A Single Centre Open Label Non-Randomized Phase-IV Post Marketing Surveillance Study to Evaluate the Efficacy and Safety of Roop Mantra Ayurvedic Medicinal Cream

Objectives: The objective of the study was to evaluate the efficacy and safety of a polyherbal Roop Mantra Ayurvedic Medicinal Cream in subjects with acne, facial scars, pimples, blemishes, dull and dry skin. Methods: This was a 60-day, single-centre, open-labelled, non-randomized phase-IV surveillance study with 120 subjects. Subjects were selected based on the study's inclusion criteria. The study included three scheduled clinical visits on days 0 (screening and baseline visit), 30 (follow-up visit), and 60 (final visit). Following an evaluation of baseline data, all subjects were given Roop Mantra Ayurvedic Medicinal Cream for 60 days. The primary outcome of the study was to assess the efficacy of Roop Mantra Ayurvedic Medicinal Cream based on changes in parameters such as skin texture, skin health, global acne assessment parameters and an investigator assessment scale. The secondary outcome of the study was the determination of local intolerance and adverse effects to Roop Mantra Ayurvedic Medicinal Cream . Results: The study findings revealed that the use of Roop Mantra Ayurvedic Medicinal Cream for 60 days improved skin texture and appearance while significantly reducing acne, pimples, blemishes, and skin dryness. Roop Mantra Ayurvedic Medicinal Cream was likewise dermatologically well tolerated and did not cause any adverse effects during the study period. Conclusion: Roop Mantra Ayurvedic Medicinal Cream showed highly satisfactory results in terms of skin texture, skin appearance and general acne parameters without having any adverse effects on the skin. Given the positive outcomes, Roop Mantra Ayurvedic Medicinal Cream is clinically effective and safe alternative for treating various skin problems.

The therapeutic efficacy of compound lidocaine cream on psoriasis / 药学学报

Psoriasis is a non-infectious chronic inflammatory skin disease. It′s acknowledged that interleukin (IL)-17 signaling pathway dominantly drives the development of psoriasis. Recently, the role of neuro-immune axis in psoriasis has attracted widespread attention. Lidocaine, a local anesthetic, has ability to block the conduction of nerve impulses, while its therapeutic efficacy on psoriasis remains to be confirmed. Here, we evaluated the therapeutic efficacy of topical application of compound lidocaine cream (LIDO) on imiquimod (IMQ)-induced mouse psoriasis model. Animal welfare and experimental procedures follow the regulations of the Ethics Committee of China Pharmaceutical University. The psoriasis area and severity index (PASI) scoring was used to evaluate the severity of psoriasis-like symptoms. Hematoxylin-eosin staining was used to examine histopathological changes and epidermal thickness was measured. Ki67 immunofluorescence staining was used to evaluate the proliferation of keratinocytes. The relative mRNA expression of inflammatory cytokines (including Il17, Il22, Il23 and Il36) in skin was measured by real-time quantitative PCR. Results show that IMQ-induced increases in the PASI score, epidermal thickness, number of Ki67+ cells and the mRNA expression of inflammatory cytokines are significantly alleviated by topical application of LIDO, whose therapeutic efficacy is also better than that of the positive control drug calcipotriol. Our study suggests that LIDO could be used for psoriasis treatment.

Effects of lattice superpulsed CO 2 laser combined with asiaticoside cream ointment on repair of facial depression acne scar / 中华医学美学美容杂志

Objective:To investigate the effect of lattice superpulsed CO 2 laser combined with asiaticoside cream ointment on the repair of facial depression acne scar. Methods:A total of 124 patients with facial acne depression scar who visited the dermatology department of Zhengzhou People's Hospital from January 2019 to December 2020 were selected as subjects, including 60 males and 64 females, aged 16-38 (27.2±4.8) years. According to the random number table, the patients were divided into the control group ( n=62) and observation group ( n=62). The control group were treated with lattice superpulsed CO 2 laser, and the observation group were treated with lattice superpulsed CO 2 laser combined with asiaticoside cream ointment for 6 months. The therapeutic efficacy, Vancouver scar scale (VSS), ECCA score, skin barrier related indicators, pain duration, healing time, delayed duration and adverse reactions were compared between the two groups. Results:The total effective rate in the observation group (91.94%) was significantly higher than that in the control group (77.42%) (χ 2=5.04, P<0.05), pain duration, scab formation time, scab removal time, complete healing time, delay period and the incidence of adverse reactions were significantly lower than those in the control group [(2.76±1.04) h, (2.64±1.03) d, (6.18±1.47) d, (8.87±1.75) d, (7.89±2.16) d, 3.23% vs. (4.11±1.29) h, (3.87±1.14) d, (7.24±1.56) d, (11.05±1.93) d, (10.52±3.01) d, 12.90%, detection value = 6.42, 6.30, 3.90, 6.59, 5.59, 3.92, P<0.05]. After treatment, the VSS scale and ECCA score in the observation group were significantly lower than those in the control group (5.71±1.06, 39.12±10.64 vs. 6.42±1.17, 42.61±11.51, t=3.54, 2.26, P<0.05). After treatment, the water content of cuticle in the observation group was significantly higher than that in the control group [(40.02±14.14) vs. (34.35±11.50) AU, t=2.45, P<0.05], and transepidermal water loss, lactic acid stimulation test score and cuticle protein content were significantly lower than those in the control group [(19.07±5.70) g/(h·m 2), (2.62±1.27) score, (30.12±10.63) μg vs. (21.39±6.51) g/(h·m 2), (3.25±1.89) score, (35.10±11.19) μg, t=2.11, 2.18, 2.54, P<0.05]. Conclusions:Lattice superpulsed CO 2 laser combined with asiaticoside cream ointmentis can effectively treat acne scar and reduce adverse reactions, and the curative effect is better than single laser treatment.

