1.Comparison of efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children: a multicenter, randomized, controlled clinical trial
Xing XIAO ; Shan WANG ; Huan YANG ; Hong SHU ; Yanping GUO ; Jinping CHEN ; Yao LU ; Qinfeng LI ; Yuan LIANG ; Mutong ZHAO ; Xiaoyan LUO ; Limin MIAO ; Rui XU ; Xuemei LI ; Sha LAI ; Jianhong LI ; Zhen LUO ; Lu YU ; Lu XING ; Meitan WANG ; Xiaoli LI ; Haitao XU ; Ping LI ; Hua WANG ; Lin MA
Chinese Journal of Dermatology 2025;58(5):425-430
Objective:To compare the efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged 2 years or older.Methods:A multicenter, randomized, open-label, controlled clinical trial was conducted. A total of 120 pediatric patients aged 2 - 17 years with mild to moderate atopic dermatitis were enrolled from departments of dermatology of 8 hospitals in China between March 2022 and February 2023. The participants were randomly assigned in a 1∶1 ratio to the crisaborole group and the pimecrolimus group, and received the treatment with crisaborole ointment 2% and pimecrolimus cream 1% respectively, twice a day for 4 weeks. Visits were scheduled at baseline/on day 1, as well as on days 8, 15, and 29. The primary efficacy outcome was the percentage of patients achieving the Investigator's Static Global Assessment (ISGA) success (defined as clear [0] or almost clear [1] on the ISGA scale, combined with ≥ 2‐grade improvement from baseline) on day 29. The secondary efficacy outcomes included changes in the Eczema Area and Severity Index (EASI) total scores from baseline to day 29, percentages of patients achieving ISGA improvement (defined as clear [0] or almost clear [1] on the ISGA scale), as well as changes in the Peak Pruritus Numerical Rating Scale (NRS) scores, Dermatology Life Quality Index (DLQI) /Infants' Dermatology Life Quality Index (IDLQI) /Children's Dermatology Life Quality Index (CDLQI) scores, and in the Dermatitis Family Impact (DFI) scores. Drug safety was evaluated according to the incidence of adverse events. Categorical data were compared using the chi-square test. Since measurement data did not follow a normal distribution, the rank sum test was used for comparisons of measurement data between groups.Results:A total of 106 children with mild to moderate atopic dermatitis were included in the per-protocol analysis set, with 52 in the crisaborole group (26 males and 26 females) and 54 in the pimecrolimus group (27 males and 27 females). There were no significant differences in age, disease duration, ISGA and EASI scores at baseline between the two groups (all P > 0.05). On day 29, 22 patients (42.31%) in the crisaborole group and 25 (46.30%) in the pimecrolimus group achieved ISGA success, with no significant difference between the two groups ( χ2 = 0.17, P = 0.68) ; 35 patients (67.31%) in the crisaborole group and 45 (83.33%) in the pimecrolimus group achieved ISGA improvement, also with no significant difference between the two groups ( χ2 = 3.68, P = 0.06) ; additionally, there were no significant differences in the EASI, pruritus NRS, DLQI/IDLQI/CDLQI, or DFI scores between the two groups (all P > 0.05). Adverse reactions to the two topical agents were mainly local reactions such as mild to moderate pain, itching, or worsening of itching, and no obvious systemic adverse reactions occurred. The incidence of drug-related adverse reactions was 46.15% (24 cases) in the crisaborole group and 37.04% (20 cases) in the pimecrolimus group, with no significant difference between the two groups ( χ2 = 0.91, P = 0.34) . Conclusion:The efficacy of crisaborole ointment 2% was comparable to that of pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged ≥ 2 years, and it yielded early and rapid improvement in the quality of life of patients and their families, with good safety and tolerability profiles.
