Objective:To investigate the spectrum and antimicrobial resistance of major pathogens causing nosocomial infections in China during 2020-2021.Methods:A total of 1 311 non-duplicated nosocomial pathogens causing bloodstream infections (BSI, n=670), hospital-acquired pneumonia (HAP, n=394) and intra-abdominal infections (IAI, n=297) were collected from 10 teaching hospitals across China. The minimum inhibitory concentrations (MICs) of clinical common strains were determined using agar dilution or broth microdilution method. Interpretation of reults followed the CLSI M100-Ed33 criteria, with data analysis conducted using WHONET-5.6 software. The Chi-square test was used to compare rates. Results:The most prevalent pathogens causing BSI were Escherichia coli (21.2%, 142/670), Klebsiella pneumoniae (14.9%, 100/670) and Staphylococcus aureus (11.5%, 77/670); the most prevalent pathogens causing HAP were K. pneumoniae (27.7%, 109/394), Acinetobacter baumanii (22.1%, 87/394) and Pseudomonas aeruginosa (18.3%, 72/394). IN IAI, E. coli (24.3%, 60/247), Enterococcus faecium and K. pneumoniae (both 14.6%, 36/247) were dominated. All S. aureus strains were susceptible to tigecycline, linezolid, daptomycin and glycopeptides. Rates of methicillin-resistant S. aureus (MRSA) and coagulase-negative Staphylococcus (MRCNS) were 36.5% (42/115) and 74.5% (38/51), respectively. The rate of vancomycin-resistant E. faecium and E. faecalis was 3.3% (3/90) and 1.9% (1/53), respectively. The prevalence of extended-spectrum β-lactamase (ESBL) was 23.7% (58/245) in K. pneumonia and 60.5% (130/215) in E. coli.The rate of carbapenem-resistant K. pneumonia and E. coli was 29.8% (73/245) and 4.2% (9/215), respectively; the percentage of tigecycline-resistant K. pneumonia and E. coli was 1.6% (4/245) and 0, respectively; the rate of colistin-resistant K. pneumonia and E. coli was 1.6% (4/245) and 2.8% (6/215), respectively; the percentage of ceftazidime/avibactam-resistant K. pneumonia and E. coli was 2.0% (5/245) and 2.3% (5/215), respectively. The rate of carbapenem-resistant A. baumanii and P. aeruginosa was 76.7% (125/163) and 28.4% (33/116), respectively. A. baumanii showed low susceptibility to most antimicrobial agents except colistin (98.8%, 161/163) and tigecycline (89.6%, 146/163). Colistin, amikacin and ceftazidime/avibactam demonstrated high antibacterial activity against P. aeruginosa with susceptility rates of 99.1% (115/116), 94.0% (109/116) and 83.6% (97/116), respectively. Conclusions:The major pathogens of nosocomial infections were K. pneumonia, E. coli, A. baumanii, P. aeruginosa and S. aureus. Nosocomial Gram-negative pathogens exhibited high susceptibilities to tigecycline, colistin and ceftazidime/avibactam. Antimicrobial resistance in A. baumannii remains a significant challenge. The increasing prevalence of carbapenem-resistant Enterobacterales underscores the urgency of antibiotics rational applications and hospital infection controls.

