Our ancestor found that some of the Chinese herbal drugs were toxic during their clinical practice. They graded the toxicity of Chinese herbal drugs into three degrees and thought that the term "toxicity of the Chinese herbal drugs" could be used in a broad and a narrow sense. In modern times, toxic components of the Chinese herbal drugs and their toxic mechanisms, especially the toxicity on the kidney, were further revealed. The factors that affect the toxicity of the Chinese herbal drugs include the species, preparation, dose and environment. To prevent the toxicity of the Chinese herbal drugs, we must strengthen the management of the Chinese herbal drugs. On the other hand, doctors' recognition of the toxicity of Chinese herbal drugs should be enhanced. At the same time, patients should be told to decoct and take Chinese herbal drugs correctly.

Pulmonary-fibrosis (PF) is the result of interstitial lung disease which has different causes and it is one of the most intractable diseases in respiratory system. The PF is characterized by progressive difficulty of breath and dying of respiratory failure, seriously threatening the health of people. Immunosuppressive drugs and glucocorticoids have been widely adopted as the main methods in treatment, but the results are not satisfactory and the side effects are obvious. Many specialists have tried traditional Chinese medicine in recent years with satisfactory effect, indicating that the prospect of using traditional Chinese medicine in the treatment of PF is optimistic. This article outlines the researches about using traditional Chinese medicine in the treatment of PF.

Fructus Xanthii is commonly used in rhinology, especially used in treatment of chronic rhinitis and sinusitis. But Fructus Xanthii is toxicant, and it maybe result in poisoning when used excessively, without preparation or in inappropriate preparation. This article reviewed all poisoning cases from 1960 to 2000, its toxicology and methods for detoxification.

The scientificalness of traditional Chinese medicine (TCM) is often doubted and criticized for the record in Huangdi Neijing that the liver is located in the left of the human body. The most popular explanation of this criticism is that the conception of zang-fu viscera in TCM is quite different from which defined in Western medicine. It means that the zang-fu viscera in TCM are not exactly the corresponding anatomical organs in modern human anatomy but reflect the functions of some systems in human body. According to the classical theories of TCM in Huangdi Neijing, we consider that the record of liver located in the left of the human body is based on the Ba Gua (Eight Diagrams) of traditional Chinese philosophy, not the human anatomy. In brief, the conception of zang-fu viscera is initially a gross anatomical conception, and in a sense the anatomic sites and functions of which are mostly similar to those described in Western medicine.

Pathology and pathophysiology are sciences studying the laws and mechanisms of the occurrence and developmont of diseases,linking up the preclinical and clinical medicine.Owing to the different perspectives and ways of thinking,the western medicine and the traditional Chinese medicine developed respectively their independent theoretical,diagnostic and therapeutic systems.Integrative medicine,combining the theories and treatments of both western medicine and traditional Chinese medicine,has become the developing trend of medicine along with the social development.For this reason,pathological and pathophysiological research in integrated traditional Chinese and western medicine is highly significant for revealing the internal relations between the clinical manifestation and the pathological changes,for expounding the causes,conditions.mechanisms and laws of the occurrence and development of diseases.In doing related research,we should combine the disease and the syndrome,combine the macro-level and the micro-level,combine the part and the whole.We should manage to systematize the clinical research,to establish animal models of the syndromes,and to integrate the animal models of syndromes with the clinical characteristics of disesses.We should apply the theories of traditional Chinese medicine to the pathological and pathophysiological research of modern medicine.

The quality of clinical trials in traditional Chinese medicine (TCM) was analyzed with respect to their methodology and outcome assessment according to the concepts of evidence-based medicine (EBM). It was suggested that the essential methodological principles of EBM should be applied in clinical trials of TCM, including randomization, control and blindness. The sample size estimation, optimal parameter selection for outcome assessment, compliance and intention-to-treat analysis are all important aspects of randomized controlled trials. To bring the benefits of EBM into clinical trials will improve the quality of research in TCM and also promote international co-operation and communications. It is necessary to establish an assessment system of clinical outcome for TCM on the basis of EBM in order to evaluate the efficacy and safety of TCM objectively and scientifically.

