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1.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-934572

ABSTRACT

Objective:To understand the medical cost ratio and its influencing factors of breast cancer chemotherapy and molecular targeted therapy in a hospital, for reference for reasonable control of medical cost.Methods:The first page data of all breast cancer chemotherapy and molecular targeted therapy cases in a tertiary hospital from January to June 2021 were selected to extract the data of age, hospitalization expenses, hospitalization time, complications or complications. The influence of each index on the distribution of medical expense ratio was analyzed by single factor analysis and chi-square test was used for comparison between groups.Results:A total of 3 109 cases of chemotherapy and molecular targeted therapy for breast malignant tumors were included, of which very low-rate, low-rate, high-rate and very high-rate accounted for 7.04%(219 cases), 58.32%(1 813 cases), 30.81%(958 cases) and 3.83%(119 cases) respectively. In addition to the way of admission, there were significant differences in the distribution of medical cost rates under different ages, time consumption index, complications or concomitants, admission departments, treatment methods and medical insurance types( P<0.01). Conclusions:There were many factors affecting the medical cost rate of breast malignant tumors. Relevant departments should expand the pilot scope of DRG payment, promote the multi-disciplinary diagnosis and treatment mode of tumors, refine the DRG grouping scheme, to provide standardized and homogeneous diagnosis and treatment services for tumor patients, and reasonably control the excessive growth of medical costs.

2.
Chinese Journal of Orthopaedics ; (12): 220-227, 2022.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-932826

ABSTRACT

Objective:To establish a new classification of lateral clavicle fractures and to evaluate its clinical value.Methods:The data of 67 patients with lateral clavicle fractures admitted from January 2016 to December 2020 were included. Thirty-seven cases were from Shanghai First People's Hospital, including 22 males and 15 females, with an average age of 49.1 years (22-78 years). Thirty cases were from the Second Upper Limb Ward of Tianjin Hospital of Tianjin, including 20 males and 10 females, with an average age of 47.6 years (19-76 years). The ligament injury was determined by measuring the coracoclavicular space on Zanca view X-ray and the distance between the fracture fragment on the inferior surface of the 3D-CT and the distal end of the clavicle. All patients were classified according to the new classification (based on the measurement on Zanca view X-ray and 3D-CT reconstruction, the relationship between the fracture and the coracoclavicular ligament footprint, coracoclavicular ligament injury, the injury of the acromioclavicular joint and the stability of the fracture), conservative treatment is preferable for stable fractures, and surgical treatment for unstable fractures. Three experienced orthopaedic surgeons and three radiologists independently observed the imaging data of 67 patients with distal clavicle fractures, determined the fracture type according to the new classification, and randomly reclassified after 4 weeks interval. Finally, 15 cases were randomly selected for internal control (2 junior orthopedic physicians), and the ICC value was used to assess the reliability. Results:The lateral clavicle fractures were divided into 5 types according to the Gongji classification. Type 1: isolated conical tubercle avulsion fracture, and the fracture line is located medial to the coracoid process; Type 2: complete involvement of the trapezoid & conical ligament at the clavicle insertion, and the fracture line extends to the middle of the clavicle, mean while the acromioclavicular joint is intact; Type 3: fracture fragments on the inferior surface involving the trapezoidal/conical ligament, respectively; Type 4: rupture of the conical ligament, and avulsion fracture of the trapezoid ligament; Type 5: conical ligament intact, and avulsion fracture of clavicle insertion of the trapezoid ligament. There were 18 cases of type 1, 4 cases of type 2, 8 cases of type 3, 32 cases of type 4, and 5 cases of type 5. The inter-observer and intra-observer agreement of all included cases was good (inter-group: first ICC=0.764, second ICC=0.778; intra-group: shoulder specialist ICC=0.782, radiologist ICC=0.750, internal control ICC=0.793). Types 1 and 2 fractures were fixed with anatomical plate and coracoid anchor. Type 3 and 4 fractures were fixed with clavicle hook plate and coracoid anchor. And type 5 underwent conservative treatment. At the last follow-up, all patients had no obvious shoulder joint instability and pain, and no internal fixation failure or fixation breakage was found. Conclusion:The Gongji classification has moderate reliability between observers and intra-observers, and the Gongji distal clavicle fracture classification has a good significance for evaluating the stability of the fracture and guiding the selection of the treatment.

