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Objective:To observe the clinical characteristics and guideline compliance of chronic obstructive pulmonary disease (COPD) patients with initial triple therapy in real-life world.Methods:This study is a cross-sectional study. The subjects of the study were COPD patients admitted to 13 hospitals in Hunan Province and Guangxi Zhuang Autonomous Region from December 2016 to December 2021. The initial treatment was triple inhaled drugs. The data collected included gender, age, diagnosis, body mass index (BMI), history of acute exacerbation (AE) in the past year, pulmonary function, COPD Assessment Test (CAT) score, modified British Medical Research Council Dyspnea Questionnaire (mMRC), inhaled drugs and other indicators. The characteristics and differences of COPD patients before and after 2020 were analyzed.Results:7 184 patients with COPD were enrolled in this study, including 2 409 COPD patients treated with initial triple therapy, accounting for 33.5%(2 409/7 184). Taking January 1st, 2020 as the cut-off point, 1 825 COPD patients (75.8%) received initial treatment with triple inhaled drugs before 2020 and 584 patients (24.2%) after 2020 were included in this study. Compared with COPD patients before 2020, the COPD patients after 2020 had higher FEV 1% [(40.9±15.5 )% vs (39.3±15.5)%, P=0.040], lower CAT [(15.8±6.5)point vs (17.5±6.2)point, P<0.001], less AE in the past year [1(0, 2)times vs 1(0, 2)times, P=0.001] and higher rate of non-AE [255(43.7%) vs 581(37.1%), P=0.006]. In addition, before 2020, patients with COPD were mainly treated with open triple drugs (1 825/1 825, 100%); after 2020, 306 patients (52.4%) received open triple inhaled drugs, and 278 patients (47.6%) received closed triple inhaled drugs. Conclusions:In real-life world, most of patients with COPD treated with triple therapy have severe lung function, obvious symptoms and high risk of acute exacerbation. The real-world prescribing of triple therapy in patients with COPD does not always reflect recommendations in guidelines and strategies, and overtreatment is common. After 2020, prescribing triple therapy for COPD patients is more positive and worse consistency with guideline.
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OBJECTIVE：To systematically evaluate the efficacy and safety of sodium-glucose co-transporter 2 （SGLT-2）inhibitors combined with insulin in the treatment of type 1 diabetes mellitus（T1DM），and to provide evidence-based reference for clinical treatment of T1DM. METHODS：Retrieved from PubMed，Cochrane library，Embase，Clinical Trials，CNKI，CBM and Wanfang database，randomized controlled trials（RCT）about SGLT-2 inhibitor（trial group）versus placebo（control group）in the treatment of T1DM based on insulin treatment were collected during the inception to Feb. 2020. After data extraction of literatures met inclusion criteria，Cochrane risk bias evaluation tool 5.1.0 was used to evaluate its quality，and Meta-analysis was perfomed by using Stata 12.0 software. RESULTS：A total of 11 RCTs were included，involving 7 003 patients. The results of Meta-analysis showed that the decrease of HbA1c [SMD＝－0.49，95％CI（－0.53，－0.44），P＜0.001]，the proportion of patients with HbA1c≥ 0.5％ and without severe hypoglycemia [OR＝3.93，95％ CI（3.49，6.21），P＜0.001]，the proportion of patients with HbA1c≥ 0.5％ [OR＝2.65，95％CI（2.25，3.12），P＜0.001]，the target rate of HbA1c level＜7.0％ [OR＝2.85，95％CI（2.44，3.33），P＜0.001] and the decrease of body weight [SMD＝－0.83，95％CI（－0.96，－0.70），P＜0.001] in trial group were significantly larger or higher than control group；the decrease values of daily insulin dosage，fasting blood glucose，postprandial blood glucose，systolic blood pressure and diastolic blood pressure in trial group were significantly higher than those in the control group，with statistical significance（P≤0.011）. The total incidence of ADR [OR＝1.14，95％CI（1.04，1.26），P＝0.007]，the incidence of SGLT-2 inhibitor related ADR [OR＝2.17，95％CI（1.75，2.99），P＜0.001]，the incidence of severe ADR [OR＝1.48，95％CI（1.24，1.77），P＜0.001]， the incidence of genital infection [OR＝3.84，95％CI（3.14，4.69），P＜0.001]，the incidence of diarrhea [OR＝1.47，95％CI（1.09，1.97），P＝0.011]，the incidence of fluid reduction related ADR [OR＝2.05，95％CI（1.37，3.08），P＝0.001]，the incidence of ketosis related ADR [OR＝4.18，95％CI（3.15，5.55），P＜0.001]，the incidence of ketoacidosis [OR＝4.33，95％CI（3.01，6.23），P＜0.001] and the incidence of severe ketoacidosis [OR＝5.06，95％CI（2.61，9.81），P＜0.001] were significantly higher than control group， with statistical significance. There was no statistical significance in the incidence of hypoglycemia，severe hypoglycemia，urinary tract infection or kidney injury between 2 groups. CONCLUSIONS：SGLT-2 inhibitors for the treatment of T1DM can significantly improve the blood glucose，reduce body weight and daily insulin dose，lower systolic blood pressure and diastolic blood pressure，while dose not increase the risk of hypoglycemia，urinary tract infections and renal impairment but increase the risk of total ADR as well as the risk of ADR such as genital infection，diarrhea，ketoacidosis，to which should be paid attention.
