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1.
China Pharmacy ; (12): 251-256, 2024.
文章 在 中文 | WPRIM | ID: wpr-1006188

摘要

Levetiracetam (LEV) is the second generation of broad-spectrum anti-epileptic drug. LEV has the advantages of rapid absorption, short half-life, precise efficacy, good tolerance and few drug interactions. In order to improve the clinical efficacy of LEV, and reduce the occurrence of adverse reactions, children, pregnant women, the elderly, and patients with renal insufficiency should receive therapeutic drug monitoring (TDM). Clinically, the samples are usually plasma or serum, and the TDM methods are mostly immunoassay or chromatography. There is currently no consensus on the effective concentration range of LEV, and the correlation between plasma concentration and adverse reactions is also unclear. The main factors affecting LEV plasma concentration include age, pregnancy, and patient compliance. How to interpret TDM results and adjust dosage based on the results will be the focus of future work.

2.
文章 在 中文 | WPRIM | ID: wpr-1032332

摘要

In recent years, the rapid development of medical information technology has made it critical to analyze large-scale diagnosis and therapeutic data and extract rules based on real medical environment. This has become an essential approach for marketing evaluation and regulatory decision-making of drugs and devices both domestically and internationally. Real world study (RWS), as a novel methodology for clinical evaluation of drugs in the field of drug utilization research (DUR), have presented opportunities and challenges for observational studies in assessing actual efficacy or effectiveness. However, despite being a popular methodological approach among scholars in the field, there are still limitations and deficiencies when analyzing population medication characteristics in RWS. Systematic evaluation research methods have not yet been established, leading to inadequate generation of real-world evidence (RWE). The research design, methodological pathways, evaluation indicators, confounding factors, and bias management involved in DUR based on real-world data (RWD) were reviewed in this artical with the intention of providing guidance for further exploration into DUR.

3.
文章 在 中文 | WPRIM | ID: wpr-1005109

摘要

The irrational use of Chinese patent medicines (CPM) is becoming more and more prominent, which makes the demand for clinical practice guidelines of CPM gradually increase. In order to make domestic scholars understand the latest developments and existing problems of the CPM guidelines, and promote its development, this paper introduced the concept of CPM guidelines, summarized the characteristics of the two development modes, namely “taking CPM as the key” and “taking disease/syndrome as the key”, and analyzed the current methodological status of developing and reporting CPM guidelines. Based on the existed problems, three suggestions have been put forward to optimize the quality of CPM guidelines, which were clarifying the target users and scope of CPM guidelines, establishing an open and transparent mechanism of the personnel involvement and process steps, and formulating implementable and operable recommendations for the use of CPM.

4.
China Pharmacy ; (12): 1-9, 2024.
文章 在 中文 | WPRIM | ID: wpr-1005205

摘要

OBJECTIVE To explore the whole-process pharmaceutical care model of iodine contrast medium and promote the rational clinical use of iodine contrast medium. METHODS Clinical Professional Committee on Rational Drug Use of China Medical Education Association and Expert Committee on Drug Evaluation and Clinical Research of Guangdong Pharmaceutical Association organized domestic experts to establish a working group on the Consensus on the whole-process pharmaceutical care for iodine contrast medium. The working group conducted literature searches, evidence-based analysis, and discussions on the development process, indications, contraindications, adverse drug reactions, drug interactions, drug use for special population, pharmaceutical care, and other key topics to summarize the content and process of the whole-process pharmaceutical care for iodine contrast medium. This consensus was ultimately formed. RESULTS The consensus on whole-process pharmaceutical care for iodine contrast medium included an evaluation of the patient, renal function, combined drug use, and hydration regimen before examination, the presence of contrast agent extravasation or suspected acute adverse reactions during examination, observation time points and follow-up after examination, and the presentation of specific work in each stage through pharmaceutical care flowchart. The medication monitoring record form was also formed to record the work situation. CONCLUSIONS The consensus has established a whole-process pharmaceutical care system for iodine contrast medium, providing scientific evidence for clinical physicians and nursing staff in the rational use of such special drugs, and also serving as a reference for pharmacists in providing related pharmaceutical care.

