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The discipline development is the pillar for the development of traditional Chinese medicine( TCM). The academic progress in TCM is the commanding height of the discipline development of TCM. To lead and promote the development and academic progress of TCM, the China Association of Chinese Medicine has summarized the Top Ten Academic Achievements in Traditional Chinese Medicine during 2020-2022, the Major Scientific Problems, Engineering Technical Problems, and Industrial Technical Problems in Traditional Chinese Medicine during 2019-2023, and the Remarkable Research Achievements of Traditional Chinese Medicine during 2012-2022. Based on the above research reports and the research achievements awarded the national science and technology prizes in TCM in the last 20 years and according to the current situation and layout of TCM discipline development, this paper reviews the major research achievements of TCM in the last two decades and the latest research progress in TCM during 2020-2023. The major scientific, engineering technical, and industrial technical problems in TCM are analyzed and the emerging trends of TCM are prospected in accordance with the development laws and characteristics of TCM. This review provides new ideas and reference for the high-quality development of TCM in the new era.

Chronic heart failure(CHF) is a comprehensive clinical syndrome caused by multiple factors that result in structural and/or functional abnormalities of the heart, leading to impaired ventricular contraction and/or relaxation functions. This medical condition represents the final stage of various cardiovascular diseases. In the treatment of CHF, multiple clinical studies have demonstrated the benefits of using traditional Chinese medicine(TCM) to control oxidative stress, inflammation, and apoptosis, thereby delaying ventricular remodeling and reducing myocardial fibrosis. In this study, common TCM syndromes in the diagnosis and treatment of CHF in recent years were reviewed and summarized. Five common treatment methods including benefiting Qi and activating blood circulation, enhancing Qi and nourishing Yin, warming Yang for diuresis, eliminating phlegm and dampness, rescuing from collapse by restoring Yang, and corresponding classic prescriptions in prevention and treatment of CHF were concluded under the guidance of TCM syndrome differentiation thinking. Meanwhile, research progress on the modern pharmacological effects of these classic prescriptions was systematically discussed, so as to establish a unique treatment system for CHF by classic prescriptions under the guidance of TCM syndrome differentiation theory and provide innovative diagnosis and treatment strategies for clinical CHF.

Chronic heart failure(CHF) is a series of clinical syndromes in which various heart diseases progress to their end stage. Its morbidity and mortality are increasing year by year, which seriously threatens people's life and health. The diseases causing CHF are complex and varied, such as coronary heart disease, hypertension, diabetes, cardiomyopathy and so on. It is of great significance to establish animal models of CHF according to different etiologies to explore the pathogenesis of CHF and develop drugs to prevent and treat CHF induced by different diseases. Therefore, based on the classification of the etiology of CHF, this paper summarizes the animal models of CHF widely used in recent 10 years, and the application of these animal models in traditional Chinese medicine(TCM) research, in order to provide ideas and strategies for studying the pathogenesis and treatment of CHF, and provide ideas for TCM modernization research.

The pharmacodynamic substances of traditional Chinese medicine(TCM) are the basis for the research of TCM and the development of innovative drugs. However, the lack of clarity of targets and molecular mechanisms is the bottleneck problem that restricts the research of pharmacodynamic substances of TCM. Bioactive components are the material basis of the efficacy of TCM, which exert activity by regulating the corresponding targets. Therefore, it is very important to identify the targets of the bioactive components to elucidate the pharmacological mechanism of TCM. Proteins are the most important drug targets, and study of the interaction between the proteins and bioactive components of TCM plays a key role in the development of pharmacological mechanism of TCM. In recent years, the main techniques for detecting the interaction between the bioactive components and proteins include surface plasmon resonance, fluorescence resonance energy transfer, bio-layer interference, molecular docking, proteome chip, target fishing, target mutant, and protein crystallization techniques, etc. This review summarized the biological target detection techniques and their applications in locating the targets of the bioactive components in TCM in the last decade, and this paper will provide useful strategies to elucidate the pharmacological mechanisms of TCM.

