OBJECTIVETo evaluate the influence and safety of denosumab on bone mineral density (BMD) of lumbar spine in women with low bone mass.

METHODSThe clinical literatures concerning denosumab for the treatment of osteopenia or osteoporosis in women were searched from Medline, Embase, Cochrane Central Register of Controlled Trials, Wanfang database, China National Knowledge Infrastructure database, Chinese Biomedical Database. Randomized controlled trials (RCT) were selected by the inclusive and exclusive criteria. The jadad scale was used in the quality assessment of included studies. Meta-analysis of valid data picked from included studies was performed by RevMan 5.0.24 software.

RESULTS5 RCT were included in this meta-analysis. The results of meta-analysis using the fixed effects model showed that, the increase level of lumbar BMD after 12 month was 5.45% (95% CI, 5.05%~5.84%) higher in denosumab group than in placebo control group (P<0.00001). The serious adverse event, serious infection event and pack pain occurred during the followed-up were analysed using fixed effects model. The results showed no significant difference between two groups.

CONCLUSIONCompared with placebo control group, denosumab can significant increase the BMD of lumbar spine, and the safety of two groups is similar.

Antibodies, Monoclonal, Humanized ; adverse effects ; pharmacology ; Bone Density ; drug effects ; Bone Density Conservation Agents ; adverse effects ; pharmacology ; Denosumab ; Female ; Humans ; Lumbar Vertebrae ; Randomized Controlled Trials as Topic

The stability of the occipitocervical region mainly depends on the integrity of the bony structure,surrounding ligaments and joint capsules.The instability of this region often leadsto the clinical symptoms of compression injury of nerve and vascular,which requires early surgical intervention to rebuild its stability.Posterior occipitocervical fixations are main surgical treatment for the occipitocervical diseases.However,the posterior fixations are not suitable for some patients with congenital or iatrogenic causes.Recently,the anterior occipitocervical fixation with the screws anchored at clivus or into the occipital condyles have been used for the following operations.1.Anterior bone graft fusion.One case which was performed by oral approach was reported well fusion,but the stability was poor and there was a possibility of displacement.2.Anterior shaped titanium cage and plate fixation.The literatures reported that this anterior operation was completed in 35 cases by oral,oral combined with mandibulotomy,and anterior retropharyngeal approaches.This fixation has a good biomechanical stability and is widely used in clinical applications,including occipitocervical tumors and deformities.And the complications including intraoperative vascular,spinal and dural injuries,postoperative drinking cough,non-fusion,deep infection,and death.3.Anterior occipital-atlantoaxial joint screw fixation.Seven cases were performed by anterior occipital-atlantoaxial joint screw fixation through anterior percutaneous approach.This fixation is less trauma,but required precise placement of screw and not conducive bone fusion,and it is suitable for traumatic instability of the upper cervical spine,atlantoaxial dislocation and basilar invagination.Each procedure of anterior occipitocervical fixation is not suitable for all patients,and it should be adopted according to the patient's condition,surgical hardware conditions and the surgeon's habits.

OBJECTIVETo conduct a clinical trial of ketogenic diet (KD) in patients with acute spinal cord injury (SCI) and evaluate its safety and feasibility by measuring blood ketone bodies and blood glucose levels.

METHODTen patients with acute SCI were recruited in the trial during the period from May, 2012 to October, 2013. The patients received a standard KD after fasting for 48 h. The levels of blood ketone, blood glucose and uric ketone were tested daily, and routine blood examination, electrolytes, liver and kidney function, body mass index (BMI), sensory and motor function, and adverse reactions were monitored weekly to assess the safety and feasibility of KD.

