北京地区18所高校医院口服降糖药利用分析

目的:了解北京地区高校社区医院近两年口服降糖药使用现状。方法:对北京地区18所高校社区医院采购的零差率中标药品中的口服降糖药物品种、购药金额、用药频度、日均费用等数据进行统计分析。结果:α-糖苷酶抑制剂的采购金额、DDDs、DDC值均排在各类口服降糖药的第1位。格列喹酮片、二甲双胍肠溶片(0.25g)的DDDs值分别排在第2、3位,而DDC值排在第5、6位。结论:α-糖苷酶抑制剂是北京高校社区糖尿病患者的首选药物。格列喹酮片、二甲双胍肠溶片(0.25g)有较高的药物利用经济价值。

二甲双胍带量采购中选仿制药疗效与安全性评价的真实世界研究

目的评估二甲双胍集中采购中选仿制药与原研药治疗2型糖尿病在临床使用中的有效性和安全性差异。方法本研究为回顾性队列研究,提取首都医科大学宣武医院电子信息系统中2021年1月1日至2021年9月30日处方使用二甲双胍原研药和仿制药治疗糖尿病的门诊患者数据,分为仿制药组和原研药组,使用倾向性评分匹配(PSM)法对两组基线水平校正后,比较两组的HbA 1c、FPG、AST、ALT、血肌酐、DDDs、DDC、持续用药率、换药率等相关疗效和安全性情况。结果对能获得至少2次HbA _(1c)等检验值匹配后所得的200对患者进行直接指标分析,原研药组与仿制药组治疗后HbA _(1c)变化值分别为-0.40(-1.50,0.00)和-0.50(-1.50,-0.02),两组差异无统计学意义(P=0.247),两组FPG变化值差异无统计学意义(P=0.473),原研药组与仿制药组HbA 1c<7.0%达标率分别为77.50%和81.50%,差异无统计学意义(P=0.322);安全性方面,ALT、AST和血肌酐的异常发生率差异均无统计学意义。对原研药组和仿制药组匹配后获得的4077对患者进行间接指标分析,原研药组DDDs以及3、6个月的药物持续治疗率高于仿制药组,仿制药组DDC明显低于原研药组,单次换药率、2次换药率均高于原研药组(P<0.001)。结论二甲双胍集采中选仿制药与原研药在有效性和安全性方面相当。

Effects of Traditional Chinese Herbal Medicines on Blood Ions and Enzymes of Egg-laying Hens Under Heat Stress

[Objective] This study was conducted to investigate the effects of tradi- tional Chinese herbal medicines on blood biochemical indices of egg-laying hens under heat stress and to provide theoretical basis for clinical application of the medicines. [Method] One hundred of 88-day-old ISA-Brown hens were randomly di- vided into five groups. The hens in four groups were administrated with Prescription I herbal medicines, Prescription II herbal medicines, Vc and blank control under ar- tificially simulated heat stress, respectively. The last group was raised under normal temperature condition. Blood samples of the hens were collected on 1, 4, 8 and 10 d later and detected for their biochemical indices. [Result] The blood sodium （Na）, phosphorus （P）, potassium （K） and chlorine （CI） concentrations in hens under heat stress were decreased, while the activities of alanine aminotransferase （ALT）, lactate dehydrogenase （LDH） and creatine kinase （CK） were increased. These indices grad- ually returned to normal levels after the use of traditional Chinese herbal medicines. [Conclusion] The herbal medicines can relieve the adverse effects caused by heat stress to blood biochemical indices via different metabolic pathways of ions and en- zymes.

