Design of case report form for oncology clinical trials based on CDASH / 中国临床药理学与治疗学

AIM: To investigate the design significance, method and content of the oncology clinical trial case report form (CRF) based on the clinical data acquisition standards harmonization (CDASH). METHODS: Compared with CDASH v 2.2, the characteristics of oncology clinical trial data were analyzed, and a standardized CRF was designed to meet the actual needs of oncology clinical trials. RESULTS: The CDASH was applied to the design of the CRF of the oncology clinical trial, and the data collection of the oncology clinical trial was standardized, so that the CRF design of the oncology clinical trial was relatively standardized and the data quality was improved. CONCLUSION: The implementation of oncology CRF design based on CDASH can promote the exchange and sharing of oncology clinical research data, which is conducive to improving the reliability of oncology clinical research results.

Reform of the bio-separation engineering curriculum under the context of "Emerging Engineering Education" / 生物工程学报

"Bio-separation engineering" is a compulsory course for undergraduate students majored in bioengineering, and an important part of the "emerging engineering education" system for bioengineering. Our teaching team follows the principle of "student development as the center, innovation thinking as the core". Guided by the concept of "learning achievement", we reconstructed the teaching contents of this course, and carried out the teaching reform aiming at solving several long-standing problems. These include, for instance, the theoretical teaching is separated from the experimental practice, and students cannot internalize the theoretical knowledge into practical ability in time. Moreover, the contents of course is out-of-date and out of line with industry demand, the teaching form and assessment methods are relatively single, and the students' professional ability and quality are not effectively cultivated. In the new curriculum system, in which the "online" and "offline" teaching are both applied, we broke the boundary between theoretical and experimental courses, and made the contents keep up with the forefront of industry development through research-based teaching. In terms of teaching methods and teaching evaluation, we made full use of modern information technology to enrich classroom teaching activities, and carried out complete, dynamic and diversified assessment for students. These teaching reform measures greatly improved the students' interest in learning this course, as well as their professionalism and research ability.

Impact of peripheral blood absolute lymphocyte count at the end of induction on survival in adult patients with acute lymphoblastic leukemia / 中国基层医药

Objective To study the impact of peripheral blood absolute lymphocyte count ( ALC) on survival in adult patients with acute lymphoblastic leukemia ( ALL ) at the end of induction chemotherapy. Methods 122 adult patients with ALL from January 2011 to December 2017 in the Second Hospital of Shanxi Medical University were retrospectively analyzed. The impact of ALC at the end of induction and ALC ratios for relapse-free( RFS) and overall survival ( OS ) of adult ALL were analyzed. Results The study cohort was divided into the two groups according ALC-28 values ( <675cells/μL and ≥675cells/μL). The median RFS (8 months vs 12 months,P=0. 001),median OS (16 months vs 23 months,P=0. 010) between the two groups had statistically significant differ-ences. ALC-28/ALC-1 was bordered by 43％. The RFS and OS in the low ratio group were significantly shorter than those in the high ratio group (P<0. 05). ALC-28/ALC-8 was compared with 86％ cut-off. Longer RFS and OS in the higher ALC-28/ALC-8 group (all P<0. 05). Low ALC-28 was independent risk factor for RFS. Low ALC-28,and low ALC-28/ALC-1 were independent risk factors of OS. Conclusion ALC at the end of induction and ALC ratios are associated with RFS and OS of adult ALL. Higher the value,the longer the survival time.

Factors influencing clinical efficacy and outcomes of adult primary immune thrombocytopenia / 中华全科医师杂志

Objective To examine the influencing factors related to clinical efficacy and outcomes of adult primary immune thrombocytopenia (ITP).Methods The clinical data of 161 cases of ITP admitted in the Second Hospital of Shanxi Medical University from June 2013 to March 2017 were collected.The influencing factors related to clinical efficacy and prognosis of adult ITP patients were analyzed.Results There were 60 males and 101 females with a M/F ratio of 0.59∶1 and a median age of 45 years (18-84 years).There were 109 newly diagnosed ITP cases,14 persistent ITP cases and 38 chronic ITP cases in this series.Seventy nine patients received intravenous immunoglobulin g (IVIg) treatment and 82 patients received high dose-dexamethasone treatment.There were no significant differences in clinical efficacy [91.13％(72/79) vs.87.80％(72/82),x2=0.181,P=0.914] and relapse rate [36.11％(26/72) vs.30.55％(22/72),x2=0.189,P=0.910] between IVIg and high dose-dexamethosone groups.Multivariate regression analysis showed that bleeding score ≥2 was the independent risk factor for the lower clinical efficacy (RR=1.415,95％CI:1.008-1.986,P＜0.05).Patients were followed up for a median of 9.0 months (0.5-55.0 months),48 patients relapsed with a relapse rate of 33.33％ and a median relapse time of 1.8 months (0.5-24.0 months).Conclusions IVIg and high dose-dexamethasone have the similar clinical efficacy and relapse rate for treatment of adult ITP.The patients with the bleeding score ≥2 are more likely to get lower remission rate.

