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As one of the key components of clinical trials, blinding, if successfully implemented, can help to mitigate the risks of implementation bias and measurement bias, consequently improving the validity and reliability of the trial results. However, successful blinding in clinical trials of traditional Chinese medicine (TCM) is hard to achieve, and the evaluation of blinding success through blinding assessment lacks established guidelines. Taking into account the challenges associated with blinding in the TCM field, here we present a framework for assessing blinding. Further, this study proposes a blinding assessment protocol for TCM clinical trials, building upon the framework and the existing methods. An assessment report checklist and an approach for evaluating the assessment results are presented based on the proposed protocol. It is anticipated that these improvements to blinding assessment will generate greater awareness among researchers, facilitate the standardization of blinding, and augment the blinding effectiveness. The use of this blinding assessment may further advance the quality and precision of TCM clinical trials and improve the accuracy of the trial results. The blinding assessment protocol will undergo continued optimization and refinement, drawing upon expert consensus and experience derived from clinical trials. Please cite this article as: Wang XC, Liu XY, Shi KL, Meng QG, Yu YF, Wang SY, Wang J, Qu C, Lei C, Yu XP. Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol. J Integr Med. 2023; 21(6): 528-536.
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Medicamentos Herbarios Chinos/uso terapéutico , Medicina Tradicional China/métodos , Evaluación de Resultado en la Atención de Salud , Estándares de Referencia , Reproducibilidad de los Resultados , Proyectos de Investigación , Ensayos Clínicos como AsuntoRESUMEN
ABSTRACT Introduction: During COVID-19, home office activity increased significantly for professionals, especially high-tech companies dominated by information production. Physical health problems attracted great attention from departments responsible for exercise prescriptions. Objective: Discuss the positive and negative effects of home exercise behavior on the health of people working from home, and propose countermeasures to prevent and improve physical health during the epidemic. Methods: Survey questionnaires and mathematical statistics were used to analyze the factors influencing home exercise behavior on the physical health of remote employees. Results: Mathematical statistics from the questionnaire showed that among all investigated factors, more than 90% showed that home exercise behavior positively impacted remote employees' physical health, and less than 10% showed that home exercise behavior did not correlate with physical health. Conclusion: Under the significance level of α= 0.05, it is believed that home exercise behavior can effectively improve physical health. Therefore, if the epidemic control policy cannot be changed, it is recommended to further promote home exercise. Level of evidence II; Therapeutic studies - investigation of treatment outcomes.
RESUMO Introdução: Durante a COVID-19, a atividade em escritório doméstico aumentou significantemente aos profissionais, especialmente empresas de alta tecnologia dominadas pela produção de informações. Os problemas de saúde física atraíram grande atenção dos departamentos responsáveis pela prescrição de exercícios físicos. Objetivo: Compreender os efeitos positivos e negativos do comportamento de exercícios domésticos relacionados à saúde de pessoas que trabalham desde suas casas, propondo contramedidas de intervenção direcionadas à prevenção e melhora na saúde física durante a epidemia. Métodos: Foram utilizados questionários de pesquisa e estatísticas matemáticas para analisar os fatores que influenciam o comportamento do exercício em casa na saúde física dos colaboradores remotos. Resultados: Os resultados estatísticos matemáticos do questionário mostraram que entre todos os fatores investigados, mais de 90% mostraram que o comportamento do exercício em casa teve um impacto positivo na saúde física dos colaboradores remotos, e menos de 10% mostraram que o comportamento do exercício em casa não teve correlação com a saúde física. Conclusão: Sob o nível de significância de α= 0,05, acredita-se que o comportamento de exercício em casa pode efetivamente melhorar a saúde física. Portanto, se a política de controle de epidemias não puder ser alterada, recomenda-se promover ainda mais o exercício físico em casa. Nível de evidência II; Estudos terapêuticos - investigação dos resultados do tratamento.
