Chinese Medicine Clinical analysis of hepatitis B must comply with norms.docVIP

 PAGE \* MERGEFORMAT 11 Chinese Medicine Clinical analysis of hepatitis B must comply with norms [Keywords:] Hepatitis B, Chinese medicine, clinical research criteria Currently, the vast majority of hepatitis B in Chinese medicine (mainly refers to the decoction, pills, powders, etc.) applicable to a wide range of clinical use is not very strict. In order to standardize the treatment of hepatitis B, and effectively protect the legitimate rights and interests of patients , I believe that traditional Chinese medicine treatment of hepatitis B clinical trials of drugs must comply with quality management practices (GCP). 1 At present the major categories of traditional Chinese medicine treatment of hepatitis B 1.1 officially listed species Such varieties have been approved by the State is the symbol of drug treatment, there are 100 kinds, such as Fufangbiejiarangan tablets, capsules Qingrejiedu hepatitis B, liver Qi Yan Fu particles. These drugs have begun to profit after listing, but still needs to be Ⅳ clinical trial, in the case of the widely used study the efficacy and adverse reactions, according to regulations to be seen 2000 cases. 1.2 The quasi-listed species These drugs is about to get national approval number, there are roughly 200 kinds. For the experienced Ⅱ clinical studies have confirmed that there efficacy, good safety of drugs, further Ⅲ clinical trials, and expand multi-center clinical trial, following the principle of stochastic control, further evaluation of the efficacy and safety, according to regulations, you need to test group of not less than 300 patients, study site approved the clinical pharmacology at the national research base. of this study is still the implementation of the principle of free treatment, the researchers can not benefit from it. 1.3 Test species Batch access to national clinical trials that the drug, about 500 species. These drugs through human safety and preliminary pharmacological tests, has e