0.03%他克莫司软膏治疗儿童特应性皮炎的疗效观察及生活质量评价

目的:评价0.03%他克莫司软膏治疗儿童特应性皮炎的疗效和安全性。方法:采用随机、双盲、平行对照方法,分别对两组儿童特应性皮炎患者外用0.03%他克莫司软膏和赋形剂,疗程为3周。每周对患儿进行随访观察,并在治疗前、后对5～17岁患者作皮肤病学生活质量指数(DLQI)问卷调查。结果:0.03%他克莫司软膏组和对照组的有效率分别为85.0%和33.3%,两组疗效比较差异有非常显著性(P<0.001)。问卷调查表明患者治疗后生活质量明显改善。结论:0.03%他克莫司软膏治疗儿童特应性皮炎安全、有效,治疗后患者的生活质量明显改善。     

A single‐center open‐label long‐term comparison of tacrolimus ointment and topical corticosteroids for treatment of atopic dermatitis

Background: Atopic dermatitis is a chronic or recurrent inflammatory skin disease that often requires treatment over years. According to its severity, atopic dermatitis is often managed with use of emollients, topical corticosteroids, topical calcineurin inhibitors or systemic agents. This long‐term study compares the efficacy of tacrolimus 0.1% ointment with topical corticosteroids as standard therapy in patients with moderate atopic dermatitis. Patients and methods: 50 patients were enrolled. They were allocated to treatment groups by the investigator (tacrolimus group or standard group), and followed over a period of six to twenty months. Efficacy was evaluated by the Eczema Area Severity Index (EASI), the percentage of affected body surface area, and the score of Rajka and Langeland. In addition, ointment usage was documented and analyzed. Results: The improvement of the skin condition was statistically significant in both groups. The comparison of the two groups, however, did not show a statistically significant advantage of one or the other treatment. Ointment usage was slightly higher in the standard group. Conclusions: The efficacy of tacrolimus 0.1% ointment was confirmed. In terms of emollient usage, no regular pattern could be demonstrated.     

Proactive disease management with 0.03% tacrolimus ointment for children with atopic dermatitis: results of a randomized, multicentre, comparative study

Background Long‐term treatment for atopic dermatitis (AD) using low‐dose, intermittent, topical anti‐inflammatory agents may control acute disease and prevent exacerbations. Objectives This 12‐month, European, multicentre, randomized study investigated if proactive, twice‐weekly application of 0·03% tacrolimus ointment can keep AD in remission and reduce the incidence of disease exacerbation (DE) in children. Patients and methods During the initial open‐label period, 267 children with AD applied 0·03% tacrolimus ointment twice daily for up to 6 weeks to all affected areas. When an Investigator Global Assessment (IGA) score of ≤ 2 was achieved, the patient entered the disease control period (DCP) and was randomized to receive tacrolimus (n = 125) or vehicle ointment (n = 125) twice weekly for 12 months. Exacerbations were treated with 0·03% tacrolimus ointment twice daily until an IGA ≤ 2 was regained, then randomized treatment was restarted. Results The outcome measure was the number of DEs during the DCP that required substantial therapeutic intervention. Proactive application of 0·03% tacrolimus ointment significantly reduced the number of DEs during the DCP that required substantial therapeutic intervention (median difference: 1·0; P < 0·001; Wilcoxon rank‐sum test), the percentage of DE treatment days (median difference: 6·2; P < 0·001; Wilcoxon rank‐sum test), and increased the time to first DE requiring intervention (median: 173 vs. 38 days; P < 0·001; stratified log‐rank test). Differences in quality of life scores were not significant between groups. The adverse event profile was similar for both treatment approaches. Conclusions Twice‐weekly proactive application of 0·03% tacrolimus ointment over 12 months was effective for most paediatric study patients in preventing, delaying and reducing the occurrence of AD exacerbations.     