Analysis of the efficacy of negative pressure suction and topical testosterone cream in the treatment of simple micropenis in school-aged obese children / 现代泌尿外科杂志

【Objective】 To investigate the efficacy of negative pressure suction and topical testosterone cream in the treatment of simple micropenis in school-aged obese children and the effects on blood lipids and serum sex hormones. 【Methods】 A total of 79 children aged 7 to 14 (10.50±1.62) years treated and followed up during Nov.2020 and Jul.2022 were involved. The patients were randomly enrolled in the negative pressure suction group (n=39) and the topical testosterone cream group (n=40). The negative pressure suction group was treated with negative pressure suction for 30 min/time, 1 time/day, for 30 d. The topical testosterone cream group was treated with topical testosterone cream applied to the scrotum of the penis 2 times/day for 30d. The transverse and longitudinal diameter of the glans, penile flaccidity, retraction length, serum sex hormones and blood lipids were measured before and after treatment. 【Results】 In both groups, penile flaccidity, retracted length and transverse and longitudinal diameter of the glans were significantly greater at 30 days of treatment and 2 months of follow-up than those before treatment (P0.025). In the topical testosterone cream group, at 30 days of treatment, there were significant differences in serum total cholesterol (CHOL), apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), high-density lipoprotein (HDL), low-density lipoprotein (LDL), sex hormone binding protein (SBG), estradiol (E2) and testosterone (TES) compared to those before treatment; at 2 months of follow-up, the differences in Apo A1, HDL, TES and DHS were still significant (P<0.025). 【Conclusion】 Both topical testosterone cream and negative pressure suction have significant efficacy in the treatment of micropenis in school-aged obese children, while topical testosterone cream has some side effects and retraction may occur after treatment. Negative pressure suction is safe and easy to operate, without side effects and retraction, and can be promoted for the treatment of micropenis in obese children.

Efficacy of low-frequency neuromuscular electrical stimulation in the treatment of penile hypersensitive premature ejaculation / 现代泌尿外科杂志

【Objective】 To investigate the efficacy of low-frequency neuromuscular electrical stimulation in the treatment of penile hypersensitive premature ejaculation. 【Methods】 A total of 66 patients treated during Nov.2021 and Aug.2022 were randomly divided into electrical stimulation group (n=22), local anesthesia group (n=21), and combined therapy group (n=23). The electrical stimulation group received low-frequency neuromuscular electrical stimulation, 5 times a week;the local anesthesia group used compound lidocaine cream 30 minutes before sexual intercourse;the combined therapy group received both treatments. After 3-month treatment, the latency of dorsal nerve somatosensory evoked potential (DNSEP), glans penis somatosensory evoked potential (GPSEP), intravaginal ejaculation latency time (IELT), premature ejaculation diagnostic tool score (PEDT), and spouse sexual satisfaction score were collected. 【Results】 After treatment, IELT, PEDT, spouse’s sexual life satisfaction score, DNSEP and GPSEP of the three groups were significantly improved (P0.05). 【Conclusion】 Low-frequency neuromuscular electrical stimulation is effective in the treatment of penile hypersensitive premature ejaculation, and the combination of local anesthetics is more effective, which is worthy of clinical application and promotion.

Study on the mechanism of haitongpi prescription extract ointment in the treatment of knee osteoarthritis based on transcriptome / 中国骨伤

OBJECTIVE@#To explore the mechanism of Haitongpi Prescription extract in the treatment of knee osteoarthritis based on transcriptome.@*METHODS@#Total of 12 SPF grade rats were divided into control group(group C), model group(group M), and Haitongpi prescription group(group HP). The knee osteoarthritis rat model was established using the Panicker method for group M and group HP, and group HP was intervened by local topical application of Haitongpi Prescription extract for 4 weeks. Total RNA from mouse knee cartilage was extracted and three sets of differential genes were obtained through sequencing.Differential genes were prediction and analysis through GO function and KEGG pathway enrichment analysis.@*RESULTS@#A total of 109 differentially expressed genes were identified in Group C versus Group M, while 118 differentially expressed genes were identified in Group M versus Group HP, resulting in a total of 28 genes. GO functional enrichment analysis showed that the mechanism of HP extract in treating knee osteoarthritis mainly involved immunoglobulin mediated immune response, immunoglobulin complexes, and antigen binding; KEGG pathway enrichment analysis showed correlation with tumor necrosis factor (TNF) signaling pathway, interleukin 17(IL-17) signaling pathway, and estrogen signaling pathway.@*CONCLUSION@#HP extract can exert therapeutic effects on knee osteoarthritis through mechanisms such as immunoglobulin mediated immune response, immunoglobulin complexes, and antigen binding, as well as signaling pathways such as TNF signaling pathway, IL-17 signaling pathway, and estrogen signaling pathway.