2.Comparison of efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children: a multicenter, randomized, controlled clinical trial
Xing XIAO ; Shan WANG ; Huan YANG ; Hong SHU ; Yanping GUO ; Jinping CHEN ; Yao LU ; Qinfeng LI ; Yuan LIANG ; Mutong ZHAO ; Xiaoyan LUO ; Limin MIAO ; Rui XU ; Xuemei LI ; Sha LAI ; Jianhong LI ; Zhen LUO ; Lu YU ; Lu XING ; Meitan WANG ; Xiaoli LI ; Haitao XU ; Ping LI ; Hua WANG ; Lin MA
Chinese Journal of Dermatology 2025;58(5):425-430
Objective:To compare the efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged 2 years or older.Methods:A multicenter, randomized, open-label, controlled clinical trial was conducted. A total of 120 pediatric patients aged 2 - 17 years with mild to moderate atopic dermatitis were enrolled from departments of dermatology of 8 hospitals in China between March 2022 and February 2023. The participants were randomly assigned in a 1∶1 ratio to the crisaborole group and the pimecrolimus group, and received the treatment with crisaborole ointment 2% and pimecrolimus cream 1% respectively, twice a day for 4 weeks. Visits were scheduled at baseline/on day 1, as well as on days 8, 15, and 29. The primary efficacy outcome was the percentage of patients achieving the Investigator's Static Global Assessment (ISGA) success (defined as clear [0] or almost clear [1] on the ISGA scale, combined with ≥ 2‐grade improvement from baseline) on day 29. The secondary efficacy outcomes included changes in the Eczema Area and Severity Index (EASI) total scores from baseline to day 29, percentages of patients achieving ISGA improvement (defined as clear [0] or almost clear [1] on the ISGA scale), as well as changes in the Peak Pruritus Numerical Rating Scale (NRS) scores, Dermatology Life Quality Index (DLQI) /Infants' Dermatology Life Quality Index (IDLQI) /Children's Dermatology Life Quality Index (CDLQI) scores, and in the Dermatitis Family Impact (DFI) scores. Drug safety was evaluated according to the incidence of adverse events. Categorical data were compared using the chi-square test. Since measurement data did not follow a normal distribution, the rank sum test was used for comparisons of measurement data between groups.Results:A total of 106 children with mild to moderate atopic dermatitis were included in the per-protocol analysis set, with 52 in the crisaborole group (26 males and 26 females) and 54 in the pimecrolimus group (27 males and 27 females). There were no significant differences in age, disease duration, ISGA and EASI scores at baseline between the two groups (all P > 0.05). On day 29, 22 patients (42.31%) in the crisaborole group and 25 (46.30%) in the pimecrolimus group achieved ISGA success, with no significant difference between the two groups ( χ2 = 0.17, P = 0.68) ; 35 patients (67.31%) in the crisaborole group and 45 (83.33%) in the pimecrolimus group achieved ISGA improvement, also with no significant difference between the two groups ( χ2 = 3.68, P = 0.06) ; additionally, there were no significant differences in the EASI, pruritus NRS, DLQI/IDLQI/CDLQI, or DFI scores between the two groups (all P > 0.05). Adverse reactions to the two topical agents were mainly local reactions such as mild to moderate pain, itching, or worsening of itching, and no obvious systemic adverse reactions occurred. The incidence of drug-related adverse reactions was 46.15% (24 cases) in the crisaborole group and 37.04% (20 cases) in the pimecrolimus group, with no significant difference between the two groups ( χ2 = 0.91, P = 0.34) . Conclusion:The efficacy of crisaborole ointment 2% was comparable to that of pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged ≥ 2 years, and it yielded early and rapid improvement in the quality of life of patients and their families, with good safety and tolerability profiles.
3.Risk factors of delirium after total knee arthroplasty in elderly patients and establishment of nomogram prediction model
Ying LIN ; Qi LIAO ; Laixiu YAN ; Jianhong LAI
Chinese Journal of Tissue Engineering Research 2024;33(33):5340-5345
BACKGROUND:Postoperative delirium is one of the serious complications after total knee arthroplasty,usually occurring 1-5 days after surgery,with confusion and cognitive impairment as the main manifestations,which is not conducive to the recovery of joint function in elderly patients.At present,the risk factors affecting delirium after total knee arthroplasty in the elderly are not clear,and there is a lack of clinical prediction studies to directly present them for promotion and application. OBJECTIVE:To explore the risk factors of delirium after total knee arthroplasty in elderly patients and establish a prediction model of nomogram. METHODS:Medical record data of 116 elderly patients receiving total knee arthroplasty treated in Ganzhou Hospital of Traditional Chinese Medicine,Jiangxi University of Chinese Medicine from January 2019 to December 2021 were retrospectively analyzed,of which 29 elderly patients with delirium after total knee arthroplasty were selected as the observation group,and the remaining 87 elderly patients without delirium after total knee arthroplasty were selected as the control group.Preoperative general clinical data,laboratory examination results,and surgical data were compared between the two groups.Multivariate Logistic regression analysis was used to analyze risk factors for delirium after total knee arthroplasty in elderly patients.The receiver operating characteristic curve was used to analyze the independent risk factors and obtain the best cut-off value.The nomogram model was constructed by R software. RESULTS AND CONCLUSION:(1)There were significant differences in age,cerebrovascular accident history,preoperative hospital stay,preoperative albumin,hemoglobin,American Society of Anesthesiologists classification,operation time,anesthesia time,and intraoperative blood transfusion volume between the two groups(P<0.05).(2)Multivariate Logistic regression analysis showed that old age,long hospital stay before surgery,high American Society of Anesthesiologists classification grade,and long operation time were risk factors for postoperative delirium in elderly knee arthroplasty patients,while high albumin and high hemoglobin were protective factors for postoperative delirium in elderly knee arthroplasty patients.(3)The areas under the curve of age,preoperative hospital stay,albumin,hemoglobin,American Society of Anesthesiologists classification grade,and operation time were 0.784,0.706,0.853,0.762,0.617,and 0.542,respectively.The optimal cut-off values were 75 years,7 days,40 g/L,125 g/L,3 and 200 minutes,respectively.(4)After internal data for verification,the consistency index was 0.974.The actual curve of the model was in good agreement with the ideal curve.(5)These results indicate that this nomogram model based on old age,long hospital stay,high American Society of Anesthesiologists classification grade,low albumin,low hemoglobin,and long operation time has far-reaching clinical significance for early identification,early warning and diagnosis of delirium risk in elderly patients after total knee arthroplasty.
