Oral absorption and effect of macromolecules in traditional Chinese medicine: a new perspective and research mode of phase structure / 中国中药杂志

Protein polypeptides and polysaccharides, the indispensable macromolecular active components in traditional Chinese medicine, are widely found in Chinese medicine decoction after the decoction of traditional Chinese medicine. However, through oral administration, these macromolecules are digested by the stomach and intestine and thus fail to be absorbed in prototype. This is inconsistent with the actual clinical efficacy of Chinese medicine decoction. According to modern research, new phase structures and effects of the macromolecules emerge during the decoction of traditional Chinese medicine, but the phase change law caused by the interaction among the components of traditional Chinese medicine and the relationship between phase structure and effect are still unclear. Thus, this study reviewed the oral absorption of macromolecular components of traditional Chinese medicine, analyzed the internal relationship of the form of macromolecules in traditional Chinese medicine with the absorption and effect based on phase structure, and summarized the research mode of oral absorption and effect of macromolecules in traditional Chinese medicine with phase structures as the core, providing new ideas and methods for future research.

Safety and efficacy of endoscopic ultrasound-guided hepaticogastrostomy for the treatment of hilar and distal biliary obstruction: a retrospective cohort study / 中华消化内镜杂志

Objective:To compare the safety and efficacy of endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) for the treatment of biliary obstruction at different locations.Methods:From January 2016 to June 2021 data of 82 patients with obstructive jaundice treated with EUS-HGS in Nanjing Drum Tower Hospital were reviewed in this retrospective cohort study. According to the location of biliary obstruction,patients were divided into hilar biliary obstruction group ( n=30) and distal biliary obstruction group ( n=52). Univariate and multivariate logistic regression analyses were conducted adjusting covariates to compare the technical success rate, the clinical success rate, the adverse reaction incidence, hospital stay and cost of the two groups. Results:The technical success rates were 93.3% (28/30) and 94.2% (49/52) in the hilar biliary obstruction group and the distal biliary obstruction group with no significant difference between the two groups ( P=0.870, OR=1.17, 95% CI: 0.18-7.41). The clinical success rates were 83.3% (25/30) and 88.5% (46/52) in the hilar biliary obstruction group and the distal biliary obstruction group with no significant difference between the two groups ( P=0.514, OR=1.53, 95% CI: 0.43-5.53). The incidence of adverse events in hilar biliary obstruction group was 10.0% (3/30), including cholangitis 3.3% (1/30), biliary fistula 6.7% (2/30), biliary peritonitis 6.7% (2/30). The incidence of adverse events in patients with distal biliary obstruction was 17.3% (9/52), including cholangitis 9.6% (5/52), biliary fistula 7.7% (4/52) and biliary peritonitis 5.8% (3/52). There was no significant difference in the incidence of adverse events between the two groups ( P>0.05). Conclusion:There is no significant difference in safety or efficacy of EUS-HGS for hilar biliary obstruction and distal biliary obstruction.

Relationship between occupational noise exposure and renal function impairment in oil workers / 环境与职业医学

Background The current oil production determines oil workers’ occupational noise exposure. Without effective protection, noise will affect various aspects of worker’s body functions, including acting on the adrenal cortex system and resulting in renal function damage. Objective To evaluate the associations of noise exposure and its cumulative exposure level with renal function impairment of oil workers. Methods Oil workers from a collective medical examination in a hospital were selected as the study subjects. In accordance with the national standard Measurement of Physical Agents in the Workplace Part 8: Noise (GBZ/T 189.8—2007), noise exposure was measured three times at the oil workers' work site, and their average value was calculated to obtain the cumulative noise exposure (CNE). A questionnaire survey was conducted to collect general information such as socio-demographic characteristics, family history, lifestyles, and occupational history. All blood biochemical indicators were measured in the fasting state. Renal function impairment was judged based on the glomerular filtration rate. The relationship between CNE and renal function was analyzed using receiver operating characteristic curve (ROC) for workers with noise exposure. Results A total of 2 917 subjects were included in the study and their prevalence of renal function impairment was 14.2%. The univariate analysis results suggested statistically significant differences in the prevalence of renal function impairment among the oil workers grouped by having hypertension or not, gender, age, marital status, marital status, smoking, and alcohol consumption (P＜0.05); the prevalence of renal impairment was significantly higher in those with abnormal values of uric acid, total cholesterol, triglycerides, high-density lipoprotein, and fasting glucose than in those with normal values (P＜0.05); the oil workers with noise exposure [n=1565, 53.7%, equivalent sound level ≥80 dB(A)] showed a higher prevalence of renal function impairment than those without (P＜0.05). The results of multiple logistic regression analysis showed that being female (OR=2.811, 95%CI: 1.960-4.030), age at 31 years and above (OR31-40=3.502, 95%CI: 1.402-8.751; OR41-50=4.255, 95%CI: 1.759-10.291; OR≥51=7.179, 95%CI: 2.864-17.996), showing abnormal uric acid (OR=5.932, 95%CI: 4.486-7.843), having hypertension (OR=1.593, 95%CI: 1.230-2.063), alcohol consumption (OR=2.648, 95%CI: 1.346-5.212), and smoking (OR=1.816, 95%CI: 1.133-2.911) had higher risks of developing renal function impairment; besides, those exposed to noise had 1.351 times (95%CI: 1.073-1.702) higher risks of developing renal function impairment than non-exposed individuals. Noise-exposed oil workers in the renal impairment group had higher noise exposure intensity and CNE compared to the noise-exposed oil workers in the normal renal function group (P＜0.05), and the workers had an increased risk of renal function impairment when the CNE was >95.85 dB(A)·year versus CNE ≤ 95.85 dB(A)·year (OR=2.583, 95%CI: 1.956-3.411). Conclusion Exposure to noise, higher noise exposure intensity, and higher level of CNE may be associated with developing renal function impairment in oil workers. Oil workers with CNE above 95.85 dB(A)·year are at an increased risk of renal impairment.

