ObjectiveTo evaluate the efficacy and toxicity of TEC and CEF regimen in preoperative chemotherapy for patients with breast cancer. MethodsA total of one hundred breast cancer patients undergoing preoperative chemotherapy were divided into TEC group (n=50) and CEF group (n=50) by the pairgroup method and received surgical therapy after three courses of chemotherapy. The efficacy and toxicity of preoperative chemotherapy of patients in two groups were analyzed. ResultsFour patients with stage ⅢB breast cancer quit from CEF group after two courses of treatment because of the worse satisfaction. Clinical complete remission (cCR) was 7 cases, clinic partial remission (cPR) was 34 cases, stable disease (SD) was 9 cases, therefore, the remission rate (RR) was 82.0% (41/50), and reduction rate of tumor was 64.0% (32/50) in TEC group. cCR was 2 cases, cPR was 32 cases, SD was 12 cases, thus the RR was 680% (34/50), and reduction rate of tumor was 40.0% (20/50) in CEF group. The clinical efficacy and reduction rate of tumor of patients in TEC group were significantly superior than those in CEF group (Plt;0.05). The negative conversion ratio of lymph nodes were 54.1% (20/37) and 57.1% (20/35) in TEC group and CEF group, which was not statistically different (Plt;0.05). The occurrence of hair loss and leukopenia of patients in TEC group were significantly higher than those in CEF group (Plt;0.05), while the differences in thrombocytopenia, low concentration of hemoglobin, nausea, vomiting, diarrhea, cardiac toxicity, and neurotoxicity were not significant (Pgt;0.05). ConclusionTEC regimen is better than CEF regimen in the efficacy and safety of neo-adjuant therapy for patients with breast cancer, and well tolerated.
Objective To evaluate the quality of Chinese literatures on the methodology of D-dimer diagnostic test. Method We searched CNKI (1994 to 2006) and CBM (1978 to 2006) for articles involving the diagnostic tests of D-dimer for coagulation disorders. Result A total of 63 relevant articles were retrieved and 7 were included in our review. Only one of these provided useful data on two two table for the evaluation of diagnostic accuracy. Conclusions Few studies on the diagnostic tests of D-dimer have been performed and publ ished in China, all of poor quality. Further studies should focus on clinical diagnostic sensitivity and specificity, so as to provide more valuable information for readers.
Objective To evaluate the diagnostic value and utility of flexible bronchoscopy in the preoperative assessment in patients with solitary pulmonary nodules (SPNs). Methods A total of 111 patients with SPNs of unknown origin treated between January and June 2016 were retrospectively enrolled. The clinical characteristics, bronchoscopy findings and surgical strategies were collected. Results In the total 111 cases, malignant and benign SPNs were 79 and 32 cases, respectively. The mean diameter of malignant SPNs was larger than that of benign SPNs [(2.04±0.58) vs. (1.70±0.75) cm, P<0.05]. Bronchoscopy identified 9 cases (8.1%) unsuspected findings. Surgeries were modified or cancelled in 3 patients (2.7%) because of bronchoscopy findings. Transbronchoscopy biopsies were performed in 26 patients, 9 of whom were diagnosed lung cancer preoperatively, with a sensitivity of 45% (9/20) and a specificity of 100% (6/6). Conclusions Flexible bronchoscopy can be contributed to diagnosis of SPN before surgery and determination of surgical strategies. It is suggested that flexible bronchoscopy could be included in the routine preoperative work-up of SPN.
Interpretation of the complete scientific connotation of functional foods accurately prior to approval and registration based on animal tests and small sample size human food tests is challenging. Further technical evaluation after market introduction should be carried out on safety, health function and other aspects of those widely used commercial scale production products. According to the analysis report on the consumption situation of post-marketing population submitted when applying for product registration extension since the implementation of the functional food registration and filing management measures more than 3 years ago, the post-marketing evaluation report of functional food still lacks systematic and perfect evidence support. Based on the successful experience of evidence-based medicine and post-marketing evaluation evidence, this paper analyzes the post-marketing evaluation content, evidence source construction, evidence classification and classification of functional food, and puts forward the preliminary idea of constructing post-marketing evaluation evidence body of functional food safety and health function technology from multiple view points, so as to provide insights into evidence system research in this field in the future.
Objective To assess the quality reports on acupuncture in the treatment of postherpetic neuralgia. Methods MEDLINE, CBM, CMCC and CNKI from 1994 to 2006 were searched electronically. Handsearching was also done. The retrieved articles were assessed in terms of several factors, including the type of clinical research, methodology, diagnostic criteria, inclusion/exclusion criteria, effectiveness measurements, calculation of sample size, follow-up, etc. Results Among the 109 included articles, only 6 were true randomized controlled trials. There were 17 quasi-randomized controlled trials, 13 non-randomized concurrent controlled trials, 1 case-control study and 63 narrative studies. 29 of the reports clearly described the diagnostic criteria, 14 mentioned the inclusion/exclusion criteria, 79 reported the effectiveness measurements, none mentioned the calculation of sample size, 24 reported the follow-up outcomes, and only 1 mentioned adverse reactions. Conclusion More prospective, multicenter, large-scale, high-quality randomised trials are needed, and recommendations should also be made for future evaluations of methodological quality.
