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ObjectiveTo explore the comprehensive clinical value of Qianlieping capsules in the treatment of chronic prostatitis with damp-heat stasis syndrome， and to provide evidence for the decision-making of clinical basic drug management. MethodBased on the "Guidelines for Comprehensive Clinical Evaluation of Drugs （Trial Version 2021）"， this study systematically reviewed the existing research on the treatment of chronic prostatitis with damp-heat stasis syndrome by Qianlieping capsules. Based on evidence-based medicine， clinical epidemiology， clinical medicine， evidence-based pharmacy， pharmacoeconomics， health statistics， health technology assessment， and other disciplines， the multi-criteria decision analysis model （MCDA） and CSC 2.0 software were used. The six dimensions of safety， effectiveness， economy， innovation， suitability， and accessibility of drugs， as well as traditional Chinese medicine（TCM） characteristics， were comprehensively evaluated qualitatively and quantitatively. ResultIn terms of safety， based on the spontaneous reporting system （SRS） of the National Center for ADR Monitoring， safety literature analysis， pharmacological and toxicological experiment report， and other evidence， the safety grade of Qianlieping capsules was evaluated as grade A， with good safety. In terms of effectiveness， based on the results of pharmacological and pharmacodynamic studies and Meta-analysis， and combined with the value and quality of the evidence for efficacy， the final efficacy grade of Qianlieping capsules was rated as B. In terms of economy， Qianlieping capsules was a class B drug of national medical insurance. Compared with those of similar Chinese patent medicines， the average daily cost of Qianlieping capsules was moderate， and there was no related cost increase during the administration process. Economic research showed that Qianlieping capsules combined with α-receptor blockers were more economical than α-receptor blockers alone. Based on the quality evaluation of economic evidence and the value evaluation of economic evidence， the economic grade of Qianlieping capsules was rated as B. In terms of innovation， Qianlieping capsules were a combination of cold and warm drugs， focusing on clearing heat， detoxifying， removing blood stasis， and relieving pain， with non-toxic medicinal materials. They obtained a number of invention patents. The enterprise service system was perfect， and the quality standard was higher than the international and Chinese standards. The innovation grade of Qianlieping capsules was rated as B. In terms of suitability， the results of the questionnaire survey showed that it had relatively good suitability for clinicians， nurses， pharmacists， and patients who used Qianlieping capsules. The information on Chinese patent medicines was complete and met the requirements of national standards. The suitability grade of Qianlieping capsules was rated as A. In terms of accessibility， Qianlieping capsules were moderately priced and affordable， with sufficient resources of medicinal materials， no shortage of medicinal materials， and good availability. The accessibility grade of Qianlieping capsules was rated as B. In terms of TCM medicine characteristics， the prescription of Qianlieping capsules was derived from Danshen Huoxue Decoction. The original prescription was used for the treatment of chronic prostatitis with blood stasis syndrome. The whole formula was recorded in The Complete Compendium of Fine Formulas （《良方大全》） published by Beijing Publishing Group Co.， Ltd. in 1991 and has been used for more than 30 years. The formula was a combination of warm and cold drugs， attacking pathogens without hurting healthy Qi. The grade of TCM characteristics of Qianlieping capsules was rated as B. ConclusionBased on the above "6+1" dimensions， the comprehensive evaluation result of Qianlieping capsules in the treatment of chronic prostatitis with damp-heat and blood stasis syndrome is grade B， and it is recommended to convert it into the relevant policy results of basic clinical drug management according to the conditions.
