摘要:The prevalence of diabetes in China is increasing year by year, and has become a health issue of close concern to the whole society. Glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1RA), as a new class of glucose-lowering drugs, is now widely used in the treatment of type 2 diabetes mellitus (T2DM) because of its significant glucose-lowering efficacy and low risk of hypoglycemia. As the level of evidence for its effects on improving cardiovascular system and renal protection and reducing body mass continues to improve, its status in the treatment guidelines for T2DM is gradually increasing. Currently, nine GLP-1RA drugs have been approved for the clinical treatment of T2DM in China. Although all of these drugs exert hypoglycemic effects based on the activation of GLP-1 receptors in the body, the differences in their own structures and natural GLP-1 amino acid homology lead to large differences in pharmacokinetic parameters and clinical efficacy among different analogs. In order to enable clinicians and pharmacists to have a full understanding of the characteristics and clinical evidence of these analogs and to better perform their therapeutic effects, Liaoning Provincial Pharmaceutical Society organized clinical medicine and pharmacy experts to develop a medication guide for nine GLP-1RA drugs to provide a reference for clinical medication needs and promote rational and standardized use by compiling and summarizing the pharmacological characteristics, clinical applications, adverse reactions, interactions, the medications in special populations and medication management.
关键词:glucagon-like peptide-1 receptor agonists;rational drug use;medication guideline
摘要:OBJECTIVETo provide suggestions and reference for enriching the selection of anti-infective medicines for children in China and promoting the establishment of the Essential Medicine List for Children in China.METHODSDescriptive analysis method was used to statistically compare the differences and similarities of anti-infective medicines included in the World Health Organization Model List of Essential Medicines for Children (EMLc), World Health Organization Model List of Essential Medicines (EML) and National Essential Medicine List (NEML) in terms of drug category, variety, dosage form, specification, symbol mark, etc.RESULTSAll anti-infective medicines of EMLc were covered by EML (85.3%). NEML lacked the information of anti-infective medicines relatively, and contained few new categories; for example, the third-generation and above cephalosporins in EMLc were not included, and the drug dosage forms were also relatively limited (mainly tablets, capsules and injections), but the specifications were relatively rich.CONCLUSIONSWith reference to EMLc, the guidance on the use of essential medicines for children in China should be added from the aspects of age, body weight, combined medication, etc., and the dosage forms suitable for children such as oral liquid preparations and scored tablets should be added to NEML; when updating the NEML the newer drugs suitable for children such as cefixime and dacatavir should be included. Finally, with reference to the continuity of EML and EMLc, the Essential Medicine List for Children in China should be established based on NEML to meet the drug needs of children and promote the safe use of drugs in children.
关键词:Essential Medicine List;medicine use of children;WHO
摘要:OBJECTIVETo construct the drug clinical comprehensive evaluation index system and quantitative grading in China, and to provide a reference for scientifically carrying out comprehensive clinical evaluation of drugs.METHODSThe analytic hierarchy model was used to establish the drug clinical comprehensive evaluation index system, the weight of the evaluation index and the quantitative grading of each index were determined through expert consultation and model calculation.RESULTSThe results of expert consultation were integrated by using the analytic hierarchy model, and the drug clinical comprehensive evaluation index system was obtained: including six first-level indicators of effectiveness, safety, economy, suitability, accessibility and innovation, as well as twenty-three second-level indicators of recommended status, medication for special populations, and drug treatment costs; the weight of each indicator was calculated through estimation-matrix method.CONCLUSIONSThe analytic hierarchy model can construct the drug clinical comprehensive evaluation index system and quantitative grading in China, which can provide methodological references for comprehensive analysis and decision-making, thus making the clinical comprehensive evaluation of drugs completer and more scientific.
摘要:OBJECTIVETo analyze the public participation mechanism of National Institute for Health and Care Excellence (NICE) health technology assessment in England and to provide experience for the dynamic adjustment of Chinese medical insurance catalog.METHODSBy retrieving related literature and official websites, types and mechanisms of public participation (management organization, selection method, participation mode, evaluation feedback) in NICE health technology assessment were analyzed comprehensively; and based on this, suggestions were put forward to adjust the public participation in Chinese medical insurance catalog. RESULTS &CONCLUSIONSThe current public participation types of NICE health technology assessment were patient and carer organizations, HTA committee lay members, patient expert and public observers. At the management level, NICE has set up a public participation team and made guidelines on public participation matters. For different public participation types, NICE has established different selection procedures, such as expression of interest, NICE invitation, open recruitment, nomination, NICE decision, etc. The public participation types are various and in the whole assessing process from the initial determination of the scope of the health technology assessment to the final appeal. Also, NICE has established a flexible and dynamic evaluation feedback system to optimize the way of public participation and the health technology assessment process; NICE has undertaken extensive international cooperation and exchanges to promote public participation at the national and international levels. It is suggested that our country should combine the national conditions, clarify the channel of public participation in health technology evaluation, set up a working group of public participation affairs, strengthen patients’ participation in evaluation and feedback, improve decision-making transparency, and improve the public participation mechanism of health technology evaluation from the aspects of channel opening, management mechanism, evaluation feedback, information disclosure and so on.