RESULTSKD treatment lasted for a mean of 12.9 days (4 to 29 days) in these patients. In all the patients, blood ketone level increased during the fasting and maintained a level above 2.0 mmol/L after taking KD, while the uric ketone level ranged from +++ to ++++. The blood glucose level was in the normal range during KD. Except for blood chloride level and BMI, routine blood test results, electrolytes, liver and kidney function showed no significant changes after KD. No significant changes were observed in the sensation of light touch and pinprick. The average motor ASIA score increased from 33.3 to 35.1 after KD. Gastrointestinal dysfunction (diarrhea, nausea, poor appetite, gastric pain, and abdominal distension) was recorded in 5 patients, hypoglycemia occurred in one patient early after KD, and one patient experienced urticaria during KD. All the adverse reactions were relieved after symptomatic treatments.

CONCLUSIONThis preliminary clinical trial demonstrated that KD could increase ketone bodies level and maintain a normal blood glucose level, suggesting its safety and feasibility in patients with acute SCI.

Adolescent ; Adult ; Aged ; Diet, Ketogenic ; adverse effects ; methods ; Feasibility Studies ; Female ; Humans ; Male ; Middle Aged ; Spinal Cord Injuries ; diet therapy ; Treatment Outcome ; Young Adult

Objective:To evaluate the effect of neuromuscular electrical stimulation (NMES) on muscle strength and duration of mechanical ventilation through cumulative Meta-analysis and sequential trial analysis (TSA).Methods:Randomized controlled trial (RCT) of NMES intervention in intensive care unit (ICU) patients with mechanical ventilation were searched from PubMed database of US National Library of Medicine, EMbase database of Netherlands Medical Abstract, Web of Science, SinoMed database of China, CNKI, Wanfang data, VIP and other Chinese and English databases from database construction to July 15, 2021. The control group received ICU routine nursing or rehabilitation exercise; the experimental group received NMES (low frequency electric current through electrode stimulation to make muscle groups twitch or contract) based on routine care in ICU. Relevant data were screened, evaluated and extracted by two researchers independently. After extracting data, STATA 15.0 and TSA software were used to analyze the data and evaluate the research results. Results:A total of 9 studies were enrolled, including 619 subjects. Among the 9 articles included, 2 were grade A and 7 were grade B, indicating good overall quality. Cumulative Meta-analysis showed that compared with ICU routine care, NMES improved muscle strength of patients undergoing mechanical ventilation [standardized mean difference ( SMD) = 0.64, 95% confidence interval (95% CI) was 0.07 to 1.21] and shortened the duration of mechanical ventilation ( SMD = -1.84, 95% CI was -2.58 to -1.10). TSA analysis of the two outcomes showed that the sample size of muscle strength outcome index ( n = 518) and mechanical ventilation outcome index ( n = 419) did not meet the expected information (RIS; n values of 618 and 685); the cumulative Z-value line of the muscle strength outcome index crossed the traditional boundary line and TSA boundary line, indicating that more tests were not needed to verify this result. In the outcome index of mechanical ventilation duration, it was found that the cumulative Z-value line only crossed the traditional boundary line, but did not cross the TSA boundary line, indicating that further studies in this area should be carried out in the future to demonstrate this result. Conclusion:NMES can improve ICU patients' muscle strength and reduce the duration of mechanical ventilation.

Objective To conduct a clinical trial of ketogenic diet (KD) in patients with acute spinal cord injury (SCI) and evaluate its safety and feasibility by measuring blood ketone bodies and blood glucose levels. Method Ten patients with acute SCI were recruited in the trial during the period from May, 2012 to October, 2013. The patients received a standard KD after fasting for 48 h. The levels of blood ketone, blood glucose and uric ketone were tested daily, and routine blood examination, electrolytes, liver and kidney function, body mass index (BMI), sensory and motor function, and adverse reactions were monitored weekly to assess the safety and feasibility of KD. Results KD treatment lasted for a mean of 12.9 days (4 to 29 days) in these patients. In all the patients, blood ketone level increased during the fasting and maintained a level above 2.0 mmol/L after taking KD, while the uric ketone level ranged from+++to++++. The blood glucose level was in the normal range during KD. Except for blood chloride level and BMI, routine blood test results, electrolytes, liver and kidney function showed no significant changes after KD. No significant changes were observed in the sensation of light touch and pinprick. The average motor ASIA score increased from 33.3 to 35.1 after KD. Gastrointestinal dysfunction (diarrhea, nausea, poor appetite, gastric pain, and abdominal distension) was recorded in 5 patients, hypoglycemia occurred in one patient early after KD, and one patient experienced urticaria during KD. All the adverse reactions were relieved after symptomatic treatments. Conclusion This preliminary clinical trial demonstrated that KD could increase ketone bodies level and maintain a normal blood glucose level, suggesting its safety and feasibility in patients with acute SCI.

