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OBJECTIVE To evaluate the cost-effectiveness of bevacizumab combined with erlotinib in the first-line treatment of advanced EGFR mutant non-squamous non-small cell lung cancer (NSCLC) from the perspective of China’s health system. METHODS A dynamic Markov model was established based on BEVERLY study data, with a cycle of 3 weeks, a research deadline until 99% of patients die, and an annual discount rate of 5%. The model outputs were total cost, quality-adjusted life year (QALY), and incremental cost-effectiveness ratio (ICER). Taking 3 times China’s per capita gross domestic product (GDP) in 2023 as the willingness-to-pay (WTP) threshold, the cost-utility analysis was used to evaluate the cost-effectiveness of bevacizumab combined with erlotinib (observation group) versus erlotinib alone (control group) in the first-line treatment of advanced EGFR mutant non-squamous NSCLC, and the single factor sensitivity analysis and probability sensitivity analysis were used to verify the robustness of the basic analysis results. RESULTS The results of the basic analysis showed that compared with the erlotinib therapy plan, ICER of bevacizumab combined with erlotinib was 1 452 243.01 yuan/QALY, which was more than 3 times China’s per capita GDP in 2023 (268 074 yuan/QALY) as the WTP threshold, indicating that bevacizumab combined with erlotinib was not cost-effective. The results of single factor sensitivity analysis showed that the cost of bevacizumab, the utility value of progression-free survival and progressed disease status had a great influence on the results. The results of probability sensitivity analysis showed that when the WTP threshold was 1 740 000 yuan/QALY, the probability of cost-effective of bevacizumab combined with erlotinib plan was 50%. CONCLUSIONS Compared with erlotinib alone, bevacizumab combined with erlotinib is not cost-effective in the first-line treatment of advanced EGFR mutant non-squamous NSCLC, when using 3 times China’s per capita GDP in 2023 as the WTP threshold.
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OBJECTIVE To evaluate the cost-effectiveness of bevacizumab combined with erlotinib in the first-line treatment of advanced EGFR mutant non-squamous non-small cell lung cancer (NSCLC) from the perspective of China’s health system. METHODS A dynamic Markov model was established based on BEVERLY study data, with a cycle of 3 weeks, a research deadline until 99% of patients die, and an annual discount rate of 5%. The model outputs were total cost, quality-adjusted life year (QALY), and incremental cost-effectiveness ratio (ICER). Taking 3 times China’s per capita gross domestic product (GDP) in 2023 as the willingness-to-pay (WTP) threshold, the cost-utility analysis was used to evaluate the cost-effectiveness of bevacizumab combined with erlotinib (observation group) versus erlotinib alone (control group) in the first-line treatment of advanced EGFR mutant non-squamous NSCLC, and the single factor sensitivity analysis and probability sensitivity analysis were used to verify the robustness of the basic analysis results. RESULTS The results of the basic analysis showed that compared with the erlotinib therapy plan, ICER of bevacizumab combined with erlotinib was 1 452 243.01 yuan/QALY, which was more than 3 times China’s per capita GDP in 2023 (268 074 yuan/QALY) as the WTP threshold, indicating that bevacizumab combined with erlotinib was not cost-effective. The results of single factor sensitivity analysis showed that the cost of bevacizumab, the utility value of progression-free survival and progressed disease status had a great influence on the results. The results of probability sensitivity analysis showed that when the WTP threshold was 1 740 000 yuan/QALY, the probability of cost-effective of bevacizumab combined with erlotinib plan was 50%. CONCLUSIONS Compared with erlotinib alone, bevacizumab combined with erlotinib is not cost-effective in the first-line treatment of advanced EGFR mutant non-squamous NSCLC, when using 3 times China’s per capita GDP in 2023 as the WTP threshold.