3.
Preprint in English | medRxiv | ID: ppmedrxiv-21263542

ABSTRACT

The attack ratio in a subpopulation is defined as the total number of infections over the total number of individuals in this subpopulation. Using a methodology based on modified age-stratified transmission dynamics model, we estimated the attack ratio of COVID-19 among children (individuals 0-11 years) in Ontario, Canada when a large proportion of individuals eligible for vaccination (age 12 and above) are vaccinated to achieve herd immunity among this subpopulation, or the effective herd immunity with additional physical distancing measures (hence effective herd immunity). We describe the relationship between this attack ratio among children, the time to remove infected individuals from the transmission chain and the children-to-children daily contact rate, while considering the increased transmissibility of virus variants (using the Delta variant as an example). We further illustrate the generality and applicability of the methodology established by performing an analysis of the attack ratio of COVID-19 among children in the Canadian population. The clinical attack ratio, the number of symptomatic infections over the total population can be informed from the attack ratio, and both can be reduced substantially via a combination of higher vaccine coverage in the vaccine eligible population, reduced social mixing among children, and rapid testing and isolation.

4.
Preprint in English | medRxiv | ID: ppmedrxiv-21255560

ABSTRACT

BackgroundAs COVID-19 vaccination coverage increases, public health and industries are contemplating re-opening measures of public spaces, including theme-parks. To re-open, theme-parks must provide public health mitigation plans. Questions on implementation of public health mitigation strategies such as park cleaning, COVID-19 testing, and enforcement of social distancing and the wearing of personal protective equipment (PPE) in the park remain. MethodsWe have developed a mathematical model of COVID-19 transmission in a theme-park that considers direct human-human and indirect environment-human transmission of the virus. The model thus tracks the changing infection/disease landscape of all visitors, workers, and environmental reservoirs in a theme park setting. FindingsModels results show that theme-park public health mitigation must include mechanisms that reduce virus contamination of the environment to ensure that workers and visitors are protected from COVID-19 transmission in the park. Thus, cleaning rates and mitigation of human-environment contact increases in importance. ConclusionOur findings have important practical implications in terms of public health as policy- and decision-makers are equipped with a mathematical tool that can guide theme-parks in developing public health mitigation strategies for a safe re-opening.

5.
Preprint in English | medRxiv | ID: ppmedrxiv-21255094

ABSTRACT

BackgroundDual dose SARS-CoV-2 vaccines demonstrate high efficacy and will be critical in public health efforts to mitigate the COVID-19 pandemic and its health consequences; however, many jurisdictions face very constrained vaccine supply. We examined the impacts of extending the interval between two doses of mRNA vaccines in Canada in order to inform deliberations of Canadas National Advisory Committee on Immunization. MethodsWe developed an age-stratified, deterministic, compartmental model of SARS-CoV-2 transmission and disease to reproduce the epidemiologic features of the epidemic in Canada. Simulated vaccination comprised mRNA vaccines with explicit examination of effectiveness against disease (67% [first dose], 94% [second dose]), hospitalization (80% [first dose], 96% [second dose]), and death (85% [first dose], 96% [second dose]) in adults aged 20 years and older. Effectiveness against infection was assumed to be 90% relative to the effectiveness against disease. We used a 6-week mRNA dose interval as our base case (consistent with early program rollout across Canadian and international jurisdictions) and compared extended intervals of 12 weeks, 16 weeks, and 24 weeks. We began vaccinations on January 1, 2021 and simulated a third wave beginning on April 1, 2021. ResultsExtending mRNA dose intervals were projected to result in 12.1-18.9% fewer symptomatic cases, 9.5-13.5% fewer hospitalizations, and 7.5-9.7% fewer deaths in the population over a 12-month time horizon. The largest reductions in hospitalizations and deaths were observed in the longest interval of 24 weeks, though benefits were diminishing as intervals extended. Benefits of extended intervals stemmed largely from the ability to accelerate coverage in individuals aged 20-74 years as older individuals were already prioritized for early vaccination. Conditions under which mRNA dose extensions led to worse outcomes included: first-dose effectiveness < 65% against death; or protection following first dose waning to 0% by month three before the scheduled 2nd dose at 24-weeks. Probabilistic simulations from a range of likely vaccine effectiveness values did not result in worse outcomes with extended intervals. ConclusionUnder real-world effectiveness conditions, our results support a strategy of extending mRNA dose intervals across all age groups to minimize symptomatic cases, hospitalizations, and deaths while vaccine supply is constrained.

