1.Prokaryotic expression and preliminary analysis of immunogenicity of outer mem-brane protein of yak-derived Escherichia coli OmpA
Shinan ZHANG ; Shengyi HAN ; Tian SHI ; Shuping LI ; Guoyuan HU ; Rui GAO ; Jiaqi TIAN ; Wenwen ZHOU ; Shengqing LI
Chinese Journal of Veterinary Science 2025;45(3):458-465,472
The amino acid sequences of the OmpA protein isolated from Escherichia coli QML2206-1(E.coli QML2206-1)in our laboratory were analyzed for homology with different strains of OmpA proteins using bioinformatics software,and the OmpA protein was analyzed for its physicochemical properties,transmembrane structure and signal peptide prediction,B-cell anti-genic epitope prediction,secondary and tertiary structure prediction.The OmpA gene fragment was ligated with pET-32a vector to construct a prokaryotic expression vector,which was purified by a nickel column affinity purification system after prokaryotic expression and optimization of ex-pression conditions in BL21(DE3).The purified recombinant protein was fully mixed with Freund's adjuvant to immunize mice,and the levels of mouse-specific IgG antibody and the expression levels of cytokines CD4,CD8 and IL-4 in mouse serum were detected by ELISA,and the immuno-protective effect was evaluated by mouse attack protection test.OmpA protein is a hydrophilic protein with no transmembrane structural domains and a secondary structure consisting mainly of irregular coils(47.98%)and α-helices(29.77%),with 12 antigenic epitopes that can bind to anti-bodies produced by B cells.The recombinant protein OmpA with a relative molecular mass of a-bout 55 kDa was successfully obtained by prokaryotic expression,and the highest expression was induced by IPTG concentration of 0.000 4 mmol/L for 6 h at 37 ℃.The serum-specific IgG anti-body potency of recombinant protein immunized mice was up to 1∶32 000;the expression levels of CD4,CD8 and IL-4 in the serum of immunized mice were elevated compared with those of the con-trol group.The survival rate of mice was 80%and 40%after attack with minimum lethal dose(MLD)and 2 times minimum lethal dose(2MLD),respectively.OmpA recombinant protein has good antigenicity and certain immunoprotective effects,and this study provides a technical basis for the next step in the development of a genetically engineered subunit vaccine against yak-appli-cable E.coli based on OmpA protein.
2.Clinical study on the"Stomach Three Needles"for preventing highly emetogenic chemotherapy-induced acute nausea and vomiting in breast cancer patients
Mengyan LIN ; Wenwu WANG ; Fangfeng LIN ; Shuping SHI ; Jie LIN ; Biyin CHEN
China Modern Doctor 2025;63(31):8-11,30
Objective To observe the effectiveness and safety of the"Stomach Three Needles"in preventing acute chemotherapy-induced nausea and vomiting(CINV)in patients with breast cancer.Methods Seventy patients with breast cancer who received highly emetogenic chemotherapy(HEC)and were admitted to the Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine from January 2023 to May 2025 were selected as research subjects.They were divided into treatment group(35 cases)and control group(35 cases)according to the random number table method.The treatment group received"Stomach Three Needles"combined with triple-drug prophylactic antiemetic therapy,while the patients in control group were given triple-drug prophylactic antiemetic therapy alone.The severity of nausea and vomiting symptoms during the acute phase,functional living index-emesis(FLIE),and adverse reactions between two groups of patients were compared.Results The severity grades of acute-phase nausea and vomiting symptoms in treatment group were all lower than those in control group(P<0.05).The complete response rate and total effective rate of acute-phase nausea and vomiting in treatment group were significantly higher than those in control group(P<0.05).The FLIE score of the patients in treatment group was significantly higher than that in control group(P<0.05).There was no statistically significant difference in the occurrence of adverse reactions such as headache,fatigue,constipation,and abdominal distension between two groups of patients(P>0.05).Conclusion The"Stomach Three Needles"combined with triple-drug prophylactic antiemetic therapy can effectively reduce the incidence and severity of acute CINV in breast cancer patients,improve their quality of life,and has good safety.It is worthy of clinical promotion.
3.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
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.