Intestinal microflora molecular markers of spleen-deficient rats and evaluation of traditional Chinese drugs

AIM:To find a rapid and efficient analysis method of gastrointestinal microflora in Pi-deficient(spleen-deficient) rats and to evaluate traditional Chinese drugs.METHODS:Enterobacterial repetitive intergenic consensus-PCR(ERIC-PCR) based assay was performed to examine changes of intestinal microflora in two Pi-deficienct animal models and to evaluate the efficacy of four traditional Chinese drugs as well as a probiotic recipe and another therapy in Pi-deficient rats.RESULTS:A molecular marker was identified for Pi-deficiency in rats.The pharmacodynamic evaluation system,including identified molecular markers(net integral area and abundance of DNA bands),Shannon's index for diversity of intestinal microflora,and Sorenson's pairwise similarity coefficient,was established.The four major clinical recipes of traditional Chinese drugs for Pi-deficiency in rats,especially at their medium dose(equivalence to the clinical dose),produced more pronounced recovery activities in Pi-deficient rats,while higher doses of these recipes did not show a better therapeutic effect but some toxic effects such as perturbation deterioration of intestinal microflora.CONCLUSION:Both fingerprint analysis and identified marker can show Pi-deficiency in rats and its difference after treatment.The identified molecular marker may be applied in screening for the active compounds both in relative traditional Chinese drugs and in pharmacodynamic study of Pi-deficiency in rats.

Outcome measures in clinical trials of traditional Chinese medicine for stable angina pectoris

Objective:This work aimed to present a descriptive analysis of the outcome measures used in clinical trials of traditional Chinese medicine(TCM)for patients with stable angina pectoris,and to provide baseline data for the development of core outcome sets(COSs)for relevant clinical trials.Methods:Medical databases were searched to identify randomized trials of the effects of TCM for the treatment of stable angina pectoris.Outcome measures of each trial were extracted.Descriptive statistics were used to analyze the baseline characteristics of outcomes in clinical trials of TCM.Results:94 randomized trials(with 9,111 participants)involving 79 different outcomes were identified.The mean number of outcomes was 5(1-21 per trial).The 5 most commonly reported outcomes were efficacy rate of electrocardiogram,efficacy rate of angina pectoris,efficacy rate of TCM syndrome,fasting lipid indices,and withdrawal rate of nitroglycerin.Several challenges were identified:(1)significant heterogeneity of outcomes and differences in the technique and timing of the measurement of the same outcome;(2)transformation of continuous data into categorical data and presented as such in>90% of trials;(3)few trials on the outcomes associated with the advantages and characteristics of TCM;and(4)selective reporting of outcomes.Conclusions:The outcomes used are excessively heterogenous,and the choice of some outcomes(timing and techniques)for measurement is confusing or inappropriate.Hence,developing and implementing a COS is necessary for greater consistency.

Core outcome set for stable angina pectoris in traditional Chinese medicine(COS-SAP-TCM)

Objective:This study aimed to develop a core outcome set(COS)for use in future studies of stable angina pectoris(SAP)in traditional Chinese medicine(TCM).Methods:Systematic literature reviews and qualitative interviews with cardiologists and patients with SAP treated using TCM were conducted to generate a set of outcomes.Outcomes were prioritized by stakeholders via two rounds of an online Delphi survey and face-to-face consensus meetings.Following the final consensus meeting,a final COS was generated.Results:An initial set of 324 outcomes was identified.A preliminary list of 65 outcomes was employed in the Delphi study.In total,223 participants from seven stakeholder groups were invited to score outcomes in the first Delphi round:87 completed round 1 and 47 completed round 2.Thirty-one participants attended the consensus meeting and agreed on a final core set of outcomes comprising six items across four domains:frequency of angina attack,duration of angina attack,Seattle angina questionnaire,total exercise duration in the exercise treadmill test,cardiovascular events,and QT interval on electrocardiography.Conclusions:The COS developed in this study provides the minimum requirements for measurement and reporting in future TCM clinical trials for the treatment of SAP.The employment of this COS may reduce heterogeneity across trials and facilitate evidencebased decision-making for stakeholders.

STANDARDIZATION OF ACU-MOXIBUSTION IS VERY IMPORTANT FOR THE INTERNATIONALIZATION AND MODERNIZATION OF ACUPUNCTUROLOGY

In the present paper, the authors present their viewpoints about the standardization of acu-moxibustion from ① orderliness of pattern-identification and acupoint prescription, ② unification of acupoint location, ③ systematization of acupoint needling, and ④ standardization of needling manipulations. The standardization is very important for the development of acupuncturology and for its popularization in the world.