6.
Preprint in English | medRxiv | ID: ppmedrxiv-21249175

ABSTRACT

The COVID-19 pandemic has been particularly threatening to the patients with end-stage kidney disease (ESKD) on intermittent hemodialysis and their care providers. Hemodialysis patients who receive life-sustaining medical therapy in healthcare settings, face unique challenges as they need to be at a dialysis unit three or more times a week, where they are confined to specific settings and tended to by dialysis nurses and staff with physical interaction and in close proximity. Despite the importance and critical situation of the dialysis units, modelling studies of the SARS-CoV-2 spread in these settings are very limited. In this paper, we have used a combination of discrete event and agent-based simulation models, to study the operations of a typical large dialysis unit and generate contact matrices to examine outbreak scenarios. We present the details of the contact matrix generation process and demonstrate how the simulation calculates a micro-scale contact matrix comprising the number and duration of contacts at a micro-scale time step. We have used the contacts matrix in an agent-based model to predict disease transmission under different scenarios. The results show that micro-simulation can be used to estimate contact matrices, which can be used effectively for disease modelling in dialysis and similar settings.

7.
Preprint in English | medRxiv | ID: ppmedrxiv-20232934

ABSTRACT

We propose a deterministic model capturing essential features of contact tracing as part of public health non-pharmaceutical interventions to mitigate an outbreak of an infectious disease. By incorporating a mechanistic formulation of the processes at the individual level, we obtain an integral equation (delayed in calendar time and advanced in time since infection) for the probability that an infected individual is detected and isolated at any point in time. This is then coupled with a renewal equation for the total incidence to form a closed system describing the transmission dynamics involving contact tracing. We define and calculate basic and effective reproduction numbers in terms of pathogen characteristics and contact tracing implementation constraints. When applied to the case of SARS-CoV-2, our results show that only combinations of diagnosis of symptomatic infections and contact tracing that are almost perfect in terms of speed and coverage can attain control, unless additional measures to reduce overall community transmission are in place. Under constraints on the testing or tracing capacity, a temporary interruption of contact tracing may, depending on the overall growth rate and prevalence of the infection, lead to an irreversible loss of control even when the epidemic was previously contained.

8.
Preprint in English | medRxiv | ID: ppmedrxiv-20248478

ABSTRACT

With success in the development of COVID-19 vaccines, it is urgent and challenging to analyse how the coming large-scale vaccination in the population and the growing public desire of relaxation of non-pharmaceutical interventions (NPIs) interact to impact the prevention and control of the COVID-19 pandemic. Using mathematical models, we focus on two aspects: 1) how the vaccination program should be designed to balance the dynamic exit of NPIs; 2) how much the vaccination coverage is needed to avoid a second wave of the epidemics when the NPIs exit in stages. We address this issue globally, and take six countries--China, Brazil, Indonesia, Russia, UK, and US--in our case study. We showed that a dynamic vaccination program in three stages can be an effective approach to balance the dynamic exit of the NPIs in terms of mitigating the epidemics. The vaccination rates and the accumulative vaccination coverage in these countries are estimated by fitting the model to the real data. We observed that the required effective vaccination coverages are greatly different to balance the dynamic exit of NPIs in these countries, providing a quantitative criterion for the requirement of an integrative package of NPIs. We predicted the epidemics under different vaccination rates for these countries, and showed that the vaccination can significantly decrease the peak value of a future wave. Furthermore, we found that a lower vaccination coverage can result in a subsequent wave once the NPIs exit. Therefore, there is a critical (minimum) vaccination coverage, depending on effectiveness of NPIs to avoid a subsequent wave. We estimated the critical vaccination coverages for China, Brazil, and Indonesia under different scenarios. In conclusion, we quantitatively showed that the dynamic vaccination program can be the effective approach to supplement or even eventually replace NPIs in mitigating the epidemics and avoiding future waves, and we suggest that country level-based exit strategies of the NPIs should be considered, according to the possible quarantine rate and testing ability, and the accessibility, affordability and efficiency of the vaccines.

