Interpretation and reflection on the Measures for the Administration of Standards for Medicinal Products / 中国药房

In July 2023， the National Medical Products Administration issued the Measures for the Administration of Standards for Medicinal Products （hereinafter referred to as the Measures）. This article interprets the main content of the Measures， and analyzes its shortcomings as unclear definition of the drug standard code and the goals of drug standard information construction. It is recommended that the national drug regulatory department promptly apply to the standardization authority for the confirmation of the drug standard code “YB” letter， and the drug standard code and numbering rules would be included in the next round of amendments to the Measures. It is necessary to clarify the construction goals of the information system for drug standards at the same time， and build a national drug standard data-sharing platform based on the basic framework of user interface layer， computing processing layer， and data storage layer. Digital drug standards will be free， and access and download services for the public will be provided.

Efficacy and safety of endoscopic diaphragm incision in children with congenital duodenal diaphragm / 中华儿科杂志

Objective: To explore the efficacy and safety of endoscopic diaphragm incision in pediatric congenital duodenal diaphragm. Methods: Eight children with duodenal diaphragm treated by endoscopic diaphragm incision in the Department of Gastroenterology of Guangzhou Women and Children's Medical Center from October 2019 to May 2022 were enrolled in this study. Their clinical data including general conditions, clinical manifestations, laboratory and imaging examinations, endoscopic procedures and outcomes were retrospectively analyzed. Results: Among the 8 children, 4 were males and 4 females. The diagnosis was confirmed at the age of 6-20 months; the age of onset was 0-12 months and the course of disease was 6-18 months. The main clinical manifestations were recurrent non-biliary vomiting, abdominal distension and malnutrition. One case complicated with refractory hyponatremia was first diagnosed with atypical congenital adrenal hyperplasia in the endocrinology department. After treatment with hydrocortisone, the blood sodium returned to normal, but vomiting was recurrent. One patient underwent laparoscopic rhomboid duodenal anastomosis in another hospital but had recurred vomiting after the operation, who was diagnosed with double duodenal diaphragm under endoscope. No other malformations were found in all the 8 cases. The duodenal diaphragm was located in the descending part of the duodenum, and the duodenal papilla was located below the diaphragm in all the 8 cases. Three cases had the diaphragm dilated by balloon to explore the diaphragm opening range before diaphragm incision; the other 5 had diaphragm incision performed after probing the diaphragm opening with guide wire. All the 8 cases were successfully treated by endoscopic incision of duodenal diaphragm, with the operation time of 12-30 minutes. There were no complications such as intestinal perforation, active bleeding or duodenal papilla injury. At one month of follow-up, their weight increased by 0.4-1.5 kg, with an increase of 5%-20%. Within the postoperative follow-up period of 2-20 months, all the 8 children had duodenal obstruction relieved, without vomiting or abdominal distension, and all resumed normal feeding. Gastroscopy reviewed at 2-3 months after the operation in 3 cases found no deformation of the duodenal bulbar cavity, and the mucosa of the incision was smooth, with a duodenal diameter of 6-7 mm. Conclusion: Endoscopic diaphragm incision is safe, effective and less invasive in pediatric congenital duodenal diaphragm, with favorable clinical applicability.

Analysis of duration of ICU delirium and its influencing factors / 中华护理杂志

Objective To describe the status of duration of ICU delirium and to analyze its influencing factors.Methods We studied patients who were delirium positive from April 2016 to January 2017 in ICU in Peking Union Medical College Hospital.We collected general information and clinical information including mechanical ventilation,usage of sedation,analgesia and antipsychotics,hypoxia,infection,internal environment and types of delirium after initial onset of delirium.We also recorded management of delirium patients until resolution of delirium or patients were discharged from ICU.We analyzed data by Kaplan-Meier single factor analysis and Cox multiple-factors analysis.Results The average duration of ICU delirium was(5.06±4.59) days.APACHE Ⅱ score(x2=4.670,P=0.031),persistent delirium or not(x2=5.801,P=0.016),duration of hypoxia(x2=14.438,P＜0.001),and duration of usage of antipsychotics(x2=13.360,P＜0.001)were influencing factors of delirium duration.Conclusion Duration of ICU delirium has huge variation.To decrease duration of ICU delirium and improve outcomes of patients,medical workers should pay attention to patients with high APACHE score,persistent delirium and hypoxia,and be cautious when using antipsychotics.

Research on China and the US drug importation registration management system / 中国药学杂志

OBJECTIVE: To provide the basis of improving drug importation registration management system of our country by studying domestic and foreign drug importation management system adequately. METHODS: Checked out and studied the laws associated with import drug of our country and United States with literature research and comparative analysis methods. RESULTS: To reform the drug importation registration management system of our country, related problems should be analyzed. Also the recommendations should be put forward, including the registration of foreign drug establishment, unified registration procedures and adopted DMF system. CONCLUSION: Based on national conditions, we must draw on the advantages of United States system selectively, to improve our system, ensure the quality of import drug lifecycle and protect public health.

