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Objective:To evaluate clinical efficacy and safety of topical compound oleum lithospermi in the treatment of mild to moderate diaper dermatitis.Methods:A multicenter, randomized, positive-drug parallel-controlled clinical trial was conducted in 19 hospitals from July 2019 to August 2020. Children aged 0 - 12 months with mild to moderate diaper dermatitis were enrolled and randomly divided into 2 groups using a random number table: test group topically treated with compound oleum lithospermi, and control group topically treated with zinc oxide cream. The treatment was carried out 6 - 8 times a day for 7 days. Visits were scheduled on days 0 and 7, and total response rate and clinical healing time were evaluated. Changes in the dermatitis family impact (DFI) score were compared between the test group and control group, and adverse events were recorded. Statistical analysis was carried out by using independent-sample t test for normally distributed continuous data, Wilcoxon rank sum test for non-normally distributed continuous data, and chi-square test or Fisher′s exact test for unordered categorical data; survival curves were drawn, and log-rank test was used for comparisons between two groups. Results:A total of 343 children with diaper dermatitis were enrolled in this study. Among them, 31 children violated the protocol, so 312 were included in the per protocol set, including 157 in the test group and 155 in the control group, and all completed the visits on days 0 and 7. The total response rate was significantly higher in the test group (87.26%, 137/157) than in the control group (78.71%, 122/155; χ2 = 4.04, P = 0.044) . The clinical healing time was significantly shorter in the test group (5.33 days) than in the control group (6.13 days; χ2 = 4.67, P = 0.025) . After 7-day treatment, the DFI score significantly decreased in both the 2 groups compared with that before the treatment, but there was no significant difference in the DFI score between the 2 groups (test group: 4.02 ± 6.96, control group: 3.58 ± 5.90, Z = -0.39, P = 0.686) . The incidence of adverse events was 2.92% (5/171) and 5.45% (9/165) in the test group and control group respectively, and there was no significant difference between the 2 groups ( χ2 = 0.03, P = 0.865) . Conclusion:Compound oleum lithospermi can markedly reduce the clinical severity of diaper dermatitis, improve the total response rate, shorten the clinical treatment period, and improve the quality of life of children′s families with a favorable safety profile.
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The epidemiology, clinical manifestations and appropriate diagnostic methods of drug eruption in children are still poorly understood.On the one hand, children′s adverse reactions to drugs are different from adults because of their weight and age characteristics.On the other hand, they can mimic many other skin diseases, especially viral exanthems, frequently appearing as a maculopapular or morbilliform rash sometimes indistinguishable from a cutaneous adverse drug reaction.Meanwhile, the tools used for drug eruption management in adults are applied also for children.Whereas this appears generally acceptable, some aspects of drug eruption and management differ with age.The pathogenesis of drug eruption in children is related to virus infection, immune state, drug and metabolic enzyme effect.Most reactions in children are still attributed to betalactams.The practicability and validity of skin test and other diagnostic procedures need further assessment in children.The key to treatment is early diagnosis, discontinuation of suspect drugs, assessment of prognosis, and specialist support.