5.
文章 在 中文 | WPRIM | ID: wpr-1005366

摘要

Recommendations for Chinese patent medicine (CPM) based on key information on rational drug use are one of the important conditions for enhancing guideline enforceability as well as facilitating guideline implementation. In this study, we discussed in detail of the key information on the rational use of CPM in five aspects, which are dosage, drug discontinuation, drug-drug and drug-food interactions, safety and economy. Following the process of multi-source search, synthesis and prioritization, it is suggested to collect key information on the rational use of CPM from a multi-source search of drug instructions, policy documents, literature, and clinical experts' experiences. Then the searched information should be summarized and prioritized with the principle that taking drug instructions as the basis and other-sources information for check and supplementation. Finally, methodological recommendations for the retrieval and synthesis of key information on rational drug use in guideline recommendations has been formed.

6.
文章 在 中文 | WPRIM | ID: wpr-1023174

摘要

Objective To establish the argatroban drug use evaluation(DUE)criteria and provide reference for the rational use of argatroban in clinical practice.Methods Based on the domestic and foreign drug instructions of argatroban,referring to relevant guidelines and literature,the DUE standard rules were established by expert consultation.Using the established standard rules,the medical records of argatroban in the Fuzhou First Hospital Affiliated with Fujian Medical University from August 2020 to August 2022 were evaluated for the rationality of medication.Results A total of 368 medical records were included,the rational rate of drug use was 48.64%,and the irrational drug use was mainly without indications(46.19%)and inappropriate combination of drugs(4.35%).Conclusion The rational rate of argatroban clinical use in the hospital is not high,and the problems mainly include off-indication drug use and unreasonable combination drug use.Through the establishment and clinical application of DUE standard rules,the clinical use of argatroban can be further standardized and the ability of rational drug use can be improved.

7.
文章 在 中文 | WPRIM | ID: wpr-1023175

摘要

Objective To establish the drug use evaluation(DUE)standards of roxadustat,and to evaluate its clinical application to promote its rational use.Methods Based on the drug labels,referring to relevant guidelines and expert consensus,the DUE criteria for roxadustat were established through the Delphi method,including items such as drug indications,drug use process and the results of medication.A retrospective study was conducted to evaluate the rationality of cases which included inpatients who used roxadustat for the first time from January 1,2020 to December 31,2022,with a medication period of more than one month in Fujian Provincial Hospital.Results A total of 175 medical records were included,of which 14 records were fully met the clinical application evaluation criteria,and the medication reasonable rate was 8.0%.The unreasonable situation were mainly manifested in the inappropriate clinical outcomes(92.0%),the inappropriate use dosages(52.6%),inappropriate monitoring of adverse reactions(34.9%),inappropriate timing of administration(13.1%),drug interactions(8.7%),inappropriate drug conversion(5.7%),inappropriate efficacy monitoring(4.0%).Conclusion The established DUE standards for roxadustat are scientific,practical and feasible,and the evaluation results show a rate of irrationality in the use of roxadustat in the hospital,and it is necessary to standardize the use of roxadustat in terms of dosage,adverse reaction monitoring,and timing of administration.

8.
文章 在 中文 | WPRIM | ID: wpr-1023176

摘要

Objective To establish evaluation of ozagrel sodium by weighted TOPSIS method so as to provide a reference for improving the rational use of ozagrel sodium.Methods Based on the drug instructions,guidelines,relevant literatures and Delphi method,the evaluation criteria for the clinical rationality of ozagrel sodium were formulated.Attribute hierarchical model(AHM)was used to assign weights to the indicators,the weighted TOPSIS method was employed to analyze and evaluate the rationality of 108 patients that discharged from the Third People's Hospital of Henan Province from January 2021 to April 2022.Results The reponse rates of two rounds of expert advice questionnaires were 100%,the authoritative coefficients(Cr)were 0.85,0.83(>0.70),and the experts fully affirmed the items of the standard.Among the 108 cases evaluated,37 cases(34.26%)were judged to be reasonable,52 cases(48.15%)were judged to be basically reasonable and 19 cases(17.59%)were judged to be unreasonable.The main unreasonable problems were manifested in indications,the timing of administration,drug course and monitoring of efficacy and laboratory parameters.Conclusion The method of DUE of ozagrel sodium based on weighted TOPSIS is more comprehensively and intuitively.The application of ozagrel sodium in the hospital is relatively standardized,but there are problems in the course of medication,indications,and timing of administration.So it is necessary to promote the rational use by strengthening the cooperation between pharmacists and physicians,and improving pharmaceutical intervention.