Advances in science and technology promote the rapid development of toxicological detection technologies. However, there is still a lack of decision-making tools for toxicological risk assessment, such as the lack of transparent schemes to evaluate current toxicological research and practice and the lag of toxicological testing tools to evaluate toxicity, resulting in difficulties in toxicity verification and hindering the transformation of toxicological research paradigm. Some scholars have proposed to integrate the concept of evidence-based medicine with the toxicological practice to improve the technical methods of toxicological research concept and risk assessment decision-making. With the promotion of relevant scholars and academic organizations, the concept and connotation of evidence-based toxicology have gradually become clear and a framework for research and practice has been initially formed. Although there are still many challenges, it also provides a new idea for the toxicity risk assessment and safe medication decision-making of traditional Chinese medicine(TCM). The era of digital intelligence has brought new opportunities and broad space for the development of TCM evidence-based toxicology. The exploration of TCM evidence-based toxicology from concept to method is an important embodiment of the development of TCM evidence-based toxicology, and will also promote the continuous enrichment and improvement of the research and practice system of TCM evidence-based toxicology.

Traditional Chinese medicine(TCM) carries the experience and theoretical knowledge of the ancients, and the use of "toxic" Chinese medicines is a major feature and advantage of TCM. "Toxic" Chinese medicines have unique clinical value and certain medication risk under the guidance of TCM theories such as compatibility for detoxification and treatment based on syndrome differentiation. In recent years, the safety events of Chinese medicines have occurred frequently, which has made the safety of Chinese medicine a public concern in China and abroad. However, limited by conventional cognitive laws and technical methods, basic research on toxicity of Chinese medicines fails to be combined with the clinical application. As a result, it is difficult to identify the clinical characteristics of, predict toxic and side effects of, or form a universal precise medication regimen for "toxic" Chinese medicines, which restricts the clinical application of them. In view of the problem that the toxicity of "toxic" Chinese medicines is difficult to be predicted and restricts the clinical application, the evidence-based research concept will provide new ideas for safe applcation of them in clinical practice. The integrated development of multiple disciplines and techniques in the field of big data and artificial intelligence will also promote the renewal and development of the research models for "toxic" Chinese medicines. Our team tried to propose the academic concept of evidence-based Chinese medicine toxicology and establish the data-intelligence research mode for "toxic" Chinese medicines and the intelligent risk prediction method for medicinal combination in the early stage, which provided methodological supports for solving the above problem. Thus, on the basis of summarizing the research status and problems of the clinical medication regimen of "toxic" Chinese medicines, our team took the evidence-based toxicology of TCM as the core concept, and tried to construct the multiple-evidence integrated evaluation and prediction method for "toxic" Chinese medicine, so as to guide the establishment of the non-toxic medication regimen of "toxic" Chinese medicines. Specifically, through the analysis of multivariate data obtained from the basic research, the evidence-based toxicology database of Chinese medicines and the individualized "toxicity-effect" intelligent prediction platform were built based on the disease-syndrome virtual patients, so as to identify the clinical characteristics and risks of "toxic" Chinese medicines and develop individualized medication regime. This study is expected to provide a methodological reference for the establishment of medication regimen and risk prevention strategy for "toxic" Chinese medicines. The method established in this study will bridge clinical research and basic research, enhance the transformation of the scientific connotation of attenuated compatibility, promote the development of evidence-based Chinese medicine toxicology, and ensure the clinical safety of "toxic" Chinese medicines.

The traditional Chinese medicine(TCM) contains very complex constituents. Besides the major constituents, there are a large number of unclear trace constituents with novel skeletons and potent bioactivities, which have been regarded as one of the important therapeutic substances and the great resources of innovative drugs derived from TCM. The present review highlighted that the development of the trace therapeutic substances of TCM is closely depends on the advanced technologies for their identification, isolation, structure elucidation, and bioactivity evaluation. Additionally, this paper reviewed the novel trace compounds derived from Chinese herbal medicines which have been published in Organic Letters during 2001-2021, and summarized the important licensed drugs originated from the trace therapeutic substances and the discovery and development of trace therapeutic substances of 8 kinds of Chinese herbal medicines. This review provides references for the research and development of TCM therapeutic substances and innovative drugs.