Clinical metabolic analysis combined with traceability of biosynthetic pathway:a new approach to quality marker of Chinese materia medica

Quality marker(Q-marker)of Chinese materia medica(CMM)plays an important role in quality control of CMM products.However,its research strategy and technique remain unclear.Based on the fact that quality standard of CMM should be associated with clinical efficacy,taking Jinqi Jiangtang tablet treating type 2 diabetes as an example,the Q-marker related to activity via the reverse analysis of drug metabolism in clinic and traceability of botanic biosynthetic pathways is discovered and validated.Therefore,we proposed a new research strategy of Q-marker of CMM with"Discovery of clinical active constituents as guidance,Reverse analysis of metabolic transformations as link,and Traceability of biosynthesis pathways as key",to improve quality control of CMM products.

北京地区18所高校医院2007～2008年口服降糖药采购数据分析

目的:了解北京地区高校医院口服降糖药的应用情况及趋势。方法:对北京地区18所高校医院2007～2008年采购的零差率中标药品中口服降糖药品种、采购金额、用药频度(DDDs)、日均费用(DDC)等数据进行统计、分析。结果:α-糖苷酶抑制剂的采购金额、DDDs、DDC均排在各类口服降糖药的第1位;格列喹酮片、二甲双胍肠溶片(0.25g)的DDDs分列第2、3位,而DDC分列第5、6位。结论:α-糖苷酶抑制剂是2007～2008年北京地区高校医院口服降糖药的首选药物,但采购金额与用药人/次的同步相关性较差。格列喹酮片、二甲双胍肠溶片(0.25g)的药物利用合理性和药物经济价值较高,值得临床和患者优先选用。

TREATMENT OF 50 CASES OF SENILE DEMENTIA BY ACUPUNCTURE COMBINED WITH INHALATION OF HERBAL DRUGS AND OXYGEN

Clinical DataCase selection: 100 cases who met thediagnostic criteria of senile dementiaformulated by American Association ofPsychiatry in Handbook of Diagnosis andStatistics (DSM-Ⅲ-R, 3rd revised edition)

Therapy Response of Chinese Herbal Medicine in Advanced Liver Cancer： A Retrospective Observational Clinical Trial

Aiming at starting the ball rolling and contributing humble effort to promote CTM （Chinese traditional medicine）, we performed the present study to assess the therapy response of Chinese herbal decoction compared to conventional therapy on critical ill patients of advanced liver cancer. A total of 6 patients （1 female and 5 males） with histologically confirmed liver cancer were included in this retrospective observational clinical trial. We administered Chinese medicine （Gan Decoction, mixed with a variety of effective herbal components） to help them to recover from poor condition. In the meantime, conventional treatment of surgical resection and artery catheterization chemotherapy was applied in cases compared. In 3 cases of CTM combined treatment, the tumor marker level decreased. Residual intrahepatic metastatic sites reduced according to ultrasonography/CT imaging, and the patients felt free from the complaint of abdominal discomfort. The quality of life has been improved, we managed to have prolonged the PFS （Progression-Free-Survival） and TTP （Time-to-Progression） from the onset to date. While in 3 cases with conventional treatment only of surgical resection and artery catheterization chemotherapy, we were not able to decrease the level of tumor marker, metastatic lesions increased according to ultrasonography/CT imaging, and the patient＇s condition worsen more. We failed in having prolonged the PFS and TTP in the compared cases of conventional treatment only. The retrospective clinical study showed no OS （overall survival） benefit for liver cancer patients treated with Gan Decoction, while the QOL （quality of life） evaluation seemed to predict survival better. Chinese herbs might be an additional choice with its better benefits and tolerability in the treatment of primary liver cancer.

Visualization analysis of the international standard ISO/TC 249 for traditional Chinese medicine