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Objective@#To investigate whether topical mucopolysaccharide polysulfate (MPS) cream can reduce the incidence of eczema and skin atrophy in patients with moderate- or low-risk infantile hemangioma after the treatment with topical beta-blockers or 595-nm pulsed dye laser (PDL) , and to analyze factors influencing the occurrence of eczema and skin atrophy.@*Methods@#A total of 722 patients aged 0- 1 years with moderate- or low-risk infantile hemangioma were enrolled from 5 Children′s Hospitals in China. According to the disease condition and therapy acceptability, these patients were divided into 6 groups to be treated with topical beta-blockers and MPS cream (blocker+ MPS group) , topical beta-blockers (blocker group) , 595-nm PDL and topical MPS cream (PDL+ MPS group) , 595-nm PDL (PDL group) , 595-nm PDL combined with topical beta-blockers and MPS cream (PDL+ blocker+ MPS group) , and 595-nm PDL and topical beta-blockers (PDL+ blocker group) , respectively. All the externally applied agents were applied twice a day, and PDL was performed once every 4 weeks. Efficacy and adverse reactions were evaluated after 3-month treatment. Univariate and multivariate Logistic regression analyses were carried out to analyze factors influencing the incidence of eczema and skin atrophy in patients with infantile hemangioma after treatment, and chi-square test was carried out to compare efficacy among the groups.@*Results@#After 3-month treatment, multivariate Logistic regression analysis for comparing the blocker+ MPS group with blocker group showed that the risk factor for eczema on the surface of hemangiomas was no topical treatment with MPS cream (P= 0.007, OR= 3.887, 95% CI: 1.439-10.493) , while no correlations were observed between the occurrence of skin atrophy on the surface of hemangiomas and analyzed factors. Multivariate Logistic regression analysis for comparing the PDL+MPS group with PDL group showed that no topical treatment with MPS cream (P < 0.001, OR= 7.402, 95% CI: 2.604-21.042) and northern areas (P < 0.001, OR= 67.048, 95% CI: 7.977-563.518) were risk factors for eczema on the surface of hemangiomas, and risk factors for skin atrophy on the surface of hemangiomas included no topical treatment with MPS cream (P = 0.001, OR = 9.371, 95 CI: 2.590 - 33.900) and abundant blood supply of hemangiomas (P = 0.036, OR = 2.971, 95% CI: 1.075-8.208) . Multivariate Logistic regression analysis for comparing the PDL + blocker+ MPS group with PDL+ blocker group showed that risk factors for eczema on the surface of hemangiomas were no topical treatment with MPS cream (P= 0.005, OR= 3.426, 95% CI: 1.446-8.119) and northern areas (P < 0.001, OR= 31.704, 95% CI: 6.924-145.158) , and risk factors for skin atrophy on the surface of hemangiomas included no topical treatment with MPS cream (P < 0.001, OR= 6.011, 95% CI: 2.558-14.126) and southern areas (P= 0.022, OR= 3.021, 95% CI: 1.177-7.753) . After 3-month treatment, the response rate was significantly higher in the PDL group than in the PDL+ MPS group (χ2= 4.531, P= 0.033) , and significantly higher in the blocker group than in the blocker+ MPS group (χ2= 4.344, P= 0.037) . There were no significant differences in the response rate or cure rate among the other groups (all P > 0.05) .@*Conclusion@#During the treatment of moderate- or low-risk infantile hemangioma with topical beta-blockers or 595-nm PDL, the combination with topical MPS cream can reduce the occurrence of eczema and skin atrophy without affecting the therapeutic effect.
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Objective To investigate whether topical mucopolysaccharide polysulfate (MPS)cream can reduce the incidence of eczema and skin atrophy in patients with moderate-or low-risk infantile hemangioma after the treatment with topical beta-blockers or 595-nm pulsed dye laser(PDL), and to analyze factors influencing the occurrence of eczema and skin atrophy. Methods A total of 722 patients aged 0-1 years with moderate-or low-risk infantile hemangioma were enrolled from 5 Children' s Hospitals in China. According to the disease condition and therapy acceptability, these patients were divided into 6 groups to be treated with topical beta-blockers and MPS cream(blocker+MPS group), topical beta-blockers(blocker group), 595-nm PDL and topical MPS cream(PDL+MPS group), 595-nm PDL(PDL group), 595-nm PDL combined with topical beta-blockers and MPS cream(PDL+blocker+MPS group), and 595-nm PDL and topical beta-blockers(PDL+blocker group), respectively. All the externally applied agents were applied twice a day, and PDL was performed once every 4 weeks. Efficacy and adverse reactions were evaluated after 3-month treatment. Univariate and multivariate Logistic regression analyses were carried out to analyze factors influencing the incidence of eczema and skin atrophy in patients with infantile hemangioma after treatment, and chi-square test was carried out to compare efficacy among the groups. Results After 3-month treatment, multivariate Logistic regression analysis for comparing the blocker + MPS group with blocker group showed that the risk factor for eczema on the surface of hemangiomas was no topical treatment with MPS cream(P = 0.007, OR = 3.887, 95％ CI: 