Source data and its source documents are the foundation of clinical research. Proper source data management plays an essential role for compliance with regulatory and GCP requirements. Both paper and electronic source data co-exist in China. Due to the increasing use of electronic technology in pharmaceutical and health care industry, electronic data source becomes an upcoming trend with clear advantages. To face new opportunities and to ensure data integrity, quality and traceability from source data to regulatory submission, this document demonstrates important concepts, principles and best practices during managing source data. It includes but not limited to: (1) important concepts of source data (e.g., source data originator, source data elements, source data identifier for audit trail, etc.); (2) various modalities of source data collection in paper and electronic methods (e.g., paper CRF, EDC, Patient Report Outcomes/eCOA, etc.); (3) seven main principles recommended in the aspect of data collection, traceability, quality standards, access control, quality control, certified copy and security during source data management; (4) a life cycle from source data creation to obsolete is used as an example to illustrate consideration and implementation of source data management.
China ; Data Collection ; standards ; Documentation ; standards ; Information Storage and Retrieval ; methods ; standards

Objective To explore the clinical manifestations of toxic epidermal necrolysis(TEN) and its rare pulmonary complications.Methods Clinical symptoms,treatment and prognosis of 1 child with TEN caused by carbamazepine were analyzed.Radiological images were reviewed to evaluate the manifestations and the outcome of chronic pulmonary complications associated with TEN.Results The patient had high fever shortly after a dosage increment of carbamazepine.A confluent erythematous exanthema developed rapidly into painful blistering with skin erosion,denudation and involvement of conjunctive and oropharyngeal mucosa.The diagnosis of TEN was made.The mucocutaneous damage was gradually recovered with steroid plus intravenous immunoglobulin for 3 weeks.However,the patient presented with respiratory failure in the recovery phase of TEN.The computer tomography revealed pulmonary bullae and pneumothorax in the right lung.Lung parenchyma was squeezed and pulmonary bullae ruptured with pneumothorax and atelectasis,which were absorbed gradually through thoracic drainages.The patient′s lung function and pulmonary bullae were partly improved during a 7-month follow-up.Conclusions TEN is a severe form of blistering skin di-sease which is characterized by an extensive loss of epidermis and mucous membrane.Chronic pulmonary complications may occur in recovery phase of TEN.Pulmonary bullae,which might be caused by mucous damage and respiratory obstruction,is a rare complication of TEN.

High-speed counter-current chromatography (HSCCC) was used to high performance separate and prepare lignans from Schisandrae chinensis fructus. The solvent system is composed of n-hexane-ethyl acetate-methanol-water (9 : 1 : 5 : 5) and n-hexane-ethyl acetate-methanol-water (9 : 1 : 9 : 5), speed is at 900 r.min-1, and flow rate is at 2.0 mL.min-1. Five fractions from Schisandrae chinensis fructus extract were separated and prepared with one HSCCC process. They were identified as schisandrin, gomisin J, schisandrol B, schisantherin A and deoxyschizandrin by electrospray ionization-multiple tandem mass spectrometry (ESI-MSn), respectively. Their contents were obtained in 98.74%, 94.32%, 99.53%, 94.23% and 98.68% by ultra high performance liquid chromatography (UPLC), separately. The rapid and simple method can be applied for the preparation of lignans from Schisandrae chinensis fructus.
Countercurrent Distribution ; Cyclooctanes ; chemistry ; isolation & purification ; Dioxoles ; chemistry ; isolation & purification ; Drugs, Chinese Herbal ; chemistry ; isolation & purification ; Fruit ; chemistry ; Lignans ; chemistry ; isolation & purification ; Molecular Structure ; Plants, Medicinal ; chemistry ; Polycyclic Compounds ; chemistry ; isolation & purification ; Schisandra ; chemistry ; Spectrometry, Mass, Electrospray Ionization ; Tandem Mass Spectrometry