Long-term efficacy of endoscopic transluminal drainage for acute pancreatitis complicated with walled-off necrosis or pancreatic pseudocyst / 中华消化内镜杂志

Objective:To evaluate the long-term efficacy of endoscopic transluminal drainage(ETD) for acute pancreatitis complicated with walled-off necrosis (WON) or pancreatic pseudocyst (PPC).Methods:A total of 79 patients who were diagnosed as having WON or PPC by abdominal CT or ultrasound and treated with ETD in Nanjing Drum Tower Hospital were enrolled. Past medical records and follow-up by phone call after discharge were analyzed for long-term outcomes including endocrine and exocrine functions and long-term quality of life.Results:A total of 50 patients were enrolled, including 31 patients with infected WON/PPC and 19 patients with uninfected WON/PPC. Seventeen patients (54.84%) in the infected WON/PPC group and 11 patients (57.89%) in the uninfected WON/PPC group lost 5% or more of their weight. There were no significant differences in the proportion of cases of weight loss of 5% or more ( P=0.833), or the weight loss between the two groups (12.59±8.89 kg VS 10.91±2.47 kg, P=0.522). Only one patient in the infected WON/PPC group had chronic abdominal pain. There was no significant difference in the Izbicki score between the two groups (23.79±6.74 VS 22.03±3.21, P=0.295). None of the patients developed steatorrhea after discharge. Five patients (16.67%, 5/30) in the infected WON/PPC group and 6 patients (40.00%, 6/15) in the uninfected WON/PPC group developed endocrine insufficiency with no significant difference ( P=0.140). Greater risk of secondary diabetes resulted from higher low-density lipoprotein cholesterol ( HR=1.9, 95% CI: 1.0-3.4, P=0.044)and triglycerides ( HR=1.2, 95% CI: 1.0-1.3, P =0.029). Conclusion:ETD is safe and effective for WON and PPC. But there is possibility that patients develop secondary diabetes. Additionally, greater risk of secondary diabetes results from higher low-density lipoprotein cholesterol and triglycerides.

Cost-effectiveness analysis of nivolumab in the second-line treatment of metastatic clear cell renal cell carcinoma / 中国药房

OBJECTIVE To ev aluate the economical efficiency of nivolumab versus everolimus in the second-line treatment of metastatic clear cell renal cell carcinoma. METHODS From the perspective of China ’s health system ，cost-effectiveness analysis of the two therapies was carried out by developing a three-state partitioned survival model. The clinical parameters were from the updated CheckMate 025 study，and the cost and health utility were from relevant websites and published literatures. The model adopted a 2-week cycle and a lifetime research time. The robustness of the results was verified by sensitivity analysis. The economical efficiency of two therapy schemes were evaluated in the scenario of model simulation time of 80 months and charitable drug donation scheme. RESULTS The results of basic analysis showed that compared with everolimus ，the incremental cost-effectiveness ratio （ICER）of nivolumab was 586 982.60 yuan/quality-adjusted life year （QALY），which was far higher than 3 times of China ’s per capita gross domestic product （GDP）in 2020. The results of single-factor sensitivity analysis showed that the 3 parameters that had the greatest impact on the economic evaluation results were the cost of nivolumab ，the utility value of nivolumab group and everolimus group in progressive disease state. The results of probability sensitivity analysis verified the robustness of the basic analysis results. Results of scenario analysis showed that in the first scenario analysis ，in which model simulation time lasted for 80 months，ICER of nivolumab was 417 204.52 yuan/QALY；in the second scenario analysis ，in which nivolumab charitable drug donation program for low-income people was considered ，ICER of nivolumab was 124 988.58 yuan/QALY. CONCLUSIONS Under the threshold of 1-3 times of China ’s per capita GDP in 2020，compared with everolimus ，it is not economical to use nivolumab as the second-line treatment for metastatic clear cell renal cell carcinoma ； nivolumab is economical when considering its charitable drug donation program for low-income people.