It was pointed out in Opinions on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine issued by the State Council in 2019 that 100 varieties of traditional Chinese medicine(TCM) with unique curative effects should be screened out within about three years. Due to the multi-component and multi-target mechanisms of TCM varieties, it is difficult to directly and simply evaluate their multi-dimensional clinical value using methods applicable to chemical or biological agents. The heterogeneity of outcomes for similar TCM makes it difficult to determine the advantages of similar products. The fuzzy comprehensive evaluation method that is developed on the basis of core outcome set and fuzzy mathematics for clinical efficacy evaluation of TCM may solve these problems. This study developed a fuzzy comprehensive evaluation model for the clinical efficacy evaluation of Chinese patent me-dicines for coronary heart disease and angina pectoris, and selected the previous normative studies with complete or incomplete data for verifying the model application. The results showed that original studies with complete data failed to evaluate and compare the comprehensive efficacy of different interventions. The original research only mentioned the advantages and disadvantages of different interventions in different aspects. The comprehensive clinical efficacy of three different interventions obtained through fuzzy comprehensive evaluation was all graded as level Ⅱ. The original research with incomplete data drew the same conclusions as the fuzzy comprehensive evaluation, and the results of fuzzy comprehensive evaluation can provide more comprehensive information. Therefore, the fuzzy comprehensive evaluation shows the products with overall advantages of clinical efficacy, which may become a feasible method for the screening of TCM.

In order to standardize the clinical diagnosis and treatment decision-making with traditional Chinese medicine for pa-tients of coronavirus disease 2019(COVID-19) and put the latest clinical study evidence into clinical practice, the international trust-worthy traditional Chinese medicine recommendations( TCM Recs) working group started the compilation of Living Evidence-based Guideline for Combination of Traditional Chinese and Western Medicine for Treatment of COVID-19 on the basis of the standards and re-quirements of WHO handbook, GRADE and RIGHT. This proposal mainly introduces the formulation methods and processes of the living guidelines in details, such as the composition of the working group, the collection and identification of clinical issues and out-comes, the production of the living systematic review and the consensus of recommendations. The guidelines will continue to monitor the clinical study evidences of TCM in the prevention and treatment of COVID-19, and conduct regular evidence updating, retrieval and screening. When there is new study evidence, the steering committee will evaluate the possibility of the evidence to change clinical practice or previous recommendations, so as to decide whether the recommendations for the guidelines shall be implemented or upda-ted. The main criteria considered in the guideline updating are as follows:(1) There are new high-quality randomized controlled trial(RCT) evidences for TCM uninvolved in the previous edition of the guidelines;(2) as for the TCM involved in the guidelines, living sys-tematic review shows that new evidence may change the direction or strength of the existing recommendations. The specific implementation of the living evidence-based guidelines will take this proposal as the study basis and framework, in order to ensure the standardization of the formulation process and methods. This will be the first exploration of the methodology for living guidelines in the field of TCM.

To systemically evaluate the effect of Qishen Yiqi Dripping Pills combined with Western medicine on adverse cardiovascular events and quality of life after percutaneous coronary intervention(PCI). A total of 7 Chinese and English databases including CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library and Web of Science were searched by computer to collect the randomized controlled trials(RCTs) on Qishen Yiqi Dripping Pills combined with Western medicine in the treatment of patients with coronary heart disease after PCI with the retrieval time from the database establishment to April 1, 2020. Two researchers independently conducted li-terature screening, data extraction and bias risk assessment. Then, Meta-analysis was performed by using RevMan 5.3 software. A total of 31 RCTs were included, involving 3 537 patients. The results of Meta-analysis showed that in terms of major adverse cardiovascular events(MACE) after PCI, the combination of Qishen Yiqi Dripping Pills could significantly reduce the recurrence of angina pectoris, incidence of arrhythmia, heart failure and re-revascularization, and the effect was better than that of Western medicine treatment alone. However, there was no significant difference between the two groups in the improvement of non-fatal myocardial infarction, cardiac death, stent restenosis, stroke and other adverse cardiovascular events. In terms of improving left ventricular ejection fraction(LVEF), 6 min walking test(6 MWT), high-sensitivity C-reactive protein(hs-CRP) and Seattle angina pectoris scale(SAQ), the combination of Qishen Yiqi Dripping Pills and Western medicine treatment had obvious advantages over Western medicine treatment alone in increasing LVEF, 6 MWT and SAQ, and reducing the level of hs-CRP, with statistically significant differences. There were few adverse reactions in both groups, and there was no significant difference between the two groups. The main manifestations were gastrointestinal reactions, rash, gingiva and other small bleeding, and no serious adverse reactions occurred. The above reactions could disappear after drug withdrawal or symptomatic treatment. The application of Qishen Yiqi Dripping Pills combined with Western medicine in the treatment of patients after PCI could reduce the occurrence of MACE, improve the clinical efficacy, quality of life and prognosis in a safe and reliable manner. However, due to the quantity and quality limitations of included studies, more standardized, rigo-rous and high-quality clinical studies are still needed to further verify the above conclusions.