Terapia tópica para prevenção e tratamento da radiodermatite aguda das mamas: revisão integrativa da literatura / Topical treatment for prevention and management of acute radiation dermatitis in breast cancer patients: an integrative review

Introdução: A radioterapia desempenha um importante papel adjuvante ao tratamento cirúrgico do câncer de mama, pois diminui as taxas de recorrência local e aumenta a sobrevida global. Entretanto, até 95% das pacientes expostas à radiação ionizante desenvolverão algum grau de radiodermatite. O presente estudo revisa a literatura referente às terapias tópicas disponíveis para prevenção e tratamento da radiodermatite aguda das mamas, sintetizando as evidências disponíveis e auxiliando a tomada de decisão clínica. Métodos: Revisão integrativa da literatura publicada nos últimos 10 anos, utilizando as bases de dados LILACS, Medline e Biblioteca Cochrane. Foram utilizados os descritores neoplasias da mama, radiodermatite, higiene da pele e creme para a pele. Resultados: Dos 158 artigos encontrados, 48 foram incluídos nesta revisão. Foram identificadas 40 diferentes terapias tópicas que foram agrupadas em sete categorias para facilitar a análise e interpretação dos dados: fitoterápicos, hormônios/vitaminas/fatores de crescimento, corticoesteroides, barreira (filme ou creme), ácido hialurônico, curativos à base de prata e outros. Conclusões: Existe evidência científica proveniente de ensaios clínicos randomizados de boa qualidade embasando a indicação dos corticosteroides tópicos de alta (valerato de 17-betametasona) e média potência (furoato de mometasona 0,1%), assim como de filmes barreira como Mepitel®, Mepilex Lite® e Hydrofilm®, no manejo da radiodermatite aguda das mamas. As demais terapias não mostraram benefícios na prevenção e/ou tratamento da radiodermatite ou têm evidência científica limitada, contraindicando ou restringindo sua utilização na prática clínica.

Introduction: Radiotherapy plays an important adjuvant role in the surgical treatment of breast cancer by reducing locoregional recurrence and improving overall survival. However, up to 95% of patients experience some degree of radiodermatitis. This study aims to review the literature regarding topical agent therapies in preventing and treating acute radiation dermatitis in breast cancer patients. Methods: Integrative review of LILACS, Medline and Cochrane Library databases. We searched for original articles published between 2010 and 2020, including the descriptors breast neoplasms, radiodermatitis, skincare, and skin cream. Results: The initial search returned 158 articles. After screening for eligibility, 48 articles were included. Forty different topical agent therapies were identified and grouped into seven categories to facilitate data analysis: herbal medicines, hormones/vitamins/growth factors, topical corticosteroids, barrier products (film or cream), hyaluronic acid, silver-based dressings and others. Conclusions: This review identifies that topical corticosteroids of high (betamethasone-17-valerate) and medium potency (mometasone furoate 0.1%), as well as barrier films such as Mepitel®, Mepilex Lite®, and Hydrofilm®, are effective in managing acute breast radiodermatitis. The other topical agent therapies did not show benefits in preventing and/or treating acute radiodermatitis or have limited evidence.

O efeito do ácido ascórbico tópico na cicatrização cutânea / The effect of topical ascorbic acid on cutaneous healing

Introdução: A ferida cirúrgica apresenta altos níveis de radicais livres em resposta ao dano cutâneo, o que gera a hipótese de um possível benefício do uso de antioxidantes no reparo destas feridas, tal como a aplicação tópica do ácido ascórbico. No entanto, pesquisas recentes obtiveram conclusões discrepantes para este tipo de tratamento. O objetivo é avaliar o efeito do ácido ascórbico tópico na cicatrização cutânea por meio de uma revisão de escopo. Métodos: A revisão de escopo foi realizada na base de dados Medline, Lilacs e Cochrane, com os descritores: ácido ascórbico, creme para a pele e cicatrização de feridas. Foram definidos como critérios de inclusão: ensaios clínicos randomizados, observacionais e revisões sistemáticas, em humanos, com data de publicação de até 5 anos, nas línguas inglesa, portuguesa ou espanhola. Foram excluídas: revisões narrativas, dissertações, teses, editoriais, estudos in vitro e em animais. Por fim, foi realizada a classificação dos estudos através da metodologia GRADE. Resultados: Foram encontrados 83 estudos e, após triagem, seis artigos foram selecionados. Destacou-se o uso do ácido ascórbico na concentração de 5 a 20% e de seus derivados (0,075% a 9,55%). Apresentaram a qualidade GRADE moderada os desfechos: aumento da firmeza cutânea e redução da vermelhidão, e alta qualidade: melhora na hidratação, elasticidade, colorometria das manchas e melhora do fechamento das feridas. Conclusão: O ácido ascórbico promove melhor elasticidade cutânea, diminuição do eritema e melhor fechamento das feridas. Apesar destes fortes indícios, ensaios clínicos randomizados com menor risco de viés de aferição e com maior casuística ainda se fazem necessários.

Introduction: The surgical wound has high levels of free radicals in response to skin damage, which raises the hypothesis of a possible benefit from using antioxidants in repairing these wounds, such as the topical application of ascorbic acid. However, recent research has found conflicting conclusions about this type of treatment. The objective is to evaluate the effect of topical ascorbic acid on skin healing through a scope review. Methods: The scope review was carried out in the Medline, Lilacs and Cochrane databases, with the descriptors: ascorbic acid, skin cream, and wound healing. Inclusion criteria were defined as randomized clinical trials, observational and systematic reviews, in humans, with a publication date of up to 5 years, in English, Portuguese or Spanish. The following were excluded: narrative reviews, dissertations, theses, editorials, in vitro and animal studies. Finally, the studies were classified using the GRADE methodology. Results: 83 studies were found, and six articles were selected after screening. The use of ascorbic acid in the concentration of 5 to 20% and its derivatives (0.075% to 9.55%) stood out. The outcomes presented a moderate GRADE quality: increased skin firmness and reduced redness, and high quality: improved hydration, elasticity, colorimetry of the stains and improved wound closure. Conclusion: Ascorbic acid promotes better skin elasticity, reduced erythema and better wound closure. Despite these strong indications, randomized clinical trials with a lower risk of measurement bias and greater casuistry are still necessary.

