Forty-four guinea-pigs were sensitized by intramuscular inoculation with the same amount (0.8ml) of 5% egg albumin in water. 3 weeks after sensitization, the animals were rondomly divided into 1 groups (group J as control; group II given small dose of piperitone 0.08ml/ 100g body weight; group J given large dose of piperitone 0.12ml/100g body weight; group IX given promethazine 2.5mg 100g body weight) and subjected to anaphylactic insult by intra-cardiac injection of 1ml of 5% egg albumin in water under the protection of different dosege of piperitone, a terpene from cymbopogon distans. given intramuscularly. Results of the experiment indicates that piperitone had significant dose-effect relation protective effect against the anaphylactic insult on the guinea-pigs and suggests that piperitone might be used clinically for the treatment of asthma

AIM:To explore the characteristics of hepatitis B virus S gene mutation in the vertical transmission after active and passive vaccination .METHODS:Fifteen cases of immunoprophylaxis failure were enrolled in the study . HBV S gene (including pres-S and S) from the mothers, newborns before active and passive vaccination and 7-month-old infants with immunoprophylaxis failure were detected by PCR amplification .The characteristics of HBV S gene mutation were compared among the 3 groups.RESULTS: The genotype of HBV in the newborns and the infants was the same as that in the mothers .The frequencies of mutation in the 2 fragments of the HBV S gene had no significant difference between the 3 groups.The homology tree model based on HBV S gene was analyzed in the 3 groups, in which every group had their own cluster.There were 15 different mutation sites between 7 pairs of mothers and newborns .There were 3 different muta-tion sites between 3 pairs of newborns and infants (nt273A→A/G, nt512C→C/T and nt1139C→A), among which the first 2 were located in the S gene region but not in the “a” determinant , and the latter was located in the overlap region of S and X genes .There were 25 different mutation sites between 9 pairs of mothers and infants , but only 1 case had a differ-ent mutation site between the mother , newborn and infant .CONCLUSION: The HBV species in newborns and infants with immunoprophylaxis failure were transmitted from the mothers .The mutations in the HBV S gene with immunoprophy-laxis failure happened before and after active and passive vaccination , mainly before vaccination .The relationship between HBV S gene mutations and immunoprophylaxis failure should be further explored .

Objective. To evaluate the results of operative treatment of spinal fracture-dislocation without neurologic deficits. Methods. Eighteen patients with spinal fracture-dislocation were neurologically intact at the time of injury, and all were treated operatively. The fracture sites were:8 cases in cervical spine, 3 cases in thoracic spine, and 7 cases in lumbar spine. Eight patients with cervical injuries had variant degrees of forward slide and kyphotic deformity. Of the 10 thoracic and lumbar fracttwes, one had lateral dislocation, 4 cases with kyphotic deformities, 5 cases with spinal canal compromise averaged 50% (ranging from 40% to 70%). Results. The average period of follow-up was 4.4 years with a range of 11 months to 13 years. All the patientsretumed to full-time work. No patient developed neurologic deterioration. Kyphotic deformity was corrected in the 4cases, and no progressive kyphosis was noted. There was no operation-related complication. The averaged post-opera-tive hospitalization time was 13 days. Conelusions. Despite the rare incidence of spinal fracture-dislocation without neumlogic deficits, we suggested that kind of fracture be considered unstable fracture because of its potential risk of delayed neurologic deterioration and kyphotic deformity, and be treated operatively to restore the sagittal ali~ment and the stability of the spine.

Non-inferiority (NI) trial is a commonly used design during new drug development and regulatory agencies around the world rely on the results from NI trials to approve new drugs or new indications.One key parameter to design an NI trial is the entire effect size (M1) of the active control arm relative to placebo.M1 is typically calculated based on a meta-analysis of relevant historical trials.The final NI margin,M2,is a fraction of M1 and the appropriate fraction is determined based on clinical relevance.The condition of the new NI trial should be similar to that of the historical trials so that the effect of the active control arm can be assumed to be the same as that from the historical trials.However,there are cases where no relevant historical trials existed to mimic the new trial condition for the NI trial.Under such a scenario,the calculation of NI margin is rather challenging mainly because it is impossible to apply the meta-analysis to calculate M1 first.This paper demonstrates how to apply a pharmacometric method together with various sensitivity analyses to address such a challenge when a new indication of Everolimus was sought and approved in the US based on an NI trial.The readers are expected to understand the basic concept of pharmacometrics and its role in solving difficult drug development questions through this case study.The authors hope to achieve the goal of promoting the application of pharmacometrics in the drug development and approval process in China.

[Objective]To explore if the enhanced recovery after surgery (ERAS) protocol for pregnant women with gestational diabetes mellitus (GDM) who are undergoing elective cesarean delivery could cause perioperative glycemic abnormalities and heighten the risk of neonatal hypoglycemia.[Methods]A retrospective analysis was conducted on a cohort of pregnant women with singleton pregnancies who underwent elective cesarean sections and received ERAS between May 1,2022,and October 31,2023,at the Third Affiliated Hospital of Sun Yat-sen University. A total of 150 patients were included in this study,comprising the GDM group (n=75) and the non-GDM group (n=75). The study included pregnant women with good glycemic control (GDM) and maternal age (18-30 years;30-35 years;35-40 years;>40 years),BMI (<18.5 kg/m2;18.5-24.9 kg/m2;25-30 kg/m2;>30 kg/m2),and gestational age (within 7 days). We used these criteria to match 1∶1 non-GDM women as the control group. After administering preoperative oral carbohydrates,we observed the trends of maternal glycemic changes,including hyperglycemia and hypoglycemia,at any time of the day. We also evaluated the incidence of hypoglycemic low Apgar scores in newborns,abnormal pH values in blood gases,and the rate of transfer to the pediatric unit immediately after delivery.[Results]No significant difference was observed in fasting blood glucose levels on the day of surgery between the two groups of pregnant women[(4.4±0.5) mmol/L vs. (4.3±0.5) mmol/L,t=1.395,P=0.165]. The blood glucose peak was reached 30 minutes after consuming 300 mL (42.6 g of low-dose carbohydrate) of a light drink[(7.2±0.9) mmol/L vs. (6.4±0.8) mmol/L,t=5.773,P<0.001],with a subsequent decline in blood glucose levels. At the 120-minute mark,blood glucose had returned to the pre-oral carbohydrate level. The blood glucose levels in GDM groups was significantly higher than those in the non-GDM group (P<0.005). Although the incidence of hyperglycemia was significantly higher in the GDM group than in the non-GDM group at the 30-minute peak blood glucose level after oral carbohydrate intake,and the difference was statistically significant (17.3％ vs. 1.3％,x2=11.354,P<0.001),severe hyperglycemia (≥10 mmol/L) did not occur. The incidence of hypoglycemia was not significantly higher in neonates in the GDM group than in the non-GDM group (22.7％ vs. 28％,x2=0.564,P=0.453). The incidence of neonatal hypoglycemia in the GDM group was not significantly elevated in comparison to the non-GDM group after adjusting for age and BMI (Model 1),primiparity and gestational week of delivery (Model 2),hypertensive disorders of pregnancy (Model 3),cesarean section indications,time of cesarean section,and intraoperative hemorrhage (Model 4),and neonatal weight (Model 5).[Conclusion]In GDM patients with excellent glycemic control,an ERAS regimen with a low oral dose of carbohydrates prior to elective cesarean section does not increase the risk of preoperative serious hyperglycemia in mothers,nor does it increase the incidence of neonatal hypoglycemia.