摘要:目的:探索可靠的卒中患者床旁吞咽评估方法。方法：61例住院卒中患者均进行各种床旁吞咽评估筛查及电视透视检查，以后者为金标准探讨各方法的敏感度、特异度及阳性、阴性预测值。结果:六种独立床旁吞咽评估方法与金标准相比较的敏感度在60%～87%之间，特异度在76%～89%之间，阳性预测值在50%～69%之间，阴性预测值在86%～95%之间；几种评估方法作为平行试验联合应用时的敏感度在89%～98%之间，阴性预测值在94%～99%之间；几种方法作为序列试验应用时的特异度在97%～99%之间，阳性预测值在82%～90%之间。结论：根据不同方法的预测特点，可得到针对不同患者的、有效的床旁评估方法。床旁吞咽评估简单、有效、便捷，是临床工作中适宜的评估方法。
Objective To assess the effectiveness and safety of one kind of ACEI—Ramipril, for providing proofs for clinical implement and we also tried to explore the practical method of evidence-based drug assessment. Method By using the methods and principles of systematic review (SR), and health technology assessment (HTA), we searched Medline and Cochrane Library, together with related materials provided by pharmaceutics and collected all the published clinical research reports on Ramipril. Based on principles of SR and HTA, we assessed all the included reports comprehensively. Results We totally collected 214 articles about Ramipril, in which there were 18 articles meeting the inclusion criteria and 31 139 patients were enrolled in these studies. The research contents include: hypertension, diabetes mellitus, heart failure, myocardial infarction, nephropathy and secondary prevention for cardio-cerebral vascular disease. Conclusion According to our clinical evidence assessment, Ramipril is an effective, safe and easy to take drug and is worthy to spread.
Objective To learn if appropriate methods and clinically relevant outcomes were used by analyzing methods of outcome assessment in Chinese acute stroke trials. Method Randomised and quasi-randomised controlled trials on acute stroke published before March 2003 in 6 Chinese neurological journals were included. Types of outcome measures, blinding of outcome assessment, duration of follow up, statistical methods used for data analysis and the significance of the results were evaluated. Types of outcomes were classified as death and four levels: ① Pathology. ② Impairment. ③ Disability. ④ Handicap/quality of life. Results Two hundreds and ten trials were included in this analysis. 57% of the trials used outcomes in pathology level, 77% in impairment level, 12% in disability level and none in the quality of life level. No dichotomous data was analyzed for disability measures. Only 16% of the trials reported number of death but few of them designed death as an outcome measure. Duration of follow up ranged from 3h to 3 years (median 17 d, interquartile range 14-30 d). Most trials did not assess outcomes blindly. Results in 95% of the trials were favorable to the tested interventions. Conclusions In Chinese acute stroke trials, outcome measures used were mainly in pathology and impairment levels and very few trials used functional outcome or death. Blinding of outcome assessment was not commonly used. The average duration of follow up was short.
