The authenticity and accuracy of data in clinical trials is extremely important. Any inauthentic data may affect the result of a clinical trial, and cause great loss. In our opinion, inauthentic data includes not only man-made spurious data, but also inaccurate data objectively formed. In this article, the features of inauthentic data are described, how to distinguish inauthentic data is discussed, and the causes of this kind of data are analyzed and concluded, which include: subjective intervention on the result of clinical trials, differentiation of the GCP knowledge level between different investigators, misunderstanding of the protocol, et al. And finally we propose that scientific training to investigators and other involved personnel and quality control during the course of data collection should be strengthened to prevent the occur of inauthentic data in clinical trials.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Drug Evaluation ; Drug Industry ; Humans ; Quality Control

Animals ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Liver Cirrhosis ; therapy ; Phytotherapy

Diagnosis, Differential ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Hepatitis B ; complications ; Humans ; Liver Cirrhosis ; drug therapy ; etiology ; Medicine, Chinese Traditional ; Phytotherapy

Humans ; Liver Cirrhosis

Fibrosis ; Humans ; Integrative Medicine ; Liver Cirrhosis ; diagnosis

Animals ; Diagnosis, Differential ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Evidence-Based Medicine ; Hepatitis B, Chronic ; drug therapy ; Humans ; Liver Cirrhosis ; drug therapy ; Medicine, Chinese Traditional ; Phytotherapy

Humans ; Liver Cirrhosis ; physiopathology ; therapy

OBJECTIVE:To establish a RP-HPLC method for the determination of Peoniflorin in Tiaojingquban tablets. METHODS:The chromatographic separation was performed on VP-ODS column (150mm?4.6mm, 5?m). The mobile phase consisted of methanol-water (25∶75) at a flow rate of 1.0mL?min-1.AUV-detector at 230nm was used. RESULTS:The linear range of Peoniflorin was 24.8～198.4?g?mL-1(r=0.999 9).The mean recovery was 99.36% with RSD being 0.86% (n=6).CONCLUSION:The method is simple, rapid, sensitive and reproducible, and it can be used for the quality control of Tiaojingquban tablets.

24hr after partial hepatectomy, the isolated remnant liver of rat was perfused to study the effects of several factors on the ability of amino acid intake. The results were as follows: (1). Twenty-four hours after operation the hepatic uptakes of amino acid increased in the hepatectomized groups. The ability of enhanced amino acid uptake by remnant liver depended on hepatic protein synthesis. In a certain range of hepatectomy there was a positive correlation between the amounts of liver which had been cut off and the amounts of amino acid uptake by remnant liver. (2). The addition of insulin alone to the perfusate could stimulate amino acid uptakes by remnant liver and the addition of glucagon alone had no effect. But, when insulin was added to the perfusate in combination with glucagon the hepatic uptake of amino acid was much higher. (3). The extract from regenerating rat liver rather than that from normal adult rat liver may contain certain factor(s) which can stimulate amino acid uptakes by remnant liver.

The treatment for severe acute respiratory syndrome (SARS) that happened epidemically this spring confirmed again that the integrated traditional Chinese and western medicine had its clinical advantage and vitality, and indicated that this integration could benefit the pathologic understanding and therapeutic strategies for the diseases. Based on the experimental research, western medicine focuses on the histological and structural changes of the diseases. In order to probe the key mechanisms of the disease's occurrence and development, it tries to develop the therapy targeting the mechanism. Materialism is the academic characteristic of western medicine. Based on the differentiation of individual patient and comprehensive analysis of all manifestations, with the academic characteristic of dynamics and dialectics, traditional Chinese medicine (TCM) focuses on the regulation and recovery of the body functions. Theoretically, materialism and dialectics are complementary to each other. Their combination and unity is the key point for the integration of TCM with western medicine in order to improve the clinical effectiveness and TCM development. Therefore, we must adhere to the principles of the evidence-based medicine, strengthen the integrated study on "disease" of western medicine and "syndrome" of TCM, insist on "materialism" and improve the understanding of the mechanism of Chinese herb formula, pay efforts on the clinical study of difficult and common hepatic diseases, in order to develop the integrated traditional and western medicine on liver diseases.