Application of real world study and human use experience in research and development of new traditional Chinese medicine drugs / 中国中药杂志

Real world study(RWS) refers to the process of collecting real world data related to the health of research subjects in the real world environment for pre-set clinical problems and obtaining the status of drug use and potential benefits/risks through analysis. The data are derived from the hospital information system(HIS), medical insurance system, disease registration system, adverse drug reaction monitoring system, etc. Human use experience of traditional Chinese medicine(TCM) is a new concept put forward by experts after summarizing the problems existing in clinical trials of new TCM drugs. The data come partially from the real world, and more importantly, such key elements as the formulated prescriptions of new TCM drugs, principles and methods, and clinical applications should be covered. RWS is mainly used for adverse drug reaction monitoring after marketing, benefit evaluation of listed drugs, decision-making of medical treatment and medical insurance, as well as supervision and approval of special medical devices and special drugs. It is complementary to randomized controlled clinical trials. Human use experience is suitable for the research and development of Chinese medicinal compound preparations and the expansion of functions and indications. There are no special provisions for clinical indications and target population. There exists a sequential relationship between the human use experience and clinical trials. Specifi-cally, the summarization of human use experience provides good support for the design and implementation of clinical trials, which is an important segment in the research and development of new TCM drugs. The correlation between real-world data and research results and their reliability should be ensured in RWS, and the unreality should be avoided. The key to summarizing the human use experience is to identify the clinical orientation, target population, course of treatment, usage and dosage of new TCM drugs, and it should be noted that human use experience does not only mean clinical experience. Experimental clinical trial(PCT), a type of study in the real world, has been commonly employed for the summary of human use experience. RWS and human use experience are different research designs targeting different clinical questions in the research and development of new TCM drugs, which can be flexibly selected depending on the actual situation.

Discussion on traditional Chinese medicine properties of Myrtus communis leaves based on literature analysis and Chinese medicine theory / 中国中药杂志

Myrtus communis is a traditional medicinal aromatic plant in the Mediterranean. At present, the plant has been introduced and cultivated in the southern part of China, and it is mostly used for ornamental or cosmetic purposes. Based on literature analysis and the theory of Chinese medicine, we discussed the medicinal parts and properties of M. communis in this paper to provide a theoretical basis for exploring the medicinal value of M. communis and its compatibility with traditional Chinese medicines. Literatures were searched from Web of Science(core collection), PubMed, CNKI, VIP and Wanfang by using the set conditions as key words. Then the obtained literatures were screened and classified. Finally, a total of 376 articles were included, consisting of 44 reviews, 54 germplasm resources, 78 chemical researches, 48 studies on application, extraction, or quality, 18 human trials, 132 pharmacological studies, and 2 safety studies. Based on literature analysis and theories of Chinese medicine, the leaves of M. communis were finally selected as the medicinal part of Chinese medicine, and the traditional Chinese medicine properties of M. communis leaves were deduced as pungent, bitter, and cool. The channel tropisms of M. communis leaves included lung, liver, and large intestine, with functions of detoxifying, resolving a mass, and insecticide. It was used for mouth sores, vaginal itching, hemorrhoids and warts, etc.; appropriate amount shall be applied for external use, and the decoction form shall be used for washing the affected parts; 3-12 g equivalent product shall be used in decoction, and this herb shall be put into the decoction in a later stage. The clarification of the medicinal parts of M. communis, and the determination of the Chinese medicine properties of M. communis leaves would lay a theoretical foundation for its compatibility and application with Chinese medicines, and can do more contribution to the medical and healthcare industry in our country.

Research progress on sedative and hypnotic effect of Sini Powder and strategic analysis of its new drug development / 中草药

Sini Powder is the traditional Chinese medicine compound, which comes from Treatise on Febrile Diseases. It is used to treat the syndrome of yang depression and reversal cold of limbs. Sini Powder has a certain effect on treating insomnia caused by liver depression and spleen deficiency. Lots of researches have shown that Sini Powder has a sedative and hypnotic effect similar to diazepam and plays an important role in improving sleep disorders caused by post-traumatic stress disorder (PTSD). Sini Powder is not included in Chinese Pharmacopoeia (2015 edition). It is probably to develop Sini Powder into a new drug for the clinic. We collated and summarized the literature about the sedative and hypnotic effect and the improvement of sleep disorders caused by PTSD of Sini Powder. Based on the modern research on the sedative and hypnotic effect of Sini Powder, we think the effect of "relieve uneasiness of mind and body tranquilization" adapts the theory of traditional Chinese medicine, so that it can improve the applied range of Sini Powder. Meanwhile, we analyzed the possibility of Sini Powder being selected into the ancient classical prescription and key problem in research and development on drug preparation of Sini Powder according to regulations of traditional Chinese medicine. Then we put forward some suggestions for further research from two aspects which are the development of Sini Powder and new drugs of traditional Chinese medicine, to provide a reference for the development of new Chinese medicine preparation of Sini Powder focus on "expelling pathogen and relieving depression, soothing liver and regulating spleen, tranquilizing mind".