9.
文章 在 中文 | WPRIM | ID: wpr-1023177

摘要

Objective To establish the drug use evaluation(DUE)standard of fibrinogenase for injection and provide a reference for the rational clinical application of fibrinogenase for injection.Methods Based on the specification of fibrinogenase for injection,the DUE standard was established from three aspects:drug indication,drug process and drug results,with reference to relevant guidelines and literature,and through discussion with clinical experts.A retrospective survey was conducted to evaluate the inpatients using fibrinogenase for injection from January 2021 to December 2021 in Ningde Hospital of Traditional Chinese Medicine,Fujian Province.Results A total of 256 patients were included,with a medication reasonable rate of 61.72%.The irrational use of drugs was mainly including the inappropriate usage and dosage(3.91%),off-label medication(1.95%),no skin test(8.98%),too long or inadequate course of medication(25.00%).Conclusion The DUE standard established of fibrinogenase for injection is scientific,practical and feasible.The use of fibrinogenase for injection in contraindications and high blood coagulation state,and off-label medication can be further optimized.

10.
文章 在 中文 | WPRIM | ID: wpr-1023181

摘要

Objective To investigate the clinical application of perioperative human serum albumin(HSA)in cardiac surgery in multiple regions in China,and to evaluate the rationality of its clinical application in conjunction with the clinical guidelines,in order to provide a reference for promoting the rational application of HSA.Methods The medical records of patients who underwent cardiac surgery from April to June 2019 in eight hospitals across the country were retrospectively collected.The statistical information on patients'general information,the dosage,course of treatment,and cost of HSA,and the serum albumin level before and after medication was analyzed to evaluate the use of HSA.Relevant evaluation criteria were established,and the rationality of its medication was evaluated.Results Data from a total of 449 patients were included for analysis,the appropriate rate of medication was 81.1%.The course of medication was mostly>2-5 days and the total amount of HSA was mostly 50-99 g.The main purpose of medicaiton were improving colloid osmotic pressure,reducing exudation to improve interstitial edema,postoperative volume expansion.Conclusion Clinical attention should be paid to ensure the rational application of HSA in cardiac surgery during the perioperative period and prevent the abuse of blood products.

11.
文章 | IMSEAR | ID: sea-217912

摘要

Background: Urinary tract infections (UTIs) are one of the commonly encountered infections and a large number of drugs are indicated in UTI ranging from oral conventional drugs to most advanced injectable drugs. Cost-minimization analysis (CMA) is employed to project the least costly drug when two treatments are shown to be therapeutic equivalents. Aims and Objectives: This study aims to perform a CMA at a tertiary care center to determine the least expensive drug for UTI and to project a cheapest alternative from available options based on the results of CMA. Materials and Methods: This was a cross-sectional study conducted over duration of 3 months in the clinical departments on patients diagnosed to have UTI and prescribed empirical antimicrobial treatment. The approval of Institutional Ethics Committee was sought before beginning the study. Pattern of drug prescription and average cost incurred in the treatment of patients with empirical antimicrobial therapy was calculated. CMA included the projection of the least expensive drug based on average cost incurred per patient in outpatients and inpatients respectively. Results: A total of 59 patients of UTI given empirical treatment were included in the study. Fluoroquinolones and cephalosporins were commonly used drugs for empirical treatment of UTI. Nitrofurantoin (average cost of 11–14 Rs. per patient) can be projected as the cheapest drug for empirical treatment of UTI on outpatient basis as well as a drug to supplement injectables in indoor patients. Injectable ciprofloxacin can be projected as the most inexpensive alternative for empirical treatment of UTI in patients of the inpatient department. Conclusion: Nitrofurantoin for oral treatment and ciprofloxacin in injectable form are cheapest among available alternatives for empirical treatment of UTI. To prevent treatment failures and increase in cost of treatment, correlation of results of CMA with local antimicrobial sensitivity pattern is important.

