Case report form (CRF) is a key document for data collection in clinical trials. A well-designed CRF is required for database construction, data accuracy, data query/cleaning, CRF completion and statistical analysis. A well-defined process or SOP should be in place for CRF design. Data collection should fully meet the demand of study protocol. The layout of CRF should be clear with well-structured fields and standard coding for fields.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Documentation ; standards ; Research Design ; standards

Child ; Diagnosis, Differential ; Humans ; Lung ; pathology ; Lung Diseases, Interstitial ; diagnosis ; therapy ; Male ; Treatment Outcome

Six kinds of saponins (I, II, VII, PA, H) content of 22 samples of Paris polyphylla var. yunnanensis collected from different regions of Yunnan province were determined by HPLC, data was analyzed by SPSS 17. The results showed that the effect of altitude on saponin content was not significant, and the effect of growth area of saponins in P. polyphylla var. yunnanensis was significant, saponin content in sample from west Yunnan was significantly higher than that of samples from other regions.
Altitude ; China ; Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal ; analysis ; Liliaceae ; chemistry ; Saponins ; analysis

AIM:To investigate the operation opportunity and therapeutic effect of intermittent exotropia.

METHODS: A prospective study of 139 patients with intermittent exotropia admitted to our hospital from May 2014 to December 2016 was conducted. Patients were divided into three groups according to their ages: Group A with 58 cases aged between 3 and 7 years old, Group B with 41 cases aged from 8 to 12 years old and Group C with 40 cases aged more than 12 years old. The therapeutic effect of each group was observed.

RESULTS: The postoperative orthographic rate between the three groups at 3d, 1, 3 and 6mo postoperatively had statistical differences(P<0.05). The postoperative orthographic rate of Group A was significantly higher than that of the other two groups at different time points(P<0.05). The postoperative orthographic rate of of Group B at 3d and 1mo after operation was significantly higher than that of Group C(P<0.05). After operation, the stereoscopic function of each group at 6mo postoperatively was significantly improved, and the statistical difference between the groups was significant(P<0.05). The proportion of patients with stereopsis recovered in Group A was significantly higher than those in Groups B and C(P<0.05). There was no significant difference in the preoperative strabismus degree between either two groups(P>0.05), while the degree of strabismus in each group after 6mo was significantly different(P<0.05). And the proportion of strabismus ≤30^△ in Group A was higher than the other two groups(P<0.05). The changes of BCVA among the three groups after operation had significant differences(P<0.01). The BCVA of Group A was better than the other two groups at 3d, 1,3 and 6mo after operation(P<0.05). There were no significant differences between BCVA of 3mo and 6mo after operation in each group(P>0.05). There was a statistically significant difference in the incidence of ocular regression rate in three groups during the 6mo follow-up(P<0.05); that of Group A was lower than Group B and Group C(P<0.05)and Group B were lower than Group C, and the statistical difference between groups was significant(P<0.05).

CONCLUSION: The surgical type of the intermittent exotropia should be based on the classification of strabismus, which can promote postoperative recovery of the eye position and visual function, improve visual acuity, and then avoid ocular regresses.

Objective To investigate the susceptibility of amphotericin B,itroconazol and voriconazole against filamentous fungi.Methods Etest was used to determine the MIC of amphotericin B, itroconazol and voriconazole against filamentous fungi including Aspergillus,Penicillium,Alternaria alternate,Mucor and Rhizopus species.Results The average MIC of voriconazol,amphotericin B and itroconazol against Aspergillus fumiagtus is O.29 ?g/ml,1.16 ?g/ml and 5.88 ?g/ml;the average MIC of amphotericin B and voriconazol to Aspergillus flavus is 6.39 ?g/ml and 0.22 ?g/ml;the average MIC of voriconazol,amphotericin B and itroconazol against Aspergillus niger is 0.69,2.31,and 19.75 ?g/ ml.Most of Penicillium are susceptable to amphotericin B,but 3 strains showed very high MIC to voriconazol and itroconazol.Both of the testing strains of Mucor and Rhizopus were resistant to all of the three antifungal agents.Conclusion Amphotericin B,itroconazol and voriconazole possessed different susceptibility on different types of filamentous fungi.It is important for clinical laboratories to identify the filamentous fungi to the level of genus and species to help physicians choose antifungal agents correctly.