ObjectiveThrough a randomized， double-blind， double-simulation， positive-control， multicenter design， this study aimed to analyze the relationship between the dosage， efficacy， and safety of Pudilan anti-inflammatory oral liquid in treating acute pharyngitis/tonsillitis in adults caused by bacterial infection and validate the regulatory effect of Pudilan anti-inflammatory oral liquid on inflammatory markers such as serum amyloid A （SAA）， C-reactive protein （CRP）， white blood cells （WBC）， neutrophil percentage （NE%）， and erythrocyte sedimentation rate （ESR）， thereby exploring the feasibility of using Pudilan anti-inflammatory oral liquid as a substitute for antibiotics in the treatment of infectious diseases and providing a basis for rational clinical medication. MethodUsing a stratified randomized， double-blind， double-simulation， positive-control， multicenter design， 220 participants were enrolled from nine centers. The participants were randomly divided into three groups at 1∶1∶1 — a Pudilan anti-inflammatory oral liquid 20 mL group （73 cases）， a Pudilan anti-inflammatory oral liquid 10 mL group （73 cases）， and a control group （amoxicillin group， 74 cases）. The treatment course was 7 days. The study observed parameters including the total effective rate of sore throat， onset and disappearance time of sore throat， health status score， treatment time， and inflammation markers. Result①Dataset division： The 211 cases were included in the full analysis dataset （FAS）， 208 cases were included in the per-protocol dataset （PPS）， and 218 cases were included in the safety dataset （SS）. ② Efficacy evaluation： There were statistically significant differences （P<0.05） in the comparison of the three groups regarding the total effective rate of sore throat， disappearance time of sore throat， and health status. Both the 20 mL and 10 mL groups were non-inferior to the control group， and there was a statistically significant difference between the 20 mL and 10 mL dosage groups （P<0.05）. There was no statistically significant difference in the comparison of onset time of sore throat among the groups. CRP， WBC， and NE% of patients in all three groups significantly decreased on the 7^th day of treatment compared with those before treatment （P<0.01）. ③Safety evaluation： Adverse events mainly occurred in various examination indicators. There were no statistically significant differences in the comparison between groups， and no adverse reactions or serious adverse events occurred. ④Economic evaluation： The increased cost of the 10 mL and 20 mL dosage groups was entirely justified as compared with that in the control group. When comparing the 10 mL and 20 mL dosage groups， the 10 mL dosage group was deemed less advantageous. ConclusionPudilan anti-inflammatory oral liquid can be used alone as an alternative to antibiotics in the treatment of acute pharyngitis/tonsillitis caused by bacterial infection. It demonstrates good safety and can lower inflammation markers such as CRP， WBC， and NE%， suggesting its potential to reduce the body's inflammatory response. Its mechanism of action may be related to its multi-target regulatory mechanism.

Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.
Medicine, Chinese Traditional ; Nonprescription Drugs ; Consensus ; China ; Reference Standards ; Drugs, Chinese Herbal

Nasal preparations have unique advantages in drug delivery and are widely used in the treatment of local and systemic diseases. Nasal administration of traditional Chinese medicine （TCM） has a long history in China. In recent years， nasal preparations of TCM have attracted wide attention. Based on the information about nasal preparations of TCM from the database of National Medical Products Administration （NMPA）， Yaozh.com and China National Knowledge Internet （CNKI） in the recent 30 years， the formulation， the listed products， commonly used TCM， pharmaceutical excipients， clinical application and safety research of modern nasal preparations of TCM were summarized and expounded. Focusing on many problems in the development of modern nasal preparations of TCM， such as inaccurate dosage of some products， incomplete quality standard system of pharmaceutical excipients， imperfect safety evaluation， lack of research and development of nasal drug delivery devices and so on， the possible solutions and prospects were put forward from the aspects of optimizing the extraction and separation process of TCM， the quality control and application method of pharmaceutical excipients， the development of new dosage forms， the safety evaluation of nasal administration of TCM， and the design and development of nasal administration devices. The aim is to provide ideas for the development of nasal preparations of TCM and provide scientific basis for its sustainable utilization.

Objective:To prepare 68Ga-2-(4, 7-bis(carboxymethyl)-1, 4, 7-triazonan-1-yl)pentanedioic acid (NODAGA)-YHWYGYTPQNVI (GE11) and evaluate its feasibility of PET imaging for pancreatic cancer. Methods:GE11 peptide was conjugated with NODAGA and then labeled with 68Ga. The labeling yield, radiochemical purity, hydrophilicity, stability and specificity in vitro were determined. Human pancreatic cancer BxPC3 nude mice models ( n=9) were established. MicroPET imaging was then obtained after 30 and 90 min, and mice were sacrificed at 90 min to acquire the radioactivity distribution of main organs and tumors. Pair t test was used to analyze the data. Results:The labeling yield was (73.5±5.4)% and radiochemical purity was more than 98%. After incubation 120 min in mouse serum at 37 ℃, radiochemical purity was more than 92%. The uptake was specific in BxPC3 cell lines. MicroPET images showed that 68Ga-NODAGA-GE11 could accumulate quickly in tumor. Value of tumor uptake was significantly higher than that of normal pancreas at 90 min ((1.38±0.25) vs (0.49±0.07) %ID/g; t=12.67, P<0.05), and the radio-uptake of blood, muscle and bone was lower than that of tumor. Conclusions:68Ga-NODAGA-GE11 is easy to be prepared with high radiochemical purity and good stability, and can specifically target BxPC3 xenograft tumor. However, due to the high uptake in the kidneys and liver, the value of 68Ga-NODAGA-GE11 in PET imaging for pancreatic tumor needs further study.

