A Biomechanical Comparison of 2 Different Topping-off Devices and Their Influence on the Sacroiliac Joint Following Lumbosacral Fusion Surgery.

OBJECTIVE: Interspinous spacer (ISS)-based and pedicle screw-rod dynamic fixator (PDF)-based topping-off devices have been applied in lumbar/lumbosacral fusion surgeries for preventing the development of proximal adjacent segment degeneration. However, little attention has been paid to sacroiliac joint (SIJ), which belongs to the adjacent joints. Accordingly, the objective of this study was to compare how these 2 topping-off devices affect the SIJ biomechanics. METHODS: A validated, normal finite-element lumbopelvic model (L3-pelvis) was initially adjusted to simulate interbody fusion with rigid fixation at the L5-S1 level, and then the DIAM or BioFlex system was instrumented at the L4-5 level to establish the ISS-based or PDF-based topping-off model, respectively. All the developed models were loaded with moments of 4 physiological motions using hybrid loading protocol. RESULTS: Compared with the rigid fusion model (without topping-off devices), range of motion and von-Mises stress at the SIJs were increased by 23.1%-64.1% and 23.6%-62.8%, respectively, for the ISS-based model and by 51.2%-126.7% and 50.4%-108.7%, respectively, for the PDF-based model. CONCLUSION: The obtained results suggest that the PDF-based topping-off device leads to higher increments in SIJ motion and stress than ISS-based topping-off device following lumbosacral fusion, implying topping-off technique could be linked to an increased risk of SIJ degeneration, especially when using PDF-based device.

Renal elasticity and perfusion changes on ultrasonography in an early-stage diabetic rat model.

Background: Renal hemodynamic changes in early diabetes occur before the onset of significant structural abnormalities or clinical manifestations, and timely detection of these changes has clinical significance. This study aimed to evaluate renal elasticity and perfusion changes in an early-stage diabetic rat model by shear wave elastography (SWE) and contrast-enhanced ultrasound (CEUS), and to explore the potential correlations between renal elasticity and perfusion parameters. Methods: A total of 18 male Sprague-Dawley rats were randomly divided into three groups: a control group (group 1, n=6), a diabetic group (group 2, n=6), and a diabetic group receiving drug therapy (group 3, n=6). An intraperitoneal injection of streptozotocin (STZ) for 2 days combined with a high-fat diet (HFD) was used as the early-stage diabetic rat model. The diabetic rats in group 3 were treated with canagliflozin and losartan for 6 weeks, whereas the rats in groups 1 and 2 were given equal amounts of purified water. Renal stiffness on SWE and perfusion parameters on CEUS were measured and compared among the three groups, then the rats were sacrificed, and serum, urine, and renal histopathology were evaluated to confirm the development of early diabetes. Results: The early-stage diabetic rats without significant pathological changes exhibited bigger kidneys and higher blood glucose (all P<0.05). Among the CEUS parameters, peak enhancement (PE), wash-in area under the curve (WiAUC), wash-in perfusion index (WiPI), wash-out AUC (WoAUC), wash-in and wash-out AUC (WiWoAUC), rise time (RT), and time to peak (TTP) of diabetic rats in group 2 were significantly increased (all P<0.05), and the hyperperfusion ameliorated significantly after drug treatment. The renal elasticity measured by SWE varied in accordance with certain perfusion parameters, and was strongly positively correlated with WiAUC (r=0.701, P<0.001), WoAUC (r=0.647, P<0.001), and WiWoAUC (r=0.655, P<0.001), and moderately positively correlated with PE (r=0.539, P=0.001), WiPI (r=0.555, P<0.001), RT (r=0.425, P=0.010), and TTP (r=0.439, P=0.007). Conclusions: Renal elasticity and perfusion changes in the early stage of diabetes, and renal elasticity was positively associated with delayed and increased perfusion.

Prediction of the biomechanical behaviour of the lumbar spine under multi-axis whole-body vibration using a whole-body finite element model.

