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Objective:The particularity of drugs determines the particularity of drug patents. From the legal perspective, this means that special terms should be included designed in the patent law system.The interests of patent holders are not fully protected currently, although some drug related provisions have been set in the current patent law. Along with the many reforms that China has implemented in the field of new drug research and development, there are some problems related to drugs that need to be resolved in the patent system, This article will explore this issue.Methods:Based on the particularity of drug patents, this paper analyzes the necessity of improving the relevant provisions of the patent law for the research and development of new drugs, and proposes suggestions for improving the terms of drug patents.Results:There is still space for improvement in terms of balancing the interests of the innovator, the generic maker and the public.Conclusions:The necessary improvements and adjustments to the drug provisions in the patent laws and regulations need to be made in order to further enhance the patent system’s role in promoting the research and development of new drugs.
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Objective@#The aim of the study was to explore the influencing factors of exercise tolerance in patients with myocardial infarction (MI) after percutaneous coronary intervention (PCI) revascularization in acute state.@*Methods@#A total of 112 patients with first MI undergoing PCI revascularization in acute state and completing cardiopulmonary exercise testing (CPET) were enrolled. Exercise capacity was evaluated by peak oxygen consumption percentage (VO2 peak%) in CPET. Patients were divided into normal exercise capacity (NEC) group (n=40) and abnormal (AEC) group (n=72) according to VO2 peak% value. Clinical manifestations, histories of hypertension and diabetes, medications, coronary arterial angiography and echocardiography findings of patients were compared. The onsets of diabetes and blood glucose levels during the period of CPET were evaluated in the MI patients with diabetes. The patients were followed up for major adverse cardiovascular events (MACE) (admission due to chest pain, re-revascularization, re-infarction and all-cause death) within 24 months after PCI. Multivariate logistic regression analyses were conducted to examine influencing factors for exercise tolerance.@*Results@#The ratio of diabetes, type C lesions in the AEC group were higher than those in the NEC group (diabetes: 37.5% vs. 17.5%; type C lesions: 69.4% vs. 42.5%, respectively, all P<0.05). The left ventricular ejection fraction (LVEF) in patients in the AEC group was lower than that in the NEC group [(60.6±10.0)% vs. (65.0±8.2)%, P=0.019]. Multivariate logistic regression analyses showed that history of diabetes and history of type C lesions were the independent risk factors for the declined exercise capacity in the MI patients after PCI revascularization (OR=3.14, 95%CI 1.167-8.362, P=0.023; OR=3.32, 95%CI 1.444-7.621, P<0.01). Among the MI patients with diabetes, the duration of diabetes in the AEC group was significantly longer than that in the NEC group[(7.7±3.6)years vs. (5.0±2.4)years] and the proportions of subjects reaching target levels of fasting plasma glucose (40.7% vs. 57.1%) and glycosylated hemoglobin A1c(HbA1c) (55.6% vs. 71.4%) in this group were significantly lower than those in the NEC group (all P<0.05). A multivariate logistic regression analysis showed that reaching HbA1c target was an independent predictor of improved exercise tolerance in MI patients with diabetes who received PCI (OR=2.518, 95%CI 1.395-7.022, P=0.021). No significant differences were observed in incidence of admission due to chest pain, re-revascularization and re-infarction between the two groups within 24 months after PCI between the groups.@*Conclusions@#Diabetes and type C lesions are independent risk factors of declined exercise capacity in patients with first myocardial infarction who received revascularization in acute state. Reaching target HbA1c is independent factor of improved exercise capacity in patients with myocardial infarction and diabetes.
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Objective To strengthen human genetic resource management in clinical trials.Methods This article analyzes the common problems in the process of reviewing human genetic resources application by the drug clinical trial institute in our hospital,and proposes solutions for solving the problems.Results Common questions are also the key points for future review of human genetic resources applications,including the collection of sample and consistency with clinical trial plan,ethical review and informed consent,intellectual property rights etc.Conclusions Strictly reviewing applications of human genetic resources,as well as strengthen the management of human genetic resources in clinical trials,are not only make traceability of human genetic resources traceable,but also have important significance for the authenticity and scientific validity of trial results.