Construction and application of modern research paradigm of new foreign introducing traditional Chinese medicine / 中国中药杂志

With the development of society, more and more foreign natural medicines have entered China, but they are faced with the problem that they are not given with the traditional Chinese medicine(TCM) properties when they are used with other TCM. When we carried out the research on introducing foreign natural plant resources to TCM, gradually, a new research model and field with original characteristics of TCM--the study of new foreign introducing TCM had been formed. In the process of it, we explored and summarized research rules to form the research paradigm, which will be conducive to the standardization and scientization of new foreign introducing TCM research. For the research of foreign introducing TCM, we analyzed the research background, reviewed the application history, sorted out the research status, elaborated the concept and summarized the research achievements. On this basis, we put forward the concept and system of the modern research paradigm of new foreign introducing TCM, studied and clarified the core elements, properties and research principles of this paradigm, and summarized the research contents and methods of new foreign introducing TCM. We interpreted the foundation of paradigm construction from multiple perspectives. The paradigm was the practical application of theoretical innovation of TCM. Under the guidance of it, more and more varieties of new foreign introducing TCM will be studied, the study will be more standardized, the conclusions will be more scientific and reliable, which will inspire and guide more researchers to focus on the research of new foreign introducing TCM, and the paradigm itself will be constantly improved. The construction and application of the paradigm will certainly accelerate the innovative research of foreign introducing TCM and play a historic role in promoting the enrichment of traditional Chinese medicine varieties.

Research and Development of New Traditional Chinese Medicine Based on Experienced Prescriptions of Prestigious Chinese Physicians / 中国实验方剂学杂志

The experienced prescriptions of famous prestigious Chinese physicians are effective prescriptions developed by prestigious Chinese doctors during their long-time clinical practice, which reflect the traditional Chinese medicine (TCM) understanding of the disease development regularity and core pathogenesis. These experienced prescriptions provide valuable experience for medication and prescription regularities, and represent the highest level of TCM treatment and the major sources of new drug research, development and technology innovation. It is of great significance to inherit academic thoughts and clinical experiences of prestigious Chinese physicians, explore and summarize experienced prescriptions, and develop new Chinese drugs. The researches of new drugs based on experienced prescriptions are the major direction encouraged by the government, with the maximum amount of new TCM drug applications but a low approval rate in recent years. The main reason for the low number of approved new TCM drug applications is that researchers know less about evaluation concepts and relevant techniques, leading to problems in research and development strategy. To facilitate a smooth advance of the new drug research and development and take full advantage of the experienced prescriptions, in this paper, we focus on the problems about new drug development of experienced prescriptions, lay emphasis on the new TCM drug research and development concepts of clinical value, history of human application and whole-process quality control, and deeply and systematically analyze concerns in such links as pharmacy, pharmacodynamics, toxicology and clinic application. The purpose of this article is to provide the reference in solving actual problems, the reliable basis of further researches on experienced prescriptions, and the important guarantee for developing more safe, effective and high-quality controllable drugs to meets clinical requirements, so as to achieve the strategy of a healthy China.

A Preliminary Discussion of Application of CDISC Standards in Clinical Research Data Management of New Traditional Chinese Medicine / 中国中医药信息杂志

In this article, a new TCM clinical trial of phaseⅢ was served as an example of application of Clinical Data Interchange Standards Consortium (CDISC). It briefly introduced seven data acquisition modules commonly used in clinical research of new traditional Chinese medicine, namely demographics, subject characteristic, clinical event, medical history, questionnaire, laboratory inspection and adverse event. It also introduced the process of transferring the above modules to Study Data Tabulation Models (STDM), and discussed the feasibility and some issues that required attention of CDISC application in clinical research of new traditional Chinese medicine.

Analysis on Application and Registration of TCM Treated as New Medicine and New TCM in Sichuan Province / 中国药房

OBJECTIVE:To provide basis and advices for the research of new traditional Chinese medicine (TCM) in Sichuan province.METHODS: The data of the application and registration of TCM treated as new medicine and new TCM in Sichuan province from 2001 to 2006 were analyzed and evaluated statistically.RESULTS: The number of the application was growing but new medicine was countable with low approval rate.The research institutes hadn’t played a prominent role in the research of new drug.CONCLUSION: The innovation and research of original TCM and the transformation of achievement should be enhanced to achieve the goal of a strong province on TCM.

Design for Tolerance Trial of Traditional Chinese Medicine for Intravenous Drip in Human Body / 中药新药与临床药理

Intravenous preparations take more risk than oral preparation and externally applied agent.In phaseⅠtoler- ance trial of intravenous preparations of TCM on human subjects,minimum dose and maximum dose should be decided in light of data derived from preclinical pharmacodynamic and toxicological experiments,combined with practical situation in clinic.Dose-ascending coefficient of the should be reasonable.During the application of intravenous preparations of TCM in tolerance trial,clinical monitoring must be done to ensure the safety of subjects.Overall and integrated observa- tional indices should be designed on the basis of the features of preparation types,administration methods,the nature of medicine,etc.,so as to provide full-scale data for safe dose range,concentration of the preparation,dripping veloci- ty and possible adverse reactions,etc.