12.
China Pharmacy ; (12): 86-90, 2023.
文章 在 中文 | WPRIM | ID: wpr-953724

摘要

OBJECTIVE To establish evaluation criteria for rational drug use of atosiban in clinic, and to provide reference for rational drug use of atosiban in clinic. METHODS Based on the drug instructions of atosiban acetate injection and related guidelines, the experts of the Evaluation Group of Rational Drug Use formulated the evaluation criteria of rational drug use, including 5 primary indexes and 8 secondary indexes. The weight coefficients of secondary indexes were calculated by analytic hierarchy process (AHP), and the use of atosiban acetate injection in 190 pregnant women from the Third Affiliated Hospital of Guangzhou Medical University (referred to as “our hospital”) was evaluated retrospectively by technique for order preference by similarity to an ideal solution (TOPSIS). The evaluation results were divided into three levels including reasonable, basic reasonable and unreasonable application based on the relative approach degree. RESULTS Among 190 pregnant women, 49 (25.8%) were treated with atosiban reasonably, 39 (20.5%) were treated with atosiban basic reasonably, and 102 (53.7%) were treated with atosiban unreasonably. The evaluation results obtained by AHP-TOPSIS method were consistent with the actual situation in clinic. The main problems of the unreasonably use were super indications, unreasonable usage and dosage, over the course of treatment and the lack of proper economic consideration. CONCLUSIONS The rationality evaluation criteria of atosiban’s clinical application are established by AHP-TOPSIS method; the evaluation results obtained by this method are quantifiable, scientific and reliable. The unreasonable use of atosiban is common in our hospital, and the management should be strengthened in clinical application.

13.
China Pharmacy ; (12): 370-375, 2023.
文章 在 中文 | WPRIM | ID: wpr-961675

摘要

OBJECTIVE To quantitatively and qualitatively analyze the progress of potentially inappropriate medication (PIM) research by means of bibliometrics, and to predict the hotspots and trends of PIM, so as to provide reference for PIM research in China. METHODS The research literature related to PIM were searched from Web of Science core database, and the publication trend of the literature was analyzed on the bibliometric online analysis platform and CiteSpace 5.8.R3 software. The research results were visualized and analyzed, and the research hotspots of PIM were summarized through gCLUTO. RESULTS About PIM research, the annual number of the literature issued from 2012 to 2021 showed a continuous growth trend totally; the United States had the largest number of literature (241 pieces); the University of Sydney in Australia was the research institution with the largest number of literature (59 pieces); O’Mahony D from University College Cork, Ireland, published the most literature (23 pieces); the research of PIM involved 57 disciplines, among which there was the largest number of literature about gerontology (384 pieces); International Journal of Clinical Pharmacy was the journal with the largest number of literature (61 pieces); Journal of the American Geriatrics Society was cited most frequently (1 197 times). The hotspots of PIM research mainly focused on seven aspects: the standard of PIM, the safety and economy research of PIM, the risk factors research of PIM, the PIM research of chronic patients, the PIM research of antipsychotics, the research of pharmacists’ participation in PIM management, and the PIM research about palliative care of tumor patients. CONCLUSIONS The heat of research on PIM has been on the rise, and there is little cooperation between countries and institutions, and more cooperation is needed. In the future, the focus of Chinese pharmacists’ research on PIM may be on the deep localization of PIM standards, PIM intervention and precise medication guidance, and PIM management of specific diseases and drugs.

14.
China Pharmacy ; (12): 1172-1176, 2023.
文章 在 中文 | WPRIM | ID: wpr-973614

摘要

OBJECTIVE To explore the construction of a new scientific management model for temporary drug purchase,and to provide a reference for hospitals to improve the level of rational drug use. METHODS Guided by clinical diagnosis and treatment needs and patient medication safety, our hospital carried out the whole process management practice of temporarily purchased drugs by optimizing the review process, creating a review team, formulating pre-audit and post follow-up evaluation standards based on comprehensive drug evaluation, and evaluated the practice effect through the number of temporary purchase applications, implementation rate, drug structure optimization and other indicators. RESULTS Since January 2021, our hospital had implemented a new mode of temporary drug purchase management. By December 2022, clinical pharmacists had reviewed 111 temporary drug procurement applications, effectively intercepted 13 irrational drug use applications (11.71%), reduced the overall implementation rate of temporary drug procurement by 8.36%,and proposed five batches of drug structure optimization suggestions; 24 drugs were successively introduced such as camrelizumab,sorafenib,busulfan. After optimizing the management mode,the number of temporary drug procurement applications decreased by more than half from 133 in 2019 and 138 in 2020 to 66 in 2021 and 45 in 2022. CONCLUSIONS The model is helpful to optimize the hospital drug catalog, strengthen rational drug use,ensure the safety of patients’ drug use, and fully reflects the professional value of clinical pharmacists in hospital pharmacy management and rational drug use.

