Clinical comprehensive evaluation of Tianshu Capsules in treatment of migraine (syndrome of blood stasis blocking collaterals and syndrome of ascendant hyperactivity of liver Yang) / 中国中药杂志

This study systematically sorted out the existing studies about Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), and conducted comprehensive clinical evaluation through "6+1" dimensions of safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM) to embody the advantages and characteristics and clarify the precise clinical position of Tianshu Capsules. The value of each dimension was calculated via health technology assessment, the multi-criteria decision analysis(MCDA) mo-del and CSC v2.0 software. The results were graded into four levels of A, B, C, or D from high to low. According to the available studies, Tianshu Capsules had low and controllable risks, with the safety rated as A. The drug has obvious clinical significance in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), with the effectiveness rated as A. It has clear economic results, with the economy rated as B. The clinical innovation, service system innovation, and industrial innovation are all good, and thus the innovation of Tianshu Capsules is grade A. The drug can meet clinical medication demand of medical care and patients, and thus its suitability is grade A. In view of the reasonable drug price, affordability, and availability, the accessibility is grade A. The prescription originated from the Daxiong Pills recorded in the classic Comprehensive Recording of Sage-like Benefit. In clinical trials, 4 675 patients have used Tianshu Capsules, which indicates rich experience in human administration, and the characteristics of traditional Chinese medicine is grade B. The statutory drug information complies with national stan-dards, and the non-statutory information is standard and accurate. Based on the comprehensive evaluation results of various dimensions of evidence, the clinical value of Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals and syndrome of ascendant hyperactivity of liver Yang) is class A. According to the Comprehensive Clinical Evaluation Management Guidelines of Drugs(trial version 2021) issued by the National Health Commission of the People's Republic of China, we recommend that Tianshu Capsules treating migraine can be transformed into relevant policy results for clinical medication management according to procedures.

Report standards for clinical comprehensive evaluation of Chinese patent medicine / 中国中药杂志

The clinical comprehensive evaluation of drugs is an important basis for the return of clinical value, decision-making of medical and health authorities, and allocation of medical resources. In July 2021, the National Health Commission issued the Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), which required the evaluation to be implemented from the six dimensions(safety, effectiveness, economy, innovation, suitability, and accessibility), and made detailed arrangements for the clinical comprehensive evaluation of drugs. As Chinese patent medicine differs from chemical medicines in terms of effective components and action modes, the clinical comprehensive evaluation of Chinese patent medicine should highlight the characteristics and advantages of traditional Chinese medicine(TCM) on the basis of general requirements of comprehensive clinical evaluation of drugs. At present, in the clinical comprehensive evaluation of Chinese patent medicine, unified report standards have not yet been generated, resulting in the uneven quality of existing reports. To standardize the clinical comprehensive evaluation report of Chinese patent medicine and improve its quality, the editorial team, based on the relevant policy documents of clinical comprehensive evaluation of drugs, formulated the clinical comprehensive evaluation report standards for Chinese patent medicine in combination with the previous practice and expert opinions. The report standards, containing seven sections with 15 items determined, focus on data source, evaluation content, evidence synthesis, quality control, and evaluation results supported with detailed interpretations to help researchers better understand and apply the report standards for clinical comprehensive evaluation of Chinese patent medicine, improve the report quality, and provide references for the decision-making by the national medical management authorities.

Visualization of research on Chinese medicine-induced kidney injury by CiteSpace / 中国中药杂志

