1.A nomogram model for predicting malnutrition after a tracheotomy
Ang CAI ; Junfeng YANG ; Ruyao LIU ; Le WANG ; Yi LI ; Liugen WANG ; Heping LI ; Xi ZENG
Chinese Journal of Physical Medicine and Rehabilitation 2024;46(3):199-204
Objective:To explore the risk factors for malnutrition after a tracheotomy and to construct a predictive model useful for its prevention through early intervention.Methods:Clinical data describing 440 tracheotomy patients were subjected to a retrospective analysis. The variables examined were age, sex, etiology, Glasgow Coma Score (GCS), activities of daily living (ADL) score, age-corrected Charlson comorbidity index (aCCI), food intake, swallowing function, incidence of infections, as well as any history of diabetes mellitus, hypertension, smoking or alcohol consumption. Patients identified as being at risk of malnutrition (NRS-2002≥3) were screened using the Nutritional Risk Screening tool (NRS-2002) and the European Society of Clinical Nutrition and Metabolism′s ESPEN2015 criteria. The subjects were thus categorized into a malnutrition group of 343 and a control group of 97. Unifactorial and multifactorial logistic regression analyses were performed, and stepwise regression was applied to include the factors found significant in the unifactorial analysis into the multifactorial logistic regression analysis, and to construct a column-line graph prediction model. The clinical utility of the model was assessed by applying the receiver operator characteristics (ROC) curves, calibration plots and decision curve analysis (DCA).Results:Of the 440 persons studied, 343 (78%) were malnourished. The multivariate logistic regression analysis showed that pulmonary infection, dysphagia, low GCS score and high aCCI score were significant risk factors for malnutrition after a tracheotomy. A prediction nomograph was constructed. After fitting and correcting, the area under the curve (AUC) of the prediction model′s ROC curve was 0.911, the specificity was 80.4%, and the sensitivity was 91.3%. That was significantly higher than the AUCs for pulmonary infection (0.809), dysphagia (0.697), aCCI (0.721) and GCS (0.802). Bootstrap self-sampling was used to verify the model internally. After 1000 samples the average absolute error between the predicted risk and the actual risk was 0.013, indicating good prediction ability. The DCA results demonstrated that the model has substantial clinical applicability across a range of nutritional interventions, particularly for threshold probability values ranging from 0 to 0.96.Conclusion:Pulmonary infection, dysphagia, low GCS score, and high aCCI score are risk factors for malnutrition among tracheotomy patients. The nomogram model constructed in this study has good predictive value for the occurrence of malnutrition among such patients.
2.Establishment of UPLC characteristic chromatogram of Pulsatilla chinensis and its application in origin differentiation and counterfeit identification
Guangming HE ; Rui LUO ; Heping ZENG ; Xiaoying LU ; Xiaolong YANG ; Weisheng LYU ; Yueyi LIANG ; Zhenyu LI ; Dongmei SUN ; Xiangdong CHEN
International Journal of Traditional Chinese Medicine 2024;46(6):743-749
Objective:To establish ultra performance liquid chromatography (UPLC) characteristic chromatogram of Pulsatilla chinensis; To provide reference for the origin identification and quality control of Pulsatilla chinensis. Methods:UPLC Method was adopted. The determination was performed on a column of Agilent SB C18 (2.1 mm×100 mm, 1.8 μm) . The mobile phase was acetonitrile-methanol (2:1) -0.1% phosphoric acid solution by fradient elution at a flow rate of 0.30ml/min. The column temperature was 30 ℃. The detection wavelength was 215 nm. The injection volume was 2 μl. The common counterfeit products and medicinal herbs of Pulsatilla chinensis from different areas were evaluated by comparison of characteristic chromatogram, principal component analysis (PCA) and orthogonal partial least squares discriminant analysis (OPLS-DA). Results:There were 9 characteristic peaks in the characteristic chromatogram of Pulsatilla chinensis, and 8 common peaks were identified by high resolution mass spectrometry and comparison of reference materials. Through PCA analysis, it was possible to clearly distinguish the medicinal herbs of Pulsatilla chinensis from different areas. Combined with OPLS-DA analysis, it was found that peak 2, peak 3, peak 6 were the main markers of Pulsatilla chinensis from different producing areas. Conclusion:The established method has good specificity, repeatability and durability, and it can effectively distinguish the common counterfeits of Pulsatilla chinensis, and provide the basis of quality control and selection of origin for Pulsatilla chinensis.