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Objective To evaluate the predictive ability and influencing factors of individualized drug administration adjuvant decision-making system Java PK® for Desktop (JPKD) for tacrolimus blood concentration in kidney transplant recipients. Methods The monitoring data of tacrolimus blood concentration from 149 recipients early after kidney transplantation were collected. The trough blood concentration of tacrolimus was predicted by JPKD. The absolute weighted deviation and relative prediction deviation between the actual and predicted concentration were calculated. The influencing factors of the absolute weighted deviation were analyzed by univariate and multivariate logistic regression analyses, and the predictive values of these influencing factors on the accuracy of software prediction were assessed by delineating the receiver operating characteristic (ROC) curve. Results Two hundred and sixty-six samples of tacrolimus blood concentration data were collected from 149 patients. The measured blood concentration of tacrolimus was (6.5±3.0) ng/mL (1.1-16.6 ng/mL), and the predicted value calculated by JPKD was (5.6±2.5) ng/mL (1.4-14.4 ng/mL). The absolute weighted deviation of the calculated data was 28.38%, and the relative prediction deviation was −13.55%. Univariate analysis showed that gender, albumin, changes in hematocrit, cytochrome P450 (CYP)3A5*3 genotype and C3435T genotype were associated with the inaccurate prediction results. Multivariate logistic regression analysis found that CYP3A5*3 genotype of AA and the changes in hematocrit were the independent risk factors affecting the accuracy of tacrolimus blood concentration predicted by JPKD. ROC curve analysis showed that when the changes in hematocrit exceeded 2.25%, the risk of inaccurate software prediction was increased. Conclusions JPKD possesses certain accuracy in predicting the blood concentration of tacrolimus in kidney transplant recipients, which may improve the qualified rate of tacrolimus blood concentration. Nevertheless, CYP3A5*3 genotype and the changes of hematocrit may affect the accuracy of predictions.
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OBJECTIVE To evaluate the cost-effectiveness of regorafenib in the treatment of hepatocellular carcinoma after failure of sorafenib from the perspective of Chinese health system. METHODS Based on a phase Ⅲ trial(RESORCE), the partition survival model (PSM) and Markov model were constructed. The cycle was set as four weeks, the duration of the study lasted for lifetime, the annual discount rate was 5%. Drug cost data was obtained from yaozhi.com, other cost data were obtained from Anhui Provincial Medical Insurance Bureau and related literature, and utility values were obtained from literature. The incremental cost-effectiveness ratio (ICER) was used as the evaluation index, and the value of willingness to pay (WTP) was three times of China’s gross domestic product (GDP) per capita in 2022; one-way sensitivity analysis and probabilistic sensitivity analysis were used to verify the robustness of the basic analysis results. RESULTS The incremental cost of regorafenib group versus placebo group in PSM and Markov model was 112 116.95 yuan and 96 617.19 yuan, respectively. The incremental effectiveness was 0.31 QALYs and 0.32 QALYs, respectively. The ICERs were 360 751.01 yuan/QALY and 301 114.45 yuan/QALY, which were both greater than the value of WTP; regorafenib was not cost-effective. Results of one-way sensitivity analysis showed that the utility of progression-free survival and progressive disease, the unit cost of regorafenib had the greatest influence on the results, but ICER was always greater than the WTP within the floating range of each parameter. Under the WTP of 3 times China’s per capita GDP in 2022, the probabilities of regorafenib with cost-effectiveness were 0.8% (PSM) and 11.4% (Markov). CONCLUSIONS Under the WTP of 3 times the per capita GDP of China, regorafenib is not cost-effective in the treatment of hepatocellular carcinoma after failure of sorafenib treatment, compared with placebo.
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OBJECTIVE To compare the efficacy, safety and economy of tacrolimus (TAC), cyclosporin A (CsA), cyclophosphamide (CTX) and rituximab (RTX) in the treatment of membranous nephropathy (MN). METHODS Retrieved from Pubmed, the Cochrane Library, Wanfang data, CNKI and health technology assessment (HTA) official website, HTA reports, systematic reviews/meta-analysis and pharmacoeconomic studies about TAC, CsA, CTX and RTX combined with glucocorticoid in the treatment of MN were collected during the inception and Mar. 2022. After data extraction and quality evaluation, descriptive analysis was performed on the results of the included studies. RESULTS A total of 15 articles were included, involving 13 systematic reviews/meta-analysis and 2 pharmacoeconomic studies. In terms of efficacy, TAC and CsA showed significant advantages in increasing the response rate, and could improve the levels of urine protein, serum albumin, serum creatinine and serum total cholesterol. In terms of safety, the incidence of adverse reaction induced by TAC, CsA and RTX was low and the symptoms were mild. In terms of economics, CTX cost lower but caused severe adverse reaction; TAC cost higher but showed higher remission rate and good safety. CONCLUSIONS TAC combined with glucocorticoid may be the recommended scheme for MN.