ObjectiveTo develop a patient satisfaction evaluation scale for day surgery and test its reliability and validity, so as to provide a scientific and effective tool for day surgery patient satisfaction assessment.MethodsThe literature review method was used to form an entry pool, and the initial version of the scale was formed in conjunction with the expert review method. And then a preliminary survey was conducted to obtain the tentative version of the scale. Finally, 290 day surgery patients discharged between June 15th and July 15th, 2019 were selected to accomplish a survey to check the reliability and validity of the scale.ResultsFinally, a day surgery patient satisfaction evaluation scale was formed, containing 3 stages (pre-hospital, hospitalization, and postdischarge follow-up), 3 dimensions (medical staff evaluation, medical service evaluation, and environment and process evaluation), and 40 items. After the formal survey, the overall Cronbach’s α coefficient of the scale was 0.980, the Spearman-Brown coefficient was 0.933, the Guttman’s half-coefficient was 0.932, and the content validity was 0.87-1.00.ConclusionThe day surgery patient satisfaction evaluation scale was proven good reliability and validity, which can be used as a measurement tool for day surgery patients and applied to clinical practice.
Objective To evaluate and select essential medicine for acute and chronic gastritis using evidence-based approaches based on the burden of disease for township health centers located in eastern, central and western regions of China. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Five guidelines for acute gastritis and seven guidelines for chronic gastritis were included. The recommended included omeprazole, ranitidine and domperidone. (2) A result of three CCTs (n=315, low quality) indicated that omeprazole was superior to famotidine and ranitidine in alleviating symptoms of chronic gastritis such as pain or discomfort in the upper abdomen, regurgitation, a burning sensation in the heart, distention and fullness in the upper abdomen (71.2% vs. 47.3%, 94.4% vs. 84.3%, Plt;0.05). A result of one RCT (n=100, low quality) and two CCTs (n=213, low quality) indicated that in HP eradication rates, omeprazole triple therapy and the control intervention had no significant difference (OR=1.09, 95%CI 0.44 to 2.70, Pgt;0.05). A result of one RCT (n=100, low quality) indicated that omeprazole caused no adverse reaction. A result of five CCTs (n=528, low quality) indicated that adverse reaction of omeprazole included poor appetite (two cases), nausea and vomiting (four cases), headache or vertigo (one case) and increased transaminase (one case). Omeprazole cost eight yuan (tablet) or four yuan (capsule) daily. (3) HP eradication rates of ranitidine bismuth citrate was higher than the control group (OR=2.05, 95%CI 1.29 to 3.25, P=0.002). A result of 15 RCTs (n=3 638, high quality) indicated adverse reaction of ranitidine bismuth citrate mainly included symptoms in the digestive system. A result of one RCT (n=100, low quality) indicated ranitidine bismuth citrate and omeprazole triple therapy had no significant difference (Pgt;0.05) and ranitidine bismuth citrate caused no adverse reaction. Ranitidine cost 0.36 yuan (tablet), 0.40 yuan (capsule) or 2.7 to 5.4 yuan (injection) daily. (4) A result of two CCTs (n=133, low quality) indicated that compared with the control intervention, domperidone was more efficient without adverse reaction in improving indigestion, promoting gastric emptying effect, and alleviating pain and distention in the upper abdomen, belching and regurgitation. Domperidone cost 1 to 1.3 yuan daily. (5) All kinds of recommended medicines are listed and legalized in China Pharmacopoeia (2010) and CNF (2010). (6) In clinical setting, above-recommended medicines should be applied strictly according to the CNF (2010) and the National Clinical Prescription Guidelines for Essential Medicine. Conclusion For acute and chronic gastritis, indigestion and HP eradication: (1) We offer a b recommendation for omeprazole (immediate release tablet/capsule for oral use, 10 mg/tablet) which should be cautiously used in children, elderly people, and women during pregnancy or lactation. (2) We offer a b recommendation for ranitidine (immediate release tablet/capsule for oral use, 150 mg/tablet) which should be cautiously used in patients with severe insufficiency in the liver or kidney, women in the pregnancy or lactation, and children under eight years of age.
