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1.
Article in Chinese | WPRIM | ID: wpr-879121

ABSTRACT

Traditional Chinese medicines(TCMs) have certain limitations in the clinical research design in their post-marketing evaluation, so that randomized controlled programs cannot be strictly implemented in some studies, while the objective performance criteria is a reasonable external controlled research method that has been gradually recognized at home and abroad in recent years in addition to randomized controlled trial(RCT) method. It is more mature in medical devices, surgery and other research fields, but there is no relevant report in the field of post-marketing evaluation of Chinese patent medicines. In this paper, the application prospect of the objective performance criteria and the problems were discussed in the field of post-marketing evaluation of TCM. The characteristics of as TCM are more consistent with the scope of the objective performance criteria, the application of the objective performance criteria in post-marketing evaluation of Chinese patent medicines, especially in single arm research, can break through the limitations of existing conventional clinical research methods, and improve the level of evidence, with good feasibility and advantages. However, in the application process, we should pay attention to the key issues such as the selection of index, research population, follow-up period and the reference selection, to ensure the quality of research. This research group has carried out some exploration and practice in the field of post-marketing evaluation of TCM injections by using single arm combined with the objective performance criteria, hoping to establish the key technology in this field, and provide certain research and design reference for the secondary development of Chinese patent medicines.


Subject(s)
Drugs, Chinese Herbal , Marketing , Medicine, Chinese Traditional , Nonprescription Drugs , Product Surveillance, Postmarketing , Randomized Controlled Trials as Topic
2.
Article in Chinese | WPRIM | ID: wpr-879120

ABSTRACT

Post-marketing evaluation of traditional Chinese medicine(TCM) is an important research stage in the life cycle of a drug, and the add-on-design is a common method for its post-marketing evaluation. This article introduces the basic concept of add-on-design, and points out that it is suitable for use based on the principles of medical ethics when the standard treatment should not be interrupted. The post-marketing evaluation of TCM should be carried out based on human experience and in compliance with regulations and ethics. The clinical values of TCM, such as the therapeutic effect for disease, improvement of disease symptoms, improvement in quality of life, as well as the synergism and toxicity attenuation of combined use of TCM and chemical drugs, should be fully reflected through the clinical trials designed with add-on-design. The key points of add-on-design are accurate clinical positioning, scientific estimation of sample size, and rigorous standard treatment. Standard treatment should be a recognized one, consistent and stable; appropriate and recognized efficacy indicators and targeted safety indicators should be selected; the design and operation of clinical research scheme should meet the requirements of randomization and blind method, with special emphasis on the production of qualified placebo. The add-on-design has the advantages that the rights and interests of the subjects are adequately protected. Besides, the research conclusions are easily put into clinical application. But there are also many difficulties, such as the influence of confounding bias, the "ceiling" effect of clinical efficacy, and the difficulty of interpretation of adverse events. Therefore, a rigorous research quality assu-rance system should be established, and the quality control of evaluation consistency of researchers should be emphasized to ensure strict quality control in the research process.


Subject(s)
Drugs, Chinese Herbal , Humans , Marketing , Medicine, Chinese Traditional , Quality Control , Quality of Life
3.
Article in Chinese | WPRIM | ID: wpr-879119

ABSTRACT

Classical Chinese patent medicines(CPMs) are a kind of modern preparation developed from the experience of compatibility and application about ancient prescriptions. Its rich history of human use and reliable clinical efficacy imply the unique theoretical essence and precious value of traditional Chinese medicine(TCM). With the development of evidence-based medicine and the improvement of medical policy, it is particularly urgent to evaluate the clinical values of post-marketing classical CPMs. In this paper, some problems on the clinical value evaluation of CPMs would be described, and it is considered that the simplified evaluation procedures can lead to the lack of evidence for evaluating clinical value of CPMs, causing the difficulty in evaluating the quality of CPM, lack of R&D motivation of enterprises, low content of science and technology, and poor international development. Based on this background, it points out that the clinical value evaluation is the core of the post-marketing evaluation of the classical CPMs, and the eva-luation should be based on the direction of literature research and the latest practice. We should adhere to the research mode of combination disease with syndrome, and select the appropriate type of trials, with clinical efficacy, health economic benefits and safety eva-luation as the main content of the studies, in order to refine the indications and standardize the clinical positioning. Clinical value eva-luation is the basis and main content of post-marketing comprehensive researches on classic and famous CPMs to clarify their clinical value, obtain the conditions for continued marketingand standardize their clinical application, so as to optimize the evidence and quality service of classic and famous CPMs and inherit the core value concept of Chinese medicine.


