Efficacy evaluation of TCM oncology call

The 2019-01-16 health

A few days ago, the international symposium on TCM tumor drug research and efficacy evaluation was held in Beijing. The theme of this conference is "multi-dimensional integration · innovative development". The conference invited domestic and foreign experts in tumor related fields to make academic speeches and exchanges, and jointly discuss the methods and strategies to scientifically lead the research and efficacy evaluation of TCM tumor drugs, promote the establishment of consensus on scientific evaluation of TCM tumor efficacy, and improve the overall level of the industry.

In recent years, the incidence of tumor increased year by year. With the development of tumor therapy, tumor has become a kind of "chronic disease". The treatment of tumor has changed from eliminating tumor to living with tumor and living in harmony with tumor. The role of traditional Chinese medicine in tumor treatment has been widely recognized in this process.

Chinese medicine is effective in treating tumors

The treatment of tumors in traditional Chinese medicine first originated in the zhou dynasty, and the word "cancer" began to appear in the song dynasty. Can say, Chinese medicine treats tumour to have origin very much. "Can the TCM therapy for cancer continues today, recognized by more and more people, because it's a curative effect", the Chinese academy of sciences, chief researcher of traditional Chinese medicine, Chinese medicine, deputy director of the institute of cancer hong-sheng Lin, says professor for high-risk groups, such as the operation period of late, lymph node metastasis, etc.) at the completion of western medicine treatment, there are still a lot of risk, the 5-year survival rate is relatively low, especially should be treated with traditional Chinese medicine.

Tumor treatment is a long and continuous process, and a large number of clinical studies have provided strong evidence of evidence-based medicine. "A large number of previous clinical studies have suggested that long-term application of traditional Chinese medicine can reduce the recurrence rate and metastasis rate after tumor surgery, and prolong the survival period of patients. Moreover, traditional Chinese medicine also plays an important role in improving the quality of life of patients, improving symptoms/symptom groups, and treating adverse reactions to radiotherapy and chemotherapy. Professor Lin hongsheng's team has done a lot of research work in recent years, which has formed a standardized diagnosis and treatment system of TCM for tumor. According to the participation of TCM in different stages of tumor treatment, it can be divided into five stages: consolidation treatment of TCM, protective treatment of TCM, loading treatment of TCM, maintenance treatment of TCM, and syndrome differentiation treatment of TCM.

The criteria for efficacy evaluation are urgent

Traditional Chinese medicine (TCM) is one of the most complete medical systems in ancient China. It has been used for more than 3,000 years and has been used in modern tumor treatment for more than 50 years. Although traditional Chinese medicine is widely used in cancer patients, there is limited evidence for high-quality non-chinese studies. A recent national survey by the American society of clinical oncology found that 40 percent of americans want to cure cancer through natural therapies, said MAO junjun, director of the center for integrative medicine at memorial Sloan Kettering cancer center. However, clinical studies demonstrating the safety and efficacy of natural products for cancer treatment and symptom management are very limited.

"Objective, scientific and internationally recognized clinical efficacy evaluation methods are still the difficulties recognized by scholars." According to Lin hongsheng, since the target of western medicine is clear, the research hypothesis is relatively easy to approach the real situation, and through data exploration, it is relatively easy to determine the main endpoint. Compound Chinese medicine regulates the dysfunction of the cytokine network in the way of multi-target action, and the research hypothesis has too little basis, so the advantages are not easy to be captured.

The experts at the meeting agreed that it is necessary to find out the appropriate evaluation criteria for the efficacy of TCM in the treatment of tumors. Wang xin, of the Anderson cancer center in the United States, said it would be useful to introduce patient reporting outcomes (PRO). PRO is the fda-approved end point for drug label declaration trials for symptom management. Although PRO has not been widely used in conventional TCM practices and clinical trials in China from concept to method, it can be used to draw TCM phenotypes through syndrome differentiation and corresponding quantitative PRO data through carefully designed descriptive studies and verified tools.

"This theory-driven TCM syndrome phenotype may be demonstrated by related symptoms or symptom clusters, with or without additional clinical variables. In addition, the selection of an effective endpoint for a given TCM trial can benefit from an identified semc-related clinically meaningful PRO derived from real-world big data. Said wang xin will be.

Lin hongsheng said, "traditional Chinese medicine is mostly compound prescription, the remission of tumor-related symptoms and symptom group is another characteristic, but also in recent years the research hotspot and research difficulty, our country scholar is carrying on the tentative research." In her opinion, the evaluation of tumor drugs in traditional Chinese medicine should pay attention to three points: 1. The efficacy of therapeutic drugs should be evaluated by integrating multiple indicators, and appropriate research indicators should be selected. 2. Developed the scales in line with the characteristics of traditional Chinese medicine, established the Chinese medicine's own quality of life evaluation scale, and quantified the symptom indicators without objective indicators. 3. Strictly define the evaluation of symptoms related to adverse reactions of radiotherapy and chemotherapy, and define the target population.

"After clarifying the efficacy of TCM in tumor treatment, how to come up with an objective and internationally recognized evaluation standard that can fully reflect the characteristics of TCM is the requirement and test for this generation of TCM people." Lin hongsheng stressed.

Preclinical evaluation should not be ignored

With the increase of the incidence of cancer worldwide, some traditional Chinese medicines have unique advantages in the treatment of tumors, and their anti-tumor effects are attracting increasing attention. However, TCM formulations as standard treatments or adjuvant treatments for cancer have not been approved worldwide.

"Most herbal or herbal formulations contain multiple compounds and have been shown to be more active than the single bioactive ingredient in the formulations. Therefore, it is necessary to find the most suitable preclinical research methods for TCM in cancer treatment, so as to further understand the role of TCM in cancer. Professor Yang peiying, from the department of integrative medicine at the Anderson cancer center in the United States, called for high-quality pre-clinical and clinical research to improve the acceptance of TCM as part of cancer treatment in western countries.

Yang peiying said that although TCM has anti-proliferation and anti-tumor activities, there are few studies directly guided by TCM theories in various tumor cells and animal models, which limits its potential for transformation and, if it exists, rarely provides support for relevant clinical studies. In addition, most research on Chinese herbal medicines, including traditional Chinese medicine or natural products, is conducted using a reductionist approach to determine the most biologically active components responsible for anticancer activity. Yang peiying's team's study showed that Chinese herbal formula may affect the pharmacokinetics of chemotherapy, but will not reduce the anti-tumor effect of chemotherapy drugs, such as 5-fu in colon cancer.

"" before conducting large-scale treatment or symptom management trials, a reasonable basis must be established, especially in combination with TCM diagnosis, to improve the successful application of TCM in cancer treatment by dosing, standardizing and targeting the molecules of any specific TCM formulation." " Yang peiying said.