beats/min, P = 0.034). There was no significant difference in the proportion of bradycardia that occurred in the two groups at V2 (0 vs. 0, P = 1.000) and V4 (0.81% vs. 0.33%, P = 0.715). There was no significant difference in the proportion of hypotension between the two groups at V2 (0.004% vs. 0.004%, P = 1.000) and V4 (0 vs. 0.005%, P = 0.560). No transient cardiac dysfunction occurred in two groups during the study. A total of five adverse events (1.70%) and one serious adverse event (0.34%) were related to the pathway in target group.
CONCLUSIONS
In Chinese ACS patients, the feasibility and tolerability of the MSDP have been proved to be acceptable.
2.A multicenter epidemiological study of acute bacterial meningitis in children.
Cai Yun WANG ; Hong Mei XU ; Jiao TIAN ; Si Qi HONG ; Gang LIU ; Si Xuan WANG ; Feng GAO ; Jing LIU ; Fu Rong LIU ; Hui YU ; Xia WU ; Bi Quan CHEN ; Fang Fang SHEN ; Guo ZHENG ; Jie YU ; Min SHU ; Lu LIU ; Li Jun DU ; Pei LI ; Zhi Wei XU ; Meng Quan ZHU ; Li Su HUANG ; He Yu HUANG ; Hai Bo LI ; Yuan Yuan HUANG ; Dong WANG ; Fang WU ; Song Ting BAI ; Jing Jing TANG ; Qing Wen SHAN ; Lian Cheng LAN ; Chun Hui ZHU ; Yan XIONG ; Jian Mei TIAN ; Jia Hui WU ; Jian Hua HAO ; Hui Ya ZHAO ; Ai Wei LIN ; Shuang Shuang SONG ; Dao Jiong LIN ; Qiong Hua ZHOU ; Yu Ping GUO ; Jin Zhun WU ; Xiao Qing YANG ; Xin Hua ZHANG ; Ying GUO ; Qing CAO ; Li Juan LUO ; Zhong Bin TAO ; Wen Kai YANG ; Yong Kang ZHOU ; Yuan CHEN ; Li Jie FENG ; Guo Long ZHU ; Yan Hong ZHANG ; Ping XUE ; Xiao Qin LI ; Zheng Zhen TANG ; De Hui ZHANG ; Xue Wen SU ; Zheng Hai QU ; Ying ZHANG ; Shi Yong ZHAO ; Zheng Hong QI ; Lin PANG ; Cai Ying WANG ; Hui Ling DENG ; Xing Lou LIU ; Ying Hu CHEN ; Sainan SHU
Chinese Journal of Pediatrics 2022;60(10):1045-1053
Objective: To analyze the clinical epidemiological characteristics including composition of pathogens , clinical characteristics, and disease prognosis acute bacterial meningitis (ABM) in Chinese children. Methods: A retrospective analysis was performed on the clinical and laboratory data of 1 610 children <15 years of age with ABM in 33 tertiary hospitals in China from January 2019 to December 2020. Patients were divided into different groups according to age,<28 days group, 28 days to <3 months group, 3 months to <1 year group, 1-<5 years of age group, 5-<15 years of age group; etiology confirmed group and clinically diagnosed group according to etiology diagnosis. Non-numeric variables were analyzed with the Chi-square test or Fisher's exact test, while non-normal distrituction numeric variables were compared with nonparametric test. Results: Among 1 610 children with ABM, 955 were male and 650 were female (5 cases were not provided with gender information), and the age of onset was 1.5 (0.5, 5.5) months. There were 588 cases age from <28 days, 462 cases age from 28 days to <3 months, 302 cases age from 3 months to <1 year of age group, 156 cases in the 1-<5 years of age and 101 cases in the 5-<15 years of age. The detection rates were 38.8% (95/245) and 31.5% (70/222) of Escherichia coli and 27.8% (68/245) and 35.1% (78/222) of Streptococcus agalactiae in infants younger than 28 days of age and 28 days to 3 months of age; the detection rates of Streptococcus pneumonia, Escherichia coli, and Streptococcus agalactiae were 34.3% (61/178), 14.0% (25/178) and 13.5% (24/178) in the 3 months of age to <1 year of age group; the dominant pathogens were Streptococcus pneumoniae and the detection rate were 67.9% (74/109) and 44.4% (16/36) in the 1-<5 years of age and 5-<15 years of age . There were 9.7% (19/195) strains of Escherichia coli producing ultra-broad-spectrum β-lactamases. The positive rates of cerebrospinal fluid (CSF) culture and blood culture were 32.2% (515/1 598) and 25.0% (400/1 598), while 38.2% (126/330)and 25.3% (21/83) in CSF metagenomics next generation sequencing and Streptococcus pneumoniae antigen detection. There were 4.3% (32/790) cases of which CSF white blood cell counts were normal in etiology confirmed group. Among 1 610 children with ABM, main