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ObjectiveTo re-evaluate the systematic reviews/Meta-analyses （SRs/MAs） of tonic traditional Chinese medicine （TCM） injections against cerebral ischemic stroke （CIS） and provide evidence support for clinical practice and decision-making. MethodTCM injections of different varieties were obtained after searching the three major drug catalogues. Seven Chinese and English databases were searched from database inception to March 13，2022，for the relevant SRs/MAs. The methodological quality，risk of bias，reporting quality，and quality of evidence were assessed by Assessment of Multiple Systematic Reviews-2 （AMSTAR-2），the Risk of Bias in Systematic Review （ROBIS），the Preferred Reporting Items for Systematic Reviews and Meta-analyses 2020 （PRISMA 2020），and the Grading of Recommendations Assessment，Development，and Evaluation （GRADE）. In addition，the literature overlap matrix was established to calculate the corrected covered area （CCA） and evaluate the rate of overlaps of the original literature. ResultFive types of TCM injections and 18 SRs/MAs were included. AMSTAR 2 evaluation showed that the methodological quality of 18 SRs/MAs was extremely low，and 14 SRs/MAs had a high risk of bias assessed by ROBIS. The quality evaluation results reported by the PRISMA 2020 showed that the scores of the studies included ranged from 19.5 to 28.5，with 10 being of medium quality and eight of low quality. The evaluation with the GRADE system demonstrated that one outcome was moderate-quality evidence，15 outcomes were low-quality evidence，and 41 outcomes were very low-quality evidence. The CCA of the included SRs/MAs was 0.263，indicating a low rate of overlaps of the original literature. ConclusionTonic TCM injections are effective and safe in the treatment of CIS，but this conclusion should be treated with caution because of the low quality of methodology，reports，and evidence in published SRs/MAs. It is recommended to improve the study design，obtain clinical evidence of higher quality，and conduct systematic evaluations in strict accordance with procedures to standardize the reporting of research results.
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The hyperacute stage of myocardial infarction refers to a period of time within 30 minutes after the occurrence of myocardial infarction, when the symptoms are not obvious and the diagnosis is difficult, and the related pathophysiological mechanism has received less attention. In this study, proteomics was used to investigate the pathological changes in the early hyperacute phase of myocardial infarction, aiming to provide experimental evidence for pathological mechanism of myocardial infarction hyperacute stage. Meanwhile, the intervention effect and related mechanism of salvianolate injection were discussed based on heat shock protein B6 (HSPB6), aiming to benefit the clinical rational use of salvianolate injection. The protein expression changes before and after myocardial infarction model establishment were detected by label-free proteomics via mass spectrometry and analyzed by bioinformatics method. Then the binding effect of salvianolate injection on the commonly differential protein HSPB6 was evaluated by molecular docking technology, which was finally verified by animal experiments. All animal experimental protocols were approved by the Ethics Committee of Xiyuan Hosptial (2022XLC041). The results of this study showed that a total of 2 166 proteins were quantified by lable-free proteomics, of which 194 shared differential proteins were involved in myocardial injury and body regulation in the hyperacute phase of myocardial infarction, mainly involving molecular functions such as protein homodimerization activity, oxygen binding and transport, and serine endopeptidase inhibitor activity. Among them, HSPB6 protein is involved in the regulation of myocardial function. Molecular docking results indicated that magnesium salvianolate acetate, which is the main component of salvianolate injection, had the lowest binding energy with HSPB6 protein: -14.53 kcal·mol-1. Animal experiments showed that compared with the Sham group, the model group had significantly lower ejection fraction (EF) and fractional shortening (FS) (P < 0.001), cardiac blood perfusion decreased significantly (P < 0.001). There were obvious pathological changes such as myocardial fiber disorder, cardiomyocyte edema and interstitial small blood vessel congestion; the injury of cardiac function of rats in the administration group was attenuated, and the FS of rats in the low-dose group was significantly improved (P < 0.05), the pathological injury of myocardial tissue was markedly mitigated, and the expression of HSPB6 protein was up-regulated to varying degrees (P < 0.01, P < 0.001). In conclusion, salvianolate injection could be able to improve the cardiac function and pathological morphology of rats in the early hyperacute stage of myocardial infarction, and its mechanism may be related to the promotion of expression of HSPB6.