15.
China Pharmacy ; (12): 1237-1241, 2023.
文章 在 中文 | WPRIM | ID: wpr-973626

摘要

OBJECTIVE To explore the effects of posaconazole combined with proton pump inhibitors (PPI) on the blood concentration and the risk of invasive fungal disease (IFD) in patients with malignant hematological disorder. METHODS In accordance with the random number table method, 40 patients with malignant hematological disorders who were admitted to the hematology department of our hospital between December 2020 and December 2021 were chosen and divided into control group (20 cases) and observation group (20 cases). The control group received Posaconazole oral suspension alone, while the observation group received Posaconazole oral suspension combined with PPI. The incidence of IFD, attainment rate of blood concentration, the time from the start of prophylaxis to IFD onset, the fatality associated with IFD, treatment of infected patients, and blood concentrations of posaconazole on 7th, 14th, 21st, and 28th day after posaconazole application were compared between 2 groups; the occurrence of adverse events during drug administration in the two groups was recorded. RESULTS The study was stopped because 2 patients in the observation group and 9 patients in the control group received hospital departures after taking posaconazole for fewer than 7 days. The incidence of IFD in the observation group was significantly higher than control group, and the attainment rate of blood concentration in the observation group was significantly lower than control group (P<0.05). There was no significant difference in the time from the start of prophylaxis to IFD onset, the fatality associated with IFD, treatment of infected patients and the incidence of adverse events (P> 0.05). The blood concentration of posaconazole in the observation group was significantly lower than control group on 7th day of medication (P<0.05); there was no significant in blood concentration of posaconazole between 2 groups on the 14th day of medication (P>0.05). CONCLUSIONS Posaconazole combined with PPI can reduce the blood concentration of patients with malignant hematological disorders, increase the risk of IFD. Clinical practice should try to avoid the combination of the two or use them under the guidance of therapeutic drug monitoring.

16.
China Pharmacy ; (12): 1374-1378, 2023.
文章 在 中文 | WPRIM | ID: wpr-974688

摘要

OBJECTIVE To provide reference for rational clinical use of mepolizumab. METHODS The reporting odds ratio method and Bayesian confidence propagation neural network method were used to conduct signal mining and analysis of adverse drug event (ADE) reports related to mepolizumab in the United States Food and Drug Administration Adverse Event Reporting System from the first quarter of 2016 to the third quarter of 2022. RESULTS A total of 57 501 ADE reports were extracted with mepolizumab as the primary suspect drug, involving 16 358 patients. Among these reports, the proportion of males (23.51%) was lower than females (50.48%). The reporting countries were primarily the United States (51.91%) and Canada (29.94%). Consumers (71.18%) constituted the main reporting population. A total of 172 ADE-positive signals were identified, mainly involving 13 system organ classes such as the respiratory, thoracic and mediastinal disorders (41.63%), as well as infectious and parasitic diseases (14.16%). There were 60 high-risk signals, including 15 that were explicitly mentioned or related to adverse reactions in the drug instructions of mepolizumab and 45 signals (such as asthmatic crisis, sputum discoloured, purulent sputum, sleep disorder due to a general medical condition) were newly identified high-risk signals. Among them, 11 high-risk signals exhibited gender or age differences. CONCLUSIONS When clinically using mepolizumab, in addition to the adverse reactions mentioned in the drug instruction, special attention should also be given to changes in the nature of sputum, painful respiration, and sleep disorders.