To evaluate the visual performance of the patients with traumatic corneal astigmatism, after the treatment of topography guided off-flap epipolis laser in situ keratomileusi (off-flap Epi-LASlK).
●METHODS: This prospective clinical study was comprised of 21 eyes of 21 patients with irregular corneal astigmatism caused by trauma, they were treated by off-flap Epi - LASlK from July 2012 to December 2013. The data included uncorrected visual acuity ( UCVA), best spectacle - corrected visual acuity ( BSCVA ), contrast sensitivity 1, 6mo before and after surgery; the healing area percentage of corneal epithelia, the healing time of corneal epithelia and pain score at 3d after surgery.
●RESULTS: Postoperative 1mo both UCVA and BSCVA were improved significantly than that before surgery (t =15. 703, 4. 351, P< 0. 05); Compared with the 1mo after surgery, UCVA at 6mo after surgery raised significantly (t= 6. 867, P <0. 05). There was no statistical significance between 6 and 1mo after surgery about BSCVA (t= 1. 497, P = 0. 140 ). After surgery, mean spherical equivalent (SE) was reduced from -2. 43±3. 02D to -0. 23±0. 49D (P<0. 05), and the mean cylinder was reduced from -1. 86± 2. 23D to - 0. 46 ± 1. 03D (P< 0. 05). Postoperative 1mo,4 kinds of spatial frequency and contrast sensitivity had no significant difference compared with the preoperative (P>0. 05 ). Postoperative 6mo except the 3c/ d spatial frequency, the remaining 3 spatial frequency contrast sensitivity compared with those before operation were significantly improved ( P < 0. 05 ). The healing area percentage of corneal epithelia was 92. 46% ±8. 24% (80% -100%) at 3d after surgery; The healing time of corneal epithelia was 3. 50 ± 1. 56d; Pain scores at 3 and 7d after surgery was 1. 54±1. 32 and 0. 04±0. 64, respectively.
●CONCLUSlON: Topography-guided off-flap Epi-LASlK is safe and effective in treating the patients with traumatic corneal irregular astigmatism. The operation can improve both the contrast sensitivity and the visual performance.

OBJECTIVETo discuss the individual operation standard and safety on the deep puncturing at Tianshu (ST 25).

METHODSThe deep insertion through the peritoneum about 1-2 millimeter was taken as individual standard depth at Tianshu (ST 25) for 39 patients. Using CT cross-section scanning and image surveying, the regression analysis was conducted on the impacts of abdominal circumference (AC,cm) to the peritoneum depth.

RESULTSIt was concluded the formula for calculating the satisfactory depth of individual insertion at Tianshu (ST 25), depth = -0.562 + 0.045 x AC.

CONCLUSIONThe depth of insertion, 1-2 millimeter through peritoneum at Tianshu (ST 25) is safe and feasible in acupuncture treatment, which can be used significantly as the reference and guidance for the assessment of clinical operation and safety on the deep puncturing of the other acupoints on the abdominal region.

Acupuncture Points ; Acupuncture Therapy ; adverse effects ; methods ; Adult ; Aged ; Aged, 80 and over ; Female ; Humans ; Male ; Middle Aged ; Regression Analysis ; Tomography, X-Ray Computed

OBJECTIVETo investigate apoptosis of tumor infiltrating dendritic cells (TIDC) and their expression of Fas/FasL (CD95/CD95L) in human endometrioid adenocarcinoma.

METHODSThe apoptotic rate of TIDC was measured in 45 cases of endometrioid adenocarcinoma and 20 cases of normal endometrium tissues (control) by double-label immunohistochemistry using the monoclonal antibody S-100 protein and TUNEL technique. The expressions of Fas and FasL in TIDCs were detected using double-label immunohistochemistry and imaging analysis.

RESULTSThe apoptotic rate of TIDCs in endometrioid adenocarcinoma were significantly higher than that in normal endormetrium [(13.02∓0.64)% vs (6.82∓0.53)%, P<0.05]. The expression levels of Fas in the TIDCs were significantly lower, whereas FasL expression significantly higher in endometrioid adenocarcinoma than in normal endormetrium (7.88∓1.05 vs 19.25∓3.03, P<0.05; 12.95∓2.25 vs 7.51∓1.14, P<0.05).

CONCLUSIONIncreased apoptosis of the TIDCs and abnormal expression of Fas/FasL in TIDCs in endometrioid adenocarcinoma may lead to tumor immune escape.

Apoptosis ; physiology ; Carcinoma, Endometrioid ; immunology ; metabolism ; pathology ; Case-Control Studies ; Dendritic Cells ; immunology ; Endometrial Neoplasms ; immunology ; metabolism ; pathology ; Fas Ligand Protein ; genetics ; metabolism ; Female ; Humans ; Lymphocytes, Tumor-Infiltrating ; immunology ; Tumor Escape ; fas Receptor ; genetics ; metabolism

Recent reports have clearly demonstrated that bone marrow cells can be differentiated into neurons, suggesting the existence of cells with the differentiation capacity in the bone marrow cell population. It is well known that hematopoietic stem cells as well as mesenchymal stem cells (MSCs) can be transplanted and therefore, alternative of them might contribute to the process. In the present study it was addressed whether marrow MSCs could be coaxed into neuron-specific antigen bearing cells and if so, whether the differentiated cells possess the cytochemical features seen in neurons. The report here showed that high concentration of 2-mercaptoethanol (2-ME) could induce some of the MSCs into neuron-like cells expressing neurofilament (NF) and neuron specific enolase (NSE). The neuron-like cells were alkaline phosphotase positive while the others MSCs were kept negative. Cells treated with 2-ME were positive for alpha-naphthylacetate esterase and glycogen and negative for acetylchonlinesterase, which were similar with the results seen in untreated cells. Furthermore, Nissel body was not observed in treated cells shown by toluidine blue staining. Therefore, it is likely that the cells described here seem not belong to the neuronal lineage. These findings, however, reveal that human MSCs could alter their committed fates under some circumstances.