RESUMEN Introducción: Durante el COVID-19, la actividad del home office aumentó significativamente para los profesionales, especialmente para las empresas de alta tecnología dominadas por la producción de información. Los problemas de salud física atrajeron una gran atención de los departamentos responsables de la prescripción del ejercicio. Objetivo: Comprender los efectos positivos y negativos de la conducta de ejercicio en el hogar relacionados con la salud de las personas que trabajan desde casa, proponiendo contramedidas de intervención dirigidas a la prevención y mejora de la salud física durante la epidemia. Métodos: Se utilizaron cuestionarios de encuesta y estadísticas matemáticas para analizar los factores que influyen en el comportamiento de ejercicio en casa sobre la salud física de los empleados a distancia. Resultados: Los resultados de la estadística matemática del cuestionario mostraron que, entre todos los factores investigados, más del 90% mostraba que el comportamiento de ejercicio en casa tenía un impacto positivo en la salud física de los empleados a distancia, y menos del 10% mostraba que el comportamiento de ejercicio en casa no tenía ninguna correlación con la salud física. Conclusión: Bajo el nivel de significación de α = 0,05, se cree que el comportamiento de ejercicio en casa puede mejorar efectivamente la salud física. Por lo tanto, si no se puede cambiar la política de control de la epidemia, se recomienda promover más el ejercicio en casa. Nivel de evidencia II; Estudios terapéuticos - investigación de los resultados del tratamiento.
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Objective:To study the clinical features and risk factors of death in patients with infected pancreatic necrosis (IPN) caused by multidrug-resistant bacteria (MDRB).Methods:The clinical data of 219 IPN patients who were managed at the Department of General Surgery of Xuanwu Hospital, Capital Medical University from January 1, 2016 to December 31, 2021 were retrospectively analyzed. There were 142 males, and 77 females, with a median age [ M( Q1, Q3)] of 51(38, 62) years old. Based on the pre-sence or absence of MDRB infection, these patients were divided into the MDRB-infected group ( n=117) and the non-MDRB-infected group ( n=102). Clinical features and outcomes were compared between the two groups, and the risk factors resulting in death in patients with MDRB infection were analyzed. Logistic regression analysis was used to determine the risk factors for poor outcomes in patients with MDRB. Results:There were significant differences in etiologies, distribution characteristics of necrosis and degrees of pancreatic necrosis between the two groups (all P<0.05). When compared with the non-MDRB-infected group, the CT severity index, the levels of procalcitonin and interleukin-6 were significantly higher in the MDRB group on admission, while the hematocrit was significantly lower (all P<0.05). Furthermore, when compared with the non-MDRB infection group, patients with MDRB infection were significantly more likely to have fungal infections [37.6%(44/117) vs. 21.6%(22/102)] and extrapancial infections [75.2%(88/117) vs. 58.8%(60/102)], more patients underwent surgery [89.7%(105/117) vs. 67.6%(69/102)], and more surgical procedures were performed [3(2, 4) times vs. 2(1, 3) times], with a higher incidence of postoperative complications [36.2%(38/117) vs. 18.8%(13/102)], an increase in a new-onset organ failure after surgery [37.1%(39/117) vs. 21.7%(15/102)], a higher in-hospital mortality rate [25.6%(30/117) vs. 10.8%(11/102)], longer hospitalization [39(28, 67) d vs. 29(18, 35) d] and ICU stays [22(10, 42) d vs. 11(6, 18) d], and a longer need for parenteral nutrition [19(9, 37) d vs. 15(7, 25) d, all P<0.05]. On multivariate regression analysis, the risk factor for death in the MDRB-infected group was co-fungal infection ( OR=1.199, 95% CI: 1.025-1.402). On the other hand, receiving therapy containing tigacycline ( OR=0.831, 95% CI: 0.715-0.965) and minimally invasive surgery ( OR=0.698, 95% CI: 0.562-0.868) reduced the risk of death in the MDRB-infected group (all P<0.05). Conclusions:IPN patients with MDRB infection had higher levels of inflammation, more serious pancreatic necrosis, longer treatment time, and increased need for surgical treatment. Measures involving fungal infection control and the use of tigacyclin and minimally invasive surgery reduced the risks of death in patients with MDRB infection.
