Screening of Clinical Efficacy Evaluation Indicators for Traditional Chinese Medicine Injections based on Mixed Method Research / 中医杂志

Currently， evidence on the efficacy and risk of traditional Chinese medicine （TCM） injections is seriously insufficient， and it is difficult to evaluate TCM injections comprehensively， truly and objectively using available efficacy evaluation indicators. Therefore， establishing a clinical efficacy evaluation system that can effectively reflect TCM injections is imperative. Core outcome set （COS） has played an important role in screening TCM efficacy evaluation indicators， however， there are still certain problems， such as large differences in efficacy indicators， non-standardization， and lack of featured and specific TCM indicators. Mixed method research （MMR） has the advantages of looking at problems from both quantitative and qualitative perspectives. It is thereby proposed to use COS and MMR integrated model to establish a clinical efficacy evaluation indicator system that not only fully considers the cha-racteristics of TCM injections， but also highlights the efficacy and advantages of TCM injections from the perspective of TCM intervention. Simultaneously， an indicator screening method using MMR to optimize COS research model is formulated， which can provide ideas for the research on efficacy evaluation indicators of TCM injections.

Discussion on Some Problems of the Items in Chinese Patent Medicine Instruction in National Essential Medicine List / 中国药房

OBJECTIVE：To investigate and study the problems in the items labeling of Chinese patent medicine instructions in National Essential Medicines List ，and to provide reference for rational drug use and instruction revision. METHODS ：Totally 268 Chinese patent medicines contained in the 2018 edition of National Essential Medicines List ，including 465 instructions of different . An dard docetaxel as first-line therapy in patients with meta - economic evaluation of docetaxel and paclitaxel regimens in metastatic breast cancer in the UK[J]. Pharmacoeco - dosage forms ，were collected ，and the labeling rate and content problems of drug instructions were counted. RESULTS ：Of the 465 instructions，86.88％ were labeled with cautions. The labeling rates of ADR ，pharmacokinetics，contraindications，drug interactions ， clinical trials ，pharmacological toxicology and pharmacological action were low ，being 20.64％，0.21％，30.1％，1.07％，2.36％， 8.81％，1.93％. All other items were labeled. Incomplete description of ingredients ，incomplete information of decoction pieces and excipients accounted for 2.15％ and 48.81％，respectively；the expression of functional indications was varied ，and there were 12 expression methods ，among which 16.5％ of indications lacked TCM indications ；specifications were not uniform ，and there were 5 expression methods ；usage and dosage were not clearly marked ，and 465 instructions did not mention the usage and dosage for the elderly or pregnant and lactating women. Drug interactions ，ADR，matters needing attention and contraindications were not fully described with no substantive content ；only 0.64％ marked interaction with chemical medicine and 12.68％ marked contraindication content. CONCLUSIONS ：There are some problems in the description of Chinese patent medicine instructions in 2018 edition of National Essential Medicine List ，such as non-standard and incomplete. It is suggested to strengthen efforts to establish and improve the information collection and feedback mechanism of Chinese patent medicine ，and introduce policies to support enterprises to carry out basic and clinical research after listing ；and through actively carrying out basic and clinical research in line with the characteristics of traditional Chinese medicine ，guided by the theory of traditional Chinese medicine ，combined with the latest research results ，so as to further improve the contents of Chinese patent medicine instructions.

Exploration on the Construction Ideas of Software Knowledge Base for Rational Use of TCM Decoction Pieces / 中国药房