Objective This study proposes to visually review the current situation and progress of standards sets by the International Organization for Standardization/Technical Committee on Traditional Chinese Medicine(ISO/TC 249). The review aims to explore the development strategies of the standards, which will exhibit the considerable impact on the economy, trade and exchanges, and cooperation in the area of traditional Chinese medicine(TCM).Methods ISO/TC 249 standards were searched on the ISO website, and their title, proposed time, current stage, scope, and classification were obtained for further summarization. Gephi was utilized to portray the co-occurrence network graph of the ISO/TC 249 standards subject.Results In ISO/TC 249, there were 116 standards, including 81 published standards and 35 developing standards by April 30, 2022. Two withdrawal standards were published after revision, which were not counted in the total standards. The number of published standards has been increasing since the first standard was published in 2014, whose title was “Sterile acupuncture needles for single use”. Among these standards, 17.24%(20/116) standards were in review, 56.03%(65/116) in publication, 3.45%(4/116) in approval, 5.17%(6/116) in enquiry,3.45%(4/116) in committee, and 14.66%(17/116) in preparation, respectively. With 116 standards, most of the research focused on the medicament, as its classification of the International Classification for Standards(ICS) showed the proportion reaching 49.54%. The network analysis data revealed that the top five most frequent words were “materials” “root” “requirements” “products” and “system”, after removing the noise data, such as prepositions,conjunctions, and pronouns. Additionally, the word “system” co-exists with the terms “computerized” “coding” “image” “tongue” and “analysis”;the word “requirement” co-exists with“manufacturing” “decoction” “process” and “materials”;whereas the word “devices” coexists with “pulse” “electric” “skin” and “measurement”.Conclusion With the increased diversification and complexity of problems, the development of standards is also oriented to multidisciplinary fields to cultivate the interdisciplinary talents, and especially the international standardization talents of compound TCM. Multi-angle analysis, formulation, and demonstration of standards, in line with industry needs in different disciplines, enhance the availability of standards and the ability to serve the industry.

Integrated approach of network pharmacology and chemometrics for quality control of Chinese patent medicine:A case study on Huo-Luo-San

Traditional Chinese medicine(TCM)has garnered significant global interest owing to its multi-component and multi-target theoretical framework and extensive therapeutic efficacy.However,the identification of quality markers(Q-markers)remains a formidable challenge in TCM.Hence,this study aimed to integrate network pharmacology and chemometrics to identify Q-markers in Chinese patent medicine,with a focus on Huo-Luo-San(HLS)as a case study.HLS,a widely used powdered Chinese patent medicine in China,comprises a complex formula of 10 herbs,initially formulated during the Qing dynasty for treating fractures.Initially,13 components,chlorogenic acid,typhaneoside,isorhamnetin-3-O-neohesperidoside,cynaroside,notoginsenoside R_1,ginsenoside Rg_1,baicalin,berberine hydrochloride,ginsenoside Rb_1,dehydrocostus lactone,dioscin,imperatorin,and costunolide,were selected as phytochemical markers for each herb based on the Chinese Pharmacopoeia(2020 version),forming the“Herbs-Compounds-targets”network of HLS using network pharmacology.Subsequently,employing network pharmacology,the 13 HLS components were quantified using UPLC-QqQ-MS.Chromatographic conditions were optimized on a Waters Cortecs C_(18)column(2.1 mm×100 mm,1.6μm)with a gradient elution comprising 0.1%formic acid in water and acetonitrile.Analyte detection was performed in the multiple-reaction monitoring mode,and the method underwent validation for linearity,detection limit,precision,repeatability,stability,and accuracy.The validated method was then utilized to analyze the 13 components in 15 batches of HLS samples.Chemometric techniques,including hierarchical cluster analysis,principal component analysis,orthogonal partial least squares projection discriminant analysis,and box map analyses,were subsequently employed to identify the Q-markers.Ultimately,six components,baicalin,notoginsenoside R_1,berberine hydrochloride,dioscin,imperatorin,and chlorogenic acid,were selected as Q-markers for HLS.The integration of network pharmacology with chemometrics represented a novel approach for selecting Q-markers in Chinese patent medicine.

Development of Hong Kong Chinese Materia Medica(HKCMM) standards

The development of HKCMM standards is one of the achievements of developing Hong Kong into an intemational centre for Chinese medicine. In order to enable more people concerned to have an intimate knowledge of this standard, the author was invited to introduce the development of HKCMM standards to readers, including： 1） the history of the project and the basis for legislative supports; 2） the composition and operation of the regulatory division, the research institution and the evaluation committee; 3） the progress of HKCMM standards; 4） the contents and features of HKCMM standards.