The classification of chronic pain is complex and its pathogenesis is not clear, which led to the limited progress of treatment measures.Traditional Chinese medicine(TCM) has certain advantages in the treatment of chronic pain, and its mechanism needs further exploration. The ideal animal model is helpful to elucidate the key mechanism of the occurrence and development of chronic pain and play an important role in the discovery of new drug targets, the development of new therapies and the research on the analgesic mechanism of TCM.In recent years, many scholars at home and abroad have done a lot of research to explore the pathogenesis of chronic pain and the mechanism of TCM, which have achieved some results. On this basis, this study summarizes the selection of experimental animals for chronic pain and the commonly evaluation methods of animal models. According to the latest international classification of diseases, this review organizes the induced methods, evaluation indicators, advantages and disadvantages of seven kinds of chronic pain animal models, such as chronic primary pain, chronic cancer-related pain and so on. Next, this review introduces the chronic pain animal models commonly used in TCM research, in order to provide guidance for the targeted selection of animal models when carrying out relevant experiments in the future.

Objective: To analyze the rules of acupoint selection in the acupuncture treatment of cervical spondylotic radiculopathy by data mining., Methods: The randomized controlled trials (RCTs) regarding acupuncture for cervical spondylotic radiculopathy published from July 15 of 2009 to July 15 of 2019 were retrieved from databases of CNKI, VIP, Wanfang, SinoMed, PubMed and EMbase. A database was established with Microsoft Excel 2016. The frequency and total effective rate of high-frequency acupoints, meridians and acupoint combinations were analyzed, and the association rules of acupoints and meridians were analyzed by Apriori algorithm., Results: A total of 87 RCTs were included, involving 104 acupoints with a total frequency of 921. Among them, the high-frequency acupoints were cervical Jiaji (EX-B 2, 87 times), Fengchi (GB 20, 70 times), Houxi (SI 3, 54 times), etc. The frequently-used acupoints were mainly distributed in the hand yangming large intestine meridian, the foot shaoyang gallbladder meridian and hand taiyang small intestine meridian. The frequently-used acupoint combination was Fengchi (GB 20)-cervical Jiaji (EX-B 2), and most of the combinations were acupoints at the proximal end and acupoints at the far and near end. With the analysis of association rules, 15 groups of acupoint association rules and meridian association rules were obtained., Conclusion: It is feasible to explore the acupoint selection and compatibility rules of acupuncture for cervical spondylotic radiculopathy by data mining. This study could provide corresponding reference for clinical treatment.

As an important representative of modern Chinese medicine, traditional Chinese medicine (TCM) injzection has become an indispensable part of the Chinese medicine industry. However, its development is now restricted by the bottleneck of insufficient core competitiveness, low-level research and production, even injection quality and the safe use are not guaranteed. Thus, it is urgent to reevaluate post-marketing TCM injection generally and to make secondary development. Under current circumstances, taking major brands which have good clinical and market foundation, as well as research value, as the main subject of cultivation and evaluation is an important approach to innovative development of TCM injection industry. Unlike oral proprietary Chinese medicine, the cultivatation of major brands of TCM injection needs higher technical support, quality standards and more timely feedback. Therefore, a post-market integral evaluation system adaptive to TCM injection is required. This article discussed some key points on the construction of a post-market integral evaluation system of TCM injection in three levels： optimizing evaluation methods, building synergistic innovation platforms which combine the medical research institutions and pharmaceutical enterprises, and finally constructing the integral evaluation system. A "five to one" structure has been proposed to enhance TCM injection effectiveness, safety and adaptability on the whole, which are from the following aspects： mechanism research, clinical evidence validation, literature information mining, sustainable development of resources and industrialization operation., Competing Interests: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose., (Copyright© by the Chinese Pharmaceutical Association.)