A 4-year follow-up study of atopic dermatitis therapy with 0.1% tacrolimus ointment in children and adult patients

Background For the treatment of a chronic disease like atopic dermatitis, sustained tolerability and efficacy of the applied medication are essential. Objectives The present open‐label, noncomparative study was conducted to obtain information on the long‐term safety and efficacy of 0·1% tacrolimus ointment. Methods Patients aged 2 years or older with an affected body surface area of more than 5%, who previously participated in a clinical trial on tacrolimus ointment, were eligible for this study. The treatment area was defined by the investigator at study entry. Both children and adults applied continuously or intermittently 0·1% tacrolimus ointment twice daily during episodes of active disease plus an additional week after remission over a follow‐up period of up to 4 years. Results The intent‐to‐treat population comprised 782 patients, with a median age of 22 years (range 2–72). Patients remained in the study for up to 4 years. Approximately half of the patients discontinued the study prematurely; the median follow‐up was 1422 days. Median tacrolimus ointment use was 31·2 g during the first week; ointment use decreased during the first year and then remained stable for the remainder of the study. The median cumulative tacrolimus use was 271·5 g at month 6, 462·5 g at month 12, 739·9 g at month 24, 1029·3 g at month 36 and 1320·8 g at month 48. Altogether 51·8% of patients discontinued the study prematurely; the main reasons were withdrawal of consent (13·3%), loss to follow‐up (11·3%) and lack of efficacy (9·4%). Adverse events led to study discontinuation in 3·7% of the patients. The most frequent application site events were skin burning and pruritus. These events were most often reported in adult patients during the initial treatment period; prevalence decreased after the first week and remained at a low level throughout the study. Nonapplication site events occurred with stable incidences throughout the study period. In general, calculated daily hazard rates did not indicate an increased risk of adverse events with prolonged treatment. The total affected body surface area decreased substantially upon onset of treatment and efficacy of treatment was maintained until the end of the study with smaller but continuous improvements throughout the follow‐up period. Overall, 75% of the patients and 76% of the investigators rated their satisfaction with the treatment as excellent, very good or good at the end of the study or at the time of premature discontinuation. Conclusions The safety profile of intermittent or continuous long‐term application of 0·1% tacrolimus ointment for up to 4 years was consistent with that which has been established from shorter studies and gave no reason for concern. In addition, 0·1% tacrolimus ointment demonstrated sustained efficacy as reflected by the expression of high satisfaction with treatment by both patients and investigators.     

0.03%他克莫司软膏治疗眼睑皮炎临床疗效观察

目的探讨0.03%他克莫司软膏治疗眼睑部皮炎的疗效。方法 26例患者外用0.03%他克莫司软膏,2次/d,共2周。于治疗前及治疗后第3天,第1、2周和停药后1月各随访1次。结果 26例患者治疗后3天、1周、2周及停药1个月后临床痊愈率分别为57.69%,76.94%,92.30%,73.08%。对红斑、瘙痒的控制起效迅速,而脱屑及肥厚改变较缓。4例(15.38%)患者局部有灼热感,均发生在治疗初3天。停药1个月后共有7例(26.92%)患者复发。结论 0.03%他克莫司软膏治疗眼睑部皮炎起效快,疗效明显,长期使用的安全性需大样本观察研究。     

Skin and systemic pharmacokinetics of tacrolimus following topical application of tacrolimus ointment in adults with moderate to severe atopic dermatitis

Background  Systemic exposure to tacrolimus following topical application of tacrolimus ointment is minimal. There are, however, no data on the distribution of tacrolimus in the skin.
Objectives  To assess the distribution of tacrolimus in the skin and the systemic pharmacokinetics of tacrolimus in adults with moderate to severe atopic dermatitis after first and repeated application of tacrolimus ointment.
Methods  We investigated skin distribution of topically applied tacrolimus and systemic pharmacokinetics of percutaneously absorbed tacrolimus in adults with atopic dermatitis after topical application of tacrolimus 0·1% ointment twice daily for 2 weeks. Tacrolimus concentrations were assessed in full-thickness skin biopsies and blood samples.
Results  Of 14 patients, 11 completed treatment and were analysed. Mean ± SD tacrolimus concentrations in the skin at 24 h after first and last ointment applications were 94 ± 20 and 595 ± 98 ng cm⁻³, respectively. At 168 h after stopping treatment, values were 97% lower than at 24 h after last application. Tacrolimus concentration decreased with increasing skin depth. Systemic tacrolimus exposure after ointment application was low and highly variable, with 31% of samples below the limit of quantification (0·025 ng mL⁻¹) and 94% below 1 ng mL⁻¹. Blood concentrations at 24 h after the first and last ointment applications were 750 and 1800 times lower, respectively, than those in skin. Physicians' assessments showed that tacrolimus ointment was effective and well tolerated.
Conclusions  Tacrolimus was primarily partitioned in the skin, with minimal systemic absorption after topical application, in patients with atopic dermatitis.     

