Guideline for clinical comprehensive evaluation of Chinese patent medicine (2022 version) / 中国中药杂志

Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.

Mechanism of Qingke Pingchuan Granule in Treatment of Acute and Chronic Bronchitis Complicated with Chronic Obstructive Pulmonary Disease： An Exploration Based on Network Pharmacology / 中国实验方剂学杂志

Objective:To explore the potential mechanism of Qingke Pingchuan granule in treating acute and chronic bronchitis complicated with chronic obstructive pulmonary disease （COPD） by network pharmacology. Method:The Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform （TCMSP） was retrieved to collect the active components of Qingke Pingchuan granule and predict the action targets， followed by the construction of component-target network using Cytoscape 3.8. GeneCards， Online Mendelian Inheritance in Man（OMIM）， and DrugBank were used to harvest disease targets， whose names were put into UniProt for standardization. The treatment targets of Qingke Pingchuan Granule against the two diseases were obtained based on Venn diagram， which were then imported into the STRING platform for constructing the protein-protein interaction （PPI） network. Following the gene ontology（GO） and Kyoto encyclopedia of genes and genomes（KEGG） pathway enrichment analysis based on MetaScape， the active component-common target-signaling pathway network of Qingke Pingchuan granule against acute and chronic bronchitis complicated with COPD was finally constructed. The accuracy of the target was confirmed by literature. Result:A total of 165 active components， 374 related targets， 512 disease-related targets， and 130 common targets were obtained. Among them， the 14 core therapeutic targets were further subjected to GO enrichment analysis， which yielded 390 biological processes， nine cell components， and 23 molecular functions. The KEGG pathway analysis revealed 22 signaling pathways. Conclusion:Qingke Pingchuan granule alleviates the diseases possibly by regulating such targets as vascular endothelial growth factor receptor 2（KDR）， transforming growth factor beta-1 （TGF-<italic>β</italic>₁）， caveolin 1（CAV1）， hypoxia-inducible factor-1alpha（HIF-1<italic>α</italic>）， and interleukin-2（IL-2）， affecting the synthesis and transport of regulatory factors in cytoplasm， and controlling the cell proliferation and apoptosis.

[Study on drug properties and syndrome-symptom-formula-herb network of traditional Chinese medicine in treatment of effort angina pectoris based on data visualization].

This article aims to explore drug properties and syndrome-symptom-formula-herb network of traditional Chinese medicine(TCM) in the treatment of effort angina pectoris based on data visualization, and provide useful references for clinical diagnosis and treatment. Literatures about TCM formula for effort angina pectoris from databases of CNKI, WanFang, VIP, and CBM were retrieved from the database-building to August 31, 2019. The name of syndromes, symptoms, formulas, and herbs were standardized, and the corresponding databases were established. Frequency, four properties, five flavors, and meridian were analyzed. Visualized syndrome-symptom-formula-herb network relationships were constructed by bioinformatic analysis. A total of 202 formulas were included, and 218 kinds of TCM were involved. There were 56 herbs with the use frequency of more than 10, involving 78 syndromes and 162 symptoms. TCM formulas in the treatment of effort angina pectoris mainly included herbs with effects in invigorating blood circulation and eliminating stasis, tonifying deficiency, Qi-regulating, resolving phlegm and relieving cough and asthma, relieving exterior disorder, and heat-clearing. The main properties were warm, cold and mild(accounting for 95%); the main flavors were sweet, bitter and pungent(accounting for 89%); and meridians were mainly spleen, heart, liver, lung, stomach, and kidney(accounting for 89%). Syndrome-symptom-formula-herb network of TCM in the treatment of effort angina pectoris were successfully constructed. The high-frequency syndromes of this disease were Qi deficiency and blood stasis, Qi stagnation and blood stasis, heart blood stasis, and turbid phlegm and blood stasis, and its high-frequency symptoms were chest tightness, chest pain, palpitation, shortness of breath, fatigue, dark purple tongue, spontaneous sweating, and abundant phlegm. High-frequency core formulas of this disease included Xuefu Zhuyu Decoction, Gualou Xiebai Banxia Decoction, Danshen Decoction, Taohong Siwu Decoction, Shengmai Powder, Buyang Huanwu Decoction and Zhigancao Decoction, and their core herbs included Salviae Miltiorrhizae Radix et Rhizoma, Astragali Radix, Chuanxiong Rhizoma, Ginseng Radix et Rhizoma, Trichosanthis Fructus, Allium Macrostemonis Bulbus, Notoginseng Radix et Rhizoma, Persicae Semen, Carthami Flos, Atractylodis Macrocephalae Rhizoma, Angelicae Sinensis Radix, Paeoniae Radix Rubra, Poria, Pinelliae Rhizoma Praeparatum. Drug properties and syndrome-symptom-formula-herb networks of TCM in the treatment of effort angina pectoris can realize data visualization, objectively reflect the clinical syndrome differentiation and rule of medication, and provide reference for clinical diagnosis and treatment.