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ObjectiveTo comprehensively evaluate the clinical value of Jintiange Capsules （JCs） in the treatment of osteoporosis （OP） and clarify the intrinsic advantages and clinical treatment characteristics of JCs， providing references for relevant departments of national health and medicine decision-making and the basis and clues for clinical and basic in-depth research. MethodBased on evidence-based medical evidence， this study integrated quantitative and qualitative methods and combined with questionnaires， official website data， human experience， pharmacoeconomic evaluation， and other research methods. From the effectiveness， safety， economy， innovation， suitability， accessibility， and traditional Chinese medicine （TCM） characteristics of the '6+1' dimension， the clinical evidence and value of JCs in the treatment of OP were comprehensively evaluated， forming the 'clinical evidence and value evaluation index'. The comprehensive evaluation of clinical value was based on the multi-criteria decision analysis framework. The expert meeting method was used to empower each dimension and value index. The clinical evidence and value evaluation software of Chinese patent medicine （CSC v2.0） was used to calculate the total value score， and the clinical advantages of JCs were comprehensively evaluated. ResultBased on randomized controlled clinical studies and systematic review， data analysis of spontaneous reporting system （SRS）， case reports， non-clinical safety studies， etc.， serious adverse drug reactions （ADRs） were reported after the launch of this product monitored by SRS， mainly involving abnormal liver function and adverse reactions of cardiovascular system. Therefore， the safety evidence adequacy of this product should be further improved， and the safety evaluation was Grade B. Meta-analysis showed that JCs were superior to the control group in improving the total clinical effective rate， improving bone mineral density， reducing visual analogue scale （VAS） score， and shortening fracture healing time. Combined with Grading of Recommendations Assessment， Development and Evaluation （GRADE） evidence evaluation， the comprehensive evaluation of effectiveness was Grade A. Pharmacoeconomic evaluation showed that JCs combined with calcium carbonate D3 tablets were more cost-effective than calcium carbonate D3 tablets alone in patients with OP. Compared with Gushukang capsules， JCs had more cost-effectiveness advantages， but the sample size included in the study was small， and the results needed to be verified by further studies. Combined with the results of the Comparative Assessment of Structure Prediction （CASP） evaluation list， the comprehensive economic evaluation was Grade B. JCs were the only bionic medicine of tiger bone in China with all intellectual property rights， with 3 national invention patents. Its process preparation and fingerprint detection had obvious technical advantages. It had innovative advantages in the supply base equipment， medicine resource management， production technology， and other aspects. Thus， its innovative comprehensive evaluation was Grade A. JCs were in capsule dosage form， which was relatively convenient for storage and transportation. The dosage form was suitable for indications， and the usage was easy for patients to grasp and accept. The statutory information and non-statutory information met the national standards. The comprehensive evaluation of suitability was Grade A. JCs did not contain toxic ingredients， had no restrictions on origin and prescription， and had abundant resources of original medicinal materials. The affordability of JCs in the treatment of OP was good in urban areas （14.97%） but not in rural areas （39.76%）. The price was higher than that of similar Chinese patent medicines， and the comprehensive evaluation of availability was Grade B. JCs had a reasonable proportion of natural animal bones， and their composition was basically the same as that of natural tiger bones. After marketing， more than 2 000 cases of real-world clinical research evidence was accumulated， and the comprehensive evaluation of TCM characteristics was Grade B. CSC v2.0 software was used for quantitative synthesis of the '6+1' dimension， and the comprehensive clinical value of JCs in the treatment of OP was Grade A. ConclusionJCs have good clinical value in the treatment of OP， and the TCM characteristics are prominent. It is suggested that JCs can be directly transformed into the related policy results of basic clinical drug management according to procedures.
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ObjectiveTo systematically review the existing studies on Xueshuantong for injection（lyophilized） in the treatment of acute cerebral infarction（ACI）， and to clarify the clinical value of Xueshuantong for injection（lyophilized） through comprehensive clinical evaluation， so as to promote clinical rational drug use and relevant policy transformation. MethodEvidence of Xueshuantong for injection（lyophilized） in terms of safety， effectiveness， economy， innovation， suitability， accessibility， traditional Chinese medicine（TCM） characteristics（6+1 dimensions） and information service was comprehensively collected. Evidence-based medicine， questionnaire survey， health technology assessment， pharmacoeconomic evaluation and other research methods were used， and the multi-criteria decision analysis model was used to measure each dimension， in order to comprehensively evaluate the clinical value of Xueshuantong for injection（lyophilized）. ResultSpontaneous reporting system， Meta-analysis of adverse reactions， and active safety monitoring study showed that the main adverse reactions of Xueshuantong for injection（lyophilized） were rash， pruritus， chest tightness， headache， dizziness and other general adverse reactions， the incidence of serious adverse reactions was judged to be rare， the known risk was small， the evidence was sufficient， and the safety evaluation was grade A. The results of Meta-analysis showed that Xueshuantong for injection（lyophilized） combined with conventional treatment for ACI was superior to conventional treatment in terms of improving neurological deficit score， improving daily activity score and clinical efficacy， and the effectiveness evaluation was grade B. The results of pharmacoeconomic evaluation showed that Xueshuantong for injection（lyophilized） combined with conventional treatment was relatively economic compared with conventional treatment alone， with the total clinical effective rate as the effect parameter， but the incremental effect was not significant， the economic evaluation was grade B. In addition to ACI and unstable angina of coronary heart disease， the drug also had good clinical efficacy in central retinal vein occlusion， and had a wider range of indications and awarded 16 patents， and its innovation evaluation was grade B. The suitability of medical personnel and patients was good without special technical and management requirements， and the suitability was evaluated as grade B. Xueshuantong for injection（lyophilized） had reasonable price， good affordability， certain prescription restrictions and general availability， the accessibility evaluation was grade B. Since the drug is an injection of effective parts of TCM， no grade evaluation of its TCM characteristics is conducted. The legal and non-legal information evaluation results of Xueshuantong for injection（lyophilized） showed that all the information was complete and in accordance with the requirements of national standards. Based on the grade scores of the 6 dimensions， the clinical comprehensive evaluation of Xueshuantong for injection（lyophilized） in the treatment of ACI was calculated as category B by CSC 2.0. ConclusionThe clinical value of Xueshuantong for injection（lyophilized） is good， and it is suggested that it can be directly translated into relevant policy outcomes for basic clinical medication management.
