1.Expert consensus on implementation strategy of awake prone positioning for non-intubated patients in China (2023).
Yuanyuan MI ; Zheyi CAI ; Jing LIU ; Fei TIAN ; Liping YANG ; Lei BAO ; Shanbing HOU ; Su GU ; Li LI ; Xueli ZHOU ; Yun XU ; Shumei ZHANG ; Xiaoxia FU ; Xiaodi LI ; Chuansheng LI ; Liang SUN ; Xiaohong ZHANG ; Hong QI ; Shiying YUAN ; Liqun ZHU ; Haiyan HUANG ; You SHANG
Chinese Critical Care Medicine 2023;35(4):337-351
		                        		
		                        			
		                        			The awake prone position plays an important role in the treatment of hypoxemia and the improvement of respiratory distress symptoms in non-intubated patients. It is widely used in clinical practice because of its simple operation, safety, and economy. To enable clinical medical staff to scientifically and normatively implement prone position for awake patients without intubation, the committees of consensus formulation, guided by evidence-based methodology and Delphi method, conducted literature search, literature quality evaluation and evidence synthesis around seven topics, including indications and contraindications, evaluation, implementation, monitoring and safety management, termination time, complication prevention and health education of awake prone position. After two rounds of expert letter consultation, Expert consensus on implementation strategy of awake prone positioning for non-intubated patients in China (2023) was formulated, and provide guidance for clinical medical staff.
		                        		
		                        		
		                        		
		                        			Humans
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		                        			Consensus
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		                        			Prone Position
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		                        			Wakefulness
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		                        			China
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		                        			Dyspnea
		                        			
		                        		
		                        	
2.Efficacy and safety of cinepazide maleate injection in acute ischemic stroke patients with obvious motor function deficit
Jun NI ; Huisheng CHEN ; Guofang CHEN ; Yong JI ; Fei YI ; Zhuobo ZHANG ; Yi YANG ; Jin WU ; Xueli CAI ; Bei SHAO ; Jianfeng WANG ; Yafang LIU ; Deqin GENG ; Xinhui QU ; Xiaohong LI ; Yan WEI ; Jianping DING ; Hua LYU ; Yining HUANG ; Yonghua HUANG ; Bo XIAO ; Tao GONG ; Liying CUI
Chinese Journal of Neurology 2022;55(5):474-480
		                        		
		                        			
		                        			Objective:To confirm the efficacy and safety of cinepazide maleate injection in acute ischemic stroke patients with obvious motor function deficit.Methods:This study is a subgroup analysis of multi-center, randomized, double-blind, placebo-controlled phase Ⅳ clinical trial. A total 812 patients of acute ischemic stroke with obvious limb motor deficit [motor function of limbs score in National Institutes of Health Stroke Scale (NIHSS) ≥4] were enrolled in this subgroup analysis. Patients received either cinepazide maleate injection or placebo. The treatment period was 14 days and follow-up was 90 days. The efficacy endpoints included the proportions of patients with a modified Rankin Scale (mRS) score ≤2, mRS score ≤1 and Barthel Index <95 on day 90. Safety was evaluated by recording all adverse events, monitoring vital signs, laboratory parameters and electrocardiogram.Results:A total of 732 patients were involved in the final efficacy analysis (361 in cinepazide maleate group and 371 in control group). The baseline limb motor function score of NIHSS was 5.23±1.43 in the cinepazide maleate group whereas 5.20±1.36 in the control group. Logistic regression analysis showed that following treatment for 90 days, the proportion of patients with a mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group [56.0% (202/361) vs 44.2% (164/371), OR=0.60, 95% CI 0.44-0.82, P=0.002]. The proportion of patients with a mRS score ≤1 was higher in the cinepazide maleate group than in the control group [43.3% (139/361) vs 35.2% (118/371), OR=0.69, 95% CI 0.50-0.97, P=0.031]. The proportion of patients with a Barthel Index <95 on day 90 was significantly lower in the cinepazide maleate group than in the control group [45.2% (145/361) vs 55.2% (185/371), OR=0.64, 95% CI 0.46-0.88, P=0.007]. During the treatment and follow-up period, the incidence of the most common adverse events in the cinepazide maleate group was 50.4% (199/395). Constipation and abnormal liver function were more common, but there were no statistically significant differences between the two groups. Conclusion:Cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery and safe in patients with acute ischemic stroke with obvious limb motor deficit.
		                        		