关键词:public participation;National Institute for Health and Care Excellence in England;enlightenment
摘要:OBJECTIVETo explore the influential factors for “Internet +” prescription circulation and construction specifications of prescription circulation platform, so as to provide reference for the government to formulate relevant policies and standardized construction of prescription circulation platform.METHODSStakeholders in the process of prescription circulation service in medical institutions in Sichuan province were selected to conduct key insider interviews, and grounded theory was used to analyze the data.RESULTSThe influential factors of prescription circulation could be divided into three aspects: participant factor, administrative decision factor and information technology factor. The influential factors of prescription circulation mainly lay in pharmacy admission and withdrawal mechanism, medical insurance reimbursement service, supporting policies and pharmaceutical care ability. In terms of pharmacy admission and withdrawal mechanism, pharmacy qualification, pharmaceutical service personnel, drug allocation and distribution should be considered to unify pharmacy admission standards; in terms of medical insurance reimbursement service, it should actively connect with social pharmacies to realize the transfer of prescription medical insurance reimbursement from designated pharmacies; in terms of supporting policies, it should pay attention to the construction of the top-level design of prescription circulation; in terms of pharmaceutical care ability, regular training and assessment of licensed pharmacists should be performed in drug consultation, prescription review and other pharmaceutical care.CONCLUSIONSParticipants have more influence on prescription circulation, and pharmacy admission and withdrawal mechanism and pharmaceutical care ability need to be improved. There are various types of prescription circulation platform construction, but each has its own advantages and disadvantages. It is suggested that relevant government departments should improve the access threshold of pharmacies, follow up medical insurance reimbursement services and supporting policies, and explore ways to improve pharmaceutical care capacity, leading and issuing relevant policies and measures to promote the prescription circulation service and make the “Internet +” prescription circulation develop in an orderly manner.
关键词:pharmacy admission and withdrawal;medical insurance reimbursement;phar- maceutical care
摘要:OBJECTIVETo construct a comprehensive evaluation index system for anti-lung cancer drugs, and to provide a basis for drug selection and rational clinical use.METHODSBased on the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs (2021 edition for trial use), a preliminary evaluation index system framework and an index preselection pool were initially formulated through literature analysis. The evaluation indices were then selected and modified by using the Delphi method. The weights of each index were determined through expert scoring and relevant calculations, thereby establishing a comprehensive evaluation index system for anti-lung cancer drugs. Referred to Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions, scoring detailed rules for clinical comprehensive evaluation indexes of anti-lung cancer drugs were formulated. The constructed comprehensive evaluation index system and scoring detailed rules were applied to conduct empirical evaluation of the anti-lung cancer drug pembrolizumab.RESULTSThe constructed comprehensive evaluation index system for anti-lung cancer drugs included 6 primary indicators and 15 secondary indicators. The weights of the primary indicators were as follows: safety (18), efficacy (38), economy (15), innovation (9), suitability (10), and accessibility (10). The scoring detailed rules for the comprehensive evaluation index system for anti-lung cancer drugs had been preliminarily established. The results of empirical evaluation showed that the comprehensive evaluation score (61 points) of pembrolizumab combined with chemotherapy regimen was higher than that of the monotherapy chemotherapy regimen (56 points). The former demonstrated superior efficacy, innovation and suitability compared to the latter, while the latter exhibited better safety and economy.CONCLUSIONSThe constructed comprehensive evaluation index system for anti-lung cancer drugs has the potential for generalizability and practical application, providing a reference basis for rational clinical drug use.