Efficacy of 1% clotrimazole drops vs. 1% clotrimazole cream vs 10% povidone-iodine in the treatment of otomycosis - A randomized controlled study

Introduction: Otomycosis is a term used to describe the epithelial infection caused by yeast and filamentous fungi, in the External Auditory Canal (EAC). It is one of the common infections seen in ENT OPD because of its prevalence in hot and humid climate. Due its high recurrence rate and different treatment modalities, it’s important to come out with ideal treatment modality. Aim: To compare efficacy of 1% clotrimazole drops vs. 1% clotrimazole cream vs 10% povidone- iodine in the treatment of otomycosis. Materials and methods: Randomized control study was performed for 2 months on clinically diagnosed otomycosis patients. Total 60 patients were included in the study, which were randomly divided in 3 groups and treated by 1% clotrimazole drops, 1% clotrimazole cream and 10% povidone- iodine respectively. Patients were reviewed after 7 days on the basis of clinical response and symptoms of pain, ear blockage, pruritus and burning sensation. Results: After 7 days of treatment groups treated with 1 % clotimazole drops and cream had good response of 90% and 95% as compared to 10% povidone-iodine group which was 70%. Clotrimazole cream group had more ear blockage complain which was 75% and clotrimazole drops group had more burning sensation complain which was 55%.Conclusion: 1% clotrimazole drops and cream are equally effective in management of otomycosis but 10% povidone-iodine can be considered if patient has complain of ear blockage and burning sensation.

Application of a cream containing madecassoside and 5% panthenol in skin repairing after nonablative fractional laser resurfacing / 中华医学美学美容杂志

Objective:To evaluate the clinical efficacy and safety of a cream containing madecassoside, 5% panthenolon skin repairing after nonablative fractional 1 565 nm laser therapy.Methods:A total of 84 patients who received nonablative fractional laser surgery in our hospital from April 2017 to April 2018 were included as research objects. The patients were divided into observation group and control group by random number table method, 42 cases in each group. The control group was treated with routine facial intervention after operation, while the observation group was treated with a cream containing madecassoside, 5% panthenolon skin repairing on the basis of routine intervention. The postoperative skin barrier function of the two groups were recorded and compared through skin property system and VISIA complexion analysis system.Results:At 1 and 2 weeks after operation, the sebum content and cuticle water content in the observation group were higher than those in the control group, and the transdermal water loss in the observation group was less than that in the control group, and the differences were statistically significant ( t=4.927, 7.833, 12.430, 4.538, 10.083, 8.017, P<0.05). The erythema index (EI) and melanin index (MI) of the observation group were lower than those of the control group at 1 and 2 weeks after operation, and the incidence of complications was significantly lower than that of the control group ( t=2.392, 2.807, 3.485, 3.009, P<0.05). Conclusions:The application of a cream containing madecassoside, 5% panthenolon in skin repairing is helpful to enhance the moisturizing effect, reduce the complications and promote the early recovery of patients with skin trauma after fractional laser operation.

Clinical efficacy of mucopolysaccharide polysulfate cream in combination with sertaconazole nitrate cream in the treatment of scaly hyperkeratotic tinea pedis / 中华皮肤科杂志

Objective:To investigate clinical efficacy of mucopolysaccharide polysulfate cream combined with sertaconazole nitrate cream in the treatment of scaly hyperkeratotic tinea pedis.Methods:From March 2019 to January 2020, 100 patients with scaly hyperkeratotic tinea pedis were enrolled into this study, and randomly and equally divided into 2 groups by using a random number table: control group treated with topical sertaconazole nitrate cream alone at a dose of 0.5-1 g twice a day; combined group treated with topical mucopolysaccharide polysulfate cream at a dose of 0.5-1 g followed by topical sertaconazole nitrate cream at a dose of 0.5-1 g 30 minutes later, which were performed twice a day. The treatment lasted 4 weeks. The time to clinical symptom relief, efficacy and incidence of adverse reactions were compared between the two groups. Dermatology life quality index (DLQI) was assessed at 0, 2 and 4 weeks after the start of treatment. Two-independent-sample t test, repeated measures analysis of variance and chi-square test were used for statistical analysis. Results:After treatment, the time to pruritus relief and that to desquamation improvement were 6.05 ± 1.98 and 12.03 ± 3.92 days respectively in the combined group, which were significantly shorter than those in the control group (8.39 ± 2.11, 15.11 ± 4.05 days, t = 5.72, 3.86, respectively, both P < 0.001) . During the 4 weeks of treatment, DLQI scores gradually decreased in both the 2 groups (all P < 0.001) , which were significantly lower in the combined group than in the control group at weeks 2 and 4 (both P < 0.001) . After 4-week treatment, the total response rate was 98% (49/50) in the combined group, significantly higher than that in the control group (82%, 41/50; χ2= 7.11, P= 0.007) . There was no significant difference in the incidence of adverse reactions between the two groups ( P > 0.05) . Conclusion:Mucopolysaccharide polysulfate cream can improve the efficacy of sertaconazole nitrate cream in the treatment of scaly hyperkeratotic tinea pedis.