This study aimed to provide researchers with a better understanding of the research status, progress and problems of Chinese medicine-induced kidney injury. The mapping knowledge domain(MKD) was chosen to visualize the research process, hotspots,and frontiers, thus providing a reference for follow-up research. The relevant articles were retrieved from China National Knowledge Infrastructure(CNKI) from its inception to November 20, 2020, and 683 were finally included for visualization, with a knowledge map covering the keywords, research institutions and authors plotted by Cite Space. Since 2006, the annual number of published articles regarding Chinese medicine-induced kidney injury has steadily declined. The top five keywords sorted by frequency of co-occurrence were tubulointerstitial nephritis(TIN), aristolochic acid(AA), Akebiae Caulis, experimental research, and descriptive research. Akebiae Caulis appeared at the highest frequency of co-occurrence among Chinese medicines and exhibited the highest burst intensity. The burst ended in 2020, when the Chinese medicine with the highest burst intensity changed to Tripterygii wilfordii and its preparations. It could be seen that Akebiae Caulis was the hotspot in the research of Chinese medicine-induced kidney injury, and T. wilfordii became the research frontier. The current research has mainly focused on " organic anion transporters" and " metabolomics". The decline in articles about Chinese medicine-induced kidney injury was attributed to the reduced clinical case reports after the in-depth study of Chinese medicine-induced kidney injury. However, more clinical studies need to be conducted based on the concept and method of pharmacovigilance to construct a pharmacovigilance system of Chinese medicine for actively and passively monitoring and collecting the clinical cases with Chinese medicine-induced kidney injury, figuring out the incidence and characteristics of adverse reactions caused by Chinese medicine, and carrying out comprehensive and multi-dimensional safety research.

Pharmacovigilance of traditional Chinese medicine: an exploration based on prescription sequence analysis and prescription sequence symmetry analysis / 中国中药杂志

Multiple methods should be incorporated into the research on pharmacovigilance of traditional Chinese medicine(TCM for a comprehensive and objective evaluation. The arrival of the era of medical big data allows it to be deeply integrated into medical research. The real world study(RWS) represented by hospital information system(HIS) provides a data basis for exploring the pharmacovigilance of TCM. Prescription sequence analysis(PSA) and prescription sequence symmetry analysis(PSSA) developed based on the former serve as a methodological basis for clinical safety evaluation of Chinese patent medicines after marketing. By collating the related studies of HIS, PSA and PSSA and employing the propensity score matching( PSM) method and nested case-control study(NCCS), this paper formed a HIS-, PSA-and PSSA-based technical system for clinical safety evaluation of Chinese patent medicines in the real world, in order to provide a methodological demonstration for the future research on the pharmacovigilance of TCM.

Cognition of traditional Chinese medicine properties and thinking of clinical rational use of drug / 中国中药杂志

This paper discusses the rational use of traditional Chinese medicine based on chemical composition, body state and biological effect. The essence and connotations of traditional Chinese medicine are explained by modern scientific theory and technical means, and the mechanism of traditional Chinese medicine in the treatment of diseases is defined in modern medicine language, which is conducive to promoting rational and safe clinical use of drugs. Based on the chemical composition of traditional Chinese medicine,the selected genuine medicinal materials were collected and processed in a standardized way, and then used in the combination with other traditional Chinese medicines, with the aim to improve the efficacy of traditional Chinese medicine in clinical indications, increase the advantages, eliminate the disadvantages, and adapt to flexible and safe clinical drug demands. Based on the body state elements, clinical diagnosis and treatment shall be patient-centered, and doctors shall distinguish the differences of pathogenesis, symptoms and diseases, and consider the drug contraindications of special groups. According to the " dose-effect-toxicity" relationship, doctors shall select the appropriate dosage form, control the drug dosage, balance the benefits and risks of drugs, and carry out appropriate medical treatment. Based on the biological effect elements and the regulatory mechanism of traditional Chinese medicine on the target and pathway of disease, traditional Chinese medicine shall strengthen the precise positioning, provide accurate treatment; evaluate the safety of traditional Chinese medicine combination, explore the adverse reaction mechanism, strengthen the clinical safety monitoring of traditional Chinese medicine, and guide the clinical rational use of drugs, in the expectation of ensuring the safe use of traditional Chinese medicine and maximize the clinical efficacy of traditional Chinese medicine.

