A perfect clinical trial must nave a solid study design, strict conduction, complete quality control, non-interference of statistical result, and acceptable risk-benefit ratio. To reach the target, the quality control (QC) should be performed from the study design to conduction, from the analysis to conclusion. We discuss the relationship between data management and biostatistics from the statistical point of view, and emphasize the importance of the statistical concept and methods in the improvement of data quality in clinical data management.
Biostatistics ; Clinical Trials as Topic ; statistics & numerical data ; Data Collection ; standards ; Quality Control ; Research Design ; standards

OBJECTIVETo investigate the role of autophagy in acute lung injury (ALI) caused by multiple trauma in rats via pretreat with 3-methyladenine (3-MA).

METHODSForty-five Sprague-Dawley male rats, with age of 4 months and body weight of 250-300 g,were randomly divided into three groups. In the sham group, the rats received sphenotresia only;in the control group, the rats were made model of femur shaft fracture combined with brain injury, and treated with physiological saline by abdominal cavity at 1 hour before making model; in the 3-MA group, the rats were made model of femur shaft fracture combined with brain injury,and treated with 3-MA of 10 mg/kg by abdominal cavity at 1 hour before making model. Histologic changes and the concentration of related inflammatory factors in the damaged lung tissue were examined at 48 h after opteration, at the same time, the effect of 3-MA on the expression of LC-3 II and Beclin-1 was examined through reverse transcriptase polymerase chain reaction technique (RT-PCR).

RESULTSCompared with sham group, LC-3 II and Beclin-1 level in control group at 48 h after operation were obviously increased (P < 0.01). Compared with control group, LC-3 II and Beclin-1 level in 3-MA group at 48 h after operation were obviously decreased (P < 0.01). Compared with sham group, the level of proinflammatory cytokines (TNF-α and IL-6) in control group obviously enhanced (P < 0.01). Compared with control group, above items in 3-MA group was obviously lower (P < 0.01). Compared with control group,the histopathological damage of lung in 3-MA group obviously reduced (P < 0.01).

CONCLUSIONAutophagy can aggravate the acute lung injury caused by fracture of shaft of femur combined with brain injuries,but 3-MA can reduce tissue damage by inhibiting the autophagy and inflammatory response.

Acute Lung Injury ; prevention & control ; Adenine ; analogs & derivatives ; therapeutic use ; Animals ; Apoptosis Regulatory Proteins ; analysis ; Beclin-1 ; Interleukin-6 ; analysis ; Lung ; chemistry ; immunology ; pathology ; Male ; Multiple Trauma ; complications ; Rats ; Rats, Sprague-Dawley ; Tumor Necrosis Factor-alpha ; analysis

Objective To investigate the value of 18F-FDG PET/CT in the phasing and grading of renal cell carcinoma (RCC) complicated with vena cava tumor thrombus (VCTT).Methods From December 2011 to September 2015,a total of 72 patients (52 males,20 females,age:36-74 years) were enrolled in this retrospectively study.All patients underwent 18F-FDG PET/CT and contrast-enhanced CT studies,and were diagnosed as RCC.The RCC patients combined with VCTT were classified by Mayo-level.Wilcoxon rank sum test was used to compare the grading of VCTT by PET/CT and contrast-enhanced CT.NM staging on abdominal area level was performed and the results were compared with x2 test.Results VCTT was identified in 18 RCC patients and the grading results by PET/CT were as follows:9 cases in Level 0,4 cases in Level Ⅰ,2 cases in Level Ⅱ,1 case in Level Ⅲ,and 2 cases in Level Ⅳ.When evaluated by PET/CT,20 cases were in N0M0,21 were in N1M0,9 were in N0M1,and 22 were in N1M1.NM staging results by contrast-enhanced CT were as follows:50 cases in N0M0,10 in N1M0,10 in N0M1,and 2 in N1M1.In addition,2 N1 and 2 M1 were found by the whole body PET/CT.The classification results of VCTT and staging of abdominal level by PET/CT were significantly better than those by contrast-enhanced CT (z=-2.462,P＜0.05;x2=32.806,P＜0.01).Conclusion 18F-FDG PET/CT is not only valuable for detecting primary RCC and local metastasis,but also useful for finding where the VCTT extends,which is conducive to therapeutic planning and further clinical treatment.