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Objective@#To compared the clinical efficacy and pharmacoeconomics of gefitinib, erlotinib, icotinib in the treatment of non-small cell lung cancer (NSCLC), thus to provide guidance on drug selection for patients from safety, efficiency and economical aspects after medical reform.@*Methods@#The patients with NSCLC who admitted to the First Affiliated Hospital of China Medical University from 2014 to 2017 and treated by gefitinib, erlotinib, icotinib were selected (30 patients in each group). All the patients were diagnosed with NSCLC by tissue or cytology study and eventually disease progressed.The clinical efficacy of the three drugs was evaluated by retrospective analysis.Specially, cost-effectiveness and cost-utility were evaluated in terms of disease control rates(DCR) and quality adjusted life years(QALY), respectively.@*Results@#The results demonstrated that the progression free survival (PFS) of gefitinib, erlotinib and icotinib were 0.934 years, 1.079 years and 1.063 years, respectively.There was no statistically significant difference in PFS among the three groups(F=0.001, P=0.9 990). The major drug adverse reactions were rash, diarrhea and hepatic injury.The DCR of gefitinib, erlotinib and icotinib were 66.7%, 70.0% and 63.3%, respectively, the difference was statistically significant(χ2=0.300, P=0.8 607). The total cost of treatment in the three groups were 85 118 CNY, 70 513 CNY and 7 2213 CNY, respectively.The cost-utility ratios of three drugs were 91 133, 65 389 and 67 973, respectively.The cost-effectiveness ratios of three drugs were 1 276, 1 007 and 1 141, respectively.The erlotinib group had lower cost and higher utility (effectiveness). Sensitivity analysis showed that the conclusion was relative stable when the price of three drugs changed at the same time.@*Conclusion@#All of the three drugs are applicable for targeted therapy of NSCLC and show similar curative effect and adverse reaction.However, erlotinib shows better economy than others.
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Objective To evaluate the protective effect of ACEI drugs on radiation pneumonitis,and to compare ACEI with ARB,statin, steroid, and NSAID on the treatment of radiation induced lung injury through the network Meta-analysis. Methods A computer-based online search of PubMed, EMbase, Cochrane Library, as well as CNKI, CBM, VIP, Wanfang database was conduce. The NOS score was used to evaluate the quality of studies,and the results were analyzed by stata14. 0 software. Results ACEI drugs showed desired effect on the treatment of radiation pneumonia,which can effectively reduce the incidence of radiation-induced lung injury,but can not prolong the survival time of the patients.The protective effects of statins and non-steroid anti-inflammatory drugs are second only to those of ACEI.Meta-analysis results were proved to be stable and credible by the sensitive-analysis.The therapeutic effect of ACEI on radiation induced lung injury is not affected by sex and age of patients. Conclusion ACEI drugs have an optimum protective effect on radiation induced lung injury.
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Objective To investigate the effects of metformin on myocardial fibrosis induced by isoproterenol(ISO) in rats and its mechanism. Methods A total of 48 SD male rats were randomly divided into four groups,normal control group,model control group,valsartan group and metformin group. Cardiac fibrosis models were induced in model group, Valsartan group and metformin group by subcutaneous injection of ISO 10 mg·kg-1·d-1in the 1stday, 5 mg·kg-1·d-1in the 2ndday, 3 mg·kg-1·d-1in the 3rd-10thday. Valsartan group and metformin group were fed valsartan 10 mg·kg-1, qd or metformin 100 mg·kg-1,bid for 28 days respectively.Rats were killed at the 3rdday,the 7thday,the 14thday and the 28thday.The value of HMI,LVMI,LVW/TL were measured,and pathological alteration were observed by HE staining and Masson staining,TGF-β and Smad3 protein expression in left ventricular myocardium were detected by western blotting,and IL-6 level in serum were detected by ELISA. Results The serum levels of IL-6 in control group, model group, valsartan group and metformin group were (59.18± 0.86) pg·mL-1, (71.90±1.35) pg·mL-1, (64.33±2.59) pg·mL-1and (65.45±1.92) pg·mL-1respectively on the 28th day. Compared with control group, the serum levels of IL-6 in model group were significantly increased(P<0.01), while their levels significantly reduced in rats received metformin (P<0.05). Conclusion Metformin may inhibit myocardial firbosis by TGF-β/Smads pathway.