		                        		
		                        		
		                        	
3.Epidemiological characteristics, diagnosis, treatment and prognosis of gallbladder cancer in China: a report of 6 159 cases
Xuheng SUN ; Yijun WANG ; Wei ZHANG ; Yajun GENG ; Yongsheng LI ; Tai REN ; Maolan LI ; Xu'an WANG ; Xiangsong WU ; Wenguang WU ; Wei CHEN ; Tao CHEN ; Min HE ; Hui WANG ; Linhua YANG ; Lu ZOU ; Peng PU ; Mingjie YANG ; Zhaonan LIU ; Wenqi TAO ; Jiayi FENG ; Ziheng JIA ; Zhiyuan ZHENG ; Lijing ZHONG ; Yuanying QIAN ; Ping DONG ; Xuefeng WANG ; Jun GU ; Lianxin LIU ; Yeben QIAN ; Jianfeng GU ; Yong LIU ; Yunfu CUI ; Bei SUN ; Bing LI ; Chenghao SHAO ; Xiaoqing JIANG ; Qiang MA ; Jinfang ZHENG ; Changjun LIU ; Hong CAO ; Xiaoliang CHEN ; Qiyun LI ; Lin WANG ; Kunhua WANG ; Lei ZHANG ; Linhui ZHENG ; Chunfu ZHU ; Hongyu CAI ; Jingyu CAO ; Haihong ZHU ; Jun LIU ; Xueyi DANG ; Jiansheng LIU ; Xueli ZHANG ; Junming XU ; Zhewei FEI ; Xiaoping YANG ; Jiahua YANG ; Zaiyang ZHANG ; Xulin WANG ; Yi WANG ; Jihui HAO ; Qiyu ZHANG ; Huihan JIN ; Chang LIU ; Wei HAN ; Jun YAN ; Buqiang WU ; Chaoliu DAI ; Wencai LYU ; Zhiwei QUAN ; Shuyou PENG ; Wei GONG ; Yingbin LIU
Chinese Journal of Digestive Surgery 2022;21(1):114-128
		                        		