Cost-effectiveness of tacrolimus ointment vs. standard treatment in patients with moderate and severe atopic dermatitis: a health-economic model simulation based on a patient survey and clinical trial data

BACKGROUND: Atopic dermatitis (AD) affects health and quality of life (QoL) and also has great impact on both healthcare costs and costs to society. OBJECTIVES: The aim of the study was to analyse the cost-effectiveness of treatment with tacrolimus ointment vs. standard treatment in patients with moderate to severe AD. METHODS: A Markov simulation model was constructed capturing several key features of AD and its treatment: disease severity, treatment alternatives, and QoL. The model was populated with data from three sources: (i) efficacy data from a randomized controlled trial including patients with moderate to severe AD treated with either tacrolimus ointment or standard treatment (corticosteroids), (ii) resource utilization and QoL data from a patient survey including 161 Swedish patients with AD, and (iii) official price lists. Costs were calculated according to disease severity for the two treatment alternatives using the perspective of the Swedish healthcare sector. Two analyses were performed, one based on the quantity of medication used in the trial and one based on the survey data. The relationship between effectiveness of tacrolimus ointment and the amount of medication used was tested in sensitivity analyses. RESULTS: In the model simulations patients with severe AD treated with tacrolimus ointment experienced on average 4.6 more AD-free weeks per year than patients given standard treatment. The corresponding figure for patients with moderate AD was 6.5 more AD-free weeks per year. The cost-effectiveness ratios [cost per Quality Adjusted Life Year (QALY) gained] for treatment with tacrolimus ointment vs. standard treatment were 2,334 British pound for moderate AD and 3,875 British pound for severe AD when treatment patterns from the survey were assumed, and 8,269 British pound for moderate AD and 12,304 British pound for severe AD when treatment patterns from the clinical trial were assumed. The results of sensitivity analyses were all well within limits to be considered cost-effective. CONCLUSIONS: Estimates of the incremental cost-effectiveness ratio are far below the currently discussed threshold in Sweden, corresponding to approximately 48,700 British pound per QALY gained, and equivalent thresholds in other countries. Treatment with tacrolimus ointment in patients with moderate and severe AD can therefore be considered cost-effective.     

0.03% Tacrolimus ointment applied once or twice daily is more efficacious than 1% hydrocortisone acetate in children with moderate to severe atopic dermatitis: results of a randomized double-blind controlled trial

BACKGROUND: Topical corticosteroids are the usual treatment for atopic dermatitis (AD) in children but can have side-effects. OBJECTIVES: This study compared the efficacy and safety of 0.03% tacrolimus ointment applied once or twice daily over a 3-week period with the twice daily application of 1% hydrocortisone acetate (HA) ointment in children with moderate to severe AD. PATIENTS AND METHODS: Patients applied ointment daily to all affected body surface areas. The primary study endpoint was the percentage change in the modified Eczema Area and Severity Index (mEASI) between baseline and treatment end. RESULTS: Six hundred and twenty-four patients, aged 2-15 years, applied 0.03% tacrolimus ointment once daily (n = 207), twice daily (n = 210) or 1% HA twice daily (n = 207). By the end of treatment, application of 0.03% tacrolimus ointment both once or twice daily resulted in significantly greater median percentage decreases in mEASI (66.7% and 76.7%, respectively) compared with 1% HA (47.6%; P < 0.001). Furthermore, the median percentage decrease in mEASI was significantly greater for patients applying 0.03% tacrolimus twice daily compared with once daily (P = 0.007). Patients with severe AD benefited especially from twice daily application of 0.03% tacrolimus ointment compared with once daily application (P = 0.001). Transient mild to moderate skin burning occurred significantly more often in the 0.03% tacrolimus groups (P = 0.028) but resolved in most cases within 3-4 days. Laboratory parameters showed no clinically relevant changes. CONCLUSIONS: 0.03% tacrolimus ointment applied once or twice daily is significantly more efficacious than 1% HA in treating moderate-severe AD in children. Twice daily application of 0.03% tacrolimus ointment results in the greatest improvement in mEASI, and is especially effective in patients with severe baseline disease.     