Low back pain has been reported to have a high prevalence among occupational drivers. Whole-body vibration during the driving environment has been found to be a possible factor leading to low back pain. Vibration loads might lead to degeneration and herniation of the intervertebral disc, which would increase incidence of low back problems among drivers. Some previous studies have reported the effects of whole-body vibration on the human body, but studies on the internal dynamic responses of the lumbar spine under multi-axis vibration are limited. In this study, the internal biomechanical response of the intervertebral disc was extracted to investigate the biomechanical behaviour of the lumbar spine under a multi-axial vibration in a whole-body environment. A whole-body finite element model, including skin, soft tissues, the bone skeleton, internal organs and a detailed ligamentous lumbar spine, was used to provide a whole-body condition for analyses. The results showed that both vibrations close to vertical and fore-and-aft resonance frequencies would increase the transmission of vibrations in the intervertebral disc, and vertical vibration might have a greater effect on the lumbar spine than fore-and-aft vibration. The larger deformation of the posterior region of the intervertebral disc in a multi-axis vibration environment might contribute to the higher susceptibility of the posterior region of the intervertebral disc to injury. The findings of this study revealed the dynamic behaviours of the lumbar spine in multi-axis vehicle vibration conditions, and suggested that both vertical and fore-and-aft vibration should be considered for protecting the lumbar health of occupational drivers.

The effects of topping-off instrumentation on biomechanics of sacroiliac joint after lumbosacral fusion.

BACKGROUND: Lumbar/lumbosacral fusion supplemented with topping-off devices has been proposed with the aim of avoiding adjacent segment degeneration proximal to the fusion construct. However, it remains unclear how the biomechanics of the sacroiliac joint (SIJ) are altered after topping-off surgery. The objective of this study was to investigate the biomechanical effects of topping-off instrumentation on SIJ after lumbosacral fusion. METHODS: The validated finite element model of an intact lumbar spine-pelvis segment was modified to simulate L5-S1 interbody fusion fixed with a pedicle screw system. An interspinous spacer, Device for Intervertebral Assisted Motion (DIAM), was used as a topping-off device and placed between interspinous processes of the L4 and L5 segments. Range of motion (ROM), von-Mises stress distribution, and ligament strain at SIJ were compared between fusion (without DIAM) and topping-off (fusion with DIAM) models under moments of four physiological motions. RESULTS: ROM at the left and right SIJs in the topping-off model was higher by 26.9% and 27.5% in flexion, 16.8% and 16.1% in extension, 18.8% and 15.8% in lateral bending, and 3.7% and 7.4% in axial rotation, respectively, compared to those in the fusion model. The predicted stress and strain data showed that under all physiological loads, the topping-off model exhibited higher stress and ligament strain at the SIJs than the fusion model. CONCLUSIONS: Motion, stress, and ligament strain at SIJ increase when supplementing lumbosacral fusion with topping-off devices, suggesting that topping-off surgery may be associated with higher risks of SIJ degeneration and pain than fusion alone.

Biomechanical responses of the human lumbar spine to vertical whole-body vibration in normal and osteoporotic conditions.

BACKGROUND: The prevalence of osteoporosis is continuing to escalate with an aging population. However, it remains unclear how biomechanical behavior of the lumbar spine is affected by osteoporosis under whole-body vibration, which is considered a significant risk factor for degenerative spinal disease and is typically present when driving a car. Accordingly, the objective of this study was to compare the spine biomechanical responses to vertical whole-body vibration between normal and osteoporotic conditions. METHODS: A three-dimensional finite-element model of the normal human lumbar spine-pelvis segment was developed using computed tomographic scans and was validated against experimental data. Osteoporotic condition was simulated by modifying material properties of bone tissues in the normal model. Transient dynamic analyses were conducted on the normal and osteoporotic models to compute deformation and stress in all lumbar motion segments. FINDINGS: When osteoporosis occurred, vibration amplitudes of the vertebral axial displacement, disc bulge, and disc stress were increased by 32.1-45.4%, 25.7-47.1% and 23.0-42.7%, respectively. In addition, it was found that for both the normal and osteoporotic models, the response values (disc bugle and disc stress) were higher in L4-L5 and L5-S1 intervertebral discs than in other discs. INTERPRETATION: Osteoporosis deteriorates the effect of whole-body vibration on lumbar spine, and the lower lumbar segments might have a higher likelihood of disc degeneration under whole-body vibration.