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Gut dysbiosis,a well-known risk factor to triggers the progression of Alzheimer's disease(AD),is strongly associated with metabolic disturbance.Trimethylamine N-oxide(TMAO),produced in the dietary choline metabolism,has been found to accelerate neurodegeneration in AD pathology.In this study,the cognitive function and gut microbiota of TgCRND8(Tg)mice of different ages were evaluated by Morris water maze task(MWMT)and 16S rRNA sequencing,respectively.Young pseudo germ-free(PGF)Tg mice that received faecal microbiota transplants from aged Tg mice and wild-type(WT)mice were selected to determine the role of the gut microbiota in the process of neuropathology.Excessive choline treatment for Tg mice was used to investigate the role of abnormal choline metabolism on the cognitive functions.Our results showed that gut dysbiosis,neuroinflammation response,Aβ deposition,tau hyper-phosphorylation,TMAO overproduction and cyclin-dependent kinase 5(CDK5)/transcription 3(STAT3)activation occurred in Tg mice age-dependently.Disordered microbiota of aged Tg mice accelerated AD pathology in young Tg mice,with the activation of CDK5/STAT3 signaling in the brains.On the contrary,faecal microbiota transplantation from WT mice alleviated the cognitive deficits,attenuated neuro-inflammation,Aβ deposition,tau hyperphosphorylation,TMAO overproduction and suppressed CDK5/STAT3 pathway activation in Tg mice.Moreover,excessive choline treatment was also shown to aggravate the cognitive deficits,Aβ deposition,neuroinflammation and CDK5/STAT3 pathway activation.These findings provide a novel insight into the interaction between gut dysbiosis and AD progression,clarifying the important roles of gut microbiota-derived substances such as TMAO in AD neuropathology.
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BACKGROUNDThe rising breakthrough infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, especially Omicron and its sub-lineages, have raised an urgent need to develop broad-spectrum vaccines against coronavirus disease 2019 (COVID-19). We have developed a mosaic-type recombinant vaccine candidate, named NVSI-06-09, having immune potentials against a broad range of SARS-CoV-2 variants. METHODSAn ongoing randomized, double-blind, controlled phase 2 trial was conducted to evaluate the safety and immunogenicity of NVSI-06-09 as a booster dose in subjects aged 18 years and older from the United Arab Emirates (UAE), who had completed two or three doses of BBIBP-CorV vaccinations at least 6 months prior to the enrollment. The participants were randomly assigned with 1:1 to receive a booster dose of NVSI-06-09 or BBIBP-CorV. The primary outcomes were immunogenicity and safety against SARS-CoV-2 Omicron variant, and the exploratory outcome was cross-immunogenicity against other circulating strains. RESULTSA total of 516 participants received booster vaccination. Interim results showed a similar safety profile between NVSI-06-09 and BBIBP-CorV booster groups, with low incidence of adverse reactions of grade 1 or 2. For immunogenicity, by day 14 after the booster vaccination, the fold rises in neutralizing antibody geometric mean titers (GMTs) from baseline level elicited by NVSI-06-09 were remarkably higher than those by BBIBP-CorV against the prototype strain (19.67 vs 4.47-fold), Omicron BA.1.1 (42.35 vs 3.78-fold), BA.2 (25.09 vs 2.91-fold), BA.4 (22.42 vs 2.69-fold), and BA.5 variants (27.06 vs 4.73-fold). Similarly, the neutralizing GMTs boosted by NVSI-06-09 against Beta and Delta variants were also 6.60-fold and 7.17-fold higher than those boosted by BBIBP-CorV. CONCLUSIONSA booster dose of NVSI-06-09 was well-tolerated and elicited broad-spectrum neutralizing responses against SARS-CoV-2 prototype strain and immune-evasive variants, including Omicron and its sub-lineages. The immunogenicity of NVSI-06-09 as a booster vaccine was superior to that of BBIBP-CorV. (Funded by LIBP and BIBP of Sinopharm; ClinicalTrials.gov number, NCT05293548).