Early detection and risk control of safety signals of Chinese medicine / 中国中药杂志

The safety of modern Chinese medicine has attracted increasing attention from society. Experts and scholars have carried out extensive in-depth research on the safety of commonly used Chinese medicines from various aspects such as safety monitoring, clinical research, and experimental analysis. The findings in the safety performance of Chinese medicines can inspire the mining and analysis of relevant signals in the drug safety alerts. A variety of methods are employed for the mining of risk signals or analysis and screening of relevant signals to accurately determine the correlation between medication and adverse reactions. The safety signal acquisition and mining techniques are the technical basis for the safety risk management of medicine products after Chinese medicines are marketed, which is critical in drug safety alerts. To accurately collect the safety signals of Chinese medicines and effectively and rapidly track, determine, and assess the sources of signals are important technical links in drug risk management. The ultimate purpose of safety signal discovery is to achieve normalized risk management through downgrading drugs from a high-risk level to a low-risk level.The five main steps in the standard drug risk management are listed below: to extensively collect predicted risk signals; to accurately identify drug risks by the techniques such as data mining; to evaluate the risks with process-based quality risk control; to employ management measures minimizing the impact of drug risks for risk management; to update and apply risk assessment to clinical evaluation after medication.

Enlightenment of international pharmacovigilance system on establishment of pharmacovigilance system of Chinese medicine / 中国中药杂志

Pharmacovigilance system is an extension of the original adverse drug reactions monitoring and reporting system as well as an internationally recognized basic system that must be matched with the whole life cycle supervision of drugs. European Union(EU)pharmacovigilance system, World Health Orgnization(WHO) Uppsala Monitoring Center system and ICH system are internationally recognized pharmacovigilance systems. They all have their own pharmacovigilance characteristics and could provide guarantee for clinical safe drug use. With the deepening of international communication, pharmacovigilance has also been developed in China. Pharmacovigilance of Chinese medicine is a new concept based on the existing pharmacovigilance system of chemical medicine and the characteristics of Chinese medicine. In ancient China, Chinese medicine also had its own ways of early warning. Ancient medical books have records on the toxicity classification, clinical pharmacovigilance and intoxication rescue of Chinese medicine. With the increase of public recognition of Chinese medicine in recent years, especially since the government issued the 13 th Five-Year Plan for the development of Chinese medicine, the pharmaceutical industry in China has paid more and more attention to the pharmacovigilance of Chinese medicine.However, the pharmacovigilance system of Chinese medicine has not yet been established, and it still needs to be explored and improved.Therefore, it is very necessary to develop the system to standardize pharmacovigilance-related activities of Chinese medicine. In this context, this study analyzed and learned the characteristics of pharmacovigilance systems of EU, ICH, and WHO Uppsala Monitoring Center, so as to provide some enlightenment for the establishment and improvement of pharmacovigilance system of Chinese medicine.

Randomized double-blind parallel controlled multicenter trial of Reyanning Mixture in treatment of acute tonsillitis / 中国中药杂志