摘要:OBJECTIVETo study the repair effect and mechanism of Zhixu burn ointment on deep second-degree burned model rats.METHODSThe deep second-degree burned model was established with a temperature-controlled apparatus. The model rats were randomly divided into model group, Jingwanhong ointment group and Zhixu burn ointment high-dose, medium-dose and low-dose groups (specifications were 20 g core+20 mL wetting agent, 10 g core+20 mL wetting agent, 5 g core+20 mL wetting agent, respectively). Another blank control group (only dehairing treatment, no modeling) was set up, with 10 rats in each group. The rats in each administration group were given corresponding drugs, the rats in the blank control group were not treated, and the rats in the model group were given normal saline once a day for 21 d. The healing of burn wounds and histomorphological changes of burned skin in each group of rats were observed, and the healing rate of wounds was calculated; the levels of vascular endothelial growth factor (VEGF), interleukin-1β (IL-1β), IL-6 and tumor necrosis factor-α(TNF-α) in the wound skin tissue of rats were detected by enzyme-linked immunosorbent assay; immunohistochemical method was used to detect the expression levels of VEGF and platelet endothelial cell adhesion molecule-1 (CD31) protein in burned skin tissue.RESULTSCompared with model group, the wound area of the rats in the Jingwanhong ointment and Zhixu burn ointment groups gradually decreased and healed significantly by day 21, and the wound healing rate was significantly higher (P<0.05 or P<0.01); thicker new epidermal layer was seen in the skin tissue, and connective tissue and new blood vessels were significantly increased in the dermis; the expression levels of IL-1β, IL-6 and TNF-α were significantly decreased (P<0.05 or P<0.01), and the expression levels of VEGF and CD31 protein were significantly increased (P<0.05 or P<0.01) in the burned skin tissue.CONCLUSIONSZhixu burn ointment can repair the skin of deep second-degree burned model rats, and the mechanism may be related to reducing the inflammatory response of burn wound and promoting the angiogenesis.
摘要:OBJECTIVETo study the effects of Yishen daluo decoction on inflammatory factors and cyclic adenosine monophosphate(cAMP)/protein kinase A (PKA)/cAMP response element binding protein (CREB) signal pathway in experimental autoimmune encephalomyelitis (EAE) model mice by inhibiting the expressions of β-arrestin1, and to explore the mechanism of Yishen daluo decoction in the treatment of EAE.METHODSSixty mice were randomly divided into normal group, model group, TCM group (Yishen daluo decoction 20 g/kg), positive control group (prednisone acetate 3.9 mg/kg), β-arrestin1 siRNA adeno-associated virus (AAV-β) group, AAV-β+TCM group, with 10 mice in each group. Except for normal group, EAE model was made in other groups. AAV-β group and AAV-β+TCM group were injected with AAV-β via tail vein to interfere with the expression of β-arrestin1 protein. Starting from the 8th day of modeling, they were given corresponding drug solution/normal saline intragastrically, once a day, for consecutive 14 days. The neurological function score of mice was detected; the pathological and morphological changes were observed in the brain and spinal cord tissues of mice; the serum levels of inflammatory factors [interleukin-2 (IL-2), IL-23, interferon-γ (IFN-γ)] in mice were determined; the expressions of β-arrestin1, cAMP, PKA and CREB in brain and spinal cord were detected.RESULTSCompared with normal group, neurological function scores, serum levels of inflammatory factors, and protein expressions of β-arrestin1 in brain and spinal cord were significantly increased (P<0.05 or P<0.01); protein expressions of PKA, CREB and cAMP in brain and spinal cord were decreased significantly(P<0.05 or P<0.01). The deep staining of cellular shrinkage and aggregation of inflammatory cells were observed in most neurons of the brain and spinal cord, with varying degrees of demyelinating. Compared with model group, the neurological function scores, pathological changes in brain and spinal cord tissues, and most indicators (except for CREB and cAMP proteins in the brain tissue of AAV-β group) were significantly reversed (P<0.05 or P<0.01). Compared with AAV-β group, the neurological function scores, the levels of IFN-γ in serum and β-arrestin1 in spinal cord were significantly decreased (P<0.05 or P<0.01), PKA and cAMP in brain and spinal cord tissues were significantly increased in AAV-β+TCM group (P<0.05 or P<0.01).CONCLUSIONSYishen daluo decoction can inhibit the expression of β-arrestin1 in the central nervous system thus activating the cAMP/PKA/CREB signaling pathway, relieving nervous system inflammation, and ultimately alleviates the symptoms of EAE.
