Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.

Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.

Objective:To investigate COVID-19 vaccination status and relevant adverse reactions in patients with psoriasis treated with biological agents, and to explore the effect of COVID-19 vaccination on psoriatic lesions.Methods:Clinical data were collected from 572 psoriasis patients aged 18 - 60 years, who were registered in the management system of psoriasis patients treated with biological agents in the University of Hong Kong-Shenzhen Hospital from May 2019 to June 2021. The COVID-19 vaccination status was investigated by telephone interviews, and the vaccination-related information was obtained by fixed healthcare workers during a fixed time period according to a predesigned questionnaire. Measurement data were compared between two groups by using t test, and enumeration data were compared by using chi-square test or Fisher′s exact test. Results:The COVID-19 vaccination coverage rate was 43.13% (226 cases) among the 524 patients who completed the telephone interview, and was significantly lower in the biological agent treatment group (30.79%, 105/341) than in the traditional drug treatment group (66.12%, 121/183; χ2 = 60.60, P < 0.001) . The main reason for not being vaccinated was patients′ fear of vaccine safety (49.66%, 148/298) , followed by doctors′ not recommending (26.51%, 79/298) . In the biological agent treatment group after vaccination, the exacerbation of psoriatic lesions was more common in patients receiving prolonged-interval treatment (42.86%, 6/14) compared with those receiving regular treatment (4.40%, 4/91; Fisher′s exact test, P < 0.001) . Skin lesions were severely aggravated in two patients after COVID-19 vaccination, who ever experienced allergic reactions and whose skin lesions did not completely subside after the treatment with biological agents. Conclusions:The COVID-19 vaccination coverage rate was relatively low in the psoriasis patients treated with biological agents, and no serious adverse reaction was observed after vaccination. Prolonged-interval treatment due to COVID-19 vaccination ran the risk of exacerbation of skin lesions.

Objective:To investigate the predictive efficacy of global inhomogeneity (GI) index based on pulmonary electrical impedance tomography (EIT) in postoperative pulmonary infection of patients with craniocerebral trauma.Methods:A total of 90 patients with emergency craniocerebral trauma underwent surgery under general anesthesia in Suzhou Science & Technology Town Hospital. According to the complication of pulmonary infection at the 3rd day after operation, they were divided into the pulmonary infection group (P3 group) and non-pulmonary infection group (NP3 group), and according to the complication of pulmonary infection at the 7th day after operation, they were divided into the P7 group and NP7 group. The average GI index within 5 min before anesthesia induction (T 0) and 5 min after endotracheal intubation (T 1) and other clinical data in the perioperative period were collected. The prevalence of pulmonary infection at the 3rd and 7th days after operation was recorded. Receiver operating characteristic (ROC) curve was used to evaluate the predictive value of preoperative GI index for pulmonary infection at the 3rd and 7th days after operation. Results:A total of 88 patients were included. Among them, 26 patients developed pulmonary infection within 3 days after operation, and the prevalence rate was 29.5%. Pulmonary infection occurred in 38 patients within 7 days after operation, and the prevalence rate was 43.2%. Within 3 days after operation, the preoperative Glasgow Coma Scale score in the P3 group was significantly lower than that in the NP3 group ( P < 0.05). Within 3 days after operation, GI index in the P3 group increased significantly at T 1 when compared with the NP3 group ( P< 0.001). Within 7 days after operation, GI index in the P7 group increased significantly at T 1 when compared with the NP7 group ( P < 0.05). GI index at T1 accurately predicted pulmonary infection within 3 days after operation (AUC = 0.857, P < 0.001), and the best intercept value was ≥0.4225 (sensitivity: 0.846, specificity: 0.823). GI index at T 1 predicted pulmonary infection within 7 days after operation (AUC = 0.667, P < 0.005), and the best intercept value was ≥0.4225 (sensitivity: 0.579, specificity: 0.780), but the prediction efficiency was poor. Conclusions:The average GI index within 5 min after endotracheal intubation can be used as an effective predictor of pulmonary infection within 3 days after operation.

Objective To study the stability of lumbar spine after transforaminal lumbar interbody fusion (TLIF) surgery combined with a novel articular process fixation system (APFS). Methods Based on the validated finite element model of L3-S1 intact segment (Model A), TLIF surgery was simulated to establish bilateral pedicle screw TLIF model (Model B), right unilateral pedicle screw TLIF model (Model C), APFS combined with right pedicle screw fixation TLIF model (Model D). The range of motion (ROM) of the lumbar spine model and stress distributions on pedicle screws, APFS and interbody fusion cages under different working conditions were observed. Results The overall ROMs of Models B, C, and D under different working conditions were comparable, which were all smaller than those of the physiological model. Compared with Models B and C, the maximum compressive stress of the right pedicle screw and the interbody fusion cage in Model D was the smallest or between Models B and C under different working conditions. Model D had the largest peak stress of APFS and right pedicle screw during anterior flexion. Conclusions APFS combined with contralateral pedicle screw fixation can be used as a novel fixation method for TLIF surgery of lumbar spine.