4.Cross-sectional investigation and analysis of the early warning threshold for intraoperative bleeding intervention during dilation and curettage in type Ⅱ cesarean scar pregnancy
Changmei SANG ; Qiuling SHI ; Yanjun KANG ; Zhibiao WANG ; Shuping ZHAO
Chinese Journal of Obstetrics and Gynecology 2025;60(10):782-787
Objective:To investigate nationwidely the alert threshold for intraoperative bleeding intervention during dilation and curettage (D&C) for type Ⅱ cesarean scar pregnancy (CSP) in the first trimester.Methods:A retrospective cross-sectional survey was conducted. From March 11 to April 14, 2022, obstetricians and gynecologists affiliated with professional associations or institutions of Family Planning Subgroup, Chinese Society of Obstetrics and Gynecology, Chinese Medical Associaton were surveyed using “Expert Consultation Questionnaire on Alert Threshold for Intraoperative Blood Loss in CSP”. The questionnaire was distributed via WeChat using the Questionnaire Star platform. Observation indicators included professional expertise of participants, preferred treatment modalities for type Ⅱ CSP, and an alert threshold for intraoperative bleeding during D&C.Results:A total of 361 valid questionnaires were collected. Among 361 participants, 73.7% (266/361) held the title of associate chief physician or higher, 61.2% (221/361) had ≥20 years of clinical experience, and 71.8% (178/248) worked in tertiary general hospitals. The most common treatment for type Ⅱ CSP was D&C following pretreatment with medication, uterine artery embolization (UAE), or high intensity focused ultrasound (HIFU), the percentage was 35.73% (129/361). 51.2% (185/361) of participants recommended an alert threshold of 100 ml for intraoperative bleeding during D&C. Cross-analysis revealed that participants managing <30 cases annually preferred ultrasound-guided D&C (32.0%, 56/175), those managing 30-99 cases or 100-199 cases per year favored pretreatment with medication, UAE or HIFU+D&C (39.0%, 55/141; 52.9%, 18/34), those managing ≥200 cases per year preferred hysteroscopic D&C (4/11). The most frequently selected alert threshold was 100 ml. In the subgroup analysis of participants with ≥100 cases annual admissions for CSP, 46.7% (21/45) of participants chose medication, UAE or HIFU pretreatment+D&C, while 53.3% (24/45) supported setting the alert threshold at 100 ml.Conclusions:The preferred treatment for type Ⅱ CSP is D&C following medication, UAE or HIFU pretreatment, with an intraoperative bleeding alert threshold of 100 ml. Timely alerts and proactive interventions could reduce injury severity, improve outcomes, and optimize CSP management strategies.
5.Transcutaneous bilirubin curves in healthy neonates based on multicenter remote monitoring data
Bi ZE ; Xiaoyue DONG ; Jin WANG ; Chuan NIE ; Jiajun ZHU ; Fang GUO ; Falin XU ; Chunhui YANG ; Bizhen SHI ; Zhankui LI ; Xinhua ZHANG ; Jing LI ; Bin YI ; Xiuying TIAN ; Lejia ZHANG ; Jun TANG ; Xinlin HOU ; Jiahua XU ; Guoying HUANG ; Shuping HAN ; Wenhao ZHOU
Chinese Journal of Pediatrics 2025;63(12):1318-1324
Objective:To establish 30-day of age transcutaneous bilirubin (TcB) reference curves for healthy neonates, and to investigate regional variations in bilirubin dynamics.Methods:A multicenter retrospective cohort study was conducted. A total of 220 950 healthy neonates born at a gestational age of 35-<42 weeks, with a birth weight ≥2 000 g, who did not receive phototherapy within 60 h after birth were recruited. All of them underwent remote TcB monitoring using the Bilibaby remote jaundice monitoring system between August 1 st, 2020 and December 31 st, 2024 in 426 hospitals. TcB data were collected within the period from birth to 30-day of age. The P40, P75, and P95 of TcB values were calculated, and dynamic TcB curves for 30-day of age were constructed. Patterns of bilirubin change, rates of change, and transition outcomes were described. Regional comparisons between South and North were conducted using linear mixed-effects models for TcB trajectories and Pearson′s chi-square test for outcome differences. Results:A total of 220 950 neonates were included, of whom 101 711 (46.03%) were female. Gestational age at birth was (38.75±1.12) weeks, and birth weight was (3 272±417) g. TcB levels increased rapidly within 3-day of age, peaked at 4-6-day of age, with peak values at P40, P75, and P95 of 200.6, 239.7 and 275.4 μmol/L (11.8, 14.1 and 16.2 mg/dl), respectively. TcB levels gradually declined thereafter and stabilized after 13-day of age, with values at P40, P75, and P95 fluctuating between 147.9-159.8, 190.4-200.6, and 231.2-239.7 μmol/L (8.7-9.4, 11.2-11.8, 13.6-14.1 mg/dl), respectively. Notably, among neonates categorized as low-or