对贵刊《他克莫司软膏治疗成人和儿童特应性皮炎51例》一文的验证

<正>笔者阅读了贵刊2005年第9期刊登的《他克莫司软膏治疗成人和儿童特应性皮炎51例》一文后深受启发,并采用此法于2006年10月—2007年5月,对门诊特应性皮炎病人进行临床验证,报道如下。一般资料36例符合特应性皮炎诊断标准的病人按随机数字表随机分为2组,对照组18例,其中     

他克莫司软膏治疗儿童中重度特应性皮炎随机双盲对照临床研究

目的 观察0．03％他克莫司软膏治疗儿童中重度特应性皮炎的疗效和安全性。方法 用随机双盲安慰剂平行对照临床试验，共人组30例儿童中重度特应性皮炎患者，用药3周，其中29例患者完成本试验。结果 治疗结束时，0．03％他克莫司软膏组痊愈率、显效率和有效率分别为35．7％（5／14），50．0％（7／14）和85．7％（12／14），与安慰组痊愈率6．7％（1／15）、显效率13．3％（2／15）和有效率为20．0％（3／15）相比，差异均有统计学意义。试验组主要药物不良反应多为轻到中度，且均为一过性；实验室检查治疗前后也未见明显异常。结论0．03％他克莫司软膏治疗儿童中重度特应性皮炎安全有效。     

他克莫司软膏联合氯雷他定治疗儿童特应性皮炎的临床疗效观察

目的探讨他克莫司软膏联合氯雷他定治疗儿童特应性皮炎的临床疗效。方法选取2009年9月至2011年5月我院诊治的特应性皮炎患儿共160例,随机分为实验组和对照组,其中治疗组采用他克莫司软膏司联合氯雷他定治疗,对照组单纯口服氯雷他定。治疗后观察患者的皮肤状况,每周复诊1次,观察患儿的皮损及瘙痒情况。结果实验组与对照组的临床疗效总有效率差异具有统计学意义(97.50%VS 78.75%,P<0.05),实验组患儿的疗效总有效率明显较高;治疗结束2周后实验组患儿的临床体征与症状评分明显较低(P<0.05)。结论他克莫司软膏联合氯雷他定治疗儿童特应性皮炎,能够有效提高临床效果及改善临床体征与症状,值得在临床上推广应用。     

他克莫司治疗特应性皮炎的疗效观察

目的观察他克莫司治疗特应性皮炎的疗效。方法根据不同年龄外用0.03%和0.1%他克莫司,每日2次,共用3周,治疗前、治疗后1周和3周观察记录症状评分及副作用。结果治疗组总有效率为93.3%,对照组为64.7%%（P〈0.05）。结论他克莫司软膏治疗特应性皮炎效果好、副作用少。     

他克莫司软膏治疗儿童与成人特应性皮炎的随机双盲对照临床研究

目的评价他克莫司软膏治疗特应性皮炎的疗效和安全性。方法用随机双盲平行对照方法，将成人特应性皮炎分为3组，分别外用0．1％，0．03％他克莫司软膏和赋形剂（对照组）；将儿童特应性皮炎分为2组，分别外用0．03％他克莫司软膏和赋形剂（对照组）；每日2次，疗程为3周；作症状和体征总评分、受累体表面积百分比（BSA％）和特应性皮炎面积与严重程度指数（EASI）评估；患者作视觉尺度VAS瘙痒症状测试及皮炎改善程度的自我评估。结果成人他克莫司软膏0．1％组、0．03％组和对照组的有效率分别为100％，80．0％和26．7％；儿童他克莫司软膏0．03％组和对照组的有效率分别为85．0％和33．3％。治疗组的有效率均显著高于对照组（P〈0.001）。治疗后，治疗组的症状和体征总评分、BSA％和EASI显著下降，与患者自我评价符合。药物不良反应轻微。结论0．1％和0．03％他克莫司软膏治疗成人特应性皮炎及0．03％他克莫司软膏治疗儿童特应性皮炎有效、安全。     