Analysis of Pulse Rate Variability and Its Application to Wearable Smart Devices / 中国医疗器械杂志

In this paper, a reflection type photoelectric pulse wave sensor was designed for short-term pulse rate variability analysis. Photoplethysmography (PPG) signals and ECG signals (obtained with the Dimetek MicroECG recorder Dicare-m1CP) were recorded synchronously from 20 healthy subjects. The analytical results show a significant correlation (correlation coefficient r > 0.99) between the PPG-derived peak-to-peak (PP) intervals and the ECG-derived RR intervals. Besides, there are no significant differences (P > 0.05) between the HRV measured by ECG and the PRV quantified by the PPG whether in time domain, frequency domain, or the Poincaré plot parameters. The experimental results suggest that the PPG-based short-term PRV analysis can be consistent with the ECG-based HRV measurement in wearable smart devices.

Effect of continuous positive airway pressure treatment on serum levels of hemorheology and c-reactive protein in patients with obstructive sleep apnea hypopnea syndrome / 实用医学杂志

Objective To investigate the effects of continuous positive airway pressure (CPAP) on the levels of hemorheology and C-reactive protein in patients with obstructive sleep hypopnea apnea syndrome (OSAHS). Methods 58 moderate to severe OSAHS subjects were selected as treatment group and 32 healthyadults were selected as control group. Hemorheology and C-reactive protein in all subjects were examined and compared. The levels of hemorheology and C-reactive protein were also examined and compared before and after 3 months CPAP treatment in treatment group. Results In treatment group, the levels of the whole blood viscosity and hs-CRP were significantly higher than those in control group (P < 0.01). After treatment of CPAP for three months, the levels of the whole blood viscosity and hs-CRP obviously decreased (P < 0.01). Conclusion Levels of hemorheology and hs-CRP are elevated in patients with OSAHS and CPAP therapy could effectively decrease serum levels of hemorheology and hs-CRP in patients with OSAHS.

Efficacy of statin in treatment of patients with chronic obstructive pulmonary disease at stable stage / 实用医学杂志

Objective To explore the therapeutic effects of statin in patients with chronic obstructive pulmonary disease (COPD) in stable period. Methods 83 patients with COPD in stable period were recruited and randomly divided into two groups, treatment group (n = 41) and control group (n = 42).The control group received conventional routine therapy, and treatment group was given rosuvastatin calcium 20 mg once per day on the basis of routine treatment. The levels of sera C-reactive protein (CRP), pulmonary function (FEV1、FEVl%pred), and COPD assessment test (CAT) were observed at the time points of 0 week and 12th week, 24th week and 48th week were compared between two groups. Results At 12th week after the treatment, sera CRP levels, FEV1, FEV1%pred and CAT scores in either control group or treatment group showed some extent of improvements as compared to those at the time point of 0 week, and there was statistical difference of sera CRP levels and CAT scores between two groups (P 0.05) .24th week and 48th week after the treatment; sera CRP levels, FEV, FEV1%pred and CAT scores in two groups all significantly improved and were statistical different between two groups (P < 0.05). Conclusion Statin can alleviate inflammatory reaction, improve pulmonary function and life quality of patients with COPD.

Continuous ECG recording for freely moving patients / 生物医学工程学杂志

As more and more people are becoming aged in China and many of them tend to suffer from chronic cardiac problems, the long-term dynamic cardiac monitoring for freely moving patients becomes essential. A new design for continuous ECG recording on the freely moving patients at home and/or at work is proposed here. It is miniature in size, using digital technologies of the low gain amplifier, the high resolution analog to digital converter and the real-time digital filter that features > 100dB input signal dynamic range (ISDR), > 100dB common-mode rejection ratio (CMRR), and < 5microV (RMS) internal noise. The device works continuously more than 24 hours with a pair of AAA batteries, and is capable of storing the recorded data into a storage card. The preliminary tests showed that the P-QRS-T waveforms were captured and displayed smoothly in resting, walking, and activities, making the device useful in monitoring and analyzing for the patients on the move.

The clinical significance of immune-related marker detection in idiopathic thrombocytopenic purpura / 中华内科杂志