		                        			
		                        			Objective:To investigate the epidemiological characteristics, diagnosis, treat-ment and prognosis of gallbladder cancer in China from 2010 to 2017.Methods:The single disease retrospective registration cohort study was conducted. Based on the concept of the real world study, the clinicopathological data, from multicenter retrospective clinical data database of gallbladder cancer of Chinese Research Group of Gallbladder Cancer (CRGGC), of 6 159 patients with gallbladder cancer who were admitted to 42 hospitals from January 2010 to December 2017 were collected. Observation indicators: (1) case resources; (2) age and sex distribution; (3) diagnosis; (4) surgical treatment and prognosis; (5) multimodality therapy and prognosis. The follow-up data of the 42 hospitals were collected and analyzed by the CRGGC. The main outcome indicator was the overall survival time from date of operation for surgical patients or date of diagnosis for non-surgical patients to the end of outcome event or the last follow-up. Measurement data with normal distribu-tion were represented as Mean±SD, and comparison between groups was conducted using the t test. Measurement data with skewed distribution were represented as M( Q1, Q3) or M(range), and com-parison between groups was conducted using the U test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test. Univariate analysis was performed using the Logistic forced regression model, and variables with P<0.1 in the univariate analysis were included for multivariate analysis. Multivariate analysis was performed using the Logistic stepwise regression model. The life table method was used to calculate survival rates and the Kaplan-Meier method was used to draw survival curves. Log-rank test was used for survival analysis. Results:(1) Case resources: of the 42 hospitals, there were 35 class A of tertiary hospitals and 7 class B of tertiary hospitals, 16 hospitals with high admission of gallbladder cancer and 26 hospitals with low admission of gallbladder cancer, respectively. Geographical distribution of the 42 hospitals: there were 9 hospitals in central China, 5 hospitals in northeast China, 22 hospitals in eastern China and 6 hospitals in western China. Geographical distribution of the 6 159 patients: there were 2 154 cases(34.973%) from central China, 705 cases(11.447%) from northeast China, 1 969 cases(31.969%) from eastern China and 1 331 cases(21.611%) from western China. The total average number of cases undergoing diagnosis and treatment in hospitals of the 6 159 patients was 18.3±4.5 per year, in which the average number of cases undergoing diagnosis and treatment in hospitals of 4 974 patients(80.760%) from hospitals with high admission of gallbladder cancer was 38.8±8.9 per year and the average number of cases undergoing diagnosis and treatment in hospitals of 1 185 patients(19.240%) from hospitals with low admission of gallbladder cancer was 5.7±1.9 per year. (2) Age and sex distribution: the age of 6 159 patients diagnosed as gallbladder cancer was 64(56,71) years, in which the age of 2 247 male patients(36.483%) diagnosed as gallbladder cancer was 64(58,71)years and the age of 3 912 female patients(63.517%) diagnosed as gallbladder cancer was 63(55,71)years. The sex ratio of female to male was 1.74:1. Of 6 159 patients, 3 886 cases(63.095%) were diagnosed as gallbladder cancer at 56 to 75 years old. There was a significant difference on age at diagnosis between male and female patients ( Z=-3.99, P<0.001). (3) Diagnosis: of 6 159 patients, 2 503 cases(40.640%) were initially diagnosed as gallbladder cancer and 3 656 cases(59.360%) were initially diagnosed as non-gallbladder cancer. There were 2 110 patients(34.259%) not undergoing surgical treatment, of which 200 cases(9.479%) were initially diagnosed as gallbladder cancer and 1 910 cases(90.521%) were initially diagnosed as non-gallbladder cancer. There were 4 049 patients(65.741%) undergoing surgical treatment, of which 2 303 cases(56.878%) were initially diagnosed as gallbladder cancer and 1 746 cases(43.122%) were initial diagnosed as non-gallbladder cancer. Of the 1 746 patients who were initially diagnosed as non-gallbladder cancer, there were 774 cases(19.116%) diagnosed as gallbladder cancer during operation and 972 cases(24.006%) diagnosed as gallbladder cancer after operation. Of 6 159 patients, there were 2 521 cases(40.932%), 2 335 cases(37.912%) and 1 114 cases(18.087%) undergoing ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI) examination before initial diagnosis, respec-tively, and there were 3 259 cases(52.914%), 3 172 cases(51.502%) and 4 016 cases(65.205%) undergoing serum carcinoembryonic antigen, CA19-9 or CA125 examination before initially diagnosis, respectively. One patient may underwent multiple examinations. Results of univariate analysis showed that geographical distribution of hospitals (eastern China or western China), age ≥72 years, gallbladder cancer annual admission of hospitals, whether undergoing ultrasound, CT, MRI, serum