Subject(s)
China , Drugs, Chinese Herbal , Humans , Marketing , Medicine, Chinese Traditional , Nonprescription Drugs
4.
Article in Chinese | WPRIM | ID: wpr-879117

ABSTRACT

At present, the value evaluation of Chinese patent medicines is in the exploratory stage, and a clinical value evaluation system that can reflect the characteristics of traditional Chinese medicine has not been established. This article investigates four universal drug value tools from abroad, namely, evidence rating matrix, cancer value label, patient-perspective value framework and multiple criteria decision analysis advance value framework. The evidence rating matrix is used to measure the benefits and risks of different treatment measures, and the net health benefit is used as the best estimate point to evaluate the value of treatment; the cancer value label is mainly used to weigh the economic value and innovative value of drug treatment programs of different anti-tumor drugs by matrix composed the ratio between the expected result and the cost; the patient-perspective value framework emphasizes the evaluation of the value of different healthcare intervention methods from the patient's perspective; multiple criteria decision analysis advance value framework measures the value of drugs or measures from multiple dimensions. Combined with the characteristics of the above universal drug value evaluation tools and the correlation research of domestic drug value evaluation, the paper proposes to analyze the characteristics of Chinese patent medicine value evaluation from the six dimensions of effectiveness, safety, innovation, economy, suitability and accessibility of Chinese patent medicine, and expounds the strategy of constructing Chinese patent medicine value evaluation tool, so as to provide reference for the drug value evaluation and decision-making application of Chinese patent medicine.


Subject(s)
China , Drugs, Chinese Herbal , Humans , Medicine, Chinese Traditional , Nonprescription Drugs
5.
Article in Chinese | WPRIM | ID: wpr-879116

ABSTRACT

The article summarized the relevant researches on the clinical orientation of Chinese patent medicines, and put forward the post-marking principle and strategies of the clinical orientation. The principle could be illustrated by four criteria: overall design, step-by-step implementation, from easiness to hardness, gradual concentration. The strategies were as follows: first carrying out the projects with little cost of money and time, and then the projects requiring much cost of money and time, so that the possibility of fai-lure would be put forward at an early stage to reduce the loss caused by research failure as much as possible by consolidating the research projects with less investment at the early stage and gradually increasing the research projects with more investment at the later stage. On this basis, the "three dimensions and four stages" key technology was proposed for the post-marketing clinical orientation of traditional Chinese medicine. Medicines, diseases and patients were the "three dimensions", so we should understand the features and interaction of the target indications, symptoms and population to establish a three-dimensional clinical positioning coordinate system. "Four stages" were the four steps of clues analyzing, hypothesis orientation, preliminary verification and clinical validation. Each latter stage should be started after full completion of the former one, and the latter stage results shall be used to validate and revise the former clinical orientational hypothesis, continuously forming a feedback circle. Based on the sufficient verification of previous study, prospective clinical trials were implemented at last to get the best evidence-based evidence of clinical orientational hypothesis.