Objective To assess the clinical significance of detecting the immune markers in idiopathic thrombocytopenic purpura (ITP). Methods The frequencies of circulating B cells secreting platelet-specific antibody, platelet-specific antibody, the percentage of T lymphocyte subsets, the percentage of reticulated platelet and the level of thrombopoietin in 64 ITP patients and 31 healthy controls were measured with enzyme-linked immunospot assay (ELISPOT),modified monoclonal antibody immunobilization of platelet antigens assay (MAIPA), flow cytometry and sandwich enzyme-linked innnunosorbent assay respectively. Results Compared with the controls[1.3 ± 0. 5/105 peripheral blood mononuclear cell (PBMC), (0.33±0.06,0.41±0.03), (22.08±4.54)% and (8.19±2.46)%], the frequencies of circulating B cells secreting platelet-specific antibody (7.6±4.6/105 PBMC in acute ITP group, 5.3±3.0/105 PBMC in chronic ITP group), platelet-specific antibody (including the anti-GP Ⅱ b/Ⅲa antibody, anti-GP Ⅰ b/X antibody) (0.51 ±0.11, 0.48±0.06 in acute ITP group; 0.49±0.10,0.46±0.09 in chronic ITP group), the percentage of CD8+ T Lymphocyte (27.09±9.86 ) %, the percentage of reticulated platelet in ITP patients[the megakaryocyte cytosis group (24. 85 ± 19. 18)%, the normal megakaryocyte group (23.89±18.90)%]were significantly increased ( all P＜0.05).The frequencies of circulating B cells secreting platelet-specific antibody in acute ITP patients were notably increased (P＜0.05) compared to the chronic ITP patients. In T lymphocyte subsets, the percentage of CD3+T lymphocyte and CD4+ T lymphocyte and the ratio of CD4+/CD8+ in the patients with ITP[(60.88±14.59)%, (28.41±10.55)%, 1.18±0.59]were notably decreased than those in the healthy controls [(69.89±6.43)%, (35.38±5.05) %, 1.64±0.29, P＜0.05]. There was no apparent difference of the level of thrombopoietin between ITP patients with megakaryocyte cytosis (72. 09 ± 41.64 ) and health controls (75.37± 26. 32, P ＞ 0. 05 ), however, the level of thrombopoietin of ITP patients with normal megakaryocyte apparently increased (118.60±70.72, P＜0.05). Conclusion Detecting the frequencies of circulating B cells secreting platelet-specific antibody, platelet-specific antibody, the percentage of T lymphocyte subsets, the percentage of reticulated platelet and the level of thrombepoietin in the patients with ITP may improve the diagnosis and guide clinical therapy.

Meta-analysis on the efficacy and safety of R-CHOP chemotherapy for the treatment of low and moderate malignant B cell non-Hodgkin lymphoma / 白血病·淋巴瘤

Objective To comprehensively evaluate the curative effect and adverse effects of rituximab plus cyclophosphamide, vincristine, doxoruhicin and prednisone(R-CHOP) chemotherapy and CHOP chemotherapy alone on the treatment for low and moderate malignant B cell non-Hodgkin lymphoma (NHL). Methods By the application of the systematic review method of Cochrance International Collaboration, the world-wide randomized controlled trials (RCT) on the comparison between different curative effects of R-CHOP and CHOP chemotherapy alone on the treatment low and moderate malignant B cell NHL was collected and the study results was evaluated systematically. Results Seven RCT studies involving 1569 patients and had no heterogeneity between themselves (χ=5.31,P=0.50). The baseline of patients characteristics was comparable in all the studies. By comparing complete response (CR) rate and adverse effects through fixed effect analysis model, the results showed that R-CHOP was better than CHOP chemotherapy on the treatment for low and moderate malignant B cell NHL(OR =2.22, 95 %CI 1.72-2.85, P ＜0.000 01), and adverse events of R-CHOP had no significant difference compared with CHOP chemotherapy alone (P＞0.05). Conclusion With good curative effect on the treatment low and moderate malignant B cell NHL and without obvious differences from the CHOP chemotherapy alone in adverse effects, R-CHOP chemotherapy should be recommended as the best treatment method for low and moderate malignant B cell NHL And much more well-designed clinical RCT should be made to further prove its clinical effect.

Expressions of matrix metalloproteinase 8 mRNA in apical granuloma and periapical cyst and their significances / 吉林大学学报(医学版)

Objective To discuss the role of matrix metalloproteinase-8(MMP-8) mRNA in apical granuloma and periapical cyst by detecting the its expressions in the periapical granuloma and periapical cyst.Methods Reverse transcription polymerase chain reaction(RT-PCR) technique was used to measure the expressions of MMP-8 mRNA in 22 cases of periapical granuloma,11 cases of periapical cyst and 10 cases of normal periapical tissues.Results The positive rates and the levels of MMP-8 mRNA expression in apical granulomas and periapical cysts were significantly higher than those in normal tissues(P0.05).Conclusion The expression of MMP-8 may play an important role in the pathogenesy of apical granuloma and periapical cyst,and it may be involved in the process of bone destruction.

Functional dyspepsia:clinical analysis of 346 cases / 中国实用内科杂志

Objective To study the etiology of functional dyspepsia (FD) and compare the clincial responses of medical treatment and psychological intervention.Methods Psychological intervention (psychologic support),advices for daily life (eating habits) and medical treatment were administered to the 346 FD patients;and the therapeutic effects were compared.Results Complete remission:225 cases (65%);partial remission:52 cases (15%);no effect:69 cases (20%).The overall effective rate was 80%.Conclusion FD is a clinical syndrome focusing in upper abdomen,but without local or systematic evidence Psychological treatment is stressed.