OBJECTIVE: To prepare parecoxib sodium freeze-dried preparation, evaluate and validate the feasibility of the production process and quality reliability of the preparation. METHODS: Risk assessment of the production process of parecoxib sodium freeze-dried preparation was performed based on the method of quality by design (QbD).The key steps and key process parameters were identified.The critical quality attributes (CQAs)of the intermediates and final product were clarified, the validation protocol and acceptable standard were accordingly developed, and the production process was validated. RESULTS: The production process of parecoxib sodium freeze-dried preparation met the GMP requirements, and the intermediate and final products met the quality standards. CONCLUSION: The established production process of parecoxib sodium freeze-dried preparation is feasible and the product quality is controllable.

OBJECTIVETo summarize the clinical effect of avulsed skin replantation of hand and foot via vacuum sealing drainage (VSD) combing low temperature technique.

METHODSFrom March 2012 to October 2013,13 cases with avulsed skin replantation of hand foot using combined technique included 8 males and 5 females with an average age of 32 years old ranging from 18 to 62 years. The time from injury to hospital was 1 to 4 hours (2.4 hour in average). The reasons of injury included machine injury in 7 cases and rolling over by cars in 6 cases. The parts of injuried involved finger in 2 cases,back of the hand in 5 cases and dorsum of foot in 6 cases. The area of avulsed skin was 5 cm x 6 cm to 12 cm x 16 cm,tendon and bone exposure was found in 4 cases. VSD was operated in all patients and the avulsed skin was refrigerated in the temperature of -4 °C or -80 °C. After 4 days, the skin stored in the -4 °C was replanted to the wounded place in 5 cases and in 3 cases the skin was planted to the donor site of flap. The skin stored in the -80 °C was replanted in 4 cases after 7 or 8 days, 1 case after 45 days.

RESULTSOf the 13 cases, 1 case of degloved injury from lower leg to dorsal foot,the replanted skin was necrosis completely; 1 case of degloving injury with fourth finger,the skin which replanted after 45 days survived approximately 30%,cured after skin-graft many times. In the other cases, the survival area of replanted skin was more than 85%, all cured after dressing. According to the standard of skin survival area evaluation by Jia et al, 11 cases showed excellent, 1 showed medium and 1 showed inferior. There were no complication about grafted skin rupture after the skin survived in 11 patients,after 4 to 22 months follow-up, the resiliency of grafted skin showed good. Sensation recovery was measured by BMRC standard: 3 cases of S3, 5 cases of S3, 3 cases of S2.

CONCLUSIONVSD combining lower temperature technique in skin replantation provides time and space for wound preparation and treatment plan for the patients who need second surgery, especially for the large area skin degloving,this method could utilize the degloved skin efficiently, decrease the donor site area, alleviate the pain and financial burden,reduce the scar formation of donor site and impediment.

Adolescent ; Adult ; Cryopreservation ; methods ; Drainage ; instrumentation ; methods ; Female ; Foot Injuries ; surgery ; Hand Injuries ; surgery ; Humans ; Male ; Middle Aged ; Replantation ; Skin ; injuries ; Skin Transplantation ; Young Adult

Aim To investigate the effect of broneol on acute lung injury(ALI) induced by lipopolysaccharide (LPS). Methods Male C57 mice were randomly di-vided into saline group, model group, broneol group and dexamethasone group, then the ALI mouse model was induced by instilling intratracheally with LPS. The levels of tumor necrosis factor-α(TNF-α),interleukin-1β(IL-1β),interleukin-6(IL-6) and keratinocyte-de-rived cytokine (KC) were measured at 6h, 12h and 24h after instillation of LPS, and the pathological changes of lung were observed. Mice alveolar macro-phages (MHS) and epithelial cells (MLE-12) were stimulated by LPS. After the stimulation of 1h, 3h, 6h,9h, 12h, 24h, the levels of TNF-α and IL-6 in MHS cells and the contents of KC and macrophage in-flammatory protein-2 (MIP-2) in MLE-12 cells were measured. Results Broneol could inhibit the secre-tion of TNF-α,KC and IL-1β;the early effect of bro-neol on IL-6 was not obvious,but the later effect after the treatment of 24 hours was obvious. After LPS instil-lation 6h and 12h,Broneol could significantly improve lung tissue pathological changes. Broneol had no effect on TNF-α secretion of MHS cells, but it obviously af-fected IL-6 secretion in the later stage. In addition, broneol significantly inhibited KC and MIP2 secretion in MLE-12 cells at the later stage of LPS stimulation. Conclusions Broneol can protect LPS-induced acute lung injury. The mechanism may be related to the inhi-bition of the release of inflammatory factors,the activa-tion of inflammatory cells and the aggregation of neutro-phils.