Comparison of the efficacy and safety of endoscopic submucosal excavation and full-thickness resection for intraluminal gastric stromal tumors / 中华消化内镜杂志

Objective:To compare the efficacy and safety of endoscopic submucosal excavation (ESE) and endoscopic full-thickness resection (EFR) for intraluminal gastric stromal tumors.Methods:Data of 441 patients diagnosed as having gastric stromal tumors in Nanjing Drum Tower Hospital from June 2009 to June 2020 were retrospectively analyzed. A total of 241 patients underwent ESE (ESE group) and 200 EFR (EFR group). Epidemiological data (gender, age and body mass index), tumor size, procedure related parameters, complications, hospital stay, cost and follow-up were compared between the two groups.Results:There were no significant differences between the two groups in gender, age, body mass index, tumor size, National Institutes of Health risk grade, complete resection rate, or block resection rate ( P>0.05). Compared with the EFR group, the ESE group required less titanium clips to close defects in the stomach wall [6.0 (4.0, 6.0) VS 6.0 (5.0, 8.0), U=18 424.0. P<0.001], shorter time of first postoperative fluid intake [2.0 (1.0, 2.0) days VS 2.0 (2.0, 3.0) days, U=17 420.0, P<0.001] and hospital stay [6.0 (5.0, 8.0) days VS 7.0 (6.0, 9.0) days, U=18 906.0, P<0.001], and lower total cost [18.9 (16.4, 21.4) thousand yuan VS 20.9 (18.1, 23.8) thousand yuan, U=17 956.0, P<0.001]. Moreover, the total incidence of complications of the ESE group was lower than that of the EFR group [5.8% (14/241) VS 11.5% (23/200), χ2=4.605, P=0.032]. Patients were followed up with the median period of 45.0 months. The disease recurrence rate was 0.45% (2/441), and there were no disease-related deaths. Conclusion:The efficacy is comparable between ESE and EFR for treating intraluminal gastric stromal tumors, but ESE shows a lower incidence of complications, and requires a shorter hospital stay and lower cost.

Clinicopathological features of gastric adenocarcinoma of fundic gland type / 中华消化内镜杂志

Objective:To investigate the clinicopathological features of gastric adenocarcinoma of fundic gland type (GA-FG).Methods:A total of 12 patients, including 7 cases treated with endoscopic submucosal dissection (ESD), were diagnosed as having GA-FG in Nanjing Drum Tower Hospital from January 2018 to August 2019. Morphological changes were analyzed by reviewing endoscopic and pathological results. Patients were followed up after definitive diagnosis.Results:The clinical symptoms of patients with GA-FG were nonspecific. No Helicobacter pylori infection was identified. The lesions were found in the non-atrophic gastric mucosa of the upper 1/3 portion in 10 cases and middle 1/3 portion in 2 cases. Endoscopically, the most common features were whitish color (9 cases), and all lesions diameter≤1 cm. Their macroscopic types were classified as 0-Ⅰ (2 cases), 0-Ⅱa (9 cases) and 0-Ⅱc (1 case) respectively. All lesions had sharp boundary, with branching dilated blood vessels on the surface. Five in 7 cases who were treated with ESD showed submucosal invasion. Immunohistochemically, 9 cases were classified as the chief cell type , 3 as the mixed type, 11 MUC6 positive, 4 MUC5AC positive, 2 MUC2 positive, and 3 CD10 positive. P53 was detected in all 12 cases, and 9 cases had low Ki-67 staining index (<10%). The mean time of follow-up was 11 months, and 11 patients survived. Conclusion:GA-FG should be taken into consideration when the polyps are found in the upper part of the stomach, with whitish color, and branch dilated blood vessels on the surface. Excellent clinical outcomes can be achieved for GA-FG patients with ESD.