intracranial imaging complications were subdural effusion and (or) empyema in 349 cases (21.7%), hydrocephalus in 233 cases (14.5%), brain abscess in 178 cases (11.1%), and other cerebrovascular diseases, including encephalomalacia, cerebral infarction, and encephalatrophy, in 174 cases (10.8%). Among the 166 cases (10.3%) with unfavorable outcome, 32 cases (2.0%) died among whom 24 cases died before 1 year of age, and 37 cases (2.3%) had recurrence among whom 25 cases had recurrence within 3 weeks. The incidences of subdural effusion and (or) empyema, brain abscess and ependymitis in the etiology confirmed group were significantly higher than those in the clinically diagnosed group (26.2% (207/790) vs. 17.3% (142/820), 13.0% (103/790) vs. 9.1% (75/820), 4.6% (36/790) vs. 2.7% (22/820), χ2=18.71, 6.20, 4.07, all P<0.05), but there was no significant difference in the unfavorable outcomes, mortility, and recurrence between these 2 groups (all P>0.05). Conclusions: The onset age of ABM in children is usually within 1 year of age, especially <3 months. The common pathogens in infants <3 months of age are Escherichia coli and Streptococcus agalactiae, and the dominant pathogen in infant ≥3 months is Streptococcus pneumoniae. Subdural effusion and (or) empyema and hydrocephalus are common complications. ABM should not be excluded even if CSF white blood cell counts is within normal range. Standardized bacteriological examination should be paid more attention to increase the pathogenic detection rate. Non-culture CSF detection methods may facilitate the pathogenic diagnosis.
Adolescent
;
Brain Abscess
;
Child
;
Child, Preschool
;
Escherichia coli
;
Female
;
Humans
;
Hydrocephalus
;
Infant
;
Infant, Newborn
;
Male
;
Meningitis, Bacterial/epidemiology*
;
Retrospective Studies
;
Streptococcus agalactiae
;
Streptococcus pneumoniae
;
Subdural Effusion
;
beta-Lactamases
3. Efficacy and safety of alfentanil hydrochloride injection in general anesthesia: A multicenter, double-blind, controlled study
Ming-Hua CHEN ; Yi FENG ; Kai-Ming DUAN ; Wen OUYANG ; Sai-Ving WANG ; Fu-Shan XUE ; Ming-Hua CHEN ; Fu-Shan XUE ; Yi FENG ; Ai-Lin LUO ; Qu-Lian GUO ; Ya-Ping WANG ; Deng-Bin AI ; Gong-Jian LIU ; Kai-Ming DUAN ; Wen OUYANG ; Sai-Ving WANG ; Ai-Lin LUO ; Qu-Lian GUO ; Ya-Ping WANG ; Deng-Bin AI ; Gong-Jian LIU
Chinese Pharmacological Bulletin 2022;38(10):1504-1510
Aim To investigate the effectiveness and safety of alfentanil in general anesthesia.Methods In this study, a multicenter randomized double-blind con¬trolled study was conducted.A total of 352 subjects were selected and randomly assigned to fentanyl group (group A, n =176) and alfentanil group (group 15, n = 176).Anesthesia induction: intravenous midazolam 0.03 mg • kg-1 + fentanyl 25 p.g • kg"'(group A) or alfentanil 4 p,g • kg-1 ( group 15) + propofol 2 mg • kg"1 + rocuronium 0.8 mg • kg"1.Sevoflurane + fent¬anyl ( group A ) or alfentanil ( group B ) + rocuronium were used for anesthesia.The vital signs of patients re¬covery time and extuhation time, anesthesia-related complications and the use of related remedial drugs during anesthesia induction and maintenance were compared between the two groups.Results During the induction and maintenance period of anesthesia, alfentanil and fentanyl could equally effectively inhibit the stress response induced by endotracheal intubation and surgical stimulation.Alfentanil also showed more effective inhibition on stress response induced by endo¬tracheal intubation and surgical stimulation than that of fentanyl ( P < 0.05 ) .However, there was no signifi¬cant difference in the incidence of intraoperative hypo¬tension and hypertension and the time of anesthesia re¬covery and extubation between the two groups.Conclu¬sions Both alfentanil and fentanyl can effectively in¬hibit the stress response induced by surgical stimulation and could be safely used in general anesthesia in sur¬gery.Alfentanil has more advantages in maintaining the stability of blood pressure and heart rate during an¬esthesia induction and maintenance.
