BACKGROUND: Locking pedicle screw system is commonly used in clinic, but it often suppresses spinal longitudinal growth of adolescent at growth phase. Thus, a pedicle screw system that can reduce even avoid the inhibition to spinal growth is needed. OBJECTIVE: To compare the biomechanical performance of sliding instrumentation of pedicle screw system and traditional locking pedicle screw system. DESIGN: Comparative observation. SETTING: Department of Orthopedics, Xinqiao Hospital of Third Military Medical University of Chinese PLA, and Department of Orthopedics, the 211 Hospital of Chinese PLA. MATERIALS: The experiment was performed at Department of Material Science, Harbin Institute of Technology on June 29th, 2007. Self-designed sliding pedicle screw system was made of Ti alloy by Wujin No. 3 Medical Instrument Factory Co., Ltd., Jiangsu Province. It consisted of sliding pedicle screw, orthopaedic rod and transversal coupling device. Twelve samples of fresh porcine spine were selected, and muscles attached on vertebral bodies of TrL5 were removed carefully but integrity of main ligament and precessus articularis posterior was retained. METHODS: The samples were randomly divided into sliding system group and locking system group with 6 samples in each group. Partial vertebral plate and surrounding ligaments of T12as well as bilateral facet joints between T11-12 and T12-L1 were removed to induce spinal destabilization, then sliding pedicle screw system and locking pedicle screw system were respectively fixed onto T10, T12, and L2 vertebral bodies of two groups. The samples then were fixed into fixture, and put onto INSTAON-4505 axial compressor. The strain gauge was connected with YJ-31 static electricity resistance strain gauge instrument human to simulate human spinal load, and the center of gravity was loaded to induce forward flexion, backward extension, lateral flexion and axial construction. Load of 100, 200, 300, 400 and 500 N was given gradually, and displacement of T12 was measured under different loads. MAIN OUTCOME MEASURES: ①Changns in principal stress and displacement under forward flexion, backward extension, lateral flexion and axial construction; ②Spinal fixation intensity and rigidity. RESULTS: No statistical difference was detected in main straining, displacement of apical vertebrae and intensity of fixation between sliding system group and locking system group under forward flexion, backward extension, lateral flexion and axial construction (P > 0.05). CONCLUSION: Sliding pedicle screw system has identical biomechanical stability as locking system. Furthermore, in sliding pedicle screw system, the screw and rod are coupled by sliding pattern, which extend along with spinal growth. It can be used to treat scoliosis at growth phase.

Objective:To evaluate the efficacy and safety of recombinant human tumor necrosis factor-α receptorⅡ: IgG Fc fusion protein (rhTNFR:Fc) in the treatment of drug-induced toxic epidermal necrolysis (TEN) .Methods:From 2009 to 2018, 22 patients with TEN were enrolled from 8 centers such as the Second Affiliated Hospital of Soochow University, including 10 males and 12 females, whose age ranged from 22 to 75 years. These patients were subcutaneously injected with rhTNFR:Fc at a dose of 25 mg once every 3 days for 6 - 8 consecutive sessions, and the initial dose was doubled. The drug eruption area and severity index (DASI) score and DASI improvement indices (DASI50, DASI75 and DASI90) were assessed before treatment and on days 4, 7, 10, 13, 16, 19, 22 and 25 after treatment; cytometric bead array (CBA) technology was used to detect the level of tumor necrosis factor (TNF) -α in peripheral blood and blister fluid samples. During the treatment, body temperature, rash changes, liver and kidney function of patients were monitored, and adverse reactions were recorded. Statistical analysis was carried out by using repeated measures analysis of variance, paired t test and Pearson correlation analysis. Results:Of the 22 patients, the temperature stopped rising in 20 patients without infections 24 - 72 hours after the first treatment, and