他克莫司软膏治疗成人特应性皮炎

目的研究他克莫司软膏治疗成人特应性皮炎(AD)的疗效与安全性.方法采用随机、双盲、赋形剂对照临床研究方法,将44例成人AD患者随机分为3组,按111比例分别接受0.1%(0.1%组)、0.03%(0.03%组)他克莫司软膏和赋形剂(赋形剂组)治疗.观察治疗第1、2和3周的临床疗效和不良反应.结果他克莫司软膏0.1%组和0.03%组的有效率分别为86.7%(13/15)和78.6%(11/14),均明显高于赋形剂组(42.9%,6/14),差异非常显著(P＜0.001).总体疗效比较0.1%组优于0.03%组,差异显著(P=0.043).治疗后第1、2、3周0.1%组和0.03%组的主要症状-体征指标平均值均明显低于赋形剂组,组间差异显著(P＜0.05～P＜0.001).治疗后患者的生活质量明显改善.药物相关不良反应主要为一过性局部刺激,但组间比较无统计学意义(P＞0.05),3组均未出现严重不良反应.结论他克莫司软膏治疗成人特应性皮炎安全有效.     

他克莫司软膏治疗特应性皮炎疗效观察及患者生活质量评价

目的:评价0.03%和0.1%他克莫司软膏治疗中国成人和儿童中、重度特应性皮炎(AD)患者后其生活质量的改善情况。方法:采用多中心、双盲、随机、赋形剂平行对照的方法对327例中、重度AD患者给予0.03%和0.1%他克莫司软膏治疗3周,在治疗前、后采用皮肤病学生活质量指数量表对患者进行生活质量评价。结果:3周后成人组总体生活质量评分及症状、日常活动和休闲3个方面评分的改善有统计学差异(P<0.05)。儿童组总体生活质量评分及症状、休闲、学校、假期、日常活动、睡眠和治疗的影响各方面改善均有统计学差异(P<0.05)。幼儿组各方面的改善无统计学差异(P>0.05)。结论:0.03%和0.1%他克莫司软膏治疗中国成人和儿童中、重度AD患者3周后,成人及儿童(>4岁)患者的生活质量均有显著改善。     

他克莫司软膏治疗成人特应性皮炎随机对照试验的Meta分析

目的:评价局部应用他克莫司治疗成人特应性皮炎(AD)的疗效和安全性.方法:计算机检索Ovid:http://gateway.ovid.com/:Cochrane图书馆(2008年第1期)、检索MEDLINE(1966～2007年),Embase数据库(1974～2007年),http://www.cnki.net/index.htm,纳入他克莫司治疗AD的随机对照试验,两名研究者独立进行各临床试验的质量评估.采用Cochrane协作网提供的RevMan 4.2.8进行统计分析.结果:共纳入6个随机对照试验(RCT),包括1 441例临床诊断为中、重度AD患者.Meta分析显示:0.03%、0.1%他克莫司软膏治疗特应性皮炎有较好疗效,0.1%他克莫司软膏疗效优于0.03%者,OR为0.65(0.48, 0.86),0.1%他克莫司软膏疗效与0.1%丁酸氢化可的松相似.主要的不良反应轻微,多为灼热感和瘙痒.结论:局部应用他克莫司治疗成人AD安全有效.     

Superiority of tacrolimus 0·1% ointment compared with fluticasone 0·005% in adults with moderate to severe atopic dermatitis of the face: results from a randomized, double-blind trial

Summary Background No specific data are available on tacrolimus ointment as a second‐line treatment in adults with facial eczema. Objectives To compare tacrolimus 0·1% and fluticasone 0·005% ointments in adults with moderate to severe atopic dermatitis (AD) of the face in whom conventional treatment was ineffective or poorly tolerated. Methods Patients were randomized to double‐blind treatment of facial AD with twice‐daily tacrolimus ointment (n = 288) or fluticasone ointment (n = 280) for 3 weeks or until clearance. After day 21, patients could continue without the study treatment, apply the same ointment once daily, or switch to the other medication twice daily, depending on lesion clearance and patient/physician satisfaction. The primary endpoint was the day‐21 response [≥ 60% reduction in the modified Local Eczema and Severity Index (mLEASI) score]. Secondary endpoints included facial erythema and pruritus, global clinical response, treatment switching at day 21 and safety. Results Response with tacrolimus ointment (93%) was superior to that with fluticasone (88%; P = 0·026). Improvements in mLEASI components were also greater with tacrolimus ointment. Facial erythema and pruritus improved in both groups. Global clinical response was rated ‘marked improvement’ or better in 88% and 79% of patients in the tacrolimus ointment and fluticasone groups, respectively. At day 21, 9% of patients switched from fluticasone to tacrolimus ointment, while 4·5% switched from tacrolimus ointment to fluticasone. Adverse events were more frequent with tacrolimus ointment as a result of the higher incidence of application‐site skin burning sensation. Safety of both drugs was in line with their respective summary of product characteristics. Conclusions Tacrolimus 0·1% ointment has superior efficacy to fluticasone 0·005% ointment for twice‐daily treatment of adults with moderate to severe facial AD in whom conventional therapy was inadequately effective or not tolerated. Tacrolimus 0·1% ointment is a safe and effective second‐line treatment for the control of moderate to severe AD of the face.     