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Objective The aim of the study was to explore the influencing factors of exercise tolerance in patients with myocardial infarction (MI) after percutaneous coronary intervention (PCI) revascularization in acute state. Methods A total of 112 patients with first MI undergoing PCI revascularization in acute state and completing cardiopulmonary exercise testing (CPET) were enrolled. Exercise capacity was evaluated by peak oxygen consumption percentage (VO2 peak%) in CPET. Patients were divided into normal exercise capacity (NEC) group (n=40) and abnormal (AEC) group (n=72) according to VO2 peak% value. Clinical manifestations, histories of hypertension and diabetes, medications, coronary arterial angiography and echocardiography findings of patients were compared. The onsets of diabetes and blood glucose levels during the period of CPET were evaluated in the MI patients with diabetes. The patients were followed up for major adverse cardiovascular events (MACE) (admission due to chest pain, re?revascularization, re?infarction and all?cause death) within 24 months after PCI. Multivariate logistic regression analyses were conducted to examine influencing factors for exercise tolerance. Results The ratio of diabetes, type C lesions in the AEC group were higher than those in the NEC group (diabetes: 37.5% vs. 17.5%; type C lesions: 69.4% vs. 42.5%, respectively, all P<0.05). The left ventricular ejection fraction (LVEF) in patients in the AEC group was lower than that in the NEC group [(60.6±10.0) % vs. (65.0±8.2) %, P=0.019]. Multivariate logistic regression analyses showed that history of diabetes and history of type C lesions were the independent risk factors for the declined exercise capacity in the MI patients after PCI revascularization ( OR=3.14, 95%CI 1.167-8.362, P=0.023; OR=3.32, 95%CI 1.444-7.621, P<0.01). Among the MI patients with diabetes, the duration of diabetes in the AEC group was significantly longer than that in the NEC group[ (7.7 ± 3.6)years vs. (5.0 ± 2.4)years] and the proportions of subjects reaching target levels of fasting plasma glucose (40.7% vs. 57.1%) and glycosylated hemoglobin A1c(HbA1c) (55.6% vs. 71.4%) in this group were significantly lower than those in the NEC group (all P<0.05). A multivariate logistic regression analysis showed that reaching HbA1c target was an independent predictor of improved exercise tolerance in MI patients with diabetes who received PCI ( OR=2.518, 95%CI 1.395-7.022, P=0.021). No significant differences were observed in incidence of admission due to chest pain, re?revascularization and re?infarction between the two groups within 24 months after PCI between the groups. Conclusions Diabetes and type C lesions are independent risk factors of declined exercise capacity in patients with first myocardial infarction who received revascularization in acute state. Reaching target HbA1c is independent factor of improved exercise capacity in patients with myocardial infarction and diabetes.
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Objective To investigate the influence factors of Cornell product and its clinical value in pa-tients with left ventricular high voltage.Methods 104 patients with left ventricular high voltage were studied and divided into two groups according to Cornell product:Cornell product normal group(n = 78)and Cornell product abnormal group(n=26). Clinical manifestations ,complicaions and ultracardiographic data in these patients were collected and analyzed. Results Chronic kidney disease(CKD)(OR=4.266,95%CI 1.276-14.257,P=0.018) and left ventricular mass index(LVMI)(OR = 1.023,95%CI 1.004-1.043,P = 0.016)were related to Cornell product. Cornell product was positively correlated LVMI appeared(r=0.497,P<0.001). The correlation of Cor-nell product with left ventricularend-diastolic dimension ,interventricular septal thickness and left ventricular poste-rior wall thickness was weak.ROC-AUC of Cornell product for CKD was 0.634,95%CI=0.506-0.780,P=0.039, sensibility 47.8%,and specificity 81.5%. Conclusions LVMI and CKD are independent influence factors of Cor-nell product. Cornell product has a certain diagnositc value for left ventricular hypertrophy ,but it has no associa-tion with the location of ventricular hypertrophy.
