The big-data era has arrived, which involves all professions and trades. Its impact on the medical field has gradually revealed. With the characteristics of big data "4V" (volume, velocity, variety, value) and its theory generality with TCM (holistic thinking, correlativity) as well as regularity of disease development, combined with present status of acupuncture clinical research, the influences of big-data era on trial design, data collection, analysis and sharing of acupuncture clinical research are discussed in this paper, aiming to provide references for solving the difficulties of study design and determining the future research direction of acupuncture clinical research.
Acupuncture Therapy ; Biomedical Research ; Clinical Trials as Topic ; Database Management Systems ; Humans ; Medicine, Chinese Traditional

Objective To study the clinical value of heat shock protein (HSP)70 in the diagnosis of neonatal asphyxia and the correlation of HSP70 and Neonatal Behavioral Neurological Assessment (NBNA)score.Methods From January 2014 to June 2016,full-term neonates born in our hospital were enrolled in the study and assigned into mild and severe asphyxia groups.Normally delivered full-term infants were assigned to the control group.Blood from umbilical artery were extracted immediately after birth and HSP70 levels were detected using ELISA.The NBNA scores were recorded at the 7th,14th and 28th-day after birth.Results HSP70levels in both mild (n =46 )and severe (n =35 )asphyxia groups were significantly higher than the control group(n =50)[(14.4 ±2.7)ng/ml、(17.7 ±4.5)ng/ml than(11 .9 ± 2.3)ng/ml,P <0.05].The severe asphyxia group had even higher HSP70 levels than the mild asphyxia group (P <0.05).The NBNA scores of both asphyxia groups were significantly lower than the control group (P <0.05).The umbilical pH values of both two asphyxia groups were also significantly lower than the control group(P <0.05).Correlation analysis showed that HSP70 level was negative correlated with NBNA score (7th,14th,28th-day)(r =-0.574、-0.493、-0.208,P <0.05).The HSP70 level was negatively correlated with umbilical pH (r =-0.576,P <0.05).The area under curve(AUC)for HSP70 levels to predict asphyxia was 0.798(95%CI 0.722 ~0.874,P <0.05).Conclusions HSP70 level in umbilical cord blood can be used as an indicator for neonatal asphyxia.The more severe the asphyxia,the higher the HSP70 levels and the lower NBNA score and umbilical pH.

Randomized controlled trials (RCT) is the source of the raw data of evidence-based medicine. Blind method is adopted in most of the high-quality RCT. Sham acupuncture is the main form of blinded in acupuncture clinical trial. In order to improve the quality of acupuncture clinical trail, based on the necessity of sham acupuncture in clinical research, the current situation as well as the existing problems of sham acupuncture, suggestions were put forward from the aspects of new way and new designation method which can be adopted as reference, and factors which have to be considered during the process of implementing. Various subjective and objective factors involving in the process of trial should be considered, and used of the current international standards, try to be quantification, and carry out strict quality monitoring.
Acupuncture Therapy ; standards ; Biomedical Research ; standards ; Evidence-Based Medicine ; Humans ; Randomized Controlled Trials as Topic ; standards

Objective To investigate the expression and significance of TGF‐β receptor Ⅰ /TGF‐β receptor Ⅱ (TGF‐β Ⅰ /TGF‐β Ⅱ) in human skin malignant melanoma A375 cell line .Methods The reverse transcription‐real time polymerase chain reac‐tion (RT‐PCR) and Western blot were utilized to assess the expressions of TGF‐βR Ⅰ /TGF‐‐βR Ⅱ in A375 cell line and human normal melanocytes .Results The expressions of TGF‐βR Ⅰ /TGF‐‐βR Ⅱ mRNA and protein of A375 cells line were significantly lower than those of human normal melanocytes .Conclusion The down‐regulated expression of TGF‐βR in the TGF‐β/Smad signal pathway of human skin malignant melanoma may be one of the pathogenesis of skin malignant melanoma .

According to foreign and domestic standards of clinical quality and the author team’ experience summary of long-term clinical study, it has been found that quality control in clinical acupuncture operators is closely related to operator’s ability, good communication between doctors and patients, signature for informed consent, implementation of inclusion and exclusion criteria, practice of blind method and random concealment, patient’s compliance, standardized writing and keeping of CRF, management of instruments and consumables, and coordination and association between researchers. The implementation method of quality control in clinical acupuncture operators is explored by the clinical practice of the author team in “973” project, and analysis and discussion of the above key points.