Clinical research progress on EGFR-TKI combined with pulmonary SBRT in advanced non-small cell lung cancer with EGFR-sensitive mutations / 中华放射肿瘤学杂志

Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) has become the standard first-line treatment for advanced non-small cell lung cancer (NSCLC) patients with EGFR-sensitive mutations. However, acquired resistance cannot be avoided during the targeted treatment of EGFR-TKI, which may lead to the progression of NSCLC. Among them, approximately 50% of patients present with primary lung lesions and/or initial metastastic lesion progression. As a major local treatment, radiation therapy plays an irreplaceable role in the management of patients with advanced cancer. Stereotactic body radiation therapy (SBRT), which is implemented with the Cyberknife, is the most advanced radiation therapy technology to better meet clinical needs. In recent years, based on the abovementioned patterns of tumor recurrence, the treatment mode of pulmonary-lesion SBRT combined with EGFR-TKI can improve the tumor-free survival in advanced NSCLC patients, which has attracted widespread attention. In this article, the clinical research progresses on this combined therapeutic strategy were reviewed.

Network Meta-analysis on efficacy and safety of non-steroidal anti-inflammatory drugs for osteoarthritis in middle aged and old people / 药学实践杂志

Objective To systematically evaluate the efficacy and safety of different non-steroidal anti-inflammatory drugs (NSAIDs) in middle-aged and old Chinese patients with osteoarthritis(OA). Methods A systematic literature search was conducted through PubMed, Cochrane Library, CNKI, Wan Fang Data and VIP databases to collect randomized controlled trials with non-steroidal anti-inflammatory drugs in middle-aged to old Chinese OA patients. The search time was from the establishment of the database to November 17, 2020. Two researchers independently carried out literature screening, data extraction and literature quality evaluation. Bayesian network meta-analysis was conducted with R3.6.0 software. Results 28 RCTs were included with 2531 patients. Based on the last follow-up pain visual analogue scale (VAS) score, the ranking chart showed that Etoricoxib had the highest probability of having the lowest pain VAS score (88.55%). In terms of total effective rate, the ranking chart showed that the probability of Etoricoxib as first choice was the highest (92.49%). As far as safety, diclofenac sodium patch had the lowest adverse effects rate (59.10%). Conclusion The results of this study indicated that Etoricoxib was the most effective treatment for middle-aged and old Chinese OA patients. It can significantly reduce the OA pain. Diclofenac sodium patch had the least adverse effects.

Cost-utility Analysis of Pembrolizumab in the Second-line Treatment of Advanced Hepatocellular Carcinoma Based on Two Models / 中国药房

OBJECTIVE：To evaluate the econo mics of pembrolizumab in the second-line treatment of advanced hepatocellular carcinoma in China. METHODS ：From the perspective of Chinese healthcare system ，a three-state PartSA model and Markov model were established ；the cost and utility for the second-line treatment of advanced hepatocellular carcinoma in China were compared between pembrolizumab and placebo. The circulation cycle of the model was 3 weeks and the study time limit was lifetime；one-way sensitivity analysis ，probability sensitivity analysis and scenario analysis were used to verify the robustness of the base-case analysis results. RESULTS ：PartSA results showed that the ICER for the second-line treatment of advanced hepato- cellular carcinoma with pembrolizumab was 1 266 846.18 yuan/QALY，which is far more than 1-3 times of China ’s per capita GDP in 2020. The results of one-way sensitivity analysis showed that the three parameters that had the greatest impact on ICER were the PFS status utility of the placebo group ，the PFS status utility of the pembrolizumab group ，and the cost of pembrolizumab. The results of probability sensitivity analysis verified the robustness of the base-case analysis. The scenario analysis showed that the treatment cost of pembrolizumab had dropped significantly when the charity donation of pembrolizumab was considered. Although it was still not economical ，ICER was close to 3 times of per capita GDP of China in 2020. When WTP threshold was 1 and 3 times of China ’s per capita GDP ，the economic prices of pabolizumab （100 mg）were 4 157.67 and 5 829.24 yuan，respectively. The results of Markov model were similar to those of PartSA model. CONCLUSIONS ：Under the WTP threshold of 1-3 times China ’s per capita GDP in 2020，pembrolizumab is not economical for second-line treatment of advanced hepatocellular carcinoma.