Effects of cold spray on pain after non-coring needle insertion into totally implantable access port / 中华临床营养杂志

Objective:To study the effects of cold spray on pain after non-coring needle insertion.Methods:This was a randomized controlled study. Patients with totally implantable access port (TIAP) were randomly divided into the experimental group and the control group. The experimental group were given cold spray, while the control group were given eutectic mixture of local anesthetics cream (EMLA). The severity of pain, comfort and satisfaction, right-first-time insertion rate and skin reaction incidence were compared between groups.Results:29 patients were included in each of the two groups. The pain assessed with numeric rating scale in the experimental group was less severe than the control group ([1.52±1.02] vs [2.24±1.62]). However, there was no significant difference (d=-0.02 [95% CI:-0.55~0.51], P=0.109). The right-first-time insertion rate was 100% for both groups. The incidence of skin reactions in experimental group was lower (ARR=27.6% [95% CI: 11.32%~43.86%], P=0.008), and comfort scores ( d=-0.97 [95% CI: -0.42~-1.52], P<0.01) and satisfaction scores(ARR=13.8% [95% CI: 1.24%~26.34%], P=0.013) were significantly higher compared with control group. Conclusions:There was no statistically significant difference in the analgesic effect of cold spray and EMLA on pain from non-coring needle insertion. Cold spray acted quickly, comfortably and safely, resulting in better patient satisfaction.

Diphenhydramine hydrochloride asaay in compound diphenhydramine cream by HPLC / 药学实践杂志

Objective To establish the HPLC method of assay for diphenhydramine hydrochloride in compound diphenhydramine cream. Method HPLC analysis was carried on ACE5C18S/N-A66766 column (150 mm×4.6 mm, 5 µm) with the mobile phase of methanol-water-triethylamine (70:30:0.67, adjusting pH to 6.50 with phosphoric acid) at room temperature. The detection wavelength was set at 230 nm and the flow rate was 1.0 ml/min. The analyte was extracted from the cream and 20 μl of sample was injected. Results The calibration curve of diphenhydramine hydrochloride was linear in the range of 39.52-197.6 µg/ml (r=0.999 7). The average recovery of diphenhydramine hydrochloride was 100.5% (RSD=1.25%, n=9). The repeatability of the method was expressed using RSD with 0.78% (n=6). The results of assay were 101.3%, 99.83% and 99.62%. Conclusion The method is accurate, sensitive, selective and repeatable, which can be applied for improving the quality standard of compound diphenhydramine cream.

Study on quality standard of Jingtian Zhitong cream / 药学实践杂志

Objective To revise the determination method in the quality standard of Jingtian Zhitong cream. Methods The total saponins of angelica sinensis, Ligusticum wallichii, Rhizoma corydalis, and Panax notoginseng saponins were qualitatively identified by thin-layer chromatography (TLC). The contents of notoginsenoside R1, ginsenoside Rg1, and ginsenoside Rb1 in the preparation were determined by high performance liquid chromatography (HPLC). Results TLC showed strong specificity and good resolution. The concentration of notoginsenoside R1 showed a good linear relationship in the range of 0.1604 and 2.0050μg (r=0. 999). The concentration of ginsenoside Rg1 showed a good linear relationship in the range of 0.8003 and 10.0035μg (r=1.000). The concentration of ginsenoside Rb1 showed good linearity in the range of 0.6182 and 7.7275μg (r=1.000). The sample recovery rates were 101.43%, 98.75% and 100.95%, respectively. The relative standard deviation (RSD) were 2.56%, 2.71% and 2.75%, respectively. Conclusion The developed method is accurate and reliable with high sensitivity, which can be used for the quality control of Jingtian Zhitong cream.

Incorporación de un novedoso complejo de tinidazol con propiedades antimicrobianas a dos formas semisólidas de uso tópico / Incorporation of a novel tinidazole complex with antimicrobial properties into two semi-solid topical forms / Incorporação de um novo complexo de tinidazol com propriedades antimicrobianas a duas formas semissólidas para uso tópico

RESUMEN Introducción: El aumento de la resistencia bacteriana a los antibióticos comúnmente empleados para el tratamiento de infecciones cutáneas pone en manifiesto la necesidad de encontrar medicamentos alternativos y eficaces, capaces de contrarrestar este problema de salud que no sólo implica una región, sino que se ha convertido en un problema de salud mundial. Se ha demostrado que un novedoso complejo a base de tinidazol y cobre ([Cu(tnz)2(NO3)2]) posee buena actividad antimicrobiana, sin embargo, para que pueda emplearse como una alternativa para el uso tópico, debe poseer las características necesarias para incorporarse en una formulación que permita su aplicación. Objetivo: Las formas farmacéuticas semisólidas constituyen el grupo más empleado dentro de las formulaciones dermatológicas; se elaboraron dos tipos formulaciones una tipo crema y otra crema-gel, con el fin de verificar en cuál de ellas incorpora convenientemente el complejo [Cu(tnz)2(NO3)2]. Para ambas formulaciones se determinaron las propiedades organolépticas, pH, área de extensibilidad, viscosidad, y tamaño de partícula del complejo. Resultados: Obtenidos evidencian las ventajas de la formulación tipo crema frente a la crema-gel.

SUMMARY Introduction: The increase in bacterial resistance to antibiotics commonly used for the treatment of skin infections highlights the need to find alternative and effective drugs, capable of counteracting this health problem that not only involves a region but has become into a global health problem. A novel complex based on tinidazole and copper ([Cu(tnz)2(NO3)2]) has been shown to have good antimicrobial activity, however, in order to be used as an alternative for topical use, it must have the characteristics necessary to be incorporated into a formulation that allows its application. Aim: Semi-solid pharmaceutical forms are the most widely used group within dermatological formulations; Two types of formulations were elaborated, one type of cream and the other cream-gel, in order to verify in which of them the complex [Cu(tnz)2(NO3)2] is conveniently incorporated. For both formulations, the organoleptic properties, pH, area of extensibility, viscosity, and particle size of the complex were determined. Results: Obtained show the advantages of the cream-type formulation compared to the cream-gel.