Expert consensus on clinical application of Chinese herbal medicine decoction pieces (First Edition) / 中国中药杂志

Chinese herbal medicine decoction pieces(CHMDP), one of the main forms of traditional Chinese medicine(TCM) in clinic, have been widely used. However, the irrational use is increasingly serious due to the lack of the indicators for judging the rational use of CHMDP in medical institutions and the codes and standards for the clinical use of CHMDP. In order to regulate the rational clinical use of CHMDP, improve the clinical efficacy and ensure the drug safety for the patients, clinical pharmaceutical experts and clinical medical experts from 40 third-grade class-A hospitals nationwide were organized to give the "expert consensus on clinical application of CHMDP" in terms of prescription writing, combined use of drugs, use of special drugs, and drug use for special population. Detailed analysis and argumentation were conducted in accordance with the laws and regulations, Chinese Pharmacopoeia 2015 edition, Chinese Pharmacopoeia Code Notice for Clinical Use of Medicine, Administrative Regulations for Prescriptions, Administrative Specifications for Hospital Prescription Review(interim), and Chinese Traditional Medicine Prescription Format and Writing Specifications, as well as relevant project findings.

Analysis of epidemiological characteristics of drug induced liver injury associated with Baixianpi Preparations / 中国中药杂志

A retrospective study was performed in drug-induced liver injury(DILI) cases associated with Dictamni Cortex(Baixianpi,BXP) Preparations,which were treated at grade Ⅲ class A liver disease hospitals from 2008 to 2016 and spontaneously reported for adverse reactions between 2012 and 2016 at HILI Cloud(hilicloud.net). The results showed 25 DLII cases associated with BXP Preparations treated at grade Ⅲ class A liver disease hospitals during the 9 years,including only 14 cases in line with the clinical diagnostic criteria of Guidelines for the Diagnosis and Treatment of Herb-Induced Liver Injury. And 74 DILI cases associated with BXP Preparations spontaneously reports adverse reactions,and 18. 92% of them had unreasonable medication,including polypharmacy(21. 43%),overdose(28. 57%) and repeated dosage(50%). And 47 DILI cases used BXP Preparations to treat psoriasis and vitiligo(a total of59. 57%). The time range of taking BXP Preparations until liver injury occurred was 1-366 d,with the median of 18 d. The dose of BXP Preparations was estimated to be 0. 09-12 g·d-1. And the cumulative dosage of taking drugs until liver injury occurred was 1. 1-336 g. Obvious associations with time-toxicity as well as quantity-toxicity could not be found based on the wide range of time-toxicity relations and quantity-toxicity relations. On the basis of the study,we found that DILI cases associated with BXP Preparations commonly occurred in patients with immune diseases,such as psoriasis and vitiligo,indicating specific individual differences. The results suggested that DILI cases associated with BXP Preparations would be correlated with the property of idiosyncratic drug-induced liver injury. In conclusion,the risk of liver injury clinically caused by BXP Preparations should be paid more attention,and the studies on the mechanism of idiosyncratic drug-induced liver injury must be enhanced,and those on risk factors,like irrational drug use,should be strengthened. Moreover,the evaluation of the risk-to-benefit ratio is supposed to be performed for the sake of improving the risk prevention and control standards for BXP preparations,and ensuring safe and rational clinical application of BXP Preparations.

