羌月乳膏联合丁酸氢化可的松乳膏治疗儿童湿疹疗效观察

我院2007年10月-2008年6月采用羌月乳膏(武汉健民药业集团有限公司)联合丁酸氢化可的松乳膏(商品名:尤卓尔,天津药业)治疗80例儿童湿疹,取得较为满意的疗效,现报告如下.     

青鹏软膏治疗儿童局限性湿疹的多中心随机对照研究

目的 评价青鹏软膏治疗儿童局限性湿疹的有效性和安全性.方法 采用多中心、随机开放、0.03％他克莫司软膏对照的临床研究,受试患儿每日2次外用青鹏软膏或0.03％他克莫司软膏,疗程2周,于治疗前、治疗1、2周随访,进行疗效和安全性评价.结果 共426例患儿纳入疗效分析.治疗1、2周,青鹏组和他克莫司组有效率比较,差异均无统计学意义(1周:78.92％比81.77％,x2=0.545,P=0.460;2周:98.65％比97.54％,x2=0.721,P=0.396);但治疗1、2周时,青鹏组瘙痒评分均显著低于他克莫司组(1周:F=14.001,P=0.000;2周:F=11.252,P=0.001).治疗1周时,青鹏组药物相关性不良反应发生率明显低于他克莫司组(P＜0.05).主要表现为轻度瘙痒、灼热感等局部刺激反应.结论 青鹏软膏治疗儿童局限性湿疹安全、有效,耐受性较好.     

舒肤林乳膏治疗儿童湿疹52例

舒肤林乳膏为湖南迪诺有限公司生产的新型外用制剂，它具有抗炎抗过敏等作用。因此，临床上常将舒肤林乳膏用于治疗湿疹皮炎性皮肤病。在临床治疗过程中，我们发现本药对儿童湿疹疗效尤为显著，现总结如下：     

5%盐酸多塞平乳膏治疗亚急性湿疹的疗效观察

我院采用 5 %盐酸多塞平乳膏先后对2 0 0 1年 1月～ 2 0 0 2年 5月间的亚急性湿疹患者进行了治疗 ,详细观察了治疗效果和不良反应。现报告如下。资料与方法　亚急性湿疹患者 4 0例 ,男 11例 ,女 2 9例。年龄限于 18～ 6 5岁 ,平均年龄 4 5 .5岁。患者近 1周未外用其它治疗药物 ,排除对本成分有过敏史的患者和皮损渗液较多或有化脓感染者。治疗观察方法　外用 5 %盐酸多塞平乳膏 (2 0ｇ 支 ) ,每日 3次 (每次涂药面积不得超过全身皮肤的 10 % ) ,8天为 1疗程。所有患者都要做治疗前、后的血尿常规对比检查。观察涂药后局部皮肤有无刺痛、烧灼…     

羌月乳膏治疗面部脂溢性皮炎的临床观察

目的探讨中药制剂羌月乳膏治疗面部脂溢性皮炎的有效性和安全性。方法将入选的120例面部脂溢性皮炎患者随机分为观察组60例(予羌月乳膏)和对照组60例(予丁苯羟酸软膏),连续局部用药4周。并在治疗结束后随访2周。结果治疗组有效率与对照组差异无统计学意义,在复发率和安全性方面治疗组优于对照组,差异有统计学意义。结论中药制剂羌月乳膏是治疗脂溢性皮炎的安全有效的外用药,而且复发率低,可作为治疗面部脂溢性皮炎的一线用药。     

