BACKGROUND: The aims of this study were to evaluate the colorimetric antifungal susceptibility test to fluconazole using 2,3-diphenyl-5-thienyl-(2)-tetrazolium chloride (STC) for various Candida species isolated from clinical specimens and to compare the results with those of the CLSI M27-A2 standard method. METHODS: The fluconazole MICs for 204 clinical Candida isolates consisting of 100 C. albicans, 45 C. glabrata, 28 C. tropicalis, 22 C. parapsilosis, and 9 other Candida species were determined by the CLSI and STC colorimetric methods. RESULTS: All 204 Candida strains were grown on the growth control wells of CLSI standard plates, but 26 Candida strains (6 C. albicans and 20 C. tropicalis) were not grown on those containing STC. Therefore, those 26 Candida strains were excluded from the comparison of MICs in this report. Overall, the STC visual and spectrophotometric readings of fluconazole MICs showed 96.1% (N=171) and 89.9% (N=160) accordance with those obtained by the CLSI standard method within 2 dilutions, respectively. The STC visual reading of C. albicans showed 76.6, 92.6, and 95.8% accordance with the CLSI standard method within 1, 2, and 3 dilutions, respectively. The agreement between the two endpoint determinations of the STC colorimetric method (visual and spectrophotometric readings) was excellent, with 170 of the 178 MICs within 2 dilutions. CONCLUSION: The STC colorimetric method to determine the MIC for Candida species except C. tropicalis showed high levels of agreement with CLSI method. And also, it is useful with objective and easy interpretation.
Candida* ; Endpoint Determination ; Fluconazole* ; Reading

This paper explores the statistical distribution characteristics of coating film thickness, so as to present a new method for determining coating endpoint based on 3σ criterion and logic regression. Firstly, the spectrum and thickness of 4 batch samples were collected. Secondly, the spectral range of normal products was obtained by 3σ criterion, with the spectral feature NI as the number of test spectrum in the above range. Then, the model based on 3σ criterion and logic regression was built according to the best condition in K-fold cross-validation and the determined threshold of qualified rate in the coating endpoint. Finally, the qualified rate of test set samples at different time points was calculated by the above model, and the above change trend and the threshold value were combined to determine the coating endpoint. The results of KS analysis showed the distribution of thickness of the qualified products followed the normal distribution(P=0.081>0.05). The accuracy of the coating endpoint determination was as high as 100% by the model based on 3σ criterion and logic regression when the determined threshold of qualified rate was 90%. Therefore, the 3σ criterion was feasible to the research of coating eligibility. This paper reveals certain random phenomena in the coating process, and the method features a high accuracy, quick analysis and a good interpretability, which provides a reference for online detection and qualify evaluation in future.
Endpoint Determination ; Logic ; Research Design ; Tablets

BACKGROUND: Minimum inhibitory concentration (MIC) endpoint determination is the major varia-tion source for the fluconazole susceptibility test, especially for Candida albicans. In this study, we evaluated spectrophotometric broth microdilution methods using RPMI 1640 and RPMI supple-mented with 18 g of glucose per liter (RPMI-2% glucose) for determining fluconazole susceptibility of C. albicans. METHODS: A total of 129 clinical isolates of C. albicans were tested by the broth microdilution method using RPMI and RPMI-2% glucose. The MIC endpoint was calculated objectively with the spectrophotometer set at 405 nm. These results were compared to those by the National Commit-tee for Clinical Laboratory Standards (NCCLS) macrodilution method and the agar dilution method. RESULTS: The mean absorbances in the drug-free wells in RPMI and RPMI-2% glucose were 0.208 +/- 0.014 and 0.316 +/- 0.061, respectively, at 24 h and 0.339 +/- 0.094 and 0.530 +/- 0.104, respectively, at 48 h (P < 0.01). The agreement of the microdilution method with the RPMI within two doubling dilutions of the macrodilution reference were 91.5% (118/129) at 24 h and 76.7% (99/129) at 48 h. The percentage of agreement in the microdilution method with the RPMI-2% glucose were significantly higher: 100% (129/129) at 24 h and 99.2% (128/129) at 48 h (P < 0.01). In addition, the MIC endpoints were easier to detect in RPMI-2% glucose, because of the greater difference in absorbance in between grown wells and fluconazole-inhibited wells (P < 0.01). CONCLUSIONS: The spectrophotometric microdilution method with RPMI-2% glucose may have an excellent agreement with the NCCLS broth macrodilution method and may provide more easily determined MIC endpoints for fluconazole susceptibility testing for C. albicans.
Agar ; Candida albicans* ; Candida* ; Endpoint Determination ; Fluconazole* ; Glucose* ; Microbial Sensitivity Tests