Application of Different Decision Analysis Models in the Economic Evaluation of Antitumor Drugs ：Taking CADTH in Canada as an Example / 中国药房

OBJECTIVE：To provide referenc e for selectin g antitumor drugs economic evaluation models and improving the quality of evidence for antitumor drugs economics evaluation in China. METHODS ：A systematic search of the antitumor drug health technology evaluation （pCODR）reports were conducted on the official website of the Canadian Agency for Drugs and Technologies in Health （CADTH）. The search time was limited to Jan. 1st，2015 to Sep. 6th，2020. The basic information ，model types and structure ，and key limitations were extracted and summarized. RESULTS & CONCLUSIONS ：A total of 185 pCODR reports were finally retrieved ，involving 114 types of tumor indications and 98 types of antitumor drugs. The number of CADTH antitumor drugs economics evaluations in the past 5 years had shown an increasing trend. Among 137 pCODR reports with final economic guidance report ，98 reports（71.5％）adopted the PartSA model ，21 reports（15.3％）used the Markov model ，and some reports（6 reports，4.3％）used both PartSA and Markov models to explore the uncertainty of the model structure. In terms of model health status setting ，86 reports（62.8％）used three-state models to evaluate the economy of different anti tumor drugs ，and 16 reports（11.7％）used no less than four health states to simulate the outcome of disease state. However ，there were still some problems in CADTH models ，such as the unreasonable choice of research time limit ，the unreasonable extrapolation method or uncertain extrapolation results of efficacy （survival）data，the uncertainty of efficacy data obtained by indirect comparison ，and some assumptions or parameter settings did not conform to the actual diagnosis and treatment environment. In view of the advantages of PartSA model ，it is suggested that PartSA model or Markov model combined with PartSA model should be used first to verify the uncertainty of model structure in the future economic evaluation of antitumor drugs ；reasonable settings of key model parameters should be considered to improve the quality of evidence for antitumor drugs economics evaluation in China.

Systematic Review of the Economics of the Second-generation Direct-acting Antiviral Agents in the Treatment of Hepatitis C / 中国药房

OBJECTIVE：To systematically evaluate the pharmacoeconomic research of the second-generation direct-acting antiviral agents （DAAs）in the treatment of hepatitis C ，and to provide methodological suggestions for economic research ，and to provide decision-making reference for the adjustment of medical insurance catalogues and market access. METHODS ：Retrieved from PubMed ，EMbase，the Cochrane library ，CNKI，Wanfang database and VIP ，the pharmacoeconomic researches of the second-generation DAAs for hepatitis C were collected during Jan. 2015-Jan. 2020. The quality of included studies were evaluated with the checklist about Consolidated Health Economics Evaluation Reporting Standards （CHEERS），and the data were extracted and analyzed quantitatively. RESULTS ：A total of 14 studies were included ，and the standard coincidence rate ranged from 79.2％ to 95.8％；the overall quality was relatively high. Thirteen （92.9％）studies had compared the economics of different treatment schemes from the perspective of the payer by using the Markov model and the lifetime study time limit. Compared with the second-generation DAAs treatment schemes based on sofosbuvir ，all the research results showed that Ombitasvir combined with Dasabuvir（3D），EBR/GZR and GLE/PIB were more economical in the target countries ；single factor sensitivity analysis showed that the research results were more sensitive to the three parameters of drug price ，drug SVR rate and health status utility value. CONCLUSIONS：Among the second-generation DAAs for hepatitis C ，the three regimens of 3D，EBR/GZR and GLE/PIB are more economical. It is recommended that future research on the economics of medicines for hepatitis C adopted dynamic model and the research perspective of the whole society to carry out direct high-quality economic research on a variety of DAAs ；at the same time，considered the effects of drug price ，drug SVR rate and health status utility value on the robustness of basic analysis results in sensitivity analysis in order to increase the credibility of the research results.

Risk factors and prognosis of synchronous tumor of early gastric cardia carcinoma treated by endoscopy / 中华消化内镜杂志

Objective:To study the different clinical features of early gastric cardia carcinoma (EGCC) patients with synchronous tumor, and identify the risk factors and prognosis of the occurence of synchronous tumor after endoscopic resection.Methods:A retrospective study was made on the data of 499 patients (512 lesions) who underwent cardiac endoscopic submucosal dissection (ESD) and were pathologically confirmed as EGCC in Nanjing Drum Tower Hospital from January 2011 to June 2018. The patients were divided into synchronous tumor group (47 patients with 50 lesions) and non-synchronous tumor group (452 patients with 462 lesions). Univariate and multivariate logistic regression analysis were performed to identify independent risk factors for the occurrence of synchronous tumor. Kaplan-Meier method was conducted to prognosis. Differences between the two groups were analyzed for significance by the log-rank test.Results:Among the 499 patients, the incidence of synchronous tumor was 9.4% (47/499). Logistic regression analysis showed that the lesion size ( P=0.046, OR=0.807, 95% CI: 0.653-0.996), atrophic gastritis and intestinal metaplasia ( P=0.017, OR=3.207, 95% CI: 1.229-8.371), Helicobacter pylori infection ( P=0.046, OR=1.952, 95% CI: 1.013-3.761) were independent risk factors for the occurrence of synchronous tumor after endoscopic resection. A total of 453 (90.8%)patients were successfully followed up. Kaplan-Meier curve showed that the overall survival rate of the synchronous tumor group and the non-synchronous tumor group were 95.2% and 97.6%, respectively ( P=0.72). Conclusion:The incidence of EGCC accompanied with synchronous tumor is not high, but it should not be neglected. For patients with small lesions, it is necessary to consider the possibility of main cancer in other parts. For patients with Helicobacter pylori infection or severe mucosal atrophy and intestinal metaplasia, more attention should be paid to the mucosa around the lesion during endoscopic examination and strict endoscopic follow-up should be carried out.