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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.
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OBJE CTIVE To provide reference for the adjustment and optimization of the policies related to traditional Chinese medicine（TCM）injection in China. METHODS The policies related to TCM injections issued at the national level were collected from Jan. 1，1990 to May 31，2021. Based on the perspective of policy tool ，the content analysis and quantitative analysis were used to classify ，code and analyze the policy terms according to “policy serial number-chapter number-specific terms ”. RESULTS & CONCLUSIONS Totally 30 policy documents related to TCM injection were included ， with a total of 389 codes. Environment-based policy tools were the most widely used （79.95％），followed by supply-oriented policy tools ，accounting for 15.42％. Demand-based policy tools accounted for the least proportion （4.63％）. Among environment-based policy tools ，the regulatory and control policy tools （38.05％） received more attention，and the policy publicity （2.06％） received fewer applications. Among supply-oriented policy tools ，there were more applications of science and technology support （10.80％）， and fewer applications of capital investment （0.26％）. Among demand- based policy tools ，organizational coordination was the most widely used （3.34％），followed by experience demonstration （1.29％），which had not yet involved the relevant policies of international exchange. In order to promote the development of TCM injection ，it is necessary to appropriately reduce the application of environment-based policy tools ，increase the application of policies such as policy publicity ，and improve the external environment for TCM injection ；optimize the internal combination of supply-oriented policy tools ，increase the use of capital investment tools ，and effectively play the role of policy boosting；emphasize the application of demand-based policy XJY21013） tools to form an effective policy pulling force for the healthy development of TCM injection.
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According to the notice on revision of the instructions for traditional Chinese medicine injections(TCMIs) issued by the National Medical Products Administration(NMPA) from January 2006 to May 2020, the revised contents in the instructions for 29 varieties involved in the notice were sorted out, and the existing problems in the instructions for TCMIs were analyzed, so as to provide the basis for dynamic revision of the instructions. It was found that the revised items of instructions for 29 varieties all involved adverse reactions, contraindications and precautions, and warnings were added for 82.76% of 29 TCMIs preparations, indicating that all the revised contents were related to safety issues. In addition, 33.33% of the drugs risks mentioned in the precautions were not indicated in the adverse reactions; 82.76% instructions did not indicate drug interactions; 17.24% instructions lacked medication notes for special populations; 48.28% instructions did not indicate traditional Chinese medicine(TCM) syndromes of the main disease; 44.83% instructions did not indicate the type and stage of indication; and 86.21% instructions did not indicate the course of treatment. It could be concluded that the instructions for TCMIs have known risks of drugs that are not fully reflected in adverse reactions and the effective information is not comprehensive. The risk control measures proposed in the precautions need to have aftereffect evaluation and there is a lack of drug interactions and medications for special populations. As an important part of the full life-cycle management of drugs, the revision of instructions for TCMIs should be continuously improved to provide the basis for safe and reasonable application of TCMIs. Based on the above problems, it is proposed that the marketing license holder as the main body of the revision of instructions should actively carry out post-marketing basic and clinical research in accordance with the characteristics of TCM, combine the updated research with the guidance of TCM theory and improve the revision level of instructions for TCMIs to provide the basis for post-marketing evaluation.
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Humans , Drugs, Chinese Herbal , Injections , Medicine, Chinese Traditional , SyndromeABSTRACT
Since the safety re-evaluation of traditional Chinese medicine(TCM) injections began in 2009, some TCM injection companies and research institutes have done a lot of work. And with the increase of drug development and drug production technology levels in China, the safety of some TCM injections has been greatly improved. There are safety risks in TCM injections, which are mainly reflected in unclear basis of medicinal materials, simple production process, poor controllability of quality standards, nonstan-dard drug instructions and irrational medication in the use process. This paper describes the research progress of the above-mentioned aspects of TCM injections. In addition, the author team found that adverse reactions of TCM injections are mainly pseudo-allergic reactions. Therefore, a lot of work has been done in detection of pseudo-allergic reactions, mechanism research and risk control. This part of the work is also described in this article.
