1.Protective effects of a sunscreen lotion containing Calendula extracts on children′s skin after sun exposure: a single-center, randomized, parallel controlled clinical study
Shan WANG ; Lei JIAO ; Ying LIU ; Mutong ZHAO ; Chunping SHEN ; Yuanyuan XIAO ; Li LI ; Yuan LIANG ; Jing TIAN ; Yang WANG ; Lin MA
Chinese Journal of Dermatology 2024;57(6):562-566
Objective:To investigate the protective effects of a sunscreen lotion containing Calendula extracts on children′s skin against sun exposure, as well as to evaluate its safety and tolerability when applied to children.Methods:A single-center, randomized, split-body/face study was conducted on 200 healthy children aged 3 - < 18 years, who were enrolled from Beijing Children′s Hospital, Capital Medical University from July to August 2022. The participants were randomly and equally divided into Group A (the left side of the body/face topically treated with the test sunscreen, and the right side with the control sunscreen) and Group B (the right side of the body/face topically treated with the test sunscreen, and the left side with the control sunscreen) at a ratio of 1∶1. After applying the sunscreen, they were engaged in outdoor activities under sunlight. Skin tests were conducted on the temporal area, the extensor aspect of the upper arm and forearm before and after sun exposure. The test product was a mild sunscreen lotion containing Calendula extracts with the sun protection factor (SPF) being 50+ and the long-wave ultraviolet protection factor (PA) being +++, and the control product was a baby sunscreen containing licorice extracts (SPF35, PA++). Bilateral differential scales were used to assess clinical symptoms after sun exposure, erythema values to clinically evaluate erythema after sun exposure, and the multifunctional skin testing platform MPA10 to measure melanin and erythema values, stratum corneum hydration, and transepidermal water loss (TEWL) at the tested sites. Related adverse events were observed and recorded during the study. The paired t-test or Wilcoxon signed-rank test was used for the comparison of quantitative data, and chi-square test (Fisher′s exact test) for the comparison of count data. Results:Totally, 198 children completed the study and visits, including 100 males (50.5%) and 98 females (49.5%), aged from 3 to 17 years (8.11 ± 0.23 years), and there were 99 cases each in the Group A and Group B. The numbers of participants with more obvious sunburn symptoms after sun exposure in the 3 tested areas were all higher on the control side than on the test side (the temporal area: 11 cases vs. 4 cases; the extensor aspect of the upper arm: 16 cases vs. 2 cases; the extensor aspect of the forearm: 33 cases vs. 3 cases), with significant differences between the bilateral sides (all P<0.001). No significant differences were observed in the erythema values between the test side and control side in the 3 tested areas (all P > 0.05). In the extensor aspect of the upper arm and forearm, the difference in the melanin value before and after sun exposure was significantly smaller on the test side (3.57 ± 2.41, 1.74 ± 1.68, respectively) than on the control side (9.50 ± 2.21, 8.13 ± 1.87, respectively, both P < 0.001) ; in the temporal region and the extensor aspect of the upper arm and forearm, the difference in the stratum corneum hydration level before and after sun exposure was significantly greater on the test side (7.72[-2.19, 19.44], 9.56 ± 1.37, 9.05 ± 1.37, respectively) than on the control side (-3.25[-13.54, 9.94], 3.63 ± 1.32, 3.73 ± 1.31, respectively, all P < 0.001) in the temporal region and the extensor aspect of the upper arm and forearm. However, there were no significant differences in the changes in the erythema or TEWL values before and after sun exposure between the test side and control side in either of the 3 tested areas (all P > 0.05). During this study, 1 case (0.51%) experienced transient urticaria on the control side, and no serious adverse events occurred. Conclusion:The mild sunscreen lotion containing Calendula extracts demonstrated superior efficacy to the control product in improving skin symptoms after sun exposure such as hyperpigmentation among healthy children aged 3 - < 18 years, with good tolerability and a relatively low incidence of adverse reactions.