RESUMO Introdução: O aumento da resistência bacteriana aos antibióticos comumente utilizados no tratamento de infecções cutâneas evidencia a necessidade de encontrar medicamentos alternativos e eficazes, capazes de fazer frente a esse problema de saúde que não envolve apenas uma região, mas se tornou um problema de saúde global. Um novo complexo à base de tinidazol e cobre ([Cu(tnz)2(NO3)2]) demonstrou ter boa atividade antimicrobiana, porém, para ser utilizado como alternativa para uso tópico, deve ter as características necessárias para ser incorporado em uma formulação que permita sua aplicação. Objetivo: As formas farmacêuticas semissól-idas são o grupo mais utilizado nas formulações dermatológicas; foram elaborados dois tipos de formulações, um tipo creme e outra creme-gel, a fim de verificar em qual delas o complexo [Cu(tnz)2(NO3)2] está convenientemente incorporado. Para ambas as formulações foram determinadas as propriedades organolépticas, pH, área de extensibilidade, viscosidade e tamanho de partícula do complexo. Resultados: Os obtidos mostram as vantagens da formulação tipo creme em relação ao gel-creme.

Microbiological evaluation of pasty and soft ice cream / Avaliação microbiológica de sorvetes pastosos e expressos / Evaluación microbiológica de helados pastosos y suaves

Ice cream is susceptible to contamination by handling and bad hygiene conditions during both the storage process and the fractioning for sale, and once contaminated, it can cause diseases. The purpose of this survey was to evaluate the microbiological quality of ice cream sold in bulk, of pasty and soft types, offered for consuming. Thirty samples of pasty ice cream sold in bulk, and thirty samples of soft ice cream were analyzed through the counting of thermotolerant coliforms, coagulase-positive Staphylococcus spp., and searching for the presence of Salmonella spp. During the study, a total of ten (33%) samples of pasty ice cream and five (16%) samples of soft ice cream were found to be beyond the limits established by the Brazilian law. Salmonella spp. was found in four samples (6.7%). These results are an alert for the need of greater attention to the microbiological quality of ice cream in order to ensure the safety of its consumers.(AU)

Os sorvetes são suscetíveis à contaminação pela manipulação e más condições higiênicas durante o processamento, armazenamento e do fracionamento para venda, uma vez contaminados podem causar doenças. O objetivo deste estudo foi avaliar a qualidade microbiológica de sorvetes, vendidos a granel, pastosos e expressos, oferecidos para consumo. Trinta amostras de sorvete pastoso, vendido a granel, e trinta amostras de sorvete expresso foram analisadas realizando-se contagem de coliformes termotolerantes, Staphylococcus spp. coagulase-positiva e pesquisando-se a presença de Salmonella spp. Foram detectadas dez (33%) amostras de sorvete pastoso e cinco (16%) amostras de sorvete expresso fora dos limites estabelecidos pela legislação brasileira. Salmonella spp. foi encontrado em quatro amostras (6,7%). Esses resultados alertam para a necessidade de uma maior atenção à qualidade microbiológica dos sorvetes, a fim de garantir a segurança do consumidor.(AU)

Los helados son susceptibles a la contaminación por manipulación y malas condiciones higiénicas durante el procesamiento, almacenamiento y fraccionamiento para venta, una vez contaminados pueden causar enfermedades. El objetivo de este estudio ha sido evaluar la calidad microbiológica de helados vendidos a granel, pastosos y suaves, ofrecidos para el consumo. Se analizaron treinta muestras de helados pastosos vendidos a granel, y treinta muestras de helados suaves, realizándose el conteo de coliformes termotolerantes, Staphylococcus spp. coagulase positiva e investigándose la presencia de Salmonella spp. Se detectaron diez (33%) muestras de helado pastoso y cinco (16%) muestras de helado blando fuera de los límites establecidos por la legislación brasileña. Salmonella spp. se encontró en cuatro muestras (6,7%). Esos resultados destacan la necesidad de una mayor atención a la calidad microbiológica de los helados, con el fin de garantizar la seguridad del consumidor.(AU)

Soothing moisturizing repair cream in promoting wound repair of acne depressed scar after laser operation: a clinical analysis / 中华医学美学美容杂志

Objective:To investigate the effectiveness and safety of soothing moisturizing repair cream on acne depressed scar exfoliative fractional laser wound repair.Methods:From October 2018 to June 2020, the Department of Dermatology, Qingdao Haici Hospital Affiliated to Qingdao University took 33 patients with acne depressed scars as the research object, including 8 males and 25 females, aged from 20 to 36 years (29.6±8.6) years. The left and right face comparison method was adopted. After laser operation, the trial side was given a soothing moisturizing repair cream, and the control side was given a placebo. By collecting the patient's facial pictures and objective skin data before and after the laser operation, 1 h, 1 d, 3 d, 7 d, 21 d, and combined with the researcher's semi-subjective evaluation and patient's subjective evaluation the wound skin reaction and wound healing were observed.Results:At 1, 3, 7, 21 days after laser operation, the skin water content of the test side was higher than that of the control side ( P<0.05), and the skin water loss was lower than the control side ( P<0.05); at 3, 7, 21 days, the skin pigment of the test side was lower than the control side ( P<0.05); at 3, 7 d, the test side skin erythema index was lower than the control side ( P<0.05); at 1, 3, 7 d, the test side wound skin erythema, edema, dryness and tightness, etc. were better than the control side ( P<0.05). The duration of pain, crusting time, scab removal time, and complete healing time of the wound on the test side were shorter than those on the control side ( P<0.05). The patient's satisfaction with the moisturization and comfort of the nursing products on the trial side was better than that on the control side ( P<0.05). Conclusions:There is no adverse reaction to the soothing moisturizing repair cream after laser surgery, which can better inhibit skin inflammation, reduce post-inflammatory pigmentation, promote skin healing, and help repair the wound after laser surgery.