This study is a randomized controlled trial of Reyanning Mixture in the treatment of acute tonsillitis. According to the ratio of 1∶1∶1, a total of 144 patients were randomly divided into Reyanning Mixture group(RYN), Reyanning Mixture+Amoxicillin Capsules group(RYN+Amoxil) and Amoxicillin Capsules group(Amoxil), with 48 cases in each group, in order to evaluate the efficacy and safety of RYN alone or combined with Amoxil in the treatment of acute tonsillitis, and provided high-quality evidences for treatment of infectious diseases with traditional Chinese medicine and reduced use of antibiotics. The dosage of RYN was 20 mL, 3 times a day, 100 mL/bottle, oral for 7 days, and Amoxil dosage was 0.5 g, 3 times a day, 0.5 g×12 tablets/plate, oral for 7 days. A total of 144 cases were included, 3 cases were excluded(1 case was mistakenly included, 2 cases did not take drugs after inclu-ded), and a total of 141 cases were included in the full analysis set(FAS). The results showed statistical differences in the recovery time of the disease, the disappearance rate of fever on the 3 rd day and the disappearance rate of tonsillar redness and swelling between RYN and Amoxil. There were statistical differences in the cure rate of disease, recovery time of disease, body temperature recovery time, fever disappearance rate on the 3 rd day, pharynx swelling and pain disappearance rate and tonsil swelling disappearance rate between the RYN+Amoxil and Amoxil, but with no significant difference in the above aspects compared with RYN. The DDD of antibiotic use in RYN+Amoxil was significantly lower than that in Amoxil(P<0.01). According to the findings, when RYN was used alone in the treatment of acute tonsillitis, it was superior to Amoxil in time of recovery, short-term improvement of fever and redness and swelling of tonsil. Compared with RYN+Amoxil, there was no difference in cure rate of disease, recovery time of disease, body temperature recovery time, short-term improvement of fever, swelling of pharynx and swelling of tonsil, with a better efficacy than Amoxil. The clinical effect of RYN was similar to that of combined Amoxil in the treatment of acute tonsillitis, and RYN was superior to Amoxil in the time of recovery, short-term improvement of fever and redness and swelling of tonsil, with no adverse event or adverse reaction. RYN+Amoxil can significantly reduce the DDD value of antibiotics in the treatment of acute tonsillitis, with significant clinical advantages over Amoxil.

Study on precise mechanism of Chinese patent medicine from perspective of activating data / 中国中药杂志

Traditional Chinese medicine(TCM) syndrome differentiation and treatment has a characteristic and advantageous efficacy in the prevention and treatment of major diseases(no matter for new or sudden infectious diseases or major chronic diseases). At present, the clinical application by Western medicine disease's name, stage, classification and other indications limits the role of TCM syndrome differentiation and treatment, and makes TCM difficult to play its advantages. Therefore, the therapeutic value and social value attribute of Chinese patent medicine after being launched in the market cannot be effectively demonstrated, or even generalized as adjuvants. Under the circumstances, it is difficult to put forward precise positioning different from chemical drugs, with fewer high-level and high-quality evidence-based evidences for precise positioning. The research on the pathological links and therapeutic mechanism of its effect on diseases is also less systematic. The development of biotechnology, such as genomics, has brought medicine into the era of precision, providing ideas and technical support for the exploration of syndrome biomarkers and the analysis of therapeutic mechanism with them as parameters. Digital China Think Tank Forum once mentioned that the development of sequencing technology provides 100% of human genetic code, while only 3% can understand it. Block data 4.0: activation data in the era of artificial intelligence puts forward the concept of activation data, which can be regarded as a theoretical hypothesis for big data, provides a new cognitive thinking and solution for increasingly prominent data paradox between bioinformation explosion and clinical big data, and is a bridge between cross-border data association and fusion. After deeply mining the dominant and recessive value of clinical data and histological data, we can make the pathogenesis of syndrome differentiation and treatment from dark knowledge to clear knowledge. Therefore, with Chinese patent medicine as the guide, the research on the efficacy and mechanism of precise positioning of traditional Chinese medicine after marketing is carried out, and the precise system of "syndrome, disease, function, pathological link and biological connotation" is constructed, which provides a powerful basis and support for increasing the scientific and technological content of varieties.

ADR/AE early warning analysis of Shujin Jianyao Pills based on spontaneous reporting system / 中国中药杂志