9.
Preprint in English | medRxiv | ID: ppmedrxiv-20070318

ABSTRACT

The COVID-19 pandemic is complex and is developing in different ways according to the country involved. To identify the key parameters or processes that have the greatest effects on the pandemic and reveal the different progressions of epidemics in different countries, we quantified enhanced control measures and the dynamics of the production and provision of medical resources. We then nested these within a COVID-19 epidemic transmission model, which is parameterized by multi-source data. We obtained rate functions related to the intensity of mitigation measures, the effective reproduction numbers and the timings and durations of runs on medical resources, given differing control measures implemented in various countries. Increased detection rates may induce runs on medical resources and prolong their durations, depending on resource availability. Nevertheless, improving the detection rate can effectively and rapidly reduce the mortality rate, even after runs on medical resources. Combinations of multiple prevention and control strategies and timely improvement of abilities to supplement medical resources are key to effective control of the COVID-19 epidemic. A 50% reduction in comprehensive control measures would have led to the cumulative numbers of confirmed cases and deaths exceeding 590000 and 60000, respectively, by 27 March 2020 in mainland China. The proposed model can assist health authorities to predict when they will be most in need of hospital beds and equipment such as ventilators, personal protection equipment, drugs and staff. One sentence summaryMultiple data sources and cross validation of a COVID-19 epidemic model, coupled with a medical resource logistic model, reveal that the key factors that affect epidemic progressions and their outbreak patterns in different countries are the type of emergency medical response to avoid runs on medical resources, especially improved detection rates, the ability to promote public health measures, and the synergistic effects of combinations of multiple prevention and control strategies.

10.
Preprint in English | medRxiv | ID: ppmedrxiv-20033464

ABSTRACT

We conducted a comparative study of COVID-19 epidemic in three different settings: mainland China, the Guangdong province of China and South Korea, by formulating two disease transmission dynamics models incorporating epidemic characteristics and setting-specific interventions, and fitting the models to multi-source data to identify initial and effective reproduction numbers and evaluate effectiveness of interventions. We estimated the initial basic reproduction number for South Korea, the Guangdong province and mainland China as 2.6 (95% confidence interval (CI): (2.5, 2.7)), 3.0 (95%CI: (2.6, 3.3)) and 3.8 (95%CI: (3.5,4.2)), respectively, given a serial interval with mean of 5 days with standard deviation of 3 days. We found that the effective reproduction number for the Guangdong province and mainland China has fallen below the threshold 1 since February 8th and 18th respectively, while the effective reproduction number for South Korea remains high, suggesting that the interventions implemented need to be enhanced in order to halt further infections. We also project the epidemic trend in South Korea under different scenarios where a portion or the entirety of the integrated package of interventions in China is used. We show that a coherent and integrated approach with stringent public health interventions is the key to the success of containing the epidemic in China and specially its provinces outside its epicenter, and we show that this approach can also be effective to mitigate the burden of the COVID-19 epidemic in South Korea. The experience of outbreak control in mainland China should be a guiding reference for the rest of the world including South Korea.

11.
Preprint in English | medRxiv | ID: ppmedrxiv-20027615

ABSTRACT

Before the lock-down of Wuhan/Hubei/China, on January 23rd 2020, a large number of individuals infected by COVID-19 moved from the epicenter Wuhan and the Hubei province due to the Spring Festival, resulting in an epidemic in the other provinces including the Shaanxi province. The epidemic scale in Shaanxi was comparatively small and with half of cases being imported from the epicenter. Based on the complete epidemic data including the symptom onset time and transmission chains, we calculate the control reproduction number (1.48-1.69) in Xian. We could also compute the time transition, for each imported or local case, from the latent, to infected, to hospitalized compartment, as well as the effective reproduction number. This calculation enables us to revise our early deterministic transmission model to a stochastic discrete epidemic model with case importation and parameterize it. Our model-based analyses reveal that the newly generated infections decay to zero quickly; the cumulative number of case-driven quarantined individuals via contact tracing stabilize at a manageable level, indicating that the intervention strategies implemented in the Shaanxi province have been effective. Risk analyses, important for the consideration of "resumption of work", show that a large second outbreak is expected if the level of case importation remains at the same level as between January 10th and February 4th 2020. However, if the case importation decreases by 30%, 60% and 90%, the second outbreak if happening will be of small-scale assuming contact tracing and quarantine/isolation remain as effective as before. Finally, we consider the effects of intermittent inflow with a Poisson distribution on the likelihood of multiple outbreaks. We believe the developed methodology and stochastic model provide an important model framework for the evaluation of revising travel restriction rules in the consideration of resuming social-economic activities while managing the disease control with potential case importation.

