Objective To characterize contemporary electrographic neonatal seizures by video electroencephalogram (VEEG) and to assess the value and the limitations of two-channel (C3-C4/T3-T4) amplitude-integrated electroencephalogram (aEEG) plus original EEG signals used to diagnose neonatal seizure with video EEG as a golden standard.Methods Sixty-six neonates admitted to Children's Hospital of Fudan University from January 2011 to July 2011 with clinical or suspected clinical seizure were investigated and bedside VEEG were recorded for more than 3 hours.VEEG signals were transformed into three kinds of aEEG signals by Galileo NT PMS software:one-channel aEEG (C3-C4),one-channel aEEG (C3-C4) plus original EEG,two-channel aEEG (C3-C4/T3-T4) plus original EEG.Electrical seizure activity on VEEG was signed out with respect to its occurrence,duration and localization of seizure onset; while aEEG seizure was recorded only with its occurrence.The relationship between aEEG and VEEG was analyzed by Spearman analysis.The value and the limitations of aEEG to diagnose neonatal seizure were evaluated by sensitivity,specificity,positive predictive value and negative predictive value.Results A total of 62 traces were suitable for analysis.(1) VEEG showed 39 seizure activities,among which 8 status epilepticus; and the rest 31 neonates had 352 non-status epilepticus electrical seizures,79.3％ (279/352) of which occurred over the centrotemporal region.(2) Eight cases with status epilepticus on VEEG were all diagnosed as status epilepticus on aEEG.For non-status epilepticus electrical seizures,the sensitivity of aEEG for detection of electrical seizures was as followed:49.1％ (173/352) for one-channel aEEG,54.5 ％ (192/352) for one-channel aEEG plus original EEG,81.2％ (286/353) for two-channel aEEG plus original EEG.Results from one-channel aEEG,one-channel aEEG plus original EEG and two-channel aEEG plus original EEG were all related to VEEG (ρ =0.790,0.907 and 0.953,respectively,P＜ 0.01).(3) Sensitivity of seizure detection was 66.7％ (26/39,95％ CI:0.62-0.81) for one-channel aEEG,74.4％(29/39,95％ CI:0.78-0.96) for one-channel aEEG(C3-C4) plus original EEG and 89.7％ (35/39,95％ CI:0.89-1.00) for two-channel aEEG(C3-C4/T3-T4) plus original EEG.Conclusions VEEG might help aEEG in diagnosis of neonatal seizure.two-channel aEEG (C3-C4/T3-T4) plus original EEG could significantly increase the sensitivity of neonatal seizures indentification.

Objective:To evaluate the efficacy and tolerability of crisaborole 2% ointment in the treatment of childhood atopic dermatitis (AD) at the early stage, and to compare the efficacy of every-other-day (Qod) regimen versus twice-a-week (Biw) regimen against recurrence in the remission stage of AD.Methods:A multicenter, randomized, open-label clinical trial was conducted. Totally, 150 children with mild to moderate AD aged 2 - < 18 years were enrolled from 6 hospitals (including Beijing Children′s Hospital, Capital Medical University, etc), and randomly divided into the Qod group (76 cases) and the Biw group (74 cases). In the acute stage of AD, both groups were treated with topical crisaborole 2% ointment on skin lesions twice a day for 2 - 4 weeks, as well as with emollients throughout the whole body. The improvement of early clinical symptoms was evaluated, and the occurrence of adverse reactions was recorded in the follow up. Once the investigator′s static global assessment (ISGA) scores decreased to 1 point or less, the patient would be enrolled into the remission stage. In the remission stage of AD, patients in the Qod group and Biw group were treated with crisaborole ointment every other day and twice a week respectively; the recurrence rate of AD in the remission stage was evaluated, as well as the severity of skin lesions, itching, life quality, and the occurrence of adverse reactions at weeks 4, 8, and 12. Statistical analysis was carried out with SPSS 23.0 software by using t test for comparisons of normally distributed continuous data between two groups, Mann-Whitney U test for non-normally distributed data, chi-square test for enumeration data, and Kaplan-Meier method for analysis of survival rates. Results:A total of 142 patients were enrolled in the modified intention-to-treat population, including 71 in the Qod group and 71 in the Biw group. In the acute stage of AD, the improvement of itching and skin