4.Application of nucleoprotein immature sperm percentage and sperm DNA damage rate detection in in vitro fertilization
Shuyuan LIU ; Jianhong WEI ; Junye HUO ; Yuqi LAI
International Journal of Laboratory Medicine 2017;38(11):1452-1453,1456
Objective To investigate the application value of sperm nucleoprotein immaturity and sperm DNA damage detection in in vitro fertilization(IVF).Methods From Mar.2015 to Feb.2016,routine sperm analysis,sperm nucleoprotein immaturity and sperm DNA damage detection were performed in 102 patients with infertility,and the correlation between these parameters were analyzed.Results Sperm DNA fragmentation rate was negatively correlated with IVF optimal embryos rate and sperm viability(P<0.05),while was not correlated with IVF fertility rate(P>0.05).Sperm nucleoprotein immaturity rate was not correlated with IVF optimal embryos rate and fertility rate(P>0.05),while was negatively correlated with sperm concentration(P<0.05).Conclusion Sperm DNA fragmentation rate could be closely correlated with IVF optimal embryos rate,which might be with prediction value in IVF treatment.
5.Comparison of the clinical efficacy of laparoscopic wedge resection and open wedge resection for the treatment of gastrointestinal stromal tumor
Lingwei JIA ; Senyan LAI ; Jianhong WU
Chinese Journal of Oncology 2016;38(7):543-547
Objective To compare the clinical efficacy of laparoscopic wedge resection and open wedge resection in the treatment of gastrointestinal stromal tumor. Methods Fifty?five patients with gastrointestinal stromal tumor who underwent laparoscopic wedge resection and 61 cases underwent open wedge resection in Tongji Hospital from January 2009 to December 2014 were included into this study. The perioperative, surgical operative and postoperative data of the patients were documented and analyzed. Results The operation time of laparoscopic group was significantly shorter than that of the open group [(108.2±27.2) min versus (139.9±75.3) min, P=0.021], the amount of intraoperative blood loss was overtly reduced in the laparoscopic group [(57.1±48.7) ml versus (100.6±45.8) ml, P=0.011], the time to postoperative exhaust or defecation was (2.2±1.4) d in the laparoscopic group and (3.5±1.8) d in the open group (P=0.028), and the length of hospital stay was (5.7±1.3) d versus (6.9±2.1) d (P=0.044). There were intraoperative complication in one case and postoperative complications in 5 cases, while neither tumor rupture nor obvious perioperative complication was observed in the laparoscopic group. During the period of follow?up ( mean, 15.3 months) , only one case of replase occurred in the laparoscopic group while four cases of relapse were observed in the open group. Conclusions With experienced skills and to strictly comply with the surgical indications, laparoscopic wedge resection is prior to tranditional open wedge resection for the treatment of gastrointestinal stromal tumor. The laparoscopic wedge resection can achieve the standard of R0 resection, keep the resected tumor with an intact capsule, reduce the operating time and operative trauma, promote the postoperative recovery and get a better prognosis. Therefore, it is a feasible, safe, minimally invasive surgical procedure associated with a rapid postoperative recovery.