carcinoembryonic antigen, CA19-9 or CA125 examination before initially diagnosis were related factors influencing initial diagnosis of gallbladder cancer patients ( odds ratio=1.45, 1.98, 0.69, 0.68, 2.43, 0.41, 1.63, 0.41, 0.39, 0.42, 95% confidence interval as 1.21-1.74, 1.64-2.40, 0.59-0.80, 0.60-0.78, 2.19-2.70, 0.37-0.45, 1.43-1.86, 0.37-0.45, 0.35-0.43, 0.38-0.47, P<0.05). Results of multivariate analysis showed that geographical distribution of hospitals (eastern China or western China), sex, age ≥72 years, gallbladder cancer annual admission of hospitals and cases undergoing ultrasound, CT, serum CA19-9 examination before initially diagnosis were indepen-dent influencing factors influencing initial diagnosis of gallbladder cancer patients ( odds ratio=1.36, 1.42, 0.89, 0.67, 1.85, 1.56, 1.57, 0.39, 95% confidence interval as 1.13-1.64, 1.16-1.73, 0.79-0.99, 0.57-0.78, 1.60-2.14, 1.38-1.77, 1.38-1.79, 0.35-0.43, P<0.05). (4) Surgical treatment and prognosis. Of the 4 049 patients undergoing surgical treatment, there were 2 447 cases(60.435%) with complete pathological staging data and follow-up data. Cases with pathological staging as stage 0, stage Ⅰ, stage Ⅱ, stage Ⅲa, stage Ⅲb, stage Ⅳa and stage Ⅳb were 85(3.474%), 201(8.214%), 71(2.902%), 890(36.371%), 382(15.611%), 33(1.348%) and 785(32.080%), respectively. The median follow-up time and median postoperative overall survival time of the 2 447 cases were 55.75 months (95% confidence interval as 52.78-58.35) and 23.46 months (95% confidence interval as 21.23-25.71), respectively. There was a significant difference in the overall survival between cases with pathological staging as stage 0, stage Ⅰ, stage Ⅱ, stage Ⅲa, stage Ⅲb, stage Ⅳa and stage Ⅳb ( χ2=512.47, P<0.001). Of the 4 049 patients undergoing surgical treatment, there were 2 988 cases(73.796%) with resectable tumor, 177 cases(4.371%) with unresectable tumor and 884 cases(21.833%) with tumor unassessable for resectabi-lity. Of the 2 988 cases with resectable tumor, there were 2 036 cases(68.139%) undergoing radical resection, 504 cases(16.867%) undergoing non-radical resection and 448 cases(14.994%) with operation unassessable for curative effect. Of the 2 447 cases with complete pathological staging data and follow-up data who underwent surgical treatment, there were 53 cases(2.166%) with unresectable tumor, 300 cases(12.260%) with resectable tumor and receiving non-radical resection, 1 441 cases(58.888%) with resectable tumor and receiving radical resection, 653 cases(26.686%) with resectable tumor and receiving operation unassessable for curative effect. There were 733 cases not undergoing surgical treatment with complete pathological staging data and follow-up data. There was a significant difference in the overall survival between cases not undergoing surgical treatment, cases undergoing surgical treatment for unresectable tumor, cases undergoing non-radical resection for resectable tumor and cases undergoing radical resection for resectable tumor ( χ2=121.04, P<0.001). (5) Multimodality therapy and prognosis: of 6 159 patients, there were 541 cases(8.784%) under-going postoperative adjuvant chemotherapy and advanced chemotherapy, 76 cases(1.234%) under-going radiotherapy. There were 1 170 advanced gallbladder cancer (pathological staging ≥stage Ⅲa) patients undergoing radical resection, including 126 cases(10.769%) with post-operative adjuvant chemotherapy and 1 044 cases(89.231%) without postoperative adjuvant chemo-therapy. There was no significant difference in the overall survival between cases with post-operative adjuvant chemotherapy and cases without postoperative adjuvant chemotherapy ( χ2=0.23, P=0.629). There were 658 patients with pathological staging as stage Ⅲa who underwent radical resection, including 66 cases(10.030%) with postoperative adjuvant chemotherapy and 592 cases(89.970%) without postoperative adjuvant chemotherapy. There was no significant difference in the overall survival between cases with postoperative adjuvant chemotherapy and cases without postoperative adjuvant chemotherapy ( χ2=0.05, P=0.817). There were 512 patients with pathological staging ≥stage Ⅲb who underwent radical resection, including 60 cases(11.719%) with postoperative adjuvant chemotherapy and 452 cases(88.281%) without postoperative adjuvant chemotherapy. There was no significant difference in the overall survival between cases with postoperative adjuvant chemo-therapy and cases without post-operative adjuvant chemo-therapy ( χ2=1.50, P=0.220). Conclusions:There are more women than men with gallbladder cancer in China and more than half of patients are diagnosed at the age of 56 to 75 years. Cases undergoing ultrasound, CT, serum CA19-9 examination before initial diagnosis are independent influencing factors influencing initial diagnosis of gallbladder cancer patients. Preoperative resectability evaluation can improve the therapy strategy and patient prognosis. Adjuvant chemotherapy for gallbladder cancer is not standardized and in low proportion in China.
		                        		
