1%盐酸普萘洛尔乳膏治疗婴幼儿体表血管瘤的安全性研究
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摘要
目的考察盐酸普萘洛尔乳膏对动物皮肤的刺激性和过敏性。方法 1%盐酸普萘洛尔乳膏被用于对新西兰大白兔进行单次和多次的完整皮肤刺激性试验和破损皮肤刺激性试验,将豚鼠随机分为4组(普萘洛尔乳膏组、阳性对照组、阴性对照组、空白对照组)进行过敏性试验,按皮肤过敏反应评分标准进行评分。结果 1%盐酸普萘洛尔乳膏单次和多次用药对新西兰大白兔的正常及破损皮肤均无刺激性;1%盐酸普萘洛尔乳膏对豚鼠皮肤轻度过敏,无明显全身性反应,4组间皮肤过敏率比较差异具有统计学意义(P=0.001)。结论 1%盐酸普萘洛尔乳膏是一种无刺激性和低过敏性的透皮吸收给药制剂。
Objective To study the skin irritation and allergy of propranolol hydrochloride cream to animal skin. Methods 1% propranolol hydrochloride cream was used for single and multipe whole skin irritation tests and the damaged skin irritation tests of New Zealand white rabbits. The guinea pigs were randomly divided into four groups(propranolol cream group, positive control group, negative control group, blank control group) for skin allergy test. The skin allergy scoring according to skin allergy scoring standard. Results 1% propranolol hydrochloride cream had no irritation to normal and damaged skin of New Zealand white rabbits. 1% propranolol hydrochloride cream was slightly allergic to the skin of guinea pigs, and had no significant systemic reaction, there was significantly different in skin allergic rate among four groups(P=0.001). Conclusion 1% propranolol hydrochloride cream is a non-irritating and hypoallergenic transdermal absorption preparation.
Objective To study the skin irritation and allergy of propranolol hydrochloride cream to animal skin. Methods 1% propranolol hydrochloride cream was used for single and multipe whole skin irritation tests and the damaged skin irritation tests of New Zealand white rabbits. The guinea pigs were randomly divided into four groups(propranolol cream group, positive control group, negative control group, blank control group) for skin allergy test. The skin allergy scoring according to skin allergy scoring standard. Results 1% propranolol hydrochloride cream had no irritation to normal and damaged skin of New Zealand white rabbits. 1% propranolol hydrochloride cream was slightly allergic to the skin of guinea pigs, and had no significant systemic reaction, there was significantly different in skin allergic rate among four groups(P=0.001). Conclusion 1% propranolol hydrochloride cream is a non-irritating and hypoallergenic transdermal absorption preparation.
引文
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[11] Park YW,Yeom KB,Choi JW,et al.Effect of propranolol on the treatment of infantile hemangiomas:a single tertiary center 3-year experience[J].J Dermatolog Treat,2014,25(5):391-395
[12] 沈纲,赵慧莉.普萘洛尔治疗婴儿型血管瘤的研究进展[J].中国医药导报,2016,13(23):49-52
[13] Hoeger PH,Harper JI,Baselga E,et al.Treatment of infantile haemangiomas:recommendations of a European expert group[J].Eur J Pediatr,2015,174(7):855-865
[14] Kunzi-Rapp K.Topical propranolol therapy for infantile hemangiomas [J].Pediatr Dermatol,2012,29(2):154-159
[15] 鲁阳春,宋洪涛,邹忠东,等.不同浓度普萘洛尔凝胶治疗婴幼儿血管瘤疗效观察[J].中华实用儿科临床杂志,2014,29(19):1510-1512
[16] Ovadia SA,Landy DC,Cohen ER,et al.Local administration of β-blockers for infantile hemangiomas:a systematic review and meta-analysis[J].Ann Plast Surg,2015,74(2):256-262
[17] Schneider M,Reimer A,Cremer H,et al.Topical treatment with propranolol gel as a supplement to the existing treatment of hemangiomas[J].World J Pediatr,2014,10(4):313-317
[18] Zhou HH,Koshakji RP,Silberstein DJ,et al.Racial differences in drug response.Altered sensitivity to and clearance of propranolol in men of Chinese descent as compared with American whites [J].N Engl J Med,1989,320(9):565-570
[2] Cuccaro P,Rapacciuolo A,Vitiello R,et al.Propranolol for severe hemangiomas of infancy[J].J Cardiovasc Med (Hagerstown),2011,12(1):5
[3] 林栋盛,温添华,蔡颖娴,等.盐酸普萘洛尔溶液的制备及其治疗婴幼儿血管瘤的临床观察[J].广东医科大学学报,2018,36(5):568-570
[4] 翁文骏,黎阳,方建培,等.4%盐酸普萘洛尔乳膏局部治疗浅表型血管瘤的疗效观察[J].中国小儿血液与肿瘤杂志,2018,23(3):124-126,136
[5] 苗杰,王爱武,杨柳,等.盐酸普萘洛尔乳膏的安全性考察[J].安徽医药,2014,18(6):1020-1023
[6] 朱婉灵,谭淑娟.盐酸普萘洛尔凝胶外涂治疗婴幼儿浅表性血管瘤的疗效及安全性[J].广州医药,2017,48(6):40-42,56
[7] 刘姗,黄雪峰,陈龙浩,等.治疗婴幼儿血管瘤的盐酸普萘洛尔乳膏处方及制备工艺研究[J].药学服务与研究,2018,18(1):26-28
[8] 谢新民,刘志刚,黄雪峰,等.高效液相色谱法测定盐酸普萘洛尔乳膏的含量[J].中国药业,2015,24(3):23-24
[9] 国家食品药品监督管理局.关于发布化学药物稳定性研究等16个技术指导原则的通知[EB/OL].(2005-03-18)[2019-05-10].http://www.nmpa.gov.cn/WS04/CL2196/323492.html
[10] 王立冬,李晋福,裴周颖,等.口服普萘洛尔与激素治疗婴幼儿血管瘤临床疗效的Meta分析[J].中国美容医学,2016,25(1):44-47
[11] Park YW,Yeom KB,Choi JW,et al.Effect of propranolol on the treatment of infantile hemangiomas:a single tertiary center 3-year experience[J].J Dermatolog Treat,2014,25(5):391-395
[12] 沈纲,赵慧莉.普萘洛尔治疗婴儿型血管瘤的研究进展[J].中国医药导报,2016,13(23):49-52
[13] Hoeger PH,Harper JI,Baselga E,et al.Treatment of infantile haemangiomas:recommendations of a European expert group[J].Eur J Pediatr,2015,174(7):855-865
[14] Kunzi-Rapp K.Topical propranolol therapy for infantile hemangiomas [J].Pediatr Dermatol,2012,29(2):154-159
[15] 鲁阳春,宋洪涛,邹忠东,等.不同浓度普萘洛尔凝胶治疗婴幼儿血管瘤疗效观察[J].中华实用儿科临床杂志,2014,29(19):1510-1512
[16] Ovadia SA,Landy DC,Cohen ER,et al.Local administration of β-blockers for infantile hemangiomas:a systematic review and meta-analysis[J].Ann Plast Surg,2015,74(2):256-262
[17] Schneider M,Reimer A,Cremer H,et al.Topical treatment with propranolol gel as a supplement to the existing treatment of hemangiomas[J].World J Pediatr,2014,10(4):313-317
[18] Zhou HH,Koshakji RP,Silberstein DJ,et al.Racial differences in drug response.Altered sensitivity to and clearance of propranolol in men of Chinese descent as compared with American whites [J].N Engl J Med,1989,320(9):565-570