Objective To study antibiotic resistance phenotypes and genotypes of extended spectrum ?-lactamases (ESBLs) and AmpC ?-lactamase-producing Klebsiella oxytoca isolated from specimens of respiratory tract in children.Methods Bacterial isolates were identified by API or VITEK32. Agar dilution was used for antibiotic susceptibility test,and ESBLs and AmpC were detected by confirmatory test recommended by CLSI/NCCLS and by 3-aminophenylboronic acid (APB) disk potentiation test, respectively.Microarray was used to determine the genotypes of ESBLs and AmpC ?-lactamases.Genotypes of Klebsiella oxytoca were determined by enterobacterial repetitive intergenic consensus (ERIC)- PCR.Results ESBLs were positive in 129 out of 165 isolates (78.2%).Both ESBLs and AmpC ?- lactamases were positive in 16 out of 165 isolates (9.7%).AmpC ?-lactamase alone producer was not detected in term of phenotype and genotype.CTX-M was the most common type of ESBLs and DHA was the only type of AmpC ?-lactamase in these isolates.Most antibiotic resistant strains of Klebsiella oxytoca possessed the same genotype by ERIC-PCR.Although all strains were susceptible to carbpenem,Klebsiella oxytoca with ?-lactamases were more resistant to other antibiotic agents than those without ?- lactamases.Conclusions There is high prevalence of ESBLs production among Klebsiella oxytoca isolated from children in Urumqi.The main genotypes of ESBLs and AmpC ?-lactamases are CTX-M and DHA.

OBJECTIVETo explore the effect of Compound Tongtu Granule (CTG) on intestinal permeability in elderly sepsis patients.

METHODSEighty elderly sepsis patients were randomly assigned to the experimental group and the control group by randomized double blinded method, 40 in each group. On the basis of conventional antiseptic treatment program, patients in the experimental group took CTG, while those in the control group took placebos. The dosage for CTG or placebos was 14.3 g each package, one package each time, twice daily for 14 successive days. Patients' abdominal symptoms and signs, levels of serum inflammatory factors (high-sensitivity C-reactive protein and procalcitonin), levels of plasma endotoxin, and the intestinal permeability (IP, represented by urinary lactulose/mannitol excretion rate) were compared between the two groups before and after treatment.

RESULTSAfter 14-day treatment, patients in the experimental group had improved abdominal symptoms, increased frequency of defecation, significantly decreased levels of plasma endotoxin and IP, when compared with the control group (P < 0.05).

CONCLUSIONCTG could improve the intestinal barrier function in elderly sepsis patients.

Aged ; C-Reactive Protein ; metabolism ; Calcitonin ; metabolism ; Calcitonin Gene-Related Peptide ; Defecation ; Drugs, Chinese Herbal ; pharmacology ; therapeutic use ; Endotoxins ; metabolism ; Humans ; Intestines ; metabolism ; Permeability ; Protein Precursors ; metabolism ; Sepsis ; drug therapy ; physiopathology

OBJECTIVETo study the effect of Huoxuezhitong recipe on the pathway of mitochondrial apoptosis and the expression of related gene (Caspase-3, -9, Bax, Bcl-2) in epidural scar tissue.

METHODSA total of 60 New Zealand rabbits, ranging in weight from 2.5 to 3.0 kg, were randomly divided into sham operative group (group A), control group (group B), sodium hyaluronate group (group C), Huoxuezhitong recipe group (group D, included Danggui 20 g, Chishao 20 g, Honghua 20 g, Ruxiang 15 g, Myrrh 15 g etc.) with 15 rabbits in each group. Except for group A, L4,5 vertebral plate were resected leading to 1.0 cm x 1.0 cm dura mater exposed area, which were covered with 0.5 ml sodium hyaluronate in group C, covered with same amount of saline in group B and D. At 2 weeks after operation, the rabbits of group D were administered with Huoxuezhitong recipe (2.5 ml/kg, once a day, continuous 14 d). Five rabbits of each group were selected randomly and were killed at 2, 4 and 8 weeks after operation; and the expression of Caspase-3, -9, Bax, Bcl-2 in scar tissue were surveyed by semiquantitative reverse transcription-polymerase chain reaction (RT-PCR).