This paper summed up the medical professionalism as taking patients'interests first , reshaping the medical good faith , improving business ability and promoting social justice .Also proposed that in order to have rea-sonable human resource allocation , ensure the construction of rural health personnel team and stability , the follow-ings are necessary:medical staff at villages and towns setting up the medical ethics , strengthening the altruism spir-it;changing the traditional model of the doctor -patient relationship , adhering to the principle of patient autonomy;cultivating professional sense of responsibility , building moral education;intensive training and striving to improve the level of medical technology;increasing the doctor -patient communication , restoring patients'interests first , re-shaping medical doctor -patient trust integrity , improving business ability and promoting social justice as well as fully exerting the social , moral and cultural supporting factors etc .

The Qinbai Qingfei concentrated pellets by traditional Chinese medicine theoryand party and group, the rats were given the drugs group, comparison of pharmacokinetics parameters changes of baicalin , discusses the rationality of Qinbai prescription. The rats were gavaged monarch drug group (Huang Qincu extract, mainly forbaicalin), and official medicine group, adjuvant group, medicine group and Qinbai group (Quan Fangzu) the content of baicalin equal as the monarch drug group, in the 28 h collection in rat plasma at different time point, application of HPLC determination of baicalin glycosides in rat plasmaconcentration time curve, with 3P97 practical pharmacokinetics program to process the data Based on the data analysis, baicalin in rat plasma of Qinbai group Cmax is 4 times as big as monarch druggroup, AUC is 6 times as big as monarch drug group; the content of baicalin in plasma of rats the highest is Qinbai group, the minister drug group, adjuvant group, medicine group of baicalin in rat plasma content of less than the Qinbai group, but was significantly higher than that of monarch drug group; the medicine group is slightly higher than that adjuvant the content of baicalin in plasma of rats. The pharmacokinetic results show that the measured plasma concentration in rats that Qinbai can significantly increase Cmax and AUC of baicalin, other components of qinbai can promoted the baicalin absorption in vivo. It showed that the reasonable of Qinbai compound compatibility. The minister drug can promote the absorption of baicalin in vivo.
Animals ; Area Under Curve ; Drugs, Chinese Herbal ; analysis ; pharmacokinetics ; Flavonoids ; blood ; pharmacokinetics ; Intestinal Absorption ; Male ; Rats ; Rats, Wistar

ObjectiveA single pump and double arterial lines piglet model was established in this piglet's experiment.The preliminary study of cerebral blood flow proportion and distribution was performed continuously during the procedure.MethodsEight female piglets were utilized in this study.The body weight ranged from 18 kg to 22 kg.The right atrium was carmulated for venous drainage.Double arterial lines were established through cannulating into right carotid artery and ascending aortic aorta.Selective antegrade cerebral perfusion (SACP) through right carotid artery started after bladder temperature was decreased to 20℃ and the perfusion from ascending aortic aorta was interrupted.The perfusion through ascending aortic aorta resumed following 60 minutes of circulatory arrest.Traditional rewarming strategy was adopted and the experiment ended when bladder temperature attained 36℃.The real-time blood flow in the double arterial lines was monitored using a TS410 transit-time tubing flowmeter (Transonic Systems Inc.,Ithaca,NY).Blood pressure in femoral artery,intra-circuit pressure was recorded every five minutes interval.Regional cerebral oxygen saturation ( rSO2 ) was assessed with NIRO-200 oximeter using Near-infrared spectroscopy (Hamamatsu Photonics,Hamamatsu City,Japan )and mixed venous oxygen saturation ( SvO2 ).Blood samples were drawn for blood chemistry measurement prior to extracorporeal circulation,before circulatory arrest and at the end of experiment.ResultsArterial blood pressure was maintained at (60 ± 20) mm Hg.Total blood flow perfusion was(85.30 ±6.81)ml · kg-1 · min-1 and(14.42 ±1.76) ml · kg-1 · min-1 in right carotid artery.The proportion of cerebral blood flow was (16.72 ± 2.77 )％ of total perfusion.Cerebral blood perfusion was controlled with( 15.11 ± 0.44)ml · kg - 1 · min - 1 during SACP.Compared to SvO2,rSO2 remained stable during the procedure.The plasma concentration of