2.Efficacy of daily use of a test emollient combined with topical glucocorticoids applied at the weekend for delaying the recurrence of atopic dermatitis in children during the maintenance period: a randomized, blank-controlled, multicenter clinical study
Chunping SHEN ; Ping LI ; Xiaoyan LUO ; Yuan LIANG ; Ying LIU ; Mutong ZHAO ; Shan WANG ; Jing TIAN ; Lei JIAO ; Yang WANG ; Zhen LUO ; Shijuan YU ; Xiao FANG ; Hua WANG ; Lin MA
Chinese Journal of Dermatology 2023;56(8):756-762
Objective:To evaluate the efficacy of daily use of a test emollient combined with topical glucocorticoids applied at the weekend for delaying the recurrence of atopic dermatitis (AD) in children during the maintenance period.Methods:A randomized, blank-controlled, multicenter clinical study was conducted in children with moderate AD from Beijing Children′s Hospital, Capital Medical University, Children′s Hospital of Chongqing Medical University and Shenzhen Children′s Hospital from March 2021 to February 2022. A total of 127 children aged 0 - 12 years with moderate AD were treated with topical glucocorticoids combined with emollients during the run-in period, 112 out of them achieved the investigator′s global assessment (IGA) score ≤ 1 point, and then the 112 patients were randomly divided into a test group (56 cases) and a control group (56 cases) at a ratio of 1∶1. Patients in the test group received treatment with a test emollient twice a day in combination with topical glucocorticoids applied at the weekend, and those in the control group were only treated with topical glucocorticoids at the weekend. Patients in the two groups were followed up at baseline, week 2 (± 3 d), week 4 (± 5 d), and week 12 (±7 d), as well as at the time of AD relapse, and the effect of the test emollient on the remission rate of AD in children during the maintenance period was evaluated, so were its effects on the dosage of topical glucocorticoids, pruritus, sleep, and skin pH. The occurrence of treatment-related adverse events was evaluated and recorded at the same time. Study endpoints were defined as AD relapse during the maintenance period, end of 12-week follow-up, or occurrence of serious adverse events. Comparisons of efficacy indicators between groups were conducted by using chi-square test, Kaplan-Meier survival analysis, Satterthwaite t′ test and Mann-Whitney U test. Results:In the full-analysis set, 45 (80.36%) patients with AD maintained remission in the test group (56 cases) and 30 (53.57%) in the control group (56 cases), and the remission rate difference between the two groups was 26.79% (95% confidence interval [ CI]: 10.09%, 43.49%; χ2 = 9.11, P = 0.003) ; the 12-week follow-up during the maintenance period showed that the time to first relapse was 75.05 ± 25.07 days in the test group, which was significantly longer than that in the control group (49.55 ± 33.92 days, t′ = 4.52, P < 0.001). At the study endpoint, the test group showed significantly decreased AD disease severity score (eczema area and severity index [EASI] score: 0.00 [0.00, 1.20] points vs. 0.60 [0.00, 4.00] points), pruritus visual analog scale (VAS) score (0.00 [0.00, 2.00] points vs. 2. 00 [0.00, 10.00] points), and sleep VAS score (0.00 [0.00, 0.00] points vs. 1.00 [0.00, 4.00] points) compared with the control group ( Z = -2.77, 2.43, 3.48, P = 0.006, = 0.015, < 0.001, respectively), while there was no significant difference in the pH value at the lesional sites between the test group and control group ( t = 0.97, P = 0.335). For the group aged 0 - 2 years, the average daily glucocorticoid dosage at the weekend in AD children during the maintenance period was significantly lower in the test group than in the control group ( Z = -1.97, P = 0.049) ; for the group aged >2 - 12 years, there was no significant difference in the average daily glucocorticoid dosage at the weekend between the two groups ( Z = -0.25, P = 0.802). During the study period, no significant difference was observed in the incidence of treatment-related adverse events between the test group (2/56, 3.57%) and control group (3/56, 5.36%; P = 1.000), and no serious adverse events occurred. Conclusion:Compared with the weekend treatment with topical glucocorticoids alone, the daily use of the test emollient combined with topical glucocorticoids at the weekend could markedly improve the remission rate of AD, prolong the time to relapse, and reduce the disease severity at relapse in children with AD during the maintenance period, which provides a new option for maintenance treatment of children with AD.