To evaluate the inflammatory factors, the pulmonary function, the efficiency and the safety of Chuankezhi injection for treating acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The randomized controlled trials (RCTs) on Chuankezhi injection for treating AECOPD were collected from 7 databases (PubMed, CNKI, et al) between inception to November 2016. Two reviewers independently screened literature and extracted the data according to the inclusion and exclusion criteria, and assessed methodological quality of included studies according to the criteria from Cochrane Reviewer's Handbook 5.3. Then, Meta-analysis was conducted by using RevMan 5.3 software. A total of 13 RCTs involving 1 016 patients were included. Meta-analysis results indicated that Chuankezhi group was superior to the control group in the clinical effectiveness [RR=1.15, 95% CI(1.06, 1.23), P=0.000 3], improved pulmonary functions including forced expiratory volume in one second (FEV1) [MD=0.21, 95% CI (0.15, 0.27), P<0.000 01], forced vital capacity (FVC) [MD=0.36, 95% CI（0.15, 0.56）, P=0.000 6], the first seconds breathing volume percentage of forced vital capacity (FEV1/FVC) [MD=6.85, 95% CI（4.68, 9.02）, P<0.000 01] and decreased the level of inflammatory factors including interleukin-6 (IL-6) [MD=-6.35, 95% CI (-8.23, -4.47), P<0.000 01], IL-8 [MD = -2.00, 95% CI ( -3.13, 0.87), P=0.000 5], tumor necrosis factor-α (TNF-α) [ MD=-2.79, 95% CI (-4.61,-0.97), P=0.003]. Besides, there were no frequently happened or serious adverse reactions observed in Chuankezhi group. The results showed that Chuankezhi injection could improve the efficiency and the pulmonary function, reduce inflammation for AECOPD with a high safety on the basis of routine symptomatic treatment. However, due to limited quantity and quality of the included studies, the conclusion above should be further verified by conducting more high quality RCTs., Competing Interests: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose., (Copyright© by the Chinese Pharmaceutical Association.)

Cholinergic neurotransmission loss is the main cause of cognitive impairment in patients with Alzheimer's disease. Phospholipids (PLs) play an essential role in memory and learning abilities. Moreover, PLs act as a source of choline in acetylcholine synthesis. This study aimed to prepare and optimize the formulation of chitosan/phospholipid/β-cyclodextrin (CTS/PL/β-CD) microspheres that can improve cognitive impairment. The CTS/PL/β-CD microspheres were prepared by spray drying, and optimized with an orthogonal design. These microspheres were also characterized in terms of morphology, structure, thermostability, drug loading, and encapsulation efficiency. The spatial learning and memory of rats were evaluated using the Morris water maze test, and the neuroprotective effects of the CTS/PL/β-CD micro-spheres were investigated by immunohistochemistry. Scanning electron microscopic images showed that the CTS/PL/β-CD microspheres were spherical with slightly wrinkled surfaces. Fourier transform infrared spectroscopy and differential scanning calorimetry proved that PLs formed hydrogen bonds with the amide group of CTS and the hydroxyl group of β-CD. The learning and memory abilities of rats in the treated group significantly improved compared with those in the model group. Immunohistochemical analysis revealed that treatment with the CTS/PL/β-CD microspheres attenuated the expression of protein kinase C-δ and inhibited the activation of microglias. These results suggest that the optimized microspheres have the potential to be used in the treatment of Alzheimer's disease.

The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

To learn about the economic studies on traditional Chinese medicines in domestic literatures, in order to analyze the current economic assessment of traditional Chinese medicines and explore the existing problems. Efforts were made to search CNKI, VIP, Wanfang database and CBM by computer and include all literatures about economic assessment of traditional Chinese medicines published on professional domestic journals in the systematic assessment and quality evaluation. Finally, 50 articles were included in the study, and the systematic assessment and quality evaluation were made for them in terms of titles, year, authors' identity, expense source, disease type, study perspective, study design type, study target, study target source, time limit, cost calculation, effect indicator, analytical technique and sensitivity analysis. The finally quality score was 0.74, which is very low. The results of the study showed insufficient studies on economics of traditional Chinese medicines, short study duration and simple evaluation methods, which will be solved through unremitting efforts in the future.

In recent years, projects funded by the Division V III of Health Sciences of the National Natural Science Foundation of China (NSFC) increased steadily, which enhanced the process of modernization of Chinese medicine (CM). We analyzed CM projects funded by NSFC during 2003 -2012, which aimed to provide reference to experts in the CM field.

The applications accepted and approved by general program, young scientist fund and fund for less developed region of national natural science funds in the discipline of Chinese materia medica, NSFC in 2012 have been introduced. The research contents of the funded projects in the popular research areas have been summarized and the problems in the applications have been analyzed to give a reference to the scientists in the field of Chinese materia medica.