Biomechanical Evaluation of Rigid Interspinous Process Fixation Combined With Lumbar Interbody Fusion Using Hybrid Testing Protocol.

Rigid interspinous process fixation (RIPF) has been recently discussed as an alternative to pedicle screw fixation (PSF) for reducing trauma in lumbar interbody fusion (LIF) surgery. This study aimed to investigate biomechanics of the lumbar spine with RIPF, and also to compare biomechanical differences between two postoperative stages (before and after bony fusion). Based on an intact finite-element model of lumbosacral spine, the models of single-level LIF with RIPF or conventional PSF were developed and were computed for biomechanical responses to the moments of four physiological motions using hybrid testing protocol. It was found that compared with PSF, range of motion (ROM), intradiscal pressure (IDP), and facet joint forces (FJF) at adjacent segments of the surgical level for RIPF were decreased by up to 8.4%, 2.3%, and 16.8%, respectively, but ROM and endplate stress at the surgical segment were increased by up to 285.3% and 174.3%, respectively. The results of comparison between lumbar spine with RIPF before and after bony fusion showed that ROM and endplate stress at the surgical segment were decreased by up to 62.6% and 40.4%, respectively, when achieved to bony fusion. These findings suggest that lumbar spine with RIPF as compared to PSF has potential to decrease the risk of adjacent segment degeneration but might have lower stability of surgical segment and an increased risk of cage subsidence; When achieved bony fusion, it might be helpful for the lumbar spine with RIPF in increasing stability of surgical segment and reducing failure of bone contact with cage.

Topology optimization and dynamic characteristic evaluation of W-shaped interspinous process device.

For reducing the adjacent segment degeneration of the lumbar spine, the interspinous process device as a kind of flexible non-fusion device was designed to overcome the deficiencies associated with rigid fusion devices. However, it was not clear how the interspinous process device influenced the human spine system, especially the lumbar spine under a vibration environment. This study was designed to evaluate the effect of StenoFix under the vibration condition and also to optimize the structure of the device to obtain better biomechanical performance. A finite element model of the intact lumbar spine was developed and validated. The surgical finite element model was constructed by implanting the interspinous process device StenoFix. Using topology optimization, a new device StenoFix-new was redesigned. The results showed that the interspinous process device decreased vibration amplitudes of annulus stress and intradiscal pressure under vibration at the surgical level. The redesigned StenoFix-new with the smaller stiffness exhibited a better dynamic flexibility performance than StenoFix. In addition, the range of motions of StenoFix-new was closer to the intact model than StenoFix at the surgical level. These results might encourage the designers to give more consideration to the dynamic characteristics of the human spine on the premise of ensuring the safety and strength of implanted devices.

Effect of different fixation methods on biomechanical property of cervical vertebral body replacement and fusion.

BACKGROUND: The main purpose of this study was to examine the effect of different fixation methods (anterior fixation, self-stabilizing fixation and anterior-posterior fixation) on biomechanical property of vertebral body replacement and fusion. METHODS: Three finite element models of cervical vertebral body replacement and fusion were established. The implanted models included artificial vertebral body and fixation system, and the loads imposed on the models included 75 N compression load and 1 Nm moment load. FINDINGS: For anterior-posterior fixation, the cervical load was mainly transmitted by the posterior pedicle screw and rod (more than 50%), and the stress shielding problem was the most significant than the self-stabilizing and anterior fixation. Self-stabilizing fixation was more helpful to the fusion of implant and vertebrae, but the higher risk of vertebral body collapse was worthy of attention if the cervical spine with osteoporosis. The stress of bone was mainly concentrated around the screw hole. The maximum stress (20.03 MPa) was lower than the yield stress of cortical bone and the possibility of fracture around the fixation device of cervical spine was low. The anterior fixation could meet the requirement of vertebral body replacement and fusion, and the addition of posterior pedicle screws and rods might obtain better treatment in cases of severe spine injury or osteoporosis. INTERPRETATION: The findings of this study may provide guidance on clinical treatments for choosing more appropriate fixation methods for different patients.

