PPK is a discipline that quantitative investigates the determinants of drug concentration in patient groups. Developing reasonable PPK design of experiment can provides the real objective data for clinical medicationand then promotes the formulating of clinical individualized medication regimens. This paper referenced over all years literatures, and combined with practical work experience. Summarizes of the main points of PPK design of experiment focused on traditional Chinese medicine. The content mainly included choosing research objects, selecting items, designing sample collection steps, blood sample analysis experiments and data analysis schemes.
Humans ; Medicine, Chinese Traditional ; Pharmacokinetics ; Product Surveillance, Postmarketing ; Research Design

Minimizing the underlying risk and maximizing the benefits of drag users, by using drags under a safe, efficient and economical principle, is both the requirement and purpose of clinical rational drug use. This paper evaluates the clinical application of traditional Chinese medicine (TCM) in the market based on its characteristics, considering if the drugs are safely applied, if the medicine has an anticipated effect, and if the medicine is properly priced. This paper also brings the idea of establishing an evaluation system integrated with the characteristics of TCM to monitor the clinical application of TCM after going into the market and thus further optimizes the clinical instructions of applying TCM and helps to guide the appropriate usage of TCM.
Drug-Related Side Effects and Adverse Reactions ; Economics, Pharmaceutical ; Humans ; Medicine, Chinese Traditional ; adverse effects ; economics

The fenrou zhijian is defined as potential gap between different layers in the three-dimensional network structure formed by the twelve meridian tendons. Various pathological changes of the meridian tendons lead to the adhesion and closure of fenrou zhijian, causing abnormal mechanical conduction of the meridian tendon system, which in turn leads to painful bi syndrome of meridian tendons. As such, restarting the fenrou zhijian is the key to acupuncture treatment for painful bi syndrome of meridian tendons. Under the guidance of musculoskeletal ultrasound, the level and the angle of needle insertion of acupuncture at fenrou zhijian could be accurately controlled, the efficacy of acupuncture is improved.
Humans ; Meridians ; Acupuncture Therapy ; Needles ; Pain ; Tendons/diagnostic imaging*

The efficacy of traditional Chinese medicine （TCM） and compound prescriptions is confirmed based on practical experience. It is a highly generalized expression of the clinical characteristics and scope of prescriptions and a unique expression of the medical effects of TCM. Network pharmacology， as a cross-disciplinary field based on the theory of systems biology and multi-level analysis of biological systems， has become a common virtual screening tool in TCM research and gradually developed with the progress in big data and artificial intelligence. In the context of modern medicine， the efficacy of TCM compound prescriptions has a vague concept and lacks scientific evidence. Elucidating the connotation of TCM efficacy and guiding TCM theoretical research has become one of the hotspots and difficulties in TCM research. This article explores the feasibility of using network pharmacology for the research on the efficacy of TCM compound prescriptions and investigates whether the research results can represent part of the efficacy of prescriptions. Furthermore， the research platforms and algorithms in this field are summarized. The research ideas and existing problems in this field are proposed from the aspects of efficacy concept embodiment， target screening， result verification， efficacy network building， and homogenization avoiding of network pharmacology research results. Finally， the future development directions are prospected. This article is expected to provide a reference for exploring the modern biological basis of the efficacy of TCM and compound prescriptions and for the clinical application and theoretical research of TCM.

Classical Chinese patent medicines(CPMs) are a kind of modern preparation developed from the experience of compatibility and application about ancient prescriptions. Its rich history of human use and reliable clinical efficacy imply the unique theoretical essence and precious value of traditional Chinese medicine(TCM). With the development of evidence-based medicine and the improvement of medical policy, it is particularly urgent to evaluate the clinical values of post-marketing classical CPMs. In this paper, some problems on the clinical value evaluation of CPMs would be described, and it is considered that the simplified evaluation procedures can lead to the lack of evidence for evaluating clinical value of CPMs, causing the difficulty in evaluating the quality of CPM, lack of R&D motivation of enterprises, low content of science and technology, and poor international development. Based on this background, it points out that the clinical value evaluation is the core of the post-marketing evaluation of the classical CPMs, and the eva-luation should be based on the direction of literature research and the latest practice. We should adhere to the research mode of combination disease with syndrome, and select the appropriate type of trials, with clinical efficacy, health economic benefits and safety eva-luation as the main content of the studies, in order to refine the indications and standardize the clinical positioning. Clinical value eva-luation is the basis and main content of post-marketing comprehensive researches on classic and famous CPMs to clarify their clinical value, obtain the conditions for continued marketingand standardize their clinical application, so as to optimize the evidence and quality service of classic and famous CPMs and inherit the core value concept of Chinese medicine.
China ; Drugs, Chinese Herbal ; Humans ; Marketing ; Medicine, Chinese Traditional ; Nonprescription Drugs

Many schools of academic doctrines have emerged throughout the development history of traditional Chinese medicine (TCM) due to geographic, time, Shicheng (mentor-apprentice system) and academic diversities. Classic TCM School, Classic Formula School and Febrile Disorder School, though all lacking a clearly demonstrable or continuous Shicheng relationship, are nevertheless so classified because of their consistency in reference to the classic TCM works. Each of the Four Famous Masters of Jin and Yuan Dynasties had its distinctively different academic doctrine, resulting in the establishment of individually integrated academic schools. The emergence of the Warming and Tonifying School in late Yuan and early Ming Dynasties was realized as a means to rectify the ill effects of the cool and cold medications prevalent at the time. On the other hand, the advent of the Warm Disease School and the rise of the Confluence School embodied the close relationship carried by TCM academic schools to contemporary historical background. Looking at this development history, it is evident that the development of TCM academic schools could flourish only if it allows dissenting, yet mutually tolerant, opinions. In present medical environment where TCM and Western medicine are of equal importance, Classic TCM Schools, TCM Modernization Schools and Integrative Medicine Schools should all receive emphasis to foster development.
Academies and Institutes ; Medicine, Chinese Traditional ; Schools, Health Occupations ; classification ; Textbooks as Topic

OBJECTIVETo find out a set of practical,objective, and quantitative laboratory indices of climacteric syndrome (CS) patients of Shen deficiency syndrome (SDS), thus studying the essence of SDS from the perspective of laboratory medicine.