Experimental study on vascular bundle implantation combined with cellular transplantation in treating rabbit femoral head necrosis / 中国骨伤

<p><b>OBJECTIVE</b>To discuss the feasibility of vascular bundle implantation combined with allogeneic bone marrow stromal cells (BMSCs) transplantation in treating rabbit femoral head osteonecrosis and bone defect, in order to explore a new method for the treatment of femoral head necrosis.</p><p><b>METHODS</b>Thirty-six New Zealand rabbits were randomly divided into three groups,with 12 rabbits in each group. Bilateral femoral heads of the rabbits were studied in the experiment. The models were made by liquid nitrogen frozen, and the femoral heads were drilled to cause bone defect. Group A was the control group,group B was stem cells transplantaion group of allograft marrow stromal,and group C was stem cells transplantation group of allograft marrow stromal combined with vascular bundle implantation. Three rabbits of each group were sacrificed respectively at 2, 4, 8, 12 weeks after operation. All specimens of the femoral heads were sliced for HE staining. Furthermore ,vascular density and the percentage of new bone trabecula of femoral head coronary section in defect area were measured and analyzed statistically.</p><p><b>RESULTS</b>In group C,new bone trabecula and original micrangium formed at the 2nd week after operation; new bone trabecula was lamellar and interlaced with abundant micrangium at the 8th week;at the 12th week,the broadened,coarsened bone trabecula lined up regularly,and the mature bone trabecula and new marrow were visible. At the 2nd week after operation,there was no statistical significance in the percentage of new bone trabecula of femoral head coronary section in defect area between group B and C. While at 4, 8, 12 week after operation, vascular density and the percentage of new bone trabecula of femoral head coronary section in defect area of group C was higher than that of group B.</p><p><b>CONCLUSION</b>Allogeneic bone marrow stromal cells cultured in vivo can form new bone trabecula, and can be applied to allotransplant. Vascular bundle implanted into the bone defect area of femoral head necrosis could improve blood supply, and promote the formation of bone trabecula.</p>

Correlation between the GFAP, NSE, SYN and Nogo-A expression and neurological outcome in tissue surrounding the infarct during the recovery after cerebral ischemia-reperfusion injury in rats / 国际脑血管病杂志

Objective To investigate the correlation between the glial fibrillary acidic protein(GFAP),neuron-specific enolase(NSE),synaptoghysin (SYN),neurite outgrowth inhibitor-A(Nogo-A)expression and neurological outcome in tissue surrounding the infarct during the recovery after cerebral ischemia-reperfusion injury in rats.Methods A 2-hour middle cerebral artery occlusion(MCAO)and reperfusion model in rats was induced by the intraluminal suture method.The modified neurological severity score(mNSS)was performed at day 28,35,42,and 49.Immunohistochemistry was used to detect the expressions of GFAP,NSE,SYN,and Noga-A in tissue surrounding the infarct.Results The mNSS score decreased gradually over time after cerdnal ischemia-reperfusion injury in rats.Except day 35(5.11±0.737)vs.day 42 (4.54±0.519),and day 42 vs.day 49(4.29±0.488),there were significant differences at all other time points(all P<0.05).The numbers of GFAP positive cells deergased gradually form day 28 to day 49,in which,the numbers of GFAP positive cells at day 42(51.00±13.59)vs.day 49(44.38±11.94) were significantly less than those at day 28(69.00±15.10)(P<0.05).There were no significant differences in the numbers of NSE positive cells at all time points,but their integrated optical density(IOD)increased gradually.There were significant differences between day 28(6 218.57±1 864.25)and day 42(9 414.00±2 491.12) or day 49(12 522.50±3 106.99),and between day 35(7 343.40±1 533.35)and day 49(all P< 0.05).There were no significant differences at all other time points.The SYN express (IOD)increased gradually.and it was significantly lower at day 49(66 503.00±12 834.61)than that at day 28(43 905.14±13 208.59)(P<0.05).The numbers of Nogo-A positive cells decreased gradually,and they were significantly less at day 49(42.13±14.45) than those at day 28(59.57±15.25)(P<0.05).The GFAP expression was positively correlated with the mNSS scores(r=0.993,P=0.007).The NSE(r=-0.954,P=0.044)and SYN(r=-0.992,P=0.008) expression was negatively correlated with the mNSS scores.Conclusion The neurological outcome was associated with the downregulation of GFAP expression and the upregalation of NSE and SYN expression during the recovery after cerebral ischemia-reperfusion injury in rats.