复方多粘菌素B软膏联合地奈德乳膏治疗亚急性/慢性湿疹的多中心、随机、双盲、平行对照临床研究

目的探讨复方多粘菌素B软膏联合地奈德乳膏治疗亚急性/慢性湿疹的临床疗效和安全性。方法采用多中心、随机、双盲、平行对照临床研究,入选亚急性湿疹患者144例（试验组72例,对照组72例）,慢性湿疹患者144例（试验组72例,对照组72例）。试验组与对照组分别外用复方多粘菌素B软膏和复方多粘菌素B软膏基质,隔3h后两组均使用地奈德乳膏,每日交替使用各2次。记录患者的症状/体征（包括瘙痒程度、炎症程度、糜烂/渗出程度、浸润/肥厚程度及靶皮损面积）和时间指标（瘙痒减轻起效时间、瘙痒减轻缓解时间）。分析两组的疗效,评估安全性。结果试验组和对照组的症状/体征总分在用药7d（亚急性湿疹：试验组6.09±2.78,对照组8.26±3.17;慢性湿疹：试验组6.56±2.68,对照组8.84±2.90）和14 d（亚急性湿疹：试验组3.68±3.18,对照组5.28±4.05;慢性湿疹：试验组4.38±3.27,对照组6.25±3.78）均较基线水平（亚急性湿疹：试验组13.44±1.66,对照组13.60±1.75;慢性湿疹：试验组12.96±1.16,对照组12.64±1.18）有不同程度的下降。试验组亚急性、慢性湿疹患者在用药7、14 d后的症状/体征均较相应的对照组低,差异有统计学意义（均P<0.05）。亚急性湿疹患者中,试验组瘙痒和浸润肥厚评分的下降幅度均显著高于对照组（均P<0.01）;慢性湿疹患者中,试验组瘙痒、浸润肥厚和靶皮损面积评分的下降幅度均显著高于对照组（均P<0.05）。亚急性湿疹患者试验组瘙痒减轻起效时间短于对照组,但瘙痒减轻缓解时间长于对照组（均P<0.05）;慢性湿疹患者试验组瘙痒减轻起效时间短于对照组（P<0.0001）,但瘙痒减轻缓解时间与对照组差异无统计学意义。试验组医生和患者对治疗效果的满意度均高于对照组（均P<0.05）。结论外用复方多粘菌素B软膏可增强外用地奈德乳膏治疗亚急性和慢性湿疹的疗效,且对亚急性湿疹的效果更为显著。复方多粘菌素B软膏还能较好地控制湿疹患者的瘙痒症状和浸润肥厚。     

卤米松乳膏联合夫西地酸乳膏治疗亚急性或慢性湿疹疗效观察

目的观察比较卤米松乳膏联合夫西地酸乳膏与单独使用卤米松乳膏治疗亚急性或慢性湿疹的临床疗效。方法治疗组交替使用卤米松乳膏和夫西地酸乳膏,2次/d,每次用药间隔大于2h;对照组单独使用卤米松乳膏,2次/d。连续用药2周。结果治疗组63例,治愈率50.8%,有效率90.5%;对照组60例,治愈率35.0%,有效率66.6%;两组有效率比较差异有统计学意义(P<0.05)。结论交替使用卤米松乳膏和夫西地酸乳膏治疗亚急性或慢性湿疹效果较好,无明显不良反应。     

湿疹喷雾剂联合湿疹纳米乳膏治疗慢性局限性湿疹的临床观察

目的 探讨湿疹喷雾剂联合湿疹纳米乳膏治疗慢性局限性湿疹的临床疗效.方法将82例患者随机分为两组,治疗组41例给予湿疹喷雾剂联合湿疹纳米乳膏治疗,对照组41例予卤米松软膏治疗,观察比较两组治疗第1、2、3周后的疗效.结果两组在治疗第1、2周后疗效比较,差异无显著性(P＞o.05);治疗第3周后治疗组有效率为85.37％,对照组有效率为70.73％,差异有统计学意义(P＜0.05).结论湿疹喷雾剂联合湿疹纳米乳膏治疗慢性局限性湿疹疗效确切,值得临床应用.     

多磺酸粘多糖乳膏联合曲咪新乳膏外用治疗婴儿湿疹220例

湿疹是由多种内外因素引起的一种具有明显渗出倾向的皮肤炎症反应.现就多磺酸粘多糖乳膏联合曲咪新乳膏治疗婴儿湿疹的疗效做一总结. 1 资料与方法 1.1 一般资料从2010年7月以来我皮肤科医治的婴儿湿疹患者220例,其中男106例,女114例,平均年龄6.4个月(20d～1.5岁).平均病程50d.主要以亚急性干性皮损为主,主要表现为红斑、丘疹、表面干燥、附糠状鳞屑,无明显渗出,未合并细菌或真菌感染、无出血倾向、无系统性疾病,多对称分布于面部,少数可见于躯干部位.     