Objective To conduct a clinical trial of ketogenic diet (KD) in patients with acute spinal cord injury (SCI) and evaluate its safety and feasibility by measuring blood ketone bodies and blood glucose levels. Method Ten patients with acute SCI were recruited in the trial during the period from May, 2012 to October, 2013. The patients received a standard KD after fasting for 48 h. The levels of blood ketone, blood glucose and uric ketone were tested daily, and routine blood examination, electrolytes, liver and kidney function, body mass index (BMI), sensory and motor function, and adverse reactions were monitored weekly to assess the safety and feasibility of KD. Results KD treatment lasted for a mean of 12.9 days (4 to 29 days) in these patients. In all the patients, blood ketone level increased during the fasting and maintained a level above 2.0 mmol/L after taking KD, while the uric ketone level ranged from+++to++++. The blood glucose level was in the normal range during KD. Except for blood chloride level and BMI, routine blood test results, electrolytes, liver and kidney function showed no significant changes after KD. No significant changes were observed in the sensation of light touch and pinprick. The average motor ASIA score increased from 33.3 to 35.1 after KD. Gastrointestinal dysfunction (diarrhea, nausea, poor appetite, gastric pain, and abdominal distension) was recorded in 5 patients, hypoglycemia occurred in one patient early after KD, and one patient experienced urticaria during KD. All the adverse reactions were relieved after symptomatic treatments. Conclusion This preliminary clinical trial demonstrated that KD could increase ketone bodies level and maintain a normal blood glucose level, suggesting its safety and feasibility in patients with acute SCI.

Objective To investigate the current status of self-perceived burden and mindfulness of chronic obstructive pulmonary disease (COPD) patients and to explore the effect of mindfulness on patients' self-perceived burden. Methods From October 2016 to April 2017, a total of 276 patients with COPD were selected from a ClassⅢ Grade A hospital in Harbin by convenience sampling. The general information questionnaire, Five Facet Mindfulness Questionnaire (FFMQ), Self-Perceived Burden Scale (SPBS) were used to investigate the patients. Pearson correlation and multiple linear regression were used to analyze the effect of mindfulness on self-perceived burden. Results The score of self-perceived burden of COPD patients was (33.34±6.54) with a medium level. The score of mindfulness was (129.87±25.78). Pearson correlation showed the scores of dimensions and the total score of mindfulness except for the dimension of observation among COPD patients were negatively correlated with the self-perceived burden (P<0.05). Multiple linear regression revealed that three dimensions, mindfulness description, mindfulness action and no judging, entered the regression equation which were the influencing factors of self-perceived burden (P<0.05). Conclusions COPD patients commonly have self-perceived burden with different degrees which influenced by mindfulness. Health care providers could improve patients' mindfulness by reasonable intervention so as to reduce their self-perceived burden.