To explore the general characteristics of adverse drug reactions/adverse events(ADR/AE) in patients after using Shujin Jianyao Pills, and explore risk warning signals, this study analyzed 166 cases of ADR/AE reports of Shujin Jianyao Pills collected from 2005 to 2017 based on the National Center for ADR Monitoring spontaneous reporting system(SRS). And the descriptive statistical method was used to analyze general characteristics. The results showed that among the 166 ADR/AE cases, 106 cases were female patients, accounting for 63.86%. Middle-aged and elderly people aged 45 to 64 accounted for the largest proportion(82 cases, 49.40%), which were followed by elderly aged 65 and over(48 cases, 28.91%). ADR/AE involved a wide range of systems and organs, of which skin and its accessories were the most damaged(30 cases, 12.93%), which were followed by systemic damage(27 cases, 11.64%). The top 10 ADR/AE manifestations were rash(15 cases, 6.33%), nausea(14 cases, 5.91%), dizziness(14 cases, 5.91%), abdominal pain(12 cases, 5.06%), pruritus(11 cases, 4.64%), low back pain(11 cases, 4.64%), vomiting(10 cases, 4.22%), hepatocyte damage(9 cases, 3.80%), headache(9 cases, 3.80%), and diarrhea(7 cases, 2.95%). Bayesian confidence propagation neural network(BCPNN) was used to mine the ADR/AE risk early warning signal of Shujin Jianyao Pills, and the propensity score method was used to control the balance of confounding factors. The results suggested warning signs for nausea, diarrhea, rash, and dizziness, vomiting, abdominal pain, headache, liver cell damage. This study provides a basis for the post-marke-ting safety evaluation of Shujin Jianyao Pills, and can provide guidance for its rational clinical use and risk management.

Suggestions on design of evidence-based traditional Chinese medicine clinical study for new public health emergencies / 中国中药杂志

2019 novel coronavirus(2019-nCoV) has occurred for 2 months, and seriously affected the people's health in the world. Therefore, scientific prevention and control strategies and effective intervention measures are the only ways to solve the world problem. In the determination of intervention measures, not only the effectiveness evaluation, but also accessibility, treatment cost, inventory and production capacity and other relevant sociological issues shall be considered, especially in low and middle-income countries and regions. With the introduction of clinical epidemiological experiment design and evidence-based medicine evidence evaluation into the evaluation of curative effect of traditional Chinese medicine(TCM), TCM has officially entered the studies of syndrome regularity of new public health emergencies(such as SARS and influenza) clearly diagnosed by modern medicine for many years, as well as the development of relevant guidelines, consensus and paths. The results of curative effect show that TCM could significantly alleviate symptoms, control disease and tendency, reduce the occurrence of critical illness, and improve the clinical efficacy and the prognosis and quality of life of patients, which fully reflects the consciousness and self-confidence of traditional Chinese medicine workers. For the evidence-based evaluation of TCM intervention in new public health emergencies, the basic principles and general methods of clinical epidemiology and evidence-based medicine shall be followed to obtain high-quality evidence; besides, we shall also fully realize that clinical scientific study is carried out with the epidemic treatment as the primary task. The scientific hypothesis comes from the clinical problems unsolved. The scientific study conclusions aim to give feedbacks to clinical diagnosis and treatment regimens. The core elements of clinical trials are population(P), intervention(I), control(C), outcome(O), which are abbreviated as "PICO". The evaluation of intervention measures for new public health emergencies with traditional Chinese medicine shall have clear study objectives and a high quality, with a correct analysis method as the guarantee of real and reliable results. Then, the selection of patients, the de-finition of intervention measures and control measures, the development of end-point indicators, the clinical quality control under special epidemics, the data verification, and the data analysis methods to be adopted are all characteristics and key points that need special consideration. It is suggested that scientific experimental design, rigorous collection and scientific data analysis shall be conducted to reflect the therapeutic value of traditional Chinese medicine, so that the study results could be adopted and shared, and become the scientific evidence for China and even the global to republish the diagnosis and treatment regimens.