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At present,the study of intestinal absorption of oral drugs mainly includes in vitro,in vivo and in situ methods.In view of the advantages of in situ intestinal perfusion such as simple operation,mature technology,controllable,ensure the neuroendocrine regulation and blood supply,and so on,which could better reflect the true situation of drug absorption.In this study,the research methods and characteristics of intestinal absorption of oral drugs were systematically introduced.The recirculating perfusion method and single-pass perfusion method were compared,and several volume correction methods were also introduced.In order to ensure the operability and accuracy of experimental results,proper experiment method of intestinal absorption will be adopt according to the factors such as drug characters,experiment requirements,experimental conditions,and so on.The article provides a scientific basis for the development of pharmaceutical dosage and clinical rational drug use.
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Objective To assess the effectiveness of Chinese materia medica (CMM) as adjuvant therapy of antibacterial for pediatric mesenteric lymphadenitis.Methods Retrieved RCT research of CMM as adjuvant therapy of antibacterial for pediatric mesenteric lymphadenitis from CNKI,Wanfang,VIP,PubMed,and Medline database from 1980 to 2016.Literatures were selected according to the inclusion and exclusion crteria,Jadad scores method was used to evaluate the literatures and meta-analysis was performed by RevMan 5.3.Results A total of 34 randomized controlled trials were included.Meta-analysis showed that the trial group was superior to the control group in terms of efficiency,cure rate,remission time of main symptoms,mesenteric lymph node recovery,and recurrence rate,there was statistical difference.Conclusions CMM as adjuvant therapy of antibacterial for pediatric mesenteric lymphadenitis is more effective than the use of antibacterial alone.
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Objective To evaluate the efficacy of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) in the treatment of idiopathic pulmonary fibrosis through the method of system evaluation. Methods A computer-based online search of Pubmed, Embase, Cochrane Library, CNKI, CBM and Wanfang were used for database retrieval. Revman 5.0 was used to assess the bias of the included studies. The Stata 14.0 was used to evaluate the extraction indexes of efficacy, p (O2), p (CO2), DLco, FEV1 and VC. GRADE score was used to evaluate the level of evidence. Results A total of 17 articles (related with 1381 patients) were included in this study, including 14 studies using ARB and 3 studies using ACEI. Compared with the control group ACEI and ARB drugs showed advantages in the treatment of pulmonary fibrosis (RR=1.34, 95%CI:1.24-1.44, Z=7.81, P<0.001). Auxiliary index analysis showed that the test groups were treated with enalapril (SMD=0.72, 95%CI:0.21-1.22, Z=2.77, P=0.006), telmisartan (SMD=3.86, 95%CI:2.44-5.27, Z=5.35, P<0.001), valsartan (SMD=1.94, 95%CI:1.33-2.55, Z=6.27, P<0.001) and captopril (SMD=0.60, 95%CI:0.11-1.09, Z=2.41, P=0.016), the p(O2) levels were significantly improved in patients ≥65 years old (SMD=0.76, 95%CI:0.52-1.00, Z=6.18, P<0.001) and patients < 65 years old (SMD=3.97, 95%CI:2.61-5.32, Z=5.73, P<0.001), and disease duration≥5 years (SMD=1.39, 95%CI:0.45-2.33, Z=2.89, P=0.004) and disease duration<5 years (SMD=3.26, 95%CI:2.06-4.46, Z=5.34, P<0.001) compared with those of control group (SMD=2.95, 95%CI:1.95-3.94, Z=5.82, P<0.001). The curative effect of telmisartan was better than that of other drug groups (P < 0.001), and which was much better for patients under 65 years old (P<0.001). There was no significant difference in the disease duration between two groups (P=0.307). The p (CO2) levels were significantly improved in patients treated with telmisartan [SMD=-12.94,95%CI:(-14.01)-(-11.86),Z=23.51,P<0.001), valsartan [SMD=-1.95,95%CI:(-2.56)-(-1.34),Z=6.29,P<0.001] compared with those of control group [SMD=-11.13,95%CI:(-17.03)-(-5.24),Z=3.70,P<0.001]. The effect of telmisartan was better than that of valsartan (P<0.001). In addition, values of DLco (SMD=0.64, 95%CI:0.45-0.83, Z=6.72, P<0.001), FEV1 (SMD=1.19, 95%CI:0.52-1.86, Z=3.47, P<0.001) and VC (SMD=0.51, 95%CI:0.16-0.85, Z=2.85, P=0.004) were improved in test group compare with those of control group. And the GRADE scores of relevant indexes were low quality to moderate quality. Conclusion ACEI and ARB can improve the efficacy, the p (O2) and p (CO2) in the treatment of pulmonary fibrosis. Patients with age<65 years old and treated with telmisartan have the best curative effect, and which is not related to the disease duration.