		                        		
		                        		
		                        	
4.Temporal trend in mortality of cardiovascular diseases and its contribution to life expectancy increase in China, 2013 to 2018.
Xue XIA ; Yue CAI ; Xiang CUI ; Ruixian WU ; Fangchao LIU ; Keyong HUANG ; Xueli YANG ; Xiangfeng LU ; Shiyong WU ; Dongfeng GU
Chinese Medical Journal 2022;135(17):2066-2075
		                        		
		                        			BACKGROUNDS:
		                        			Cardiovascular disease (CVD) remains the leading cause of deaths nationwide. However, little is understood about its temporal trend and corresponding influence on longevity improvements. We aimed to describe the updated tendency in CVD mortality and to quantify its impact on life expectancy (LE) increase in China.
		                        		
		                        			METHODS:
		                        			All-cause mortality rates were calculated with population sizes from the National Bureau of Statistics and death counts from the National Health Commission. We estimated CVD mortality rates by allocating age- and sex-based mortality envelopes to each CVD subtype based on its proportion derived from the Disease Surveillance Points system. The probability of CVD premature deaths and LE were calculated with life tables and we adopted Arriaga's method to quantitate age- and cause-specific contributions to LE gains.
		                        		
		                        			RESULTS:
		                        			During 2013 to 2018, the age-standardized mortality rate of CVD decreased from 289.69 (95% confidence interval [CI]: 289.03, 290.35)/100,000 to 272.37 (95%CI: 271.81, 272.94)/100,000, along with a decline in probability of CVD premature deaths from 9.05% (95%CI: 9.02%, 9.09%) to 8.13% (95%CI: 8.10%, 8.16%). The gap in CVD mortality across sexes expanded with more remarkable declines in females, especially for those aged 15 to 64 years. Among major subtypes, the probability of premature deaths from hemorrhage stroke declined fastest, while improvements of ischemic stroke and ischemic heart disease were limited, and there was an increase in stroke sequelae. LE in China reached 77.04 (95%CI: 76.96, 77.12) years in 2018 with an increase of 1.38 years from 2013. Of the total LE gains, 21.15% (0.29 years) were attributed to reductions of CVD mortality in the overall population, mostly driven by those aged >65 years.
		                        		
		                        			CONCLUSIONS
		                        			The general process in reducing CVD mortality has contributed to longevity improvements in China. More attention should be paid to prevention and control of atherosclerotic CVD and stroke sequelae, especially for the elderly. Working-age males also deserve additional attention due to inadequate improvements.
		                        		
		                        		
		                        		
		                        			Aged
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		                        			Male
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		                        			Female
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		                        			Humans
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		                        			Cardiovascular Diseases
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		                        			Life Expectancy
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		                        			China/epidemiology*
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		                        			Disease Progression
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		                        			Stroke
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		                        			Cause of Death
		                        			
		                        		
		                        	
5.Effects of cinepazide maleate injection on blood pressure in patients with acute ischemic stroke and hypertension
Huisheng CHEN ; Yi YANG ; Jun NI ; Guofang CHEN ; Yong JI ; Fei YI ; Zhuobo ZHANG ; Jin WU ; Xueli CAI ; Bei SHAO ; Jianfeng WANG ; Yafang LIU ; Deqin GENG ; Xinhui QU ; Xiaohong LI ; Yan WEI ; Shugen HAN ; Runxiu ZHU ; Jianping DING ; Hua LYU ; Yining HUANG ; Yonghua HUANG ; Bo XIAO ; Tao GONG ; Xiaofei YU ; Liying CUI
Chinese Journal of Internal Medicine 2022;61(8):916-920
		                        		
		                        			
		                        			Objective:To investigate the blood pressure change in patients with acute ischemic stroke (AIS) and hypertension treated with cinepazide maleate injection.Methods:This was a subgroup analysis of post-marketing clinical confirmation study of cinepazide maleate injection for acute ischemic stroke: a randomized, double-blinded, multicenter, placebo-parallel controlled trial, which conducted in China from August 2016 to February 2019. Eligible patients fulfilled the inclusive criteria of acute anterior circulation ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores of 7-25. The primary endpoints were mean blood pressure of AIS patients treated with cinepazide maleate or control, which were assessed during the treatment period (14 days), and the proportion of the patients with normal blood pressure was analyzed after the treatment period. Furthermore, a subgroup analysis was performed to investigate a possible effect of the history of hypertension on outcomes.Results:This analysis included 809 patients with hypertension. There was no significant difference in patients blood pressure and the proportion of patients with normal blood pressure (60.5% vs. 59.0%, P>0.05) between cinepazide maleate group and control group. Conclusion:Administration of cinepazide maleate injection does not affect the management of clinical blood pressure in patients with AIS.
		                        		