Subject(s)
Drugs, Chinese Herbal , Humans , Marketing , Medicine, Chinese Traditional , Nonprescription Drugs , Prospective Studies
6.
Article in Chinese | WPRIM | ID: wpr-828417

ABSTRACT

To analyze the clinincal application characteristics of Xiyanping Injection in real world. The data of the patients came from the hospital information systerm(HIS) of 29 tertiary hospitals in China from 2006 to 2016. It included three parts about basic information, Western medicine diagnosis information, and doctor advice information. The exploration was conducted for the characteristics of the patients and disease distribution as well as the therapeutic regimen. Apriori algorithm was adopted to establish the models, and Clementing 12.0 was used for a correlation analysis of the comprehensive therapeutic regimen of Xiyanping Injection. There were 194 873 cases in the study. The male to female ratio was 1.44∶1. The median age was 4 years old. The median daily dosage was 200 mg. 46.68% of the patients were administered with 250-500 mg, and 33.07% were 50-100 mg one day. 47.08% of the patients were administered for 4-7 d, and 32.65% of the patients were 1-3 d. In the doctor advice information, the most frequently types of Western medicine, traditional Chinese medicine were mucilagin, heat-clearing agent. Second generation cephalosporins, third generation cephalosporins, compound penicillin were the most common types of antibiotic. Interferon, nucleoside and nucleotide, human immunoglobulin were the most common types of antiviral drug. The mining association rules results were analyzed, finding the application of Xiyanping Injection in severe infectious diseases. To improve respiratory symptoms, Xiyanping Injection treaments were Budesonide + Ipratropium Bromide + Ambroxol. To severe pulmonary infection, the treaments were Dopamine + Ambroxine. To severe hand, foot and mouth disease, the treatments were Namefen + Mannitol. To pulmonary heart failure, the treatments were Dobutamine + Heparin. Based on the results of the real world HIS, we could provide clinical application the idea, and a reference for further excavation of the applicable diseases of Xiyanping Injection.


Subject(s)
Child, Preschool , China , Drugs, Chinese Herbal , Therapeutic Uses , Female , Humans , Injections , Male , Medicine, Chinese Traditional , Respiratory Tract Infections , Drug Therapy
7.
Article in Chinese | WPRIM | ID: wpr-827952

ABSTRACT

High-quality clinical study on traditional Chinese medicine is of great significance to effectively control new public health emergencies represented by outbreaks of infectious diseases and ensure people's health and safety, but it still faces a series of ethical issues. Based on the seven core values of equity, good deeds, effectiveness, respect for individuals, freedom, reciprocity, and solida-rity proposed in the Guidelines for Management of Ethical Issues in Outbreaks of Infectious Diseases, this article emphasizes the characteristics and laws of clinical studies on traditional Chinese medicine. Main points of ethical review of traditional Chinese medicine were summarized in the aspects of overall concept, syndrome differentiation and treatment, prevention before disease onset, cultural value, and clinical basis. Based on the outbreak of coronavirus disease 2019(COVID-19), we collected relevant registered Chinese medicine clinical studies, summarized the core issues of the ethics review for COVID-19, and further improved the traditional Chinese medicine ethics review system and resources, so as to better serve ethical review and scientific studies in public health emergencies.


Subject(s)
Betacoronavirus , Coronavirus Infections , Emergencies , Ethical Review , Humans , Medicine, Chinese Traditional , Pandemics , Pneumonia, Viral , Public Health
8.
Article in Chinese | WPRIM | ID: wpr-827946