Objective To compare the newest essential medicine lists (EMLs) of China and the World Health Organization (WHO) in 2009, so as to provide the evidence for the selection, adjustment and implementation of the newest national EML of China. Methods Differences in the procedures of selection, implementation and the categories as well as the number of medicines in 2009 EMLs of the WHO and China were compared by descriptive analysis. Result Principles and procedures of selecting and updating EML of China were based on those of the WHO EML. However, the transparency of procedures, methods of selection, and evidence of efficacy, safety, cost-effectiveness and suitability were not enough. Essential medicines of the WHO were categorized by the Anatomical-Therapeutic-Chemical (ATC) classification system, while those of China were classified by clinical pharmacology. Twenty-one identical categories of the first class were found in the two lists. There were 8 and 3 unique categories in the WHO EML and China EML, respectively. A total of 358 and 255 medicines (including medicines in its explanation) were included in the EMLs of the WHO and China, respectively, with 133 identical medicines as well as 206 and 108 unique medicines. There were 51 antiinfective medicines in China EML, accounting for half of the WHO EML. Forty medicines were the same in both lists, and 11 and 60 anti-infective medicines were unique in EMLs of China and the WHO, except for 40 identical medicines. Among them, 22 and 31 antibacterials were included in the lists of the WHO and China with 17 identical medicines. Antifungal, antituberculosis and antiviral medicines in China EML were fewer than those in the WHO EML. The numbers of the identical medicines acting on the respiratory, digestive, and nervous systems and hormones in the both lists were 1, 7, 9, and 17, respectively, while the unique ones in China EML were 6, 12, 7, and 14, respectively. However, most of them were selected without adequate evidence in efficacy and safety. The medicines acting on cardiovascular system were 19 and 29 in both lists with 14 identical medicines. Some antihypertensive and antiarrhythmic medicines were included in China EML with similar mechanism, whereas some of them were excluded by the EML. Conclusion The total numbers of both EMLs are close to each other with half of the identical medicines. The selection of China EML mostly meets the needs of disease burden in China. However, the transparency of selection and evidence are not enough. We suggest that health authorities should cooperate with other stakeholders to promote the transparency of selection, to enhance the capacity of producing high-quality evidence, to develop related technical documents and guidelines, and to disseminate and monitor the implementation of EML.
ObjectiveTo analyze the clinical predictive factors of tumor pathological response to preoperative chemoradiotherapy for rectal cancer. MethodsOne hundred and seven patients treated with preoperative capecitabine and pelvic conformal radiotherapy and underwent total mesorectal excision from January 2005 to December 2012 in this hospital were analyzed retrospectively.Tumor response according to tumor regression grade was evaluated.The correlation of clinicopathologic factors with tumor response was analyzed by logistic regression analysis. ResultsThe single factor analysis results showed that the age, gender, distance of tumor from anal verge, differentiation degree of tumor, infiltration depth of tumor, and pretreatment CA19-9 level were not correlated with rectal cancer pathological response to preoperative chemoradiotherapy (P > 0.05).The tumor circumferential extent, tumor mobilit, lymph node metastasis, pretreatment carcinoembryonic antigen (CEA) level, and pretreatment hemoglobin level were correlated with it (P < 0.05).The logistic regression analysis results showed that non-fixed tumor (P=0.015), pretreatment CEA level≤5.0μg/L (P=0.012), and pretreatment hemoglobin level > 10 g/L (P=0.007) independently predicted a good pathologic response rate. ConclusionTumor mobility, pretreatment CEA level, and hemoglobin level are important predictors of pathological response to preoperative chemoradiotherapy in rectal cancer.
Objective To evaluate the correlation between pelvic incidence (PI) angle, hip deflection angle (HDA), combined deflection angle (CDA) and osteonecrosis of the femoral head (ONFH) after femoral neck fracture, in order to explore early predictive indicators for ONFH occurrence after femoral neck fracture. Methods A study was conducted on patients with femoral neck fractures who underwent cannulated screw internal fixation between December 2018 and December 2020. Among them, 208 patients met the selection criteria and were included in the study. According to the occurrence of ONFH, the patients were allocated into ONFH group and non-NOFH group. PI, HDA, and CDA were measured based on the anteroposterior X-ray films of pelvis and axial X-ray films of the affected hip joint before operation, and the differences between the two groups were compared. The receiver operating characteristic curve (ROC) was used to evaluate the value of the above imaging indicators in predicting the occurrence of ONFH. ResultsAmong the 208 patients included in the study, 84 patients experienced ONFH during follow-up (ONFH group) and 124 patients did not experience ONFH (non-ONFH group). In the non-ONFH group, there were 59 males and 65 females, the age was 18-86 years (mean, 53.9 years), and the follow-up time was 18-50 months (mean, 33.2 months). In the ONFH group, there were 37 males and 47 females, the age was 18-76 years (mean, 51.6 years), and the follow-up time was 8-45 months (mean, 22.1 months). The PI, HDA, and CDA were significantly larger in the ONFH group than in the non-ONFH group (P<0.05). ROC curve analysis showed that the critical value of PI was 19.82° (sensitivity of 40.5%, specificity of 86.3%, P<0.05); the critical value of HDA was 20.94° (sensitivity of 77.4%, specificity of 75.8%, P<0.05); and the critical value of CDA was 39.16° (sensitivity of 89.3%, specificity of 83.1%, P<0.05). Conclusion There is a correlation between PI, HDA, CDA and the occurrence of ONFH after femoral neck fracture, in which CDA can be used as an important reference indicator. Patients with CDA≥39.16° have a higher risk of ONFH after femoral neck fracture.