1.439- 10.493), while no correlations were observed between the occurrence of skin atrophy on the surface of hemangiomas and analyzed factors. Multivariate Logistic regression analysis for comparing the PDL + MPS group with PDL group showed that no topical treatment with MPS cream(P < 0.001, OR = 7.402, 95％ CI: 2.604- 21.042)and northern areas(P <0.001, OR=67.048, 95％CI:7.977-563.518)were risk factors for eczema on the surface of hemangiomas, and risk factors for skin atrophy on the surface of hemangiomas included no topical treatment with MPS cream(P=0.001, OR=9.371, 95 CI:2.590-33.900)and abundant blood supply of hemangiomas(P=0.036, OR=2.971, 95％CI:1.075-8.208). Multivariate Logistic regression analysis for comparing the PDL+ blocker + MPS group with PDL + blocker group showed that risk factors for eczema on the surface of hemangiomas were no topical treatment with MPS cream(P=0.005, OR=3.426, 95％CI:1.446-8.119) and northern areas(P<0.001, OR=31.704, 95％CI:6.924-145.158), and risk factors for skin atrophy on the surface of hemangiomas included no topical treatment with MPS cream(P<0.001, OR=6.011, 95％CI:2.558- 14.126) and southern areas (P = 0.022, OR = 3.021, 95％ CI: 1.177- 7.753). After 3-month treatment, the response rate was significantly higher in the PDL group than in the PDL+MPS group(χ2=4.531, P = 0.033), and significantly higher in the blocker group than in the blocker + MPS group (χ2 =4.344, P=0.037). There were no significant differences in the response rate or cure rate among the other groups(all P>0.05). Conclusion During the treatment of moderate-or low-risk infantile hemangioma with topical beta-blockers or 595-nm PDL, the combination with topical MPS cream can reduce the occurrence of eczema and skin atrophy without affecting the therapeutic effect.
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Objective To evaluate the effect of an emollient containing Prinsepia utilis Royle oil extracts and other extracts on clinical symptoms and disease recurrence in children aged 2-12 years with atopic dermatitis (AD) in the remission period.Methods A multicenter,randomized,parallel-group,controlled clinical trial was conducted from December 2017 to September 2018.A total of 297 children aged 2-12 years with moderate AD were enrolled from 5 hospitals in China,and randomly divided into the test group (148 cases) and control group (149 cases).In the acute stage,the two groups were both topically treated with mometasone furoate cream once a day on the skin lesions,and with an emollient containing Prinsepia utilis Royle oil extracts and other extracts twice a day throughout the whole body for 2-4 weeks.The children would be enrolled into the remission stage if their Investigator's Global Assessment (IGA) score was ≤ 1 at following visits.In the remission stage,the test group was only topically treated with the emollient twice a day throughout the whole body,while mometasone furoate cream and the emollient were both withdrawn in the control group.At weeks 4,8 and 12 in the remission stage,the recurrence of AD,eczema area and severity index (EASI),children's dermatology life quality index (CDQOL) and adverse events were evaluated.Statistical analysis was carried out with SAS 9.4 software by using t test for comparison of normally distributed continuous data between two groups,chi-square test for comparison of unordered categorical data,Kaplan-Meier method for analysis of survival rates,Cox regression analysis for evaluating the effect of different therapies on AD recurrence in children in the remission stage,and Logistic regression analysis for analysis of odds ratio (OR) of EASI or CDQOL at week 4 in the remission stage between the test group and control group.Results Of the 297 children with AD,31 breached the clinical trial protocol,and 266 were included in the per protocol set (PPS),including 132 in the test group and 134 in the control group.In the PPS,114 and 106 patients completed the follow-up in the test group and control group respectively,and the recurrence rate was significantly lower in the test group (47,41.23％) than in the control group (84,79.25％;x2 =32.96,P ＜ 0.001).The time to recurrence was significantly longer in the test group(61.99 d ± 2.80 d)than in the control group(39.17 d ± 2.54 d,t =6.03,P ＜ 0.001),and the recurrence risk was significantly lower in the test group than in the control group (Log rank test,x2 =32.02,P ＜ 0.001).After adjustment for age and gender,Cox regression analysis showed that the recurrence risk in the test group was 0.35 times that in the control group (HR =0.35,95％ CI:0.24-0.51,P ＜ 0.01).At week 4 in the remission stage,the EASI score at P50-P75 and P75-P100 in the test group were 0.42,0.25 times that in the control group respectively (95％ CI:0.20-0.86,0.12-0.54 respectively;P =0.02,＜ 0.01respectively).Moreover,the CDQOL score at P75-P100 in the test group was 0.33 times that in the control group (95％ CI:0.17-0.65,P ＜ 0.01).No significant difference in the incidence of adverse events was observed between the two groups (P ＞ 0.05).Conclusion Maintenance treatment with the emollient containing Prinsepia utilis Royle oil extracts and other extracts can markedly reduce the recurrence risk in AD children,improve clinical symptoms,and enhance the quality of life.
