OBJECTIVES: Clinical research plays a vital role in disease research and population health. The public is the main source of clinical research volunteers. Understanding the public's cognition of clinical research plays a decisive role in the development of clinical research. This study aims to understand the Chinese public's cognition for clinical research and the influencing factors. METHODS: The questionnaire based on Chinese-translated Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment (PARTAKE) was used to investigate the public's cognition for clinical research. RESULTS: Of the 2 513 valid respondents, 91.84% had heard of "clinical research", 91.76% of the respondents believed that clinical research was beneficial to society, 65.90% were willing to participate in clinical research, 87.50% believed that confidentiality was a very important thing, 73.70% believed that their personal information had been protected when participating in clinical research, and, 46.40% did not know whether volunteers participating in clinical research could receive adequate compensation. Educational levels, employment status, and annual income impacted in public perceptions of willingness to participate in clinical research, especially in privacy protection, informed consent, whether clinical research is intended for society, compensation for clinical research, and safety of clinical research (all P<0.01). CONCLUSIONS The Chinese public's cognition level for clinical research is acceptable, but there is still a lot of room for improvement in privacy protection, informed consent, and compensation. By designing a reasonable knowledge training program for clinical research and using the multimedia, improving access to the relevant knowledge, more public will know about clinical research recruitment information, which is of great significance for the development of clinical research in China.
Humans ; China ; East Asian People ; Educational Status ; Surveys and Questionnaires ; Public Opinion ; Knowledge ; Biomedical Research

Objective:To systematically evaluate the effect of hydrocortisone combined with vitamin C and vitamin B1 on the efficacy of patients with sepsis or septic shock.Methods:Databases including CNKI, Sino Med, VIP, Wanfang, PubMed, the Cochrane Library, and Embase were searched from inception to January 2021 for the randomized controlled trial (RCT) about hydrocortisone combined with vitamin C and vitamin B1 to treat sepsis or septic shock. The experimental group was given intravenous injection of hydrocortisone, vitamin B1 and vitamin C based on conventional treatment; the control group was given conventional treatment or placebo/hydrocortisone/hydrocortisone+vitamin B1 based on conventional treatment. Outcome indicators included sequential organ failure assessment (SOFA), mortality, the duration of vasoactive drugs, new acute kidney injury (AKI) patients, length of stay in intensive care unit (ICU) and in hospital. Two researchers independently screened the literature, extracted data, and evaluated the risk of bias in the included studies. RevMan 5.3 software was then used to perform Meta-analysis. Funnel plot was used to test publication bias.Results:A total of 6 articles involving 816 patients were included, with 411 patients in the experimental group and 405 patients in the control group. The Meta-analysis results showed that the duration of vasoactive drugs in the experimental group was significantly shorter than that in the control group [mean difference ( MD) = -24.02, 95% confidence interval (95% CI) was -32.36 to -15.68, P < 0.000 01]. However, there were no significant differences in SOFA, mortality, new AKI patients, the length of ICU stay and hospital stay between the two groups [SOFA: MD = -0.14, 95% CI was -1.15 to 0.87, P = 0.79; mortality: relative risk ( RR) = 0.99, 95% CI was 0.81 to 1.21, P = 0.92; new AKI patients: RR = 1.10, 95% CI was 0.42 to 2.87, P = 0.84; length of ICU stay: MD = 1.33, 95% CI was -2.22 to 4.89, P = 0.46; length of hospital stay: MD = 1.02, 95% CI was -0.66 to 2.69, P = 0.23]. The funnel plot showed that most of the points were symmetrical and showed an inverted funnel shape, suggesting that the publication bias among the studies was small. There was no significant publication bias on this Meta-analysis. Conclusions:Hydrocortisone combined with vitamin C and vitamin B1 can shorten the duration of vasoactive drugs in patients with sepsis or septic shock, but it cannot effectively reduce the SOFA score, mortality, new AKI patients, length of stay in ICU and in hospital. Limited by the number and quality of the included studies, further large-scale, multi-center, blinded, RCT are still needed for verification.