3.Intermittent feeding through an oral to esophageal tube is best for patients with a late-onset swallowing disorder after radiotherapy
Hongji ZENG ; Xi ZENG ; Weijia ZHAO ; Jihong WEI ; Furong BAO ; Heping LI ; Liugen WANG
Chinese Journal of Physical Medicine and Rehabilitation 2024;46(6):534-538
Objective:To observe the clinical efficacy of intermittent feeding through an oral to esophageal (IOE) tube for persons with a late-onset swallowing disorder after radiotherapy for nasopharyngeal carcinoma.Methods:Fifty-six patients with late-onset swallowing difficulties after radiotherapy for nasopharyngeal carcinoma were divided at random into an observation group and a control group, each of 28. In addition to conventional therapy, the controls were fed through an indwelling nasogastric tube (NGT) while an IOE tube was used in the observation group. The nutritional status of the two groups was compared after 20 hours and after 15 days of treatment. Depression, oral feeding ability, leakage and aspiration, and life quality were evaluated using patient health questionnaire-9 (PHQ-9), a functional oral feeding scale (FOIS), a leakage-aspiration scale (PAS), and a swallowing-quality of life (SWAL-QOL) evaluation. From the 3rd day after admission the daily amount fed was recorded.Results:At admission there were no significant differences between the two groups. After 15 days, however, there was significantly greater improvement observed in the average serum albumin, hemoglobin, serum total protein, serum prealbumin level, body mass index(BMI) and SWAL-QOL score of the experimental group compared to the control group, with significantly fewer members suffering from depression. From the 4th day after admission the observation group′s members ate a significantly larger proportion of the target feeding amount.Conclusion:IOE feeding can improve the nutritional status, psychological status, and life quality of persons with a late-onset swallowing disorder more effectively than NGT feeding, with a lower incidence of adverse events.
4.Combining ultrasound with balloon-guided injection of botulinum toxin in the treatment of cricopharyngeal achalasia
Yuli ZHU ; Yi LI ; Qiongshuai ZHANG ; Heping LI ; Hongji ZENG ; Jing ZENG ; Dejun ZHU ; Xueyun MA ; Xi ZENG ; Liugen WANG
Chinese Journal of Physical Medicine and Rehabilitation 2024;46(10):898-903
Objective:To observe any clinical effect of supplementing ultrasound stimulation with balloon-guided injection of botulinum toxin into the upper esophageal sphincter in the treatment of cricopharyngeal achalasia.Methods:Forty patients with cricopharyngeal achalasia were randomly divided into an observation group and a control group, each of 20. Both groups were given routine swallowing rehabilitation training, while the observation group additionally had botulinum toxin injected into the upper esophageal sphincter guided by ultrasound and with the aid of balloon dilation. Before the experiment and after 2 weeks, both groups were evaluated videofluoroscopically and flexible endoscopic evaluation of swallowing was performed. Moreover, 2 weeks before the treatment and 2, 4 and 24 weeks afterward, everyone′s eating, leakage and aspiration, and oral and pharyngeal secretions were assessed using the functional oral intake scale (FOIS), the penetration-aspiration scale (PAS), the fiberoptic endoscopic dysphagia severity scale (FEDSS) and the Murray secretion scale (MSS).Results:After 2 weeks the average PAS, FEDSS and MSS scores of both groups had improved significantly, but the observation group′s averages[3(2, 5), 3(2, 5) and 2(1, 2)] were significantly better than those of the control group. 2, 4 and 24 weeks after the experiment the average FOIS scores of both groups also showed significant improvement, with the observation group′s average[3(2, 4), 4(2, 6) and 6(3, 7)] again significantly better than that of the control group.Conclusions:A botulinum toxin injection into the upper esophageal sphincter can effectively improve the swallowing of persons with cricopharyngeal achalasia with adequate safety and significant long-term benefits. Therefore, such treatment is worthy of clinical promotion and application.