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OBJECTIVE To compare the efficacy and safety of icotinib and gefitinib in the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC). METHODS The data of 146 patients with EGFR- mutant advanced NSCLC of our Hospital from December 2015 to September 2021 were retrospectively analyzed and divided into the gefitinib group (73 cases) and the icotinib group (73 cases) according to the drug use. Patients in the gefitinib group were given 0.25 g of gefitinib tablets once a day orally by single drug or combined with conventional chemotherapy, while patients in the icotinib group were given 125 mg of icotinib hydrochloride tablets three times a day orally by single drug or combined with conventional chemotherapy. Short-term efficacy, progression-free survival (PFS) were observed; Cox regression model was used to analyze the factors affecting the prognosis of patients; the occurrence of ADR were observed in the two groups. RESULTS There was no statistically significant difference in the objective remission rate, disease control rate, and the incidence of grade 1-2 and grade 3-4 adverse drug reactions between the two groups (P>0.05); median PFS was significantly better in the icotinib group than in the gefitinib group (P=0.048). Results of subgroup analysis based on patients basic information showed that compared with the gefitinib group, PFS of female [HR=0.57,95%CI(0.34,0.96),P=0.031] and non-brain metastatic patients [HR=0.58,95%CI(0.36,0.91),P=0.017] in icotinib group were prolonged significantly. Results of regression model analysis showed that EGFR19 exon Del mutation [HR=0.50, 95%CI(0.25,1.00), P=0.049], EGFR21 exon L858R mutation [HR=0.44, 95%CI(0.21,0.89), P=0.022] and icotinib treatment [HR=0.65, 95%CI (0.44,0.96), P=0.030] were influential factors for prognosis. CONCLUSIONS The short-term efficacy and safety of icotinib and gefitinib in the treatment of EGFR- mutant advanced NSCLC are comparable, but icotinib can significantly prolong the patients’ PFS; EGFR19 exon Del, EGFR21 exon L858R mutations and icotinib treatment are factors affecting patients’ prognosis.
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In view of the current situation of the construction of clinical pharmacist system and the teaching and training of clinical pharmacist training base in China, this paper provides a reference for perfecting and improving the training mode of clinical pharmacists in China. By establishing a clinical pharmacist system that develops a "two-focus" model, it takes the "trinity" of "hierarchical teaching-innovative practice-stage assessment" as the operating mechanism of teaching management, and the innovative mode of training clinical pharmacist talents with diversified information service platform as the technical support system, thereby providing an effective model for training excellent clinical pharmaceutical care talents.
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OBJECTIVE To provide reference for scientifi c and standardized development of clinical comprehensive evaluation of drugs in China. METHODS Guided by the theory of total quality management (TQM),drawing lessons from the successful experience of the British and German conducting evaluation ,combining with plan-do-check-act cycle and other quality management methods and tools ,drug clinical comprehensive evaluation of total quality management system was constructed in accordance with the requirements for our country related policy and local practice. RESULTS & CONCLUSIONS To construct total quality management system of clinical comprehensive evaluation of drugs in China from 5 aspects of organization system ,management process,assessment system ,evaluation and supervision platform ,support and guarantee mechanism. The organization system included national ,provincial and medical institutions ;management process should focus on the key links in the 3 stages of theme selection,evaluation and implementation ,and result transformation and application ;assessment system ,evaluation and supervision platform,support and guarantee mechanism should be established together so as to further improve the scientificity ,rationality, practicality and standardization of total quality management of clinical comprehensive evaluation of drugs. The development of total quality management is an effective starting point to promote the continual improvement of the drug clinical comprehensive evaluation;relevant government departments and the implementation of evaluation of medical institutions should further set up quality management consciousness ,establish report quality feedback mechanism and the results co-constructing and sharing mechanism and strengthen professional personnel training and innovation synergy regulation mode to ensure that the authenticity and reliability of evaluation results.