关键词:experimental autoimmune encephalomyelitis;β-arrestin1;protein kinase A;cAMP response element binding protein;inflammatory factor
摘要:METHODSAMI model of SD rats was established by ligating anterior descending branch of left coronary artery. Fifty model rats were randomly divided into model group (0.8% carboxymethyl cellulose solution), positive control group (Compound danshen tablet, 300 mg/kg), B. balsamifera total flavonoids low-dose, medium-dose and high-dose groups (3, 10, 30 mg/kg), with 10 rats in each group. Other 10 rats were included in sham operation group (0.8% carboxymethyl cellulose solution). After 1 day of surgery, they were given relevant medicine 3 mL/kg intragastrically, once a day, for 4 consecutive weeks. The changes of S-T segment were recorded before and after operation, after weekly intragastric administration. The hemodynamic indexes of rats were all determined, i.e. systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), left ventricular systolic pressure (LVSP), left ventricular end diastolic blood pressure (LVEDP), maximal left ventricular pressure rising rate (+LVdp/dtmax), maximal left ventricular pressure decreasing rate (-LVdp/dtmax). The levels of serum myocardial enzymes [lactate dehydrogenase (LDH), creatine kinase isoenzyme-MB (CK-MB)] and inflammatory factors [tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), IL-1β] were determined. The myocardial infarction rate of rats and the phosphorylation levels of phosphoinositide 3-kinase (PI3K) and protein kinase B (Akt) proteins in myocardial tissue were determined. RESULTS Compared with model group, S-T segments of electrocardiogram were all decreased significantly in administration groups (P<0.05). SBP, DBP, MAP, LVSP, +LVdp/dtmax, -LVdp/dtmax, and ratio of p-PI3KTyr607/PI3K, p-AktThr308/Akt, p-Aktser473/Akt were increased significantly in B. balsamifera total flavonoids medium-dose and high-dose groups (P<0.05). The levels of LVEDP, serum myocardial enzymes and inflammatory factors, myocardial infarction rate were all decreased significantly (P<0.05). CONCLUSIONS B. balsamifera total flavonoids can improve cardiac function of AMI model rats, the mechanism of which may be associated with inhibiting the expression of inflammatory factor and activating PI3K/Akt signaling pathway.OBJECTIVETo study pharmacodynamics and potential mechanism of Blumea balsamifera total flavonoids against acute myocardial infarction (AMI) model rats.
摘要:OBJECTIVETo study active components and antitussive effect of aboveground part of Pinellia ternata (non-medicinal stems and leaves), and compare them with the underground part of P. ternata (medicinal underground tubers), providing scientific basis for the comprehensive utilization and product development of P. ternata.METHODSTLC, GC, HPLC and UPLC-MS/MS were used for qualitative and quantitative analysis of amino acids, volatile oil, total flavonoids and succinic acid from the aboveground and underground parts of P. ternata. The antitussive effects of the aboveground and underground parts of P. ternata were compared and studied through cough inducing experiment with concentrated ammonia water.RESULTSResults of TLC showed that at the corresponding positions on the chromatograms of the reference substances of P. ternata, and arginine, alanine, valine, leucine and rutin control, the aboveground and underground parts of P. ternata showed spots of the same color. Results of GC showed that the similarity among characteristic chromatograms of volatile oil from aboveground and underground parts of P. ternata was 0.767; results of HPLC and UPLC-MS/MS showed that compared with underground parts of P. ternata, the contents of succinic acid, quercetin, kaempferol and isorhamnetin increased by 0.15%, 0.15%, 0.09% and 0.03%, and aspartate content decreased by 2.5 mg/g. Pharmacodynamics results showed that compared with model control group, the cough incubation period of rats was prolonged significantly in administration groups (P<0.05), and the cough frequency within 3 min was significantly decreased (P<0.05); there was no statistical significance in the cough frequency within 3 min among administration groups (P>0.05).CONCLUSIONSThe composition of amino acids, volatile oils and total flavonoids in aboveground part of P. ternata are similar to underground part of P. ternata, while the content of aspartic acid is lower than that in underground part. The aboveground part of P. ternata can prolong the cough incubation period of rats and reduce the number of coughs, which has a certain antitussive effect, but the effect is slightly weaker than that of the underground part.