OBJECTIVE：To provide referenc e for the construction and software development of knowledge base for rational use of TCM decoction pieces. METHODS ：By reviewing the literatures on rational drug use software and TCM decoction pieces in recent years ，the clinical characteristics of rational drug use of TCM decoction pieces as well as the characteristics and shortcomings of existing rational drug use software in the detection of rational drug use of TCM decoction pieces were analyzed ， and the core contents and difficulties in the construction of knowledge base of rational drug use software of TCM decoction pieces were summarized. RESULTS & CONCLUSIONS ：Clinical application of TCM decoction pieces was mainly based on “syndrome differentiation”，which reflected the unity of dialectics ，treatment，prescription selection and medication. Therefore ，the consideration of the rationality of clinical use of TCM decoction pieces could not blindly imitate the evaluation method of chemical medicine. Current rational drug use software was not based on the theoretical system of traditional Chinese medicine ，and it was not comprehensive and mature in the aspect of rational drug use review of TCM decoction pieces ，and lacks the knowledge base that could meet the requirements of rational use of TCM decoction pieces. Therefore ，it is necessary to construct a set of knowledge base which can meet the evaluation requirements of “consistency of principle ，method and prescription use ”of TCM decoction pieces under the guidance of TCM theoretical system. Its contents include that patient information collection ，construction of knowledge base related to diseases and syndromes ，selection of processed products of TCM dec oction pieces ，addition andsubtraction of clinical symptoms ，selection taboo of varieties of TCM decoction pieces ， compatibility taboo ， combined application of Chinese patent medicine or chemical medicine ， dosage of TCM decoction pieces ， total dosage and tastquantity of each prescription ， special de coction drugs ， medication methods and administration frequency ，etc. There are still some difficulties in the development of rational drug use software of TCM decoction pieces ，such as the construction of disease and syndrome related knowledge base and the difficulty in judging the rationality of clinical symptom addition and subtraction.

Analysis of the Historical Evolution of “Eighteen Incompatible Medicaments ”and“Nineteen Medicaments of Mutual Restraint ” of TCM and Its Clinical Application / 中国药房

OBJECTIVE： To investigate the historical evolution and clinical application of “eighteen incompatible medicaments” and “nineteen medicaments of mutual restraint” of TCM， and to provide reference for enriching the contents of rational use of TCM. METHODS： Through the methods of literature mining， using “eighteen incompatible medicaments” “nineteen medicaments of mutual restraint” “incompatible medicaments” “clinical use” “ADR” “ADE” as keywords， retrieved from CNKI， Wanfang， VIP database （from the date of database establishment to August 2018） and library of Henan University of TCM， related literatures about “eighteen incompatible medicaments” and “nineteen medicaments of mutual restraint” were extracted and combed， and the history and clinical application of them were summarized and analyzed. RESULTS & CONCLUSIONS： “Eighteen incompatible medicaments” is one of the main contents of TCM basic theory. The word is first published in Shubencao， which is the concrete embodiment of the “opposite” in the “seven compatibility regularities” of TCM， and the number of “eighteen incompatible medicaments” of TCM recorded in the medical books of TCM is different from each other in the past dynasties. “Nineteen medicaments of mutual restraint” is one of the taboos of TCM compatibility， which is first found in Shennong’s Herbal. There are mixed use of “mutual inhibition” “incompatible” and “mutual restraint” in all dynasties， and there is still controversy about the attribution of “seven compatibility regularities” of “nineteen medicaments of mutual restraint” among physicians. Regardless of ancient medical books， modern medical books， various editions of Chinese Pharmacopeia， literature reports and clinical applications， there are compatibility usage of drug pairs of “eighteen incompatible medicaments” and “nineteen medicaments of mutual restraint”. Among them， 8 kinds of set prescription preparations containing drug pair of “eighteen incompatible medicaments” were involved in 2015 edition of Chinese Pharmacopoeia （part Ⅰ）， most of which were Aconitum carmichaelii/Aconitum kusnezoffii-Bletilla striata/Ampelopsis japonica； 9 kinds of set prescription preparations containing drug pair of “nineteen medicaments of mutual restraint” were also involved， most of which were Syringa oblate-Curcuma rcenyujin， Cinnamomum cassia-Halloysitum rubrum. Although there are medical records or literature pointing out that it can be used to treat critical and difficult diseases， and some studies have preliminarily confirmed the compatibility rationality of individual incompatibility medicaments/medicaments of mutual restraint， the conclusions of relevant studies are not entirely consistent， and the intensity of research evidence is not high， and the research evidence is insufficient.  Basic researches should be strengthened and large-scle， multiple-center and high-quality  clinical studies are needed to confirm this conclusion so as to guaratetee the rationality and safety of drug use in clinic.