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The epidemiology, clinical manifestations and appropriate diagnostic methods of drug eruption in children are still poorly understood. On the one hand,children′s adverse reactions to drugs are dif-ferent from adults because of their weight and age characteristics. On the other hand,they can mimic many other skin diseases,especially viral exanthems,frequently appearing as a maculopapular or morbilliform rash sometimes indistinguishable from a cutaneous adverse drug reaction. Meanwhile,the tools used for drug erup-tion management in adults are applied also for children. Whereas this appears generally acceptable, some aspects of drug eruption and management differ with age. The pathogenesis of drug eruption in children is related to virus infection,immune state,drug and metabolic enzyme effect. Most reactions in children are still attributed to betalactams. The practicability and validity of skin test and other diagnostic procedures need further assessment in children. The key to treatment is early diagnosis, discontinuation of suspect drugs, assessment of prognosis,and specialist support.
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Objective To evaluate the efficacy and safety of desonide 0.05％ cream in the treatment of mild to moderate infantile atopic dermatitis (AD).Methods A multicenter,randomized,openlabeled,active-controlled clinical trial was conducted.A total of 120 infants with AD were enrolled from Department of Dermatology,Beijing Children's Hospital,Capital Medical University,Children's Hospital of Chongqing Medical University and Children's Hospital of Fudan University between December 2016 and November 2017.These patients were randomly divided into 2 groups to be topically treated with desonide 0.05％ cream (test group,n =61) and hydrocortisone butyrate 0.1％ cream (control group,n =59),respectively.After the treatment for 1,2 and 3 weeks,the response rate,improvement of eczema area and severity index (EASI) and infants' dermatitis quality of life (IDQOL) were evaluated,and adverse events and reactions were recorded.Statistical analysis was carried out with SAS 9.4 software using confidence interval method and non-inferiority test for the comparison of response rates between the test group and control group,two-sample t test for the comparison of quantitative data between two groups,paired t test for comparing pre-and post-treatment EASI scores and IDQOL scores.If the data were not normally distributed or there was heterogeneity of variance,Wilcoxon rank sum test was used for the comparisons of pre-and posttreatment EASI scores and IDQOL scores before and after the treatment,and chi-square test was used for the comparison of unordered categorical data between the test group and control group.Results At weeks 1,2and 3 after the initial treatment,analysis of the full analysis set (FAS) showed that 46 (86.79％),49(92.45％) and 51 (96.23％) patients in the test group received improvement respectively,and 36 (83.72％),35 (81.40％) and 41 (95.35％) in the control group received improvement respectively.The non-inferiority test showed that the response rate in the test group was non-inferior to that in the control group (non-inferiority boundary value was-0.15).At the baseline,1,2 and 3 weeks,the EASI scores in the test group were 4.57 ± 3.19,0.72 ± 0.89,0.45 ± 0.87 and 0.18 ± 0.40 respectively,and the EASI scores in control group were 4.50 ± 3.29,1.03 ± 1.81,0.62 ± 0.85 and 0.28 ± 0.82 respectively.Paired Wilcoxon rank sum test showed that the EASI scores in the test group and control group significantly decreased after the treatment for 1,2 and 3 weeks compared with those at the baseline (the test group:T =-715.5,-9.4,-715.5,respectively,all P ＜ 0.001;the control group:T =-437.5,-473.0,-472.0,respectively,all P ＜0.001).However,Wilcoxon rank sum test revealed that there was no significant difference in the EASI scores between the two groups at any of the above time points (P ＞ 0.05).Paired Wilcoxon rank sum test showed that IDQOL scores in the test group significantly decreased at the above time points after the treatment compared with those at the baseline (all P ＜ 0.001),while Wilcoxon rank sum test revealed that there was no significant difference in the IDQOL score between the test group and control group (all P ＞0.05).Adverse reactions were observed in 12 (19.7％) patients in the test group,and 10 (16.9％) in the control group,and there was no significant difference in the adverse reactions between the two groups (x2 =0.029,P ＞ 0.05).Conclusion The efficacy of desonide 0.05％ cream in the treatment of mild to moderate infantile AD is equivalent to that of hydrocortisone butyrate 0.1％ cream,so desonide 0.05％ cream can be a treatment option for mild to moderate infantile AD.