Economic evaluation of maintenance treatment with tacrolimus 0.1% ointment in adults with moderate to severe atopic dermatitis

Background Rational health care decision‐making based on outcomes and economic evidence is essential to provide the best possible care for individual patients with atopic dermatitis (AD). Objectives To describe treatment outcomes and to evaluate resource utilization and associated cost of maintenance use of tacrolimus ointment (MU) vs. standard use of tacrolimus ointment (SU) in adults with AD. Methods A pan‐European, phase III multicentre randomized clinical trial was conducted. Patients with mild to severe AD were randomized to tacrolimus 0·1% ointment (MU) or vehicle (SU) twice per week for 12 months. Disease exacerbations were treated by using open‐label tacrolimus 0·1% ointment twice daily. Resource utilization data were collected prospectively alongside the clinical trial. Costs of pooled resource data were determined using German unit cost data. Direct and indirect costs were considered from third party payer, patient and societal perspectives. Results All patients with moderate and severe AD were included in a subanalysis, 75 patients in the MU arm (57% moderately affected) and 59 patients in the SU arm (59% moderately affected). In patients with moderate AD, the number of disease exacerbations in the MU arm was 2·4 vs. 5·5 in the SU arm (P < 0·001); in patients with severe AD corresponding figures were 2·3 vs. 7·4 (P < 0·001), respectively. Mean ± SD total annual cost per patient was €1525 ± 1081 (MU) vs. €1729 ± 1209 (SU) in patients with moderate AD and €2045 ± 2013 (MU) vs. €2904 ± 1510 (SU) in patients with severe AD. Conclusions Maintenance treatment with 0·1% tacrolimus ointment is more effective and leads to cost savings and improved health‐related quality of life in comparison with standard use of 0·1% tacrolimus ointment, especially in patients with severe AD.     

Effects of 1-year intermittent treatment with topical tacrolimus monotherapy on skin collagen synthesis in patients with atopic dermatitis

BACKGROUND: Topical corticosteroids decrease collagen synthesis during short-term treatment and can induce skin atrophy when applied over the long term. In contrast, short-term tacrolimus ointment therapy does not affect collagen synthesis. OBJECTIVES: Our aim was to evaluate the long-term effects of 0.1% tacrolimus ointment on collagen synthesis and on skin thickness in adults with moderate to severe atopic dermatitis (AD) and to compare the findings with the effects of conventional steroid-based therapy. METHODS: Fifty-six patients with AD were treated with 0.1% tacrolimus ointment in a 1-year, open-label, prospective clinical trial. Thirty-six patients with AD applied conventional steroid-based therapy and 27 healthy subjects were recruited as controls. The primary endpoint was the change in levels of procollagen propeptides I and III measured by radioimmunoassay between baseline and month 12. Additional endpoints included the change in skin thickness measured by ultrasound between baseline and month 12. RESULTS: Procollagen propeptide baseline values were significantly lower in the group to be treated with tacrolimus ointment than in healthy controls. One-year treatment with tacrolimus ointment was associated with an increase in collagen synthesis; the median increase in combined procollagen propeptide levels was 272 micro g L-1 (+ 140.9%, P < 0.001) and was accompanied by a significant increase in skin thickness. In three patients with visible skin atrophy, this condition ameliorated. Corticosteroid-based therapy had no significant effect on collagen synthesis; the median increase in combined procollagen propeptide levels was 11 micro g L-1 (+ 3.9%). A significant reduction in skin thickness was demonstrated. CONCLUSIONS: Long-term tacrolimus ointment therapy in patients with AD is nonatrophogenic and reverses corticosteroid-induced skin atrophy.     