6.Comparison of the clinical efficacy of laparoscopic wedge resection and open wedge resection for the treatment of gastrointestinal stromal tumor
Lingwei JIA ; Senyan LAI ; Jianhong WU
Chinese Journal of Oncology 2016;38(7):543-547
Objective To compare the clinical efficacy of laparoscopic wedge resection and open wedge resection in the treatment of gastrointestinal stromal tumor. Methods Fifty?five patients with gastrointestinal stromal tumor who underwent laparoscopic wedge resection and 61 cases underwent open wedge resection in Tongji Hospital from January 2009 to December 2014 were included into this study. The perioperative, surgical operative and postoperative data of the patients were documented and analyzed. Results The operation time of laparoscopic group was significantly shorter than that of the open group [(108.2±27.2) min versus (139.9±75.3) min, P=0.021], the amount of intraoperative blood loss was overtly reduced in the laparoscopic group [(57.1±48.7) ml versus (100.6±45.8) ml, P=0.011], the time to postoperative exhaust or defecation was (2.2±1.4) d in the laparoscopic group and (3.5±1.8) d in the open group (P=0.028), and the length of hospital stay was (5.7±1.3) d versus (6.9±2.1) d (P=0.044). There were intraoperative complication in one case and postoperative complications in 5 cases, while neither tumor rupture nor obvious perioperative complication was observed in the laparoscopic group. During the period of follow?up ( mean, 15.3 months) , only one case of replase occurred in the laparoscopic group while four cases of relapse were observed in the open group. Conclusions With experienced skills and to strictly comply with the surgical indications, laparoscopic wedge resection is prior to tranditional open wedge resection for the treatment of gastrointestinal stromal tumor. The laparoscopic wedge resection can achieve the standard of R0 resection, keep the resected tumor with an intact capsule, reduce the operating time and operative trauma, promote the postoperative recovery and get a better prognosis. Therefore, it is a feasible, safe, minimally invasive surgical procedure associated with a rapid postoperative recovery.
7.Correlation of vascular endothelial cell dysfunction to vascular restenosis following coronary artery stent implantation
Jinchuan LAI ; Biao CHENG ; Jie LI ; Hong KONG ; Yan SHU ; Jianhong TAO ; Rongjian JIANG ; Chunmei LI ; Yan DENG
Chinese Journal of Tissue Engineering Research 2008;12(22):4357-4360
BACKGROUND: Dysfunction of endothelial cells is independently associated with coronary atherosclerotic heart disease. Correlation of dysfunction of endothelial cells to restenosis after stent implantation is not yet clearly determined.OBJECTIVE: To evaluate the correlation of vascular endothelial dysfunction to restenosis after stent implantation. DESIGN, TIME AND SETTING: A case control study was performed at the Department of Cardiology and Department of Heart Ultrasound, Sichuan People's Hospital from March 2005 to January 2007.PARTICIPANTS: After review, coronary angiography showed that 11 patients who occurred restenosis at the lesion region after stent implantation were included in a restenosis group, and an additional 15 patients who did not develop in-stent restenosis were included in a control group. Patients in the following conditions were excluded: over 70 years old, histories of long-term smoking, diabetes mellitus, multivessel disease, long coronary lesion and chronic total occlusion, heart failure (Killip's class Ⅲ or above), severe hepatic and/or renal insufficiency.METHODS: High-resolution ultrasound was used to assess the percentage of flow-mediated dilatation of brachial artery. Differences in endothelial function were compared between both groups.MAIN OUTCOME MEASURES: Ultrasound parameter of the brachial artery in both groups; Partial correlation analysis on control variable including sex, age, blood lipid level, diseased region and stent type.RESULTS: No significant difference was found in basic diameter of brachial artery in both groups. During reactive hyperemia, inner diameter and its absolute variation of brachial artery were smaller in the restenosis group than in the control group (P<0.01). The percentage of brachial artery flow-mediated dilatation was lower in the restenosis group compared with the control group (P=0.013). The partial correlation coefficient between the percentage of flow-mediated dilatation of brachial artery and in-stent restenosis was 0.47 (P=0.04).CONCLUSION: The endothelial dysfunction significantly decreases in patients with restenosis compared with controls following stent implantation. There is a correlation between endothelial dysfunction and restenosis.
8.Investigation and Analysis of Hospital Onset of Infection of Fungus in Our Hospital
Lianxi XIU ; Jianhong LIN ; Tenghuo LUO ; Shancheng LAI
China Pharmacy 2001;0(09):-
OBJECTIVE:To prevent and reduce the occurrence of hospital onset of infection of fungus in our hospi-tal.METHODS:The case history of patients with fungus infection in our hospital during the period from October2002to September2004were consulted and analyzed.RESULTS:Of the107patients with fungus infection in our hospital,72%of whom were above the age of60;the predilection sites were respiratory tract which accounted for81.3%,digestive which ac-counted for14.0%and urinary tract which accounted for10.3%;the main pathogenic bacteria were Candida albicans which accounted for92.5%of the total.All of the infected people were found to have used broad-spectrum antibiotics in a large quantity and some had used corticoid drugs.CONCLUSION:Rational drug use of broad-spectrum antibiotics and corticoid is an important means to prevent hospital onset of infection of fungus.

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