Maturity-onset diabetes of the young type 10 caused by an Ala2Thr mutation of INS: A case report.

BACKGROUND: Maturity-onset diabetes of the young 10 caused by the c.4G>A (p.Ala2Thr) mutation is extremely rare, with only two reported studies to date. Herein, we report another case that differs from previous cases in phenotype. CASE SUMMARY: The proband developed diabetes at the age of 27 years, despite having a normal body mass index (BMI). She exhibited partial impairment of islet function, tested positive for islet antibodies, and required high doses of insulin. Her sister also carried the c.4G>A (p.Ala2Thr) mutation, and their mother was strongly suspected to carry the mutated gene. Her sister developed diabetes around 40 years of age and required high doses of insulin, while the mother was diagnosed in her 20s and was managed with oral hypoglycemic agents; neither of them were obese. CONCLUSION: p.Ala2Thr mutation carriers often experience relatively later onset and normal BMI. Treatment regimens vary between individuals.

Role of omega-3 fatty acids in the prevention and treatment of cardiovascular Diseases: A consensus statement from the Experts' Committee Of National Society Of Cardiometabolic Medicine.

Low-density lipoprotein cholesterol (LDL-C) has been considered as the primary target for the prevention and treatment of atherosclerotic cardiovascular disease (ASCVD). However, there are still residual cardiovascular risks in some patients even if LDL-C achieves the target level. Emerging evidence suggestes that elevated triglyceride (TG) level or triglyceride-rich lipoprotein (TRL) cholesterol (TRL-C) is one of the important components of the residual cardiovascular risks. Omega-3 fatty acids have been shown to be one of the effective drugs for reducing TG. However, its efficacy in reducing the risk of ASCVD is inconsistent in large randomized clinical trials. There is lack of consensus among Experts regarding the application of omega-3 fatty acids in cardiovascular diseases including heart failure, arrhythmia, cardiomyopathy, hypertension, and sudden death. Hence, the current consensus will comprehensively and scientifically present the detailed knowledge about the omega-3 fatty acids from a variety of aspects to provide a reference for its management of omega-3 fatty acids application in the Chinese population.

Effect of whole-body vibration at different frequencies on the lumbar spine: A finite element study based on a whole human body model.

Many previous studies have found that occupational drivers commonly suffered from low back pain, and low back pain and degeneration of the intervertebral disc might be associated with vibration conditions. However, the biomechanical mechanisms of whole-body vibration that caused pain and injury were not clear. In this study, a validated whole human body finite element model was used, and vibration loads at frequencies of 3, 5, 7 and 9 Hz were loaded to evaluate the frequency effects on the spine. The results showed that the responses of the spine were strong at the 5 Hz vibration load. Vibration loads would produce alternating stresses and bulges in the annulus fibrosus and change the direction of the pressure in the nucleus pulposus. The posterior region of the intervertebral disc showed greater stress fluctuations than the anterior region. The Risk Factors showed that long-term exposure to whole-body vibrations at 5 and 7 Hz might have greater adverse effects on the spine. The findings of this study confirmed that vibrations near the resonance frequency of the human body would cause more injuries to the spine than other frequencies. Alternating stress and bulge might cause fatigue and the degeneration of the intervertebral disc, which might be the mechanisms of spinal injury caused by whole-body vibration, and the posterior regions of the intervertebral disc were more susceptible to degeneration. Some appropriate measures should be taken to reduce the adverse effects of whole-body vibration on spinal health.

Strip SAR image simulation of a composite vehicle-ground model.