5.Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
Chengyuan GU ; Zengjun WANG ; Tianxin LIN ; Zhiyu LIU ; Weiqing HAN ; Xuhui ZHANG ; Chao LIANG ; Hao LIU ; Yang YU ; Zhenzhou XU ; Shuang LIU ; Jingen WANG ; Linghua JIA ; Xin YAO ; Wenfeng LIAO ; Cheng FU ; Zhaohui TAN ; Guohua HE ; Guoxi ZHU ; Rui FAN ; Wenzeng YANG ; Xin CHEN ; Zhizhong LIU ; Liqiang ZHONG ; Benkang SHI ; Degang DING ; Shubo CHEN ; Junli WEI ; Xudong YAO ; Ming CHEN ; Zhanpeng LU ; Qun XIE ; Zhiquan HU ; Yinhuai WANG ; Hongqian GUO ; Tiwu FAN ; Zhaozhao LIANG ; Peng CHEN ; Wei WANG ; Tao XU ; Chunsheng LI ; Jinchun XING ; Hong LIAO ; Dalin HE ; Zhibin WU ; Jiandi YU ; Zhongwen FENG ; Mengxiang YANG ; Qifeng DOU ; Quan ZENG ; Yuanwei LI ; Xin GOU ; Guangchen ZHOU ; Xiaofeng WANG ; Rujian ZHU ; Zhonghua ZHANG ; Bo ZHANG ; Wanlong TAN ; Xueling QU ; Hongliang SUN ; Tianyi GAN ; Dingwei YE
Chinese Medical Journal 2023;136(10):1207-1215
BACKGROUND:
LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.
METHODS:
We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.
RESULTS:
On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).
CONCLUSION:
LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04563936.
Humans
;
Male
;
Antineoplastic Agents, Hormonal/therapeutic use*
;
East Asian People
;
Gonadotropin-Releasing Hormone/agonists*
;
Goserelin/therapeutic use*
;
Prostate-Specific Antigen
;
Prostatic Neoplasms/drug therapy*
;
Testosterone
6.Analysis of risk factors and a predictive model of malnutrition in disabled stroke patients
Ang CAI ; Yi LI ; Liugen WANG ; Heping LI ; Xi ZENG
Chinese Journal of Physical Medicine and Rehabilitation 2023;45(1):24-28
Objective:To analyze the risk factors for malnutrition among disabled stroke survivors and devise a prediction model.Methods:A total of 373 disabled stroke survivors treated in the Department of Rehabilitation Medicine, the First Affiliated Hospital of Zhengzhou University in 2021 formed a control group ( n=102) and a malnutrition group ( n=271) according to their nutritional status. Univariate correlation analysis and multivariate logistic regression were used to analyze the risk factors for malnutrition and their predictive value. Results:Age, dysphagia, pulmonary infection, disability score and feeding style were found to be related significantly to the occurrence of malnutrition. Multivariate logistic regression confirmed that age, pulmonary infection, dysphagia, low total intake and a low Barthel index were useful predictors of malnutrition in such persons. Moreover, patients who had received nasogastric tube feeding were at much higher risk of malnutrition than those with intermittent oroesophageal tube feeding. The area under the receiver operating characteristics curve of the Barthel index combined with dysphagia to predict malnutrition was 0.84. The critical value was 0.67 with a sensitivity of 88% and a specificity of 72.5%.Conclusions:Age, pulmonary infection, dysphagia, feeding method, total intake and disability score are risk factors for malnutrition in disabled stroke survivors. The Barthel index combined with dysphagia has good predictive power for the occurrence of malnutrition in such persons.
7.Applying ultrasound in exploring the parameters of the geniohyoid muscle in stroke survivors with dysphagia
Xiaolei FANG ; Fangquan ZHANG ; Lu LIU ; Yi LI ; Liugen WANG ; Heping LI ; Xi ZENG
Chinese Journal of Physical Medicine and Rehabilitation 2023;45(10):912-916
Objective:To investigate the value of applying B+ M type and shear-wave elastic ultrasound in determining the parameters of the geniohyoid muscles of stroke survivors with dysphagia.Methods:Forty stroke survivors with dysphagia formed an observation group, while 20 healthy counterparts were chosen as the control group. The thickness of the geniohyoid muscle, as well as the movement distance, time, rate and shear wave velocity were measured using B+ M ultrasound and shear wave elastic ultrasound when swallowing nothing or 5ml of water, respectively.Results:The average thickness of the geniohyoid muscle and the average shear wave velocity of the observation group were significantly smaller than among the controls. When swallowing either nothing or water, the geniohyoid muscle in the observation group tended to move farther than among the controls, acting more slowly and taking significantly more time.Conclusion:Ultrasound can quantify the thickness of the geniohyoid muscle and its motor parameters and stiffness. It can be used to evaluate the swallowing function of stroke survivors with dysphagia.