3.Efficacy of crisaborole ointment in clinical symptom relief in the early stage of childhood atopic dermatitis and in symptom improvement in the remission stage: a multicenter clinical study
Shan WANG ; Xingyu WANG ; Hong SHU ; Bin ZHANG ; Hang SHI ; Huan YANG ; Qiufang QIAN ; Hongyan MA ; Yuan LIANG ; Mutong ZHAO ; Chunping SHEN ; Lei JIAO ; Jing TIAN ; Yang WANG ; Ying GU ; Jing SUN ; Ying LIU ; Ping LI ; Hua WANG ; Lin MA
Chinese Journal of Dermatology 2023;56(9):815-821
Objective:To evaluate the efficacy and tolerability of crisaborole 2% ointment in the treatment of childhood atopic dermatitis (AD) at the early stage, and to compare the efficacy of every-other-day (Qod) regimen versus twice-a-week (Biw) regimen against recurrence in the remission stage of AD.Methods:A multicenter, randomized, open-label clinical trial was conducted. Totally, 150 children with mild to moderate AD aged 2 - < 18 years were enrolled from 6 hospitals (including Beijing Children′s Hospital, Capital Medical University, etc), and randomly divided into the Qod group (76 cases) and the Biw group (74 cases). In the acute stage of AD, both groups were treated with topical crisaborole 2% ointment on skin lesions twice a day for 2 - 4 weeks, as well as with emollients throughout the whole body. The improvement of early clinical symptoms was evaluated, and the occurrence of adverse reactions was recorded in the follow up. Once the investigator′s static global assessment (ISGA) scores decreased to 1 point or less, the patient would be enrolled into the remission stage. In the remission stage of AD, patients in the Qod group and Biw group were treated with crisaborole ointment every other day and twice a week respectively; the recurrence rate of AD in the remission stage was evaluated, as well as the severity of skin lesions, itching, life quality, and the occurrence of adverse reactions at weeks 4, 8, and 12. Statistical analysis was carried out with SPSS 23.0 software by using t test for comparisons of normally distributed continuous data between two groups, Mann-Whitney U test for non-normally distributed data, chi-square test for enumeration data, and Kaplan-Meier method for analysis of survival rates. Results:A total of 142 patients were enrolled in the modified intention-to-treat population, including 71 in the Qod group and 71 in the Biw group. In the acute stage of AD, the improvement of itching and skin lesions self-reported by the children or their family members occurred on days 1.9 (1.0, 3.0) and 2.0 (1.0, 4.1) after the application of crisaborole ointment, respectively. At the end of treatment in the acute stage, 89 children (62.7%) achieved ISGA 0/1 and successfully transferred into the remission stage. The follow-up in the remission stage was completed in 83 patients (44 in the Qod group and 39 in the Biw group). In addition, recurrence occurred in 19 (43.2%) and 12 (30.8%) patients in the Qod group and Biw group respectively, and there was no significant difference in the recurrence rate between the two groups ( χ2 = 1.36, P = 0.243) ; the average time to recurrence was 64.25 (95% CI: 53.33 - 75.17) days and 75.78 (95% CI: 65.46 - 86.10) days in the Qod group and Biw group respectively. Among the patients who were in the remission stage and had not yet experienced relapse at weeks 4, 8, and 12, there were no significant differences in the eczema area and severity index (EASI) scores, ISGA scores, pruritus numerical rating scale (NRS) scores, or quality-of-life scores between the two groups (all P > 0.05) at any time points, except for the ISGA scores at week 12 (Biw group: 0 [0, 1] point vs. Qod group: 1 [0, 1] point; Z = -2.31, P = 0.021). A total of 146 patients were enrolled in the safety set. During the study period, 70 adverse events occurred in 65 patients, with an incidence rate of 44.5%, and all were mild or moderate adverse events; 55 (37.7%) patients experienced discomfort at the medication site, which mainly referred to pain (45 cases, 30.8%) and mostly occurred in the tender and skinfold areas. Conclusions:Crisaborole 2% ointment could effectively relieve clinical symptoms in children with mild to moderate AD in the early stage, and intermittent treatment could continuously relieve clinical symptoms in the remission stage. The common adverse reaction was discomfort at the application site in the early stage of AD. There was no significant difference in the impact on AD recurrence in the remission stage between the Qod regimen and Biw regimen.