Abstract: Objective To compare the multiple organ dysfunction score (MODS), the sequential organ failure assessment (SOFA), the acute physiology, age, and chronic health evaluation system Ⅱ(APACHE Ⅱ), the acute physiology, age, and chronic health evaluation system Ⅲ(APACHE Ⅲ) in evaluating risks for patients after cardiac surgery, in order to provide better treatment and prediction of prognosis after cardiac operation. Methods A prospective study was carried out on 1 935 cardiac postoperative patients, including 1 050 males and 885 females, enrolled in cardiac postoperative intensive care unitof Anzhen hospital between October 2007 and April 2008. The age of the patients ranged from 18 to 86 years with the mean age of 53.96 years. The patients underwent the surgery because of various cardiac diseases including coronary heart disease, valve disease, congenital heart disease, aortic aneurysm, pericardial disease, atrial fibrillation, and pulmonary embolism. We used MODS, SOFA, APACHE Ⅱ, and APACHE Ⅲ respectively to calculate the value of the first day after operation, the maximum value during the first three days, the maximum value, and the change of the value between the third day and the first day for every patient, and then we compared the calibration and discrimination of these different systems using HosmerLemeshow goodnessoffit analysis and Receiver Operating Characteristic (ROC) curve. Results There were 47 perioperative deaths because of circulating system failure, respiration failure, kidney failure, liver failure or nervous system diseases. The death rate was 2.43%. In discrimination analysis, the area under the curve (AUC) in ROC of the first day value after operation, the maximum value, the maximum value during the first three days, and the change of value between the third day and the first day for MODS were respectively 0.747, 0.901, 0.892, and 0.786; for SOFA were respectively 0.736, 0.891, 0.880, and 0.798; for APACHE Ⅱ were respectively 0.699, 0.848, 0,827, and 0.562; for APACHE Ⅲ were respectively 0.721, 0.872, 0.869, and 0.587. In calibration analysis, we compared the χ2 value of the first day value, the maximum value, the maximum value during the first 3 days, and the change of value between the third day and the first day of these systems. χ2 value of MODS was 4.712, 5.905, 5.384, and 13.215; χ2 value of SOFA was 8.673, 3.189, 3.111, and 14.225; χ2 value of APACHE Ⅱ was 15.688, 10.132, 8.061, and 42.253; χ2 value of APACHE Ⅲ was 13.608, 11.196, 19.310, and 47.576. AUC value of MODS and SOFA were all larger than those of APACHE Ⅱ and APACHE Ⅲ (Plt;0.05); AUC value of APACHE Ⅱ was smaller than that of APACHE Ⅲ (Plt;0.05). Conclusion MODS, SOFA, APACHE Ⅱ and APACHE Ⅲ are all applicable in evaluating risks for patients after cardiac surgery. However, MODS and SOFA are better than APACHE Ⅱ、APACHE Ⅲ in predicting mortality after cardiac surgery. In cardiac surgery, the complicated APACHE Ⅱ and APACHE Ⅲ systems can be replaced by MODS and SOFA systems which are simpler for use.
ObjectivesTo evaluate the characteristics, main contents, key elements and techniques of global drug value assessment tools, especially for those developed for antineoplastic agents, and to provide reference for the establishment of the first value assessment tool for antineoplastic agents in China.MethodsDatabases including MEDLINE, EMbase, CBM, CNKI, VIP, WanFang Data and 19 relevant websites of institutions and societies were searched from inception to October 31st, 2018 to identify all the drug value assessment tools worldwide. Two independent reviewers screened the literatures, extracted the data and cross-checked them according to the inclusion and exclusion criteria. A qualitative analysis was conducted to describe the characteristics of these drug value assessment tools, including the publishing organization, year of publication, country, applicable type of disease and drug category, result display, and etc. Key elements and techniques in terms of evaluation dimensions, sources and levels of evidence, methods and procedures to form the tool were compared.ResultsA total of 12 English drug value assessment tools were included, which were published in 2010 to 2018 exclusively from Europe and North America. The applicable types of diseases and drug categories are not identical. The target users and stakeholders of each tool were slightly different. Evaluation dimensions, sources and levels of evidence, methods and procedures to form the tool were vital issues in value evaluation for drugs.ConclusionsThe structures of existing drug value assessment tools were almost the identical. However, there is no consensus on value definitions, evaluation dimensions, sources of evidence and result display. Methods and procedures to form the tool are not well described. It is urgent to explore and develop a value-oriented, focused and feasible drug assessment tool for antineoplastic agents in order to satisfy the strategic requirements of value-based post-marketing drug reevaluation.
This paper discusses the characteristics of pharmacoecomomics and its evaluation methods. After launching a drug to the market, a large amount of clinical use provides the opportunity to evaluate the effectiveness and adverse effects. The methods of economic evaluation in post-marketing pay more attention to the value-added pharmacoeconomics activities to maintain product status, such as risk-benefit analysis, drug reimbursement application and budget impact analysis, etc.