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OBJECTIVE:To esta blish a special management system of carbapenems ,and to standardize the clinical and rational application of carbapenem antibacterial drugs. METHODS :According to the requirements of the relevant documents of National Health Commission of the People ’s Republic of China ,the special management system of carbapenems in the First Affiliated Hospital of University of Science and Technology of China (called“our hospital ”in short )was constructed. The use intensity,reasonable rate of prescription and the detection rate of carbapenem resistant Enterobacteriaceae were analyzed before and after management. RESULTS :The special management system of carbapenems in our hospital included organization construction,information construction of special management ,prescription review of special management drugs ,prescription comment intervention and so on. After the implementation of the special management system ,the intensity of carbapenems use decreased from 2.78 to 2.03,the reasonable rate of prescription increased from 62.8% to 98.3%(P<0.05). The detection rates of Acinetobacter baumannii ,Escherichia coli and Pseudomonas aeruginosa resistance to carbapenems decreased from 91.4%,2.4%, 49.5% to 79.7%,1.6%,39.7%,respectively. However ,the detection rate of Klebsiella pneumoniae resistance to imipenem increased from 34.4% to 50.0%. CONCLUSIONS :The special management system of carbapenems in our hospital has achieved some results in practice ,which helps to reduce the abuse of these drugs and improve the reasonable level of drug use and reduce the detection rate of drug-resistant bacteria. At the same time ,hospital infection control of K. pneumoniae resistance to imipenem should be strengthened.
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OBJECTIVE:To prov ide reference for mobilizing the work enthusiasm of clinical pharmacists ,and further promoting the strategic objectives of performance appraisal in three-level public hospitals (“National examination ”for short ). METHODS:A department performance appraisal team was established ,and a key performance indicator system consisting of 4 first-level indicators and 9 second-level indicators was constructed by using literature retrieval and expert consultation. The performance distribution method of double assessment of performance score and performance score was established ,and a performance publicity and feedback performance mechanism was formed. Relevant data were collected to compare the core work indicators of clinical pharmacists ,use intensity of antibiotics ,compliance rate of essential drugs in our hospital from Apr. to Dec. 2019(before implementation )and Apr. to Dec. 2020(after implementation ). RESULTS :After the implementation of performance appraisal scheme ,the total number of medication recommendations of clinical pharmacists increased from 1 192 to 5 226,with an increase of 338.42%;the number of medication suggestions received increased from 846 to 4 855,with an increase of 473.88%; and the rate of drug suggestions received increased from 70.97% to 92.90%;the number of pharmaceutical consultation increased from 195 to 1 284,with an increase of 558.46%;the number of drug counseling increased from 1 203 to 2 719,increasing by 126.02%. Form Apr. to Dec. 2020,the number of patient safety medication evaluation forms reached 660. The antibiotics use density(AUD)in clinical departments of 13 clinical pharmacists were decreased to different extent after the implementation of performance appraisal scheme ,the decine rate was 92.31%(12/13),and the compliance rate was 69.23%(9/13);utilization rate of essential medicine among outpatients of 11 clinical pharmacists ’clinical departments had achieved positive growth ,and those among inpatients of 2 clinical pharmacists ’clinical departments had achieved positive growth. CONCLUSIONS :The performance appraisal system of clinical pharm acists formulated by our hospital links the “National examination ”index with the performance , appraisal of clinical pharmacists ,which can provide ideas for No.2018sxzx57,No.2020jyxm2328,No.2020jyxm2307) the performance appraisal of three-level public hospitals and help to promote the high-quality and sustainable development of hospital pharmaceutical care.
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Afatinib, a second-generation oral tyrosine kinase inhibitor (TKI), is suitable for first-line treatment of advanced non-small-cell lung cancer (NSCLC) and second-line treatment of squamous NSCLC. At present, a large number of strong clinical research data has confirmed the efficacy and safety of afatinib. Therefore, this article reviews the mechanism of action, pharmacokinetic clinical efficacy, combination of drugs, adverse reactions and dose adjustment of afatinib in order to provide ideas for individual rational drug use guidance.