Acupuncture is widely used as an alternative therapy with few side effects because of its simple manipulation and low cost. However, accidents may occur if the practitioner uses it improperly. Early in the Qin dynastuy, the Canon of Medicine mentioned that improper use of acupuncture could cause injury to the body and even death, and it systematically described the occurrence and prevention of acupuncture accidents. Physicians in the successive dynasties frequently reported it, and nealized that the manipulation skills were significantly important in preventing the occurrence of acupuncture accidents.Since the 1950s, acupuncture accidents had been effectively prevented because of the improving of acupuncture instruments, enhancing of the quality of the practitioners, popularizing of sterilization and disseminating of anatomic knowledge. Nevertherless, with the renovating of acupuncture techniques, new accidents may occur constantly. The prevention of acupuncture accidents still should be an arduors task for acupuncturists. Nowadays, acupuncture therapy is being used in more than 140 countries, and acupuncture accidents due to improper application are incrcasing. Prevention of acupuncture accidents has become a global issue deserving of great attention.

The ZHENG (syndrome of traditional Chinese medicine) oriented effects and the multiple-targets' mechanism are the main challenges encountered by recent researches for Chinese herbal formula. Using methods of bioinformatics and systems biology, we proposed a biological network-based framework for understanding the mechanism of Chinese herbal formula, and reviewed our studies under this framework which aimed to explore the relationship between Chinese herbal formula and corresponding ZHENGs, as well as the synergism of herbal combinations. These studies include the network construction for cold or heat ZHENG and its relationship with herbal formula of hot or cold nature, the biological network construction of angiogenesis, and the network regulation-based emergent property of an herbal combination with anti-angiogenesis synergism extracting from the cold formula. It is shown that the ZHENG-oriented effects and the herbal synergism can be nicely explicated by such network-based approaches. Thus, the network-based drug combination discovery, as well as the "traditional Chinese medicine bioinformatics (TCMB)" and "TCM computational systems biology" combining with computational and experimental approaches, is conceivable and can open a new avenue for understanding Chinese herbal formula.

The concept of "three-yin and three-yang" in Shanghan Lun (Treatise on Cold Pathogenic Diseases), a classic written by Zhang Zhongjing in Han Dynasty, has been always the focus of dispute in successive dynasties. The essence of "three-yin and three-yang" has not been fully revealed up till now. Through studying the six divisions of day and night, the six diseases, the combination of syndromes, the complicated diseases, the complete recovery time and the space division of "three-yin and three-yang", the authors draw a conclusion that the "three-yin and three-yang" in Shanghan Lun is a concept of time-sequence, which is associated with the location of disease in space. So it is suggested that the "six diseases" in Shanghan Lun is a categorization for exogenous febrile diseases, and this categorization reveals a sort of inner relationship between the emergence, development, transformation of the febrile diseases and the time.

Objective: To establish Caco-2 (a human colon adenocarcinoma cell line) cell monolayer model and the standard operation procedure for studying and assessing intestinal absorption of chemical components of traditional Chinese medicine.Methods: Caco-2 cell monolayer model was established and evaluated by morphology feature using scanning electron microscope, inverted microscope and transepithelial electrical resistance (TEER) assay. Additionally, the model was further tested for the activity of alkaline phosphatase and the apparent permeability (P_app) of standard compounds, i.e. propranolol and atenolol, which were the control substances for high and poor transcellular transport marker, respectively.Results: The integrality of cell monolayer, cell differentiation (reflected by expression of alkaline phosphatase and cell monolayer morphology), and the P_app value of standard compounds in the established Caco-2 cell model were satisfactory. All parameters tested were in good agreement with those reported in the literature.Conclusion: The established Caco-2 cell model can be used to study the intestinal absorption of orally administrated chemical components of traditional Chinese medicine and their absorption mechanism.

Spinal disease is the injury caused by congenital malformation, degeneration, inflammation and trauma. These injuries lead to structural lesion of spinal itself, intervertebral discs, spinal cord, nerve root and the attachment, and can cause spinal and associated diseases. Spinal diseases include some frequently encountered diseases, as well as some stubborn and serious diseases. These diseases may cause pain of head and neck, shoulder and arm, waist and leg when they are mild, and partial or thorough paralysis when they are serious. In this article, the history, development, foundations and research progress of non-surgical operation of spinal diseases and the developing tendency of modern spinology are introduced.

World Health Organization aims to develop safe, effective and practical traditional medicine. Traditional Chinese medicine (TCM) and other complementary and alternative medicine are being recognized in the whole world nowadays. However, the definite effect of Chinese medicine is still in need of scientific research proof. Placebo control is of equal importance to active control and blank control in clinical trial of TCM. This article briefly reviewed the importance of placebo control and commented on its present situation in clinical trial of TCM. This article also brought up the preliminary proposals of placebo application in TCM clinical trial. We should emphasize scientific placebo preparation and good design of placebo-controlled trial, which are directed by International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. A good clinical trial project will avoid unnecessary wastes and provide safe and effective treatment for people.