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Traditional Chinese medicine (TCM) syndromes have a certain genetic background. It is of great significance to study the essence of syndromes, and through genetic polymorphism research, the objectification of TCM syndromes can be realized. There are multiple relationships between genetic polymorphisms and TCM syndromes:including the relationship between internal factors and external manifestations, the relationship between macrocosmic view and microcosmic view, and the relationship between objectivity and subjectivity. This article reviews the current research progress on the correlation between genetic polymorphism and TCM syndromes in order to provide some ideas for the objectification of syndromes.
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This study was aimed to explore the death rule of viral hepatitis patient according to the 24-calendar cycle and time.Information of 40 681 inpatients diagnosed as viral hepatitis from 20 triple-A hospitals in China were collected from December 2003 to August 2011.The death rule of viral hepatitis patient according to the 24-calendar cycle and time was analyzed.It is the first time to put traditional Chinese medicine (TCM) concept of time into survival ending.Its mechanism was explained from the aspects of both TCM and modern medicine.It provided a reference method to combine TCM theory and clinical practice.The results showed that among 40 681 patients,36 547 patients had treatment ending.Among them,386 patients were dead,with the total death rate of 1.06％;308 patients were diagnosed as viral hepatitis B,which was about 79.79％ of the whole dead patients.The proportion of the death time is focused on the Great Heat and the Cold Dew,which is about 6.67％ and 6.4％,respectively.And the percentage of death in the winter is lowest,which is about 3％.The highest percentage of death in one day is Shen-Shi (from 3 pm to 5 pm,23.82％) and You-Shi (from 5 pm to 7 pm,21.78％).It was concluded that the death rule of viral hepatitis patient was at the highest percentage in summer and autumn;that of the spring was the second;and that of the winter was the lowest.In one day,the highest percentage of death lies in Jin-Shi (from 3 pm to 7 pm).
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This paper was aimed to understand the clinical features of traditional Chinese medicine (TCM) through the analysis of relevant information among fracture patients treated by the Cervus and Cucumis Polypeptide Injection (CCPI).The study was conducted among fracture patients treated by CCPI in the hospital information systems (HIS) among 26 national triple-A hospitals from 2003 to 2014.The general information,TCM syndrome and solar term of morbidity were analyzed.The results showed that the number of patients from 45-64 years old were the most,accounting for 39.84％.Among them,the number of male patients from 18-44 years old was the most,accounting for 43.38％;the number of female patients from 45-64 year old was the most,accounting for 44.33％.The main TCM syndrome of admission and discharge was qi stagnation and blood stasis,which accounted for 60.53％ and 53.08％,respectively.Beginning of Summer (7th solar term) and Rain Water (2nd solar term) were solar terms with the most patients,which accounted for 5.26％ and 5.24％,respectively.It was concluded that the majority of fractures patients treated with CCPI were the elderly.The syndrome of qi stagnation and blood stasis was the most.The hospital admission of most patients was at the Beginning of Summer and Rain Water.It provided theoretical basis to pay attention on TCM syndrome differentiation in the treatment of clinical fractures.The treatment should be adapted to the characteristics of the disease itself,the change of solar terms,and dialectical medication.