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Humans , China , Drugs, Chinese Herbal/adverse effects , Hypersensitivity/etiology , Injections , Medicine, Chinese Traditional/adverse effectsABSTRACT
Objective@#To study on the effect of clinical nursing in preventing adverse drug reaction of injection preparation of traditional Chinese medicine, explore nursing strategy of adverse drug reaction,promote the rational use of traditional Chinese medicine injection preparations in clinical practice by analyzing the adverse drug reactions of traditional Chinese medicine injection in our hospital.@*Methods@#A retrospective analysis of 362 cases of adverse drug reactions reported by the National ADR Surveillance Center from January 2017 to November 2018 was carried out in our hospital. In accordance with the guidelines of the Ministry of Health Manual on reporting and monitoring adverse drug reactions. By using Microsoft office Excel 2007, the ADR reports were summarized and analyzed according to age, sex, type and frequency, time of adverse reactions, and involvement system of adverse reactions.@*Results@#In 362 cases of ADR, the ratio of male to female patients was about 1.1∶1.There were 65 cases of children under 12 years old, accounting for 18%, and 117 cases of people over 61 years old, accounting for 32.3%,the proportion of other age groups was lower than those of the elderly and children. Most of the drugs with ADR appeared in blood circulation (208 cases), followed by heat-clearing and detoxifying drugs (102 cases) and anti-tumor drugs (52 cases). The common ADR involvement system of traditional Chinese medicine injection is nervous system reaction, skin allergic reaction, cardiovascular system reaction, local injury of injection, gastrointestinal tract system.@*Conclusions@#Attention should be paid to the role of nurses in monitoring adverse reactions of traditional Chinese medicine injections, strengthening the propaganda and education of nurses' ADR monitoring work, strengthening nurses' cognition of ADR, enhancing nurses' service and consciousness to patients with static injection of traditional Chinese medicine, and standardizing the process of drug use, thus reducing possible injury to patients due to adverse reactions caused by the use of traditional Chinese medicine injection.
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Injectable traditional Chinese medicine often contains multiple components including undefined toxic substances, can have high variability between batches, with undefined mechanisms of action. It is urgent to improve the quality and consistency and reduce the toxicity risk of traditional Chinese medicine. The Microtox technology is a simple, rapid method for the detection of toxic substances in the environment that uses non-pathogenic luminescent bacteria as an indicator, and the change in luminosity as an index. Using this bioassay we have systematically applied Microtox technology for the detection of microtoxicity in injectable traditional Chinese medicine. As a new method of bioactivity characterization, Microtox technology is expected to be used in the detection of quality fluctuations and toxicity risks at an early stage in the preparation of injectable traditional Chinese medicines and to improve the quality of injectable traditional Chinese medicine.
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Traditional Chinese medicine (TCM) injections are very useful in the treatment of acute and severe diseases due to their rapid onset. While, adverse drug reactions (ADRs) of TCM injections is an important problem, how to quickly detect ADRs signal of TCM injections is a key and difficult issue to make sure the safely application of TCM injections.Prescription sequence symmetry analysis (PSSA) is an effective surveillance tool for drug associated ADRs, through examining the distribution of marker drugs (potentially used for managing ADRs), before and after initiation of index drugs, PSSA can evaluate the causal association of index drugs and ADRs. PSSA can quickly detect ADRs signal based on medical electronic databases or prescription databases, which is suitable for the rapid emergence of ADRs for TCM injections. We described the basic principle and worldwide researches of PSSA, then we introduced the research methods when using PSSA to analyze the three aspects of ADRs for TCM injections. At present, when we use PSSA to detect ADRs signals in electronic prescription databases in China, we still need to think about the number of patients, structure and combination of data. With the development of medical electronic databases in China, PSSA can be more used to detect ADRs signal.
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Based on the fact that chromogenic reaction of blue complex, a reaction product which can be dissolved in organic solvents, can be realized by polyethoxy and ammonium thiocyanate in tween 80, a rapid and accurate way for the determination for tween 80 in pharmaceutical adjuvant was established in this study, providing reliable technical means for quality control of traditional Chinese medicine injections. Based on the study of reaction kinetics, chromogenic reaction temperature and time, as well as extraction of organic solvents and other key conditions were optimized, and Kumu injection was used as the test material for method validation and applicability investigation. It was finally determined that 3 mL ammonium thiocyanate solution was added in the sample solution, and the reaction was carried out in a boiling water bath for 2 h. After cooling to room temperature, 5 mL of dichloromethane was added to extract the chromogenic product. The absorbance value was measured at the wavelength of 623 nm to calculate the tween 80 content in the sample. Under optimized conditions, tween 80 solution showed a good linear relationship with the absorbance in the range from 0.8 mg to 3.0 mg. The linear regression equation was ＝0.258-0.047. The correlation coefficient was 0.999 6. Under the experimental conditions, the average recovery was 99.66%, and the precision RSD was less than 2.0%. The results showed that this method can quickly and accurately determine the content of tween 80 in Kumu injection, and it could be applicable to the quality control of traditional Chinese medicine injections.