To provide insights into the mechanism for the attenuate-synergistic effect of Zuota to Tibetan medicine Renqing Mangjue, a contrasted study was carried out on the pharmacokinetics of brucine and strychnine in mice plasm, which are active and toxicant ingredient in the Tibetan medicine Renqing Mangjue. LC-MS/MS was used to detect simultaneously the concentrations of brucine and strychnine in mice plasm at-different time intervals after administration parallelly and randomly, and the pharmacokinetic software Kinetica 5. 0 was selected to non-compartmental analysis (NCA) for data, and statistical analysis software SPSS 19. 0 was used for significance test on the pharmacokinetic parameters. A reliable LC-MS/MS method was established for the determination of brucine and strychnine in blood plasma, which are consistent with the requirements of the preclinical pharmacokinetic study confirmed by the methodology. The linear concentration ranges of brucine and strychnine were 0.301-104.4 µg · L(-1) (r = 0.999 5) and 0.305-106 µg · L(-1) (r = 0.999 7), respectively; The intra-day and inter-day variable coefficients were both less than 10.0% with good precision; The average extraction recoveries of brucine and strychnine were 116.23% and 112.82%, and RSD were 3.2% and 2.3% separately;The average matrix effects of brucine and strychnine were 122.48% and 116.36%, and RSD were 7.7% and 4.4%, respectively. The pharmacokinetic results showed that AUCtot of brucine and strychnine in Zuota group were both increased remarkably (P < 0.05), and the Cmax of brucine in Zuota group was about 5.25-fold higher than that of brucine in non-Zuota group (P < 0.05). The Tmax of brucine and strychnine reduced to one-eighth and one-quarter respectively compared with those in Non-Zuota group. In addition, the eliminations of brucine and strychnine in vivo were accelerated after the compatibility of Zuota. A significant difference (P < 0.05) occurred at the MRT0-t, of brucine, while the MRT0-∞ and Lz of strychnine were statistically significant upon the inspection level α = 0.1. It was found that the absorption degree of brucine and strychnine in Zuota group increased in the range of the safe dose (or concentration), while their elimination rates were accelerated, which may be one of the mechanisms for attenuate-synergistic effect of Zuota to Tibetan medicine Renqing Mangjue.
Animals ; Female ; Male ; Medicine, Tibetan Traditional ; Mice ; Strychnine ; analogs & derivatives ; pharmacokinetics

Literatures on acupuncture-moxibustion treatment of chemotherapy-induced peripheral neuropathy (CIPN) in the recent decade were searched in the databases of Pubmed, MEDLINE, Biological Abstracts, EMBASE, Sinomed, CNKI, Wanfang, VIP, et al. The general situation was comprehensively analyzed and reviewed from experimental design, treatment method, efficacy evaluation, mechanism research and so on. The results showed that acupuncture has a certain therapeutic effect, but the research is still in the preliminary stage, the relative literatures are insufficient and in a low quality. There is still a controversy on the efficacy of acupuncture in the treatment of CIPN. High quality, large sample and multicenter randomized controlled trials and systematic reviews are needed to verify the efficacy of acupuncture. The mechanism of acupuncture treatment of CIPN is still unclear and needs further research and exploration.

Female ; Heart Septal Defects, Atrial ; complications ; Humans ; Levocardia ; complications ; Situs Inversus ; complications ; Young Adult

Objective To understand the clinical distribution characteristics and antimicrobial resistance of pathogens causing healthcare-associated infection(HAI) in a comprehensive hospital.Methods Clinical data of patients with HAI in this hospital between May 2012 and May 2015 were collected,the distribution and antimicrobial resistance of pathogens isolated from patients were analyzed.Results A total of 6 563 cases of HAI occurred among 183 850 patients,incidence of HAI was 3.57％,445 patients were isolated at least two kinds of pathogens,375 (84.27％) patients were isolated two kinds of pathogens,132 of whom were infected with both gram negative bacilli.4 478 specimens were sent for pathogenic detection,2 503 (55.90％) of which were isolated pathogens;a total of 2 755 pathogens were isolated,including 1 713(62.18％) strains of gram-negative bacilli,732(26.57％) gram positive cocci,304(11.03％) yeast-like fungi,and 6(0.22％) anaerobic bacteria.524(19.02％)strains were mainly from patients in department of neurology.The main specimen was sputum (n =1 340,48.64％).The isolation rates of carbapenem-resistant Escherichia coli (CREC),Klebsiella pneumoniae (CRKP),Acinetobacter baumnannii (CRAB),and Pseudomonas aeruginosa (CRPA) were 0.39％ (2/510),1.66％ (3/181),59.14％ (207/ 350),and 5.29 ％ (11/208) respectively;isolation rate of methicillin-resistant Staphylococcus aureus (MRSA) was 21.55％(25/116).Conclusion Multidrug-resistant organisms causing HAl are various,it is necessary to understand distribution characteristics and prevalence of pathogens,monitor multidrug-resistant organisms,and implement contact isolation measures,so as to prevent the outbreak of HAI.

Clinical training together emphasized the combination of theory and practice. It not only improved students'clinical thinking and skills and enhanced their communication skills and medical treatment writing skills but also demanded the teachers to have higher sense of responsibility and teaching skills.