肝素钠乳膏联合卤米松乳膏治疗慢性湿疹疗效观察

目的评价肝素钠乳膏联合卤米松乳膏治疗慢性湿疹的临床疗效。方法治疗组每日外用肝素钠乳膏和卤米松乳膏各一次,对照组单纯外用卤米松乳膏1次/d,均治疗2周后判定疗效。结果治疗组有效率为77.78%,对照组为48.62%,两组有效率差异有显著性差异(P<0.05)。结论肝素钠乳膏联合卤米松乳膏治疗慢性湿疹疗效较单用卤米松乳膏好。     

二丙酸倍他米松乳膏治疗湿疹和神经性皮炎的多中心、随机双盲对照研究

0.05%二丙酸倍他米松乳膏是一种超强效外用糖皮质激素类药物,可用于多种皮肤病的治疗。临床剂量下本品为一种安全的药物,患者耐受性好［１］。本研究旨在观察0.05%二丙酸倍他米松乳膏（重庆华邦制药有限公司）外用治疗亚急性或慢性湿疹和神经性皮炎的临床疗效和安全性,以0.05%醋酸氟轻松软膏（天津药业集团）作为阳性对照,进行多中心、随机、双盲、对照临床试验……     

Efficacy and tolerability of pale sulfonated shale oil cream 4% in the treatment of mild to moderate atopic eczema in children: a multicentre,randomized vehicle‐controlled trial

Background Reports on controlled trials on the efficacy and tolerability of sulfonated shale oils in atopic eczema are not available so far. The aim of this study was to investigate whether topically applied, specially prepared pale sulfonated shale oil (PSSO) cream is capable of improving symptoms/signs of mild to moderate atopic eczema in children more efficaciously than a corresponding vehicle cream. Patients and methods A total of 99 children suffering from mild to moderate atopic eczema were enrolled in this multicentre, randomized, vehicle‐controlled study. Verum or vehicle cream was applied to the affected skin area three times a day over 4 weeks. As the primary outcome parameter served the reduction of the total score after 4 weeks of treatment, compared with the initial examination. Secondary outcome parameters were addressed as well. Tolerability was judged by investigators and patients/parents, and adverse events were documented. Results After 4 weeks of treatment, the total score declined from 13.4 ± 3.7 to 4.5 ± 7.4 score points in the verum group and from 13.0 ± 3.1 to 11.7 ± 8.6 score points in the vehicle group (P < 0.0001). The superiority of verum regarding total score was already apparent after a treatment period of 1 week (reduction by 5.6 ± 4.3 vs. 1.3 ± 5.9 score points; P < 0.0001). Tolerability was found superior at the end of the treatment in the verum when compared with the control group – both by investigators (P < 0.0001) and patients/parents (P = 0.0051). Conclusion Pale sulfonated shale oil cream 4% is capable to treat mild to moderate atopic eczema in children more efficaciously than vehicle and is well tolerated. PSSO thus represents a valuable addition to our therapeutic armamentarium. PSSO should be considered in particular when valid alternatives for topical glucocorticoids are sought for.     

A randomized controlled trial in children with eczema: nurse practitioner vs. dermatologist

