目的:汇总体外透皮试验(In Vitro Permeation Test,IVPT)的设计要求和评价方法,并以Excel中函数公式计算IVPT,助力评价皮肤局部外用制剂仿制药研发质量与疗效。方法:对比美国食品药品管理局(Food and Drug Administration,FDA)、欧洲药...目的:汇总体外透皮试验(In Vitro Permeation Test,IVPT)的设计要求和评价方法,并以Excel中函数公式计算IVPT,助力评价皮肤局部外用制剂仿制药研发质量与疗效。方法:对比美国食品药品管理局(Food and Drug Administration,FDA)、欧洲药品管理局(European Medicines Agency,EMA)、日本医药品医疗器械综合机构(Pharmaceuticals and Medical Devices Agency,PMDA)及国家药品监督管理局(National Medical Products Administration,NMPA)相关指导原则中IVPT设计要求及评价方法,并以Excel软件中函数公式计算IVPT,与SAS软件计算结果进行比较。结果:相比于EMA和PMDA对皮肤局部外用制剂仿制药IVPT的评价标准,FDA的评价标准更适合我们对仿制药IVPT进行评价,也较容易被我国药监部门所接受。体外透皮试验除皮肤膜选择PMDA推荐的大鼠、小鼠或猪等至少任何一种动物的腹部或背部外,其他设计可参考FDA指导原则相关建议。对于IVPT结果,Execl软件函数公式计算结果与SAS软件计算结果一致。结论:可优先采用FDA的皮肤局部外用制剂仿制药IVPT指导原则设计试验,并以其评价标准进行等效性评价。此外,本研究已验证Excel替代SAS软件准确计算IVPT,可用于判断皮肤局部外用制剂仿制药研发质量及生物等效性。展开更多
Dead Sea (DS) mud and water are known for their unique composition of minerals, and for their therapeutic properties on inflammatory skin diseases. The objective of the study was to evaluate the efficacy of an emollie...Dead Sea (DS) mud and water are known for their unique composition of minerals, and for their therapeutic properties on inflammatory skin diseases. The objective of the study was to evaluate the efficacy of an emollient cream enriched with DS water in children with atopic dermatitis (AD). Eighty six AD children were randomized in a double-blind controlled study to receive twice-daily topical treatment with a body cream enriched with DS minerals (TP) compared to two types of control: 1) DM, DS minerals with lower DS water concentrations than TP, and 2) an emollient (E) with no DS minerals. Efficacy was assessed by a change in clinical skin severity scores: SCORing Atopic Dermatitis (SCORAD), investigator’s global assessment (IGA) and patient global assessment (PGA) as well as by objective physiological parameters: transepidermal water loss (TEWL), stratum corneum hydration (SCH), affected body surface area (BSA) and Objective Severity Assessment of Atopic Dermatitis (OSAAD). The total length of the trial was 12 weeks divided to 6 visits at weeks 0, 2, 4, 6, 8, 12. The study showed that both TP and DM creams improved OSAAD scores. Only TP improved TEWL and SCH. TP was the most effective regarding TEWL, SCH and OSAAD compared to DM and E. Treatment with E decreased more significantly IGA score compared to TP. Although within each treatment group significant improvements in SCH, BSA, SCORAD, IGA and PGA were observed, the reduction in BSA, SCORAD and PGA was not significantly different among the groups. Our results clearly show the benefits of TP as a leave on-skin emulsion enrich with DS water in terms of skin barrier function. Thus, TP can serve as an effective adjuvant treatment for AD skin as well as for its maintenance.展开更多
A kind of aquatic gelatin was prepared from squid skin. The technological parameters for extracting gelatin were optimized by the method of orthogonal design. The fundamental properties of the raw material and gelatin...A kind of aquatic gelatin was prepared from squid skin. The technological parameters for extracting gelatin were optimized by the method of orthogonal design. The fundamental properties of the raw material and gelatin were analyzed. The results showed that the optimal extraction conditions were as follows： pH val- ue of 8, temperature at 70 ℃, material-to-liquid ratio at 1：4, and extraction time of 1.5 h. under such conditions, the highest yield of gelatin and the purity were 5.94% and 96.73%, respectively. The physicoehemical properties of squid skin gelatin were coincided with standards of edible gelatin. In addition, the contents of amino acids were similar to many kinds of aquatic gelatin.展开更多