RESULTSThe results by RT-PCR showed significant different in expressions of Caspase-3, -9, Bax, Bcl-2 of group A and others groups at each period (P < 0.01). At 2, 4, 8 weeks after operation, compared with group B, the expressions of Caspase-3, -9, Bcl-2 in group C and D were decreased (P < 0.05), but the expression of Bax in group C and D were increased (P < 0.05). At 8 weeks after operation, the expressions of Caspase-3, -9, Bax, Bcl-2 in group D was significant decreased compared with group C (P < 0.05).

CONCLUSIONHuoxuezhitong recipe can regulate the levels of expression of Caspase-3, -9, Bax, Bcl-2 mRNA and further induce the pathway of mitochondrial apoptosis, thereby, achieve the effect of prophylaxis for the proliferation and conglutination of epidural scar tissue.

Actins ; genetics ; metabolism ; Animals ; Apoptosis ; drug effects ; genetics ; Carthamus tinctorius ; Caspase 3 ; genetics ; metabolism ; Caspase 9 ; genetics ; metabolism ; Drugs, Chinese Herbal ; pharmacology ; Female ; Genes, bcl-2 ; drug effects ; genetics ; Mitochondria ; drug effects ; pathology ; Proto-Oncogene Proteins c-bcl-2 ; genetics ; metabolism ; RNA, Messenger ; metabolism ; Rabbits ; Reverse Transcriptase Polymerase Chain Reaction ; bcl-2-Associated X Protein ; genetics ; metabolism

Adolescent ; Biopsy ; Cystic Adenomatoid Malformation of Lung, Congenital ; diagnosis ; diagnostic imaging ; therapy ; Diagnosis, Differential ; Diagnostic Errors ; adverse effects ; prevention & control ; Humans ; Infant ; Lung Diseases ; diagnosis ; diagnostic imaging ; therapy ; Male ; Middle Lobe Syndrome ; diagnosis ; diagnostic imaging ; surgery ; Tomography, X-Ray Computed ; Treatment Outcome

OBJECTIVESTo study the effect of Houxue Zhitong decoration on the expression of the mitochondria-initiated apoptosis pathway and transmembrane protein I an II of the epidural scar tissue.

METHODSA total of 60 New Zealand rabbits (weight: 2.5-3.0 kg) were randomly divided into four groups, sham operation group (D, n=15), control group (B, n=14), sodium hyaluronate group (C, n=15), Houxue Zhitong decoration group (D, n=15). Except for group A, 1.0 cm x 1.0 cm dura mater uncovered area laminectomy was performed at I (4) and I(5), covered with 0.5 ml sodium hyaluronate in group C, covered with same amount of saline in group B and D. First 2 weeks after operation, animals in group D were lavaged with 2.5 ml/kg Houxue Zhitong decoction by one a day for 14 days. Five rabbits of each group selected randomly were killed in the 2,4,8 weeks after laminectomy. The specimens were prepared for determination of the expression of Fas and FasL, at scar tissue by semiquantitative reserve transcription-polymerase chain reaction (RT-PCR). The degree of scar adhesion was evaluated according by Rydell method.

RESULTSThe adhesion area in group B was larger than of group C and D in the 4th and 8th week. However, the number of fibroblasts and inflammantory cells in group D was the least among the three groups in the 8th week. At 2, 4, 8 weeks after operation, as compared with group B the expression of Fas, FasL of group C and D were decreased (P < 0.05). Especially, at 2 weeks, as compared with group B the expression of this two cytokines of group D was significant decreased (P < 0.05), too. In group C and D the duramater adhesion was decreased (P < 0.05). The proliferation of fibroblast and fibroblastic function were inhibited (P < 0.05).

CONCLUSIONHuoxue Zhitong is able to down-regulated the expression of Fas, FasL, which inhibited the proliferation of fibroblast, the fibroblastic function and the synthesis of extracellular matrix in the epidural scar tissue. It is an effective way of reducing peridural scar formation and prevent the failed back surgery syndrome.

Animals ; Apoptosis ; drug effects ; Cicatrix ; genetics ; metabolism ; pathology ; Drugs, Chinese Herbal ; pharmacology ; Epidural Space ; pathology ; Fas Ligand Protein ; genetics ; metabolism ; Female ; Gene Expression Regulation ; drug effects ; Rabbits ; Signal Transduction ; drug effects ; fas Receptor ; genetics ; metabolism