Background We hypothesized that a nurse practitioner would improve the quality of life of a child with eczema more than a dermatologist because of a structured intervention and more consultation time. Objectives To compare the level of care by nurse practitioners with that by dermatologists in children with eczema. Methods New referrals aged ≤ 16 years with a diagnosis of eczema were recruited. In a randomized, parallel‐group study with a follow‐up period of 1 year, 160 participants were randomized either to conventional care from a dermatologist or to care from a nurse practitioner. The primary outcome measure was change in quality of life at 12 months, as assessed by the Infants’ Dermatitis Quality of Life Index (IDQOL) for children aged ≤ 4 years, and by the illustrated version of the Children’s Dermatology Life Quality Index (CDLQI) for children aged 4–16 years. Secondary outcomes were changes in IDQOL and CDLQI at 4 and 8 months, family impact of childhood atopic dermatitis (Dermatitis Family Impact Questionnaire, DFI), eczema severity (objective SCORAD) and patient satisfaction (Client Satisfaction Questionnaire‐8, CSQ‐8) at 4, 8 and 12 months. Results The mean IDQOL in the dermatologist group improved significantly from 11·6 [SD 8·1; 95% confidence interval (CI) 9·0–14·2] at the baseline to 5·6 (SD 3·9; 95% CI 4·3–7·0) at 12 months with a mean change from the baseline of ?6·5 (SD 6·6; 95% CI ?14·2 to ?8·9; P < 0·001). The mean IDQOL in the nurse practitioner group improved significantly from 10·7 (SD 4·9; 95% CI 9·1–12·3) at baseline to 5·7 (SD 5·4; 95% CI 4·0–7·5) at 12 months with a mean change from the baseline of ?4·9 (SD 5·5; 95% CI ?6·8 to ?3·0; P < 0·001). The between‐groups difference was (?)1·7 (95% CI ?4·6 to 1·2; P = 0·26). The mean CDLQI in the dermatologist group improved significantly from 12·1 (SD 6·3; 95% CI 9·9–14·2) at baseline to 5·6 (SD 4·2; 95% CI 4·2–7·1) at 12 months with a mean change from the baseline of ?5·9 (SD 6·0; 95% CI ?8·0 to ?3·9; P < 0·001). The mean CDLQI in the nurse practitioner group improved significantly from 10·0 (SD 4·4; 95% CI 8·5–11·4) at the baseline to 4·9 (SD 3·5; 95% CI 3·7–6·1) at 12 months with a mean change from the baseline of ?5·2 (SD 4·0; 95% CI ?6·6 to ?3·8; P < 0·001). The between‐groups difference was (?)0·7 (95% CI ?3·3 to 1·7; P = 0·55). The between‐groups comparison was not significant for the IDQOL and the CDLQI at baseline or 4, 8 and 12 months. Both treatment groups showed significant improvement in DFI and objective SCORAD at 12 months. The between‐groups comparison was not significant at baseline or 4, 8 and 12 months. Significantly higher satisfaction levels were observed at 4, 8 and 12 months in the nurse practitioner group. Conclusions The level of care provided by a nurse practitioner in terms of the improvement in the eczema severity and the quality of life outcomes was comparable with that provided by a dermatologist. In addition, the parents were more satisfied with the care that was provided by a nurse practitioner.     

A multicentre randomized controlled trial of ion-exchange water softeners for the treatment of eczema in children: protocol for the Softened Water Eczema Trial (SWET) (ISRCTN: 71423189)

Background  There is epidemiological evidence linking increased water hardness with increased eczema prevalence. A number of plausible mechanisms can be forwarded to suggest why hard water could exacerbate eczema. The most likely explanation is increased soap usage in hard water areas, the deposits of which can cause skin irritation in individuals with eczema.
Objectives  To assess the cost and cost-effectiveness of ion-exchange water softeners for the treatment of eczema in children.
Patients/Methods  Three hundred and ten children aged 6 months to 16 years, with moderate to severe eczema. The children must live in hard water areas (≥ 200 mg L⁻¹ of calcium carbonate) and have a home that is suitable for the installation of a water softener. This is a single-blind, parallel-group, randomized controlled trial of 12 weeks duration followed by a 4-week cross-over period.
Results/Analysis Plan  Primary outcome: difference in the mean change in disease severity (Six Area, Six Sign Atopic Dermatitis score) at 12 weeks compared with baseline. Secondary outcomes: (i) proportion of time spent moving during the night; (ii) self-reported global changes in eczema severity; (iii) amount of topical treatment used; (iv) Patient Oriented Eczema Measure; (v) number of totally controlled and well controlled weeks; (vi) impact on health-related quality of life for the child (EQ-5D) and the family (Dermatitis Family Impact questionnaire); and (vii) cost-effectiveness. It is planned that recruitment will be completed by the end of 2008 and results will be available towards the end of 2009.     