Objective: Sex differences have been observed in many aspects of schizophrenia, including cognitive deficits. Despite extensive research into the relationship between metabolic factors and cognitive deficits in schizophrenia, few studies have explored the potential sex difference in their association. Methods: We recruited 358 schizophrenia patients and 231 healthy controls. The participants underwent measurements of body mass index (BMI), waist circumference, blood pressure, triglycerides, high-density lipoprotein cholesterol, and fasting blood glucose. Metabolic risk factors included abdominal obesity, hypertension, hyperglycemia, and dyslipidemia. A collection of these metabolic risk factors has been defined as metabolic syndrome. These diagnoses were based on the criteria of the National Cholesterol Education Program’s Adult Treatment Panel III. Cognitive performance was measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). A descriptive analysis, difference analysis, and linear regression model were used to identify the metabolic risk factors for cognitive function in schizophrenia. Results: Our findings revealed sex differences in the rate of abdominal obesity and hypertension in schizophrenic patients. Additionally, we observed sex differences in the association between metabolic risk factors and cognitive impairment in schizophrenia. Specifically, hyperglycemia was associated with the immediate memory index score of RBANS in male patients, while dyslipidemia was associated with language, attention, delayed memory index scores, and RBANS total score in female patients. Conclusion Our results suggest that sex should be considered when evaluating the impact of metabolic disorders on the cognitive function of schizophrenic patients. Moreover, our study identifies hyperglycemia and dyslipidemia as potential targets for precise treatment by sex stratification, which could benefit the improvement of cognitive impairment in schizophrenic patients.

Objective To present the changes of surgical approaches for the resection of juvenile nasopharyngeal angiofibromas(JNA)and the follow-up results.Methods The clinical records of 59 patients with JNA treated under endoscope between 2002 and 2009 were reviewed retrospectively.The patients were divided into two groups:Group A(RadkowskiⅠa-Ⅱb)and Group B(Radkowsik Ⅱc-Ⅲb).The tumor stages,feeding vessels,operating time,complications and recurrence were observed and recorded.Results There were 7 patients with stageⅠa,3 patients with stageⅠb,5 patients with stage Ⅱ a,6 patients with stage Ⅱ b,4 patients with stage Ⅱc,23 patients with stage Ⅲa,11 patients with stage Ⅲb.The average age at diagnosis in Group A(21 cases)was 23.9 years old.The average operating time was(106.0±43.7)min.The follow-up ranged from 3 months to 74 months(median 36 months)except for 3 missing cases.The average age at diagnosis in Group B(38 cases)was 16.2 years old and the average operating time was(152.9±58.0)min.The follow-up ranged from 3 months to 87 months(median 25 months)except for 5 missing cases.During follow-up,6 patients in group B recurred.Infarction of thalamencephalon happened in 1 patient in group B who recovered totally afterwards.The difierence in operating time between two groups was statistically significant(t=-3.232,P=0.002).The life table was used to evaluate the survival curves and Log-rank test showed that the difference of recurrent time between two groups was statistically significant(P=0.03).Conclusions The key techniques to remove tumor are bleeding control,drilling-out the bone that tumor invaded.Transpterygoid or posterolateral wall of maxillary sinus approach are recommended for tumors that extend to infratemporal fossa.Small and intermediate-sized JNA which have no deep invasion of skull base(Radkowski Ⅰ a-Ⅱ b)have a low morbidity.JNA at Radkowski stage Ⅱ c and above have residual and recurrent risk.