ABSTRACT

From January 1, 2004 to July 21, 2016 a total of 2 796 cases of adverse drug reaction/adverse event(ADR/AE) after the use of Xianling Gubao Capsules/Tablets were reported by National Adverse Drug Reaction Monitoring Center. The following results were obtained by analyzing the reports of 2 796 cases of adverse drug reactions/adverse drug events after the use of Xianling Gubao Capsules/Tablets. A total of 75 patients, accounting for 2.68% of the total ADR/AE time, had severe ADR/AE events. Among them, 30 patients were aged 65 and above, accounting for 40.00% of the total number of severe ADR/AE patients. All the patients with ADR/AE were aged 45-64 years, which totaled 1 346 cases and took up 48.14% of the total patients with ADR/AE. All of ADR/AE cases and severe ADR/AE cases were orally given Xianling Gubao Capsules/Tablets. Females accounted for 52.50% and 76.00%, respectively, and the proportion of females was significantly higher than that of males. Among patients with a medical history of ADR/AE, severe ADR/AE was higher than the average, accounting for about 1.33%. The proportion of cases orally given 1-3 tablets of Xianling Gubao Capsules/Tablets in all ADR/AE cases and severe ADR/AE cases was 95.32% and 96.00%, which conformed to the usage in the package insert. All ADR/AE cases and severe ADR/AE cases orally given Xianling Gubao Capsules/Tablets twice daily occupied the highest proportions, or 77.00% and 61.00%, respectively. The proportion of severe ADR/AE cases orally given Xianling Gubao Capsules/Tablets was slightly higher than that of all ADR/AE cases in the medication frequency, which didn't conform to the usage in the package insert. All the symptoms of ADR/AE orally given Xianling Gubao Capsules showed many manifestations, and the top 10 symptoms were nausea, rash, itching, stomach dysfunction, vomiting, abdominal pain, dizziness, diarrhea, anaphylaxis, and reflux heartburn. The symptoms of severe ADR/AE after oral administration of Xianling Gubao Capsules were varied, and the top 10 symptoms were abnormal liver function, rash, suffocation, itching, dizziness, vomiting, anaphylaxis, abdominal pain, weakness, and convulsions. Abnormal liver function accounted for 44.12%. All of ADR/AE cases occurred within 2 days after oral administration of Xianling Gubao Capsules/Tablets, accounting for 54.26%. Severe ADR/AE occurred within 2 days after the use of Xianling Gubao Capsules/Tablets, accounting for 25.34%. The proportion of ADR/AE cases occurring within 15 days after oral administration of Xianling Gubao Capsules/Tablets increased again(57.33%). The overall trend contained two peaks.


Subject(s)
Administration, Oral , Aged , Anaphylaxis , Capsules , Dizziness , Drug-Related Side Effects and Adverse Reactions , Female , Humans , Male , Middle Aged
9.
Article in Chinese | WPRIM | ID: wpr-773213

ABSTRACT

The three elements in evidence-based clinical decisions are " best clinical research evidence,physicians' personal experience,and patients' basic values and wishes". This concept coincides with the " bio-psycho-social" model of systematic medicine,and this is the key reason why evidence-based medicine has become the most important diagnostic and therapeutic system under the new medical model. However,there is no methodological support for the implementation of " respecting patients' basic values and wishes".As a result,this concept is difficult to be implemented in clinical practice,and has become the form of " patient or family member' s signature for consent". In narrative medicine,doctors are advocated to record details,psychological processes and even family members' feelings in non-technical language to form parallel medical records,and the key point is to achieve " empathy" between doctors and patients. This idea is consistent with traditional Chinese medicine( TCM),and also provides a practical operation method " to respect patients' basic values and wishes". Medicine is a discipline based on human science,with dual attributes of science and humanity. Humanistic care is the tradition of TCM,and also is one of the basic characteristics and core connotations in TCM. Therefore,in the development of evidence-based TCM,we should combine evidence-based medicine with narrative medicine,and inject humanistic care into evidence-based medicine with the concept and methodology of narrative medicine,so as to achieve the deep integration of science and humanity.


Subject(s)
Evidence-Based Medicine , Humans , Medicine, Chinese Traditional
10.
Article in Chinese | WPRIM | ID: wpr-773208