用中药药浴联合他克莫司软膏治疗儿童特应性皮炎有效性和安全性的随机单盲临床试验疗效观察

目的评价中药药浴联合他克莫司软膏外用治疗儿童特应性皮炎的临床疗效及安全性。方法本试验采用随机、单盲、阳性平行对照试验将45例儿童患者采用随机数字表分成治疗组和对照组。治疗组23例,对照组22例。治疗组采用中药药浴治疗联合外用0.03%他克莫司软膏外用。对照组单用0.03%他克莫司软膏外用。结果 4周疗程结束后,两组间有效率差异有显著性(u=-2.411,P<0.05)。两组初诊时SCORAD积分值比较无统计学差异(t=0.557,P>0.05),治疗4周后SCORAD积分值比较,差异具有显著性(u=-2.411,P<0.05)。结论中药药浴联合0.03%他克莫司软膏较单用0.03%他克莫司软膏治疗特应性皮炎疗效较优,复发率低,安全性好,值得临床推广。     

他克莫司软膏联合盐酸依匹斯汀胶囊治疗轻中度特应性皮炎临床疗效及炎性因子水平的影响

目的：探究他克莫司软膏联合盐酸依匹斯汀胶囊治疗轻中度特应性皮炎（AD）临床疗效及炎性因子水平的影响。方法：选择80例江西省赣州市皮肤病医院2019年1月至2021年7月收治的轻中度AD患者,采用随机数字表法分为对照组及观察组,各40例。所有患者均先于皮损处涂抹薇诺娜舒敏保湿特护霜,对照组单用丁酸氢化可的松乳膏,观察组采用他克莫司软膏联合盐酸依匹斯汀胶囊治疗,持续用药3周,之后随访3个月。对比两组治疗效果。结果：相比于对照组（77.50%）,观察组治疗总有效率（95.00%）较高（P<0.05）;观察组治疗后IL-13水平为（27.36±2.26）ng/L、IL-17水平为（24.52±4.26）ng/L,均低于对照组的（31.72±2.51）ng/L（、30.44±3.25）ng/L,IFN-γ水平为（14.72±2.27）ng/L高于对照组的（13.18±2.13）ng/L,均差异有统计学意义（P<0.05）;相比于对照组（25.00%）,观察组复发率（7.50%）较低（P<0.05）;观察组不良反应发生率为2.50%,对照组为15.00%,两组对比差异无统计学意义...     

他克莫司软膏在儿童口周皮炎中的临床应用

目的分析0.03%他克莫司软膏在儿童口周皮炎治疗中的应用价值。方法儿童口周皮炎患儿70例,年龄2～14岁,随机分为观察组及对照组。观察组给予0.03%他克莫司软膏联合保湿软膏每日外用1次治疗。对照组采用保湿乳膏每日外用2次治疗。两组疗程均为4周。比较两组患儿治疗后1、2、4周治疗效果。结果观察组有效率高于对照组(P<0.01),观察组2周、4周的有效率明显高于1周(P<0.05)。观察组的药物不良反应发生率为13.9%(5/36),主要表现为轻微的红斑、烧灼及痒痛感。结论 0.03%他克莫司软膏治疗儿童口周皮炎疗效确切,安全性高。     

他克莫司软膏治疗面部激素依赖性皮炎35例

目的探讨面部糖皮质激素依赖性皮炎的有效治疗方法。方法 72例面部糖皮质激素依赖性皮炎患者随机分为治疗组36例,外涂0.1%他克莫司软膏,2次/d;对照组36例外涂0.1%糠酸莫米松乳膏,1次/d,逐渐延长间隔至撤停,同时配合外涂0.3%多磺酸粘多糖乳膏1～2次/d。两组均口服左西替利嗪5mg/d,维生素C0.2g,3次/d,于治疗4周后判断疗效。结果两组各有35例完成治疗。治疗组有效33例（91.42%）,对照组有效24例（68.57%）,两组比较差异有显著性（P〈0.05）;治疗组局部不良反应11例、对照组8例,不良反应发生率无显著差异。结论 0.1%他克莫司软膏治疗面部糖皮质激素依赖性皮炎起效迅速、依从性较好、疗效显著。     