12.
Preprint in English | medRxiv | ID: ppmedrxiv-20025338

ABSTRACT

BACKGROUNDThe outbreak of COVID-19 has laid unprecedented psychological stress on health workers (HWs). We aimed to assess the immediate psychological impact on HWs at Tongji Hospital in Wuhan, China. METHODSWe conducted a single-center, cross-sectional survey of HWs via online questionnaires between February 8th and 10th, 2020. We evaluated stress, depression and anxiety by Impact of Event Scale-Revised (IES-R), Patient Health Questionnaire-9 (PHQ-9), and Generalized Anxiety Disorder 7-item (GAD-7), respectively. We also designed a questionnaire to assess the effect of psychological protective measures taken by Tongji Hospital. Multivariate logistic regression was used to identify predictors of acute stress, depression, and anxiety. RESULTSWe received 5062 completed questionnaires (response rate, 77.1 percent). 1509 (29.8 percent), 681 (13.5 percent) and 1218 (24.1 percent) HWs reported stress, depression and anxiety symptoms. Women (hazard ratio[HR], 1.31; P=0.032), years of working> 10 years (HR, 2.02; P<0.001), concomitant chronic diseases (HR, 1.51; P<0.001), history of mental disorders (HR, 3.27; P<0.001), and family members or relatives confirmed or suspected (HR, 1.23; P=0.030) were risk factors for stress, whereas care provided by hospital and department administrators(odds ratio [OR], 0.76; P=0.024) and full coverage of all departments with protective measures (OR, 0.69; P=0.004) were protective factors. CONCLUSIONSWomen and those who have more than 10 years of working, concomitant chronic diseases, history of mental disorders, and family members or relatives confirmed or suspected are susceptible to stress, depression and anxiety among HWs during the COVID-19 pandemic. Psychological protective measures implemented by the hospital could be helpful.

13.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-799115

ABSTRACT

Objective@#To explore the operative strategy of distal clavicle fracture involving coracoclavicular ligament.@*Methods@#Data of 17 cases of distal clavicle fracture involving coracoclavicular ligament in our hospital from January 2013 to December 2018 were analyzed retrospectively. According to whether the coracoclavicular ligament was reconstructed or not, the patients were divided into two groups: non reconstruction group (10 cases), male (7 cases), female (3 cases), 19-60 years old (37.9±11.9). In the reconstruction group, 7 cases were male 5, female 2, 25-62 years old (44.9±13.0). Three dimensional CT was used to judge the ligament injury and X-ray was used to evaluate the fracture reduction and healing after operation. The time of fracture healing was compared between the two groups. The function of shoulder joint was evaluated by visual analog scale (VAS) and Constant score of shoulder joint.@*Results@#The patients in both groups were followed up for (18.7±6.7) months (range, 9-27 months). At the latest follow-up, the time of fracture healing in the reconstruction group was 12.6±0.7 weeks (range, 12-14 weeks); VAS score was 3.0±1.3 and Constant-Murley score was 85±11. While those in the non reconstruction group were 23.7±7.9 (range, 16- 48 weeks), 3.1±1.8 and 77±10 respectively. The time of fracture healing was statistically significant (t=3.361, P=0.004). There was no significant difference in VAS score and Constant score (P> 0.05). In the non reconstruction group, there were 1 case of delayed union of fracture (healed 48 weeks after operation), 1 case of loosening of clavicular hook plate, 5 cases of acromioclavicular joint dislocation (Rockwood type II) after removal of internal fixation, and the overall complication rate was 70% (7/10). Reconstruction group: 1 case of acromial fracture, the overall complication rate was 14.3% (1/7). There was significant difference between the two groups (χ2=5.13, P=0.024).@*Conclusion@#Reconstruction of clavicular insertion of coracoclavicular ligament can effectively reduce the postoperative complications of distal clavicular fracture involving the coracoclavicular insertion. Attention should be paid to the repair and reconstruction of coracoclavicular ligament injury during fracture treatment.