In this paper, the strip synthetic aperture radar (SAR) image of a composite vehicle-ground model is simulated by combining the electromagnetic scattering algorithm and radar imaging algorithm. A linear frequency modulated wave is incident on the composite model, which is partitioned into a mass of triangular patches. In the "stop-and-go" radar mode, for each patch, the amplitude of scattered echo in the frequency domain is solved by a hybrid method of physical optics (PO)-shooting and bouncing ray (SBR)-physical theory of diffraction (PTD). For the composite model, the total scattered echo in terms of range frequency and azimuth time is obtained by the vector superposition of echo on patches. Then the SAR image of the composite model is generated by the range-Doppler algorithm. In numerical simulations, both the electromagnetic scattering of a target by the SBR-PTD method and composite scattering by the PO-SBR-PTD method are validated and evaluated by comparing with the multilevel fast multipole method (MLFMM) in FEKO software. Moreover, the SAR image of the composite vehicle-ground model is also compared with the real image in Moving and Stationary Target Acquisition and Recognition database, which verifies the feasibility of the proposed method. SAR images of the composite model for different incident angles are also presented and analyzed.

Biomechanical analysis of lumbar nonfusion dynamic stabilization using a pedicle screw-based dynamic stabilizer or an interspinous process spacer.

This study aimed to investigate and compare the effects of two widely used nonfusion posterior dynamic stabilization (NPDS) devices, pedicle screw-based dynamic stabilizer (PSDS) and interspinous process spacer (IPS), on biomechanics of the implanted lumbar spine under static and vibration loadings. The finite element model of healthy human lumbosacral segment was modified to incorporate NPDS device insertion at L4-L5 segment. Bioflex and DIAM were used as PSDS-based and IPS-based NPDS devices, respectively. As a comparison, lumbar interbody fusion with rigid stabilization was also simulated at L4-L5. For static loading, segmental range of motion (ROM) of the models under moments of four physiological motions was computed using hybrid testing protocol. For vibration loading, resonant modes and dynamic stress of the models under vertical excitation were extracted through random response analysis. The results showed that compared with the rigid fusion model, ROM of the nonfusion models was higher at L4-L5 level but lower at adjacent levels (L1- L2, L2-L3, L3-L4, L5-S1). Compared with the Bioflex model, the DIAM model produced higher ROM at L4-L5 level but lower ROM at adjacent levels, especially under lateral bending and axial rotation; resonant frequency of the DIAM model was slightly lower; dynamic response of nucleus stress at L4-L5 level was slightly higher for the DIAM model, and the dynamic stress at adjacent levels was no obvious difference between the nonfusion models. This study reveals biomechanical differences between the Bioflex and DIAM systems, which may provide references for selecting surgical approaches in clinical practice.

Biomechanical role of cement augmentation in the vibration characteristics of the osteoporotic lumbar spine after lumbar interbody fusion.

Under whole body vibration, how the cement augmentation affects the vibration characteristic of the osteoporotic fusion lumbar spine, complications, and fusion outcomes is unclear. A L1-L5 lumbar spine finite element model was developed to simulate a transforaminal lumbar interbody fusion (TLIF) model with bilateral pedicle screws at L4-L5 level, a polymethylmethacrylate (PMMA) cement-augmented TLIF model (TLIF-PMMA) and an osteoporotic TLIF model. A 40 N sinusoidal vertical load at 5 Hz and a 400 N preload were utilized to simulate a vertical vibration of the human body and the physiological compression caused by muscle contraction and the weight of human body. The results showed that PMMA cement augmentation may produce a stiffer pedicle screw/rod construct and decrease the risk of adjacent segment disease, subsidence, and rod failure under whole-body vibration(WBV). Cement augmentation might restore the disc height and segmental lordosis and decrease the risk of poor outcomes, but it might also increase the risk of cage failure and prolong the period of lumbar fusion under WBV. The findings may provide new insights for performing lumbar interbody fusion in patients affected by osteoporosis of the lumbar spine. Graphical abstract.

Development and Validation of a Whole Human Body Finite Element Model with Detailed Lumbar Spine.