Long-term safety of tacrolimus ointment in atopic dermatitis

Background: Tacrolimus ointment has shown efficacy as monotherapy in both short- and long-term studies in atopic dermatitis. Absorption of tacrolimus after topical application is dependent on the barrier function of the skin. Absorption through the intact epidermis is very low and eczematic skin a little higher. In comparison to systemic tacrolimus used for prevention and treatment of rejection after organ transplantation, the bioavailability of topical tacrolimus in patients with atopic dermatitis is between 3 and 4%. Long-term safety studies of up to 4 years have not shown adverse events associated with systemic use of immunosuppressive agents, that is, increased risk of infections, lymphomas or skin cancers. Despite these findings, many physicians remain concerned about possible long-term malignancies associated with long-term treatment with a topical calcineurin inhibitor. Objective: To identify in the published literature possible long-term safety issues associated with topical tacrolimus treatment. Methods: PubMed was used to identify studies of atopic dermatitis therapy in which tacrolimus ointment was used for at least 6 months. We evaluated the safety data available from these studies. In addition, some safety data were evaluated from clinical follow-up of our own patients who have used tacrolimus ointment intermittently for up to 14 years. Conclusions: During a follow-up period of 4 years in clinical studies, no increased risk of infections or cancer was associated with long-term use of tacrolimus ointment. Only short-term adverse events were detected. They included increased burning and stinging of the skin, and a temporary increase in skin infections. No signs of immunosuppression were observed after 1 – 4 years of intermittent treatment with tacrolimus ointment.     

Long-term safety of tacrolimus ointment in children treated for atopic dermatitis

Atopic dermatitis (AD) is a chronic, relapsing, highly pruritic inflammatory skin disease that is particularly prevalent in the paediatric population. Emollients and topical corticosteroids have represented the standard of treatment for patients with AD, despite their numerous adverse effects and patients’ tendency towards steroid resistance. Topical tacrolimus marks the introduction of an entirely new class of medications, the non-corticosteroid topical immunomodulators. Numerous short- and long-term and ongoing paediatric and adult studies have demonstrated the excellent efficacy and superb safety profile of this anti-inflammatory agent. The authors review many of these landmark studies and discuss the mechanism of action and safety profile of tacrolimus, in the context of the pathophysiology of AD.     

Tacrolimus ointment: the treatment of atopic dermatitis and other inflammatory cutaneous disease

Topical tacrolimus (FK506, Protopic^?) has been developed and marketed for the treatment of atopic dermatitis (AD). Tacrolimus works as an inhibitor of calcineurin, which creates a downregulation of the inflammatory cascade. Numerous trials have shown the efficacy and safety of tacrolimus in treating AD in both adults and children. Additionally, comparison data with other medications commonly used for AD, such as topical steroids and pimecrolimus, show improved efficacy of tacrolimus. A comprehensive review of the off-label uses of tacrolimus in other dermatoses, including psoriasis, lichen planus and seborrhoeic dermatitis, is provided. The efficacy of tacrolimus in treating these diseases is based on Phase IV clinical trials and on case reports or series in the literature. Overall, tacrolimus has proven to be a safe and useful topical therapy for many inflammatory dermatological conditions, with AD being the principal indication.     

Calcineurin inhibitors for the treatment of atopic dermatitis

Background: Atopic dermatitis (AD) is a chronic disease characterized by periods of remission and relapse. Therapeutic objectives for AD should be to quickly reduce disease symptoms by targeting pathophysiological pathways, and to provide long-term management by reducing recurrences. Objective: Calcineurin inhibitors currently appear to be one of the most promising alternative systemic and topical compounds to treat AD. This review focuses on new developments of topical calcineurin inhibitors, therapeutic regimens including long-term management, and prophylaxis of AD. Methods: The published clinical studies that present data on treatment of AD with calcineurin inhibitors were assessed. Results/conclusion: Topical calcineurin inhibitors such as tacrolimus and pimecrolimus provide an effective treatment for AD. They are useful for long-term management and prophylaxis of AD. Safety concerns with regard to increased risk for lymphomas or skin cancer could not be confirmed but will remain under careful observation.     