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OBJECTIVE:To provide referenc e for the construction of prescription review model in medical institution and key monitored drugs management. METHODS :A multidisciplinary collaborative prescription review mode was established in the First Affiliated Hospital of University of Science and Technology of China (called“our hospital ”for short ). The prescription management group (composed of the president in charge ,the director of pharmacy department ,the director of medical department and the person in charge of pharmacy ,medicine,nursing and administrative management )was set up under the Pharmaceutical Affairs Management and Drug Treatment Committee ;and then prescription review expert group (be responsible for providing professional technical consultation and final evaluation of prescriptions )and prescription review working group (be responsible for the initial evaluation of prescriptions )were set up. According to the Drug Administration Law ,the Law of Licensed Doctors and the Law of Anti-unfair Competition Act and so on ,the Measures for the Supervision and Administration of Drug Purchase ,Sale and Use in our hospital was formulated. The multi-disciplinary collaborative prescription review procedure was established to intervene key monitored drugs prescriptions. The utilization rate of key monitored varieties and prescription reasonability in our hospital were investigated before (Jun. 2019)and after the intervention (Sept. 2019)by the mode. RESULTS :The multidisciplinary collaborative prescription review mode was established sucessfully. The proportion of key monitored drugs in total drug sales amount decreased from 1.322% before intervention to 0.735% after intervention (P=0.010). The irrational rate of prescriptions decreased from 46.76% before intervention to 15.70% after intervention (P=0.023). The main types of irrational prescriptions were inappropriate usage and dosage (18.52%),inappropriate indications(12.50%),inappropriateroute of administration (9.26%)before intervention changed into inappropriate usage and dosage (15.70%)after intervention ; other irrational prescription types had been significantly improved. CONCLUSIONS : The multidisciplinary collaborative prescription review model shows significant effect on key monitored drugs and reduce irrational use of this variety in the clinic significantly.
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OBJECTIVE:To evaluate the economics of infliximab in the treatment of ulcerative colitis. METHODS :Retrieved from CNKI ,Wanfang database ,VIP,PubMed,Embase database and Cochrane Library since Oct. 16th in 2019,randomized controlled trials (RCTs)about infliximab (trial group )vs. conventional drugs (control group )in the treatment of ulcerative colitis were collected ,and efficacy and safety of two groups were compared by Meta-analysis. The economics were analyzed by cost-utility analysis ,and single factor sensitivity analysis and probability sensitivity analysis were conducted. RESULTS :The results of Meta-analysis showed that clinical response rate [RR =1.97,95% CI (1.64,2.36),P<0.000 01] and clinical remission rate [RR =3.19,95%CI(1.83,5.57),P<0.000 1] in double blind trial subgroup of infliximab treatment were both significantly higher than than control group of conventional treatment. There was no statistical significance in the incidence of severe ADR between 2 groups [RR =0.76,95%CI(0.54,1.06),P=0.10]. The incremental cost-utility ratio of trial group was 348 243.88 yuan/quality-adjusted life-year (QALY),which was significantly higher than the patient ’s willingness to pay threshold (212 676 yuan).The sensitivity analysis supported above results. CONCLUSIONS :Under the current level of medical security in China , compared with conventional therapy ,infliximab is less economical for the treatment of ulcerative colitis.
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OBJECTIVE:To provide method reference for scientifically eva luating the rationality of the use of saxagliptin . METHODS:Based on the drug instructions ,clinical guidelines ,clinical pathways ,related references ,clinical endocrinology department and pharmaceutical experts of a hospital jointly discussed and formulated the evaluation criteria for the rationality of the use of saxagliptin. AHP method was used to assign weights to various indexes of evaluation criteria ;TOPSIS method was used to analyze the use of saxagliptin of 106 cases in the hospital during Nov. 2018-Apr. 2019 retrospectively and evaluate rational drug use. RESULTS :A total of 6 primary indicators and 12 secondary indicators were established. The first three indicators with a relatively high index weight were indications (with a weight of 0.25),dose and adjustment of administration (with a weight of 0.21)and frequency of administration (with a weight of 0.15). Among 106 cases,39.6% of drug use were reasonable ,51.0% were basically reasonable and 9.4% were unreasonable. Evaluation results made by weighted TOPSIS were consistent with the actual situation. CONCLUSIONS :TOPSIS method weighted by AHP is reasonable and feasible for evaluating the rationality of saxagliptin use.