Effect of clinical intervention on human body is multistage and multifaceted, involving physiology, psychology, social function and the surrounding resources, etc. Therefore, the range of clinical outcome assessment includes patient, his or her family and care giver. The evaluation of clinical intervention mainly focuses on its effectiveness, safety and health economics. Effects of clinical interventions are measured by comparisons of the outcome of intervention and control groups. Different effect measures come from different comparisons.

Icariin is one of the key active components of Epimedium species, which is most widely applied to supplement the kidney in traditional Chinese medicine. Scientific research has found that icariin possesses extensive therapeutic effects such as protecting neurons from injury, promoting growth of neuronal synapse, improving sexual dysfunction and bone morphogenesis, as well as anti-inflammation, anti-tumor and anti-depression functions. Considering that molecular mechanism is the fundamental basis for pharmaceutical efficacy of icariin, in this article, the authors retrospectively retrieved 122 scientific papers recorded in the PubMed database with "icariin" in the title from January 1, 1995 to January 5, 2011. It was found that icariin has been closely highlighted in the intervention of p38 mitogen-activated protein kinases and phosphatidylinositol 3-kinase/Akt signal pathways, inhibition of phosphodiesterase 5, and regulation of nuclear receptors. Besides, the authors also discussed the main orientation for molecular mechanism of icariin in future research.

Objective

To introduce and analyse the present status of research on decomposed recipes of traditional Chinese medicine (TCM).

Methods

The relevant literature on the study of the decomposed recipes of TCM in the past five years was collected and analysed.

Results and Conclusion

Studies on the decomposed recipes of TCM have been made from the whole body level to the organ, cell and molecular research level. The pharmacological research in vitro is the main way and quantitative changes of the chemical ingredients have been measured before and after composition. It is very important to combine the modern science and technology in exploring the composing mechanisms of TCM remedies.

Objective

To evaluate the correlations between clinical symptoms and treatment efficacy in patients with rheumatoid arthritis (RA).

Methods

Four hundred and thirteen patients were included in the clinical trial from 9 clinical centers. They were randomly divided into Western medicine-treated group with 204 cases and Chinese herbal drug-treated group with 209 cases. Eighteen clinical symptoms were evaluated before and after treatment. The Western medicine therapy included voltaren extended release tablets, methotrexate and sulfasalazine. The Chinese herbal drug therapy included glucosidorum Tripterygii totorum tablets and Yishen Juanbi Tablets combined with treatment based on syndrome differentiation. The American college of rheumatology 20 (ACR20) was used as efficacy evaluation criteria.

Results

In the Chinese herbal drug-treated group, clinical symptoms such as arthralgia and tenderness of joints were positively correlated with the efficacy after 12-week treatment, while frequent urination at night was negatively correlated. In the same group, tenderness of joints and fever were positively correlated with the efficacy after 24-week treatment, while deep-colored and turbid urine was negatively correlated. In the Western medicine-treated group, tenderness of joints and thirst were positively correlated with the efficacy after 12-week treatment, while vertigo was negatively correlated. And in the same group, tenderness of joints was positively correlated with the efficacy after 24-week treatment, while heaviness of limbs was negatively correlated to the efficacy. The statistical results showed that the treatment efficacy was improved when the correlated symptoms were included in the indications.

Conclusion

The treatment efficacy of RA is correlated with some symptoms, so further studies should proceed on these correlations in order to achieve better treatment outcome.