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OBJECTIVE: To characterize naringenin (NAR) pop- ulation pharmacokinetics (PPK) in Chinese women with primary osteoporosis. METHODS: Ninety-eight female patients with primary osteoporosis from the Jingshan, Beixinqiao, Jiaodaokou, Chaoyangmen, and Donghuamen communities in Beijing, China, aged 40 to 80 years, re- ceived oral Qianggu capsules (250 mg). Blood samples were collected before and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h after administration. The concentration of NAR in the blood samples was measured using high performance liquid chromatography-tandem mass spectrometry. PPK analyses were performed with nonlinear mixed-effect modeling software (version 7.1.2, PsN3.2.12). The clearance (C1), central distribution volume (V), absorption rate constant (Ka1), peripheral distribution volume (VII), and inter-compartmental clearance (CLII) were set as parameters and estimated by the base model, covariate model, and final model. Kidney-Yang deficiency [Shenyangxu (SYAX)] and liver-kidney-Yin deficiency (Ganshenyinxu) are patterns of symptoms in Traditional Chinese Medicine that were set as covariates, along with age, height, blood urea nitrogen, serum creatinine, alanine transaminase, aspartate transaminase, and hyperlipidemia. Both stepwise forward and backward procedures were accomplished to build models. The final model was evaluated by internal and external validation, visual predictive check, bootstrap, and leverage analysis. RESULTS: A one compartment open model with first order degradation was the best fitted to the concentration-time profiles following oral administration of NAR. The mean of population parameters of the final model, C1, SYAX on C1, V, Ka1, CLII, and VII, were measured to be 37.6 L/h, 0.427 L, 123 L/h, 0.12/h, 0.3056, and 1.446, respectively. Inter-individual variability was estimated and SYAX was identified as a significant covariate. CONCLUSION: The population pharmacokinetic model described in this study could effectively characterize the pharmacokinetic profile of NAR following administration of a single dose of oral Qianggu capsules in Chinese women with primary osteoporosis. Among the tested covariates, only SYAX was a significant factor.
Subject(s)
Drugs, Chinese Herbal/pharmacokinetics , Flavanones/pharmacokinetics , Osteoporosis/drug therapy , Adult , Aged , Aged, 80 and over , Capsules/administration & dosage , China , Drugs, Chinese Herbal/administration & dosage , Female , Flavanones/administration & dosage , Flavanones/blood , Humans , Middle Aged , Models, Biological , Treatment OutcomeABSTRACT
Drug risk assessment and management is an important measure for reducing the adverse drug reaction and enhancing medication safety of the patient. Based on the concepts of drug risk assessment and risk management, and domestic and international drug risk management situation, this paper discusses the risk management of post-marketing Chinese medicine.
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Humans , Adverse Drug Reaction Reporting Systems , Drug-Related Side Effects and Adverse Reactions , Medicine, Chinese Traditional , Product Surveillance, Postmarketing , Methods , Risk Assessment , Methods , Risk FactorsABSTRACT
<p><b>OBJECTIVE</b>To determine the relation between the change of immunology indexes of serum and the occurrence of anaphylaxis in patients induced by Qingkailing injection, and to establish the method of detection of the type of anaphylaxis in patients induced by traditional Chinese medicine (TCM) injection.</p><p><b>METHOD</b>In a prospective nested case-control study, we compared the concentration of IgE, IgG, IL-2, IL-4 of 20 cases in anaphylaxis induced by Qingkailing injection with those from 60 matched controls who remained normal after the using Qingkailing injection. The correlation between the change of IgE, IgG, IL-2, IL-4 of serum and the occurrence of anaphylaxis in patients induced by Qingkailing injection was determined, and we also evaluate the clinical values of IgE, IgG, IL-2, IL-4 of serum in diagnosis of anaphylaxis in patients induced by Qingkailing injection by Binary-Logistic regression analysis.</p><p><b>RESULT</b>The concentrations of IgE, IgG, IL-2, IL-4 of serum of 20 cases were significantly higher than those in controls (P < or = 0. 05). The concentrations of IgE, IgG, IL-2, IL4 of serum of 20 cases after the treatment with Qingkailing injection were significantly higher than those before the treatment with Qingkailing injection (P < or = 0.05). The Exp(B) of IgE, IgG, IL-2, IL-4 were 22. 018 (95.0% CI for EXP was 3.268-310.831), 11.271 (95.0% CI for EXP was 1.91-3.024), 23.612 (95.0% CI for EXP was 3.012-421.187), 16.486 (95.0% CI for EXP was 1.233-205.413), respectively.</p><p><b>CONCLUSION</b>The allergic reaction caused by Qingkailing injection may be due to type I allergic reactions; The presence of IgE, IgG, IL-2, IL-4 can serve as clinical evaluation indicators in evaluation the damage degree of immune system caused by anaphylaxis in patients induced by Qingkailing injection. Cytokines are more likely to become the effective evaluation index in diagnosis of anaphylaxis in patients induced by TCM injection.</p>
