With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.
Clinical Trials as Topic ; Data Collection ; methods ; Information Storage and Retrieval ; methods ; Outsourced Services ; Quality Control

Objective To investigate the clinical values of loop electrosurgical excision procedure (LEEP) in diagnosis and treatment of cervical intraepithelial neoplasia(CIN). Methods Fifty-two patients with cervical intraepithelial neoplasia underwent LEEP following cytology, colposcopy and multiple biopsies, were treated by LEEP. The cure rate, the operative time, bleeding volume and patients reaction of LEEP to the cervical intraepithelial neoplasia were investigated during the follow-up. Results The effective rate was 98.07 % in the patients treated by LEEP. The effective rate was 100 % in the patients in grade CIN Ⅰ or CIN Ⅱ by LEEP. No patients in grade CIN Ⅰ and Ⅱ had recurrence during the follow-up 1 year. The mean operative time was 7.8 minutes. The mean bleeding volume was 10 ml. No secondary bleeding and post-operative infection occurred. All these surgical specimens were checked successfully for pathology diagnosis. Conclusion The advantages to use the LEEP to manage cervical intraepithelial neoplasia include its simpleness to handle, short operative time,less bleeding, less vaginal discharge, safety, and high cure rate. LEEP can offer intact sample for pathological diagnosis. LEEP electrotome is a very ideal therapy for the cervical intraepithelial neoplasia, and can block the development of precancerosis to infiltrating carcinoma effectively.

Epigenetic regulation involved in eukaryotic gene expression plays an important role in the progression of colorectal cancer. Colorectal cancer epigenetics is evolved in DNA methylation which is associated with the activation of oncogene and inactivation of tumor suppressor gene. The potential reversibility of DNA methylation offers exciting opportunities for therapy and diagnosis of colorectal carcinoma.

Triple-negative breast cancer (TNBC) is a special type of breast cancer, accounting for 15%-20% of all diagnosed breast cancer cases. Its estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor-2 (HER-2) expression is negative, with unique biological characteristics, clinicopathological features and tumor heterogeneity. Its clinical features include high incidence of relapse, early metastasis and poor prognosis. Currently, it lacks effective treatment. This review described the clinicopathological features of TNBC, its molecular subtypes, several important pathways and targets, as well as presented the progress in clinical studies of targeted drugs in the hope of generating new ideas for the treatment of TNBC in the future.

With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.

Objective To evaluate retrospectively the efficacy of cistema magna plastic repair in the treatment of Chiari malformation complicated with syringomyelia Methods Fifty-one patients suffered from Chiari malformation complicated with syringomyelia were treated in our department from May 2004 to October 2009. Seventeen patients received cistema magna plastic repairment (the decompression of posterior cranial fossa, duraplastic repair,resection of hernia below cerebellar tonsil and separation of adherence of arachnoid membrane). Results Clinical symptoms disappeared or improved in 15 cases (effective rate of 90%). MRI showed tonsillar herniation disappeared,syringomyelia narrow. MRI showed cistema magna plastic repair, syringomyelia disappeared or significantly thinned and spinal cord subarachnoid space widened. Effective treatment obtained in 12 cases (effective rate 70%). Conclusions The efficiency of Cistern magna plastic repair treating Chiari malformation with syringomyelia is satisfied.

Insulin resistance ,a key component of type 2 diabetes,is recognized as the pathological basis of the metabolic syndrome. H owever,its underlying mechanisms are still not fully understood.Recently,eleva ted levels of free fatty acids (FFA)have been observed in many insulin-resist ance states,which has gradually drawn attention.Not only do FFA interfere in se veral steps involved in glucose metabolism,but also play an important role in i nsulin signal transduction,resulting in decreased insulin-stimulated glucose t ransport. The thiazolidinediones,as insulin-sensitizing drugs,have entered th e market. A prominent effect of these agents is the lowering of circulating FFA levels and it is believed that targeting FFA metabolism may therefore offer wide r expectations in therapy for insulin resistance and type 2 diabetes.

Differences in their pharmacognostic features, microscopic appearance of their powders and UV spectrums, can be used to differentiate Artemisia rupestris from its confusable Achillea millefolium. It is of value to identify them in actual practice.

Objective To study the mechanism of toxicity of hexane. Methods SD rats inhaled 15 g/ma n-hexane statically for 8 hours. Results The levels of GSH in whole blood of rats declined significantly (t-test,P＜0. 01). The levels of MDA in serum of rats revealed increasing trend but without statistical significance (t-test,P＞0. 05). The activities of SOD and GSH-Px in liver of rats decreased significantly (t-test,P＜0.01). Conclusion n-Hexane could induce or enhance the reaction of oxygen free radical in organism,and result in damages of lipid peroxidation,which might be one of the mechanisms of the toxicity of alkane.