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OBJECTIVE:To provide reference for clinical individual medication of voriconatole. METHODS:The distribution of MIC of voriconazole to Aspergillus fumigatus and Candida albicans were summarized as well as the pharmacokinetic parameters of voriconazole in different populations. Using probability of target attainment(PTA)and cumulative fraction of response(CFR)as indexes,crystal ball software 11.1.2.4 was used for Monte Carlo simulation of different dosage regimens of same population and same dosage regimen of different populations. RESULTS:For children with impaired immunity,when the drug doses of were 4,6 mg/kg and MIC was lower than 0.125 mg/L,PTA was higher than 90%;when the drug doses was increased to 8 mg/kg and MIC was lower than 0.125 mg/L,PTA was higher than 90%. For different populations receiving same dosage regimens(4 mg/kg),MIC of teenagers with impaired immunity was lower than 0.25 mg/L and those of healthy adults,patients underwent hematopoietic stem cell transplantation and adults with impaired immunity were all lower than 0.5 mg/L,PTA was higher than 90%. CFR to A. fumigatus were 42.53%,58.41%,77.74%,70.16%,89.40%,93.72%,95.42% and CFR to C. albicans were 96.68%,97.13%,97.94%, 97.54%,98.07%,98.28%,98.35%among children with impaired immunity receiving different drug doses(4,6,8 mg/kg)and dif-ferent populations receiving drug dose of 4 mg/kg(teenagers with impaired immunity,healthy adults,patients underwent hemato-poietic stem cell transplantation,adults with impaired immunity). CONCLUSIONS:Various dosage regimens of different popula-tions included in this study could effectively control C. albicans infection. It is necessary to increase the drug dose of children and teenagers with impaired immunity in order to meet the needs of A. fumigatus infection treatment.
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Objective:To evaluate the impact of atorvastatin and rosuvastatin at different doses on liver function in the patients with coronary artery disease. Methods:A retrospective study was used, and the patients with coronary heart disease hospitalized in the first hospital of China medical university from January 2013 to March 2014 were selected. According to the drug variety and dosage, the patients were divided into four groups: A (atorvastatin, 20 mg·d-1), B (atorvastatin, 40 mg·d-1), C (rosuvastatin, 10 mg· d-1 ) and D ( rosuvastatin, 20 mg·d-1 ) . The basic information of patients, the indices of liver function( ALT,AST,ALP and TBIL) , the time of abnormal liver function, treatment strategies and prognosis were recorded. The incidence of abnormal liver function in the groups was compared, and the rationality and effectiveness of the intervetion strategies were evaluated. Results:A total of 269 patients were collected. Among them, 149 cases were with abnormal liver function in varying degrees, and 21 patients were with ALT>3?ULN. The incidence of ALT>3?ULN in atorvastatin high dose group was much higher than that in atorvastatin low dose group( P<0. 05). Conclusion:The patients treated with high dose atorvastatin (40 mg·d-1) have a high risk of liver injury.
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Objective To study thechemicalconstituentsof Ixerissonchifolia.Methods Monomericcompoundswerei‐solated by chromatography on silica gel column ,Sephadex LH‐20 ,ODS chromatography column and HPLC .Thestructure of the compound wasconfirmed on the basis of physio‐chemical constants and spectroscopic analysis .2 ,2‐diphenyl‐1‐pikrylhydra‐zyl (DPPH) and 3‐ethylbenzthiazoline‐6‐sulfonic acid(ABTS)assay were usedto evaluate the antioxidant activities of isolated compounds .Results Five compounds were isolated from 70% ethanol‐water extraction and their structures were identified as (+ )‐pinoresinol‐4‐O‐β‐D‐glucopyranoside(1) ,glochidioboside(2) ,3 ,4 ,5‐trimethoxyphenyl‐1‐O‐β‐D‐glucopy‐ranoside(3) ,on‐onin(4) ,daidzein(5) ,luteolin (6) ,and apigenin (7) .Meanwhile ,antioxidant activities of all the isolates were evaluated by DPPHand ABTS .Conclusion Compounds 1‐5 were isolated from this genus for the first time .The active results showed that 1 ,2 ,4‐7 exhibited potent antioxidant activity .