Subject(s)
Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Young Adult , Anaphylaxis , Blood , Allergy and Immunology , Case-Control Studies , Cytokines , Blood , Allergy and Immunology , Drug Hypersensitivity , Allergy and Immunology , Drugs, Chinese Herbal , Immunoglobulins , Blood , Allergy and Immunology , Prospective StudiesABSTRACT
Reviewing the progress on study about the major allergen of Shuanghuanglian injection in recent years, resulted in that individual differences of anaphylactic shock are closely related with HLA gene polymorphism. Basing on this, we put forward the research strategy on susceptibility gene of important allergen of Shuanghuanglian injection based on the theory of genetic fingerprints, in order to make sure about the relationship the major allergen of Shuanghuanglian injection and HLA-DRB gene polymorphism and specificity IgE antibody, and to clarify the allergic reaction loci reduced allergic reactions, which can provide the reference data for the study on mechanisms for anaphylactic reaction of Shuanghuanglian injection, and research ideas for the sensitization mechanism of traditional Chinese medicine injection study.
Subject(s)
Humans , Allergens , Anaphylaxis , Genetics , Allergy and Immunology , Drugs, Chinese Herbal , Genetic Predisposition to Disease , Genetics , HLA-DR Antigens , Genetics , HLA-DRB1 Chains , Immunoglobulin E , Allergy and Immunology , Injections , Polymorphism, Genetic , GeneticsABSTRACT
Sample size is one of important factors determining the results of a clinical trial, and the choice of sample size estimation methods is related to the specific design of clinical trials. On clinical safety reevaluation of postmarketing Chinese medicine, we often design cohort study, case-control study, nested case-control study or hospital centralized monitoring, which need large sample sizes. In evaluating the effectiveness of postmarketing Chinese medicine widely applied in the large population, pragmatic randomized controlled trial (PRCT) is more suitable than explanatory randomized controlled trial (ERCT). ERCT is necessary to conduct confirmatory study for new indications of postmarketing Chinese medicine. According to the specific purpose, design type and evaluation index, we choose the suitable sample size estimation method, and determine the corresponding parameters. We must estimate and determine the suitable sample size according to the specific clinical evaluation design, with comprehensive consideration of the test power, research cost and practical operability.
Subject(s)
Humans , Cohort Studies , Drug Therapy , Reference Standards , Drug-Related Side Effects and Adverse Reactions , Drugs, Chinese Herbal , Reference Standards , Therapeutic Uses , Product Surveillance, Postmarketing , Public Health , Randomized Controlled Trials as Topic , Sample SizeABSTRACT
Post-marketing re-evaluation of Chinese herbs can well reflect Chinese medicine characteristics, which is the most easily overlooked the clinical re-evaluation content. Since little attention has been paid to this, study on the clinical trial design method was lost. It is difficult to improving the effectiveness and safety of traditional Chinese medicine. Therefore, more attention should be paid on re-evaluation of the clinical trial design method point about tcm syndrome such as the type of research program design, the study of Chinese medical information collection scale and statistical analysis methods, so as to improve the clinical trial design method study about tcm syndrome of Chinese herbs postmarketing re-evalutation status.
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Humans , Clinical Trials as Topic , Medicine, Chinese Traditional , Product Surveillance, Postmarketing , Research DesignABSTRACT
In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.
Subject(s)
Humans , Drug-Related Side Effects and Adverse Reactions , Medicine, Chinese Traditional , Product Surveillance, Postmarketing , Sample SizeABSTRACT
The purpose of post-marketing Chinese medicine re-evaluation is to identify Chinese medicine clinical indications, while designing scientific and rational of Chinese medicine symptoms items are important to the result of symptoms re-evaluation. This study give screening of traditional Chinese medicine(TCM) symptoms item of post-marketing medicine Xuezhikang re-evaluation as example that reference to principle dyslipidemia clinical research, academic dissertations, Xuezhikang directions, clinical expert practice experience etc. while standardization those symptom names and screening 41 dyslipidemia common symptoms. Furthermore, this paper discuss about the accoerdance and announcements when screening symptoms item, so as to providing a research thread to manufacture PRO chart for post-marketing medicine re-evaluation.