METHODSRecruited were 40 CS patients of SDS (or of SDS as main syndrome) as the SDS group, while another 40 healthy subjects were recruited as the control group. Their serum samples were collected. Serum levels of total triiodothyronine (TT3), total thyroxine (TT4), free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), testosterone (TESTO), estradiol (E2), prolactin (PRL), progesterone (PROG), cortisol (CORT), immunoglobulin M (IgM), immunoglobulin G (lgG), Complement 3 (C3), complement hemolysis 50% (CH50), angiotensin converting enzyme (ACE), aldosterone (ALD), serum alkaline phosphatase (ALP), and bone Gla-protein (BGP) were measured by automatic electrochemical luminescence assay analyzer, automatic chemiluminescence assay analyzer, automatic biochemistry analyzer, and automatic enzyme-linked immunosorbent assay (ELISA) analyzer. The correlation between syndrome types and laboratory indices were judged by gradual discriminant analyses.

RESULTS(1) Compared with the control group,serum levels of CORT, TESTO, E2, TT3, FT3, FT4, TSH, C3, CH50, ALP, and BGP significantly decreased in the SDS group (P < 0.01, P < 0. 05), while FSH, LH, and ACE significantly increased (P < 0.05). (2) The index with stronger capacity for diagnosing CS patients of SDS was ranked from high to low as CH50, PROG, TSH, TESTO, BGP, CORT, and C3, with their contribution rate of the discriminant function being 95.9%. (3) Discriminant analysis equation of CS patients of SDS was Y = -25.904 - 0.468CH50 + 0.002PROG + 0.182TSH + 9.690TESTO + 1.015BGP + 0.016CORT + 33.581 C3.

CONCLUSIONS(1) CS patients of SDS were closely correlated with thyroid hypothalamus-pituitary-adrenal axis, hypothalamus-pituitary-adrenal axis, renin-renin-angiotensin-aldosterone system,the immune function, and bone formation, and etc. (2) CH50 might be of a high sensibility marker for diagnosing CS patients of SDS. (3) Discriminant analysis equations of laboratory medicine index may be used in preliminary diagnosis and auxiliary certificate of CS patients of SDS.

Case-Control Studies ; Climacteric ; metabolism ; Discriminant Analysis ; Estradiol ; blood ; Female ; Follicle Stimulating Hormone ; blood ; Humans ; Hydrocortisone ; blood ; Luteinizing Hormone ; blood ; Medicine, Chinese Traditional ; methods ; Middle Aged ; Pituitary-Adrenal System ; Progesterone ; metabolism ; Prolactin ; blood ; Renin-Angiotensin System ; Testosterone ; blood ; Thyrotropin ; blood ; Thyroxine ; blood ; Triiodothyronine ; blood

OBJECTIVETo study the effects of flavonoids of Rhizoma Drynariae on gene level of rats without ovaries (OP) by technology of cDNA array.

METHODThe models of rats without ovaries were made After. 24 weeks of treatment, put them to death and sampled 6 ml blood from the abdominal aorta and 4cm spinal cord. Take out the total RNA, then separate the mRNA to check.

RESULTThere is 70 genes difference between the blank control group and model group, 9 genes difference between the blank control group and flavonoids of Rhizoma Drynariae group. The genes over expression of OP rats models regain normal after the models were fed on flavonoids of Rhizoma Drynariae. There are no differences in the spinal cords genes in the cDNA array analysis of this trail.

CONCLUSIONThe genes over expression of OP rats models regain normal after the models were fed on flavonoids of Rhizoma Drynariae for 6 months. The result shows that the flavonoids of Rhizoma Drynariae does have certain effects on the gene expression of rats without ovaries.

Animals ; Female ; Flavonoids ; isolation & purification ; pharmacology ; Gene Expression Profiling ; Gene Expression Regulation ; drug effects ; Oligonucleotide Array Sequence Analysis ; Ovariectomy ; Plants, Medicinal ; chemistry ; Polypodiaceae ; chemistry ; Random Allocation ; Rats ; Rats, Wistar

Traditional Chinese medicine (TCM) safety assessment is an important content of post-marketing Chinese herbal medicine assessment and the primary question. It includes safety monitoring and safety evaluation. China has established the elementary system for the TCM safety monitoring, but did few things on safety evaluation. People have knew that the methods of pharmacoepidemiology have good practicability on drug safety assessment in recent years. This article analyzed three methods of pharmacoepidemiology used in post-marketing Chinese herbal medicine safety assessment. There are three examples that may give some suggestions to fellow doctors working for safety monitoring and evaluation of TCM.
Drug-Related Side Effects and Adverse Reactions ; Humans ; Medicine, Chinese Traditional ; adverse effects ; Pharmacoepidemiology ; methods ; Product Surveillance, Postmarketing ; methods ; Risk Assessment