Analysis of adverse reactions risk signal of Xinyuan Capsules based on national ADR monitoring spontaneous reporting system / 中国中药杂志

In recent years, the safety problems and events of traditional Chinese medicine represented by liver injury have occurred frequently. In particular, Polygonum multiflorum has been widely used and considered as a "non-toxic" tonic traditional Chinese medicine for thousands of years. However, in recent years, frequent reports of liver injury events have attracted widespread attention at home and abroad, which has made unfavorable impacts on traditional Chinese medicine and its international development. Some scho-lars have found that susceptible genes of P. multiflorum on liver injury lay a scientific foundation for formulating rational comprehensive prevention and control measures for liver injury risk of P. multiflorum and its relevant preparations. But what are the risk signals of adverse reactions of P. multiflorum in clinical application? Spontaneous reporting system is an important way to monitor and find adverse drug reaction(ADR) signals after the drug is launched in the market. It can find the ADR signals in time and effectively, and then effectively prevent and avoid the occurrence of adverse drug events. At present, the data mining technique has gradually become the main method of ADR/adverse event(AE) report analysis and evaluation at home and abroad. Specifically, Bayesian confidence propagation neural network in Bayesian method is a commonly used risk signal early warning analysis method. In this paper, BCPNN method was used to excavate the risk signals of adverse reactions of Xinyuan Capsules, a traditional Chinese medicine preparation containing P. multiflorum, such as nausea, diarrhea, rash, dizziness, vomiting, abdominal pain, headache, liver cell damage, so as to provide evidence-based evidence for clinical safe and rational use of drugs.

Analysis of drug combination characteristics of Qingkailing injection for treating abnormal inflammatory factors in real world / 中国中药杂志

To analyze the drug combination characteristics of Qingkailing injection for treating abnormal inflammatory factors such as elevated white blood cells and C reactive protein in real world. The patients with Qingkailing injection for abnormal C reactive proteins and abnormal white blood cells were extracted from hospital information system (HIS) of 16 Class 3A hospitals. Then the basic information, traditional Chinese medicine and Western medicine diagnostic information, doctor's advice information, and laboratory information were analyzed; Apriori algorithm was used to construct the models, and Clementine 12.0 was used for correlation analysis to analyze the clinical medication rules and drug combination characteristics in the patients with Qingkailing injection for treatment of elevated C reactive protein and white blood cells in the real world. The results of the study showed that when Qingkailing injection was combined with one kind of western medicine and traditional Chinese medicine in treatment of patients with abnormal C reactive protein, vitamin C (159 cases, 74.30%) and Tanreqing injection (71 cases, 33.18%) were most frequently used; when it was combined with 2 kinds of traditional Chinese medicines, Xueshuantong injection plus Tanreqing injection (support degree 10.75%) were most frequently used. When Qingkailing injection was combined with one kind of western medicine and traditional Chinese medicine in treatment of patients with abnormal white blood cells, vitamin C (596 cases, 56.02%) and Ganmao Qingre granules (247 cases, 23.21%) were most frequently used; when it was combined with 2 kinds of traditional Chinese medicines, Shuanghuanglian+Ganmao Qingre granules (support degree 5.26%) were most frequently used. In the patients with abnormal C-reactive protein and white blood cells, its combinations with antibiotics and nutritional support agents were most common from the pharmacological perspective, indicating that in the treatment of abnormal C-reactive protein, white blood cells and other increased inflammatory indicators, Qingkailing injection was most frequently combined with antibiotic drugs to achieve synergistic effect.

Clinical features analysis of Qingkailing injection for adolescent patients based on real world HIS / 中国中药杂志