BACKGROUND:Operative approaches of lumbar interbody fusion include anterior (ALIF),posterior (PLIF) and transforaminal lumbar interbody fusion (TLIF).The resected structures and cage implantation sites are different,and the initial stability of lumbar spine is varied.OBJECTIVE:To compare the initial stability of lumbar spine following ALIF,PLIF or TLIF in combination with bilateral pedicle screw fixation.DESIGN:Comparative observation.MATERIALS:Fifteen samples of fresh calf lumbar spine were used.METHODS:Models ofALIE PLIF and TLIF were simulated.After examination as normal group,the samples were randomly divided into three groups (n=5).Besides anterior,posterior and transforaminal lumbar interbody fusion include anterior,bilateral pedicle screw fixation was performed.MAIN OUTCOME MEASURES:Biomechanical characteristics of the lumbar spine before and after ALIF,PLIF or TLIF in combination with bilateral pedicle screw fixation.RESULTS:Following three approaches of lumbar interbody fusion,the stability of lumbar spine was significantly reduced,which was enhanced after bilateral pedicle screw fixation (torsion indexes were also increased).In addition,rigidity of the lumbar spine was enhanced.The stability indexes of lumbar spine following TLIF were significantly greater than the other approaches,indicating the initial stability of TLIF was the best.The rigidity,stress,and swain of lumbar spine following PLIF were greater than ALIE but torsion indexes were smaller than ALIE CONCLUSION:The stability of lumbar spine following lumbar interbody fusion was significantly reduced compared with normal sample.But bilateral pedicle screw fixation greatly increases the stability.Among three types of lumbar interbody fusion,the initial stability of lumbar spine following TLIF is the best.

BACKGROUND:Transforaminal lumbar interbody fusion(TLIF)can be applied in any lumbar segment,and retain integrity of lateral vertebral plate and zygapophysiai joints.However,few studies have been conducted about the biomechanical performance.OBJECTIVE:To explore the stability of lumbar intervertebral segment following TLIF appHed bilateral and unilateral transpedicular screws fixation.DESIGN,TIME AND SETTING:Biomechanical test was performed at the Institute of Biomechanics,Shanghai University and Nantong University between August 2005 and April 2006.MATERIALS:Twenty samples of fresh one-month-old calf lumbar vertebra.METHODS:Twenty samples of calf lumbar vertebra underwent TLIF alone,TLIF in combination with bilateral or unilateral transpedicular screws fixation.Biomechanical test was performed on spinal three dimensional motion testing machine.MAIN OUTCOME MEASURES:Stress,displacement.strain and torsion angle were recorded.RESULTS:After TLIF without fixation.no obvious changes were found in mean stress and strain,but the axes stiffness and rotational stiffness were significantly decreased,indicating TLIF could produce immediate lumbar stability.After TLIF with unilateral or bilateral transpedicular screws fixation,the lumbar stability was significantly enhanced compared with TLIF alone,especially bilateral transpedicular screws fixadon.Although the lumbar stability following unilateral transpedicular screws fixation was inferior to bilateral fixation,it was still greatly enhanced,even bxceeded normal sample,indicating TLIF with unilateral transpedicular screws fixation could produce enough initiallumbar stability.CONCLUSION:TLIF alone cannot support sufficient initial stability,but TLIF with bilateral and unilateral transpedicular screws fixation can enhance lumbar initial stability.

OBJECTIVETo investigate the inherent characteristics of Vibrio cholerae (V. cholerae) and other vibrios and their relationship.

METHODSPolymerase chain reaction (PCR), DNA sequence analysis, randomly amplified polymorphic DNA (RAPD) analysis and average linkage cluster analysis were used to study 3 isolates of V. cholerae strains O139, three isolates O1 biotype El Tor, four isolates O1 biotype classical and 3 other vibrios.

RESULTSV. cholerae O139 contained the genomic sequences of ctx A2-B as well as V. cholerae O1. V. cholerae and others vibrios were divided into 4 groups by fingerprint patterns of RAPD, that is (1) V. cholerae O139 and V. cholerae O1 El Tor; (2) V. cholerae O1 classical; (3) V. paraheamolyticus and V. vulnificus and (4) V. flluvialis. V. cholerae O139 DNA fingerprint of RAPD was consistent with the El Tor biotype: average linkage cluster distance was 0, and slightly different from the classical biotype, with a distance of 2.07. It was much more different from vibrio paraheamolyticus and others, with a distance of 6.76 - 8.54.

CONCLUSIONV. cholerae and other vibrios are polymorphic in inherent characteristics. The inherent characteristics of V. cholerae O139 are the same as El Tor biotype. O139 may have evolved from the El Tor biotype. The inherent characteristics of vibrio paraheamolyticus are the same as vibrio vulnificus.

DNA, Bacterial ; chemistry ; genetics ; Polymorphism, Genetic ; Random Amplified Polymorphic DNA Technique ; Sequence Analysis, DNA ; Species Specificity ; Vibrio ; genetics ; Vibrio cholerae ; genetics