14.
Chinese Journal of Orthopaedics ; (12): 593-596, 2020.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-869001

ABSTRACT

A case of acute posterior dislocation of shoulder with fracture of greater tubercle of humerus was reported. The patient came to hospital complaining pain and limited motion of left shoulder caused by traffic accident. The diagnosis of posterior dislocation of the left shoulder and fracture of the greater tubercle was confirmed by medical history, physical examination and imaging. After the failure of manual reduction under anesthesia, MRI was conducted which revealed that the biceps brachii longus and supraspinatus and infraspinatus muscle were embedded between the head of humerus and glenoid scapula. Then open reduction and internal fixation was performed. The biceps brachii longus was cut off and then fixed in the inter nodal groove. After the rotator cuff was relieved from the impaction, the dislocation of the humeral head was successfully reduced and the fracture of the greater tubercle was reduced and fixed. According to the operation process, the possible trauma mechanism is discussed as follows: the displaced fracture of the greater tubercle destroyed the integrity of the lateral wall of the inter tubercular groove, and the biceps brachii longus slipped out of the inter tubercular groove and shifted to the medial side, which was embedded between the humeral head and the scapular glenoid, thus forcing the humeral head to fall posteriorly, and causing the fracture of the greater tubercle to move anteriorly and inferiorly. Attention should be paid to the possible acute dislocation of shoulder joint for the patients with high energy injury. The only way to avoid missed diagnosis is to combine with multi-directional X-ray or CT examination of shoulder. MRI should be used to determine whether there is tendon incarceration of rotator cuff and/or biceps brachii longus in patients with acute posterior dislocation of shoulder. Anatomic reduction of tubercle fracture is the key to recover the range of motion and muscle strength of shoulder joint.

15.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-868939

ABSTRACT

Objective To explore the operative strategy of distal clavicle fracture involving coracoclavicular ligament.Methods Data of 17 cases of distal clavicle fracture involving coracoclavicular ligament in our hospital from January 2013 to December 2018 were analyzed retrospectively.According to whether the coracoclavicular ligament was reconstructed or not,the patients were divided into two groups:non reconstruction group (10 cases),male (7 cases),female (3 cases),19-60 years old (37.9± 11.9).In the reconstruction group,7 cases were male 5,female 2,25-62 years old (44.9± 13.0).Three dimensional CT was used to judge the ligament injury and X-ray was used to evaluate the fracture reduction and healing after operation.The time of fracture healing was compared between the two groups.The function of shoulder joint was evaluated by visual analog scale (VAS) and Constant score of shoulder joint.Results The patients in both groups were followed up for (18.7±6.7) months (range,9-27 months).At the latest follow-up,the time of fracture healing in the reconstruction group was 12.6±0.7 weeks (range,12-14 weeks);VAS score was 3.0± 1.3 and Constant-Murley score was 85± 11.While those in the non reconstruction group were 23.7±7.9 (range,16-48 weeks),3.1± 1.8 and 77± 10 respectively.The time of fracture healing was statistically significant (t=3.361,P=0.004).There was no significant difference in VAS score and Constant score (P> 0.05).In the non reconstruction group,there were 1 case of delayed union of fracture (healed 48 weeks after operation),1 case of loosening of clavicular hook plate,5 cases of acromioclavicular joint dislocation (Rockwood type Ⅱ) after removal of internal fixation,and the overall complication rate was 70% (7/10).Reconstruction group:1 case of acromial fracture,the overall complication rate was 14.3% (1/7).There was significant difference between the two groups (x2=5.13,P=0.024).Conclusion Reconstruction of clavicular insertion of coracoclavicular ligament can effectively reduce the postoperative complications of distal clavicular fracture involving the coracoclavicular insertion.Attention should be paid to the repair and reconstruction of coracoclavicular ligament injury during fracture treatment.