Standardization of names in prescriptions of traditional Chinese medicines / 中国中药杂志

Chinese medicine prescriptions are a type of medical documents written by doctors after they understand the patients' conditions for syndrome differentiation. Chinese medicine prescriptions are also the basis for pharmacy personnel to dispense medicines and guide patients to use drugs. It has the legal, technical and economic significances. Chinese medicine prescriptions contain such information of names, quantity and usage. Whether the names of drugs in Chinese medicine prescriptions are standardized or not is directly related to the safety and efficacy of the drugs. At present, nonstandard clinical prescriptions are frequently seen. With "Chinese medicine prescription", "names of drug in Chinese medicine prescription" and "standards of Chinese medicine prescription" as key words, the author searched CNKI, Wanfang and other databases, and consulted nearly 100 literatures, so as to summarize current names of drugs in traditional Chinese medicine prescription, analyze the reasons, and give suggestions, in the expectation of standardizing the names of drugs used in traditional Chinese medicine prescriptions.

Assessment on the Efficacy and Safety of Aidi Injection Combined with Vinorelbine and Cisplatin for Treatment of Advanced Nonsmall Cell Lung Cancer / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The aim of this study was to assess the efficacy and safety of vinorelbine and cisplatin (NP chemotherapy) alone or in combination with Aidi injection for the treatment of advanced nonsmall cell lung cancer (NSCLC).</p><p><b>METHODS</b>Pertinent publications were identified in PubMed, EMBASE, Cochrane Library, CNKI, CQVIP, and Wanfang databases, up to December 8, 2015. After quality assessment of all included randomized controlled trials evaluating Aidi injection combined with NP chemotherapy for the treatment of advanced NSCLC, a meta-analysis was performed by Review Manager 5.2 and STATA 12.0 for statistical analyses.</p><p><b>RESULTS</b>Twelve studies including 509 and 503 cases in the experimental and control groups, respectively, were finally analyzed. The meta-analysis revealed that when cisplatin dose ranging from 20 to 40 mg/m 2 , combination of Aidi injection and NP chemotherapy was statistically different compared with NP chemotherapy alone in enhancing efficiency (relative risk [RR] = 1.24, 95% confidence interval [CI] [1.05-1.47], P = 0.010) and reducing the incidence of Grade II or above nausea and vomiting (RR = 0.49, 95% CI [0.30-0.80], P = 0.005). Meanwhile, with cisplatin ranging from 80 to 120 mg/m 2 , no significant differences in efficiency (RR = 1.11, 95% CI [0.87-1.42], P = 0.390) and Grade II or above nausea and vomiting (RR = 0.88, 95% CI [0.71-1.10], P = 0.260) were obtained. In addition, Aidi injection combined with NP chemotherapy was superior to NP chemotherapy alone in improving the quality of life, alleviating Grade II or above leukopenia and thrombocytopenia.</p><p><b>CONCLUSIONS</b>Aidi injection combined with NP chemotherapy can enhance efficiency, improve the quality of life, and decrease adverse effects in patients with advanced NSCLC.</p>

Brief introduction of research methods of commodity specification and grade of Chinese medicinal materials / 中国中药杂志

The commodity specification and grade of Chinese medicinal materials is a measure of the quality of traditional Chinese medicines (TCMs), which directly impacts on the safety and effectiveness of clinical medicines. It is an urgent problem to establish a set of standards which can both interpret the scientific connotation of the commodity specification and grade of Chinese medicinal materials and play a significant role on clinical medicines as well as markets. This paper reviews the research methods of the commodity specification and grade of Chinese medicinal materials such as sensory evaluation, chemical assessment, biological evaluation, and cited the applications of various methods for the classification of TCMs. It provides technical support for establishing standards of the commodity specification and grade of Chinese medicinal materials, and also constructs scientific basis for clinical rational drug use.