low-intermediate-risk within 3-day of age, 6 700 (12.76%) progressed to intermediate-high or high risk between 4 and 30 days of age. Before 13-day of age, TcB levels in the southern regions were consistently higher than those in the northern regions ( P=0.039); from 14 to 30 days of age, the overall TcB levels had no statistically difference, but the temporal changes in TcB still showed regional differences (degrees of freedom=3, all interaction P<0.05). Among neonates classified as low-or low-intermediate risk within 3-day of age, 25 326 were from southern regions, of whom 4 254 (16.80%) progressed to intermediate-high or high risk between 4 and 30 days of age. In northern regions, 27 193 neonates were classified as low-or low-intermediate risk within 3-day of age, among whom 2 446 (8.99%) progressed to intermediate-high or high risk. The risk progression between the 2 regions had statistically difference ( χ2=716.49, P<0.001). Conclusions:A TcB percentile curve for neonates within 30-day of age was established, revealing that both the overall TcB level and its temporal trend were higher in southern than in northern newborns. These findings provide baseline data to support continuous management of neonatal jaundice.
6.Treatment of extensive wound of Degree IV burns in limbs with free anterolateral thigh perforator flap: a report of 9 cases
Pancheng SHI ; Shuping ZHOU ; Shimin LI ; Liwu ZHENG ; Junjie CHEN ; Xinfeng XING ; Sen LI ; Huanpeng WANG ; Chaonan CHANG ; Dong ZHANG
Chinese Journal of Microsurgery 2025;48(5):511-516
Objective:To explore the clinical efficacy of anterolateral thigh perforator flap (ALTPF) in treatment of extensive wound of Degree IV burns in limbs.Methods:A retrospective analysis was conducted on 9 patients who had extensive wound of Degree IV burns in limbs caused by stove burns admitted to Department of Burns and Plastic Surgery, the 988th Hospital of the Joint Logistics Support Force of the Chinese PLA between January 2017 and January 2024. Among the patients, there were 8 males and 1 female, aged between 36 and 63 years. Three patients had the wound from anterior leg to dorsal foot, 3 from leg down to ankle, 1 from forearm to hand and 2 from arm to forearm. Area of burns ranged from 20 cm × 15 cm to 30 cm × 25 cm, and all patients were treated by free ALTPF. According to whether the main artery at the recipient site was feasible for direct anastomosis with the vessels carried in flap, 4 patients were treated by bilateral parallel ALTPFs, and 5 were treated by unilateral ultra-long internally supercharged ALTPF. A total of 13 ALTPFs were harvested, with individual flap size at 20 cm × 8 cm to 46 cm × 12 cm. Donor sites were directly sutured. Time for flap harvesting, flap survival and wound healing time were records. Scheduled postoperative follow-up was conducted at outpatient clinic and via telephone interviews to evaluate functional recovery. Follow-up assessments included evaluation of flap condition, two-point discrimination (TPD), recovery of joint function at recipient sites, flap appearance and donor site recovery.Results:The time for flap harvest was 1.0 to 4.5 hours. All 13 ALTPFs successfully survived. The time from surgery to healing of recipient sites was 18 to 72 days, and all donor sites healed. Over the postoperative follow-up that lasted for 6 to 34 months, the recipient sites had found with good cosmetic outcomes, without osteomyelitis or deep tissue infection. Four ALTPFs in 2 patients were found swelling, which were revised at 6 months after surgery. Four ALTPFs in other 2 patients had pigment deposition at edges. One ALTPF was scalded, which healed after dressing changes but left with patchy scars. The remaining ALTPFs were soft, elastic, free from pain and well-perfused, with regained protective sensation at S 3. However, all of the ALTPFs failed to detect TPD. Six patients with lower limb injuries were evaluated using the American Orthopedic Foot and Ankle Society (AOFAS) ankle hindfoot scoring system: 2 patients were rated as excellent and 4 were rated as good. Three patients with upper limb injuries were evaluated using Evaluation Trial Standards of Upper Limb Partial Functional of Hand Surgery of Chinese Medical Association: 1 patient was rated as excellent and 2 were rated as good. Only linear scars left at the 13 donor sites, with normal blood supply to the distal limbs, and without restrictions in range of motion of knee joints nor muscle strength of quadriceps. Conclusion:The ALTPF offers advantages such as anatomical consistency, reliable blood supply and flexible combination in treatment of extensive wound of Degree Ⅳ burns in limbs. It is an ideal surgical procedure for treatment of large soft tissue defects of extremities.