8.The prevalence of malnutrition among stroke survivors with bulbar palsy and the associated risk factors
Lianlian LIU ; Fangquan ZHANG ; Xi ZENG ; Yi LI ; Liugen WANG ; Shujing ZHANG ; Heping LI
Chinese Journal of Physical Medicine and Rehabilitation 2023;45(12):1094-1098
Objective:To explore the prevalence of malnutrition among stroke survivors with bulbar palsy and the risk factors involved, and to construct a prediction model.Methods:This was a retrospective study of 325 stroke survivors. The nutritional status of those with and without bulbar palsy was compared. Univariate and multivariate logistic regressions were evaluated to highlight risk factors. A risk prediction model was constructed and a receiver operating characteristics (ROC) curve was drawn.Results:The prevalence of malnutrition among the stroke survivors with bulbar palsy was 66%, significantly greater than among all patients (52%). Among the stroke survivors with bulbar palsy there were significant differences between the normal nutrition group and the malnutrition group in terms of age, National Institutes of Health Stroke Scale (NIHSS) scores, hemoglobin, daily activities and pulmonary infection. The multivariate logistic regressions showed that pulmonary infection, a higher NIHSS score and lower hemoglobin were independent risk factors predicting malnutrition among stroke survivors with bulbar palsy. A risk prediction model for malnutrition was constructed based on the 3 major indicators and the area under the ROC curve was 0.86, with sensitivity of 0.79 and specificity of 0.83. A Hosmer-Lemeshow test indicated that the model was well calibrated, indicating that it would have good predictive value.Conclusions:Malnutrition is prevalent among stroke survivors with bulbar palsy. Pulmonary infection, a high NIHSS score and low hemoglobin are independent risk factors. They should be treated as important by medical staff.
9.Factors influencing the extubation of patients in a vegetative state after tracheotomy
Shaowei WANG ; Xi ZENG ; Qingfu LI ; Liugen WANG ; Heping LI
Chinese Journal of Physical Medicine and Rehabilitation 2022;44(10):907-911
Objective:To explore the factors influencing the extubation time of patients in a persistent vegetative state (PVS) after tracheotomy so as to provide a theoretical basis for early extubation for such patients.Methods:Clinical data were collected on PVS patients after a tracheotomy. The cases were divided into an extubation group and a difficult extubation group according to whether the extubation was successful or not. Version 22.0 of the SPSS software was used to evaluate univariate and multivariate logistic regressions analyzing the factors influencing the success of extubation.Results:The single-factor analysis revealed significant differences between the groups in terms of average age, nursing level, nutrition, swallowing function, hypoalbuminemia and incubation time. Gender, brain injury, stroke, ischemic anoxic encephalopathy and lung infection were not, however, significant predictors. The multivariate logistic regression analysis highlighted nutritional mode, swallowing function, intubation time, pulmonary infection, full-time care and age as independent predictors of extubation success.Conclusions:Intermittent oral to esophageal tube feeding and full-time care are protective factors for extubation of patients in a PVS after a tracheotomy. Swallowing disorders, intubation for more than 30 days, pulmonary infection and greater age are risk factors for unsuccessful extubation. Nutritional support, swallowing function training and intensive nursing can effectively improve the success rate of extubation.
10.The application of intermittent oro-esophageal tube feeding in cerebral hemorrhage patients undergoing tracheotomy
Danyang WANG ; Liugen WANG ; Junfeng YANG ; Heping LI ; Xi ZENG
Chinese Journal of Physical Medicine and Rehabilitation 2022;44(12):1079-1083
Objective:To explore the effects of intermittent oral-esophageal tube feeding (IOE) on cerebral hemorrhage (CH) survivors receiving a tracheotomy.Methods:A total of 126 CH patients undergoing tracheotomy were randomly divided into an IOE group ( n=65) and a nasogastric tube feeding (NGT) group ( n=61). The feeding continued for 4 weeks along with medication and thorough rehabilitation interventions (including hemiplegic limb training, swallowing training, and pulmonary function training). Before and after the treatment, the body mass index, hemoglobin, albumin, proalbumin, creatinine height index, extubation rate and intubation time of the tracheotomy, as well as the incidence of complications were evaluated for both groups. Both groups were also assessed using the clinical pulmonary infection scale (CPIS) and National Institutes of Health stroke scale (NIHSS). Results:After the 4 weeks the nutrition indexes, average extubation rate (90.76%) and intubation time [(15.96±3.86)d], CPIS score (3.00±1.69), NIHSS score (11.86±4.08) and the overall incidence of complications in the IOE group were all significantly better than the NGT group′s averages.Conclusions:Where feasible, intermittent oro-esophageal tube feeding is superior to nasogastric tube feeding of cerebral hemorrhage patients undergoing tracheotomy. It reduces the risk of pulmonary infection and other complications, resulting in early removal of the tracheotomy cannula and quicker recovery.

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