Objective To assess the efficacy and safety of morinidazole combined with appendectomy in treating purulent or gangrenous appendicitis.Methods Double-blind randomized controlled multicenter clinical trial was designed and conducted.Totally 437 patients were included,219 in the control group and 218 in the experimental group.Cases of purulent or gangrenous appendicitis were enrolled and assigned to each of the two groups.The control group received ornidazole injection for 5 to 7 days while the experimental group received morinidazole injection.Both groups underwent appendectomy.Clinical response,micrombiological outcomes,overall response were evaluated.Adverse events and side effects were recorded.Results No significant difference was observed between the two groups regarding the clinical healing rate at 5-10 days after medicine withdrawal,anaerobia clearance and overall healing rates.Adverse events occurred in 140 patients (32.1％).Incidence of adverse events in the control group and the experimental group was 34.7％ and 29.4％,respectively (P ＞ 0.05).The overall incidence of side effects was 15.1％ (66 cases).Side effects were less seen in the experimental group compared with that in the control group (11.5％ vs.18.7％,P ＜ 0.05).The most frequent side effects were aminotransferase rising,thrombocytosis,nausea,vomiting and electrocardiographic abnormality.Conclusions The effect of morinidazole plus operation was comparable with ornidazole in treating purulent or gangrenous appendicitis.The safety of morinidazole is better than ornidazole.

Objective To investigate the application value of magnetic-controlled capsule endoscopy (MCE) for gastric diseases in physical examination of asymptomatic population.Methods Data of 211 asymptomatic individuals who received MCE examinations from July 2015 to December 2016 in Changhai Hospital were collected and rctrospectively analyzed.The tolerance and safety of MCE were studied by analyzing the detection rate for the focal lesions and the rate of endoscopy transfer.Results Among 211 patients,the detection rate of the gastric focal lesions was 9.5％ (20/211).The detection rate in male was higher than that in female (P＜0.05).All patients completed MCE examination successfully and no adverse event was reported.Conclusion MCE,a non-invasive endoscopic modality,is safe and better tolerated than conventional endoscopy,and can be used as a promising approach to screening the gastric diseases in asymptomatic population due to high detection rate of these diseases.

Objective To analysis the clinical features of dorsal pancreas agenesis ( DPA) and the associated diabetes, pancreatitis and other congenital organ malformations.Methods Chinese databases of Sinomed, CQVIP and CNKI using the term of short pancreas, pancreas agenesis, bulbar pancreas and dorsal pancreas, and English databases of PubMed using the term of dorsal pancreas agenesis, short pancreas and pancreas hypoplasia were searched.The clinical manifestation, pancreatic head characteristics and associations with diabetes, pancreatitis and other congenital organ malformations were analyzed.Results Six related publications from Chinese databases were searched and 21 patients were included with 2 cases excluded.Sixty-one publications from English database were searched and 71 patients were included.Thus, a total of 91 patients with DPA were analyzed.Abdominal pain was the most common manifestation, which was reported by 61.5% of the patients. 15.3% patients were identified during regular physical examination. Other manifestations including jaundice, fatigue, abdominal discomfort and diabetes were rare.After removing cases with insufficient information, 39 patients (61.9%) carried abnormal pancreatic head.Prevalence of diabetes or impaired glucose tolerance was 56.7% and the percentage of insulin-dependent diabetes in patients with abnormal glycaemia was 47.3%(n=18).20 patients (26.7%) were associated with pancreatitis, including 15 patients (75.0%) with acute pancreatitis, 1 patient (5.0%) with recurrent pancreatitis, and 4 patients (20.0%) with chronic pancreatitis. Thirty-three patients ( 36.2%) suffered other congenital organ malformations, including 21 patients (63.6%) with splenic malformation, 8 patients (24.2%) with heart malformation, and 17 patients (51.5%) with multi-organs malformations like gastrointestinal malformation, azygos vein and inferior cava vena fusion, duodenal and biliary atresia and renal absence.Conclusions The main diagnostic criteria of DPA was the absence of dorsal pancreatic duct.Diabetes was the most common complication followed by pancreatitis.

