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

OBJECTIVETo observe the effect of external application of Zhuangshenling Recipe (ZR) combined with Western medicine (WM) on the heart function of chronic heart failure (CHF) patients of Xin-Shen yang deficiency, interior retention of water-fluid syndrome (XSYDIRWFS).

METHODSTotally 140 CHF patients of XSYDIRWFS were randomly assigned to two groups, the treatment group and the control group, 70 in each group. All patients received WM therapy. Those in the treatment group were applied with ZR at Xinshu (BL15) and Shenshu (BL23), while those in the control group were applied with placebos at Xinshu (BL15) and Shenshu (BL23). The therapeutic course for all was 12 weeks. The integrals of TCM syndrome, grading of cardiac function, brain natriuretic polypeptide (BNP), and 6 min walking distance were observed before and after treatment.

RESULTSAfter twelve weeks of treatment, the effective rate of improved grading of cardiac function, the total effective rate of TCM syndrome efficacy, and the BNP level were obviously better in the treatment group (P < 0.05). There was no statistical difference in 6 min walking distance between the two groups (P > 0.05).

CONCLUSIONExternal application of ZR combined with WM could improve the heart function of CHF patients of XSYDIRWFS.

Aged ; Chronic Disease ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Heart Failure ; drug therapy ; Humans ; Male ; Middle Aged ; Treatment Outcome ; Yang Deficiency ; drug therapy

Objective To investigate the patients with postoperative skin damage around the stoma after Miles operation,take measures according to the influencing factors,and explore an effective way to reduce the incidence of skin damage around the stoma patients.Methods There were 62 cases of skin damage around the stoma in 110 cases of patients with permanent colostomy in out-patient follow-up.Each patient with skin damage occurring around the stoma were retrospectively analyzed the reasons,and the related factors that might affect Miles postoperative stoma skin damage were analyzed.Results The incidence rate of Miles postoperative skin damage around the stoma was 56.36％,through the multi-factor Logistic regression analysis,there were six related factors with the Miles postoperative skin damage around the stoma,patients' excrement stimulation,ostomy bag allergies,improper operation of the replacement of the ostomy bag,the potential skin disease,excessive scrub / rub the skin,unfamiliar with ostomy care knowledge were the influencing factors of patients with skin damage around the stoma.Conclusions Appropriate stoma care products and paste methods,detailed guiding of patients and their families about ostomy care knowledge and skills can significantly reduce the incidence rate of Miles postoperative skin damage around the stoma.

Objective To explore the microbial etiology of early onset pulmonary infection after liver transplantation.Methods The 40 episodes of early onset pulmonary infection in 75 patients receiving liver transplantation in our hospital were reviewed and analyzed retrospectively.Results The incidence rate of pulmonary infection was 53.30% in these patients.A total of 54 pathogens were isolated,including 41(75.9%)strains of bacteria and 13(24.1%)fungal isolates.Gram-negative bacillus ac- counted for 68.3%(n=28)of the bacterial isolates,11(39.3%)of which were positive for extended spectrum?-lactamase. Gram-positive coccus accounted for 31.7%(n=13).Seven (58.3%)of the staphylococcal strains were methicillin-resistant. Conclusions The incidence of pulmonary infection is high early af- ter liver transplantation.Most of the isolated pathogens are drug resistant.Culture of sputum or secretion of lower respiratory tract and bedside X-ray examination are useful for the diagnosis.

Objective To compare the treatment effects,dosimetry,and toxicities to organs at risk of intensity-modulated radiation therapy (IMRT) and 3-dimentional conformal radiotherapy (3DCRT) plans for cervical carcinoma patients with recurrence and metastasis. Methods 62 cervical carcinoma patients with recurrence and metastasis were analyzed retrospectively, and divided into two groups including intensitymodulated radiation therapy group (n=29) and 3-dimentional conformal radiotherapy group (n=32).Patients were performed with 6 MV-X ray.The regimen was 1.8-2.2 Gy/f,1 f/d,18-33 times in total.Prescribed dose was 40-60 Gy and median dose was 52.8 Gy. At the same time for the IMRT group 29 cases were performed with 3DCRT, which was designed using the same prescribed dose to compare radiation dose distributed in organs at risk (OAR).Results The maximum dose of the two plans showed that bladder and small intestine in IMRT plans were lower than that in 3DCRT (P＜0.05), showing the IMRT's protective advantage. The maximum dose of PTV in IMRT plans were significantly higher than 3DCRT (P＜0.05). In the group of IMRT plans, the overall 1-,2-,and 3-year survival rates were 65.5 ％(19/29), 42.1％(8/19), and 25.0 ％(2/8),respectively,the median survival time was 19 months,of 28 deaths,21 patients died of tumor progression,7 patients died of distant metastases.In the group of 3DCRT plans,the overall 1-,2-,and 3-year survival rates were 60.6 ％(20/33),35.0 ％(7/20),and 14.3 ％(1/7),respectively,the median survival time was 17 months,of 32 deaths, 24 patients died of tumor progression, 8 patients died of distant metastasis. There were no significant differences in overall 1-, 2-, and 3-year survival rates between the two groups (P＞0.05). The incidence rate of toxicity in the IMRT plans was significantly lower than that in the 3DCRT plans, especially for patients with Ⅰ level and Ⅱ level.Conclusion The treatment effects of the IMRT plans are better than the 3DCRT plans for cervical carcinoma patients with recurrence and metastasis. IMRT plans can improve radiation dose in tumors and reduce the dose distributed in normal issue and reduce the incidence of the side effect.