摘要:OBJECTIVETo explore the mechanism of modified Xianfang huoming decoction in the treatment of sepsis-induced liver injury from the perspective of gut microbiota and metabolites.METHODSSixty SD rats were divided into blank group (normal saline), model group (normal saline), positive control drug group (Dexamethasone tablet, 5.0 mg/kg), modified Xianfang huoming decoction high-dose, middle-dose and low-dose groups (6.0, 3.0, 1.5 g/kg, calculated by crude drug) according to equilibrium-partitioning approach of body mass, with 10 rats in each group. They were given relevant drug/normal saline 10 mL/kg, once a day, for consecutive 14 days. After the last medication, except for blank group, other groups were given intraperitoneal injection of lipopolysaccharide 10 mg/kg to induce sepsis model. Twelve hours after modeling, serum levels of inflammatory indexes in rats [interleukin-1β (IL-1β), IL-6, tumor necrosis factor-α (TNF-α)] and liver function indicators [total cholesterol (TC), triglyceride (TG), aspartate transaminase (AST), alanine transaminase (ALT)] were detected. The changes of gut microbiota and liver metabolites in rats were analyzed by 16S rRNA technology and liver metabolomics.RESULTSModified Xianfang huoming decoction could significantly improve the indexes of serum inflammatory indexes and liver function in rats with sepsis-induced liver injury (P<0.05 or P<0.01); there was a significant callback effect on the relative abundance of 11 genera of bacteria (such as Akkermansia, Lactobacillus and Bilophila) among the 5 dominant phyla(P<0.05 or P<0.01). Twelve metabolites related to liver injury caused by sepsis were identified, such as glycine cholic acid, phosphatidylcholine, taurine (P<0.05 or P<0.01), mainly involving glycerol phospholipid metabolism, purine metabolism and primary bile acid metabolism.CONCLUSIONSModified Xianfang huoming decoction can improve liver injury induced by sepsis by regulating gut microbiota and liver metabolites.
摘要:OBJECTIVETo screen the active site of Jiegu ointment in promoting fracture healing in New Zealand rabbits.METHODSThe ethanol extract of Jiegu ointment, as well as the ethyl acetate and n-butanol parts, were prepared and mixed with honey to form a plaster with appropriate viscosity. The radial fracture model of left forelimb in New Zealand rabbit was established and divided into model control group, ethanol extract group, ethyl acetate fraction group and n-butanol fraction group, with 6 rabbits in each group. Except for model control group, rabbits of all other groups were treated with corresponding polar part of Jiegu ointment for external application, for 4 weeks. The radial fracture healing of rabbits was studied by X-ray examination. Enzyme-linked immunosorbent assay was used to detect the serum levels of interleukin-6 (IL-6), tumor necrosis factor α (TNF-α), osteocalcin (OC), vascular endothelial growth factor A (VEGFA), basic fibroblast growth factor 2 (bFGF2) and alkaline phosphatase (ALP). HE staining was adopted to observe the changes of pathological morphology of rabbit fracture site, and immunohistochemical method was used to detect the protein expression of bFGF2 in fracture site of rabbits.RESULTSThe healing speed of the fracture site in the n-butanol fraction group was the fastest, followed by ethanol extract group, and the ethyl acetate fraction group was the slowest; the serum levels of TNF-α and IL-6 in n-butanol fraction group decreased the fastest, while the levels of ALP, bFGF2, OC and VEGFA increased the fastest [significant increase compared with ethanol extract group (P<0.01)]; the chondrocytes at the fracture fraction completely disappeared, forming a large number of bone marrow cavities, and the bone trabeculae in the bone marrow cavity were officially formed. The expression level of bFGF2 was also higher than ethanol extract group.CONCLUSIONSThe effect of n-butanol fraction on promoting fracture healing is more significant than ethyl acetate fraction and ethanol extract, and n-butanol fraction is the active fraction of Jiegu ointment to promote fracture healing.
摘要:OBJECTIVETo establish the ion mobility mass spectrometry method for simultaneous determination of epiberberine, berberine, coptisine, palmatine, calycosin-7-glucoside, 3,5-O-dicaffeoylquinic acid, 4,5-O-dicaffeoylquinic acid and chlorogenic acid in Jinqi jiangtang tablets.METHODSIon mobility mass spectrometry method was used. The determination was performed on Waters ACQUITY UPLC HSS T3 (2.1 mm×50 mm, 1.8 μm) with mobile phase consisted of 0.1% formic acid solution-acetonitrile (gradient elution) at the flow rate of 0.3 mL/min. The column temperature was 40 ℃, and the injection volume was 5 μL. The contents of 8 components in Jinqi jiangtang tablets were determined by scanning detection under positive and negative ion modes with an electric spray ion source, and setting ion mobility mass parameters according to the peak response of each component.RESULTSThe results showed that the linear relationship of the eight components was good within their respective ranges (r≥0.999); RSDs of precision, repeatability and stability (24 h) tests were not more than 4.0%; average recoveries were 94.6%-101.2% , RSDs were 2.6%-3.9% (n=9). The contents of the above eight components in three batches of Jinqi jiangtang tablets were 3.060-3.545, 24.50-26.74, 2.795-4.149, 1.437-2.501, 0.204-0.242, 0.950-1.281, 2.272-2.828, 7.314-7.960 mg/g, respectively.CONCLUSIONSThe established method has high sensitivity and good reproducibility, and can provide reference for the quality control of the preparation.