4.A multicenter survey of antibiotic use in very and extremely low birth weight infants in Hunan Province.
Ming-Jie WANG ; Shao-Jie YUE ; Jin LIN ; Xi-Rong GAO ; Xiao-Ming PENG ; Meng-Yu CHEN ; Hua-Bao PENG ; Bei CAO ; Yun-Qing ZENG ; Shu-Lian WANG ; Bo WEN ; Xi-Lin HUANG ; Xiao-Ping LI ; Ai-Zhen ZHANG ; Ting CAO ; Yi-Hua CHEN ; Tie-Qiang CHEN ; Chun-Hua YE ; Tao BO ; De-Lin JIANG ; Xiu-Qun HUANG ; Na-Fang REN ; Long-Zhang TAO ; Fang YAO ; Chang-Jun TIAN ; Hong-Ming LI ; Ai-Min ZHANG ; Fu-Rong HUANG ; Wei-Guo ZHANG ; Xiang-Hong CHEN ; Yu-Chan LIU ; Zheng-Lin LIU ; Yan-Shan XU ; Jing-Song MING ; Li CHEN ; Ning-Yi ZHU ; Jun-Min HE ; Sai-Jun YI ; Tuan-Mei WANG ; Zhao-Hui LI ; Gui-Tian WANG
Chinese Journal of Contemporary Pediatrics 2020;22(6):561-566
OBJECTIVE:
To investigate the current status of antibiotic use for very and extremely low birth weight (VLBW/ELBW) infants in neonatal intensive care units (NICUs) of Hunan Province.
METHODS:
The use of antibiotics was investigated in multiple level 3 NICUs of Hunan Province for VLBW and ELBW infants born between January, 2017 and December, 2017.
RESULTS:
The clinical data of 1 442 VLBW/ELBW infants were collected from 24 NICUs in 2017. The median antibiotic use duration was 17 days (range: 0-86 days), accounting for 53.0% of the total length of hospital stay. The highest duration of antibiotic use was up to 91.4% of the total length of hospital stay, with the lowest at 14.6%. In 16 out of 24 NICUs, the antibiotic use duration was accounted for more than 50.0% of the hospitalization days. There were 113 cases with positive bacterial culture grown in blood or cerebrospinal fluid, making the positive rate of overall bacterial culture as 7.84%. The positive rate of bacterial culture in different NICUs was significantly different from 0% to 14.9%. The common isolated bacterial pathogens Klebsiella pneumoniae was 29 cases (25.7%); Escherichia coli 12 cases (10.6%); Staphylococcus aureus 3 cases (2.7%). The most commonly used antibiotics were third-generation of cephalosporins, accounting for 41.00% of the total antibiotics, followed by penicillins, accounting for 32.10%, and followed by carbapenems, accounting for 13.15%. The proportion of antibiotic use time was negatively correlated with birth weight Z-score and the change in weight Z-score between birth and hospital discharge (r=-0.095, -0.151 respectively, P<0.01), positively correlated with death/withdrawal of care (r=0.196, P<0.01).
CONCLUSIONS
Antibiotics used for VLBW/ELBW infants in NICUs of Hunan Province are obviously prolonged in many NICUs. The proportion of routine use of third-generation of cephalosporins and carbapenems antibiotics is high among the NICUs.
Anti-Bacterial Agents
;
Birth Weight
;
Humans
;
Infant
;
Infant, Extremely Low Birth Weight
;
Infant, Newborn
;
Intensive Care Units, Neonatal
;
Surveys and Questionnaires
5.Design and Application of Virtual Isolation Private Cloud Storage in Hospital
Xiao XU ; Ai-Qing LI ; Min-Lian CHEN ; Wai-Guang HU ; Shan-Shan HU
Journal of Medical Informatics 2018;39(1):30-32
In order to improve the access and control of core data in medical information security,the paper builds a virtual isolation private cloud storage architecture in hospital,including virtualized reconstruction,metadata model application based on hierarchical model,access to remote clients design and application based on virtual isolation and so on,providing a reliable method for the isolation and intercommunication between the intranet and extranet.