BACKGROUND: Chronic lung diseases, including bronchial asthma, chronic obstructive pulmonary disease (COPD),chronic bronchitis, allergic rhinitis and repeated respiratory tract infection (RRTL) in infants, exacerbate frequently in winter because of respiratory viral infections and low temperature. Summer acupoint application therapy (SAAT) is thought to be effective in reducing exacerbation frequency of chronic lung diseases in winter. It is a kind of therapy using a herbal mixture for external application on special acupoints during summer. The herbal mixture basically contains Semen Sinapis Albae, Herba Asari,Radix Euphorbiae Kansui and Rhizoma Cory dal is. The acupoints include Feishu (BL13), Dazhui (GV14) and Danzhong (CV17). Through a large-scale multicenter trial based on three years of clinical observation, and retrospective and prospective analyses, this study aims to explore the efficacy of SAAT.METHODS AND DESIGN: In this clinical observation trial, patients who have been diagnosed with bronchial asthma,COPD,chronic bronchitis, allergic rhinitis or RRTL will be enrolled from 13 centers. All patients enrolled will be treated with SAAT over a two-year period by medical practitioners. After this, an initial case report form (CRF) will be completed and forwarded to the central study site (China Academy of Chinese Medical Sciences, Beijing, China). The CRF is designed to investigate patients’ history of medical treatment (including SAAT) and chronic lung disease exacerbation, also self-reported health condition. For retrospective analyses, the authors will focus on those who have accepted SAAT before enrollment and will collect their SAAT history and chronic lung disease exacerbation history, to evaluate the effects of SAAT. For prospective analyses, medical students will follow up with patients by phone interviews in winter once a year. The primary outcome is frequency of chronic lung disease exacerbation in winter. The secondary outcomes include conditions of lung disease recovery, non-SAAT therapy, and a self health report.DISCUSSION: The authors aim to collect 7 400 patients from July 2008 to August 2009. The final follow-up has been completed in December 2010. To reduce the selection bias, a total of 13 clinical centers from different areas of China have participated in this study. The results from this study will provide a high-quality evidence base for evaluating the efficacy of SAAT in reducing exacerbation frequency of chronic lung diseases in winter.TRIAL REGISTRATION NUMBER: This trial has been registered in Chinese Clinical Trial Registry (Identifier： ChiCTR-TNRC-10001292).

The theory of formulas corresponding to syndromes is one of the characteristics of Treatise on Cold Damage and Miscellaneous Diseases (Shanghan Zabing Lun) and one of the main principles in applying classic prescriptions. It is important to take effect by following the principle of formulas corresponding to syndromes. However, some medical practitioners always feel that the actual clinical effect is far less than expected. Six errors in the use of classic prescriptions as well as the theory of formulas corresponding to syndromes are the most important causes to be considered, i.e. paying attention only to the local syndromes while neglecting the whole, paying attention only to formulas corresponding to syndromes while neglecting the pathogenesis, paying attention only to syndromes while neglecting the pulse diagnosis, paying attention only to unilateral prescription but neglecting the combined prescriptions, paying attention only to classic prescriptions while neglecting the modern formulas, and paying attention only to the formulas but neglecting the drug dosage. Therefore, not only the patients’ clinical syndromes, but also the combination of main syndrome and pathogenesis simultaneously is necessary in the clinical applications of classic prescriptions and the theory of prescription corresponding to syndrome. In addition, comprehensive syndrome differentiation, modern formulas, current prescriptions, combined prescriptions, and drug dosage all contribute to avoid clinical errors and improve clinical effects.

With the further development of clinical modernization of traditional Chinese medicine (TCM), new request to tongue diagnosis for objectivity and quantification is raised. Many researchers have devoted themselves to this field and have achieved some accomplishments since 1950's. Especially in recent years, the revolution of information technique derived from computer industry brings the research new chances. The research history of the past five decades can be divided into three stages: (1) looking for micro-markers by newly-developed medical technique; (2) quantifying traditional markers by new technique; (3) further development based on information technique and corporation of multiple subjects. This article reviewed the three stages and described its prospect.

The concept of syndrome in traditional Chinese medicine (TCM) is a nonlinear, open and complicated huge system. Syndrome differentiation in TCM belongs to cognitive and noetic science. To establish a new syndrome differentiation system based on the key elements of the syndrome is necessary for TCM practitioners to promote differentiation ability and reach consensus on differentiation method. With combination of experience and computation models, the Bayesian network was used in the study of the relationship between the key elements of syndrome and the symptoms, and the relationship among different key elements, in which the computing diagnosis result was identical to the result from an experienced TCM doctor. The study showed that Bayesian network is a good method to deal with the information of symptoms and signs for syndrome differentiation, but it is also not to reflect comprehensively the thinking ability of TCM doctors in doing syndrome differentiation.

Objective

To study the efficacy and safety of Fuzheng Huayu Capsule (FZHY Capsule) against liver fibrosis with chronic hepatitis B.

Methods

Multicentric, randomized, double blinded and paralleled control led trial was conducted on patients (aged between 18 and 65) with liver fibrosis in chronic hepatitis B．Indexes observed: (1) hepatic histological changes and HBV markers were observed at 0 and 24th week during the treatment; serological indexes (HA, LN, P-Ⅲ-P, Ⅳ-C) were determined and B ultrasound examination of spleen and liver was taken at 0, 12th, 24th week; liver function (during the period of follow-up, liver function and serological indexes for liver fibrosis were evaluated) were observed at 0, 6th, 12th, 18th, 24th week; (2) indexes for safety: blood and urine routine tests, renal function and ECG were examined.