Antioxidative effect of rhodiola granules in vitro and in vivo / 中国药学杂志

METHODS: Female Kunming mice were randomly divided into five groups, ie, blank control group, low-dose group, middle-dose group, high-dose group, and the positive control group. The three treatment groups were given various doses of Rhodiola granules, ie, 0. 1, 1, 3 g��kg-1 respectively, the positive control group were given Nuodikang capsules at 280 mg��kg-1, and the blank control group was given deionized water for 35 d. The levels of SOD, MDA, GSH-PX in serum, liver, and brain were determined. For the experiment in vitro, with vitamin C as the control drug, the absorbance of Rhodiola granule solution at concentrations of 0.01, 0.1, 1, 10 mg��mL-1 was measured, and the activity of scavenging superoxide anion free radicals and hydroxyl free radicals was calculated.

Promotion of the articular cartilage proteoglycan degradation by T-2 toxin and selenium protective effect / 浙江大学学报（英文版）（B辑：生物医学和生物技术）

<p><b>OBJECTIVE</b>To identify the relationship between T-2 toxin and Kashin-Beck disease (KBD), the effects of T-2 toxin on aggrecan metabolism in human chondrocytes and cartilage were investigated in vitro.</p><p><b>METHODS</b>Chondrocytes were isolated from human articular cartilage and cultured in vitro. Hyaluronic acid (HA), soluble CD44 (sCD44), IL-1beta and TNF-alpha levels in supernatants were measured by enzyme-linked immunosorbent assay (ELISA). CD44 content in chondrocyte membrane was determined by flow cytometry (FCM). CD44, hyaluronic acid synthetase-2 (HAS-2) and aggrecanases mRNA levels in chondrocytes were determined using reverse transcription polymerase chain reaction (RT-PCR). Immunocytochemical method was used to investigate expressions of BC-13, 3-B-3(-) and 2-B-6 epitopes in the cartilage reconstructed in vitro.</p><p><b>RESULTS</b>T-2 toxin inhibited CD44, HAS-2, and aggrecan mRNA expressions, but promoted aggrecanase-2 mRNA expression. Meanwhile, CD44 expression was found to be the lowest in the chondrocytes cultured with T-2 toxin and the highest in control plus selenium group. In addition, ELISA results indicated that there were higher sCD44, IL-1beta and TNF-alpha levels in T-2 toxin group. Similarly, higher HA levels were also observed in T-2 toxin group using radioimmunoprecipitation assay (RIPA). Furthermore, using monoclonal antibodies BC-13, 3-B-3 and 2-B-6, strong positive immunostaining was found in the reconstructed cartilage cultured with T-2 toxin, whereas no positive staining or very weak staining was observed in the cartilage cultured without T-2 toxin. Selenium could partly inhibit the effects of T-2 toxin above.</p><p><b>CONCLUSION</b>T-2 toxin could inhibit aggrecan synthesis, promote aggrecanases and pro-inflammatory cytokines production, and consequently induce aggrecan degradation in chondrocytes. These will perturb metabolism balance between aggrecan synthesis and degradation in cartilage, inducing aggrecan loss in the end, which may be the initiation of the cartilage degradation.</p>

Butenolide induces apoptosis of cultured chondrocytes: study of its mechanism / 南方医科大学学报