The Baumann Skin Typing System diagnoses patients as having one of 16 skin types based on their answers to a validated questionnaire [i] known as the Baumann Skin Type Indicator [ii]. The BSTI questionnaire has been t...The Baumann Skin Typing System diagnoses patients as having one of 16 skin types based on their answers to a validated questionnaire [i] known as the Baumann Skin Type Indicator [ii]. The BSTI questionnaire has been tested over the last decade on over 200,000 people of various ages and ethnicities in different geographic locations around the world. In this study, data were collected from 52,862 patients to compare skin type prevalence between those who presented to doctor’s offices and those who took the quiz without supervision online. The most common skin types varied only slightly between patients that took the quiz online and those that completed the questionnaire in their doctor’s office. This indicates that the prevalence of skin types seen in the doctor’s office is similar to that in the general population and that supervision is not necessary to get an accurate result on the BSTI. [iii] In addition, comparison of data gathered in China, Korea, and the US did not show a significant difference in skin type prevalence between Asian and Caucasian skin types. [iv] This study demonstrates that the English version of the BSTI is valid for English speaking patients online, and in doctors’ offices in the US, China and Korea.展开更多
目的探讨基于加速康复外科(enhanced recovery after surgery,ERAS)理念下女性开颅手术患者切口周边微范围备皮法的应用实践效果。方法回顾性分析2021年5月—2022年5月在福建医科大学附属第一医院神经外科进行开颅手术的100例女性肿瘤患...目的探讨基于加速康复外科(enhanced recovery after surgery,ERAS)理念下女性开颅手术患者切口周边微范围备皮法的应用实践效果。方法回顾性分析2021年5月—2022年5月在福建医科大学附属第一医院神经外科进行开颅手术的100例女性肿瘤患者,其中对照组和观察组各50例,对照组采用传统全头备皮法,观察组采取基于ERAS理念下切口周边微范围备皮法。比较两组患者一般情况、备皮时间、重复备皮、切口愈合情况、颅内感染发生率、备皮满意度以及焦虑评分的差异。结果两组患者手术时间、出血量、住院时间、切口愈合情况、颅内感染发生率比较,差异无统计学意义(P>0.05);两组患者备皮时间、重复备皮、综合备皮满意度及焦虑评分比较,差异有统计学意义(P<0.05)。结论基于ERAS理念下切口周边微范围备皮法不仅没有影响开颅手术患者切口愈合情况以及颅内感染发生率,反而还提高了患者备皮满意度,减轻患者心理和生理负担,加快回归社会生活。展开更多
文摘术前皮肤准备(Preoperative skin preparation,PSP)是预防手术部位感染的重要方法。文章综述了PSP的基本原理、常见方法(包括物理和化学方法)以及最新研究进展,评价了不同方案的临床效果。传统方法如清洁剂、消毒剂仍为主流,但存在一些不足;新兴方法如聚维酮碘涂抹器、内窥镜消毒剂、紫外线消毒等正在兴起,具有一定潜力。未来术前皮肤准备方案仍需持续优化,以进一步降低手术部位感染(Surgical site infection,SSI)风险。
文摘目的:汇总体外透皮试验(In Vitro Permeation Test,IVPT)的设计要求和评价方法,并以Excel中函数公式计算IVPT,助力评价皮肤局部外用制剂仿制药研发质量与疗效。方法:对比美国食品药品管理局(Food and Drug Administration,FDA)、欧洲药品管理局(European Medicines Agency,EMA)、日本医药品医疗器械综合机构(Pharmaceuticals and Medical Devices Agency,PMDA)及国家药品监督管理局(National Medical Products Administration,NMPA)相关指导原则中IVPT设计要求及评价方法,并以Excel软件中函数公式计算IVPT,与SAS软件计算结果进行比较。结果:相比于EMA和PMDA对皮肤局部外用制剂仿制药IVPT的评价标准,FDA的评价标准更适合我们对仿制药IVPT进行评价,也较容易被我国药监部门所接受。体外透皮试验除皮肤膜选择PMDA推荐的大鼠、小鼠或猪等至少任何一种动物的腹部或背部外,其他设计可参考FDA指导原则相关建议。对于IVPT结果,Execl软件函数公式计算结果与SAS软件计算结果一致。结论:可优先采用FDA的皮肤局部外用制剂仿制药IVPT指导原则设计试验,并以其评价标准进行等效性评价。此外,本研究已验证Excel替代SAS软件准确计算IVPT,可用于判断皮肤局部外用制剂仿制药研发质量及生物等效性。
文摘Dead Sea (DS) mud and water are known for their unique composition of minerals, and for their therapeutic properties on inflammatory skin diseases. The objective of the study was to evaluate the efficacy of an emollient cream enriched with DS water in children with atopic dermatitis (AD). Eighty six AD children were randomized in a double-blind controlled study to receive twice-daily topical treatment with a body cream enriched with DS minerals (TP) compared to two types of control: 1) DM, DS minerals with lower DS water concentrations than