ABSTRACT

Xiyanping Injection is a commonly used medicine in clinical treatment,which is recommended by many pediatric disease guidelines/consensus. However,the instraction is relatively simple and lack of guidance for clinical application,which affects the efficacy and brings safety risks. Therefore,more detailed clinical guidance is urgently needed. This consensus is formulated by clinical experts of traditional Chinese medicine and Western medicine in pediatrics. This consensus follows Manual for the clinical experts consensus of Chinese patent medicine which published by China Association of Chinese Medicine. The study identified clinical problems using clinical investigation,searched the literature based on PICO clinical problems,using GRADE system to carry out evidences evaluation,classification and recommendation,and adopted the nominal grouping method to reach expert consensus. The consensus combines evidence-based evidence with expert experience,sufficient evidence of clinical problems would lead to " recommendations",and clinical problems with insufficient evidence will lead to " consensus suggestions". This expert consensus recommends the indications,intervention time for treatment,route of drug administration,dose conversion,the indications of being used alone,suitability and taboos of medicine combination,and introduces the safety and clinical application,to provide reference for clinical using.


Subject(s)
Child , China , Consensus , Drugs, Chinese Herbal , Therapeutic Uses , Humans , Injections , Medicine, Chinese Traditional , Nonprescription Drugs , Pediatrics
11.
Article in Chinese | WPRIM | ID: wpr-774507

ABSTRACT

To analyze the clinical characteristics of Maixuekang Capsules combined with traditional Chinese medicines in the treatment of patients with nephrotic syndrome,and provide references for improving rationality of clinical drug use. Based on the database of hospital information system(HIS) in 15 hospitals in China,the electrical medical records of the patients diagnosed as nephrotic syndrome and treated with Maixuekang Capsules were collected. Their diagnostic information and characteristics of combined traditional Chinese medicines were analyzed by using association rules. The results showed that 1 588 patients of nephrotic syndrome who used Maixuekang Capsules were often complicated with hypertension(863 cases,accounting for 7. 54%),anemia(551 cases,accounting for 4. 81%),and coronary heart disease(349 cases,accounting for 3. 05%). Maixuekang Capsules were mainly combined with Tabellae Rhei et Natrii Bicarbonatis,Baining Capsules,tanshinone,Ganmao Qingre Granule,Shuxuening Injection in treating nephrotic syndrome. The results indicated that in the real world,Maixuekang Capsules was mainly used in combination with traditional Chinese medicines such as blood-activating and stasis-removing agents,pathogens eliminating and supporting healthy Qi agents,digestants,anti-bacterial and anti-inflammatory agents,wind-dispersing and antipyretic agents for patients with nephropathy. By the pharmacological effect,it was suitable for nephropathy patients based on combined diagnosis. The association rules of combination were specific,and can provide reference for subsequent studies and rational clinical medication of traditional Chinese medicines.


Subject(s)
Anemia , Capsules , China , Coronary Disease , Drugs, Chinese Herbal , Therapeutic Uses , Humans , Hypertension , Medicine, Chinese Traditional , Nephrotic Syndrome , Drug Therapy
12.
Article in Chinese | WPRIM | ID: wpr-256021

ABSTRACT

This paper is to report the implementation and results of safety monitoring of Shenfu injection. Prospective, multicenter, large sample, registry-type centralized hospital monitoring mode was used, and the three-level quality control and anti-omissive mechanisms were used strictly. In the monitoring was carried out in 28 hospitals and lasted for 4 years. 30 106 patients were registered; ADE occurred in 114 patients, and ADR was identified in 23 patients with an incidence rate of 0.076% for ADR [95% confidence interval (0.045%,0.108%), which was in a rare level. The main ADRs included rash, pruritus, discomfort at the site of the infusion, nausea, vomiting, abdominal pain, dizziness, chest tightness, heart palpitations, chills, fever and dyspnea. No severe ADRs were found in the monitoring. This paper also fund that history of allergy, methods of administration, dosage, solvent, concentration, and combined medication may affect the incidence of ADR in the use of Shenfu injection.