		                        		
		                        		
		                        	
6.Value of serum amyloid protein dynamic changes on evaluating condition and prognosis of patients with viral and mycoplasma community-acquired pneumonia
Chunxia MA ; Xueli LI ; Xiaofang GAO ; Qiong HE ; Bing ZHUAN ; Wei JI ; Zhong CAI ; Juan TIAN ; Li LIU ; Hui LIU ; Ping WANG ; Xiangyuan CAO
Chinese Critical Care Medicine 2022;34(6):592-596
		                        		
		                        			
		                        			Objective:To investigate the predictive role of dynamic changes of plasma biomarkers in patients with viral and mycoplasma community-acquired pneumonia (CAP).Methods:From January 2020 to June 2020, 141 patients with viral and mycoplasma CAP in People's Hospital of Ningxia Hui Autonomous Region were enrolled. Pneumonia severity index (PSI) scores [grade Ⅰ-Ⅱ(PSI score ≤ 70), grade Ⅲ (PSI score 71-90) and grade Ⅳ-Ⅴ(PSI score ≥ 91)], serum amyloid A (SAA), hypersensitive C-reactive protein (hs-CRP), procalcitonin (PCT), erythrocyte sedimentation rate (ESR) and white blood cell (WBC) on the 1 day after admission were compared between the different pathogens (viral and mycoplasma) or different disease severity. The change in level of SAA, hs-CRP on the third day (Δ 3 d = 1 d-3 d) were compared among different disease outcome groups (patients were divided into improved group, stable group and exacerbation group based on PSI scores or lung CT images on the third day). The change in the level of SAA, hs-CRP on the seventh day (Δ 7 d = 1 d-7 d) were compared among different disease prognosis groups (patients were divided into survival group and death group based on 28-day survival data). The receiver operating characteristic curve (ROC) were drawn to evaluate the value of SAA in the evaluation of disease and prediction prognosis. Results:The level of SAA in mycoplasma group (43 cases) was significantly higher than that in virus group (98 cases) on the 1 day after admission. There were no significant differences in other plasma biomarkers between the two groups. The more severe the illness, the higher the SAA level on the 1 day after admission. The trends of other plasma biomarkers in the two groups were consistent with SAA. The levels of SAA in the patients with exacerbation of the virus group and mycoplasma group (12 cases, 9 cases) were significantly higher than those of the improved group (57 cases, 26 cases) and the stable group (29 cases, 8 cases). SAA increased gradually in the exacerbation group, decreased gradually in the improved group, and slightly increased in the stable group. ΔSAA 3 d were differences among three groups. The change trend of hs-CPR was consistent with SAA. The level of SAA in the death group was higher than that in the survival group on the seventh day. SAA increased in the death group and decreased in survival group with time from hospital admission. There were differences according to ΔSAA 7 d between death group and survival group. The change trend of hs-CPR was consistent with SAA. ROC curve showed that the value of SAA was better than hs-CRP in assessing the severity of patients on admission day, and the area under ROC curve (AUC) was respectively 0.777 [95% confidence interval (95% CI) was 0.669-0.886], 0.729 (95% CI was 0.628-0.830). The value of ΔSAA 3 d was better than SAA on the third day predicting disease trends, and AUC was respectively 0.979 (95% CI was 0.921-1.000), 0.850 (95% CI was 0.660-1.000). hs-CRP on the third day and Δhs-CRP 3 d had no predictive value. Both SAA on the seventh day and ΔSAA 7 d have predictive value for prognosis. AUC was respectively 0.954 (95% CI was 0.898-0.993) and 0.890 (95% CI was 0.689-1.000). SAA on the seventh day and ΔSAA 7 d were better than hs-CRP on the seventh day. Δhs-CRP 7 d have no predictive value. Conclusions:SAA is a sensitive and valuable indicator for CAP patients with viruses and mycoplasma. Dynamic monitoring of SAA can evaluate the patient's progression, prognosis, and assist diagnosis and treatment.
		                        		
		                        		
		                        		
		                        	
7.Effect of Shengxianquyu decoction combined with irbesartan and atorvastatin on TCM efficacy, blood lipid level and blood pressure variability in patients with hypertension
Huaqing XU ; Xinghui CAI ; Mingkui LU ; Xueli ZHUO ; Pangbo GAO ; Zhongjun LIN
Journal of Chinese Physician 2020;22(10):1483-1487
		                        		