Results

(1) Enrollment and demographic data: There was no significant difference between the trial (110 cases) and control group (106 cases) in demographic feature, vital signs, course of illness,history for drug anaphylaxis, history of previous therapy, liver function, serological indexes for liver fibrosis, liver histological examination (99 cases for test group, 96 cases for control group), HBV markers, and renal function, etc. (2) Histological pathological examination: 93 cases of liver histological examination were taken, of these 50 cases for the trial group and 43 cases for control group which turned out to be at S mean value of 2.33 and 2.11 respectively pretreatment according to criteria for liver fibrosis staging. Post-treatment, the trial showed a significant decrease with S value of 1.80 compared to that of pretreatment; however, there was no significant improvement in control group before and after the treatment with S mean value of 2.14. There was significant difference in reversing rate (decrease at least 1 stage according to criteria for liver fibrosis staging) between the trial (52%) and control (23.3%) after liver biopsy. The trial had a rather good effect on improving inflammatory activity and was superior to control group with a marked decrease of mean value of inflammatory activity and score of inflammation (P<0.05). (3) Serological indexes for liver fibrosis: There was a significant decrease in HA, LN, P-Ⅲ-P, Ⅳ-C content in test group after 12 and 24 weeks' treatment compared to that of pretreatment; the differences of HA, LN, P-Ⅲ-P, Ⅳ-C between 12 , 24 weeks' treatment and pretreatment were significantly greater than control group (P<0.01 or 0.05); the effectual was defined as 2 of 4 indexes lowered more than 30% of the baseline, according to this criteria, the trial was 72.7%, while control group 27.4% (P<0.01). (4) Liver function: Obvious improvement of serum Alb, ALT, AST, GGT was seen in 2 groups; compared with control group, marked improvement of GGT and Alb in the trial (P<0.05); the effective rate of serum ALT in the trial group was 72.7%, while control 59.4%. (5) No changes of significant difference between pre- and post-treatment in routine tests for blood and urine, renal function and ECG, etc. There was also no difference in the stable rate of ALT and serological indexes for liver fibrosis between the trial and control group 12 weeks after withdrawal (P<0.05).

Conclusion

Fuzheng Huayu Capsule has good effect on alleviating liver fibrosis in chronic hepatitis B without any adverse effect and is superior to Heluo Shugan Capsule. Fuzheng Huayu Capsule is a safe and effective medicine for the treatment of liver fibrosis in chronic hepatitis B.

Objective: To study the possible pathway of the effect of musk on brain disorder,distributing into the brain through blood brain barrier.Methods: We used the musk ketone (muscone), a main composition of musk,to inject through the tail vein of the rats into the blood and took the brain and other organs at different times to make samples. Then gas chromatography was used to measure the distribution of muscone in the brain and other organs.Results: Muscone could pass through the normal rat's blood brain barrier into the brain and soon reached the highest peak and remained in higher concentration, and more slowly metabolized as compared with other organs.Conclusion: Musk distributing into the brain through blood brain barrier provides the basis for its effect in treating brain disorders. Chromatography is an effective method to study the active composition of Chinese herbal medicine distributing through the blood brain barrier into the brain.

The paper discussed a variety of experimental designs of compound compatibility law of traditional Chinese medicine (TCM): study of whole formula and different ingredients of formula.The latter includes study of single ingredient, study of functional ingredient group, orthogonal design, clustering analysis, homogeneous design, factorial analysis and so on. It was proposed that experimental designs of formula should be based on the theory of TCM, and combined with modern sciences.

According to TCM theory of the wholistic concept and the principles of sydrome differentiation and treatment, the characteristics of the pathogenesis of aplastic anemia (AA) were summarized and corresponding treatment was put forward on the basis of clinical observation and the study of literature. In the pathogenesis of AA, the deficiency of spleen and kidney is the primary aspect, fire attacking blood vessels is the secondary aspect and there is change because of blood stasis. In treatment,the method of invigorating spleen and tonifying kidney is adopted in order to get at the root, and releasing fire to stop bleeding is adopted in order to bring about a temporary solution, and activating blood circulation to dissipate blood stasis is adopted in order to produce blood. The outline should be caught hold of that consumption is primary aspect and fire is secondary aspect and there is change because of blood stasis in order to obtain satisfactory curative effect.