摘要:OBJECTIVETo explore the extraction process of volatile oil from the stems, leaves and roots of Glehnia littoralis, analyze the chemical components of the volatile oil from the stems, leaves and roots of G. littoralis, and preliminarily evaluate its in vitro antifungal activity.METHODSBased on the steam distillation method, single factor test and orthogonal experiment were conducted to optimize the extraction method of volatile oil from the stems, leaves and roots of G. littoralis. The chemical components of the volatile oil from the stems, leaves and roots of G. littoralis were identified by using gas chromatography-mass spectrometry (GC-MS) technology and their relative contents were calculated. The antifungal activity of volatile oils from the stems, leaves and roots of G. littoralis against Fusarium solani, Fusarium incarnatum, Fusarium oxysporum, Aspergillus parasiticus and Aspergillus flavus was determined by paper diffusion method.RESULTSThe optimal extraction process of G. littoralis was solid-liquid ratio of 1∶15, distillation time of 5 hours, and KCl concentration of 15%. Eleven components were identified from the volatile oil of the stems and leaves of G. littoralis, and a total of eight components were identified from the volatile oil of the roots. Ginsenethinol was a common component in the volatile oil from the stems, leaves and roots of G. littoralis, its contents in the stems and leaves, roots were 38.21% and 74.02%, respectively. The volatile oil from the stems, leaves and roots of G. littoralis had a certain inhibitory effect on F. solani, F. incarnatum, F. oxysporum, A. parasiticus and A. flavus, especially volatile oil from the stems and leaves.CONCLUSIONSThere is a significant difference in chemical components of the volatile oil between the roots, stems and leaves of G. littoralis, both of which have certain in vitro antifungal activity.
摘要:OBJECTIVETo study the quality of Codonopsis pilosula with different commodity specification grades, and to provide the data support for market transactions, scientific research and clinical use.METHODSAccording to the classification standard of commodity specification grades of C. pilosula, 17 batches of C. pilosula from different producing areas, origins and commodity specification grades were collected. The contents of tangshenoside Ⅰ, lobetyolin and atractylenolide Ⅲ were determined by HPLC. The contents of alcohol-soluble extracts were determined by hot dipping method stated in general rule 2201 of Chinese Pharmacopeia (part Ⅳ). The contents of polysaccharide were determined by phenol-sulfuric acid method (calculated by D-glucose anhydrous).RESULTSFor cultivar of C. pilosula, four specifications and three commodity grades of C. pilosula all contained tangshenoside Ⅰ and lobetyolin; Radix C. pilosula from Shanxi of China and C. pilosula from Wenxian County of China, also contained atractylenolide Ⅲ. In terms of the contents of tangshenoside Ⅰ, lobetyolin and atractylenolide Ⅲ, the content of second class was equivalent to that of first class, even better than the first class, while the content of third class was lower than that of first class and second class; the content of tangshenoside Ⅰ was the highest among the two types of wild C. pilosula. The contents of alcohol-soluble extracts and polysaccharides in first class cultivated C. pilosula were higher than those of second class, and the second class was higher than the third class; wild C. pilosula had low content of alcohol-soluble extracts and polysaccharides.CONCLUSIONSThe internal quality of C. pilosula is basically consistent with the classification standard of different commodity specification grades; the content of each indicator in first-class and second-class medicinal herb is high, making them high-quality medicinal herbs.