17.
China Pharmacy ; (12): 1547-1554, 2023.
文章 在 中文 | WPRIM | ID: wpr-977840

摘要

At present, many antidepressant drug categories have been marketed in China, but still lack a scientific and standardized system for drug comprehensive clinical evaluation. To guide and promote medical institutions to standardize the comprehensive clinical evaluation of antidepressant drugs, 19 clinical, pharmacy and evidence-based medicine experts from China were organized by the China Population Welfare Foundation to evaluate 11 drugs in 5 categories, including sertraline/escitalopram/ paroxetine/fluvoxamine/citalopram/fluoxetine/venlafaxine/duloxetine/vortioxetine/agomelatine/mirtazapine, through seminars and interviews, concerning clinical real-world data and evidence-based medicine, and to form the first draft of Expert Consensus on Comprehensive Clinical Evaluation of Antidepressant drugs, which is finalized after peer review by 18 clinical and pharmacy experts. The evaluation system of this expert consensus adopts the quantitative evaluation system of percentile and carries out a systematic evaluation from 6 dimensions of effectiveness, safety, economy, suitability, accessibility and innovativeness, while the evaluation dimensions are more detailed, with the operability of the drug evaluation system and the characteristics of drugs in the field of antidepressants. It aims to provide a theoretical basis for the rational use of drugs in the field of psychiatric disorders in medical institutions and help improve the quality of pharmacy services to better meet the needs of the people for medication.

18.
China Pharmacy ; (12): 1646-1650, 2023.
文章 在 中文 | WPRIM | ID: wpr-977858

摘要

OBJECTIVE To further improve the rational drug use control mechanism based on performance appraisal, explore new paths of pharmaceutical care and promote the rational clinical drug use management to deepen development. METHODS The reform of pharmaceutical management system in our hospital was performed through implementing the “ten-point system of prescription behavior management”, supplemented by the two carriages of “strengthening prescription review” and “standardizing clinical medication”. By implementing a number of auxiliary measures such as man-machine integration pre-prescription review, improving pharmacists’ prescription review ability, optimizing prescription review mechanism in real time, regulating physicians’ off-label drug use behavior, and improving drug evaluation mechanism, pre-control and in-process intervention were completed. The evaluation results were incorporated into performance assessment by referring to the “ten-point system of prescription behavior management”, so as to realize multi-dimensional and fully closed-loop rational drug use management. The effects of management were evaluated by comparing the statistical results of related indexes before and after the management. RESULTS Compared with before management, irrational rate of prescriptions and medical orders in our hospital in 2022 decreased significantly, compared to the same period in 2020; the irrational rate of inpatient medical orders decreased from 5.00% in 2020 to 2.69% in 2022, and that of outpatient prescriptions decreased from 4.59% to 2.48%; the frequency of communication between clinical pharmacists and physicians increased; the times of clinical consultations increased from 16 to 58, and doctors’ acceptance of intervention for irrational drug use had improved from 52% to 87% ; physicians had a deeper understanding and recognition of clinical pharmaceutical care, the awareness of clinical rational drug use had been significantly improved. CONCLUSIONS The rational drug use control mechanism guided by performance appraisal further standardizes the issuance of prescriptions and medical orders, and makes physician-pharmacist cooperation more prominent, so as to realize the closed-loop pharmaceutical management of “pre- review, in-process supervision and post-evaluation”, and promote rational drug use in clinical practice.

