ObjectiveTo introduce economic evaluation methods for anticancer-drugs with basket trial design, and to provide references for related research and decision-making. MethodsA case analysis was conducted on economic evaluation methods for anticancer-drugs with basket trial design, which was issued by Canadian Agency for Drugs and Technologies in Health (CADTH) in the Economic Guidance Report. Moreover, both the advantages and disadvantages of the methods were analyzed in accordance with the characteristics of basket trials. ResultsPooled analysis and tumor-specific analysis were two methods frequently employed in the case analysis. However, great uncertainties were available in both of them. The uncertainty of the former was mainly reflected in the heterogeneity of the targeted population, while the uncertainty of the latter was mainly shown in the insufficient sample size of the subgroup. ConclusionCurrently, economic evaluation methods for anticancer-drugs with basket trial design are immature. Thus, researchers are required to explore the methods of innovation evaluation with lower uncertainty; reimbursement decision-makers should fully consider the uncertainty of evaluation results and enterprises should collect the real-world data for the demands of evaluation to promote the reasonable allocation of healthcare resources in China.
Objective To evaluate the quality of evidence of systematic reviews or meta-analyses regarding outcomes in nursing field in China using the Grade system, so as to get known of the status of the quality of evidence and promote the application of the evaluation of the quality of evidence of systematic reviews. Methods The quality of evidence regarding the included outcomes was input, extracted and qualitatively graded, using GRADEpro 3.6 software. Then, we carefully analyzed and elaborated the factors of downgrading and upgrading that affects the quality of evidence in the process of evaluation. Results 53 systematic reviews or meta-analyses involving 188 outcomes were identified and evaluated. The results showed that high, moderate, low and very low levels of quality of evidence were 2.7%, 27.1%, 51.1%, and 19.1%, respectively; and low-level quality of evidence accounted for the most. Conclusion The quality of evidence produced by systematic reviews or meta-analyses in nursing field in China is poor and urgently needs improvement. The reviewers should abide by the methodological standards in the process of making systematic reviews or meta-analyses. The quality of evidence in terms of each outcome should be evaluated and fully reported.
In order to investigate the application of lattice Boltzmann method (LBM) in the numerical simulation of computed tomography angiography-derived fractional flow reserve (FFRCT), an idealized narrowed tube model and two coronary stenosis arterymodels are studied. Based on the open source code library (Palabos), the relative algorithm program in the development environment (Codeblocks) was improved. Through comparing and analyzing the results of FFRCT which is simulated by LBM and finite element analysis software ANSYS, and the feasibility of the numerical simulation of FFRCT by LBM was verified . The results show that the relative error between the results of LBM and finite element analysis software ANSYS is about 1%, which vertifies the feasibility of simulating the coronary FFRCT by LBM. The simulation of this study provides technical support for developing future FFRCT application software, and lays the foundation for the calculation of clinical FFRCT.
Objective To analyze the application value of swallowing function therapeutic instrument in dysphagia after stroke. Methods Stroke patients with dysphagia treated in the Department of Rehabilitation Medicine of Qinghai University Affiliated Hospital between July 2018 and April 2020 were selected. The patients were randomly divided into experimental group and control group. The control group was treated with comprehensive rehabilitation treatment, and the experimental group was treated with comprehensive rehabilitation treatment and swallowing function therapeutic instrument. The improvement of dysphagia and the changes of clinical indexes were observed in the two groups. Results A total of 100 patients were included, with 50 patients in each group. Before the intervention, there was no significant difference between the two groups in Standardized Swallowing Assessment (SSA), video fluoroscopy swallowing study (VFSS), ultrasonic exercise amplitude and duration (P>0.05). After 4 weeks of intervention, the SSA score, VFSS score, ultrasonic exercise amplitude and duration of the two groups were improved compared with those before intervention (P<0.05), and the experimental group was better than the control group (P<0.05). The improvement of dysphagia between the two groups was statistically significant (Z=−2.452, P=0.014). The total effective rate of dysphagia improvement in the experimental group (92.00%) was higher than that in the control group (82.00%), but there was no significant difference between the two groups (χ2=2.210, P=0.137). Conclusion The application of swallowing function therapeutic instrument in the adjuvant treatment of dysphagia after stroke is helpful to improve the clinical symptoms of patients and obtain ideal therapeutic effect, which is worth popularizing.
With the increase in the number of single-arm clinical trials and lack of head-to-head clinical studies, the application of unadjusted indirect comparisons and network meta-analysis methods has been limited. Matching-adjusted indirect comparison (MAIC) is an alternative method to fully utilize individual patient data from one study and balance potential bias caused by baseline characteristics differences in different trials through propensity score matching with aggregated data reported in other studies, and complete the comparison of the efficacy between target interventions. This study introduced the concept and principles of MAIC. In addition, we demonstrated how to use the anchored MAIC method based on R language for survival data, which has been widely used in anti-cancer drug evaluation. This study aimed to provide an alternative method to inform evidence-based decisions.