摘要:OBJECTIVETo evaluate the economics of serplulimab combined with chemotherapy regimens for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) from the perspective of health system in China.METHODSA partitioned survival model was constructed based on the ASTRUM-005 clinical trial and related literature data, with a model simulation time frame of 10 years and a 3-week cycle, and both cost and utility values were discounted using a 5% discount rate. The quality-adjusted life year (QALY) was used as a model output indicator and the incremental cost-effectiveness ratio (ICER) was calculated to evaluate the economics of serplulimab combined with chemotherapy regimens (serplulimab group) versus chemotherapy alone regimens (chemotherapy alone group) for the first-line treatment of ES-SCLC. One-way sensitivity analysis and probabilistic sensitivity analysis were used to verify the robustness of the results of the base-case analysis and to conduct a scenario analysis for the serplulimab patient assistance program.RESULTSThe results of the base-case analysis showed that compared with chemotherapy alone group, ICER of serplulimab group was 758 690.27 yuan/QALY, which was higher than 3 times China’s per capita gross domestic product (GDP) in 2022 as the willingness-to-pay (WTP) threshold. The results of the scenario analysis showed that compared with chemotherapy alone group, the ICER of serplulimab group was 172 275.74 yuan/QALY, which was below above WTP threshold. The one-way sensitivity analysis showed that the progress-free survival utility value, serplulimab price and so on had a significant impact on the model results. The results of the probabilistic sensitivity analysis showed that the probability of the serplulimab group being economic was 0 when the serplulimab patient assistance program was not considered, but 100% when the patient assistance program was considered.CONCLUSIONSAt a WTP threshold of 3 times China’s per capita GDP in 2022, the serplulimab group is no cost-effectiveness compared to the chemotherapy alone group; however, this result is reversed when the patient assistance program is taken into account.
关键词:extensive-stage small cell lung cancer;first-line chemotherapy;partitioned survival model;cost-utility analysis;pharmacoeconomics
摘要:OBJECTIVETo provide reference for rational clinical use of mepolizumab.METHODSThe 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.RESULTSA 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.CONCLUSIONSWhen 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.
关键词:adverse drug events;signal mining;rational drug use;adverse drug reaction
摘要:OBJECTIVETo understand the safety of Ilaprazole sodium for injection in clinical practice.METHODSFrom Jan. 1st 2019 to Feb. 29th 2020, the data of 3 926 valid hospitalized patients receiving Ilaprazole sodium for injection were collected prospectively from 5 third-level hospitals through CHPS, and the post-marketing safety analysis was performed by using retrospective multicenter single cohort study. At the same time, a nested case-control study (the ratio of trial group and control group was 1∶4) was used to confirm the baseline stability of this study cohort and the correlation between adverse reactions and Ilaprazole sodium for injection.RESULTSAmong 3 926 patients, 3 patients experienced 5 adverse drug events after using Ilaprazole sodium for injection, with the incidence of 0.076%. There was no serious adverse event, and the occurrence time was 2 days after medication; adverse drug events mainly include elevated liver function indicators (alanine transaminase, aspartate transaminase, total bilirubin), which were mild and untreated, and all adverse drug events were improved. The results of the nested case-control study showed that the trial group and the control group belonged to the same background baseline, and the occurrence of adverse drug events was more closely related to Ilaprazole sodium for injection.CONCLUSIONSThe overall safety of Ilaprazole sodium for injection is relatively high, and the occurrence of adverse events is more related to it.
关键词:retrospective study;nested case-control;safety study;adverse drug reaction;adverse drug events
摘要:OBJECTIVETo systematically evaluate the efficacy and safety of denosumab versus bisphosphonates in the treatment of osteoporosis, and to provide evidence-based reference for clinical treatment.METHODSRandomized controlled trials (RCTs) about denosumab (trial group) versus bisphosphonates (control group) in the treatment of osteoporosis were retrieved from PubMed, Embase, Medline, the Cochrane Library, Chinese Journal Fulltext Database, Chinese Science and Technology Journal Database, Wanfang database from January 2012 to December 2022. After the data extraction of included clinical studies, the quality of included studies was evaluated with Cochrane Handbook for Systematic Review 5.1.0, and meta-analysis was performed by using RevMan 5.3 software.RESULTSA total of 6 RCTs were included, involving 3 145 patients. Meta-analysis showed that the improvement rate of lumbar bone mineral density (BMD) [MD=1.78, 95%CI(1.13, 2.43), P<0.000 01], femoral neck BMD [MD=1.26, 95%CI (1.08, 1.45), P<0.000 01] and total hip BMD [MD=1.16,95%CI(0.93,1.39),P<0.000 01] in trial group were significantly better than control group. C-terminal telopeptide of type Ⅰ collagen after 6 months [MD=-0.09, 95%CI (-0.16, -0.02), P=0.01] and N-terminal propeptide of type Ⅰ collagen after 12 months [MD=-9.07, 95%CI (-11.22, -6.92), P<0.001] in trial group were significantly higher than control group. There was no statistical difference in the fracture incidence rate after 12 months [OR=1.02, 95%CI (0.67,1.54), P=0.92] and the incidence of adverse reaction [OR=0.99, 95%CI (0.67,1.46), P=0.97] between 2 groups.CONCLUSIONSDenosumab has more advantages in improving BMD and bone metabolism, compared with bisphosphonates.