Clinical and pathological characteristics of gastric hyperplastic polyps coexisting with gastric cancers / 中华消化内镜杂志

Objective:To investigate the clinical, endoscopic and pathologic characteristics of gastric hyperplastic polyps coexisting with gastric cancers.Methods:A retrospective study was performed involving 18 patients who were pathologically confirmed with gastric hyperplastic polyps coexisting with gastric cancers. The clinical features, endoscopic findings, pathological characteristics and treatment strategy were analyzed.Results:The age of 18 patients was 67. 2±7. 8 years (ranged 45-79), including 6 males and 12 females. The symptoms included abdominal pain, distention, and some patients were asymptomatic. Multiple polyps (13/18) were common. Single lesions were often located in the gastric corpus (7/18). Endoscopy showed various morphological changes. Pedunculated polyp was the most common type (15/18). All polyps were larger than 10 mm in diameter, and the polyps in 9 patients were larger than 20 mm. Fourteen patients had atrophic gastritis in the background mucosa, and 4 patients had Helicobacter pylori ( HP) infection. Conclusion:Gastric hyperplastic polyps coexisting with gastric cancers shows no specific symptoms. For HP (-) atrophic gastritis patients accompanied with multiple gastric polyps, malignant transformation of those larger and pedunculated polyps is of possibility.

Effects of source difference of sodium carboxymethyl starch on its properties and function / 药学学报

During the process of consistency evaluation, it was found that the consistency of drug release between generic and original brands in vitro was not sufficient to demonstrate their same release in vivo. The disintegration of tablets, as a premise for the release of tablet drugs, greatly affects the release of drugs, depending on the structure and properties of disintegrants. Hence the systematic research on disintegrants would be very important for the evaluation of generic consistency. In this experiment, the physicochemical properties and application of 11 different sodium carboxymethyl starch (CMS-Na) from 9 manufacturers were investigated. This provides the reference for selection of excipients for consistency evaluation. The particle morphology of CMS-Na was observed by scanning electron microscope. The particle size distribution was determined by dry particle size analyzer. The determination of pH and loss on drying was carried out according to the 2015 edition of Chinese pharmacopoeia method. The powder fluidity was evaluated with Carr's index, Hausner ratio and angle of repose. The disintegration performance of CMS-Na was evaluated through determining the water absorption and swelling. The disintegration effect of CMS-Na tablets was studied using lactose and microcrystalline cellulose as fillers. The results showed that pH values and weight loss on drying of all samples met the requirements, whereas the particle morphology, fluidity, water swell-ability and disintegration time had a large variation, which leads to the large differences the properties of CMS-Na depending on the sources. Therefore in order to ensure that the reproducibility of generic drugs from their name brand, our studies indicate that only a sizable choice of disintegrants could ensure good inter batch reproducibility.

Correlation of platelet/lymphocyte ratio with short-term and long-term prognosis in patients with acute myocardial infarction / 中华全科医师杂志

Ninety-five patients with acute myocardial infarction (AMI) treated in our hospital from January 2015 to December 2017 were enrolled. According to thrombolysis in myocardial infarction (TIMI) risk score, 95 patients were divided into high group (TIMI>4, n=46) and low group (TIMI≤4, n=49) . According to platelet/lymphocyte ratio (PLR), 95 patients were divided into low PLR group (PLR≤170, n=60) and high PLR group (PLR>170, n=35) . The correlation of PLR with short-term and long-term prognosis in patients with acute myocardial infarction was analyzed. The results showed that there were no significant differences in red blood cell count (RBC), hemoglobin (HB), white blood cell count (WBC), neutrophil ratio (NEU), percentage of intermediate cells (MON), lymphocyte count (LYM), basophils (Bas), red blood cells distribution width (RDW), eosinophils (EO) between high and low TIMI groups ( P>0.05) . The platelet count (PLT) and PLR in high TIMI group was significantly higher than that in low TIMI group ( t=42.196, 10.053; P<0.05) . The in-hospital mortality and all-cause mortality of high PLR group were significantly higher than those of low PLR group [1.67%(1/60) vs. 14.28%(5/35), χ 2=5.949, P=0.02; 3.33%(2/60) vs. 17.14%(6/35), χ 2=5.466, P=0.04]; while there was no significant difference in 1-year re-hospitalization rate, interventional therapy and thrombolytic therapy between the two groups ( P>0.05) . Pearson correlation analysis showed that PLR was positively correlated with TIMI score ( r=0.563, P=0.024) . Logistic regression analysis showed that Killip grade, serum creatinine and PLR were independent risk factors of AMI ( OR=7.532,60.14,8.234; P<0.05). PLR may effectively evaluate the prognosis of acute myocardial infarction, suggesting that its clinical value should be condidered.