Skin colonization by Staphylococcus aureus in patients with eczema and atopic dermatitis and relevant combined topical therapy: a double-blind multicentre randomized controlled trial

BACKGROUND: Staphylococcus aureus has a peculiar ability to colonize the skin of patients with eczema and atopic dermatitis (AD), and is consistently found in eczematous skin lesions in these patients. A correlation between the severity of the eczema and colonization with S. aureus has been demonstrated, and it has been determined that bacterial colonization is an important factor aggravating skin lesions. Patients colonized with S. aureus have been treated with antibiotics in several open and double-blind placebo-controlled studies, with conflicting results. OBJECTIVES: To investigate the colonizing features of S. aureus in the lesional and nonlesional skin of patients with eczema and AD in China and to compare the therapeutic effect of mupirocin plus hydrocortisone butyrate with vehicle ointment plus hydrocortisone butyrate. METHODS: A multicentre, double-blind randomized trial was conducted. Eczema Area and Severity Index (EASI) scores were evaluated before the start of the trial and on the 7th, 14th and 28th day of treatment. Swabs for bacterial isolation were taken from lesional skin before the start of the trial and on the 7th, 14th and 28th day of treatment, and from nonlesional skin only before the start of the trial. A combination topical therapy with mupirocin plus hydrocortisone butyrate ointment was used in the experimental group, with vehicle ointment plus hydrocortisone butyrate ointment as a control. RESULTS: Of 327 patients enrolled in the study, 208 had eczema and 119 had AD. Bacteria were isolated from 70.2% of lesional and 32.7% of nonlesional skin samples from patients with eczema, of which S. aureus accounted for 47.3% and 27.9%, respectively. Bacteria were isolated from 74.8% of lesional and 34.5% of nonlesional skin samples from patients with AD, of which S. aureus accounted for 79.8% and 80.5%, respectively. The colonization density of S. aureus was markedly higher in lesional than in nonlesional skin, both in patients with eczema and with AD (P < 0.01, P < 0.05), and was positively correlated with lesion severity. Considering the EASI scores before and after treatment and the final effective rate, good therapeutic effects were obtained in both the combination experimental groups and the control groups (P < 0.01), and there were no differences in the global therapeutic effect between the two groups in patients with eczema and with AD (P > 0.05). However, in patients with eczema with a clinical score of > 8 or in patients with AD with a clinical score of > 7, the therapeutic effect in the experimental groups was superior to that in the control groups (P < 0.05) on the 7th day of treatment. There were no differences between the two groups on the 14th and 28th days of treatment (P > 0.05). Following the improvement of symptoms and signs of eczema and AD, the positive rates of bacteria and S. aureus were reduced on the 7th day of treatment. CONCLUSIONS: This study confirmed that lesional skin of patients with eczema and AD was more frequently colonized with S. aureus than was nonlesional skin. The more severe the eczema, the higher the colonization rate of S. aureus, and S. aureus was also more often present in lesional and nonlesional skin in patients with AD than in those with eczema. Staphylococcus aureus infection is related to the pathogenesis of eczema and AD. An antibiotic-corticosteroid combination and corticosteroid alone both gave good therapeutic effect in eczema and in AD, and both reduced colonization by S. aureus. Early combined topical therapy is beneficial to patients with moderate to severe eczema and AD, and it is unnecessary to use antibiotics at later stages of disease or in mild eczema or AD.     

The effectiveness of integrated care for patients with hand eczema: results of a randomized, controlled trial

Objectives. To evaluate the effectiveness of integrated, multidisciplinary care as compared with usual care for patients with moderate to severe, chronic hand eczema after 26 weeks of follow‐up. Background. This study was designed as a randomized, controlled trial. Methods. Patients who visited one of the participating hospitals were randomized to integrated care or usual care. Integrated care was carried out by a multidisciplinary team, and integrated clinical and occupational care to optimize treatment, and the patient's quality of life and social functioning. Outcome variables were clinical assessment of hand eczema with the Hand Eczema Severity Index (HECSI) (primary outcome), quality of life, patient's global assessment of hand eczema, and sick leave. Results. Average improvement on the HECSI was 22.4 points in the intervention group and 11.7 points in the control group. The mean difference in improvement on the HECSI between both groups after 26 weeks was 10.7 points in favour of the integrated care group (standard error 5.3, 95% confidence interval 0.3–21.1, p = 0.044). No differences in improvement between the groups were found for any of the other outcomes. Conclusions. The integrated care programme significantly improved clinical outcome measures as compared with usual care, and was effective for treating patients with chronic hand eczema.     