19.
文章 在 英语 | WPRIM | ID: wpr-982314

摘要

OBJECTIVES@#Metformin is the basic drug for treating diabetes, and the plateau hypoxic environment is an important factor affecting the pharmacokinetics of metformin, but there have been no reports of metformin pharmacokinetic parameters in patients with diabetes mellitus type 2 (T2DM) in the high-altitude hypoxic environment. This study aims to investigate the effect of the hypoxic environment on the pharmacokinetics and assess the efficacy and safety of metformin administration in patients with Type 2 diabetes mellitus (T2DM).@*METHODS@#A total of 85 patients with T2DM taking metformin tablets in the plateau group (n=32, altitude: 1 500 m) and control group (n=53, altitude: 3 800 m) were enrolled according to the inclusion and exclusion criteria, and 172 blood samples were collected in the plateau group and the control Group. A ultra-performance liquid chromatography/tandem mass spectrometry (UFLC-MS/MS) method was established to determine the blood concentration of metformin, and Phoenix NLME software was used to establish a model of pharmacokinetics of metformin in the Chinese T2DM population. The efficacy and serious adverse effects of metformin were compared between the 2 groups.@*RESULTS@#The population pharmacokinetic modeling results showed that plateau hypoxia and age were the main covariates for model building, and the pharmacokinetic parameters were significantly different between the plateau and control groups (all P<0.05), including distribution volume (V), clearance (CL), elimination rate constant (Ke), half-life(T1/2), area under the curve (AUC), time to reach maximum concentration (Tmax). Compared with the control group, AUC was increased by 23.5%, Tmax and T1/2 were prolonged by 35.8% and 11.7%, respectively, and CL was decreased by 31.9% in the plateau group. The pharmacodynamic results showed that the hypoglycaemic effect of T2DM patients in the plateau group was similar to that in the control group, the concentration of lactic acid was higher in the plateau group than that in the control group, and the risk of lactic acidosis was increased after taking metformin in the plateau population.@*CONCLUSIONS@#Metformin metabolism is slowed down in T2DM patients in the hypoxic environment of the plateau; the glucose-lowering effect of the plateau is similar, and the attainment rate is low, the possibility of having serious adverse effects of lactic acidosis is higher in T2DM patients on the plateau than on the control one. It is probably suggested that patients with T2DM on the plateau can achieve glucose lowering effect by extending the interval between medication doses and enhancing medication education to improve patient compliance.


Subject(s)
Humans , Diabetes Mellitus, Type 2/drug therapy , Metformin/therapeutic use , Acidosis, Lactic , Tandem Mass Spectrometry , Hypoxia , Glucose
20.
China Pharmacy ; (12): 513-519, 2023.
文章 在 中文 | WPRIM | ID: wpr-964757

摘要

OBJECTIVE To compare the clinical comprehensive value of 15 Chinese patent medicines for the treatment of chronic hepatitis B, in order to provide reference for clinical rational drug use. METHODS According to the Management Guidelines for Clinical Comprehensive Evaluation of Pharmaceuticals (2021 Version for Trial Implementation), systematic literature review, meta-analysis and other related data analysis methods were used to perform qualitative and quantitative analysis for the safety, efficacy, economy, suitability, accessibility and innovation of 15 Chinese patent medicines. RESULTS In terms of safety, most of the adverse drug reactions of chronic hepatitis B Chinese patent medicines before the market were unobserved or unclear; post-marketing safety took nucleoside analogs as the intermediate bridge for meta-analysis, there was no significant difference in the incidence of adverse drug reactions among the combined regimens of Chinese patent medicines (P>0.05), except that the combination regimen of Fuzheng huayu capsule, Compound yiganling capsules versus combination regimen of Jiuwei gantai capsules showed statistically significant differences (P<0.05). In terms of effectiveness, the results of network meta-analysis showed that most Chinese patent medicines, such as Fuzheng huayu capsules combined regimens, had no significant differences in effective rate, HBeAg negative conversion rate and HBV-DNA negative conversion rate (P>0.05); however, in reducing the liver elastic hardness value, the combined regimen of Dangfei liganning tablet (capsule) was better than the other combined regimens (P<0.05). In terms of economy, the highest cost was the Shuganning injection, and the lowest was Hepatitis B qingre jiedu granules. In terms of suitability, most of the medicines were capsules, tablets and granules, which only needed to be sealed to store and taken orally or taken with boiling water. Compared with injections and some similar products that required strict control of storage temperature, its suitability was better. In terms of accessibility, from the perspective of drug price and affordability, Shuganning injection had the highest average daily cost, the number of days that needed to be borne by the average daily wage was the highest; the average daily cost of Compound yiganling tablets was the lowest, and the number of days required to be borne by the average daily wage was the lowest. From the perspective of availability, Compound biejia ruangan tablets, Dangfei liganning capsules and Wuzhi granules were easier to obtain. In terms of innovation, the 15 Chinese patent medicines included in the study were all domestically produced medicines with a relatively long-term theoretical basis of traditional Chinese medicine and experience in human medicine, and had good industrial innovation. Among them, Compound huayu tablets (capsules) and Anluo huaxian pills were protected varieties of traditional Chinese medicine; Fuzheng huayu tablets (capsules) with more patents had 6 valid patents, all of which were patents for invention. CONCLUSIONS Wuzhi capsule, Sedum sarmentosum granules, Compound yiganling tablets, Rhubarb buchong pills and Dangfei liganning capsules have high clinical comprehensive value.

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