After over five decades of vigorous development in China, integrative medicine (IM) has developed into an academic discipline with some overlaps but independent from both Chinese medicine (CM) and Western medicine (WM). CHEN Zhu, the Minister of the Ministry of Health pointed out that IM represents the developing direction for future medicine at the conference commemorating the 50th anniversary of Chairman MAO Zedong' s important instructions on WM doctors learning from CM, which was sponsored by State Administration of Traditional Chinese Medicine and Chinese Association of Integrative Medicine in Beijing on November 27,2008. In this article, the author stresses basic research should be paid attention to in developing IM from the concepts and connotation, development and evolution, achievements and problems, layers and pathways of IM.

Comparative effectiveness research (CER) is well developed in international medical research. This article analyzes the basic connotations of CER from five aspects, including selection of objective, positioning of target population, comparison of intervention scheme, identification of contrast condition and analysis of therapeutic effects. The inclusiveness and advanced nature of CER were revealed by comparing with modern medical research methods, such as evidence-based medicine, patient-important outcome and randomized controlled trials. Based on the superiority of CER, the feasibility of applying CER in clinical evaluation of traditional Chinese medicine is explored. CER should be combined with the holistic concept, syndrome differentiation and individuality-concerned treatment so as to facilitate its development in research of traditional Chinese medicine in China.

As the post-genome era is approaching, omics has become a hot topic in the research field of life sciences and is also widely used in traditional Chinese medicine (TCM) research. For discussing the correlation between syndromes and omics, the authors explored the application of genomics, proteomics and metabonomics in the study of syndrome classification from the macroscopic view, after a systematic and normative study of the literature. The authors drew the conclusion that research into the correlation between syndromes and omics has great clinical significance in terms of the scientific application and quantification of TCM treatment based on syndrome differentiation.

In this article, the authors firstly summarized the number of applications submitted to and projects supported by the National Natural Science Foundation of China (NSFC) in the field of traditional Chinese medicine research in 2010. Then they described the district distribution, research direction layout and allotment of the approved projects in the three primary disciplines (traditional Chinese medicine, Chinese materia medica and integrated traditional Chinese and Western medicine) and their 43 subdisciplines. The targeting suggestions for improvement were given respectively by concluding the reason of disapproved projects from the point of view of applicants and supporting institution, and by stating the common problems existing in the review process from the perspectives of fund managers and evaluation experts. Lastly, the major funding fields in the near future were predicted in the hope of providing guidance for applicants.

Traditional Chinese medicine (TCM) has its own system of diagnosis and treatment theory, and its methods for evaluating clinical efficacy are different from those of Western medicine. Applying evaluation techniques and methods that are used in Western medicine mechanically to TCM will not work. So building evaluation techniques, which adhere to regulations and characteristics of TCM, is necessary and imperative. As the quality of life and patient-reported outcome instruments were brought into practice and developed, clinical evaluation ideas and methods for TCM are provided with an opportunity for development. This article puts forward the concept of subjective complex outcomes (SCOs), which constitutes subjective feelings gained from the patient, doctor and caregiver, different from laboratory parameters. SCOs provide a multidimensional and complex health-related quality of life (HRQL) assessment and focus on the source of assessment information of diseases. This article also introduces a case study building SCO methods of TCM treatment for chronic obstructive pulmonary diseases, in order to promote discussion and provide a platform for future research.

Aimed at the ubiquitous problems in the secondary development of famous and superior Chinese patent drugs, the concept of clinical orientation is suggested by the authors. Its necessity in secondary development was explained and the method for establishment and confirmation was explored in this paper, which set up a favorable basis for secondary development of famous and superior Chinese patent drugs.

Although traditional Chinese medicine (TCM) shows its effectiveness undoubtedly in clinical practice, the deficiency in objective assessment methods is yet a bottleneck which has restricted its development of modernization and internationalization. On the basis of clinical experiences, the authors discussed the title cutting from current situation and tendency, and expanded gradually. It is concluded that by aiming directly at problems and referring to the principle and methods of evidence-based medicine (EBM), using rationally the design in clinical practice and combined with individualization and standardization should be a feasible way for TCM clinical therapeutic effect assessment.

Therapeutic effect is the core in clinic medicine. Traditional Chinese medicine (TCM) has certain advantages on clinical efficacy, but is still lack of reliable evidence. With the rapid development of evidence based medicine (EBM), more and more attention is paid on scientific evaluation of clinical efficacy increasingly. To carry out TCM clinical therapeutic research and to scientifically evaluate its efficacy has become a very important task for TCM development. Scientific and precise protocol design is the precondition for progressing the research and obtaining high quality evidences. The article puts stress on how to design the clinical therapeutic program of research on TCM in combining with characteristics of TCM.