		                        			
		                        			Objective:To investigate the effect of Shengxian decoction combined with irbesartan and atorvastatin on tranditonal Chinese medicine (TCM) efficacy, blood lipid levels and blood pressure variability in patients with hypertension.Methods:This study prospectively selected 80 cases of hypertension patients in Chuzhou First People's Hospital from March 2016 to March 2019 as the objects, and were randomly divided into observation group and control group with 40 cases in each group. The control group was treated with irbesartan and atorvastatin, and the observation group was treated with Shengxian decoction on the basis of the treatment. After the treatment, the TCM efficacy , related blood lipids and improvement of blood pressure variability of the two groups were compared.Results:The total effective rate of TCM syndrome in the observation group (92.5%) was significantly higher than that in the control group (70.0%), with statistically significant difference ( P<0.05); compared with before treatment, the systolic blood pressure (SBP) in both groups was significantly decreased ( P<0.05), but there was no significant difference in diastolic blood pressure (DBP) between the two groups before and after treatment ( P>0.05); there was no significant difference in SBP and DBP between the two groups after treatment ( P<0.05). Compared with that before treatment, 24 h standard deviation of systolic blood pressure (24 h SSD), day standard deviation of systolic blood pressure (dSSD) and night standard deviation of systolic blood pressure (nSSD) in the two groups were significantly decreased ( P<0.05), while there was no significant difference in 24 h standard deviation of diastolic blood pressure (24 h DSD), day standard deviation of diastolic blood pressure (dDSD) and night standard deviation of diastolic blood pressure (nDSD) between the two groups ( P>0.05). Compared with the control group, the levels of 24 h SSD, dSSD and nSSD in the observation group were significantly lower ( P<0.05), while there was no significant difference in 24 h DSD, dDSD, nDSD between the two groups ( P>0.05); after treatment, the levels of total cholesterol (TC), triglyceride (TG) and low-density lipoprotein (LDL) in the two groups were significantly decreased ( P<0.05), and the observation group was significantly lower than the control group ( P<0.05). Conclusions:Shengxian decoction is effective in treating blood stasis type hypertension, which can effectively improve blood pressure variability and blood lipid levels.
		                        		
		                        		
		                        		
		                        	
8.Cinepazide maleate injection reduced the disability rate for acute ischemic stroke patients: a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase Ⅳ clinical trial
Jun NI ; Huisheng CHEN ; Guofang CHEN ; Yong JI ; Fei YI ; Zhuobo ZHANG ; Yi YANG ; Jin WU ; Xueli CAI ; Bei SHAO ; Jianfeng WANG ; Yafang LIU ; Deqin GENG ; Xinhui QU ; Xiaohong LI ; Yan WEI ; Jianping DING ; Hua LYU ; Yining HUANG ; Yonghua HUANG ; Bo XIAO ; Tao GONG ; Liying CUI
Chinese Journal of Neurology 2020;53(10):790-797
		                        		
		                        			
		                        			Objective:To assess the efficacy and safety of cinepazide maleate injection in the treatment of patients with acute ischemic stroke.Methods:A multicenter, randomized, double-blind, placebo-controlled phase Ⅳ clinical trial, led by Peking Union Medical College Hospital, was conducted in 65 Hospitals in China. The efficacy of cinepazide maleate injection in patients with acute anterior circulation cerebral infarction with onset time of ≤48 hours, 7≤National Institute of Health stroke scale (NIHSS) score ≤25 was assessed from August 2016 to February 2019, using the proportion of modified Rankin scale (mRS) score≤1 and Barthel index (BI) score≤95 on day 14 as efficacy endpoint. The patients were divided into treatment group who were treated with cinepazide maleate injection and control group who were treated with placebo.Results:A total 937 patients were involved in the final efficacy analysis (466 in treatment group and 471 in control group). The proportion of subjects with mRS score≤1 on day 14 after treatment were higher in the treatment group than that in the control group (102/466(21.89%) vs76/471(16.14%)). Logistic regression analysis showed that patients treated with cinepazide maleate were significantly more likely to have a favorable outcome (mRS score≤1) than patients treated with placebo on day 14 ( OR=0.677, 95% CI 0.484-0.948 , P=0.023), and patients treated with cinepazide maleate were more likely to reach independence in activities of daily living (Barthel Index ≥95) than those treated with placebo on day 14 (125/466(26.82%) vs 91/471(19.32%); OR=0.632, 95% CI0.459-0.869, P=0.005). The rate of adverse events was similar between the treatment and control groups. Conclusion:The 14-day treatment with cinepazide maleate injection could reduce the degree of disability whereas did not increase the risk of adverse events.
		                        		