To explore the clinical application features of Qingkailing injection for adolescent patients. This study was based on the information from the hospitalized patients in 1998-2011 in HIS (hospital information system) of 16 tertiary hospitals in China. 615 adolescent patients with Qingkailing injection were used to investigate the clinical characteristics of Qingkailing injection. Apriori algorithm was adopted to establish the model, and Clementine 12.0 was used for correlation analysis. The results showed that male patients (355 cases) were more than female patients (243 cases); the age of the most patients was under 14 years old, with an average age of 9.40 years old; the hospital stay was most of 4-7 d; the patients were mostly concentrated in pediatrics, mainly including upper respiratory tract infection; outpatient admission to the majority (451 cases, accounting for 75.54%). The traditional Chinese medicine (TCM) syndrome mainly included phlegm-dampness internal resistance (38.46%), Qi and Yin Deficiency (11.54%), Liver qi stagnation (15.38%), and Yang deficiency syndrome (11.54%); the highest admission rate was during Slight Cold (13.01%). In combined application, the most common western medicine pair was Cephalosporin injection+vitamin C (with supporting rate of 24.6%) and the most common TCM pair was Shuanghuanglian+Ganmao Qingre granules (with supporting rate of 4.065%). The most common 3 western medicines in combined use were Potassium chloride injection+Cephalosporin injection+vitamin C (supporting rate of 15.93%); while the most common three Chinese medicines were Shuanghuanglian+Yunnan Baiyao+Ganmao Qingre granules (supporting rate of 1.138%). Qingkailing injection was also widely used in adolescent patients; the diagnosis and use were basically in line with the instructions; men were slightly more than women; age of onset, solar terms and TCM syndromes were highly consistent. Qingkailing injection was mainly combined with western medicines in combined drug use, and Chinese medicines were also available. Combined drug use was more reasonable. Based on the results of the real world HIS, Qingkailing injection could provide the idea and reference for regulating the medication in adolescent patients.

Combined application of Chinese and western medicine, precise positioning for clinical efficacy / 中国中药杂志

Combined application of Chinese and western medicine is widespread in clinical real world because national policy emphasizes both Chinese medicine and western medicine. The studies on the combined use of Chinese and western medicine, are conducive to clinical precise positioning, promote self positioning of Chinese patent medicines and Chinese medicine enterprises based on suitable application fields, and provide direction for the deepening development of herbal industry. In addition, the studies on clinical evaluation and mechanism of combined use of Chinese and western medicine can provide basis for formulating national health policies and promoting medical resource fairness.

Efficacy and safety of smiltiorrhizadepsidesal combined with conventional western medicine treatment for stable angina pectoris / 中国中药杂志

In recent years, Chinese patent medicines such as smiltiorrhizadepsidesal(SMDS) injection are combined with western medicine to achieve good clinical efficacy for stable angina pectoris(SAP). SMDS is prepared by the water-soluble active ingredients extracted from Salvia miltiorrhiza, with the functions of promoting blood circulation, removing blood stasis and activating blood vessels, and it is used to treat type ⅠSAP and type ⅡSAP. The efficacy and safety of SMDS combined with simple routine western medicine for SAP were investigated by searching PubMed, EMbase, the Cochrane Library, CNKI, VIP, WanFang Data and CBM Database. SMDS combined with conventional western medicine treatment showed better efficacy for SAP as compared with western medicine alone, and better than other traditional Chinese medicines(such as Danshen injection and compound Danshen injection) combined with conventional western medicine. It was found that SMDS had a positive role in reducing blood viscosity, atherosclerosis, and improving microcirculation. The reported adverse drug reactions (ADRs) of SMDS combined with conventional western medicine therapy in clinical research were basically the same with ADRs reported by spontaneous reporting system(SRS) warning signals. Overall, SMDS combined with conventional western medicine had low incidence of ADR and no serious ADR occurred for SAP treatment in clinical trials. Currently, some drugs related to cardiovascular diseases such as ascinepazidemaleate injection, sodium succinate, propafenone hydrochloride and papaverine hydrochloride injection combined with SMDS have incompatibility, which should be highly emphasized in clinical use.

Registration of 30 026 cases of Shenqi Fuzheng injection combined with other drugs in real world / 中国中药杂志

Prospective, multi-center, large-sample and registered design was used to analyze the drug combination features of Shenqi Fuzheng injection in the real world clinical application, and comprehend the drug combination in the real world. A total of 30 026 patients with the use of Shenqi Fuzheng injection were registered, where the chemical drugs were used for 57 436 times (accounting for 82.76%), and the Chinese patent medicines were used for 11 962 times (accounting for 17.24%), mainly including anti-acid drugs and anti-ulcer drugs, nutritional agent, immune enhancement agent, etc. According to the association rules, drug combinations of 2 drugs were closely related to inhibiting gastric acid secretion and anti-tumor; drug combinations of 3 drugs were closely related to inhibiting gastric acid secretion, antiemetic and anti tumor; drug combinations of 4 drugs were closely related to inhibiting gastric acid secretion, antiemetic, anti-tumor, and immune enhancement. The above results were consistent with the Instruction, providing clues for accurate treatment, and laying the foundation for clinical rational drug use.

