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.

OBJECTIVE:To investigate the improvement effect of Prostatitis capsule on chronic non-bacterial prostatitis(CNP) model rats. METHODS:60 rats were randomly divided into sham operation group (distilled water),model group (distilled wa-ter),Pule'an tablet group(positive control,2 g/kg)and Prostatitis capsule high-dose,medium-dose,low-dose groups(16,8,4 g/kg). Except for sham operation group,other 5 groups were injected Xiaozhiling injection 0.2 mL to reduce CNP model. After 7 d of modeling,they received related medicines,ig,once a day,for 45 d. After 24 h of last administration,prostate lesions were ob-served by eyes and wet quality was weighed. White blood cell(WBC)count and lecithin body(SPL)count were conducted under microscope,and prostate tissue slices were pathologically observed. RESULTS:Compared with sham operation group,prostate showed gray nodules,adhesion in glands and surrounding tissue;wet quality of prostate and WBC,SPL count in prostate tissue were significantly increased(P<0.01);under microscope,there were significant congestion,edema and a variety of inflammatory cell infiltration in prostate interstitial. Compared with model group,gray nodules in prostate in Pule'an tablet group and Prostatitis capsule group were reduced,as well as adhesion degree in prostate and surrounding tissue;wet quality of prostate and WBC,SPL count in prostate tissue were significantly decreased(P<0.01);pathological changes had improved to varying degrees under micro-scope,especially the changes in Prostatitis capsule high-dose group,and prostate tissue only showed mild congestion,edema and little inflammatory cell infiltration. CONCLUSIONS:Prostatitis capsule has a certain improvement effect on CNP model rats.

Objective To investigate the effects of inhaled aerosolized low dose ambroxol on the inflammatory response to one-lung ventilation (OLV) in patients undergoing open-chest esophagus surgery.Methods Sixty patients (aged 39-64 years,weighing 50-85 kg and with height of 153-181 cm) with normal heart and lung function undergoing open-chest esophagus surgery were randomly divided into three groups:20 patients receiving intravenous infusion of normal saline (control group,group C),20 receiving intravenous infusion of ambroxol 10 mg/kg after induction of anesthesia (group IA) and 20 inhaling aerosolized ambroxol 30 mg after induction of anesthesia (group AIA).Arterial blood samples were taken after induction of anesthesia before ambroxol administration (T0,baseline),after 90 minutes of OLV (T1) and at 30 minutes after OLV (T2) for determination of plasma concentrations of tumor necrosis factor-alpha (TNF-α),interleukin-1 beta (IL-1β),IL-8 and IL-10 by enzyme linked immunosorbent assay (ELISA).Results The levels of TNF-α,IL-1β,and IL-8 in plasma significantly increased while the level of IL-10 in plasma significantly decreased at T1 and T2 as compared with the baseline at T0 in all the three groups.The levels of TNF-α,IL-1β,and IL-8 in plasma were significantly lower and the level of IL-10 in plasma was significantly higher at T1 and T2 in groups IA and AIA than in group C.Conclusion Both intravenous injection of large dose ambroxol and inhaled aerosolized low dose ambroxol can inhibit the inflammatory response to OLV in patients undergoing open-chest esophagus surgery.

Objective To compare the effect of applying low molecular weight heparin calcium in different periods of reteplase for acute myocardial infarction(AMI).Methods Ninety-one cases of AMI were divided into group A(30 cases),group B(30 cases)and group C(31 cases)by random digits table.The patients in three groups were given reteplase intravenous thrombolysis,and 5000 U low molecular weight heparin calcium was abdominal wall subcutaneous injections once 12 h at intravenous thrombolysis immediately(group A),after intravenous thrombolysis 6 h(group B)and 12 h(group C).They all were treated for 7-10 d.The rate of coronary artery recanalization,acute phase complication and adverse reaction were compared among three groups.Results The rate of coronary artery recanalization in group A,B and C was 76.7％(23/30),96.7％(29/30),74.2％(23/31)respectively.The rate of coronary artery recanalization in group B was significantly higher than that in group A and C(P ＜ 0.05).The rate of acute phase complication and adverse reaction in group B[33.3％(10/30)]was significantly lower than that in group A and C[70.0％ (21/30)and 61.3％(19/31)](P ＜ 0.05).Conclusions After reteplase intravenous thrombolysis in 6 h,applying low molecular weight heparin calcium can significantly improve the rate of coronary artery recanalization and reduce the rate of acute phase complication and adverse reaction.