4.Comparative Analysis of Trends and Hotspots in Medical Ethics Research at Home and Abroad from 2012 to 2022 and Its Teaching Enlightenment
Yang LI ; Xiaoqin WANG ; Yan HUA ; Yue LIN ; Mei HUANG ; Chunping NI
Chinese Medical Ethics 2023;36(10):1155-1163
【Objective:】 To compare and analyze the trends and hotspots in the field of medical ethics at home and abroad, and explore their teaching enlightenment for medical ethics in China. 【Methods:】 The relevant papers indexed in CNKI and Web of Science database from December 31, 2011 to December 31, 2022 were retrieved with "medical ethics" as the key word. The bibliometric method was used to compare and analyze the research trends, keyword co-occurrence, and changes of research hotspots of medical ethics at home and abroad. 【Results:】 A total of 1,187 Chinese and English papers were included. Medical ethics education and bioethics were the common research topics both domestically and internationally. The research topics in China focused on ethical teaching and the ethical principles in clinical practice, and the research hotspots in the past two years were curriculum ideological and political education, teaching practice, etc. Foreign research focused on ethical issues in clinical practice, and in the past two years, the hotspots were clinical trial ethics, informed consent, and so on. 【Conclusion:】 Medical ethics research at home and abroad has different emphasis, with domestic research being theoretical oriented and foreign research being practical oriented. By deepening the content of courses, improving the sustainable education system, and strengthening interdisciplinary cooperation, the development of ethical education in China can be promoted. This paper can provide reference for improving the education system of medical ethics in China and pointing out the direction of further research on medical ethics.
5.Analysis of risk factors for hypokalemia caused by amphotericin B liposome
Xinyin FU ; Chunping ZHANG ; Xiufen ZHENG ; Xiaoru LIN ; Qibing LIU
China Pharmacy 2023;34(17):2149-2153
OBJECTIVE To investigate the risk factors for hypokalemia caused by amphotericin B liposome, and to provide reference for clinical use of drugs. METHODS A retrospective analysis was used to collect the information of patients who used amphotericin B liposome during the hospitalization in First Affiliated Hospital of Hainan Medical College from January 2012 to December 2021. The details of use information about amphotericin B liposome and the potassium supplementation were collected. The patients were divided into hypokalemia group and normal group according to the occurrence of hypokalemia. Univariate and multi-variate Logistic regression analyses were used to analyze the risk factors for hypokalemia induced by amphotericin B liposome. RESULTS Of the 121 patients included in this analysis, 60 patients were in hypokalemia group, 61 patients were in normal group. The following parameters of the hypokalemic group were significantly higher or longer than those of the normal group, such as the maintenance dose, cumulative dose and maximum daily dose (in patients with severe hypokalemia) of amphotericin B liposome, treatment days, the maintained days of hypokalemia, daily dose of potassium supplement (in patients with moderate or severe hypokalemia), the duration of potassium supplement (in patients with moderate hypokalemia). Results of single factor analysis showed that the cumulative dose of amphotericin B liposome ≥200 mg and the duration of treatment ≥5 days were independent risk factors of hypokalemia caused by this drug (P<0.05). Multi-variate analysis results showed that the presence of basic hypokalemia, body weight <50 kg, cumulative dose of amphotericin B liposome ≥200 mg and the duration of treatment ≥5 days were the independent risk factors for hypokalemia caused by amphotericin B liposome (P<0.05). CONCLUSIONS The incidence of hypokalemia caused by amphotericin B liposome is high, the independent risk factors for hypokalemia include cumulative dose ≥200 mg, treatment days ≥5 days, the presence of basic hypokalemia and body weight < 50 kg. It is suggested that serum potassium should be elevated to normal level before amphotericin B liposome treatment, and the level of serum potassium should be monitored during medication to reduce the occurrence of hypokalemia.