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The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants with immune escape ability raises the urgent need for developing cross-neutralizing vaccines against the virus. NVSI-06-08 is a potential broad-spectrum recombinant COVID-19 vaccine that integrates the antigens from multiple SARS-CoV-2 strains into a single immunogen. Here, we evaluated the safety and immunogenicity of NVSI-06-08 as a heterologous booster dose in adults previously vaccinated with the inactivated vaccine BBIBP-CorV in a randomized, double-blind, controlled, phase 2 trial conducted in the United Arab Emirates (NCT05069129). Three groups of healthy adults over 18 years of age (600 participants per group) who had administered two doses of BBIBP-CorV 4-6-month, 7-9-month and >9-month earlier, respectively, were vaccinated with either a homologous booster of BBIBP-CorV or a heterologous booster of NVSI-06-08. The primary outcome was immunogenicity and safety of booster vaccinations. The exploratory outcome was cross-reactive immunogenicity against multiple SARS-CoV-2 variants of concerns (VOCs). The incidence of adverse reactions was low in both booster vaccinations, and the overall safety profile of heterologous boost was quite similar to that of homologous boost. Heterologous NVSI-06-08 booster was immunogenically superior to homologous booster of BBIBP-CorV. Both Neutralizing and IgG antibodies elicited by NVSI-06-08 booster were significantly higher than by the booster of BBIBP-CorV against not only SARS-CoV-2 prototype strain but also multiple VOCs. Especially, the neutralizing activity induced by NVSI-06-08 booster against the immune-evasive Beta variant was no less than that against the prototype strain, and a considerable level of neutralizing antibodies against Omicron (GMT: 367.67; 95%CI, 295.50-457.47) was induced by heterologous booster, which was substantially higher than that boosted by BBIBP-CorV (GMT: 45.03; 95%CI, 36.37-55.74). Our findings showed that NVSI-06-08 was safe and immunogenic as a booster dose following two doses of BBIBP-CorV, which was immunogenically superior to homologous boost with another dose of BBIBP-CorV. Our study also indicated that the design of hybrid antigen may provide an effective strategy for broad-spectrum vaccine developments.
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BackgroundThe increased coronavirus disease 2019 (COVID-19) breakthrough cases pose the need of booster vaccinations. In this study, we reported the safety and immunogenicity of a heterologous boost with a recombinant COVID-19 vaccine (CHO cells), named NVSI-06-07, as a third dose in participants who have previously received two doses of the inactivated vaccine (BBIBP-CorV) at pre-specified time intervals. Using homologous boost with BBIBP-CorV as control, the safety and immunogenicity of the heterologous boost with NVSI-06-07 against various SARS-CoV-2 strains, including Omicron, were characterized. MethodsThis study is a single-center, randomised, double-blinded, controlled phase 2 trial for heterologous boost of NVSI-06-07 in BBIBP-CorV recipients from the United Arab Emirates (UAE). Healthy adults (aged [≥]18 years) were enrolled and grouped by the specified prior vaccination interval of BBIBP-CorV, i.e., 1-3 months, 4-6 months or [≥]6 months, respectively, with 600 individuals per group. For each group, participants were randomly assigned at 1:1 ratio to receive either a heterologous boost of NVSI-06-07 or a homologous booster dose of BBIBP-CorV. The primary outcome was to comparatively assess the immunogenicity between heterologous and homologous boosts at 14 and 28 days post-boosting immunization, by evaluation of the geometric mean titers (GMTs) of IgG and neutralizing antibodies as well as the corresponding seroconversion rate ([≥]4-fold rise in antibody titers). The secondary outcomes were the safety profile of the boosting strategies within 30 days post vaccination. The exploratory outcome was the immune efficacy against Omicron and other variants of concern (VOCs) of SARS-CoV-2. This trial is registered with ClinicalTrials.gov, NCT05033847. FindingsA total of 1800 individuals who have received two doses of BBIBP-CorV were enrolled, of which 899 participants received a heterologous boost of NVSI-06-07 and 901 received a homologous boost for comparison. No vaccine-related serious adverse event (SAE) and no adverse events of special interest (AESI) were reported. 184 (20{middle dot}47%) participants in the heterologous boost groups and 177 (19{middle dot}64%) in the homologous boost groups reported at least one adverse reaction within 30 days. Most of the local and systemic adverse reactions reported were grades 1 (mild) or 2 (moderate), and there was no significant difference in the overall safety between heterologous and homologous boosts. Immunogenicity assays showed that the seroconversion rates in neutralizing antibodies against prototype SARS-CoV-2 elicited by heterologous boost were 89{middle dot}96% - 97{middle dot}52% on day 28 post-boosting vaccination, which was much higher than what was induced by homologous boost (36{middle dot}80% - 81{middle dot}75%). Similarly, in heterologous NVSI-06-07 booster groups, the neutralizing geometric mean titers (GMTs) against the prototype strain increased by 21{middle dot}01 - 63{middle dot}85 folds from