Approaches to establish Q-markers for the quality standards of traditional Chinese medicines

Traditional Chinese medicine(TCM) has played a pivotal role in maintaining the health of Chinese people and is now gaining increasing acceptance around the global scope. However, TCM is confronting more and more concerns with respect to its quality. The intrinsic "multicomponent and multitarget" feature of TCM necessitates the establishment of a unique quality and bioactivity evaluation system, which is different from that of the Western medicine. However, TCM is investigated essentially as"herbal medicine" or "natural product", and the pharmacopoeia quality monographs are actually chemicalmarkers-based, which can ensure the consistency only in the assigned chemical markers, but, to some extent, have deviated from the basic TCM theory. A concept of "quality marker"(Q-marker), following the "property-effect-component" theory, is proposed. The establishment of Q-marker integrates multidisciplinary technologies like natural products chemistry, analytical chemistry, bionics, chemometrics,pharmacology, systems biology, and pharmacodynamics, etc. Q-marker-based fingerprint and multicomponent determination conduce to the construction of more scientific quality control system of TCM.This review delineates the background, definition, and properties of Q-marker, and the associated technologies applied for its establishment. Strategies and approaches for establishing Q-marker-based TCM quality control system are presented and highlighted with a few TCM examples.

TCM Standardization Today

In this paper, current developments and tendencies in the field of TCM international standardization were discussed：（1） Standardization on TCM nomenclature is the fundamental work which can assist to establish a unified platform thus various stakeholders can gather data and exchange meaningful information globally.（2） The trend of tele-medical services and big-data health care require a standardized system of TCM informatics and efforts of WHO in the field of classification and information deserve sufficient consideration.（3） International standards can assist to eliminate large disparities in levels of regulation between countries which have serious implications for the performance, distribution and use of Chinese medicines.（4） The case of the Eastern-Central Europe indicates that international standards on education and training positively support the reputation of TCM and safeguard the communities where it is used in.（5） Many international organizations are making very important contributions for TCM and related TCM systems. These international standards help to harmonize requirements thus removing barriers to trade, define acceptable performance and provide a resource for countries and others to use.

Evaluation indexes for symptom changes in Chinese medicine

OBJECTIVE: To screen and summarize evaluation indexes for symptom changes in Chinese medicine(CM).METHODS: A case database was established based on information from subsequent patient visits from the case records of famous doctors since 1866.Symptom change descriptions in the database were regarded as research materials. The evaluation indexes of the symptom changes were screened and summarized.RESULTS: In total, 243 evaluation indexes for 256symptoms were summarized. Among them, common symptoms were frequency, quantity, degree,mobility, color, and correlation with fatigue.CONCLUSION: There are many aspects to evaluating the changes in a symptom. Some symptoms occur with other simultaneous symptoms. The alleviation or aggravation of simultaneous symptoms could reflect the corresponding changes in a symptom. The changes of inducing factors are important to judging changes in symptoms.

Chinese herbal dose in ancient and modern times:a comparative study

OBJECTIVE： Appropriate dose guarantees Chinese herb＇s safety and effectiveness. There are adult dose criteria for Chinese herbs in decoction in the Pharmacopoeia of the People＇s Republic of China （2010 Edition） at present. But Chinese herbs have been frequently used in much higher doses than the dose criteria. This study has been conducted to test the dependability of the dose criteria. METHODS： Twenty Chinese herbs were selected as representatives and their adult doses in decoction in Bei Ji Qian .lin Yao Fang, a famous ancient litera- ture, have been reviewed and compared with those in the Pharmacopoeia of the People＇s Republic of China （2010 Edition）. RESULTS： The adult dose criteria for all these 20 Chinese herbs in the Pharmacopoeia of the People＇s Republic of China （2010 Edition） haven＇t covered those in Bei Ji Qian .fin Yao Fang. Furthermore, maxi- mal adult doses in the dose criteria are much lower than those in Bei Ji Qian Jin Yao Fang. CONCLUSION： The dose criteria in the Pharmaco- poeia of the People＇s Republic of China （2010 Edition） are not comprehensive enough. Studying ancient literatures is an effective method to gain preciousChinese herbs＇ dose data and helps for new dose criteria＇s establishment in the future.