Effects of Jinqi Zhizhu Decoction on Gastric Motility of GK Rats with Diabetic Gastroparesis / 中国中医药信息杂志

Objective To investigate the effects of Jinqi Zhizhu Decoction (JQZZD) on gastric motility of GK rats with diabetic gastroparesis (DGP); To discuss its mechanism of action. Methods 12 out of 80 male GK rats were randomly selected as normal group, and others were induced to be DGP model by irregular feeding with high sugar and high fat diet for 8 weeks. The model rats were randomly divided into model group, positive medicine group, JQZZD low-, medium-, and high-dose groups. All rats were given continuous intragastric administration for 12 weeks. The residual rate of pigment in stomach was detected and calculated. The concentration of DA, ACh and 5-HT in plasma were detected by ELISA. The morphological changes of gastric antrum were observed by HE staining. The ultrastructure of mucous layer of gastric antrum was observed by transmission electron microscope. The protein expressions of Rho A, ROCK1 and ROCK2 were detected by Western blot. Results Compared with normal group, the residual rate of pigment in model group increased, while DA, ACh and 5-HT, relative amount of protein expressions of Rho A, ROCK1 and ROCK2 decreased (P＜0.01). Compared with model group, the residual rate of pigment in positive medicine group and JQZZD high-dose group decreased, while DA, ACh and 5-HT, relative amount of protein expressions of Rho A, ROCK1 and ROCK2 increased (P＜0.05, P＜0.01), and morphological changes and ultrastructure of mucous layer obviously improved. There was no significant differences in the residual rate of pigment, DA content and protein expressions of Rho A, ROCK1 and ROCK2 between positive medicine group and JQZZD high-dose group (P＞0.05). Compared with JQZZD low-dose group, the residual rate of pigment in JQZZD high-dose group decreased, while DA, ACh and 5-HT, relative amount of protein expressions of Rho A, ROCK1 and ROCK2 increased (P＜0.05, P＜0.01). Conclusion JQZZD may improve gastric motility, promote gastric emptying, and improve and repair damage of mucous membrane in the gastric antrum. All of these may be related to regulating protein expressions of Rho A/ROCK signal pathway.

Master documentation and records in the clinical data management / 药学学报

This list of clincal data management documentation is to ensure standardized and adequate archival of trial documents and records in clinical data management, which is applicable to all of phase I-IV clinical trials.

Documentation archiving in clinical data management / 药学学报

ICH GCP requires that all information of clinical trial should be recorded, processed, and stored in a way that allows the accurate reporting, interpretation and verification. A trial master file (TMF) contains all paper or electronic records/documentations related to a clinical trial. As a tool of the retrospective analysis, the TMF profile should be able to reproduce the full procedure of the trial completely. As a part of TMF profiles, both the accuracy and completeness of clinical data management documentation are important in data integrity. It is helpful to learn the workflow of clinical data management in different stage of a clinical trial, to understand which documents are essential, and why the documentation of clinical data management is important for data integrity. This paper elaborates how to perform the good documentation practice of clinical data management, and suggests that both the precise and efficient document management and regular quality control may ensure the high quality of clinical data documentation management on the basis of an intensive awareness of the overall process of clinical data management.

Quality control of statistical analysis in data management of clinical trials / 药学学报

Data is the basis and soul of clinical trials. To obtain accurate data, strict and standard data management is essential, which can be effectively supported by quality control in statistical analysis. In this paper, we briefly introduce the concept of the quality control in clinical trials, and describe its contents and methods. We hope that this work will be helpful to the application of statistical quality control in data management of clinical trials.