Efficacy and safety of oral alitretinoin (9-cis retinoic acid) in patients with severe chronic hand eczema refractory to topical corticosteroids: results of a randomized, double-blind, placebo-controlled, multicentre trial

BACKGROUND: Patients with severe chronic hand eczema (CHE) refractory to topical corticosteroids currently have limited treatment options suited for chronic use, and few controlled clinical studies have investigated new therapies in this setting. OBJECTIVES: To assess the efficacy and safety of oral alitretinoin (9-cis retinoic acid) taken at 10 mg or 30 mg once daily for up to 24 weeks, compared with placebo control, in the treatment of severe CHE refractory to topical corticosteroids. METHODS: A randomized, double-blind, placebo-controlled, prospective, multicentre trial was conducted in 111 dermatology outpatient clinics in Europe and Canada. A total of 1032 patients with severe refractory CHE were randomized in a 1 : 2 : 2 ratio to placebo, or 10 mg or 30 mg of oral alitretinoin once daily for up to 24 weeks. Safety was assessed for all patients during a follow-up period of 4 weeks, and responders were observed for relapse for 24 weeks after the end of therapy. The primary efficacy parameter was Physician Global Assessment of overall CHE severity, with response defined as clear or almost clear hands. RESULTS: Responses, defined as clear or almost clear hands, were achieved in up to 48% of patients treated with alitretinoin, compared with 17% for placebo (P < 0.001), with up to 75% median reduction in disease signs and symptoms. Treatment was well tolerated, with dose-dependent adverse effects comprising headache, mucocutaneous events, hyperlipidaemia, and decreased free thyroxine and thyroid-stimulating hormone. The median time to relapse, defined as recurrence of 75% of initial signs and symptoms, was 5.5-6.2 months in the absence of anti-eczema medication. CONCLUSIONS: Alitretinoin given at well-tolerated doses induced clearing of CHE in a substantial proportion of patients with severe disease refractory to standard therapy.     

0.05%卤米松乳膏治疗皮炎湿疹类皮肤病多中心、随机对照、开放研究

目的观察0.05%卤米松乳膏治疗皮炎湿疹类皮肤病的疗效和安全性,并与0.1%糠酸莫米松乳膏进行比较。方法采用多中心、随机、开放试验,对92例亚急性湿疹和神经性皮炎患者外用0.05%卤米松乳膏或0.1%糠酸莫米松乳膏进行治疗,观察记录患者的临床表现和治疗反应。结果0.05%卤米松乳膏临床疗效优于0.1%糠酸莫米松乳膏,有效率分别为91.3%和71.7%(P<0.05),治疗指数分别为86.79%和74.37%(P<0.05)。结论0.05%卤米松乳膏治疗亚急性湿疹和神经性皮炎效果好,不良反应轻。     

醋酸丙酸氢化可的松霜治疗湿疹的疗效观察

目的：比较醋酸丙酸氢化可的松霜(益芙可)和丁酸氢化可的松霜(来可得)治疗湿疹的疗效，并评价醋酸丙酸氢化可的松霜的安全性。方法：采用多中心、随机、研究者单盲、阳性对照、平行组比较方法，将湿疹患者随机分为两组，其中治疗组119例外用醋酸丙酸氢化可的松霜，对照组123例外用丁酸氢化可的松霜.结果：靶皮损总积分，治疗组改善83．1％，对照组改善84．8％。采用协方差分析模型统计学分析，醋酸丙酸氢化可的松霜的疗效与丁酸氢化可的松霜的疗效相当。治疗组有1例发生轻度刺激性皮炎。结论：醋酸丙酸氢化可的松霜治疗湿疹的疗效与丁酸氢化可的松霜相似，是一种安全、有效的外用皮质类固醇药物。