Effect of remote ischemic preconditioning combined with postconditioning on postoperative pulmonary complications in aged patients undergoing thoracoscopic radical surgery for lung cancer / 中华麻醉学杂志

Objective:To evaluate the effect of remote ischemic preconditioning (RIPC) combined with postconditioning (RIPostC) on postoperative pulmonary complications in elderly patients undergoing thoracoscopic radical surgery for lung cancer.Methods:Eighty American Society of Anesthesiologists physical status Ⅱ or Ⅲ elderly patients, aged 65-79 yr, with height 155-180 cm, weighing 45-80 kg, were divided into 2 groups ( n=40 each) by the random number table method: control group (group C) and RIPC combined with RIPostC group (group R). RIPC was induced by 3 cycles of 5 min ischemia (cuff inflation to 200 mmHg) followed by 5 min reperfusion (cuff deflation to 0 mmHg) though applying a mercury sphygmomanometer adult cuff to the right upper extremity at 30 min before one-lung ventilation and 30 min before the end of one-lung ventilation in group R. The adult cuff was only bound to the right upper extremity without inflation and deflation in group C. The occurrence of pulmonary complications was recorded within 72 h after operation in both groups.The Quality of Recovery-15 score was used to assess the early postoperative quality of recovery on 1 and 2 days after operation.The number of white blood cells and neutrophils and percentage of neutrophils were recorded at 1 day before surgery and 1 and 3 days after surgery.The postanesthesia care unit stay time and hospital stay time were recorded. Results:Compared with group C, the incidence of pulmonary complications was significantly decreased within 72 h after operation, Quality of Recovery-15 scores were increased at 1 and 2 days after operation, the number of white blood cells and neutrophils and percentage of neutrophils were decreased at 1 and 3 days after operation, and the postanesthesia care unit stay time and postoperative hospital stay time were shortened in group R ( P<0.05). Conclusion:RIPC combined with RIPostC can decrease the risk of postoperative pulmonary complications and is helpful for early postoperative rehabilitation in elderly patients undergoing thoracoscopic radical surgery for lung cancer.

Analysis of anticoagulant status and in-hospital ischemic and bleeding events in atrial fibrillation patients aged 90 years and over / 中华老年医学杂志

Objective:To investigate the current status of anticoagulant therapy and the incidence of ischemic and bleeding events in hospitalized patients aged 90 years and over with non-valvular atrial fibrillation(NVAF).Methods:We retrospectively collected clinical data, antithrombotic treatment strategies, in-hospital ischemic stroke and bleeding events from NVAF patients(≥90 years)who were admitted to our hospital from June 2014 to August 2018.Based on the CHA 2DS 2-VASc score(2, 3, and ≥4 respectively), patients were divided into three ischemic risk groups, and antithrombotic treatment strategies and in-hospital ischemic stroke events were compared between the three groups.Alternatively, patients were divided into the high bleeding risk group(HAS-BLED score ≥3, )and the non-high bleeding risk group(HAS-BLED score ≤2), and antithrombic treatment strategies and the major bleeding events were compared between the two groups. Results:Among the 223 hospitalized NVAF patients aged 90 years and over, 42.6% of them received anticoagulant treatment, 25.6% received antiplatelet drugs, and 31.8% received non-antithrombotic treatment.With the increase of the CHA 2DS 2-VASc score, there was a trend of declined rates of non-antithrombotic treatment among the three ischemic risk groups(47.4%, 42.9%, 26.4%, P=0.06), and the rates of in-hospital ischemic stroke were similar among groups(10.5%, 12.2%, 15.5%, P=0.75). Moreover, compared with the non-high bleeding risk group, patients in the high bleeding risk group more frequently received anticoagulant treatment(47.2% vs.38.3%)and less frequently received non-antithrombotic therapy(28.7% vs.34.7%). There was no significant difference in antithrombotic treatment strategies( P=0.39)or rate of in-hospital major bleeding events(13.0% vs.10.2%, P=0.51). However, the rate of in-hospital major bleeding events was significantly higher in those with concurrent infections(16.8% vs.6.4%, P=0.02)or respiratory failure(21.3% vs.8.0%, P=0.01). Conclusions:The rate of anticoagulant use in NVAF patients aged 90 years and over is too low during hospitalization, and anticoagulant therapy should be standardized.In addition to the HAS-BLED score, we should consider the complications that increase the bleeding risk, such as infections and respiratory failure, when evaluating the bleeding risk.

