合成单宁与苯胺染料治疗原发性与继发性浅表性脓皮病疗效的比较研究

D. Zaslavsky, A. Iskra, E. Iskra, E. Manylova, E. Shander
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The trial included 50 patients of both sexes, aged 0 to 77 years, with various types of primary or secondary pyoderma. Age composition of patients: 0-1 years old – 2 people (4%), 1-6 years old – 9 subjects (18%), 7-12 years old – 8 subjects (16%), 13-77 years old – 35 subjects (70%). The patients were randomly divided into 4 groups: the first group used tannin preparation (spray, lotion/suspension or cream) as topical monotherapy; the second group used the solution of carbol- fuchsin as topical monotherapy (alcoholic solution or, in patients under 10 years of age, aqueousone); the third group used the combination therapy with tannin preparation (spray, lotion/suspension) or cream) and systemic antibacterial drugs; the fourth group used an alcoholic solution of carbol-fuchsin (in patients under 10 years of age, an aqueous solution) and systemic antibacterial drugs. The patients were followed up for 5-14 days. 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引用次数: 0

摘要

单宁的药理作用主要与其收敛作用有关。近几十年来的几项医学研究表明单宁还具有抗菌和抗炎的特性。研究目的:评估固定单宁组合,包括喷雾/洗剂(悬浮液)和乳霜“neotanin”治疗原发性或继发性细菌性皮肤感染患者的疗效和安全性。评估和比较在单宁成分或胭脂红溶液(Castellani油漆)局部单一治疗或全身抗菌药物复合治疗期间脓皮病临床解决的时间框架。材料和方法。在门诊和住院环境中进行了一项开放标签的比较临床研究。该试验包括50名男女患者,年龄在0至77岁之间,患有各种类型的原发性或继发性脓皮病。患者年龄构成:0-1岁2人(4%),1-6岁9人(18%),7-12岁8人(16%),13-77岁35人(70%)。患者随机分为4组:第一组使用单宁制剂(喷雾、洗剂/悬浮液或乳膏)进行局部单药治疗;第二组使用胭脂红溶液作为局部单一疗法(酒精溶液或10岁以下患者使用水);第三组采用单宁制剂(喷雾、洗剂/悬浮液)或乳膏联合全身抗菌药物治疗;第四组使用胭脂醇溶液(10岁以下患者为水溶液)和全身抗菌药物。随访5 ~ 14 d。评估研究药物安全性和有效性的标准在两组中是相同的。对这些制剂的有效性进行动态评估,评估患者的主观主诉、临床症状的存在和严重程度以及受影响的区域。结果。单宁局部治疗组:使用一周后,脓皮病症状严重程度至少降低90%。用药第7天无疼痛,瘙痒和灼烧减少93.2%。到使用第7天,擦伤减少了80%。药物具有明显的抗炎作用,因此,在使用第7天,红斑症状消退了89.8%,100%的患者没有湿气和水肿的表现。皮肤病变面积减少73%。微生物培养结果证实了单宁制剂对皮肤脓皮病主要致病菌和条件致病菌的抑菌作用。胭脂红组:胭脂红局部治疗组:使用一周后,脓皮病症状的严重程度仅下降50%。使用第7天,疼痛仅减轻55%,瘙痒减轻50%,灼烧减轻60%。到使用第7天,擦伤只减少了66%。用药第7天,红斑症状消退60%,湿润症状减轻84.7%,肿胀症状减轻57.9%。皮肤病变面积仅减少4%。结论。含有单宁的固定局部组合物已被证明对成人和儿童(包括婴儿)的原发性和继发性脓皮病具有很高的疗效和安全性。使用基于合成单宁和传统苯胺染料的现代医学组合物的比较试验,使我们能够推荐“neotanin”产品线作为比carol -fuchsin更有效的局部配方(无论是单一疗法还是与全身抗菌药物联合使用)。
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Comparative study of the effectiveness of synthetic tannins and aniline dyes in patients with primary or secondary superficial pyoderma
The pharmacological effects of tannins are mainly related to their astringent action. Several medical studies in recent decades have shown additional antimicrobial and anti- inflammatory properties of tannins. Purpose of the study. To evaluate the efficacy and safety of fixed tannin combinations, including spray / lotion (suspension) and cream «neotanin» in the treatment of patients with primary or secondary bacterial skin infections. To assess and compare the time frames for clinical resolution of pyoderma during of topical monotherapy with either tannin composition or carbol-fuchsin solution (Castellani paint) or complex therapy with systemic antibacterial drugs. Material and methods. An open-label comparative clinical study was carried out in an outpatient and inpatient setting. The trial included 50 patients of both sexes, aged 0 to 77 years, with various types of primary or secondary pyoderma. Age composition of patients: 0-1 years old – 2 people (4%), 1-6 years old – 9 subjects (18%), 7-12 years old – 8 subjects (16%), 13-77 years old – 35 subjects (70%). The patients were randomly divided into 4 groups: the first group used tannin preparation (spray, lotion/suspension or cream) as topical monotherapy; the second group used the solution of carbol- fuchsin as topical monotherapy (alcoholic solution or, in patients under 10 years of age, aqueousone); the third group used the combination therapy with tannin preparation (spray, lotion/suspension) or cream) and systemic antibacterial drugs; the fourth group used an alcoholic solution of carbol-fuchsin (in patients under 10 years of age, an aqueous solution) and systemic antibacterial drugs. The patients were followed up for 5-14 days. The criteria for assessing the safety and efficacy of the study drugs were identical in both groups. The effectiveness of these preparations was assessed dynamically assessing subjective complaints of the patient, the presence and severity of clinical symptoms and the affected area. Results. In the tannin topical therapy group: after a week of use, the severity of pyoderma symptoms decreased by at least 90%. Soreness was absent on the 7th day of using the drugs, itching and burning decreased to 93.2%. By the 7th day of use, excoriation decreased by 80%. The drugs showed a pronounced anti-inflammatory effect – so, on the 7th day of use, symptoms of erythema regressed by 89,8%, manifestation of wetness and edema was absent in 100% of the patients. The area of skin lesions decreased by 73%. The results of microbial culturing confirm the antibacterial activity of tannin preparation against the main and conditionally pathogenic pathogens of skin pyoderma. In the carbol-fuchsin group: in the carbol-fuchsin topical therapy group: after a week of use, the severity of pyoderma symptoms decreased by only 50%. Soreness decreased by only 55% by the 7th day of using carbol-fuchsin, itching decreased by 50%, burning decreased by 60%. By the 7th day of use, excoriation decreased by only 66%. On the 7th day of application, symptoms of erythema regressed by 60%, manifestation of wetness decreased by 84.7%, swelling decreased by 57.9%. The area of skin lesion decreased by only 4%. Conclusion. Fixed topical compositions with tannins have demonstrated high efficacy and safety in primary and secondary forms of pyoderma in adults and children including infants. Comparative trial of use of modern medical composition based on synthetic tannins with traditional aniline dyes allows us to recommend «neotanin» product line as a more effective topical formulations than carbol-fuchsin (both in monotherapy and in combination with systemic antibacterial drugs).
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