13.
Article in Chinese | WPRIM | ID: wpr-256020

ABSTRACT

To analyze the clinical application features of Fufang Kushen injection in treating malignant esophageal tumors in the real world by using hospital information system database, and provide reference for clinical application of Fufang Kushen injection. The electronic medical data from 2 550 patients with malignant esophageal tumors using Fufang Kushen injection from 22 large-scale hospitals nationwide were extracted based on the hospital information system (HIS) established by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences. Then the descriptive analysis based on frequency and rate was conducted for general characteristics, diagnostic characteristics, characteristics of dosage and medication information, characteristics of drug combination, and discharge outcome characteristics. The results showed that the average age of patients treated with Fufang Kushen injection for malignant esophageal tumors was 62.3 years old; more males than females; admitted to hospital mainly in department of cardiology, oncology and digestology first. The total efficiency was 47.15% based on the discharge outcome characteristics; the most common dosage was 10-20 mL for single use; the course of treatment was mainly 4-7 d; and the common drugs in drug combinations included dexamethasone, tropisetron injection, thymosin injection, compound amino acid injection, pantoprazole sodium injection, fluorouracil, et al. The characteristics of the crowd using Fufang Kushen injection to treat the malignant esophageal tumors were clear and in line with the general rule of malignant esophageal tumors; its clinical dosage and scope of treatment for malignant esophageal tumors in the real world were basically consistent with the specification; and the types of clinical drug use combinations were more extensive.

14.
Article in Chinese | WPRIM | ID: wpr-335812

ABSTRACT

By studying the relationship between syndromes, physique and MMP-9, IL-6 and MTHFR gene polymorphisms in patients with ischemic stroke,The relationship between MMP-9, IL-6 and MTHFR gene polymorphism was analyzed in patients with ischemic stroke.The data were collected by collecting the data of patients with ischemic stroke, and the statistical analysis was carried out. Syndrome:61 cases of ischemic stroke patients with stroke phlegm stasis syndrome in patients with the highest frequency, a total of 30 cases; Physical constitution: phlegm is ischemic stroke patients prone to physical, a total of 20 cases; The analysis of the relationship between constitution and syndrome shows that the patients with qi deficiency constitution tend to show qi deficiency and blood stasis syndrome after onset, The analysis of the relationship between constitution and syndrome shows that the patients with qi deficiency constitution tend to show qi deficiency and blood stasis syndrome after onset, Phlegm constitution and physical condition after the onset of symptoms tend to wind phlegm stasis syndrome; Syndrome and MMP-9, IL-6 relationship:The distribution of MMP-9 and IL-6 in patients with qi and phlegm stasis syndrome and qi deficiency and blood stasis syndrome was significantly different from that in Z test (P<0.05). The level of MMP-9 in patients with qi deficiency and blood stasis syndrome was significantly higher than that in patients with wind phlegm and blood stasis syndrome;The level of IL-6 in patients with phlegm and blood stasis syndrome was significantly higher than that in patients with qi deficiency and blood stasis syndrome. Syndrome, constitution and MTHFR gene polymorphism: among the 61 samples, 34 were heterozygous mutations, 15 were pure and mutated, 12 had no mutation, The mutation rate of this locus was 4.08 times that of patients without mutations.The genotype of MTHFR C677T in patients with phlegm dampness tends to be CT genotype. Wind phlegm stasis syndrome in patients with easy to appear after the TT genotype; Yin deficiency syndrome in patients prone to miscellaneous and mutations, the performance of CT genotype; Analysis of the relationship between syndromes and physique in patients with ischemic stroke,Phlegm and dampness, flat quality patients after the onset of easy to show the wind phlegm stasis syndrome; Qi deficiency after the onset of symptoms in patients with Qi and blood stasis. Suggesting that before the onset of such as for the partial physical conditioning, may be on the prevention of ischemic stroke have a certain effect; Analysis of the relationship between syndromes and MMP-9 and IL-6 in patients with ischemic stroke, Wind phlegm stasis syndrome and IL-6 levels are related, Qi deficiency and blood stasis syndrome and MMP-9 levels are related. Analysis of the relationship between syndromes and MTHFR gene polymorphism in patients with ischemic stroke, TT genotype after the onset of symptoms prone to wind phlegm stasis syndrome, CT genotype patients after the onset of easy manifestations of Yin deficiency wind syndrome; Analysis of the relationship between physique and MTHFR gene polymorphism in patients with ischemic stroke, CT genotype is easy to show phlegm.For more in-depth understanding of pathogenesis of ischemic stroke to provide the basis, For the clinical treatment and prevention to provide intervention strategies.