baseline to 28 days post-boosting vaccination, whereas only 4{middle dot}20 - 16{middle dot}78 folds of increases were observed in homologous BBIBP-CorV booster group. For Omicron variant, the neutralizing antibody GMT elicited by the homologous boost of BBIBP-CorV was 37{middle dot}91 (95%CI, 30{middle dot}35-47{middle dot}35), however, a significantly higher level of neutralizing antibodies with GMT 292{middle dot}53 (95%CI, 222{middle dot}81-384{middle dot}07) was induced by the heterologous boost of NVSI-06-07, suggesting that it may serve as an effective boosting strategy combating the pandemic of Omicron. The similar results were obtained for other VOCs, including Alpha, Beta and Delta, in which the neutralizing response elicited by the heterologous boost was also significantly greater than that of the homologous boost. In the participants primed with BBIBP-CorV over 6 months, the largest increase in the neutralizing GMTs was obtained both in the heterologous and homologous boost groups, and thus the booster vaccination with over 6 months intervals was optimal. InterpretationOur findings indicated that the heterologous boost with NVSI-06-07 was safe, well-tolerated and immunogenic in adults primed with a full regimen of BBIBP-CorV. Compared to homologous boost with a third dose of BBIBP-CorV, incremental increases in immune responses were achieved by the heterologous boost with NVSI-06-07 against SARS-CoV-2 prototype strain, Omicron variant, and other VOCs. The heterologous BBIBP-CorV/NVSI-06-07 prime-boosting vaccination may be valuable in preventing the pandemic of Omicron. The optimal booster strategy was the heterologous boost with NVSI-06-07 over 6 months after a priming with two doses of BBIBP-CorV. Research in contextO_ST_ABSEvidence before this studyC_ST_ABSWe searched PubMed for clinical trials or prospective/cohort studies involving heterologous booster vaccination in non-immunocompromised population published up to Dec 25, 2021, using the term "(COVID) AND (vaccin*) AND (clinical trial OR cohort OR prospective) AND (heterologous) AND (booster OR prime-boost OR third dose)" with no language restrictions. Nine studies of heterologous prime-boost vaccinations with adenovirus-vector vaccines (ChAdOx1 nCov-19, Oxford-AstraZeneca, Ad26.COV2.S, Janssen) and mRNA vaccines (BNT162b2, Pfizer-BioNtech; mRNA1273, Moderna) were identified. The adenovirus-vector and mRNA heterologous prime-boost vaccination was found to be well tolerated and immunogenic. In individuals primed with adenovirus-vector vaccine, mRNA booster vaccination led to greater immune response than homologous boost. However, varied results were obtained on whether heterologous boost was immunogenically superior to the homologous mRNA prime-boost vaccination. Besides that, A preprint trial in population previously immunized with inactivated vaccines (CoronaVac, Sinovac Biotech) showed that the heterologous boost with adenovirus-vector vaccine (Convidecia, CanSino Biologicals) was safe and induced higher level of live-virus neutralizing antibodies than by the homogeneous boost. A pilot study reported that boosting with BNT162b2 in individuals primed with two doses of inactivated vaccines (BBIBP-CorV) was significantly more immunogenic than homologous vaccination with two-dose of BNT162b2. In addition, a preprint paper demonstrated that heterologous boost of ZF2001, a recombinant protein subunit vaccine, after CoronaVac or BBIBP-CorV vaccination potently improved the immunogenicity. But only a small size of samples was tested in this study and the live-virus neutralization was not detected. Till now, it is still lacking a formal clinical trial to evaluate the immunogenicity and safety of the heterologous prime-boost vaccination with an inactivated vaccine followed by a recombinant protein subunit-based vaccine. Added value of this studyTo our knowledge, this is the first reported result of a large-scale randomised, controlled clinical trial of heterologous prime-boost vaccination with an inactivated vaccine followed by a recombinant protein subunit vaccine. This trial demonstrated that the heterologous prime-booster vaccination with BBIBP-CorV/NVSI-06-07 is safe and immunogenic. Its immunoreactivity is similar to that of homologous vaccination with BBIBP-CorV. Compared to homologous boost, heterologous boost with NVSI-06-07 in BBIBP-CorV recipients elicited significantly higher immunogenicity not only against the SARS-CoV-2 prototype strain but also against Omicron and other variants of concern (VOCs). Implications of all the available evidenceBooster vaccination is considered an effective strategy to improve the protection efficacy of COVID-19 vaccines and control the epidemic waves of SARS-CoV-2. Data from our trial suggested that the booster vaccination of NVSI-06-07 in BBIBP-CorV recipients significantly improved the immune responses against various SARS-CoV-2 strains, including Omicron. Due to no Omicron-specific vaccine available currently, the BBIBP-CorV/NVSI-06-07 heterologous prime-boost might serve as an effective strategy combating Omicron variant. Besides that, BBIBP-CorV has been widely inoculated in population, and thus further boosting vaccination with NVSI-06-07 is valuable in preventing the COVID-19 pandemic. But further studies are needed to assess the long-term protection of BBIBP-CorV/NVSI-06-07 prime-booster vaccination.