Clinical effects of isotretinoin combined with anti-sensitive moisturizing tolerance-extreme cream on severe acne / 中华医学美学美容杂志

Objective:To observe the efficacy of anti-sensitive moisturizing tolerance-extreme cream combined with isotretinoin in the treatment of severe acne.Methods:Fifty patients with severe acne were selected in the Dermatology Clinic of the Third People＇s Hospital of Hangzhou from November 2018 to July 2019. They were randomly divided into the experimental group of 25 cases and the control group of 25 cases. The experimental group was treated with anti-sensitive moisturizing tolerance-extreme cream combined with isotretinoin orally. The control group was treated with isotretinoin orally alone. Before and after treatment for 56 days, lactate score, skin cuticle hydration (SCH), transepidermal water loss (TEWL) and skin physiological indexes were measured.Results:After 56 days of treatment, the TEWL and SCH of the control group were 15.75±3.31 and 10.13±3.62, the TEWL and SCH of the experimental group were 12.17±3.61 and 28.07±3.17, respectively; the difference was statistically significant ( T was 3.610 and 12.398, P was 0.002 and 0.000, respectively). The volume and depth of cyst nodule, scar depression, skin roughness, absolute value and area of erythema in the experimental group were significantly lower than those in the control group ( T was 2.280, 1.676, 2.332, 1.508, 4.813 and 3.637; P was 0.031, 0.011, 0.027, 0.040, 0.000 and 0.001, respectively). Conclusions:Anti-sensitive moisturizing tolerance-extreme cream combined with isotretinoin has a good effect on severe acne and it can reduce the barrier damage and other adverse reactions.

Efficacy and safety of two prolonged therapeutic regimens in patients with plaque psoriasis after treatment with tazarotene/betamethasone dipropionate cream: a multicenter clinical observation / 中华皮肤科杂志

Objective:To explore the prolonged therapeutic regimen for patients with plaque psoriasis, who showed a positive response to 4-week treatment with tazarotene/betamethasone dipropionate cream, but were not completely cured.Methods:A multicenter, randomized, open-labelled, parallel-controlled clinical study was conducted. A total of 232 patients with plaque psoriasis were collected, who showed a positive response to previous 4-week treatment with 0.05%/0.05% tazarotene/betamethasone dipropionate cream, but were not completely cured with the psoriasis area and severity index[PASI] improvement rate being 50%-90%. At week 5, they were randomly and equally divided into 2 groups: test group receiving treatment with 0.05%/0.05% tazarotene/betamethasone dipropionate cream once a day, and control group receiving a sequential regimen of 0.05% tazarotene gel on weekdays once a day followed by 0.05%/0.05% tazarotene/betamethasone dipropionate cream on weekends once a day. After 2-and 4-week prolonged treatment, the efficacy and safety of the 2 therapeutic regimens were evaluated and compared. Measurement data were compared between 2 groups by using covariance analysis or t test, and enumeration data were compared by using chi-square test. Results:From the 5th to the 8th week, 200 out of the 232 patients completed the treatment. Data collected from 110 patients in the test group and 112 in the control group were enrolled into the full analysis set, and those from both 113 patients in the test group and control group were enrolled into safety analysis set. After consecutive 6-and 8-week treatment, the decline rates of the PASI score were 73.05% ± 16.69% and 78.46% ± 15.40% respectively in the test group, which were significantly higher than those in the control group (66.73% ± 21.77%, 67.02% ± 34.19%, respectively, both P < 0.05) . After 6-week treatment, the proportion of subjects who achieved PASI90 was significantly higher in the test group (14 cases, 12.7%) than in the control group (5 cases, 4.5%, χ2=4.842, P=0.028) ; After 8-week treatment, the proportions of subjects who achieved PASI75 and PASI90 (61.8%, 23.6%, respectively) were significantly higher in the test group than in the control group (48.2%, 12.5%, respectively, both P < 0.05) . During the consecutive 8-week treatment, there was no significant difference in the incidence rate of adverse reactions between the test group (15.0%) and control group (23.9%, χ2=2.822, P=0.093) . Conclusion:For patients who showed a positive response to 4-week treatment with 0.05%/0.05% tazarotene/betamethasone dipropionate cream, but were not completely cured, the continuous use of 0.05%/0.05% tazarotene/betamethasone dipropionate cream for 4 weeks is a superior therapeutic regimen compared with the sequential regimen of 0.05% tazarotene gel followed by 0.05%/0.05% tazarotene/betamethasone dipropionate cream.