AIM: To study the pharmacokinetic characteristics of single-dose oral moxifloxacin hydrochloride tablets under fasting and fed conditions, and use moxifloxacin hydrochloride tablets produced by Bayer Pharma AG as a reference to compare the pharmacokinetic parameters of the two preparations, and evaluate the human bioequivalence of the two preparations. METHODS: A single-center, randomized, open, two-period, and self-crossover design was adopted to conduct a fasting and fed bioequivalence study of 23 healthy subjects each. The 0.4 g dose preparations were taken orally per cycle on fasting or fed administration. The plasma concentrations of moxifloxacin at different times after administration were determined by HPLC-MS/MS. The main pharmacokinetic parameters were calculated, and the bioavailability of the test preparation relative to the reference preparation was evaluated. RESULTS: After subjects in the fasting group took the test preparation T and the reference preparation R, the main pharmacokinetic parameters of moxifloxacin hydrochloride were: C

AIM: To evaluate the bioequivalence of the test and reference preparations of solifenacin succinate tablets administered once orally under fasting and fed conditions in Chinese healthy volunteers. METHODS: The study was designed as single-center, randomized, open, self-crossover and twenty four healthy volunteers were recruited respectively in fasting and fed conditions. Subjects were assigned to receive a single oral of the test or reference formulation per period at a dose of 10 mg. The plasma concentration of solifenacin was analyzed by LC-MS/MS. The major pharmacokinetic parameters were calculated by WinNonlin 7.0, then the bioequivalence was evaluated.RESULTS: The main pharmacokinetic parameters of a single oral solifenacin succinate under fasting condition for test and reference preparation were as follows: C

Objective: To understand the characteristics relating to the etiology and complications of hand, foot and mouth disease (HFMD) based on data from the pilot National Sentinel Surveillance (NSS) program so as to explore the feasibility, advantages and disadvantages of the NSS. Methods: Data were extracted from the NSS system, conducted in 11 provinces of China from November 2015 to October 2016. Characteristics regarding the etiology, complications of HFMD and factors related to the positive rates of HFMD specimens were analyzed under the logistic regression method by SPSS 20.0 software. Results: A total of 4 783 specimens were collected, including 3 390 from mild, 1 390 from severe and 3 from death cases. The overall positive rate was 81.43% (3 895/4 783). Other enteroviruses (non EV71/Cox A16 enteroviruses) appeared the major serotype (52.68%, 1 482/2 813) for mild infection of the disease while EV71 was for the severe cases (65.31%, 706/1 081). The serotype spectrum revealed by the pilot NSS was almost identical with the existing surveillance system. Other enteroviruses tended to infect younger children (χ²=130.17, P<0.001) than EV71 and Cox A16, in China. The multivariate logistic regression results showed that higher positive rate was associated with specimens which were collected from males, at children’ hospitals, in peak seasons, timely and in stools. The positive rates presented downwarding trends with the extension of the onset-sampling interval (χ²=14.47, P<0.001 in stool specimen; χ²=31.99, P<0.001 in throat swab; χ²=24.26, P<0.001 in anal swab). Aseptic meningitis, non-brainstem encephalitis and brainstem encephalitis appeared the top three complications of both EV71-associated and other enteroviruses-associated severe HFMD cases. Conclusions Factors as gender, season/place/timeliness of specimen collection, and types of hospital all appeared independently influenced the positive rates. NSS seemed feasible to be used as an alternative or supplement tool to the existing surveillance program in China.

Objective To investigate the clinical severity,etiological classification and risk factors of severe cases with hand,foot and mouth disease (HFMD).Methods A total of 1 489 records on severe and fatal HFMD cases reported to the national pilot surveillance system of HFMD were used to analyze the demographic,medical treatment,etiological classification of the cases.Treatment outcome related risk factors were also studied with multi-variable stepwise logistic regression method.Results Seven out of the 1 489 severe HFMD cases died of this disease.A total of 960 (72.9％) were under three years old and 62.9％ were male and most of the cases (937,62.9％) resided in rural areas.Among all the cases,494 (33.2％) went to seek the first medical assistance at the institutions of village or township level.Durations between disease onset and first medical attendance,being diagnosed as the disease or diagnosed as severe cases were 0(0-1) d,1 (0-2) d and 2 (1-4) d,respectively.In total,773 (51.9％) of the severe HFMD cases were diagnosed as with aseptic meningitis,260 (17.5％) with brainstem encephalitis,377 (25.3 ％) with non-brainstem encephalitis,6 (0.4％) with encephalomyelitis,1 (0.1％) with acute flaccid paralysis,4 (0.3％) with pulmonary hemorrhage/pulmonary edema and 68 (4.6％) with cardiopulmonary failure.Of the etiologically diagnosed 1 217 severe and fatal HFMD cases,642 (52.8％) were with EV71,other enterovirus 261 (21.5％),Cox A16 36 (3.0％),1 (0.1％) with both EV71 and Cox A16.However,277 (22.8％) showed negative on any pathogenic virus.Complication (Z=3.15,P=0.002) and duration between onset and diagnosed as severe cases (Z=3.95,P＜0.001) were shown as key factors related to treatment outcomes.Conclusions Most severe HFMD cases appeared in boys,especially living in the rural areas.Frequently seen complications would include aseptic meningitis,non-brainstem encephalitis and brainstem encephalitis.EV71 was the dominant etiology for severe and fatal cases.Early diagnosis and complication control were crucial,related to the treatment outcome of HFMD.