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Aim To investigate pro-angiogenic effect of SEHM formula on HUVEC cells in vitro and Zebrafish in vivo and the related action mechanism .Methods VEGFR tyrosine kinase inhibitor II ( VRI)-induced ze-brafish intersegmental vessels ( ISVs ) damaged model was established to observe the protective effect of SE-HM formula on ISVs under fluorescence microscope . The pro-angiogenic effect on subintestinal vessels ( SIVs ) of water decoction of SEHM formula in ze-brafish was observed and the mRNA level of VEGFRs , including flt-1, kdr, kdrl, was measured by real-time PCR.The experimental models of the HUVEC cells were set up and the toxicity and promoting proliferation effect of water decoction of SEHM formula in HUVEC cells were assessed by cell viability assay (MTT), and then the levels of Akt, p38, p-p38, p44/42, p-p44/42, VEGFR-1 were detected by Western blot at 6, 12 and 24 h.Results SEHM formula treatment groups could significantly protect VRI-induced zebrafish ISVs loss(P<0.01) and presented pro-angiogenic effect on zebrafish SIVs obviously(P<0.01).The mRNA level of VEGFRs, including flt-1, kdr, kdrl.was up-regula-ted by SEHM formula treatment group significantly (P<0.05) compared with VRI group.Compared with control group , and SEHM formula treatment group could apparently promote proliferation in HUVEC cells and up-regulate the level of Akt, p38, p-p38, p44/42, p-p44/42, VEGFR-1.Conclusions Water de-coction of SEHM formula could present pro-angiogenic effect on SIVs in zebrafish and promote proliferation of HUVEC cells significantly , and its action mechanism may be related to up-regulating the expression of VEG-FR.
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BACKGROUND: As a metal internal fixation material, magnesium alloy has more unique advantages, such as biodegradability and elastic modulus. The elastic modulus of magnesium alloy is similar to the compact bone,which is enough to avoid stress-shelter effect. However, biological activity represents bonding ability with the bone in the body for fracture fixation materials, which is of great significance for studies on new kinds of magnesium alloys.OBJECTIVE: To observe the microstructure of Mg-Zn-Gd alloys and to analyze the corrosion products on the material surface after immersed in simulation body fluid.METHODS: The Mg-Zn-Gd alloys were manufactured by the method of fusion casting. Scanning electron microscope with spectrometer was applied to observe microstructure and distribution of precipitated phase and corrosion products of Mg-Zn-Gd alloys in simulated body fluid.RESULTS AND CONCLUSION: The Mg-Zn-Gd alloy was composed of α-Mg solid solution containing Gd and Zn elements and eutectic structure. The eutectic structure was almost feathery, oval-shaped, herringbone-shaped and strip-shaped along the grain boundary. The main ingredients of eutectic structure included Mg, Zn and Gd elements.Deposition layer was composed of O, Mg, Ca and P elements on the surface of Mg-Zn-Gd alloy after 72 hours soak in Hank's solution. X-ray diffraction analysis showed that film layer contained Mg(OH)2 phase, which promoted calcium salt deposition and reduced the corrosion rate. So Mg-Zn-Gd alloy can obtain better biological activity.