6.Epidemic status and model analysis of cardiovascular and cerebrovascular diseases attributed to renal insufficiency in elderly Chinese
Yuetong LIN ; Yan LIU ; Xiang QU ; Jiachen WANG ; Ruoyu XYU ; Chunping WANG
Journal of Public Health and Preventive Medicine 2023;34(3):12-16
Objective To analyze the changing trend of disease burden attributable to renal insufficiency in cardiovascular disease (CVD) among the elderly in China from 1990 to 2019, and to forecast the disability-adjusted life years (DALY) in the next 10 years, so as to provide a reference basis for accurate prevention and control of CVD attributable to renal insufficiency in China. Methods Data were obtained from the Global Health Data Exchange (GHDx) database to describe the current status of CVD prevalence attributable to renal insufficiency. The joinpoint model was used to estimate the annual percentage change and average annual percentage change to assess the temporal trend of CVD attributable to renal insufficiency in China. An autoregressive moving average model was created by R4.0.2 software to predict the disease burden of CVD attributable to renal insufficiency in China. Results Compared with 1990, CVD mortality and DALY rates attributed to renal insufficiency increased in the male elderly population and decreased in women. Mortality and DALY rates attributed to ischemic heart disease, ischemic stroke, and peripheral arterial disease attributed to renal insufficiency showed an increasing trend, and mortality and DALY rates for cerebral hemorrhage decreased. There was an overall increasing trend in the attribution of CVD due to renal insufficiency. Conclusion The burden of diseases attributable to renal insufficiency in Chinese elderly with CVD is relatively high, and the impact on each disease is different, which requires the attention of relevant authorities.
7.Research progress on nervous system related diseases complicated with pneumonia
Chunping SUN ; Jun LI ; Lianjun LIN ; Xinmin LIU
Chinese Journal of Geriatrics 2023;42(3):282-286
With the rising aging population, the number of people with stroke, dementia and Parkinson's disease is huge.These patients often have swallowing dysfunction, cognitive decline, decreased immune function, long-term bed rest, malnutrition, and sarcopenia, and are prone to pneumonia.However, the clinical manifestations of these patients with pneumonia are non-specific.The patients often cannot accurately express their complaints, resulting in symptoms being ignored.The underlying diseases of the nervous system increase the risk of pneumonia-related death, and is associated with poor prognosis.This article aimed to review the risk factors, prevention and treatment of these three neurological disorders complicated with pneumonia.
8.Research progress on community-acquired pneumonia in elderly immunocompromised patients
Jun LI ; Chunping SUN ; Shanchen WEI ; Lianjun LIN ; Xinmin LIU
Chinese Journal of Geriatrics 2023;42(3):352-356
Community acquired pneumonia(CAP)is characterized by high morbidity and mortality in immunocompromised patients, with the elderly as the main vulnerable population.However, current guidelines in China and elsewhere do not offer specific recommendations on the diagnosis and treatment of such patients.This paper reviews the definition, classification, epidemiology, etiological characteristics, clinical manifestations, diagnosis, treatment and prognosis of CAP in immunocompromised elderly patients, to provide a theoretical framework for its diagnosis and treatment and for the formulation of guidelines.