OBJECTIVE: Investigations showed that low back pain of occupational drivers might be closely related to the whole-body vibration. Restricted by ethical concerns, the finite element method had become a viable alternative to invasive human experiments. Many mechanical behaviors of the human spine inside of the human body were unclear; therefore, a human whole-body finite element model might be required to better understand the lumbar behavior under whole-body vibration. METHODS: In this study, a human whole-body finite element model with a detailed lumbar spine segment was developed. Several validations were performed to ensure the correctness of this model. RESULTS: The results of anthropometry and geometry validation, static validation, and dynamic validation were presented in this study. The validation results showed that the whole human body model was reasonable and valid by comparing with published data. CONCLUSIONS: The model developed in this study could reflect the biomechanical response of the human lumbar spine under vibration and could be used in further vibration analysis and offer proposals for protecting human body under whole-body vibration environment.

Efficacy of Exenatide Administered Twice Daily in Body Mass Index Reduction in Patients with Type 2 Diabetes Mellitus.

Background: Exenatide is a glucagon-like peptide-1 receptor agonist that can reduce body weight. This study aimed to determine the efficacy of exenatide on body mass index (BMI) reduction in patients with type 2 diabetes mellitus (T2DM) with differing baseline body weight, blood glucose, and atherosclerotic status and to determine if there is a correlation between BMI reduction and cardiometabolic indices in these patients. Methods: This retrospective cohort study used data from our randomized controlled trial. A total of 27 T2DM patients treated with combination therapy of exenatide twice daily and metformin for 52 weeks were included. The primary endpoint was a change in the BMI from the baseline to week 52. The secondary endpoint was a correlation between BMI reduction and cardiometabolic indices. Findings. The BMIs of overweight and obesity patients and those with glycated hemoglobin (HbA1c) ≥ 9% significantly decreased -1.42 ± 1.48 kg/m2(P=0.015) and -0.87 ± 0.93 kg/m2(P=0.003), respectively, at the baseline after 52 weeks of treatment. There was no reduction in BMI in patients with normal weight, HbA1c <9%, the nonatherosclerosis group, and the atherosclerosis group. The decrease in BMI was positively correlated with changes in blood glucose, high-sensitivity C-reactive protein (hsCRP), and systolic blood pressure (SBP). Conclusion: BMI scores improved after exenatide treatment for 52 weeks in T2DM patients. Weight loss was affected by baseline body weight and blood glucose level. In addition, BMI reduction from the baseline to 52 weeks was positively correlated with baseline HbA1c, hsCRP, and SBP. Trial Registration. Chinese Clinical Trial Registry (ChiCTR-1800015658).

Influence of seat lumbar support adjustment on muscle fatigue under whole body vibration: An in vivo experimental study.

BACKGROUND: In order to alleviate muscle fatigue and improve ride comfort, many published studies aimed to improve the seat environment or optimize seating posture. However, the effect of lumbar support on the lumbar muscle of seated subjects under whole body vibration is still unclear. OBJECTIVE: This study aimed to investigate the effect of lumbar support magnitude of the seat on lumbar muscle fatigue relief under whole body vibration. METHODS: Twenty healthy volunteers without low back pain participated in the experiment. By measuring surface electromyographic signals of erector spinae muscles under vibration or non-vibration for 30 minutes, the effect of different lumbar support conditions on muscle fatigue was analyzed. The magnitude of lumbar support d is assigned as d1= 0 mm, d2= 20 mm and d3= 40 mm for no support, small support and large support, respectively. RESULTS: The results showed that lumbar muscle activation levels vary under different support conditions. For the small support case (d2= 20 mm), the muscle activation level under vibration and no-vibration was the minimum, 42.3% and 77.7% of that under no support (d1= 0 mm). For all support conditions, the muscle activation level under vibration is higher than that under no-vibration. CONCLUSIONS: The results indicate that the small support yields the minimum muscle contraction (low muscle contraction intensity) under vibration, which is more helpful for relieving lumbar muscle fatigue than no support or large support cases. Therefore, an appropriate lumbar support of seats is necessary for alleviating lumbar muscle fatigue.