Objective To investigate the effects of rapid response system of chest pain on the short-term and long-term prognosis of patients with acute ST segment elevation myocardial infarction (STEMI).Methods Referring to the international association of chest pain centers,the chest pain center was established in this hospital,and the corresponding management system and treatment process were worked out.A total of 374 acute STEMI patients who were recruited as the observation group were admitted to this hospital after the establishment of the chest pain center (December 2014 to June 2016),and 250 STEMI patients admitted before the establishment of the chest pain center (January 2012 to December 2012) were recruited as control group.Patients in observation group were treated in the chest pain center,and those in control groupreceived conventional treatment.The general situation,basic diseases,the finishing time of the first electrocardiogram(ECG),the time of door-to balloon expansion(D2B),the time of hospital stay,the average hospitalization expenses,in-hospital cardiac events and in-6-month cardiac events were compared between the two groups.All patients were followed up for 1 years,left ventricular ejection fraction(LVEF),left ventricular end diastolic diameter (LVEDD),left ventricular aneurysm,B type natriuretic peptide (pro-BNP),serum creatinine (Scr),C-reactive protein (CRP) levels and adverse cardiac events (heart failure,death,readmission rate etc.)were compared between two groups.Results Compared with the control group,the average completion time of the first electrocardiogram in the observation group was shortened (P=0.001),the time of entry balloon dilatation,the time of hospital stay,the average hospitalization expenses were less than that of the control group (P＜0.05),the adverse cardiac events (hospital death and heart failure) were lower in the observation group than in the control group (P＜0.05).After 6 months of follow-up,LVEF was significantly higher in the observation group than in the control group (P＜0.05).the levels of LVEDD,pro-BNP,CRP and adverse cardiac events in the observation group were significantly lower than those in the control group (P＜0.05),there was no significant difference in the formation rate of ventricular aneurysm and Scr between the observation group and the control group (P＞0.05).After 1 year of follow-up,LVEF was still higher in the observation group than in the control group (P＜0.05).The incidence of LVEDD,pro-BNP,CREA,CRP,left ventricular aneurysm formation rate,the incidence of adverse cardiac events were lower in the observation group than in the control group (P＜0.05).Conclusion The establishment of rapid response system of chest pain treatment not only effectively shortenthe treatment time of STEMI patients,improve the treatment efficiency,shorten the hospital stay,reduce the cost of hospitalization,but also improve the quality of life and disease prognosis.

Objective:To compare the efficacy and safety between WangShiBaoChiWan and mosapride in the treatment of functional dyspepsia (FD).Methods:From September 2019 to September 2020, patients with postprandial fullness and early satiation who met the Rome Ⅳ criteria for FD diagnosis were enrolled from 15 hospitals, including the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital), Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical College. The subjects were randomly divided into WangShiBaoChiWan (experimental) group and mosapride (control) group in the ratio of 1∶1. The treatment regimens were WangShiBaoChiWan+ mosapride simulator, WangShiBaoChiWan simulator+ mosapride, respectively with a treatment period of 2 weeks. The primary efficacy outcome was the improvement rates of main symptoms before and after treatment, the secondary efficacy primary efficacy outcome was the total clinical effective rate and the change of the single symptom score. And the safety indicator included adverse events. Independent sample t-test, paired t-test and chi-square test were used for statistical analysis. Results:A total of 251 FD patients were enrolled in the full analysis set, including 124 in the experimental group and 127 in the control group; 241 FD patients were in the per-protocol analysis set, including 117 in the experimental group and 124 in the control group. The analysis of per-protocol analysis set showed that the improvement rates of the main symptoms of the experimental group and the control group were (66±29)% and (60±30)%, respectively, and the difference was not statistically significant ( P>0.05). The improvement rate of the main symptoms of the experimental group reached 117% of that of the control group, which exceeded the expected non-inferiority standard of 80%. The total clinical effective rates of the experimental group and the control group were 76.07% (89/117) and 75.81% (94/124), respectively, and the difference was not statistically significant ( P>0.05). The results of full analysis set showed that the incidence of adverse events of the experimental group and the control group was 1.62% (2/124) and 1.57% (2/127), respectively, and the difference was not statistically significant ( P>0.05). There were no serious adverse events in the two groups. Conclusion:The improvement rate of the main symptoms of WangShiBaoChiWan is not inferior to that of mosapride in the treatment of FD, and it has good safety.