9.Analysis of short-term efficacy and safety of the first subcutaneous injection of dupilumab in the treatment of moderate-to-severe childhood atopic dermatitis
Jing TIAN ; Yuan LIANG ; Chunping SHEN ; Mutong ZHAO ; Yang WANG ; Shan WANG ; Lei JIAO ; Lin MA
Chinese Journal of Dermatology 2022;55(4):299-303
Objective:To investigate short-term efficacy and safety of subcutaneous injection of dupilumab in the treatment of moderate-to-severe childhood atopic dermatitis (AD) .Methods:A retrospective study was conducted on clinical data from children who were diagnosed with moderate-to-severe AD and subcutaneously injected with dupilumab in Department of Dermatology, Beijing Children′s Hospital, Capital Medical University from March 2021 to August 2021. Changes in the Eczema Area and Severity Index (EASI), itch Numeric Rating Scale (NRS) score, SCORing Atopic Dermatitis (SCORAD) index, and Dermatology Family quality of life Index (DFI) were analyzed before and 4 weeks after the first subcutaneous injection of dupilumab. Adverse events were collected during the first injection to the first follow-up visit at week 4 after the start of treatment. Normally distributed measurement indices were compared by using paired t test, non-normally distributed measurement indices were compared by using signed rank test, and logistic regression analysis was used to evaluate the effects of disease duration, eosinophil counts, IgE levels, personal and family history of allergic diseases on EASI50 (≥ 50% decrease in the EASI score) after dupilumab treatment. Results:A total of 39 children were enrolled in this study, including 21 males and 18 females. Twenty-one patients were aged 2 to < 6 years, 18 were aged 6 to < 18 years, and their median age ( Q1, Q3) was 65.0 (53.0, 111.0) months. Four weeks after the single-dose subcutaneous injection of dupilumab, 18 patients (84.85%) achieved ≥ 50% decrease in EASI score, 13 (60.61%) ≥ 75% decrease in EASI score; 18 (75.76%) experienced a decrease of ≥ 4 points in peak NRS, and 20 (81.82%) ≥ 3 points in peak NRS; the SCORAD score decreased by ≥ 50% in 15 (68.75%) patients, and by ≥ 75% in 7 (18.75%). Neither common adverse events such as conjunctivitis, skin infections, injection site reactions, nor serious adverse events were observed in any of the children from the first injection to the first follow-up visit at week 4. Logistic regression analysis showed no significant effect of the disease duration, eosinophil counts, IgE levels, personal or family history of allergic diseases on EASI50 (all P > 0.05) . Conclusion:A single-dose subcutaneous injection of dupilumab can markedly improve pruritus and severity of skin lesions in children with moderate-to-severe AD, and enhance the family quality of life, with favorable short-term safety.
10.Correlation analysis of survival time in patients with advanced breast cancer and the scores of Care Evaluation Scale in cancer patients
Jiumei LIU ; Yanjie SONG ; Lin SHEN ; Chunping XIAO
Chinese Journal of Modern Nursing 2022;28(28):3924-3929
Objective:To explore the value of Care Evaluation Scale (CES) in cancer patients for predicting survival time in patients with advanced breast cancer.Methods:From November 2018 to June 2020, the convenient sampling was used to select 140 patients with advanced breast cancer who were treated in Qingdao Central Hospital Affiliated to Qingdao University and 140 home caregivers as the research objects. Researchers contacted home caregivers of patients with advanced breast cancer to set up a time and place to conduct one-on-one surveys of research objects using the Cancer Patient CES. Pearson correlation was used to analyze the correlation between survival time and CES score in patients with advanced breast cancer. Multiple stepwise regression analysis was used to analyze the influencing factors of CES scores in patients with advanced breast cancer. A total of 140 questionnaires were distributed, of which 133 were valid, and the effective recovery rate was 95.00% (133/140) .Results:Among the 133 patients with advanced breast cancer, 76 were Luminal A, 19 were Luminal B, 12 were ERBB 2+ and 26 were Basal-like. Luminal type A advanced breast cancer patients had the longest survival time, and the differences were statistically significant compared with those of ERBB 2+ and Basal-like advanced breast cancer patients ( P<0.05) . There was no statistically significant difference in survival time between Luminal B type advanced breast cancer and Luminal A, ERBB 2+ and Basal-like advanced breast cancer patients ( P>0.05) . Luminal type A advanced breast cancer patients had the highest CES score, and the differences were statistically significant compared with those of Luminal type B, ERBB 2+ and Basal-like advanced breast cancer patients ( P<0.05) . There was no statistically significant difference in the CES score between Luminal B advanced breast cancer and Luminal A, ERBB 2+ and Basal-like advanced breast cancer ( P>0.05) . Pearson correlation analysis found that the survival time of patients with advanced breast cancer was positively correlated with the CES score ( r=0.892, P<0.05) . The influencing factors of CES empowerment in patients with advanced breast cancer included physical care provided by doctors, mental health care, environment, explanation or instructions by doctors to family members, collaboration and persistence, consideration for family members, availability, cost, explanation or instructions by doctors to patients and physical care provided by nurses. Conclusions:CES in cancer patients can effectively predict the survival time of patients with advanced breast cancer. The molecular types of patients with advanced breast cancer are different and the effect of predicting survival time is also different.


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