15.
Article in Chinese | WPRIM | ID: wpr-256566

ABSTRACT

<p><b>OBJECTIVE</b>To assess the value of urinary liver-type fatty acid-binding protein (L-FABP) in early assessment of the severity of traumatic brain injury and in predicting the occurrence of acute kidney injury (AKI) following the brain injury.</p><p><b>METHODS</b>Sixty-five patients with traumatic brain injury patients were divided into 4 groups according to their Glasgow coma scale (GCS) scores. Blood and urine samples were collected at 2, 6, 12, 24, 48 and 72 h after the injury to detect serum creatinine (SCr) level using biochemical analyzer and urinary L-FABP using enzyme-linked immunosorbent assay (ELISA), with samples from 15 healthy adults as controls. The correlations were analyzed among SCr, urinary L-FABP, GCS score upon admission and AKI occurrence.</p><p><b>RESULTS</b>The patients with moderate to severe brain injuries showed significantly higher SCr and urinary L-FABP levels than the control group (P<0.05). GCS score of the patients was inversely correlated with the levels of SCr and urinary L-FABP (P<0.05), and the changes were more prominent in urinary L-FABP than in SCr. The incidence of AKI was 21.54% in these patients. In patients with AKI, urinary L-FABP reached the peak level as soon as 6 h after the injury, as compared with 24 to 48 h when peak SCr level occurred.</p><p><b>CONCLUSION</b>Urinary L-FABP can be used as a marker for early assessment of the severity of traumatic brain injury and for predicting the occurrence of AKI following the injury.</p>

16.
Article in Chinese | WPRIM | ID: wpr-328293

ABSTRACT

<p><b>OBJECTIVE</b>To explore the effects of integrative medicine (IM) rehabilitation protocolon motor function, activity of daily living, and quality of life (QOL) in hemiplegia patients after stroke.</p><p><b>METHODS</b>Totally 120 patients with post-stroke hemiplegia were allocated to four groups using sealed envalope drawing, i.e., the rehabilitation group, the Chinese medical treatment group, the acupuncture group, and the comprehensive rehabilitation group, 30 cases in each group. Based on routine rehabilitative training, patients in the Chinese medical treatment group, the acupuncture group, and the compre-hensive rehabilitation group received standardized treatment based on syndrome typing, Shi's Consciousness-Restoring Resuscitation acupuncture, Chinese herbs + acupuncture comprehensive rehabilitatino protocol, respectively. The treatmet cycle consisted of 4 weeks with 24-week follow-ups. Fugl-Meyer motor assessment (FMA), Modified Barthel Index (MBI), and Stroke-Specific Quality of Life Scale(SS-QQL), and safety assessment were taken as main effect indices before treatment, at week 4 of treatment, at week 12 and 24 of follow-ups, respectively.</p><p><b>RESULTS</b>There was no statistical difference in FMA score, MBI score, SS-QOL score among the four groups before treatment (P > 0.05). These scores were significantly improved in the four groups at week 4 of treatment, week 12 and 24 of follow-ups, respectively (P < 0.05). Besides, FMA score and SS-QOL score were significantly improved in the comprehensive rehabilitation group at each corresponding time point, as compared with other treatment groups (P < 0.05).</p><p><b>CONCLUSIONS</b>The comprehensive protocol could significantly improve motor function, activity of daily living in hemiplegia patients after stroke, and further improve their QOL. Its effect was better than other single treatment.</p>


Subject(s)
Activities of Daily Living , Acupuncture Therapy , Hemiplegia , Rehabilitation , Humans , Integrative Medicine , Methods , Medicine, Chinese Traditional , Motor Skills , Quality of Life , Stroke Rehabilitation , Treatment Outcome
17.
Article in Chinese | WPRIM | ID: wpr-231027