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Objective To explore the risk factors for perioperative myocardial infarction(PMI) in aged patients undergoing nonneurologic and noncardiac surgery.Methods A total of 9285 inpatients aged 65 or above receiving nonneurologic and noncardiac surgery at Peking University People's Hospital from November 2012 to May 2016 were retrospectively recruited to our study.Patients who had suffered PMI were assigned to a myocardial infarction group(MI group)and others were allocated to a nonmyocardial infarction group(non-MI group).Clinical manifestations,comorbidities,preoperative laboratory test results,polypharmacy,characteristics of operation and anesthesia,and prognosis were analyzed and compared between the two groups.A multivariate logistic regression model was built to evaluate risk factors for PMI in aged patients undergoing nonneurologic and noncardiac surgery.Results PMI occurred in 12 patients(0.13％).Previous stroke or transient ischemic attack(TIA) history (OR =159.254,P ＜ 0.001),cardiovascular heart disease (CHD) history (OR=33.645,P ＜0.001),and chronic kidney disease(CKD) (OR =19.393,P =0.003) were independent risk factors for PMI in aged patients undergoing nonneurologic and noncardiac surgery.PMI was associated with longer hospitalization[29 (15 59) days vs.9 (6-15) days,P ＜ 0.001] and higher mortality(58.3 ％).Conclusions Previous stroke or TIA history,CHD history,and CKD are independent risk factors for PMI in aged patients undergoing nonneurologic and noncardiac surgery.The incidence of PMI in patients with these risk factors is not high,but the mortality will be high and hospitalization will be prolonged once PMI occurs.Patients with these characteristics need more careful perioperative care.
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Objective To explore the effect of percutaneous coronary intervention(PCI) revascularization degree on exercise tolerance in the patients with multivessel coronary heart disease(CHD).Methods Ninety-three cases of coronary multivessel disease undergoing PCI revascularization and completing the cardiopulmonary exercise testing(CPET) were selected and divided into the complete revascularization group(CR group) and incomplete revascularization group(ICR group).The patients' general condition,co-existence diseases,medication,CHD and vessel lesion situation,echocardiography and CPET results at revascularization and within 1 week of CPET in the two groups were collected.Then the exercise tolerance was evaluated and compared between the two groups.Results The peak metabolic equivalent in the CR group and ICR group were 6.1(3.0-11.0) Mets and 6.3 (3.0-9.0) Mets;the VO2 at anaerobic threshold were 16.3(4.0-23.0) mL · kg-1 · min-1 and 15.9(4.0-26.0) mL · kg-1 · min-1,respectively;the peak VO2 were 21.1(13.0-35.0) mL · kg-1 · min-1 and 21.9(13.0-31.0) mL · kg-1 · min-1,respectively(P=0.919,0.350,0.991).Conclusion For the patients with multivessel CHD receiving ICR,their exercise tolerance is not inferior to those receiving CR.
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A random sample survey was conducted in 17 community medical institutes in 4 districts in Beijing.Among an effective sample of 385 residents.47.5％ (n =183)of community residents chose community medical institutes for first contact care while 52.5％ (n =202) opted for class other hospitals.Residents with lower education levels tended to choose community medical institutes (P =0.01).And those with chronic diseases preferred to choose communities (P=0.00).
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Objective:To investigate the correlation between Duke treadmill score (DTS) and corrected thrombolysis in myocardial infarction frame count(CTFC)in patients with coronary atherosclerotic heart disease(CAD). Methods:Seventy-two patients with coronary atherosclerotic heart disease, who underwent treadmill exercise tests in 2 weeks before coronary angiography were enrolled in our study. All the patients were divided into 2 groups according to the value of DTS: low-risk group (DTS≥5) and moderate-high-risk group (DTS