Effects of remote ischemic preconditioning on occurrence of postoperative delirium in elderly patients undergoing radical mastectomy / 中华麻醉学杂志

Objective To evaluate the effects of remote ischemic preconditioning (RIPC) on occurrence of postoperative delirium in elderly patients undergoing radical mastectomy.Methods Sixty elderly patients,aged 65-78 yr,of American Society of Anesthesiologists physical status Ⅱ or Ⅲ,scheduled for elective radical mastectomy,were allocated into 2 groups (n =30 each) using a random number table method:control group (group C) and RIPC group.Three cycles of 5-min ischemia/5-min reperfusion induced by a blood pressure cuff placed on the upper arm of the right upper arm served as RIPC treatment at 5 min after induction of anesthesia in RIPC group.The blood pressure cuff was only placed on the upper arm of the right upper arm without inflation and deflation in group C.Jugular bulb venous blood samples were obtained at 10 min before anesthesia induction (T0) and 1,12,24,48 and 72 h after the end of operation (T1-5) for determination of S-100β protein and neuron-specific enolase (NSE) concentrations in serum.The occurrence of delirium within 72 h after operation was estimated using Confusion Assessment Method for the Intensive Care Unit.The occurrence of hypotension,sinus bradycardia and reintubation was recorded.The Quality of Recovery-15 (QoR-15) was used to evaluate the early postoperative quality of recovery at 1 and 2 days after operation.Results Compared with group C,the concentrations of S-100β protein and NSE in serum and incidence of delirium within 72 h after operation were significantly decreased at T1-T5,and the Quality of Recovery-15 scores were increased at 1 and 2 days after operation in group RIPC (P＜0.05).There was no significant difference in the duration of delirium or incidence of hypotension,sinus bradycardia and reintubation between the two groups (P＞0.05).Conclusion RIPC can decrease the development of postoperative delirium and is helpful for the early postoperative recovery of elderly patients undergoing radical mastectomy.

Effects of remote ischemic preconditioning on occurrence of postoperative delirium in elderly patients undergoing radical mastectomy / 中华麻醉学杂志

Objective@#To evaluate the effects of remote ischemic preconditioning (RIPC) on occurrence of postoperative delirium in elderly patients undergoing radical mastectomy.@*Methods@#Sixty elderly patients, aged 65-78 yr, of American Society of Anesthesiologists physical status Ⅱ or Ⅲ, scheduled for elective radical mastectomy, were allocated into 2 groups (n=30 each) using a random number table method: control group (group C) and RIPC group.Three cycles of 5-min ischemia/5-min reperfusion induced by a blood pressure cuff placed on the upper arm of the right upper arm served as RIPC treatment at 5 min after induction of anesthesia in RIPC group.The blood pressure cuff was only placed on the upper arm of the right upper arm without inflation and deflation in group C. Jugular bulb venous blood samples were obtained at 10 min before anesthesia induction (T0) and 1, 12, 24, 48 and 72 h after the end of operation (T1-5) for determination of S-100β protein and neuron-specific enolase (NSE) concentrations in serum.The occurrence of delirium within 72 h after operation was estimated using Confusion Assessment Method for the Intensive Care Unit.The occurrence of hypotension, sinus bradycardia and reintubation was recorded.The Quality of Recovery-15 (QoR-15) was used to evaluate the early postoperative quality of recovery at 1 and 2 days after operation.@*Results@#Compared with group C, the concentrations of S-100β protein and NSE in serum and incidence of delirium within 72 h after operation were significantly decreased at T1-T5, and the Quality of Recovery-15 scores were increased at 1 and 2 days after operation in group RIPC (P<0.05). There was no significant difference in the duration of delirium or incidence of hypotension, sinus bradycardia and reintubation between the two groups (P>0.05).@*Conclusion@#RIPC can decrease the development of postoperative delirium and is helpful for the early postoperative recovery of elderly patients undergoing radical mastectomy.