Objective:To study feasibility of preparing artificial antigen by membrane coated with hapten-carrier.To compare the Emodin-BSA membrane antigen immunogenicity and specificity against the liquid antigen.Methods:Emodin-BSA-PVDF membrane was prepared by the method that BSA was coated on PVDF membrane and the BSA was coupled with Emodin-couplint agent derivative.Rats were immunized by subcutaneous implantation.The immunogenicity and antibody specificity were characterized using Emodin-CA or Chrysophanol-CA or Physcion-CA membrane immunoassay. Results: The immunogenicity of Emodin-BSA coated membrane antigen was higher than Emodin-BSA liquid antigen;the specificity for three anthraquinones was almost the same(P>0.05). Conclusion:Emodin antiserum generated using Emodin-BSA coated membrane antigen has a high immunogenicity and specificity to Emodin.The results show it is feasible that membrane coated with hapten-carrier is used as artificial antigen.

Objective To investigate the significance of bone marrow cell morphology on clinical diagnosis of children hematopoietic diseases.Methods The data of bone marrow cell morphology in the bone marrow puncture specimens from 4 590 children admitted to Children' s Hospital of Shanxi Province from January 2009 to December 2014 were retrospectively analyzed.Results The proportion of infancy patients was the highest in 4 590 bone marrow specimens, accounting for 29.0 ％ (1 333/4 590), then that of the toddler age patients was second highest, accounting for 26.7 ％ (1 224/4 590).The constituent ratio of thrombocytopenic purpura (ITP) at the different ages was the highest.The most common diseases in bone marrow cell morphology diagnosis were in order of ITP, iron deficiency anemia (IDA), infectious bone marrow, leukemia (acute lymphoblastic leukemia, acute myeloid leukemia), aplastic anemia and so on.Conclusions Accurate analysis of bone marrow cell morphology is still the most basic and rapid approach in children with hematopoietic system disease, which has important value.Except hematopoietic system diseases, once fever of unknown origin, hepatosplenomegaly and enlargement of lymph nodes the patients should be early given bone marrow cell morphology check, early diagnosis and therapy.

This study was aimed to establish an HPLC method for simultaneous content determination of valtrate, acevaltrate, and their degradation products, which were baldrinal and 11-ethoxyviburtinal, in Valeriana jatamansi Jones. The separation and quantification of 4 constituents mentioned above were performed on an Agilent ZORBAX SB-C18 (4.6 mm×250 mm, 5 μm). The mobile phase consisted of water (A) - acetonitrile (B) with an optimized gradient program. The flow rate was 1 mL·min-1. The column temperature was set at 25℃. The wavelength was set at 241 nm. And the injection volume was 10μL. The results showed that among 14 different places of V. jatamansi, the 4 contents determined were different. The contents of valtrate, acevaltrate, and baldrinal in the Yunnan Baoshan Mount were the highest. And the content of 11-ethoxyviburtinal was the highest in Yunnan Dali. It was concluded that the method was with good precision, reproducibility and stability. And it was suitable for the determination of 4 valepotriates ingredients in V. jatamansi. It also provided references for the quality control and exploitation of V. jatamansi.

Objective To evaluate the clinical significance of minimal residual disease (MRD)detecion in ALL-B of children by flow cytometric (FCM).Methods 52 cases of children with ALL-B were performed bone marrow MRD by FCM analisis after induction therapy,3 moths therapy,and 6 moths therapy.After that,MRD detection was performed every 6 months. According to disease risks, three group were categorized,standard risk (SR),imidiete risk (IR) and high risk(HR).Results After 6 months,SR groups MRD positive cases were 4/21(19 ％),IR groups MRD position cases were 8/23 (35 ％),HR groups MRD position cases were 5/8 (63 ％).9 cases relapsed in all 52 patients.There were significant differrence in replased rate between the positive and negtive MRD (P＜0.001). Conclution The dynamic detection of MRD by FCM can be used to evaluate the therapeutic effect and prognosis of children with ALL-B. It is also useful in adjusting treatment strategy and for following up in children with ALL.