lesions self-reported by the children or their family members occurred on days 1.9 (1.0, 3.0) and 2.0 (1.0, 4.1) after the application of crisaborole ointment, respectively. At the end of treatment in the acute stage, 89 children (62.7%) achieved ISGA 0/1 and successfully transferred into the remission stage. The follow-up in the remission stage was completed in 83 patients (44 in the Qod group and 39 in the Biw group). In addition, recurrence occurred in 19 (43.2%) and 12 (30.8%) patients in the Qod group and Biw group respectively, and there was no significant difference in the recurrence rate between the two groups ( χ2 = 1.36, P = 0.243) ; the average time to recurrence was 64.25 (95% CI: 53.33 - 75.17) days and 75.78 (95% CI: 65.46 - 86.10) days in the Qod group and Biw group respectively. Among the patients who were in the remission stage and had not yet experienced relapse at weeks 4, 8, and 12, there were no significant differences in the eczema area and severity index (EASI) scores, ISGA scores, pruritus numerical rating scale (NRS) scores, or quality-of-life scores between the two groups (all P > 0.05) at any time points, except for the ISGA scores at week 12 (Biw group: 0 [0, 1] point vs. Qod group: 1 [0, 1] point; Z = -2.31, P = 0.021). A total of 146 patients were enrolled in the safety set. During the study period, 70 adverse events occurred in 65 patients, with an incidence rate of 44.5%, and all were mild or moderate adverse events; 55 (37.7%) patients experienced discomfort at the medication site, which mainly referred to pain (45 cases, 30.8%) and mostly occurred in the tender and skinfold areas. Conclusions:Crisaborole 2% ointment could effectively relieve clinical symptoms in children with mild to moderate AD in the early stage, and intermittent treatment could continuously relieve clinical symptoms in the remission stage. The common adverse reaction was discomfort at the application site in the early stage of AD. There was no significant difference in the impact on AD recurrence in the remission stage between the Qod regimen and Biw regimen.

OBJECTIVE To monitor the occurrence of tenofovir disoproxil fumarate （TDF）-induced kidney injury and investigate the risk factors， and provide reference for rational use of TDF in clinic. METHODS The information of inpatients with hepatitis B was collected by China Hospital Pharmacovigilance System （CHPS） from the Second People’s Hospital of Lanzhou during Jan. 1st， 2019 to Dec. 31st 2021. The search criteria were set according to kidney injury criteria， and suspected TDF- induced kidney injury cases were actively monitored； then the clinical pharmacist confirmed the positive patients with TDF-induced kidney injury one by one and calculated the incidence of TDF-induced renal injury； the risk factors for TDF-induced kidney injury in real world were explored by collecting and analyzing the correlation of basic data of patients， main indexes of liver and kidney function， complications and combined use of drugs with TDF-induced renal indexes. RESULTS Totally 1 226 inpatients with hepatitis B using TDF were included. Through active monitoring of CHPS， 160 suspected patients with TDF-induced kidney injury were found， and 64 positive patients were finally confirmed manually. The incidence of TDF-induced kidney injury was 5.22%. Compared with pre-medication， the levels of serum creatinine and cystatin C， the proportion of patients with urinary protein 2+ and above were increased significantly after medication （P＜0.001）， glomerular filtration rate and blood phosphorus level were reduced significantly （P＜0.001） and other indicators had no statistical difference. Treatment time for more than 36 months， disease progresses to decompensated cirrhosis， and concomitant use of more than 10 kinds of drugs were significantly correlated with TDF- related kidney injury （P＜0.05 or P＜0.012 5）. CONCLUSIONS The active monitoring scheme of TDF-induced kidney injury established by CHPS has the characteristics of time-saving， labor-saving and high efficiency； based on real-world evidence， it is imperative to strengthen monitoring kidney function of patients when using TDF， especially when the patient has been on medication for a long time， in decompensated cirrhosis and combination of multiple drugs， and thus， we can identify earlier and avoid adverse effects in high-risk patientseffectively.