Objective To establish a Chinese clinical controlled trials database of neurology. Methods We identified relevant studies by electronic searching of CBMdisc from 1978 to April 2002, and the Library of Evidence-Based Medicine (Chinese). We also searched manually 11 journals and 4 conference proceedings relevant to neurological diseases. The studies included in this database should be controlled studies relevant to treatment on neurological disease, randomized or only controlled without randomization. Results 3 641 studies were included in this database. Conclusions The Chinese neurological trials database was established. This database will provide Chinese evidence on treatments of various neurological diseases. Studies in this database will also be included in the Cochrane Library to facilitate systematic reviewers.
Objectives To systematically evaluate the clinical characteristics of adverse drug reactions (ADRs) caused by Shuanghuanglian Injection (SHLI) and to provide reference for post-market evaluation and clinical application of SHLI. Methods We searched electronic databases such as the Chinese National Knowledge Infrastructure (CNKI, 1979.1-2009.9), the Chinese Science and Technology Journal Full-text Database (VIP, 1989.1-2009.9), and the Chinese Biomedical Disc (CBMdisc, 1978.1-2009.9). ADR cases were analyzed according to occurrences categorized. Available data was assessed using the Chi-square test including relative ratios (RR) with 95% confidence intervals (95%CI). Different medicine combinations and comparisons between SHL powder injection and SHL injection were calculated using the statistical software Stata 9.1. Results (1) A total of 452 articles were included with a total of 2 799 ADR cases reported. Case reports were the main design type of included literature, which accounted for 84.51%. According to 31165 cases of SHLI treatment and 1 013 corresponding ADRs, the incidence of SHLI ADR was calculated as 3.25%. (2) The ratio of male to female in the reported ADR cases was 1.13׃1. (3) Allergy to Penicillin, which accounted for 13.38% of the total cases, was at the top for past allergic history, followed by sulfonamides and asthma (2.68%). (4) In terms of disease treated respiratory disease accounted for 91.75% of all cases of SHLI ADRs, followed by digestive diseases (5.17%), and urinary diseases (1.11%). (5) Penicillins were the most common combination choice with SHLI, and such combination showed higher ADR risk than SHLI used alone [RR=3.14, 95%CI (2.58, 3.81)]. (6) Multiple systems/organs were involved in SHLI ADRs, and were ranked downwards according to proportion as: skin, digestive system, general reactions, respiratory system, nervous system, cardiovascular system, local reactions, urinary system, hematologic system and others. (7) According to the WHO ADR Classification Criteria, ADR cases were divided into four grades. There were 6.36%, 5.48%, 45.62%, and 2.12% cases of Grade Ⅰ, Ⅱ, Ⅲ and Ⅳ , respectively. And the prognoses of the rest 52.42% cases were reported unclearly. (8) All cases of death were caused by allergic shock, except for one, which was caused by myocardial infarction induced by pain at the injection site. The fastest ADR case occurred 1 minute after being injected. (9) There was a remarkable difference (Plt;0.05) in the rate of ADR caused by SHLI in power form (2.25%) and as a solution (4.14%). Conclusion The clinical manifestations of ADRs caused by SHLI mainly include skin allergic reactions and gastrointestinal reactions. There is an increased risk of ADR induced by combined uses of SHLI and other drugs, especially antibiotics. Compared to the solution, the powder has lower ADR occurrence and higher safety with statistical significance. We propose strengthening management and surveillance on SHLI from manufacturing to application, and improving the level of the risk management for post-market drugs.