Biomechanical investigation of topping-off technique using an interspinous process device following lumbar interbody fusion under vibration loading.

Topping-off technique has been proposed to prevent adjacent-segment degeneration/disease following spine fusion surgery. Nevertheless, few studies have investigated biomechanics of the fusion surgery with topping-off device under whole-body vibration (WBV). This biomechanical study aimed to investigate the vibration characteristics of human lumbar spine after topping-off surgery, and also to evaluate the effect of bony fusion on spine biomechanics. Based on a healthy finite-element model of lumbosacral spine (L1-sacrum), the models of topping-off surgery before and after bony fusion were developed. The simulated surgical procedures consisted of interbody fusion with rigid stabilizer at L4-L5 segment (rigid fusion) and dynamic stabilizer at degenerated L3-L4 segment. An interspinous implant, Device for Intervertebral Assisted Motion (DIAM, Medtronic Inc., Minnesota, USA), was used as the dynamic stabilizer. The stress responses of spine segments and implants under a vertical cyclic load were calculated and analyzed. The results showed that compared with rigid fusion alone, the topping-off technique significantly decreased disc stress at transition segment (L3-L4) as expected, and resulted in a slight increase in disc stress at its supra-adjacent segment (L2-L3). It indicated that the topping-off stabilization using DIAM might provide a good tradeoff between protection of transition segment and deterioration of its supra-adjacent segment during WBV. Also, it was found that bony fusion decreased stress in L4 inferior endplate and rigid stabilizer but had nearly no effect on stress in DIAM and L3-L4 disc, which was helpful to determine the biomechanical differences before and after bony fusion.

Fuzzy Logic Analysis for Key Factors for Customer Loyalty in E-Shopping Environment.

Due to subjective evaluation and qualitative characteristics, the assessment processes of loyalty often cannot use the crisp value to express the final value. That makes the evaluation of online store performance usually filled with uncertainty and ambiguity. The loyalty assessment of electronic shopping is complex, and online stores' strategy and production control problems are frequently accompanied by uncertain conditions. This study constructs a conceptual model to leverage the fuzzy logic approach for understanding the consumers' decision-making in the e-service context of shopping. This study also exposes the relationships between system quality, information quality, and service quality to understand their impacts on customer loyalty. Implications and future research directions for service providers and researchers are discussed.

Comparison of Clinical Efficacy and Safety of Metformin Sustained-Release Tablet (II) (Dulening) and Metformin Tablet (Glucophage) in Treatment of Type 2 Diabetes Mellitus.

Objectives: This study investigated the clinical efficacy and safety of metformin hydrochloride sustained-release (SR) tablet (II) produced by Dulening and the original metformin hydrochloride tablet produced by Glucophage in the treatment of type 2 diabetes mellitus (T2DM). Methods: This randomized, open and parallel controlled clinical trial consecutively recruited a total of 886 patients with T2DM in 40 clinical centers between May 2016 and December 2018. These patients were randomly assigned to the Dulening group (n=446), in which patients were treated with Dulening metformin SR tablets, and the Glucophage group (n=440), in which patients were treated with Glucophage metformin tablets, for 16 weeks. The changes in the levels of glycated hemoglobin (HbAc1) and fasting blood glucose (FBG) as well as weight loss were compared between these two groups. Also, the overall incidence of adverse drug reactions (ADRs) and the incidence of ADR of the gastrointestinal system observed in patients of these two groups were also compared. Results: There were no significant differences in demographic and basal clinical characteristics between these two groups. The Dulening and Glucophage groups showed comparable levels of decrease in HbA1c levels, FBG and weight loss after 12-week treatment (all p>0.05). The Dulening group had a significantly lower overall incidence of ADRs as well as gastrointestinal ADR than the Glucophage group. Conclusions: Metformin SR tablets (II) and the original metformin tablets exhibit similar therapeutic efficacy in the treatment of T2DM, but metformin SR tablets (II) has the significantly lower incidence of ADRs than the original metformin tablets.