Mechanism of Salvianolate injection combined with aspirin in treatment of stable angina pectoris based on biomolecules network / 中国中药杂志

Biomolecular network analysis was used to predict the mechanism of Salvianolate injection combined with aspirin for the treatment of stable angina pectoris(SAP). Related genes of Salvianolate injection, aspirin and SAP were obtained from Genecards, STITCH and DisGeNET databases. Agilent literature search software was used to construct biomolecular network; modules were identified by AP, MCODE and MCL methods. DAVID software was used for identification of related KEGG pathways. Results showed that Salvianolate injection and aspirin had a coverage rate of 45.92%, 62.56% respectively for SAP molecular network, and the coverage rate was 71.64% in combined use. The top 10 important nodes of SAP overlapped with Salvianolate injection and aspirin included MAPK14, MAPK8, IL-6 and IL-8. The important SAP nodes overlapped with Salvianolate injection alone included AKT1 and IFNG, and the important SAP nodes overlapped with aspirin included EPHB2 and TP53. Related SAP signaling pathways with combined Salvianolate injection and aspirin included Jak-STAT signaling pathway and MAPK signaling pathway. Related SAP signaling pathways with Salvianolate injection alone included VEGF signaling pathway and type 1 diabetes signaling pathway. Related SAP signaling pathways with aspirin alone included AA metabolism, linoleic acid metabolism signaling pathway, etc. The results showed that Salvianolate injection and aspirin combination had an enhancement effect in treatment of SAP through anti-inflammatory reaction and inhibition of atherosclerosis development; in addition, the combination use may have an additive effect through the antiplatelet aggregation, protecting endothelial cells, regulating blood lipid and regulating glucose metabolism.

Clinical safety studies based on 30 026 post-marketing cases of Shenqi Fuzheng injection by intensive hospital monitoring nested NCCS / 中国中药杂志

This study adopted a large sample, multicenter, registered hospital centralized monitoring nested prospective case-control study design. From the real world clinical application of Shenqi Fuzheng injection, monitored 30 026 cases of patients with the use of Shenqi Fuzheng injection. A total of 51 adverse drug reaction (ADR) cases was monitored, including 1 case of severe adverse reactions. ADR incidence rate was 1.7 per 1,000. Blood samples were collected from patients with allergic reactions and their matched controls. Related biological indicators of allergic reactions were unified detected and analysed in order to explore the mechanism of allergic reaction and promote the clinical safety.

Post-marketing clinical safety assessment of Shenmai injection based on active monitoring and passive monitoring in large data background / 中国中药杂志

This paper adopted a series of related analysis methods to comprehensively analyze post-marketing clinical safety data of Shenmai injection from 4,220 cases of SRS and 32,358 cases of multicenter, prospective, registered hospital centralized monitoring in large data background, calculated ADR incidence rate was 0.93 per 1,000, main symptoms of ADR includes chest pain, chills, skin itching, palpitations, fever, nausea, dizziness, vomiting, flushing, numbness, allergic reaction, cyanosis, rash, low back pain, and "breath", "anaphylactoid reaction" and "flush" were the safety warning signals of Shenmai injection. Primary disease for chronic pulmonary heart disease, thyroid disease, and combined with cerebral vascular disease, prior to the injection and continuous use of alprostadil, cyclic adenosine monophosphate, combined with quinolones, penicillins were suspicious influence factors of ADR of Shenmai injection, these promot the clinical safety.