The physiological effects of Panax notoginseng seedlings under simulated drought stress by PEG 6000 on antioxidant enzymes, osmotic substances and root activities were studied. The results showed that the activity of POD and APX in roots and leaves kept rising with increasing processing concentration and time. However, on the one hand, at the same processing time, SOD in roots and leaves firstly increased and then decreased with the increase of processing concentration. On the other hand, at the same processing concentration, SOD kept rising with the extension of processing time. In addition, the activity of CAT in roots and leaves tended to increase with the increasing concentration at the same processing time, while it increased at first and then decreased with the extension of time at the same concentration. The activity of SOD and APX in stem did not change obviously, whereas CAT activity in stem increased with the increasing processing time and concentration. With the increase of processing concentration and the extension of processing time, the MDA, soluble protein, proline content and root activity in leaves and roots apparently rose. Moreover, fluorescence signal of H2O2 and NO in root tip enhanced as the processing concentration increased after treated for 1 d. In summary, P. notoginseng seedlings could deal with drought stress by means of adjusting the system of antioxidant enzyme, permeating stress substances and impeded stress signal substances. Thus, when the concentration of PEG 6000 was more than 5%, it would have harm on P. notoginseng seedlings.
Dose-Response Relationship, Drug ; Droughts ; Panax notoginseng ; drug effects ; physiology ; Polyethylene Glycols ; pharmacology ; Seedlings ; drug effects ; physiology ; Stress, Physiological ; physiology ; Superoxide Dismutase ; metabolism

The physiological response and bioaccumulation of 2-year-old Panax notoginseng to cadmium stress was investigated under a hydroponic experiment with different cadmium concentrations (0, 2.5, 5, 10 μmol · L(-1)). Result showed that low concentration (2.5 μmol · L(-1)) of cadmium could stimulate the activities of SOD, POD, APX in P. notoginseng, while high concentration (10 μmol · L(-1)) treatment made activities of antioxidant enzyme descended obviously. But, no matter how high the concentration of cadmium was, the activities of CAT were inhibited. The Pn, Tr, Gs in P. notoginseng decreased gradually with the increase of cadmium concentration, however Ci showed a trend from rise to decline. The enrichment coefficients of different parts in P. notoginseng ranked in the order of hair root > root > rhizome > leaf > stem, and all enrichment coefficients decreased with the increase of concentration of cadmium treatments; while the cadmium content in different parts of P. notoginseng and the transport coefficients rose. To sum up, cadmium could affect antioxidant enzyme system and photosynthetic system of P. notoginseng; P. notoginseng had the ability of cadmium enrichment, so we should plant it in suitable place reduce for reducing the absorption of cadmium; and choose medicinal parts properly to lessen cadmium intake.
Cadmium ; pharmacokinetics ; toxicity ; Hydroponics ; Panax notoginseng ; drug effects ; growth & development ; metabolism ; Photosynthesis ; drug effects ; Superoxide Dismutase ; metabolism

CD40/CD40L interactions play a pivotal role in T cell activation, and take part in many physiologic and pathologic procedures and different levels. In this article, stable CHO transformants secreting human CD40-Ig fusion protein were established through transfection and selection with Lipofectamaine and G418, respectively. In order to obtain great valume of recombinant protein, big batch serum-free cultures of engineered CHO cells were performed in roller-bottle using CHO-II-SFM medium. After cultures, the cell-culture supernatants were harvested, concentrated through ultra-filtration, and finally purified by affinity choromatography with Protein G Sepharose Fast Flow. Human peripheral bloods were collected freshly and seperated with Ficoll, CFU-T was cultured in semi-solid culture system with peripheral blood mononuclear cells (PBMNC). Effect of human CD40-Ig fusion protein on the formation of CFU-T was observed in vitro. The results showed that the yield of human CD40-Ig fusion protein was 30 mg in total 3 liter CHO-II-SFM culture supernatant, and it supposed that the expression level of CD40-Ig in CHO cells was more than 10 micro g/ml. The purity of purified fusion protein is above 95%. Furthermore, compared with human IgG, human CD40-Ig fusion protein significantly inhibited the formation of CFU-T at dose 0.25, 1.0, 4.0, and 10 micro g/ml, it lays a good foundation to evaluate its potential functions in vivo.