【摘要】 目的 评价生长抑素联合中药在治疗重症急性胰腺炎中的有效性。 方法 应用国际Cochrane协作网系统评价方法对生长抑素联合中药治疗重症急性胰腺炎的随机对照试验（RCT）进行系统评价。计算机检索MEDLINE（Ovid）、PubMed数据库、中文科技期全文数据库（VIP）、万方数据库、中国期刊全文数据库（CNKI）、中国生物医学文献数据库（CBM）。检索时间均为建库至2009年9月。文献检索语种为英语和中文。 结果 共纳入8个RCT，436例患者，所有纳入试验在治疗末均未进行随访。Meta分析结果显示，生长抑素联合中药治疗组（治疗组）的病死率（13/188，6.9%）明显低于单纯生长抑素治疗组（对照组）（24/174，13.7%），差异有统计学意义[Peto OR=0.46，95%CI（0.22，0.94），Plt;0.05]。治疗组平均住院日低于对照组[WMD=-7.01，95%CI（-7.89，-6.13），Plt;0.000 01]。治疗组腹痛缓解时间明显低于对照组，其差异有统计学意义[WMD=-0.77，95%CI（-0.82，-0.72），Plt;0.000 01]。治疗组与对照组治疗第7天APACHE Ⅱ评分均下降，治疗组下降幅度大于对照组，两组比较差异有统计学意义（Plt;0.05）。治疗组并发症发生率（26/91，28.6%）与对照组（35/88，39.8%）相比，其差异无统计学意义[Peto OR=0.61，95%CI（0.32，1.13），P=0.12]。 结论 生长抑素联合中药治疗在改善重症急性胰腺炎的病死率、平均住院时间、腹痛缓解时间、APACHE Ⅱ评分下降幅度优于单纯生长抑素治疗。
【摘要】 目的 探讨血浆胰蛋白酶原激活肽(trypsinogen activation peptide,TAP)水平与重症急性胰腺炎(severe acute pancreatitis,SAP)胰腺坏死的关系。方法 2008年6月1日—2008年12月31日,采用ELISA法测定本院的35例SAP患者血浆TAP水平,并与胰腺增强CT扫描结果作对比,分析血浆TAP水平与胰腺坏死的关系,以及SAP无胰腺坏死组与SAP胰腺坏死组血浆TAP水平的差异。结果 入院时血浆TAP水平预测胰腺坏死的最佳截值点是10.43 nmol/mL,其敏感性、特异性、阳性预测值、阴性预测值分别为75%、73.9%、60%、15%,阳性比为2.87,阴性比为0.338。入院第1天血浆TAP水平预测胰腺坏死的最佳截值点是6.91 μmol/L,其敏感性、特异性、阳性预测值、阴性预测值分别为90.9%、65.2%、55.6%、6.3%,阳性似然比为2.61,阴性似然比为0.001。SAP胰腺坏死组入院时、入院第一天血浆TAP水平高于SAP无胰腺坏死组(Plt;0.05)。结论 血浆TAP水平变化与SAP病情变化密切相关,病程早期检测血浆TAP水平有助于SAP患者胰腺坏死的预测
ObjectiveTo study the preparation and properties of the hyaluronic acid (HA)/α-calcium sulfate hemihydrate (α-CSH)/β-tricalcium phosphate (β-TCP) material (hereinafter referred to as composite material). Methods Firstly, the α-CSH was prepared from calcium sulfate dihydrate by hydrothermal method, and the β-TCP was prepared by wet reaction of soluble calcium salt and phosphate. Secondly, the α-CSH and β-TCP were mixed in different proportions (10∶0, 9∶1, 8∶2, 7∶3, 5∶5, and 3∶7), and then mixed with HA solutions with concentrations of 0.1%, 0.25%, 0.5%, 1.0%, and 2.0%, respectively, at a liquid-solid ratio of 0.30 and 0.35 respectively to prepare HA/α-CSH/ β-TCP composite material. The α-CSH/β-TCP composite material prepared with α-CSH, β-TCP, and deionized water was used as the control. The composite material was analyzed by scanning electron microscope, X-ray diffraction analysis, initial/final setting time, degradation, compressive strength, dispersion, injectability, and cytotoxicity. ResultsThe HA/α-CSH/β-TCP composite material was prepared successfully. The composite material has rough surface, densely packed irregular block particles and strip particles, and microporous structures, with the pore size mainly between 5 and 15 μm. When the content of β-TCP increased, the initial/final setting time of composite material increased, the degradation rate decreased, and the compressive strength showed a trend of first increasing and then weakening; there were significant differences between the composite materials with different α-CSH/β-TCP proportion (P<0.05). Adding HA improved the injectable property of the composite material, and it showed an increasing trend with the increase of concentration (P<0.05), but it has no obvious effect on the setting time of composite material (P>0.05). The cytotoxicity level of HA/α-CSH/β-TCP composite material ranged from 0 to 1, without cytotoxicity. Conclusion The HA/α-CSH/β-TCP composite materials have good biocompatibility. Theoretically, it can meet the clinical needs of bone defect repairing, and may be a new artificial bone material with potential clinical application prospect.