returned to normal after 48 - 120 hours. Among the 22 patients, new blisters stopped appearing 24 - 48 hours after the first treatment, the skin color changed from bright red to dark purple after 48 - 96 hours, and most skin lesions subsided after 2 weeks. After 2 - 4 weeks of treatment, levels of alanine aminotransferase and aspartate aminotransferase returned to normal in 19 patients with abnormal liver function. After 4 - 13 days of treatment, levels of creatinine and urea nitrogen stopped rising in 7 patients with abnormal renal function. During the treatment, the DASI score of the 22 patients gradually decreased ( F = 532.81, P < 0.01) , from 53.64 ± 8.67 before treatment to 2.05 ± 1.21 on day 25 after treatment ( t = 26.60, P < 0.001) . On day 10 after treatment, 22 patients (100%) achieved DASI50; on day 19, 22 (100%) achieved DASI75; on day 25, 20 (90.90%) achieved DASI90. The level of TNF-α in peripheral blood of the 22 patients gradually decreased along with the extension of treatment duration, from 33.95 ± 27.90 ng/L before treatment to 2.38 ± 0.79 ng/L on day 25. Before treatment, the level of TNF-α in blister fluid of 15 patients was 111.99 ± 99.41 ng/L, and the ratio of blister-fluid TNF-α level to peripheral blood TNF-α level was 1.83 - 28.21. Before treatment, no correlation was observed between the serum level of TNF-α and DASI score in the 22 patients ( P = 0.10) , while the blister-fluid TNF-α level was positively correlated with DASI score in the 15 patients ( r = 0.59, P = 0.02) . No acute adverse reactions were observed during the treatment. All the 22 patients completed the treatment and were discharged with complete recovery. During 6 months of follow-up after discharge, no recurrence or any complication was observed. Conclusion:rhTNFR:Fc is effective and safe for the treatment of drug-induced TEN.

Objective:To compare the efficacy and safety of Tonghua Dongbao′s insulin aspart injection (Rishulin) and NovoRapid (Novo Nordisk) in the treatment of diabetes.Methods:A 26-week, randomized, open-label, parallel-group, positive control drug and non-inferiority trial was conducted in 23 centers in China. A total of 563 diabetes with poor blood glucose control treated with insulin for at least 3 months before were included. The subjects were randomized(stratified block random method) into those receiving Rishulin or NovoRapid at a ratio of 3∶1. Both groups were combined with basal insulin (Lantus). The primary endpoint was the change in glycosylated hemoglobin (HbA1c) from baseline to the end of 24 weeks of treatment.Results:For full analysis set, after 24 weeks of treatment, HbA1c level of Ruishulin group decreased from (8.66±1.28)% to (7.77±1.09)% ( P<0.001), and that of NovoRapid group decreased from (8.47±1.28) % to (7.65±0.97) % ( P<0.001). Treatment difference in HbA1c (NovoRapid group-Ruishulin group) was -0.061% (95% CI -0.320-0.199). HbA1c<7.0% target reacing rates were 24.26% and 21.21% ( P=0.456), and HbA1c<6.5% target reacing rates were 9.65% and 6.82% ( P=0.310) in Ruishulin group and NovoRapid group, repectively. The standard 2 hours postprandial blood glucose (2hPG) in Ruishulin group decreased from (16.23±5.22) mmol/L to (12.65±4.57) mmol/L ( P<0.001), and 2hPG in NovoRapid group decreased from (16.13±5.37) mmol/L to (11.91)±4.21) mmol/L ( P<0.001). The fingertips blood glucose at 7-point of both groups exhibited varying degrees of reduction compared with those at baseline, repectively. Positive ratios of specific antibodies were 31.68% in Ruishulin group and 36.36% in NovoRapid group ( P=0.320). Ratios of negative to positive were 7.43% and 10.61% ( P=0.360), and ratios of positive to negative were 10.40% and 7.58% ( P=0.360) in Ruishulin group and NovoRapid group, respectively. The incidence of hypoglycemia was 60.05% and 55.40% ( P=0.371), and the incidence of adverse events was 76.60% and 77.70% ( P=0.818) in Ruishulin group and NovoRapid group, respectively. Conclusions:Rishulin is not inferior to NovoRapid, and has shown good efficacy and safety. It can be an ideal choice for clinicians in patients with poor blood glucose control with insulin.