BACKGROUND: Standardization of antifungal susceptibility testing for dermatophytes is important and several variables, such as inoculum size, length and temperature of incubation, media, and end point determination has recently been established. However, a more improved test model which can evaluate bioavailability and has clinical relevance is still needed. OBJECTIVE: We performed antifungal susceptibility testing by using three-dimensional keratinoctyte culture model, living skin equivalent (LSE), as an in vitro model. METHODS: LSE was prepared and various concentrations of antifungals were added to media. Microconidia of Trichophyton mentagrophytes was inoculated onto LSE and incubated for 6 days at 35 degrees C. RESULTS: Inhibition of fungal proliferation and invasion were observed at 0.1microgram/ml of terbinafine, 0.01 microgram/ml of itraconazole solution, 0.1 microgramg/ml of itraconazole powder, and 10 microgram/ml of fluconazole, respectively. CONCLUSION: Our culture model is similar to in vivo situation and the results were relatively well accordant to those of other previous studies. Our LSE model is considered as a promising in vitro system for evaluating the activity and safety of antifungal agents. However, further study using more various species of dermatophytes and more strains is still needed.
Antifungal Agents ; Arthrodermataceae ; Biological Availability ; Endpoint Determination ; Fluconazole ; Itraconazole ; Keratinocytes* ; Skin ; Trichophyton

Combining technical requirement from main international administration and status quo of China administration, current regulatory requirement on clinical trail of conventional intervertebral fusion devices has been simplified. Cervical, thoracic and lumbar cases can be grouped into the same cohort, and primary endpoints are mainly based on imageology rather than clinical score. This is an attempt to rationally lessen industrial burdensome.
China ; Clinical Trials as Topic ; standards ; Cohort Studies ; Endpoint Determination ; Humans ; Research Design ; standards ; Spinal Fusion ; instrumentation

Functional dyspepsia is a disease, in which there is no organic lesion but chronic and repetitive postprandial fullness, early satiation, epigastric pain, and epigastric burning. Functional dyspepsia is not life-threatening but its symptoms are relapsing and remitting and persist over a lifetime, limiting the social life and reducing the quality of life. Therefore, the treatment for acute relapsing period may help improve the short-term symptoms. Continuous medication may be needed to improve the long-term symptoms. Research designs to demonstrate the short-term efficacy of therapeutic agents may differ from clinical trials to demonstrate long-term efficacy. There are many difficulties in clinical trial design, implementation, and screening because there are no international standards of clinical trials for functional dyspepsia. The purpose of this guideline recommendation is to develop a standard for clinical trials, such as clinical trial subjects and evaluation methods, in the development of therapeutic agents for functional dyspepsia. The ultimate aim is to enhance the safety and efficacy of therapeutic agents for functional dyspepsia and promote the development of new therapeutic agents.
Burns ; Dyspepsia* ; Endpoint Determination ; Gastrointestinal Diseases ; Mass Screening ; Quality of Life ; Research Design ; Satiation

Clinical trial outcome reporting differs between studies integrating traditional Chinese medicine (TCM) and Western medicine, so that some clinical trials are not eligible for inclusion in a systematic review. The excluded studies are therefore less widely disseminated, and even valid studies are less likely to yield impact. This problem may be addressed by developing core outcome sets (COSs) for integrative medicine in specific healthcare areas. The first stage of development is to define the scope of the COS for integrative medicine, the second stage is to establish the need for such a COS, and the third stage is to develop a protocol and register the COS. The final stage involves three steps: (i) development of a comprehensive list of outcomes (including efficacy outcomes and safety outcomes and TCM syndromes) using systematic review, qualitative or cross-sectional research, and reviews of package inserts and medical records; (ii) merging and grouping of outcomes within domains; (iii) conducting two rounds of Delphi survey and consensus meetings with a range of stakeholders. The final COS will include a general COS and core TCM syndrome- set. Development of COSs for clinical trials of integrative medicine may help to standardize outcome reporting and reduce publication bias in the future.
Cross-Sectional Studies ; Delphi Technique ; Endpoint Determination ; Medicine, Chinese Traditional ; Research Design ; Treatment Outcome