ABSTRACT

Integrated network analysis was used in this paper to analyze Xiyanping injection combined therapy for hand-foot-mouth disease based on the registered research data of 3 204 cases. It was found that the drug combination therapy was almost consistent with the guidelines for the diagnosis and treatment of hand foot mouth disease, but there were some problems to be noticed: there were too many applications of antibiotics, more than the need in preventing secondary infection; and ribavirin was not necessary for use. This article showed that the clinical antibacterial and antiviral values of Xiyanping injection has not been well recognized for hand-foot-mouth disease.

18.
Article in Chinese | WPRIM | ID: wpr-236049

ABSTRACT

This study collected demographic data, past history, personal history, family history, dosage, solvent, combined medication information of adverse reaction cases from a prospective, multi center, large sample intensive hospital monitoring, and found the influencing factors with cross-tab analysis. The results showed that in the medication group of 19-45, patients with allergic histories had a higher proportion in ADR; in the medication group of 46-65, male patients with allergic histories had a higher proportion in ADR; indication and non-indication group, patients of 19-45 years old, with combined medications and allergy histories had a higher proportion in ADR; Non-indication medication group, patients with combined medication, higher concentration, out-instruction solvent and dosage, had a higher proportion in ADR. So, the ADRs of Shenfu injection were related to the history of drug allergy, and also related to the indication, dosage, solvent, concentration when it was used.


Subject(s)
Adult , Aged , Drug Hypersensitivity , Drugs, Chinese Herbal , Female , Humans , Injections , Male , Middle Aged , Prospective Studies
19.
Article in Chinese | WPRIM | ID: wpr-236046

ABSTRACT

The purpose of the study is to find the allergic reaction types and characteristics of Chinese medicine injection ( CMI). The authors monitored patients who used Shuxuetong injection, Dengzhan Xixin injection, Shenqi Fuzheng injection, Shenmai injection, Ciwujia injection, Shuxuening injection, Tanreqing injection, Reduning injection, a total of 150,000 cases were monitored. They used a nested case-control design to group the patients and obtained the serum samples from 14 allergic patients and 55 matched patients. They used enzyme-linked immunosorbent assay (ELISA) to detect serum C3, C4, IgE, IgG, MCT-P, and judge the allergic reaction types: Shuxuetong injection hypersensitivity (1 case), can not determine (1 case); Dengzhan Xixin injection hypersensitivity (1 case), hypersensitivity & anaphylactoid reaction (1 case), can not determine (1 case); Shenqi Fuzheng injection hypersensitivity (3 cases), can not determine (1 case); Shenmai injection anaphylactoid reaction (1 case); Ciwujia injection can not determine (1 case), Shuxuening injection can not determine (1 case), Tanreqing injection can not determine (1 case), Reduning injection can not determine (1 case). The results showed that the main type of allergic reaction of CMI was hypersensitivity, the type of allergic reaction was closely related to the varieties of CMI, the hypersensitivity and anaphylactoid reaction might occur in one patient at the same time which used Dengzhan Xixin injection.


Subject(s)
Drug Hypersensitivity , Drugs, Chinese Herbal , Humans , Immune System , Injections
20.
Article in English | WPRIM | ID: wpr-262680

ABSTRACT

Pharmacoeconomics is an important part of the postmarketing Chinese medicine (CM) evaluation, and postmarketing pharmacoeconomic evaluation can reveal the clinical and market value of CM. The purpose of establishing the guideline for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines both scientific and fair. Every country's guidelines for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the guideline that takes into account the special characteristics of CM; and these are in preparation for the postmarketing CM pharmacoeconomic evaluation.


Subject(s)
Clinical Trials as Topic , Cost-Benefit Analysis , Economics, Pharmaceutical , Guidelines as Topic , Humans , Pharmaceutical Preparations , Economics , Product Surveillance, Postmarketing , Economics , Statistics as Topic
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