Bitterness-masking Effects of Neotame on Five Bitter Chinese Herbal Ingredients / 世界科学技术-中医药现代化

This study was ai med to observe the taste-masking effects of Neotame on bitter Chinese herbal ingredients. Five kinds of herbal ingredients, which include Scutellaria baicalensis Georgi, Cortex Phellodendri chinensis, Coptis chinensis Franch, Gentiana scabra Bunge, Andrographis paniculata, were selected to measure the bitterness degree of decoctions with berberine solution as the benchmark. The decreasing of bitterness degree was used as index. Healthy volunteers were recruited to taste and compare the changes of bitterness of decoctions with the taste-masking effects of Neotame. Different concentrations of Neotame were selected in the determination of the influence on changes of bitterness. The results showed that when the concentration of Neotame was at 0.012 5‰-0.4‰, taste-masking effects of Neotame on selected herbal decoctions were in a concentration-dependent fashion. When the concentration of Neotame was 0.4‰, the reduced bitterness of S. baicalensis Georgi and Cortex P. chinensis decoctions were 1.22 and 1.77, by 70.11% and 71.88%, respectively. Three highly-bitter herbal ingredients C. chinensis Franch, G. scabra Bunge and A . paniculata were also reduced in bitter taste by 49.12%, 50.87% and 38.39%, with the bitter reduced value (△I) of 1.78, 2.02 and 1.43, respectively. It was concluded that Neotame exerted taste masking potential on bitter herbal ingredients with different bitter degrees.

Comparative study on four kinds of assessment methods of post-marketing safety of Danhong injection / 中国中药杂志

<p><b>OBJECTIVE</b>To study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection.</p><p><b>METHOD</b>Set down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis.</p><p><b>RESULT</b>Study the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions.</p><p><b>CONCLUSION</b>The central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.</p>

Study on 10 409 cases of post-marketing safety Danhong injection centralized monitoring of hospital / 中国中药杂志

<p><b>OBJECTIVE</b>To study Danhong injection adverse reactions (ADR) incidence, nature and clinical performance, provide the basis for the clinical safety of drugs.</p><p><b>METHOD</b>Multi-center, a large sample of hospitals focused on monitoring method.</p><p><b>RESULT</b>Danhong injection ADR for the rapid onset and ease the quick recovery, the rate was 0. 682% , the newly discovered ADR constipation, sweating, tinnitus, irritability, joint disease, erythema, venous pain, phlebitis, local numbness, pain, weakness, gastrointestinal ulcer bleeding, vasospasm, cyanosis.</p><p><b>CONCLUSION</b>Danhong injection adverse reactions are type A adverse reactions occasionally, centralized monitoring of hospital medicine injection method is to carry out post-marketing safety re-evaluation of appropriate methods.</p>

On "Pill,Is Sluggish" / 中国药房

OBJECTIVE: To provide reference for research & development and application of pill preparation. METHODS: Our understanding on the statement "Pill, Is Sluggish" was come up with, and the pertinetn literature and research results were analyzed and summarized. RESULTS: The statement "Pill, Is Sluggish" is not only the description of the traditional pill's dosage-form characteristic, but also contains the requirement on administration method. It is a relative description. There is also difference in speed of taking effect between different kinds of pills. Its origin contains the factor of dosage as well as the factor of dosage-form; It does not apply to some new type pills. CONCLUSION: The connotation of "Pill, Is Sluggish" is extremely rich, which should be viewed relatively, comprehensively and developmentally so as to continuously enrich and develop the dosage form theory of Chinese materia medica and make pills serve better for the clinic.

Improvement of the Quality Standard of Toxic Traditional Chinese Medicines / 中国药房

OBJECTIVE:Suggest to improve the quality standard of toxic traditional Chinese medicines.METHODS:The"content determination"and"limit test"of 72 toxic traditional Chinese medicines recorded in Chinese pharmacopoeia(2005 edition) were briefly introduced.RESULTS:Only 11%of the total 72 toxic traditional Chinese medicines had the items of both"content determination"and"limit test".CONCLUSION:The quality standard of toxic traditional Chinese medicines should be improved to achieve quality control in accordance with the standard of"low toxicity but high effectiveness"so as to ensure safe and effective drug use in the clinic.

Exploration on the Effect of Micro-powder Technique on the Application of Traditional Chinese Medicine / 中国药房

OBJECTIVE:To explore the effect of micro-powder technique on the application of traditional Chinese medicine. METHODS:The physical property of the micro-powder and its effect on curative effect, toxicity and pharmaceutical engineering were analyzed. The efficacy of traditional Chinese medicine micro-powder was compared with traditional pieces and decoction. RESULTS:As compared with traditional pieces and decoction, traditional Chinese medicine micro-powder represented many advantages but there were a series of problems such as the change of curative effect and the toxicity in the process of application. CONCLUSION:The micro-powder technology is beneficial exploration to the traditional Chinese medicine dosage-form reform, which should be paid attention and studied.