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ObjectiveTo study the methods,techniques,content about standardized induction training of pharmacists.Methods49 pharmacy recruits are accepted standardized 3-month pre-service training.ResultsThe new team of pharmacists enhance their self-confidence,improve skills and can adapt to the hospital environment faster and enter the role of pharmacists.ConclusionThe implementation of standardized training is conductive to increasing the overall quality of pharmacists and practice skills rapidly,in order to meet the clinical role,avoid health risks and ensure drug safety of patients.
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Objective To discover the effects of the Prescription Administrative Policy in force on the quality of the prescriptions in a tertiary hospital in 2007. Methods The prescriptions of 400 cases were sampled systematically for evaluation, and 60 patients were interviewed. Results The average eligibility rate of the prescriptions was but 37. 2% in this hospital, which was mainly plagued by incompleteness, nonstandard and irrationality found in prescriptions. Implementation of the Policy contributed to a significant improvement of some indicators. For example, the eligibility rate increased by 12. 2% (P=0. 004) ,the percentage of the use of antimicrobial agents dropped significantly (P=0. 001),and the percentage of generic names used rose significantly (P = 0. 000). Conclusions The implementation of the Policy is highly positive for prescription quality.
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Objective:To investigate the influencing factors and medication compliance of hypertension.Method: 3 grade-Ⅲand 15 grade-Ⅱgeneral hospitals in Anhui Province were selected by random sampling.732 outpatients with a hypertension course of 6 months or above were interviewed during July and October of 2004 with the medication compliance schedule.All data were input into computers with the software Epi info 6.04,and analyzed with SPSS 11.5.Result:①The medication compliance schedule had high reliability and validity,which could be used in the surveys of medication compliance of hypertension.②The medication compliance rate of the 732 patients was only 46.4%.③Trust in medical pro- fessionals,more attention paid to the disease,more knowledge of non-compliance harm,satisfactory family income,and longer consulting time were the common advancing factors in improving the medication compliance,but a longer duration of the medication regimen,a larger number of preparations and drugs,and higher frequency of taking medicine were the bloc- king factors.Conclusion:The medication compliance of hypertensives was generally not good,and it was influenced by many factors.It is necessary that medical professionals,patients,families and society all take part in its improvement.
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Objective:To investigate the recognition degree and attitude to adverse drug reaction (ADR) reports among the healthcare professionals in our hospital.Method:Through random cluster sampling,the doctors,nurses and pharmacists in our hospital were interviewed on the spot.The questionnaires were input by EPI6.04 and analyzed by soft- ware SPSS11.5.Result:1077 eligible questionnaires were obtained and the recovery was 89.8%.Our bealthcare profes- sionals had a good recognition of basic ADR knowledge.The pharmacists had a better recognition degree than doctors and nurses.The better academic background the healthcare professionals had,the higher their score of recognition was,and there was a significant difference among them.There was no significant difference among the Scores of the healthcare profes- sionals with different working years,and nor was there among the scores of them with different professional titles.The atti- tude to ADR reporting was entirely right,but there were some wrong ideas.Conclusion:It is urgent to provide more train- ing courses for healthcare professionals so as to raise their consciousness of ADR reporting,ability of discrimination and lev- el of monitoring and avoid serious consequences caused by ADR.
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0,most symptoms of ADR were reported for the first time with the homogeneous literature ratio being 0.The predominant outcome of severe ADR were hospitalization or delayed hospitalization course,followed by increased risk of death or patients' permanent or distinct disabling.CONCLUSION:New and severe ADR should be given close attention in the clinic to guard against severe ADR.
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OBJECTIVE: To determine the content of total flavonoids in extract of Bidens bipinnata L. by spectrophotometry. METHODS: The Bidens bipinnata L. was extracted with ethanol and purified by HPD100 macroporous resin. With rutin as reference substance, the content of total flavonoids in the extract of Bidens bipinnata L. was determined by spectrop-hotometry at a wavelength of 510 mn. RESULTS: The linear range of Rutin was 0.008 16~0.048 96 mg?mL-1(r=0.999 3), its average recovery was 99.03% (RSD=2.27%,n=6).CONCLUSION: The method is of high sensitivity and good stability, and it is applicable for the quality control of Bidens bipinnata L.