To find the status of outcome indicators reported in published randomized controlled trial(RCT) of traditional Chinese medicine(TCM) for essential hypertension in the past two years, we searched for relevant information from four Chinese databases, three English databases and two clinical trial registries in this study, from January 2018 to September 2019. The outcome indicators of RCT were extracted and categorized from trials and the risk of bias was assessed by ROB tools from the Cochrane Collaboration. A total of 125 RCTs and 15 RCT protocols were finally included after study screening. The results showed that the RCT outcomes mainly included efficacy and safety outcomes. Efficacy indicators mainly included blood pressure measurement, quality of life assessment, blood biochemical indicators, urine analysis, arterial ultrasound, vascular endothelial function indicators, hematocrit, hemorheology indicators and other indicators. The safety indicators mainly included general physical examination items, heart, liver and kidney function tests, blood, urine, and stool routine examinations as well as adverse drug reactions/events. The current RCTs cannot distinguish primary and secondary outcomes, and the RCT protocols didn't report efficacy criteria clearly. They both didn't report health economic indicators and the methodological qualities were relatively low. In view of the current status on outcome indicators reported in TCM RCTs, constructing a core outcome set of TCM for essential hypertension and improving the methodology quality of RCTs will help to accurately reflect the actual efficacy of TCM intervention.
Endpoint Determination ; Essential Hypertension ; Humans ; Medicine, Chinese Traditional ; Quality of Life ; Randomized Controlled Trials as Topic ; Treatment Outcome

The endpoint detection of cough signal in continuous speech has been researched in order to improve the efficiency and veracity of manual recognition or computer-based automatic recognition. First, using the short time zero crossing ratio(ZCR) for identifying the suspicious coughs and getting the threshold of short time energy based on acoustic characteristics of cough. Then, the short time energy is combined with short time ZCR in order to implement the endpoint detection of cough in continuous speech. To evaluate the effect of the method, first, the virtual number of coughs in each recording was identified by two experienced doctors using the graphical user interface (GUI). Second, the recordings were analyzed by automatic endpoint detection program under Matlab7.0. Finally, the comparison between these two results showed: The error rate of undetected cough is 2.18%, and 98.13% of noise, silence and speech were removed. The way of setting short time energy threshold is robust. The endpoint detection program can remove most speech and noise, thus maintaining a lower rate of error.
Algorithms ; Artificial Intelligence ; Cough ; physiopathology ; Endpoint Determination ; Humans ; Pattern Recognition, Automated ; methods ; Signal Processing, Computer-Assisted ; Sound

OBJECTIVETo compare the impact of the first 24 hours mean blood glucose (MBG) level and admission glucose (AG) during hospitalization on the short term mortality and combined end point events in patients with ST-segment elevation acute myocardial infarction (STEMI).

METHODSA total of 7446 Chinese STEMI patients hospitalized within 12 hours of symptom onset were included. Plasma glucose was measured at admission, 6 and 24 hours after admission, respectively. The MBG level through the first 24 hours for each patient was calculated. Patients were stratified into six groups according to their MBG levels: < 4.5, 4.5 - 5.5, 5.6 - 7.0, 7.1 - 8.5, 8.6 - 11.0 and > 11.0 mmol/L. The incidence of all-cause mortality and combined end point of death, re-infarction, cardiogenic shock, recurrence ischemia, and stroke at 7 days and 30 days post hospitalization were analyzed. Nested models were compared to determine whether logistic regression models that included MBG provided a significantly better fit than logistic regression models included AG.

RESULTSCompared with the MBG of 4.5 - 5.5 mmol/L group, 7-day and 30-day mortality and combined end point events increased in proportion to plasma MBG level increase. Multivariate logistic regression analysis showed that elevated MBG (equal or greater than 7.1 - 8.5 mmol/L) level is an independent predictor of 7-day and 30-day mortality and combined end point events. Nested models analysis showed that the prognostic impact of MBG is superior to AG (P < 0.001) on predicting 7-day and 30-day mortality and combined end point events in this patient cohort.

CONCLUSIONElevated MBG (≥ 7.1 mmol/L) level is an independent predictor of 7-day and 30-day mortality and combined end point events. MBG is superior to AG on predicting short-term prognosis in this patient cohort.

Aged ; Blood Glucose ; analysis ; China ; Electrocardiography ; Endpoint Determination ; Female ; Hospital Mortality ; Humans ; Logistic Models ; Male ; Middle Aged ; Multivariate Analysis ; Myocardial Infarction ; diagnosis ; mortality ; physiopathology ; Prognosis