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OBJECTIVE:To establish an overall teaching evaluation system for clinical pharmacology with PBL(problem-based learning) mode. METHODS:The teaching evaluation system was established by“Delphi”method,and it has been applied to 270 students at China Medical University in 2013-2014. RESULTS:According to the result of test score,PBL method can improve abil-ity of analyzing medical records,while formative evaluation indicates most of the students are satisfied with class response.And PBL method also can enhance student’s skill of clinical practice,broaden the knowledge an so on. CONCLUSIONS:The evaluation sys-tem was comprehensive with contents,systematic and objective,and it also can provide an effective feedback in teaching,which can accelerate the optimization of the teaching mode and improve the quality of education.
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Objective To optimize the formulations of venlafaxine hydrochloride ( VH ) emulsions by using central composite design-response surface methodology. Methods The effect of amounts of Arlacel P135, VH, PEG-400, and NaCl on the emulsion viscosity, centrifugation breakage, and mean diameter was systemically investigated, respectively. The desirable formulation that combining these three response variables was constructed. Linear equations and a second-order polynomial equation were fitted to the data, and the outcome equation was used to predict the responses in the optimal region. Results There was a quantitative relationship between 4 factors and 3 evaluation indexes and evaluation the “desirability” . The optimal formulation of the VH emulsion were as follows:taking 0. 48 g of Arlacel P135, 0. 40 g of VH, 0. 26 g of PEG-400, and 0. 025 g of NaCl. The experimental values of the response variables were highly closed to the predict values. Conclusion The model presents good prediction and can be used to optimize the preparation of VH emulsion, which obtaining stable W/O emulsion.
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Objective To explore the possible role of CD28 +/CD152 +:B7 eostimulators in immune pathophysiology of severe pneumonia.Methods 22 severe pneumonia peripheral blood sample were used to analyze the expression of CD3+ T cell CD28+,CD152+,CD14++ on mononuelear cell CD86+,and HLA - DR + by FACS expression.The relationship between CD28+,CTLA4,CD86+ and the HLA-DR +,and the relationship between APACHE Ⅱ Grading,CD28+,CD152+,CD86+ and HLA-DR + were analyzed.Results Compared with the control group,the expression of CD3 + T cell,CD86+ and HLA - DR + were remarkably reduced while the expression of CD28+ and CD152+ were markedly increased in patients with severe pneumonia who were hospitalized in 24 h(P＜0.05).However,T cells with positive CD8+ CD3+ and CD4+ CD3+ had no significant change between two groups(P＞0.05).For patients with severe pneumonia who survived,the APACHE Ⅱ scores were significantly reduced while the expression of CD28+,CD152+,CD86+,HLA-DR + and CD3+ + cells were significantly increased after 10 days from admission(P＜0.05).By contrast,T cells with positive CD8+ CD3+ and CD4+CD3+ had no significant change between two groups(P＞0.05).There were no relation between costimulators CD28+ and HLA - DR + (r=-0.12,P=0.54)and APACHE Ⅱ scores(r=-0.30,P=0.19) in control group.CD86+ and HLA - DR + showed positive correlation(r=0.65,P=0.00).CD86+ and APACHE Ⅱ scores had no correlation(r=-0.38,P=0.09).Conclusion The costimulators expressed abnormally in circumference blood of patients with severe pneumonia,CD86+ decreased,but CD28+,CD152+ increased.T cell of circumference blood was at the condition of "anergy".The increase of CD28+,CD86+,CD86+ and HLA - DR + during convalescence stages in patient with severe pneumonia showed that spocific immunity was advantageous for restoration in these patients.The relationship among CD86+,CTLA4 and HLA - DR + indicated that CD28+/CD152+:B7 play an role in the occurrence and development of severe pneumonia.
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OBJECTIVE:To analyse compound pharmaceutical preparations by the signal conversion combined with multicomponent calibration methods METHODS:One-order derivative spectrum data was obtained by one-order derivative conversion On the basis of this,we combined them with the MLR method and PLS method to determine the contents of metrozole and chloromycetin in co metrozole injection RESULTS:The labelling quantity and RSD(n=5) were:metrozole 99 6%,0 11%;chloromycetin 99 3%,0 20% by derivate-MLR;The labelling quantity and RSD(n=5) were:metrozole 97 5%,0 43%;chloromycetin 94 6%,0 89% by derivate-PLS respectively CONCLUSION:One-order derivative spectrum signals aplied to the MLR method is better than the D1 PLS method