Objective To analyze the assets and liabilities of secondary public hospitals of Wuhan city in Hubei province ,in order to provide references to control the debt scale of such hospitals .Methods Twenty‐one public secondary public hospitals of Wuhan city were analyzed using official statistics on their asset and liabilities from 2012-2014 .Results Such a timeframe witnessed a year‐on‐year growth of both total assets and liabilities of these hospitals ,yet the growth rate of total assets(35.15% ) falls behind that of total liabilities (53.62% )significantly ;significantly slower growth rate of non‐current assets since 2013 ;higher current liabilities than long‐term liabilities on yearly basis ;year‐on‐year grow th of liquidity rate and quick ratio in general ;significant rise of debt‐to‐assets ratio .Conclusions The overall debt scale of such hospitals keeps growing ,a trend deserving actions and correction .

As an important part of the hierarchical medical system in China ,urban secondary hospitals play as a pivot between tertiary hospitals and community healthcare centers.By describing the overall development status of such hospitals in China ,the paper discussed the problems existing in the development of urban secondary hospitals and put forward strategies in the hope of providing reference for the transformation of these hospitals .

Aim To investigate the effect of sphingo-sine kinase 1 (SphK1 )on unilateral ureteral obstruc-tion(UUO)-induced tubulointerstitial fibrosis and ex-plore the possible mechanism.Methods The CD-1 mice were randomly divided into four groups:sham-op-eration group(Sham),PF-543 treatment control group (Sham +PF-543),model group(UUO)and PF-543 treatment group(UUO +PF-543).On 1 ,3,7 and 1 4 d after operation,eight mice were selected randomly from each group and sacrificed.The protein expressions of SphK1 ,mature TGF-β1 ,FN,ColⅠ,LC3,Beclin1 ,Atg5 and Atg1 2 were observed by Western blot.The histo-logical changes were examined by Masson′s trichrome stain.Immunhistochemistry was performed to measure the levels of expression of SphK1 ,FN and Col Ⅰ. Transmission electron microscope was used to observe the autophagic body.Results SphK1 expression and autophagy were both upregulated in a mouse model of kidney fibrosis induced by UUO. Meanwhile, in-creased mature TGF-β1 and deposition of extracellular matrix(ECM)were observed in tubulointerstitial areas compared with sham-operated mice.After intraperito-neal injection with the SphK1 specific inhibitor PF-543 in UUO mice,enhanced expression of SphK1 and acti-vated autophagy were significantly abrogated.Howev-er,aggravation of renal fibrosis was detected when SphK1 inhibitor PF-543 was applied to suppress SphK1 expression in UUO mice.Conclusion SphK1 activa-tion is renoprotective through the induction of autoph-agy in the pathogenesis of kidney fibrosis.

This study was aimed to construct a lentiviral vector of ha1 gene and obtain a stable packaging cell lines, which will be beneficial to guiding further study on the foundation of ha1 on the dissociation of graft versus host disease (GVHD) and graft versus leukemia (GVL) effect after allogenic hematopoietic stem cell transplantation (allo-HSCT). The targeting ha1 gene was obtained from plasmid T-ha1 by digesting. Then the ha1 gene was subcloned into the lentiviral vector pRRLSIN, cPPT, PGK/GFP, WPRE to construct a lentiviral vector carrying ha1 gene named pLenti-ha1 plasmid. And the pLenti-ha1 plasmid was confirmed by PCR, digesting and sequencing. 293T cells were co-transfected with lentiviral vector pLenti-ha1 and packaging system. The titer of virus was tested by real-time PCR. The results indicated that the construction of ha1 recombinant lentiviral vector was confirmed to be exact by PCR assay, digesting and sequencing; the assayed titer of virus was 2.0 × 10(8) TU/ml. In conclusion, the lentiviral vector of ha1 gene is constructed successfully.
Cell Line ; Gene Expression ; Genetic Engineering ; Genetic Vectors ; Humans ; Lentivirus ; genetics ; Plasmids ; genetics ; Transfection