7.Clinical efficacy of the first dorsal metatarsal artery pedicled lateral toe bilobed flap in repairing the finger pulp defects of two adjacent fingers
Shimin LI ; Shuping ZHOU ; Junjie CHEN ; Sen LI ; Yingguang SHI ; Liwu ZHENG ; Chaonan CHANG ; Huanpeng WANG ; Ke SUN ; Daqing YIN
Chinese Journal of Burns 2025;41(1):70-76
Objective:To explore the clinical efficacy of the first dorsal metatarsal artery pedicled lateral toe bilobed flap in repairing the finger pulp defects of two adjacent fingers.Methods:This study was a retrospective observational study. From January 2018 to December 2022, 9 patients with finger pulp defects in two adjacent fingers who met the inclusion criteria were admitted to the Department of Burns and Plastic Surgery of the 988 th Hospital of Joint Logistics Support Force of PLA, including 6 males and 3 females, aged 26 to 48 years. The injured fingers were the index finger and middle finger (5 cases) or the middle finger and ring finger (4 cases). After debridement, the wound area of a single finger ranged from 1.2 cm×0.8 cm to 3.2 cm×2.8 cm. The finger pulp defects of two adjacent fingers were repaired with the first dorsal metatarsal artery pedicled lateral toe bilobed flap, and the two adjacent fingers were sutured together. The area of single flap ranged from 1.5 cm×1.0 cm to 3.5 cm×3.0 cm. The wound in the flap donor site was sutured directly or repaired with full-thickness skin graft from the groin region. The finger separation surgery was performed 3 weeks after surgery. The survival and blood supply of flaps, and survival of skin grafts and wound healing of the donor sites were observed after surgery. During follow-up, the texture, sliding, and shape of the flap, movement function of the finger, and the shape and function of the foot donor site were observed. At the last follow-up, the sensory of the flap was evaluated according to the sensory evaluation standard of the British Medical Research Council, and the hand function was evaluated according to the functional evaluation trial standard for severed finger replantation of the Hand Surgery Society of the Chinese Medical Association. Results:After surgery, all the flaps of 9 patients survived without vascular crisis. The flaps were soft in texture and good in shape. One patient had partial necrosis at the edge of the skin graft in the toe, and the wound healed after dressing change; the skin grafts in the toe in the other 8 patients survived, and the wounds healed well. During follow-up of 12 to 18 months after surgery, the flaps had soft texture, good elasticity, low sliding, and good shape. The finger movement function was normal. The wound in foot donor site recovered well without ulceration and deformity, and walking was not affected. At the last follow-up, the sensation of the flaps was sensitive, of which 8 flaps reached S3 and 10 flaps reached S3 + in sensation, and the two-point discrimination distance of the flaps was 9-13 mm. The functional scores of the affected fingers were 85 to 95, all of which were excellent. Conclusions:The first dorsal metatarsal artery pedicled lateral toe bilobed flap can repair finger pulp defects of two adjacent fingers at the same time, and the appearance, sensation, and function of the affected fingers recovered well after surgery, with less damage to the foot donor site. It is one of good methods to repair finger pulp defects of two adjacent fingers in clinic.