Avaliação do desempenho de oleogéis estruturados com ceras vegetais como base lipídica reduzida em ácidos graxos saturados aplicados em cream cheeses / Performance evaluation of structured oleogels with vegetable waxes as a reduced lipid base in saturated fatty acids applied in cream cheeses

Diante das exigências crescentes das agências regulatórias do mundo todo quanto à redução/eliminação de ácidos graxos trans nos alimentos industrializados, bem como da conscientização do consumidor sobre a relação entre alimentação e saúde, o desenvolvimento de alternativas mais saudáveis aos óleos parcialmente hidrogenados e a outras fontes lipídicas com alto grau de saturaçã o se faz necessário. O oleogel, um sistema composto por um óleo preso em uma rede tridimensional formada por um agente estruturante, se apresenta como uma solução promissora. Dentre os diversos agentes estruturantes, as ceras vegetais se destacam por sua excelente capacidade de gelificação de óleos. Contudo, apresentam uma desvantagem sob o aspecto sensorial, pois podem conferir cerosidade e sabor residual desagradável aos alimentos. Com o objetivo de viabilizar o uso das ceras como agentes estruturantes em oleogéis face ao seu excelente desempenho tecnológico, este projeto propõe o estudo e a aplicação de oleogéis à base de óleo de soja (SBO) estruturado com ceras de farelo de arroz (RBW) a 2 e 4 % (m/m) ou carnaúba (CBW) a 3 e 6% (m/m), isoladamente. As matérias-primas foram caracterizadas e o comportamento de gelificação de cada cera foi avaliado por análises de textura por penetração de cone, estabilidade à perda de óleo por centrifugação, energia coesiva por parâmetro de solubilidade de Hansen (HSP) e comportamento de cristalização e fusão por calorimetria exploratória diferencial (DSC). Os resultados mostraram que ambas as ceras são capazes de formar oleogéis estruturalmente estáveis, contudo, o oleogel com 2% de RBW apresentou maior firmeza a 20 °C (190,4 gf/cm2) do que o oleogel com 6% de CBW a 5 °C (186,1 gf/cm2). Ao final de 5 dias, a capacidade de retenção de óleo do oleogel preparado com RBW foi de 100% às concentrações de 2 e 4% (m/m), contra 61 e 99,3% do oleogel elaborado com CBW às concentrações de 3 e 6% (m/m), respectivamente. Esses resultados podem ser explicados pela diferença entre as energias coesivas, ou seja, do grau de interação molecular entre o solvente e o soluto de cada oleogel. De acordo com os resultados de distância, que prevê se o gel formado será forte, fraco ou se não haverá formação de gel, o soluto CBW apresentou menor interação com o óleo (3,3 MPa1/2) do que o soluto RBW (3,7 MPa1/2). Os oleogéis foram aplicados como ingredientes em diferentes formulações de cream cheese, que foram analisados quanto a diferentes parâmetros de textura e esses resultados foram comparados a uma referência comercial. Nenhuma das amostras produzidas obteve resultados de textura estatisticamente iguais aos do cream cheese comercial (CC), o que pode ser explicado pelas diferenças de formulação e processamento dos produtos. Face aos resultados para textura e estabilidade à perda de óleo dos oleogéis de RBW, este agente estruturante apresenta ria maior potencial de aplicação, porém o oleogel CBW6 obteve alta capacidade de retenção de óleo (99,3%) e quando aplicado na formulação de cream cheese (CCBW6) apresentou resultados de firmeza e espalhabilidade mais próximos da amostra de referência, feita com gordura do leite (CMF)

Given the growing demands of regulatory agencies around the world regarding the reduction/elimination of trans fatty acids in processed foods, as well as consumer awareness about the relationship between food and health, the development of healthier alternatives to partially hydrogenated oils and others lipid sources with a high degree of saturation are necessary. Oleogel, a system composed of an oil trapped in a three-dimensional network formed by a structuring agent, presents itself as a promising solution. Among the various structuring agents, vegetable waxes stand out for their excellent oil gelling capacity. However, they have a sensory disadvantage, as they can give waxy and unpleasant aftertaste to foods. Aiming at enabling the use of waxes as structuring agents in oleogels in view of their excellent technological performance, this study proposes the evaluation and application of oleogels based on soybean oil (SBO) structured with rice bran wax (RBW) at 2 and 4% (m/m) or carnauba (CBW) at 3 and 6% (m/m). The raw materials were characterized and the gelling behavior of each wax was evaluated by analysis of texture by cone penetration, stability to oil loss by centrifugation, cohesive energy by Hansen solubility parameter (HSP) and crystallization and melting behavior. by differential scanning calorimetry (DSC). The results showed that both waxes are able to form structurally stable oleogels, however, oleogel with 2% RBW showed greater firmness at 20 °C (190.4 gf/cm2) than oleogel with 6% CBW at 5° C (186.1 gf/cm2). At the end of 5 days, the oil retention capacity of oleogel prepared with RBW was 100% at concentrations of 2 and 4% (m/m), against 61 and 99.3% of oleogel prepared with CBW at concentrations of 3 and 6% (m/m), respectively. These results can be explained by the difference between the cohesive energies, that is, the degree of molecular interaction between the solvent and the solute of each oleogel. According to the distance results, which predicts if the formed gel will be strong, weak or if there will be no gel formation, the CBW solute showed less interaction with the oil (3.3 MPa1/2) than the RBW solute (3 ,7 MPa1/2). Oleogels were applied as ingredients in different cream cheese formulations, which were analyzed for different texture parameters and these results were compared to a commercial reference. None of the samples produced had texture results statistically equal to those of commercial cream cheese (CC), which can be explained by the differences in formulation and processing of the products. Given the results for texture and oil binding capacity of RBW oleogels, this structuring agent would present greater application potential, but CBW6 oleogel obtained high oil biding capacity (99.3%) and when applied in cream cheese formulation (CCBW6) showed firmness and spreadability results closer to the reference sample, made with milk fat (CMF)