Long-term safety of tacrolimus ointment in children treated for atopic dermatitis

Atopic dermatitis (AD) is a chronic, relapsing, highly pruritic inflammatory skin disease that is particularly prevalent in the paediatric population. Emollients and topical corticosteroids have represented the standard of treatment for patients with AD, despite their numerous adverse effects and patients' tendency towards steroid resistance. Topical tacrolimus marks the introduction of an entirely new class of medications, the non-corticosteroid topical immunomodulators. Numerous short- and long-term and ongoing paediatric and adult studies have demonstrated the excellent efficacy and superb safety profile of this anti-inflammatory agent. The authors review many of these landmark studies and discuss the mechanism of action and safety profile of tacrolimus, in the context of the pathophysiology of AD.     

AAPE proliposomes for topical atopic dermatitis treatment

Abstract

Context: Anti-inflammatory effect of advanced adipose stem cell derived protein extract (AAPE) could be improved by minimising protein degradation. Objective: To develop a proliposomal formulation of AAPE for the treatment of topical atopic dermatitis. Materials and methods: Proliposomal powder was manufactured by evaporating a solution of soy phosphatidyl choline, AAPE and Poloxamer 407 in ethanol under vacuum on sorbitol powder. Characterisation of proliposomes (zeta potential, diameter, stability and flowability) as well as in vivo efficacy in a dermatitis mouse model was investigated. Results and discussion: Reconstitution of the proliposomal powder formed liposomes of 589?±?3.6?nm diameter with zeta potential of ?51.33?±?0.36?mV. Protein stability was maintained up to 90 days at 25?°C as proliposomes. In vivo studies on atopic dermatitis mouse model showed a significant reduction in IgE levels after topical AAPE proliposome treatment. Conclusion: AAPE proliposomes maintained protein stability and showed promising results for atopic dermatitis treatment.     

他克莫司治疗IgA肾病的疗效及安全性的观察研究

目的:观察他克莫司治疗IgA肾病(IgA nephropathy,IgAN)的长期疗效和安全性。方法:回顾性分析我科IgAN随访队列中应用他克莫司治疗并且随访时间>1年的原发性IgAN患者,观察用药及随访期间患者尿蛋白定量、血清白蛋白水平及估算肾小球滤过率(eGFR)的变化,并评价用药相关不良事件。结果:共21例IgAN患者纳入本研究,平均年龄(29.4±10.6)岁,平均随访时间为(54.0±35.8)月,所有患者在应用他克莫司之前均应用了ACEI/ARB和/或激素免疫抑制治疗,且尿蛋白仍>1 g·d-1,应用他克莫司前的平均尿蛋白(4.84±2.40)g·d-1,平均eGFR(78.33±37.30)m L·min-1·1.73 m-2。5/21例eGFR(34.70±9.67)m L·min-1·1.73 m-2的患者在用药1~1.5月后因eGFR下降>15%而停药,其余16/21例患者用药时间≥6个月,其中13/16例(81.3%)在治疗平均(5.31±3.35)周时获得蛋白尿缓解,包括12例完全缓解和1例部分缓解,8/13例获得缓解的时间在应用他克莫司治疗后的4周内,患者用药前与治疗结束时的eGFR差异没有统计学意义(93.5±32.8)vs(80.4±32.5)m L·min-1·1.73 m-2,P=0.27)。6/13例(46.2%)在他克莫司减量或停药后出现复发。用药相关不良事件包括感染(2例),新发高血压(1例),高尿酸血症(3例)等。结论:1他克莫司在对ACEI/ARB和/或激素免疫抑制治疗效果不佳的IgAN治疗中显现出快速的蛋白尿缓解趋势,但在CKD3期以上的患者中应慎重使用。2他克莫司在减量或停药过程中复发率较高。