TP, and 2) an emollient (E) with no DS minerals. Efficacy was assessed by a change in clinical skin severity scores: SCORing Atopic Dermatitis (SCORAD), investigator’s global assessment (IGA) and patient global assessment (PGA) as well as by objective physiological parameters: transepidermal water loss (TEWL), stratum corneum hydration (SCH), affected body surface area (BSA) and Objective Severity Assessment of Atopic Dermatitis (OSAAD). The total length of the trial was 12 weeks divided to 6 visits at weeks 0, 2, 4, 6, 8, 12. The study showed that both TP and DM creams improved OSAAD scores. Only TP improved TEWL and SCH. TP was the most effective regarding TEWL, SCH and OSAAD compared to DM and E. Treatment with E decreased more significantly IGA score compared to TP. Although within each treatment group significant improvements in SCH, BSA, SCORAD, IGA and PGA were observed, the reduction in BSA, SCORAD and PGA was not significantly different among the groups. Our results clearly show the benefits of TP as a leave on-skin emulsion enrich with DS water in terms of skin barrier function. Thus, TP can serve as an effective adjuvant treatment for AD skin as well as for its maintenance.
文摘A kind of aquatic gelatin was prepared from squid skin. The technological parameters for extracting gelatin were optimized by the method of orthogonal design. The fundamental properties of the raw material and gelatin were analyzed. The results showed that the optimal extraction conditions were as follows： pH val- ue of 8, temperature at 70 ℃, material-to-liquid ratio at 1：4, and extraction time of 1.5 h. under such conditions, the highest yield of gelatin and the purity were 5.94% and 96.73%, respectively. The physicoehemical properties of squid skin gelatin were coincided with standards of edible gelatin. In addition, the contents of amino acids were similar to many kinds of aquatic gelatin.
文摘The Baumann Skin Typing System diagnoses patients as having one of 16 skin types based on their answers to a validated questionnaire [i] known as the Baumann Skin Type Indicator [ii]. The BSTI questionnaire has been tested over the last decade on over 200,000 people of various ages and ethnicities in different geographic locations around the world. In this study, data were collected from 52,862 patients to compare skin type prevalence between those who presented to doctor’s offices and those who took the quiz without supervision online. The most common skin types varied only slightly between patients that took the quiz online and those that completed the questionnaire in their doctor’s office. This indicates that the prevalence of skin types seen in the doctor’s office is similar to that in the general population and that supervision is not necessary to get an accurate result on the BSTI. [iii] In addition, comparison of data gathered in China, Korea, and the US did not show a significant difference in skin type prevalence between Asian and Caucasian skin types. [iv] This study demonstrates that the English version of the BSTI is valid for English speaking patients online, and in doctors’ offices in the US, China and Korea.
文摘目的探讨基于加速康复外科(enhanced recovery after surgery,ERAS)理念下女性开颅手术患者切口周边微范围备皮法的应用实践效果。方法回顾性分析2021年5月—2022年5月在福建医科大学附属第一医院神经外科进行开颅手术的100例女性肿瘤患者,其中对照组和观察组各50例,对照组采用传统全头备皮法,观察组采取基于ERAS理念下切口周边微范围备皮法。比较两组患者一般情况、备皮时间、重复备皮、切口愈合情况、颅内感染发生率、备皮满意度以及焦虑评分的差异。结果两组患者手术时间、出血量、住院时间、切口愈合情况、颅内感染发生率比较,差异无统计学意义(P>0.05);两组患者备皮时间、重复备皮、综合备皮满意度及焦虑评分比较,差异有统计学意义(P<0.05)。结论基于ERAS理念下切口周边微范围备皮法不仅没有影响开颅手术患者切口愈合情况以及颅内感染发生率,反而还提高了患者备皮满意度,减轻患者心理和生理负担,加快回归社会生活。