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Adjuvants, Pharmaceutic , Chemistry , Medicine, Chinese Traditional , Polysorbates , Chemistry , Quality Control , Solvents , TemperatureABSTRACT
With the rapid development and wide application of traditional Chinese medicine injection (TCMI), a number of adverse events of some TCMIs have incessantly been reported and have drawn broad attention in recent years. Establishing effective and practical analytical methods for safety evaluation and quality control of TCMI can help to improve the safety of TCMIs in clinical applications. In this study, a sensitive and rapid high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method has been developed and validated for the quantitative determination of potentially harmful substance 5,5'-oxydimethylenebis (2-furfural, OMBF) in TCMI samples. Chromatographic separation was performed on a C18 reversed-phase column (150 mm × 2.1 mm, 5 µm) by gradient elution, using methanol-water containing 0.1% formic acid as mobile phase at the flow rate of 0.3 mL/min. MS/MS detection was performed on a triple quadrupole mass spectrometer with positive electrospray ionization in the multiple reaction-monitoring mode. The method was sensitive with a limit of quantification of 0.3 ng/mL and linear over the range of 0.3-30 ng/mL (=0.9998). Intra- and inter-day precision for analyte was <9.52% RSD with recoveries in the range 88.0-109.67% at three concentration levels. The validated method was successfully applied to quantitatively determine the compound OMBF in TCMIs and glucose injections. Our study indicates that this method is simple, sensitive, practicable and reliable, and could be applied for safety evaluation and quality control of TCMIs and glucose injections.
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Objective To learn the adverse drug reaction (ADR) of traditional Chinese medicine injection (TCMI) in Dongfang Hospital of Beijing University of Chinese Medicine (BUCM),to master the characteristics of the occurrences of ADR,and to provide basis for safe and rational clinical drug use.Methods Locating all the reported ADR cases by Dongfang Hospital of BUCM to national ADR monitoring system from June 2011 to May 2016,and make retrospective analysis of them.Results Eighteen kinds of TCMI that caused the total 135 ADR cases,50 out of all the 135 instances were male patients,whilst the rest 85 instances were female patients;The main kinds of TCMI that caused ADR problems were TCMI for relieving heat and toxic material and TCMI for promoting blood circulation to remove blood stasis;TCMI was used jointly with antibiotics and biological product etc.;And the circumstances of ultra-dose and improper infusion allocation existed.The clinical manifestation included many skin lesion cases.All the patients suffered from ADR were cure.Conclusion Prudent and rational use of drugs,standardized clinical use procedure,and clinical re-evaluation are key aspects to lower the incidence rate ofADR of TCMI and to safe and rational use of drugs.
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Safety issues of traditional Chinese medicine injections has been heated debate. There are two diametrically opposed views: it should be used reasonable and developed healthily or be forbidden to use. Some people have many misunderstandings and prejudices about the safety of traditional Chinese medicine injections. Compared with western medicine,traditional Chinese medicine has its own particularity. Traditional Chinese medicine has complex components. Its research and clinical application is different from western medicine. Adverse reactions of traditional Chinese medicine injections are related to many factors,such as a large number of irrational use,blind use of traditional Chinese medicine injections and western medicine injections,counterfeit and substandard drugs,incorrect methods of intravenous infusion,toxicity of supplementary materials,drug ingredients. Developing traditional Chinese medicine injection is the need for curing sickness to save patients. The purposeful, targeted, organized and planned systematic research of traditional Chinese medicine injections should be strengthened,especially the safety of traditional Chinese medicine. Strengthen supervision and control of rational drug use.Strengthen the examination and approval,supervision and management of all aspects to ensure the safety of patients.