OBJECTIVETo summarize the experience and short-term clinical outcomes of hand-assisted laparoscopic surgery (HALS) in sphincter-preserving surgery for low and ultralow rectal cancer.

METHODSData of 49 patients with rectal cancer who underwent HALS for low or ultralow anterior resection between January 2010 and January 2011 were analyzed retrospectively.

RESULTSThe proximal resection margin was (14.3±6.9) cm and the distal margin was(4.3±1.9) cm. The mean operative time was(128.3±70.9) min. On postoperative macroscopic evaluation, the mesorectum was intact in 42 cases, nearly intact in 7 cases. The circumferential resection margin was more than 2 mm in 42 cases, and less than 2 mm in 7 cases. Forty-six patients underwent R0 resection, and 3 cases underwent R1 resection. The median retrieved lymph node (LN) was 16.20±9.23, and the median positive LN was 1.12±2.19. Postoperative pathological examination showed TNM stage was I( in 12 patients, II(A in 18, II(B in 1, III(A in 2, III(B in 8, III(C in 5, IIII( in 3. The median postoperative hospital stay was (6.25±3.87) d. There were no anastomotic leakage, ileus, intra-abdominal or anastomotic bleeding. There were two wound infections.

CONCLUSIONLow and ultralow anterior resection for rectal cancer using HALS approach is safe and feasible with favorable short-term outcome.

Adult ; Aged ; Aged, 80 and over ; Anal Canal ; surgery ; Female ; Hand-Assisted Laparoscopy ; methods ; Humans ; Male ; Middle Aged ; Rectal Neoplasms ; surgery ; Retrospective Studies ; Treatment Outcome

OBJECTIVETo compare the differences of injuries and recovery between video-assisted thoracoscopic surgery (VATS) and mini-thoracotomy (MT) in patients with clinical early stage non-small cell lung cancer (NSCLC) after lobectomy.

METHODSFrom March 2004 to December 2006, 47 consecutive patients with early stage NSCLC with a diameter of tumor less than 6 cm were recruited and randomized to VATS group and MT group. Incision length, duration of operation and intraoperative blood loss were recorded. Postoperative pain was assessed using a visual analogue scale before operation and daily for the first 7 days after operation. The serum levels of interleukin-6 (IL-6) and interleukin-10 (IL-10) were measured by cytometric bead array before operation and at 4, 24, and 48 h after operation. Karnofsky performance status (KPS) was assessed before operation and daily for the first 7 days after operation.

RESULTSIncision length was (6.0 +/- 0. 9) cm in the VATS group and (12.5 +/- 1.5) cm in the MT group. There was no significant difference in duration of operation and intraoperative blood loss between the VATS group and the MT group. Postoperative pain was significantly less in the VATS group in the 5th to 7th day postoperatively (P < 0.05). There was no significant difference of serum concentrations of IL-6 and IL-10 between the VATS group and the MT group at 4, 24, and 48 h after operation. KPS score was significantly higher in the VATS group on 2nd to 7th day postoperatively (P < 0.05).

CONCLUSIONCompared with MT, VATS for lobectomy has less postoperative pain, faster recovery, but can't reduce postoperative release of cytokines.