8.Visual analysis of non-pharmacological interventions for geriatric depression based on CiteSpace
Li PANG ; Xiumei HOU ; Shuping SI ; Lan WANG ; Zhijiao ZHAO ; Zhongli SHI
Chinese Journal of Modern Nursing 2025;31(21):2829-2836
Objective:To analyze the research hotspots and trends of non-pharmacological interventions for geriatric depression, to provide a reference for conducting relevant research in China.Methods:Literature on non-pharmacological interventions for geriatric depression was electronically searched in the China National Knowledge Infrastructure and Web of Science Core Collection databases. The search period was from database establishment to June 1, 2024. The authors, institutions, countries, and keywords of the published articles were visually analyzed based on CiteSpace 6.2.R7.Results:A total of 238 articles in Chinese and 342 articles in English were included. There was an overall fluctuating upward trend in the number of publications on non-pharmacological interventions for geriatric depression. Repetitive transcranial magnetic stimulation, electroconvulsive therapy, acupuncture therapy and psychotherapy, music therapy, and exercise therapy were the research hotspots. Repetitive transcranial magnetic stimulation and music therapy for the improvement of cognitive function and neurotransmitters in patients, and Meta-analysis and systematic review of related studies were the research trends.Conclusions:Non-pharmacological interventions for geriatric depression have attracted the attention of scholars at home and abroad. High-quality studies should be conducted in China to strengthen the cooperation among institutions and authors, and to explore non-pharmacological intervention programs suitable for our geriatric depression population.
9.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
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.
10.Cross-sectional investigation and analysis of the early warning threshold for intraoperative bleeding intervention during dilation and curettage in type Ⅱ cesarean scar pregnancy
Changmei SANG ; Qiuling SHI ; Yanjun KANG ; Zhibiao WANG ; Shuping ZHAO
Chinese Journal of Obstetrics and Gynecology 2025;60(10):782-787
Objective:To investigate nationwidely the alert threshold for intraoperative bleeding intervention during dilation and curettage (D&C) for type Ⅱ cesarean scar pregnancy (CSP) in the first trimester.Methods:A retrospective cross-sectional survey was conducted. From March 11 to April 14, 2022, obstetricians and gynecologists affiliated with professional associations or institutions of Family Planning Subgroup, Chinese Society of Obstetrics and Gynecology, Chinese Medical Associaton were surveyed using “Expert Consultation Questionnaire on Alert Threshold for Intraoperative Blood Loss in CSP”. The questionnaire was distributed via WeChat using the Questionnaire Star platform. Observation indicators included professional expertise of participants, preferred treatment modalities for type Ⅱ CSP, and an alert threshold for intraoperative bleeding during D&C.Results:A total of 361 valid questionnaires were collected. Among 361 participants, 73.7% (266/361) held the title of associate chief physician or higher, 61.2% (221/361) had ≥20 years of clinical experience, and 71.8% (178/248) worked in tertiary general hospitals. The most common treatment for type Ⅱ CSP was D&C following pretreatment with medication, uterine artery embolization (UAE), or high intensity focused ultrasound (HIFU), the percentage was 35.73% (129/361). 51.2% (185/361) of participants recommended an alert threshold of 100 ml for intraoperative bleeding during D&C. Cross-analysis revealed that participants managing <30 cases annually preferred ultrasound-guided D&C (32.0%, 56/175), those managing 30-99 cases or 100-199 cases per year favored pretreatment with medication, UAE or HIFU+D&C (39.0%, 55/141; 52.9%, 18/34), those managing ≥200 cases per year preferred hysteroscopic D&C (4/11). The most frequently selected alert threshold was 100 ml. In the subgroup analysis of participants with ≥100 cases annual admissions for CSP, 46.7% (21/45) of participants chose medication, UAE or HIFU pretreatment+D&C, while 53.3% (24/45) supported setting the alert threshold at 100 ml.Conclusions:The preferred treatment for type Ⅱ CSP is D&C following medication, UAE or HIFU pretreatment, with an intraoperative bleeding alert threshold of 100 ml. Timely alerts and proactive interventions could reduce injury severity, improve outcomes, and optimize CSP management strategies.

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