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Humans , Hypoglycemic Agents , Medicine, Chinese Traditional , Product Surveillance, PostmarketingABSTRACT
The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine. It is also the expansion and stretch of new drug evaluation. Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use. It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security. This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan.
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Humans , Medicine, Chinese Traditional , Product Surveillance, PostmarketingABSTRACT
Computerizing extracting information from Chinese medicine literature seems more convenient than hand searching, which could simplify searching process and improve the accuracy. However, many computerized auto-extracting methods are increasingly used, regular expression is so special that could be efficient for extracting useful information in research. This article focused on regular expression applying in extracting information from Chinese medicine literature. Two practical examples were reported in this article about regular expression to extract "case number (non-terminology)" and "efficacy rate (subgroups for related information identification)", which explored how to extract information in Chinese medicine literature by means of some special research method.
Subject(s)
Artificial Intelligence , Information Storage and Retrieval , Medicine, Chinese Traditional , Product Surveillance, PostmarketingABSTRACT
<p><b>OBJECTIVE</b>To construct real world integrated data warehouse on re-evaluation of post-marketing traditional Chinese medicine for the research on key techniques of clinic re-evaluation which mainly includes indication of traditional Chinese medicine, dosage usage, course of treatment, unit medication, combined disease and adverse reaction, which provides data for reviewed research on its safety,availability and economy,and provides foundation for perspective research.</p><p><b>METHOD</b>The integrated data warehouse extracts and integrate data from HIS by information collection system and data warehouse technique and forms standard structure and data. The further research is on process based on the data.</p><p><b>RESULT</b>A data warehouse and several sub data warehouses were built, which focused on patients' main records, doctor orders, diseases diagnoses, laboratory results and economic indications in hospital.</p><p><b>CONCLUSION</b>These data warehouses can provide research data for re-evaluation of post-marketing traditional Chinese medicine, and it has clinical value. Besides, it points out the direction for further research.</p>
Subject(s)
Humans , Hospital Information Systems , Medicine, Chinese Traditional , Product Surveillance, PostmarketingABSTRACT
<p><b>OBJECTIVE</b>To discuss the feasibility and necessity of using HIS data integration to build large data warehouse system which is extensively used on re-evaluation of post-marketing traditional Chinese medicine, and to provide the thought and method of the overall design for it.</p><p><b>METHOD</b>With domestic and overseas' analysis and comparison on clinical experiments' design based on real world using electronic information system, and with characteristics of HIS in China, a general framework was designed and discussed which refers to design thought, design characteristics, existing problems and solutions and so on.</p><p><b>RESULT</b>A design scheme of HIS data warehouse on re-evaluation of post-marketing traditional Chinese medicine was presented.</p><p><b>CONCLUSION</b>The design scheme was proved to be high coherence and low coupling, safe, Universal, efficient and easy to maintain, which can effectively solve the problems many hospitals have faced during the process of HIS data integration.</p>
Subject(s)
Humans , Data Mining , Hospital Information Systems , Medicine, Chinese Traditional , Product Surveillance, PostmarketingABSTRACT
Anaphylaxis is the most common adverse reaction caused by traditional Chinese medicine (TCM) injection, the most serious of which is type I, so post-marketed safety re-evaluation is necessary. Skin test can be used to screen type I allergy reaction, which is of great significance for TCM injection safe use. Skin test is not only able to find the population sensitization situation of TCM injection, but also is a way of understanding the mechanism of allergy reaction. TCM injection varieties that often occur type I anaphylaxis are applicable to skin test, and study population include healthy volunteers and patients whose disease is listed in the drug specification, intracutaneous test and prick test are the alternative method. The concentration of skin-test solution may influence the positive rate of skin test, penicillin skin-test solution preparation method can be used as the reference in TCM injection. Different doses of TCM injection skin-test solution,glucose injection and normal saline, histamine hydrochloride are comprised in comparison. Given the characteristics of type I allergy reaction,we should be pay close attention to skin test reaction in half an hour, and observation index need be designed based on post-marketed re-evaluation of clinical safety.