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As an important representative of modern Chinese medicine, traditional Chinese medicine (TCM) injzection has become an indispensable part of the Chinese medicine industry. However, its development is now restricted by the bottleneck of insufficient core competitiveness, low-level research and production, even injection quality and the safe use are not guaranteed. Thus, it is urgent to reevaluate post-marketing TCM injection generally and to make secondary development. Under current circumstances, taking major brands which have good clinical and market foundation, as well as research value, as the main subject of cultivation and evaluation is an important approach to innovative development of TCM injection industry. Unlike oral proprietary Chinese medicine, the cultivatation of major brands of TCM injection needs higher technical support, quality standards and more timely feedback. Therefore, a post-market integral evaluation system adaptive to TCM injection is required. This article discussed some key points on the construction of a post-market integral evaluation system of TCM injection in three levels： optimizing evaluation methods, building synergistic innovation platforms which combine the medical research institutions and pharmaceutical enterprises, and finally constructing the integral evaluation system. A "five to one" structure has been proposed to enhance TCM injection effectiveness, safety and adaptability on the whole, which are from the following aspects： mechanism research, clinical evidence validation, literature information mining, sustainable development of resources and industrialization operation.
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Screening out the safety-related substances and establishing the corresponding standard has been a key research issue to improve the safety of traditional Chinese medicine injections(TCMIs). 5-HMF which widely exists in sugar-containing TCMIs has long been considered as an important safety-related substance. In this review, we summarizes the research progress on the toxicology of 5-HMF as well as the content and standards of 5-HMF in TCMIs.Therein, both literature summary and analysis results indicate that there are lack of toxicology researches of 5-HMF and its metabolites in TCMIs, although the potential toxicity of 5-HMF and its metabolites has been reported. Moreover, the content of 5-HMF largely varies from TCMIs to TCMIs, and even in the same TCMIs from different factories. To ensure the clinical efficacy of TCMIs, it urgent to carry out the study of the toxicology of 5-HMF in TCMIs comprehensively and systematically, so as to set up a relatively uniform standard as well as to develop process quality control method.
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OBJECTIVE: To optimize the preparation process of liquiritigenin injection. METHODS: Single factor experiment was carried out to determine the solvents, dosage of adjuvants, pH of solution, pyrogen removal method and sterilization process. RESULTS: The optimal conditions were determined as follows: liquiritigenin was dissolved in 40% propylene glycol solution at pH 4.0-6.0. Ultrafiltration was employed to remove bacterial endotoxin. The solution was sterilized at 121℃ (97 kPa) for 15 min. CONCLUSION: The established preparation process of liquiritigenin injection is reasonable and suitable for industrialized production.
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Vibrio fischeri CS234 was used to establish and optimize microtox assay system, laying a foundation for the application of this method in comprehensive acute toxicity test of traditional Chinese medicine (TCM) injections. Firstly, the Plackett-Burman method was carried out to optimize the factors which would affect Vibrio fischeri CS234 luminescence. Secondly, ZnSO4•7H2O was chosen as reference substance to establish its reaction system with quality control samples. The optimal luminescence conditions were achieved as follows: ①At a temperature of (15±1) ℃, Vibrio fischeri CS234 lyophilized powders were balanced for 15 min, then, 1 mL resuscitation fluid was added and blended for 10 min. 100 μL bacteria suspension was taken to measure the initial luminescence intensity, and then 1 mL resuscitation fluid or test sample was immediately added; after reaction for 10 min, corresponding luminescence intensity was measured again. Resuscitation diluent, osmotic pressure regulator and ZnSO4•7H2O stock solution showed no interference to the determination of Vibrio fischeri CS234 luminescence intensity, so this method was of good specificity. The within-and between-batch precisions of quality controls and the lower limit of quantification (LLOQ) samples were <5% and <10% respectively, while the accuracy ranged between 85.8% and 103.2%. The standard curve equation of ZnSO4•7H2O ranged from 3.86 mg•L⁻¹ to 77.22 mg•L⁻¹ (final concentrations) was y=21.78lnx-15.14, R2=0.998; meanwhile, IC₅₀ of ZnSO4•7H2O to Vibrio fischeri CS234 was 19.90 mg•L⁻¹. ZnSO4•7H2O stock solution and its quality controls were continuously investigated for 120 h and 8 h respectively, and their RSD was lower than 2%, indicating stability at room temperature and 4 ℃ storage conditions. Between pH 4.5-8.0, luminescence intensity of Vibrio fischeri CS234 was controlled within ±10%, and such pH value range could meet the testing needs of the vast majority of traditional Chinese medicine injections. The Vibrio fischeri strain CS234 assay system was specific, stable, sensitive, accurate and adaptable after optimization, so it was suitable for the comprehensive acute toxicity assessment of TCM injections.