16.
China Pharmacist ; (12): 1731-1734, 2018.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-705692

ABSTRACT

Objective: To compare the pharmacokinetics and bioavailability of pirfenidone in the fasted and fed states in healthy volunteers. Methods: An open-label, randomized crossover study was conducted in 12 healthy subjects. Food effects were examined by comparing pharmacokinetic data of pirfenidone after administration of a single oral 400 mg dose under fasted or fed conditions. Plas-ma pirfenidone concentration was determined by an HPLC method and its pharmacokinetic parameters were calculated with DAS v2. 0 software. Results: Under fasted and fed conditions, the concentration-time profiles of pirfenidone were fitted a one-compartment model and the pharmacokinetic parameters were as follows: t1/2were (2. 16 ± 0. 47) and (2. 05 ± 0. 42) h;tmaxwere(0. 69 ± 0. 16)and (1. 46 ± 0. 40)h;Cmaxwere (12. 95 ± 1. 79) and (9. 16 ± 2. 87) mg·L-1;AUC0-12were (44. 97 ± 15. 06) and (36. 19 ± 14. 44) mg·h·L-1;AUC0-∞were (46. 55 ± 16. 79) and (37. 41 ± 15. 43) mg·h·L-1, respectively. When compared with that of the fasted group, tmaxwas significantly increased (P<0. 001) while Cmaxand AUC were remarkedly decreased in the fed group (P<0. 001 and P<0. 01, respectively). Conclusion: Concomitant food intake significantly influences the pharmacokinetics and bioavail-ability of pirfenidone as indicated by reducing its extent and rate of absorption, which is associated with better tolerability.

17.
Herald of Medicine ; (12): 803-808, 2016.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-495496

ABSTRACT

Objective To retrospectively analyze adverse drug reaction ( ADR ) of Yuxingcao ( Houttuyniae Herba ) preparations, thus provide reference for post-market re-evaluation of traditional Chinese medicine injections. Methods The ADR from Chinese ADR spontaneous reporting system database from 2006 to 2008 were analyzed by descriptive statistic method. Results A total of 2 282 reports on ADR induced by Yuxingcao preparations were concluded in this study, and 98.07% ADR of the total cases ( 2 238 case ) were due to vein injection. The main ADR were anaphylactic reactions which injure multiple systems and organs.The most frequent symptoms were respiratory system damage, such as expiratory dyspnea (with the incidence rate of 27.25%).Skin and mucous membrane were the secondly susceptible (with the incidence rate of 21.35%).The ratio of serious ADR in the total case was 13.50% (308 case), rate of allergic shock was 8.37% (191 case), and 22 cases were dead. Conclusion By strengthening the ADR reporting and monitoring, the risk of traditional Chinese medicine injection could be controlled.Safety re-evaluation should be performed to overall enhance safety, effectiveness and quality control of these kinds of medicine.

18.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-494442

ABSTRACT

Objective:To study the antidepressant effect of Baihe Zhimu decoction (BZD)and its influence in the key factors (CaM,CaMKⅡ,CREB)of CaM signaling pathway in hippocampus of the rats with depression,and to explore the antidepressant effect of BZD. Methods:Fifty rats were divided into control group,model group, fluoxetine group,low and high doses of BDZ groups (n = 10).Expect for control group,all the rats in other groups were made depression models by means of chronic unpredictable mild stress along with isolated raising,for 21 d.Then the rats were fed with NS, fluoxetine (1.8 mg · kg-1 ), and BZD (1.5 and 3.0 g · kg-1 ), respectively;for 28 d.The learning and memory ability,autonomous activities and the fixed time in 5 min of the rats were tested by Morris water amaze,Open-field Test and Forced Swimming Test respectively. The damage and repair status of hippocampal neurons were observed by Nissl staining method;the expression levels of CaM,CaMKⅡ protein,CREB mRNA in hippocampus of the rats were detected by Western blotting and RT-PCR method. Results:Compared with model group,the total time of rats in the platform quadrant of Morris water maze in BZD groups and fluoxetine group,the total distance and the number of crossing platform were increased (P <0.05 or P <0.01),and the time of first crossing platform were shortened (P <0.01);the total scores in open field test were increased (P <0.01),the fixed time with 5 min in the forced swimming test was shortened (P <0.05 or P <0.01).Compared with fluoxetine group,the fixed time within 5 min of the rats in swimming test was shortened (P <0.05).The result of Nissl staining showed that the hippocampal neuron injury in BZD groups and fluoxetine group was improved compared with model group.The molecular test results showed that the CaM and CaMKⅡprotein expression levels in hippocampus of the rats in BZD groups and fluoxetine group were increased compared with model group (P < 0.05 or P < 0.01).Compared with model group,the CREB mRNA expression levels in fluoxetime group and BZD groups were increased (P < 0.05 or P < 0.01).Conclusion:BZD has antidepressant effect and can improve the hippocampal neuron injury of the rats with depression and its mechanism is related to increasing the expression levels of CaM,CaMKⅡ and CREB in hippocampus CAM signaling pathway of the rats.