A multicentre, randomized, double-blind, controlled study of long-term treatment with 0.1% tacrolimus ointment in adults with moderate to severe atopic dermatitis

BACKGROUND: Atopic dermatis (AD) is a chronic disease that often requires long-term treatment. Topical corticosteroids are the usual therapy for patients with AD, but prolonged usage can result in skin atrophy and other side-effects. OBJECTIVES: In a randomized, double-blind, comparative study, to compare the efficacy and safety of a 6-month treatment period with 0.1% tacrolimus ointment vs. a corticosteroid ointment regimen in adults with moderate to severe AD. METHODS: Treatment was applied twice daily for a maximum of 6 months. Patients in the tacrolimus treatment group (n = 487) applied 0.1% tacrolimus ointment to all affected areas over the whole body. The patients treated with the corticosteroid regimen (n = 485) applied 0.1% hydrocortisone butyrate ointment to affected areas on the trunk and extremities and 1% hydrocortisone acetate ointment to affected areas on the face and neck. The study primary endpoint was the response rate, i.e. the proportion of patients with at least 60% improvement in the modified Eczema Area and Severity Index (mEASI) between baseline and month 3. RESULTS: By month 3, more patients in the 0.1% tacrolimus group responded to treatment (72.6% vs. 52.3% in the corticosteroid group, P < 0.001). The patients treated with 0.1% tacrolimus also showed greater improvement in mEASI, EASI, affected body surface area and physician and patient assessments of global response. Patients applying 0.1% tacrolimus ointment experienced more skin burning (52.4% vs. 13.8% in the corticosteroid group; P < 0.001). In most patients, skin burning was mild to moderate in severity and decreased rapidly after the first week of treatment. There was no increase in the incidence of infections or malignancies over time in either treatment group. CONCLUSIONS: Long-term treatment with 0.1% tacrolimus ointment is significantly more efficacious than a corticosteroid ointment regimen in adults with moderate to severe AD.     

Quality of life and health‐related utility analysis of adults with moderate and severe atopic dermatitis treated with tacrolimus ointment vs. topical corticosteroids

Background The purpose of this study was to measure change in quality of life (QoL) and estimate health‐related utility in adults with moderate and severe atopic dermatitis (AD) following the use of either tacrolimus ointment or topical corticosteroids. Methods Data were analysed from a double‐blind, randomized controlled trial comparing the treatment of adults with moderate and severe AD with either tacrolimus ointment or a standard corticosteroid regimen. Following randomisation, patients applied their medication twice‐daily for 6 months. Monthly assessments determined response and QoL. Health‐related utility (EQ5Dindex) was estimated by Monte Carlo simulation from SF‐12 responses via a published mapping algorithm. Results At baseline, estimated utility data were available for 926 (95%) of the intention‐to‐treat patients, 57% of whom had AD of moderate severity (43% severe). The mean age at baseline was 32.5 years (SD ± 11.8), 46.2% were male, with a mean EQ5Dindex for moderate cases of 0.770 (SD ± 0.157), and 0.665 (SD ± 0.225) for those with severe disease (P < 0.001). Patients treated with tacrolimus ointment showed significantly greater improvement in all but one domain of the SF‐36. At baseline, there was no difference in estimated utility between the two groups; however, a difference in utility in favour of tacrolimus ointment emerged after 1 month’s treatment (0.849 vs. 0.820; P = 0.004). Over the 6‐month study period, the mean, marginal utility difference between the study arms was 0.032 U (utility) in favour of tacrolimus (P < 0.001). Conclusion Treatment with 0.1% tacrolimus ointment rather than a standard topical corticosteroid ointment regimen was associated with clinically significant, incremental improvement in QoL, sustained over a 6‐month period. A within‐trial cost‐utility estimate based on study medication cost alone suggests that tacrolimus ointment is highly cost‐effective given existing willingness‐to‐pay thresholds.     

他克莫司软膏治疗儿童特应性皮炎疗效和依从性评价

目的评价0.03%他克莫司软膏治疗儿童轻、中度特应性皮炎(AD)的疗效和安全性及依从性。方法采用随机双盲平行对照方法将入选的60例AD患儿分为对照组和试验组,每组各30例。试验组患儿外用0.03%他克莫司软膏,对照组患儿外用凡士林乳膏、夫西地酸软膏,两组均连续治疗3周,采用AD评分评价疗效。结果试验组患儿瘙痒、症状积分下降明显大于对照组(P<0.05);症状控制时间和临床治愈用药时间明显短于对照组(P<0.05)。试验组和对照组治疗的有效率分别为93.3%和69.5%,两组疗效比较差异有统计学意义(P<0.05);试验组和对照组依从率分别为100%和76.7%,两组比较差异具有统计学意义(P<0.05)。结论 0.03%他克莫司软膏治疗儿童轻、中度AD安全而有效,患儿依从性良好。