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Objective In order to improve the accuracy and efficiency of the measurement of range of motion (ROM) of human lower limbs and simplify process of ROM measurement,an automatic measurement of ROM of human lower limbs based on Kinect technique was proposed and tested in this study.Methods Fifty examinee were randomly divided into 5 groups,namely groups a,b,c,d and e,respectively,each group had 10 members.Using the human skeleton tracking technology from Kinect,the positions of the examinee's lower limbs were captured and tracked by processing the depth data of lower limbs' key joints.Then the information of ROM of hip and knee was output on human-computer interaction interface in real-time.By comparison with traditional manual measurement results,the accuracy of automatic measuring method could be verified.Meanwhile,with the aid of speech recognition and output technology,the mode of warning information transfer and the way of subject switch were optimized.Results According to the method of Grubbs-test and t-test,the ROM values | t | from the subjects' hip abduction (t =0.57,P =0.597),hip adduction (t =0.52,P =0.621),hip anteflexion (t =1.01,P =0.371),hip postextension (t =0.12,P =0.902),hip external rotation (t =0.00,P =1.000),hip internal rotation (t =0.34,P =0.753),knee flexion and extension (t =1.12,P =0.280) all were under the threshold value t0.025 (4) =2.776 on the premise of a level of significance α =0.05,which indicated that there was no significant difference between measured results and expected values(P > 0.05).Conclusion The automatic measurement of ROM of lower limbs can be realized which can improve the measurement accuracy,simplify the measurement process and enhance the practicability of ROM of lower limbs measurement.
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<p><b>OBJECTIVE</b>To compare the differences in the efficacy on distant version of naked eye in the patients of juvenile myopia between rotating manipulation and lifting-thrusting manipulation of acupuncture.</p><p><b>METHODS</b>One hundred and twenty cases (240 eyes) were randomized into a rotating manipulation group and a lifting-thrusting manipulation group, 60 cases (120 eyes) in each group. Additionally, a corrective lenses group, 60 cases (120 eyes), was set up as the control. In both manipulation groups, Cuanzhu (BL 2),Yuyao (EX-HN 4), Sizhukong (TE 23), Taiyang (EX-HN 5), Fengchi (GB 20), Zusanli (ST 36), Guangming (GB 37) and Sanyinjiao (SP 6) were punctured, but stimulated with rotating manipulation and lifting-thrusting manipulation respectively three times per week, 10 times as a treatment session and totally one session was required. In the corrective lenses group, the glasses were applied at daytime. The clinical efficacy and the changes in distant vision of naked eye before and after treatment were compared among the three groups.</p><p><b>RESULTS</b>The total effective rate was 87.5% (105/120) in the rotating manipulation group, which was better than 69.2% (83/120) in the lifting-thrusting manipulation group (P < 0.05). The distant vision of naked eye was improved apparently in the rotating manipulation group and the lifting-thrusting manipulation group after treatment (both P < 0.05). But it was not improved in the corrective lenses group (P > 0.05). The distant vision of naked eye was improved more apparently after treatment in the rotating manipulation group as compared with that in the lifting-thrusting manipulation group (0.75 +/- 0.23 vs 0.68 +/- 0.24, P < 0.05). For 96 cases (192 eyes) with acupuncture treatment, in 3-month follow-up, 87.0% (167/192) of the cases maintained the stable vision as the original level and 13.0% (25/192) of them were reduced in the vision In the acupuncture groups, it was found that the improvement of distant vision of naked eye was more obvious after treatment with younger age, better basic vision and shorter duration of sickness (all P < 0.05).</p><p><b>CONCLUSION</b>Acupuncture achieves the positive and sustainable clinical effect on juvenile myopia, and the results of rotating manipulation are superior to that of lifting-thrusting manipulation. Age, basic vision and duration of sickness impact the clinical efficacy.</p>
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Adolescente , Niño , Femenino , Humanos , Adulto Joven , Puntos de Acupuntura , Terapia por Acupuntura , Métodos , Miopía , TerapéuticaRESUMEN
@#The application and advance of somatic sense interactive devices, such as EyeToy, Wii and Kinect, in the motor rehabilitation were introduced in this paper. The prospect of application of somatic sense interactive technology as an effective approach in rehabilitation is wide and bright.