关键词:dinomumab;bisphosphonates;bone mineral density;bone metabolism;meta-analysis
摘要:OBJECTIVETo provide reference for improving the dispensing accuracy of similar drugs and reducing dispensing error risk through exploring the dispensing mode of similar drugs.METHODSThe effectiveness and feasibility of the similar drug dispensing management mode was explored through adjusting the traditional horizontal or vertical sorting method to a “Z” shaped cargo location sorting, implementing similar drug in different zones dispensed by different people, and combining measures such as adjusting the format of drug dispensing documents and improving inventory methods. The role of similar drug dispensing mode in drug dispensing management was evaluated comprehensively from two aspects: work quality and work efficiency.RESULTSAfter the implementation of similar drug dispensing mode, total number of monthly dispensing errors (18.42±8.79 vs. 28.50±6.87,P=0.005) and the proportion of monthly dispensing errors of similar drugs [(4.17±5.71)% vs. (10.96±7.05)%,P=0.017] were significantly lower than before the implementation; the monthly consistency rate between accounts and materials [(98.46±0.73)% vs. (97.61±0.57)%, P=0.004] was significantly higher than before implementation; completion time of dispensing in each batch was not significantly affected, and daily work was carried out smoothly and orderly.CONCLUSIONSThe similar drug dispensing mode has a significant effect in improving the accuracy of dispensing similar drugs, reducing the risk of dispensing errors, and does not affect the efficiency of dispensing work.
摘要:Compound formulas of traditional Chinese medicines (TCM), also known as prescription in clinic, refers to a form of medication in which several TCMs are selectively combined according to the certain compatibility principles and the needs of patient’s condition, based on syndrome differentiation and treatment. At present, the methods and strategies for investigating the compatibility mechanisms of TCM prescriptions mainly focus on the following two aspects: analysis of pharmacological substances (including chemical composition analysis of TCM, ingredients of TCM analysis in blood, and pharmacokinetic analysis) and pharmacological signaling pathways analysis (involving network pharmacology analysis, signal pathway indicator detection, and metabolomics analysis). In future research, the compatibility relationships of TCM prescriptions should be explored according to the principles of “Qiqing Hehe”, “Shengjiang Fuchen”, “Junchen Zuoshi”, and “Siqi Wuwei”. The regularity of TCM prescriptions compatibility should be shown in the change regularity of chemical components, pharmacokinetics, pharmacological pathways, and chemical compositions of various ratios of TCMs. Based on the insurance of holistic efficacy of TCM prescriptions, the underlying mechanisms of compatibility should be uncovered, which will provide references for the optimization of clinical applications of prescriptions and new directions for the creation of innovative TCM prescriptions.
摘要:Polyporus umbellatus, as a traditional Chinese medicine for promoting diuresis and clearing dampness, mainly contains steroids and polysaccharides. It is usually used to treat diseases of urinary system. In this paper, the research progress of the effective components, pharmacological mechanisms and clinical use of P. umbellatus in diuresis-promotion and dampness-clearance is reviewed. Steroids such as ergosterone, peroxyergosterone, ergosta-7,22-dien-3-one and P. umbellatus polysaccharide PPS1, PPS2, PPS3, GUMP-1-1 and GUMP-1-2 promote diuresis and eliminate dampness through diuresis, renal protection, anti-inflammatory, bacteriostatic and immunomodulatory effects. Traditional Chinese medicine compound preparations such as P. umbellatus powder, P. umbellatus decoction, and Wuling powder have significant effects in treating urinary tract infections, lithiasis, renal edema and lesions, which providing reference for the further development and application of P. umbellatus.
关键词:diuresis-promotion and dampness-clearance;effective components;steroids;Polyporus umbellatus polysaccharide
摘要:Diabetic retinopathy (DR) is a common complication of diabetes, which causes a great threat to the health of human vision. Recent studies have shown that saponins, polysaccharides and flavonoids in Astragali Radix regulate phosphoinositide 3-kinase/protein kinase B/mammalian target of rapamycin pathway, silent information regulator 1/nuclear factor erythroid 2-related factor 2 pathway, B-cell lymphoma-2 and other signaling pathways by acting on nuclear factor-κB, hypoxia-inducible factor-1α, glial fibrillary acidic protein, glutamine synthetase, aldose reductase, multiple miRNA and other related targets, so as to exert anti-inflammatory, anti-microangiopathy, anti-neurodegenerative disease and anti-apoptosis, and then achieve the purpose of treating DR.