Problem Analysis And Design Of Clinical Trial Program For The Treatment Of Chronic Hepatitis B With Integrated Traditional Chinese And Western Medicine

Objective: To analyze the problems in the design of clinical trials for the treatment of chronic hepatitis B with Chinese and Western medicine,and to combine the clinical trial design and practice of XX granules for the treatment of chronic hepatitis B(hepatobiliary damp-heat syndrome),and to explore the treatment of chronic diseases with Chinese and Western medicine.Hepatitis B drug clinical trial program design to provide reference.Methods: In the first part,bibliometrics was used to analyze the design of clinical trials for the treatment of chronic hepatitis B with integrated traditional Chinese and western medicine,and to find out the common problems.The second part combines the project in charge of the company's practice to carry out the clinical design and practice of XX granules for the treatment of chronic hepatitis B(hepatobiliary damp-heat and liver stagnation and blood stasis),summarizing the experience and exploring the existence of such clinical trial design.Solution to the problem,making suggestions and countermeasures.Results: The analysis of the clinical research literature(n=188)in the treatment of chronic hepatitis B in combination with traditional Chinese and Western medicine in recent years found that there are lack of ethical concerns in the design of the protocol,no random or random methods are not used,and the efficacy evaluation criteria are systematically poor.The safety evaluation was fully conducted and the features of TCM were not highlighted(the diagnosis was not included in TCM syndromes,and the efficacy evaluation did not include TCM syndromes.These problems will lead to low quality of the literature,affect the authenticity of clinical research,and fail to assess TCM in the medical process.The role and status,wasting clinical resources,and even causing unnecessary harm to the subjects,etc.To solve this problem,establish a standardized program design of traditional Chinese medicine clinical research and provide reference for existing clinical research of the same type,Now with its own professional practice,design a clinical trial program with thehighest requirements for clinical research,namely Phase II specific clinical trials of XX granules for the treatment of chronic hepatitis B(hepatobiliary damp-heat and liver stasis and blood stasis),and in the design of the program Requires the signing of informed consent,clear randomization methods,and use of dual efficacy evaluation systems Quantitative scores of indicators and efficacy evaluation criteria,attention to safety evaluation,diagnosis included in TCM syndromes,and curative effects evaluation to increase TCM quantitative scores to highlight the characteristics of TCM.Conclusion: Based on the preliminary practice of this phase II clinical trial program,strict implementation of the plan is fundamentally protected.The subjects' rights and interests will also obtain more credible research results and provide more evidence of the efficacy and safety of Chinese medicine.This is a clinical study of chronic hepatitis B(including non-registration and registration)and even Chinese medicine clinical research.The design of the plan will have great reference value and reference significance.At the same time,there are still some problems in the actual operation of clinical trials to be improved,which requires the design of the same type of clinical trials to pay more attention to the late clinical practice.The operability makes the experimental design more scientific and rigorous in order to achieve an accurate and objective assessment of the effectiveness and safety of the drug.