Objective To investigate the association between albuminuria incidence and blood pressure (BP) level or body weight index (BMI) in patients with essential hypertension from five regions in China. Methods A total of 5021 non-diabetic patients with clearly diagnosed essential hypertension were enrolled in our study. The participants came from five cities in China.Urinary albumin/creatinine ratio was measured in these patients for two times. The associations of albuminuria with BP level and BMI were analyzed. Results (1)There was no significant difference of albuminuria incidence between ＜60-year-old and ≥60-year-old patients. The longer the hypertension exited, the higher the albuminuria incidence was. (2) The albuminuria incidence was associated with blood pressure level significantly. The urinary protein excretion increased with the level of blood pressure. The albuminuria incidences in patients with normal BP, upper range of normal BP, Ⅰ , Ⅱ or Ⅲ stage hypertension were 26.3%, 27.3%, 28.7%, 31.5% and 40.3% respectively. (3) The albuminuria incidence was significantly different in patients with uncontrolled BP (≥ 140/90 mm Hg) compared with those with well controlled BP (＜ 140/90 mm Hg) (27.1% vs 30.2%, P＜0.05 ). (4) The albuminuria incidence was higher in obese patients compared with those with normal BMI at same BP level, but the difference was not statistically significant. (5) Patients with albuminuria had more cardiocerebral or renal events as compared to those without proteinuria. Conclusions The albuminuria incidence of non-diabetic hypertensive patients from 5 cities in China is 28.8%, of which the microalbuminuria incidence is 18.6% and the clinical albuminuria incidence is 10.2%. Uncontrolled BP is an important risk factor of proteinuria.

OBJECTIVETo study the effects of artemether and dihydroarteannuin on the mouse model of scleroderma.

METHODSixty mice were randomly divided into 8 groups: PBS control group, model group, menstruum group (20% Tween-80, 0.4%CMC-Na), positive medicine group (penicillamine 200 mg kg(-1)), low-dose artemether group (5 mg kg(-1)), high-dose artemether group (20 mg kg(-1)), low-dose dihydroarteannuin group (5 mg kg(-1)), high-dose dihydroarteannuin group (25 mg kg(-1)). We have established a mouse model for scleroderma in Balb/c mice by subcutaneous injections of bleomycin 0.1 mL per day (200 mg L(-1) BLM) for 3 weeks. Meanwhile, the administration lasted for 4 weeks. The back skin was removed in the next day after the final administration. Treated skins and lungs were harvested and analyzed for histological sclerosis. The thickness of the skin and fibrosis degree of derma were observed and made an analysis of the contents of collagen and hydroxyproline.

RESULTCompared with the model groups, the high-dose groups markedly inhibited the thickness of derma (P<0.001), furthermore, the contents of collagen and hydroxyproline in the skin were also significantly reduced (P<0.05). Other groups of mice showed improvement on scleroderma.

CONCLUSIONOur results suggest that administration of artemether or dihydroarteannuin may be an effective approach in preventing systemic sclerosis.

Animals ; Artemisinins ; pharmacology ; Collagen ; metabolism ; Female ; Hydroxyproline ; metabolism ; Lung ; drug effects ; pathology ; Mice ; Mice, Inbred BALB C ; Scleroderma, Systemic ; metabolism ; pathology ; prevention & control ; Sesquiterpenes ; pharmacology ; Skin ; drug effects ; metabolism ; pathology