		                        		
		                        		
		                        	
9.Research on multicenter randomized controlled clinical trial of human-like collagen scar repair gel in the treatment of proliferative hypertrophic scar
Jinglong CAI ; Xiaodong CHEN ; Xueli LI ; Pan XU ; Xiaomei CUI ; Chunyang ZHANG ; Huajuan WU ; Yunfei LI
Chinese Journal of Plastic Surgery 2020;36(4):423-428
		                        		
		                        			
		                        			Objective:To evaluate the clinical efficacy of human-like collagen scar repair gel in the treatment of proliferative hypertrophic scar.Methods:The clinical effect of smear-like silicone ointment on patients with hypertrophic scars after prolonged injury or 4-6 months after surgery, the difference of curative effects between 3-18 years old juvenile group and 19-45 years old adult group, were analyzed by multicenter randomized controlled clinical study. Among them, 58 cases were treated with human-like collagen scar repair gel, 39 cases in adult group and 19 cases in minor group; 30 cases were using Silicone Gel, 20 cases in adult group and 10 cases in minor group. The differences in scar color, thickness, blood vessel distribution, softness, patient's self-conscious symptoms, clinical efficacy scores and adverse reactions were analyzed before and after application of the products at 4, 8, 12 and 24 weeks.Results:The scores of the two groups before treatment were slightly higher than those of the control group except the softness and thickness score test group ( P<0.05). There was no significant difference in the remaining parameters ( P>0.05). The efficacy scores at the 4th, 8th, 12th and the 24th week after application of the two groups showed that there were significant differences in the therapeutic indicators after treatment for different time ( P<0.05) and age grouping. There was no significant difference between juvenile group and adult group ( P>0.05). There was a statistically significant difference in the time points of different clinical evaluation scores ( P<0.05). There was no interaction between the evaluation time and the experimental control group and age group ( P>0.05); and not affected by group or age grouping ( P>0.05), no adverse reactions occurred in either group. Conclusions:Human-like collagen scar repair gel is safe and effective in the treatment of proliferative hypertrophic scar, and the clinical efficacy is not inferior to Silicone gel.
		                        		
		                        		
		                        		
		                        	
10.Research on multicenter randomized controlled clinical trial of human-like collagen scar repair gel in the treatment of proliferative hypertrophic scar
Jinglong CAI ; Xiaodong CHEN ; Xueli LI ; Pan XU ; Xiaomei CUI ; Chunyang ZHANG ; Huajuan WU ; Yunfei LI
Chinese Journal of Plastic Surgery 2020;36(4):423-428
		                        		
		                        			
		                        			Objective:To evaluate the clinical efficacy of human-like collagen scar repair gel in the treatment of proliferative hypertrophic scar.Methods:The clinical effect of smear-like silicone ointment on patients with hypertrophic scars after prolonged injury or 4-6 months after surgery, the difference of curative effects between 3-18 years old juvenile group and 19-45 years old adult group, were analyzed by multicenter randomized controlled clinical study. Among them, 58 cases were treated with human-like collagen scar repair gel, 39 cases in adult group and 19 cases in minor group; 30 cases were using Silicone Gel, 20 cases in adult group and 10 cases in minor group. The differences in scar color, thickness, blood vessel distribution, softness, patient's self-conscious symptoms, clinical efficacy scores and adverse reactions were analyzed before and after application of the products at 4, 8, 12 and 24 weeks.Results:The scores of the two groups before treatment were slightly higher than those of the control group except the softness and thickness score test group ( P<0.05). There was no significant difference in the remaining parameters ( P>0.05). The efficacy scores at the 4th, 8th, 12th and the 24th week after application of the two groups showed that there were significant differences in the therapeutic indicators after treatment for different time ( P<0.05) and age grouping. There was no significant difference between juvenile group and adult group ( P>0.05). There was a statistically significant difference in the time points of different clinical evaluation scores ( P<0.05). There was no interaction between the evaluation time and the experimental control group and age group ( P>0.05); and not affected by group or age grouping ( P>0.05), no adverse reactions occurred in either group. Conclusions:Human-like collagen scar repair gel is safe and effective in the treatment of proliferative hypertrophic scar, and the clinical efficacy is not inferior to Silicone gel.
		                        		
		                        		
		                        		
		                        	
            
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