19.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-489221

ABSTRACT

Objective To explore the clinical significance of the inferior displacement sign on the initial anterioposterior (AP) view X-ray for fractures of humeral greater tuberosity.Methods This study retrospectively analyzed the imaging and clinical data of 24 patients with isolated fracture of humeral greater tuberosity who had sought medical treatment during the period from January 2008 to June 2015.They were 10 males and 14 females,with an average age of 54 years (from 19 to 68 years).Laterality:8 left sides and 16 right sides.The AP view X-ray films of the 24 patients present the inferior displacement sign defined as the inferior cortical margin of the greater tuberosity overlapping the proximal humeral shaft on the initial AP view.The patients received further CT examination to determine the displacement direction and whether the humeral neck fracture was complicated.Results A slight displacement of humeral anatomic neck fracture was shown on the initial AP view X-ray in 10 patients.Further CT examination revealed that humeral anatomic neck fracture was confirmed in 23 patients,the greater tuberosity was displaced posteriorly in 22 patients and posteroinferiorly in 2 patients.Radiographic measurements showed:the mean posterior displacement was 10.5 ±4.5 mm;the displacement between the humeral head and the humeral shaft was 2.5 ± 1.5 mm;the neck shaft angle was 147.2° ± 9.2°;the distance between the humeral head and greater tuberosity was 10.8 ± 3.4 mm;the overlap between the inferior edge of greater tuberosity and the upper edge of lateral humeral shaft was 12.5±5.9 mm.Pearson correlation analysis showed no correlation between the overlap and the head-tuberosity distance (P > 0.05),but a significant correlation between the overlap and the neck-shaft angle (P < 0.05).Conclusions The inferior displacement sign on the initial AP view X-ray is actually the overlap of posterior displaced greater tuberosity fracture shown on the X-ray.The posterior displaced greater tuberosity fracture complicated with slight displaced anatomic neck fracture is a presentation of the valgus impacted fracture of the proximal humerus.The inferior displacement sign in the fracture of humeral greater tuberosity can highly suggest the presence of occult or slight displacement of the humeral anatomic neck fracture.

20.
Herald of Medicine ; (12): 448-453, 2016.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-486464

ABSTRACT

Objective To investigate the different components of Acorus tatarinowii and Polygala tenuifolia(volatile oil, aqueous extract)on the expression of phosphorylated Tau protein at site Ser396 and Tau-5 in the hippocampus of rats with Alzheimer′s disease(AD). Methods Male Sprague Dawley rats were randomly divided into 8 groups:normal control group, model control group,low-,middle-,and high-dose groups of volatile oil of Acorus tatarinowii and Polygala tenuifolia,and low-, middle-,and high-dose groups of aqueous extract of Acorus tatarinowii and Polygala tenuifolia. The subacute aging model was established by intraperitoneal injection of D-galactose( D-gal). Rats were given different components of Acorus tatarinowii and Polygala tenuifolia(crude drug dosage,0.6,1.2,1.8 g·kg-1 )in experimental groups,and 0.9% sodium chloride solution in normal control group and model control group,by gavage for 28 days.The levels of phosphorylated Tau protein at site Ser396 and Tau-5 were detected in hippocampal tissues by Western blotting and immunohistochemistry. Results The levels of phosphorylated Tau protein at site Ser396 were significantly enhanced in the model control group,as compared with those in normal control group (P0.05). Conclusion Acorus tatarinowii and Polygala tenuifolia could promote the dephosphorylation of Ser396 site of Tau protein in the hippocampus of AD rats,with the aqueous extract component having better effects.

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