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Objective To evaluate the efficacy and safety of Chushizhiyang ointment for the treatment of mild atopic dermatitis in infants.Methods A multicenter,randomized,open,active-controlled clinical trial was conducted.A total of 204 infants with atopic dermatitis were enrolled and randomly divided into 2 groups to be topically treated with Chushizhiyang ointment (test group,n =103) and hydrocortisone butyrate cream (control group,n =101),respectively,for 2 weeks.The improvement of eczema area and severity index (EASI) scores and quality of life was evaluated at 7 days and 14 days after the treatment,so was the incidence of adverse events and adverse reactions.Results Ninety-eight infants in the test group and 101 in the control group were included in the full analysis set,which revealed that the disease severity significantly decreased after the treatment in both groups.The EASI scores at the baseline and on days 7 and 14 were 2.47 ± 4.04,0.92 ± 1.25 and 0.39 ± 1.04 respectively in the test group,as well as 2.13 ± 2.01,0.85 ± 1.58 and 0.45 ± 1.65 respectively in the control group.Furthermore,the test group and control group both showed that EASI scores on days 7 and 14 significantly decreased compared with those at the baseline (the test group:T =-1 666,-1 793,respectively,both P ＜ 0.001;the control group:T =-1 951,-1 941,respectively,both P ＜ 0.001).No significant differences in EASI scores at the baseline or on days 7 and 14 were observed between the test group and control group (all P ＞ 0.05).The response rates in the test group and control group were 47.96％ (47/98) and 55.44％ (56/101) respectively on day 7,as well as 79.59％ (78/98) and 84.16％ (85/101) respectively on day 14,and there were also no significant differences between the two groups (both P ＞ 0.05).The adverse reactions mainly manifested as erythema,itching and scaling in the test group,as well as hypopigmentation,telangiectasia,scaling and hyperpigmentation in the control group.No significant difference in the incidence of adverse events was found between the test group (2.9％,3/103) and control group (6.9％,7/101).Conclusion Chushizhiyang ointment shows definite efficacy for mild atopic dermatitis in infants with good safety and tolerability,and can be a teatment option for mild atopic dermatitis in infants.
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OBJECTIVE:To explore the characteristics of pathogens distribution of pediatric vulvovaginitis and drug resis-tance,and to provide reference for clinical drug use. METHODS:409 strains of positive routine bacteria and fungus culture were collected from 380 children with vulvovaginitis in 2014. The pathogens culture and drug sensitivity were recorded. RESULTS:The top 5 bacteria were Escherichia coli [36.67%(150/409)],Haemophilus influenzae [20.29%(83/409)],Streptococcus hemolyticus group A [13.20%(54/409)],Klebsiella pneumonia [8.80%(36/409)] and Staphylococcus aureus [5.37%(22/409)]. CONCLU-SIONS:The main pathogenic bacteria of pediatric vulvovaginitis is Gram negative bacilli,so that drug resistance should be paid at-tention to improve therapeutic efficacy when antibiotics are used in the clinic. The result of sensitivity test should be taken as basis for rational application of antibiotics in the treatment.