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Objective To survey the incidence of adverse reaction induced by traditional Chinese medicine injection and provide valuable suggestion for using traditional Chinese medicine injection.Methods Clinical data of 1860 patients who were under treatment of traditional Chinese medicine injection during January 2010 to December 2014 were studied to survey adverse reaction incidence, effected system-organs and risk factors of adverse reaction.Results Comparison of incidence adverse reaction of traditional Chinese medicine injection, Qingkailing injection adverse occurrence rate reached the highest 11.76% for all types, followed by Shenmai injection and Shuanghuanglian injection.Adverse reactions involving the organ and the performance was compared, adverse reactions mainly involved the organs for the skin and accessories, circulatory system, accounting for 56.15%, the incidence of adverse reactions of the rest of the organ system was less.Not determine the treatment based on differentiation of symptoms and signs, combined with injection, ultra treatment application and distribution of liquid static for a long time all differences were statistically significant ( P <0.05), leading to the main risk factors of the occurrence of adverse reactions.Conclusion Traditional Chinese medicine injections occurred and the incidence of adverse reactions was higher, wider range, organ involvement mainly skin and its appendages and circulatory system, not dialectical treatment and rational drug use is lead to adverse risk factors, actively preventment and timely treatment to reduce the incidence of adverse reactions.
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OBJECTIVE: To discuss the methods for clinical rational use and state regulation of high risk Traditional Chinese Medicine Injections (TCMIs) based on our hospital TCMIs analysis and literature review. METHODS: By analyzing the prescription rates and amount percentage of TCMIs in emergency, outpatient and inpatient departments of our hospital as well as literature searching to learn the current state and conditions of TCMIs. RESULTS: Utilities of TCMIs from 2012 to 2014 shows an elevated tendency with percentages of 1.19%, 1.34% and 1.40% respectively. Emergency, ENT and internal neurology departments oi outpatient are the top 3 on prescription rates and amount percentage. Inpatients' order rates of TCMIs are 0.79%, 0.80% and 0.79% respectively. Oncology (20%-26%), emergency (12%-14%) and internal neurology (10%-11%) departments are the top 3 amount rates in ordering TCMIs,however, the department of TCM only account for 4%-5%. The percentages of TMCIs amount vs. annual total drug amount during 2012-2014 are 2.10%, 2.07% and 2.14%, which is lower than literature reports. CONCLUSION: Not all the TCMIs use in our hospital are rational, mainly reflects in non-TCM doctors having used the most amount of TCMIs. Therefore, the TCM consultation policy should be established to support TCMI rational utility, TCMIs labels should be strictly regulated and the quality standards of TCMIs should be elevated to ensure the safety and effectiveness. All above efforts should be done to protect and develop TCMI, an innovation of TCM.
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ObjectiveTo study the occurrence and influence factors of drug-induced injuries of vital organs caused by traditional Chinese medicine injection.MethodsChina Hospital Knowledge Database (CHKD) from 1993-2013 and case reports concerning adverse effects and drug-induced diseases caused by traditional Chinese medicine injection from Wanfang Data Knowledge Service Platformwere retrieved. Indicator systemwasestablished and relevant contentsweresummarized and analyzed.Results34 types of traditional Chinese medicine injectionswereincluded and 699 drug-induced diseasesweresummarized, taking up 53.98% of the total adverse effects. Among them, the top three included in the drug-induced diseaseswere acanthopanax injection, safflower injection and Mailuoning injection. The non-conformance between the traditional Chinese medicine injections in the literature and instructions mainly reflects unreasonable solvent selection, large compatibility concentration and usage and dosage beyond those specified in the instructions. ConclusionThe occurrence of drug-induced injuries of vital organs caused by traditional Chinese medicine injectionis relatively high, drug instructions shall be strictly followed in accordance with requirements during clinical application.