Objective To investigate the effects of inhaled aerosolized low dose ambroxol on the inflammatory response to one-lung ventilation ( OLV) in patients undergoing open-chest esophagus surgery. Methods Sixty patients with normal heart and lung function undergoing open-chest esophagus surgery were randomly divided into 3 groups ( n = 20 each): control group (group C) ; group IA received Ⅳ ambroxol 10 mg/kg after induction of anesthesia and group AIA inhaled aerosolized ambroxol 30 mg after induction of anesthesia. Arterial blood samples were taken after induction of anesthesia before ambroxol administration (T0, baseline) , at 90 min of OLV (T1 )and at 30 min after OLV (T2) for determination of plasma concentrations of TNF-α, IL-1β, IL-8 and IL-10 by ELBA.Results Plasma TNF-α, IL-1β, and IL-8 concentrations were significantly increased while plasma IL-10 concentration was significantly decreased at T1 and T2 as compared with the baseline at T0 in all 3 groups. Plasma TNF-α, IL-1β, and IL-8 concentrations were significantly lower and plasma IL-10 concentration was significantly higher at T1 and T2 in groups IA and AIA than in group C. Conclusion Both Ⅳ large dose ambroxol and inhaled aerosolized low dose ambroxol can inhibit the inflammatory response to OLV in patients undergoing open-chest esophagus surgery.

Objective To explore predictive value of endometrial receptivity and pregnancy outcome by hysteroscopy examination at the phase of implantation window in unexplained infertile women.Methods From Oct.2007 to Mar.2009,93 unexplained infertile women underwent hysteroscopy examination at 7-9 days after a spontaneous ovulation in Family Planning Research Institute of Guangdong Province.According to the endometrial glandular openings and vascular shape,79 cases without pathological endometrial changes were divided into 60 cases in good endometrium group and 19 cases in poor endometrium group.The following clinical parameters were analyzed and compared between two groups,including endometrial configuration,thickness,secretion,the development and number of pinopodes,vascular distribution,and the level of sex hormone,leukemia inhibitory factor (LIF) and glycodelin in the uterine flushing,and pregnancy outcome.Results (1)There was no statistical difference in the level of serum estrogen and progesterone at the phase of implantation window,which were (518 ± 176)pmol/L,(40 ±20)nmol/L in good group and (513 ±244) ptnol/L,(37 ± 19) nmol/L in poor group (P<0.05).The endometrium thickness at periovulatroy and implantation window days (1.06 ±0.10)cm/(1.16 ± 0.08)cm in good group did not show significant difference with (0.93 ±0.12) cm /(1.02 ±0.10) cm in poor group (P>0.05).The proportion of type A,B and C endometrium at periovulatory days were 63% (12/19),37% (7/19) and 0 (0/19) in good group and 23% (14/60),77% (46/60) and 0 (0/60) in poor group.When compared with those of type A or B between two groups respectively,it all showed statistical difference (P<0.05).However,at phase of implantation window,endometrium configurations were all type B at both groups.(2)90% (17/19)of women in good group and 7% (4/60)of women in poor group showed normal endometrial secretion function,which showed significant differences (P< 0.01).(3)The percentage of fully developed pinopodes and abundant pinopodes [84% (16/19) and 90% (17/19)] in good group were significantly higher than 42% (25/60)and 57% (34/60) in poor group (P<0.05).(4) The level of CD_(34) expression and microvessel density[MVD; (40.1 ± 1.2) positive unit(PU) and(21.7 ±4.0)/high power field (HP)] in good group were significantly higher than(18.1 ± 1.3) PU and (8.5 ± 1.3)/HP in poor group (P< 0.01).(5)The level of LIF and glycodelin in uterine flushing [(72 ± 54)ng/L and (196 ±20)μg/L] in good group were significantly higher than (15±16) ng/L and (116 ±26) μg/L in poor group (P<0.05).(6) The rate of clinical pregnancy,spontaneous abortion and term delivery were 74% (14/19),0 (0/14) and 100% (14/14) in good group and 23% (14/60),14% (2/14) and 86% (12/14) in poor group,the rate of clinical pregnancy and term delivery in good group were significantly increased when compared with those in poor group (P<0.01).Conclusions Hysteroscopy examination at the phase of implantation window could reflect the development of glandular openings and vasculature.It is a preferable method to evaluate the endometrial receptivity and predict pregnancy outcome.