6.In vitro synergistic interactions between palmatine and commonly used antibiotics
Yun LI ; Yuan L(U) ; Jian LIU ; Feng XUE ; Wei-Wei YANG ; Jia ZHANG ; Ai-Lian SHAN
The Chinese Journal of Clinical Pharmacology 2018;34(7):821-823
Objective To evaluate in vitro synergy between palmatine and commonly used antibiotic against main clinical isolated strains in recent three years.Methods All of 118 strains isolated in recent three years and 2 standard strains were studied.Minimal inhibition concentrations (MIC) were tested by agar dilution method and combination effects were measured by checkerboard method.Results Palmatine showed moderate in vitro activity against Staphylococcus.Synergy was detected with palmatine in combination with levofloxacin against gram-positive and negative strains,though synergistic rate less than 20%.Synergy was not show between palmatine and linezolid.Additive effect was found widely between palmatine and two agents against almost all tested species.Conclusion The results of in vitro synergy tests may be different sometimes on account of various strains,methods,etc.So,more deeper understanding of action mechanism of traditional Chinese medicine and correlation between in vitro test and clinical outcomes will help medical to select antibiotic more suitablly.
7.Determination of sitagliptin in human plasma by HPLC-MS/MS
Ai-Lian SHAN ; Rong-Yuan DAI ; Chao-Qun WANG ; Hao LI
The Chinese Journal of Clinical Pharmacology 2018;34(20):2438-2440
Objective To establish a HPLC-MS/MS method to deter-minate the concentration of sitagliptin in human plasma .Methods The samples were treated by protein precipitation method .The chromato-graphic column was Venusil ASB C 18(2.1 mm ×50.0 mm,3.0 μm), mobile phase was 100% water contained with 0.1% formic acid -100%acetonitrile contained with 0.1%formic acid, flow rate was 0.40 mL· min-1, column temperature was 50 ℃, injection volume was 20.0 μL, mobile phase.The specificity, standard curve and lower limit of quantitation, precision and recovery , matrix effect and stability of the method were investigated.Results The standard curve of metformin was y=4.73×10 -3x+7.32×10 -4( r=0.998 8 ), and sitagliptin had good linear relationship in 1.00 -800.00 ng· mL-1.The limit of quantifica-tion was 1.00 ng· mL-1.The intra-day RSD and inter-day RSD were less than 12.0%, respectively.The recovery rate of extraction was over 95.9%.Conclusion The method is simple, rapid, accurate and sensi-tive, which is suitable for the determination of sitagliptin in human plasma.
8.Design and Application of the Security Mode for the Mobile Business Platform of Hospital
Xiao XU ; qing Ai LI ; lian Min CHEN ; guang Wai HU ; shan Shan HU
Journal of Medical Informatics 2017;38(10):47-50
Taking Children's Hospital in Hunan Province as an example,the paper introduces the design and application of the security mode for the mobile business platform of hospital from the aspects of the overall structure,implementation plans of security access equipment,security authentication modes and strategies,etc.,and provides ideas for safely implementing remote deployment and mobile application.
9.Some opinion of pregnancy test in the drug clinical trial
Qiang ZHANG ; Ping MENG ; Ai-Lian SHAN
The Chinese Journal of Clinical Pharmacology 2017;33(7):579-581,598
During the screening process,the women at childbearing age have to take the pregnancy test in order to avoid the harm of some new drugs for fetal or neonatal.However in the clinical process,some researchers have doubts,for example,if it is necessary for all the childbearing subjects to take a pregnancy test while some subjects do not or have no chance to get pregnant.Whether the regular urine pregnancy test that cannot indeed trace the source could reach the requirements of drug clinical trials'verification? In most clinical protocols,there is such a brief description like pregnancy or lactation women,is it rigid? Therefore,we put forward our own opinion and suggestion after investigating relevant laws,regulation and literature and combining the pregnancy description of 92 drugs clinical trial protocols.We suggest that the childbearing age women who do not or have no chance to get pregnant by asking the medical history do not take the pregnancy test.In the exclusion standard we should describe all the situation of pregnant in detail including the requirement and limitation for mail.What's more,it is also important to strengthen the education of the subjects and pay special attention on the subjects who will get pregnant in a short period for protecting their right and finishing the experiment.
10.Progress in clinical pharmacology of polymyxins
Xu-Zhu MA ; Ai-Lian SHAN ; Xu-Yan CHEN ; Lei DING
The Chinese Journal of Clinical Pharmacology 2017;33(7):665-667,672
With increasing antibiotic resistance among important gram-negative bacteria and the limited development for new antimicrobial agents,there is resurgence in the clinical use of polymyxins,including polymyxin B and polymyxin E.They has demonstrated excellent activity against various Gram-negative bacteria in vitro with complicated and deficient clinical data of pharmacodynamics and pharmacokinetics.This article summarizes polymyxin B and polymyxin E of chemical structure,mechanism,antimicrobial activity,clinical use and toxic effects to provide references for clinical application.

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