Adult ; Aged ; Carcinoma, Non-Small-Cell Lung ; surgery ; Double-Blind Method ; Female ; Humans ; Lung Neoplasms ; surgery ; Male ; Middle Aged ; Pain, Postoperative ; prevention & control ; Pneumonectomy ; methods ; Prospective Studies ; Thoracic Surgery, Video-Assisted ; Thoracotomy

Objective To investigate the relationship between the phenotypes and the patterns of genetic mutations in the corresponding resistance genes (rpoB, katG, inhA, ahpC, rrs, rpsL, embB and gyrA) in resistant Mycobacterium tuberculosis (MTB) isolates. Methods Rifampicin-resistant gene (rpoB), isoniazid-resistant genes (katG, inhA, ahpC), streptomycin-resistant genes (rrs, rpsL), ethambutol-resistant gene (embB) and quinolinone-resistant gene (gyrA) were amplified by PCR with sequence-specific primers, then mutants screened by single-stranded conformation polymorphism (SSCP) were sequenced. Results rpoB mutation with predominant Ser450Trp pattern was 94. 9% (56/59) in 59 rifampicin-resistant isolates;katG mutation rate was 38. 9% (35/90) and the main pattern was Ser315Thr, but only 3 inhA mutants and no ahpC mutation were determined in 90 isoniazid-resistant isolates;gyrA mutation with main Asp94Gly then Ala90Val pattern was 82.4% (28/34) in 34 quinolinone-resistant isolates;the total mutation rate was 77.4% in 31 streptomycin-resistant isolates, of which 15 isolates mutated in rrs with main pattern A514C or A1041G, 10 isolates mutated in rpsL Lys88Arg;and embB mutation with main Met306Val accounted for 19.4% (6/31) in 31 ethambutol-resistant isolates. Conclusions The results showed that resistance of resistant MTB may be complicated, and DNA sequencing-based mutation analysis could efficiently detect the molecular makers such as rpoB, katG, gyrA, rrs, rpsL and embB in resistant MTB isolates. Meanwhile, it is notable that the rpoB mutation pattern in our isolates is different from previous report, further effort are needed to confirm the characteristics. The spectrum of potential resistance-related mutations in MTB clinical isolates may lay substantial foundation for the rapid molecular diagnosis and rational use of drug to MTB patients.

OBJECTIVEThis study examined the levels of exhaled nitric oxide (eNO) and peripheral blood eosinophils (EOS) as well as the correlation between the two markers in children with bronchial asthma (AS),AS complicated by allergic rhinitis (AS/AR) and chronic cough variant asthma (CVA), in order to explore the value of eNOS detection in children with AS.

METHODSThe eNO level was measured using light-emitting electrochemical photometry in 12 children with AS, 29 children with AS/AR and 10 children with CVA. Peripheral blood EOS was counted by blood cell counter (Coulter JT). Forced expiratory volume in one second (FEV1) was assessed by lung function measurement. Thirty children without atopic disease and acute respiratory infection as well as without a family history of atopic diseasea served as the control group.

RESULTSThe levels of eNO and blood EOS in the AS, the AS/AR and the CVA groups were significantly higher than those in the control group (p<0.01). The AS/AR group showed increased levels of eNO (50.3 + or - 6.7 ppb) and EOS (5.9 + or -4.2 x 109 ) compared with the AS (30.5 + or - 8.8 ppb and 4.2 + or - 3.2 x 109 respectively) and the CVA groups (26.0 + or - 3.2 ppb and 3.7 + or - 6.9 x 109 respectively) (p<0.05). There were no significant differences in eNO and EOS levels between the AS and the CVA groups. The eNO level was positively correlated with the EOS level (r=0.51, p<0.05), but not with FEV1 (r=0.144, p>0.05) in the AS group.

CONCLUSIONSNO is highly expressed in children with symptoms of atopy and can reflect the levels of eosinophilic airway inflammation in children with AS.

Adolescent ; Asthma ; blood ; physiopathology ; Breath Tests ; Child ; Child, Preschool ; Eosinophils ; physiology ; Female ; Forced Expiratory Volume ; Humans ; Male ; Nitric Oxide ; metabolism