<p><b>OBJECTIVE</b>To observe cell apoptosis and Bcl-2 and Bax expression changes of chondrocytes induced by butenolide (BUT) and the inhibitory effect of selenium against BUT-induced chondrcyte apoptosis, to gain insights into the mechanism by which BUT induces chondrcyte apoptosis.</p><p><b>METHODS</b>Cartilage tissue reestablished from human fetal articular chondrocytes in vitro were treated with BUT at the concentrations of 0.1, 1.0 and 5.0 microg/ml and with the protective factor selenium. TUNEL method was used to detect chondrocyte apoptosis, which was quantified by flow cytometry. Immunohitochemistry was performed to analyze the expression of Bcl-2 and Bax in the reestablished cartilage tissue.</p><p><b>RESULTS</b>BUT exposure induced chondrocyte apoptosis, and the apoptosis rate increased with the concentration increment of BUT from 0 to 1.0 mg/ml, resulting also increased positive expression rate of Bcl-2 and Bax(P<0.05). The apoptosis rate of chondrocytes in BUT+ selenium group was significantly lower than that of BUT groups (P<0.05), as was the positivity rate of Bcl-2 and Bax expression (P<0.05).</p><p><b>CONCLUSION</b>BUT induces chondrocyte apoptosis in positive relation with BUT concentration (from 0 to 1.0 mg/ml) and causes increased expressions of Bcl-2 and Bax. Selenium can inhibit the chondrocyte apoptosis induced by BUT.</p>

Protective effect of selenium against T-2 toxin-induced inhibition of chondrocyte aggrecan and collagen II synthesis / 南方医科大学学报

<p><b>OBJECTIVE</b>To study the inhibitory effect of T-2 toxin on the expression of aggrecan and collagen II in chondrocytes and the protection of selenium against this effect.</p><p><b>METHODS</b>Human chondrocytes cultured in vitro were treated with T-2 toxin at different concentrations for varied time periods (1-5 days), and the cell viability was measured by MTT assay. Aggrecan expression was detected by toluidine blue staining and collagen II expression by immunostaining using monoclonal antibody of collagen. Aggrecan and collagen II mRNA expressions were measured by semiquantitative RT-PCR.</p><p><b>RESULTS</b>T-2 toxin dose- and time-dependently affected chondrocyte viability within the concentration range of 0.001-2 mg/L, the prolonged treatment time further enhanced the dose dependence of the inhibitory effect. T-2 toxin lowered aggrecan and collagen II synthesis in the chondrocytes and reduced their mRNA expressions. Selenium could partly attenuate the inhibitory effects of T-2 toxin on aggrecan mRNA expression, but showed no such effect against T-2-induced collagen II expression.</p><p><b>CONCLUSION</b>T-2 toxin can obviously inhibit aggrecan and collagen II synthesis in human chondrocytes, and selenium can partly antagonize the inhibitory effects of T-2 toxin on aggrecan.</p>

Toxic effect of butenolide on chondrocyte differentiation and the protective effect of selenium / 中国医学科学院学报

<p><b>OBJECTIVE</b>To study the effect of butenolide (BUT) on cultured chondrocytes differentiation and the possible protective effects of selenium (Se).</p><p><b>METHODS</b>Ex-vivo cultured chondrocytes were divided into six groups: (1) Control group (without BUT and Se); (2) Se 0.1 microg/ml control group; (3) BUT 0.1 microg/ml group; (4) BUT 1.0 microg/ml group; (5) BUT 5.0 microg/ml group; and (6) BUT 1.0 microg/ml + Se 0.1 microg/ml group. The expression of collagen II (Col II), collagen X (ColX), basic fibroblast growth factor (bFGF), and parathyroid hormone-related peptide (PTHrP) in (or around) chondrocytes in all groups were analyzed by immunohistochemistry.</p><p><b>RESULTS</b>The expressions of Col II in 1.0 microg/ml BUT group and 5.0 microg/ml BUT group were significantly lower than those in the control group (P < 0.05). The expression of Col II in 1.0 microg/ml BUT + Se group were significantly higher than those in the 1.0 microg/ml BUT group and 5.0 microg/ml BUT group (P < 0.05). The expressions of bFGF and PTHrP of BUT groups were significantly higher than those in the Se and control groups (P < 0.05). No expression of ColX was observed in all groups.</p><p><b>CONCLUSION</b>BUT can affect the collagen II synthesis of the chondrocytes. Selenium supplementation may play a protective role.</p>