Objective:To investigate the clinical efficacy and safety of Chuzhi Shengfa Tablets combined with ketoconazole shampoo and Chuzhi Shengfa Tablets combined with 5%minoxidil foam in the treatment of male androgenetic al...Objective:To investigate the clinical efficacy and safety of Chuzhi Shengfa Tablets combined with ketoconazole shampoo and Chuzhi Shengfa Tablets combined with 5%minoxidil foam in the treatment of male androgenetic alopecia.Methods:From July 2022 to July 2023,120 male patients with androgenetic alopecia were selected from our Department of Dermatology and randomly divided into Control Group 1,Control Group 2,Observation Group 1,and Observation Group 2,with 30 patients in each group.Control Group 1 was treated with ketoconazole shampoo,Control Group 2 with 5%minoxidil foam,Observation Group 1 with ketoconazole shampoo combined with Chuzhi Shengfa Tablets,and Observation Group 2 with 5%minoxidil foam combined with Chuzhi Shengfa Tablets.Hair density,hair diameter,scalp oil secretion(using oil secretion scoring),and adverse reactions were compared before and after treatment across the four groups.Results:After treatment,hair density and hair diameter significantly increased in all four groups compared to before treatment,while scalp oil secretion scores significantly decreased(P<0.05).The improvements in Observation Groups 1 and 2 were significantly better than those in Control Groups 1 and 2(P<0.05).No significant differences in the incidence of adverse reactions were observed among the four groups(P>0.05).Conclusion:Chuzhi Shengfa Tablets combined with ketoconazole shampoo and Chuzhi Shengfa Tablets combined with 5%minoxidil foam are both effective and safe for treating male androgenetic alopecia.These combinations can significantly improve hair growth and are worthy of clinical promotion.展开更多
Related substances in pharmaceutical formulations are associated with their safety, efficacy and stability. However, there is no overall study already published on the assessment of related substances in the Compound ...Related substances in pharmaceutical formulations are associated with their safety, efficacy and stability. However, there is no overall study already published on the assessment of related substances in the Compound Ketoconazole and Clobetasol Propionate Cream. In this work, a reliable HPLC-TOF-MS qualitative method was developed for the analysis of related substances in this preparation with a quick and easy extraction procedure. Besides the active pharmaceutical ingredients, two compounds named ketoconazole impurity B′ optical isomer and ketoconazole impurity E were identified. Furthermore, a new HPLC method for qualitative and quantitative assessment on related substances and degradation products, which were found in the stability test, was established and validated. The single standard to determine multi-components method was applied in the quantitative analysis, which was an effective way for reducing cost and improving accuracy. This study can provide a creative idea for routine analysis of quality control of the Compound Ketoconazole and Clobetasol Propionate Cream.展开更多
Objective To evaluate the incidence of Ketoconazole associated hepatotoxicity and related factors Methods Literature retrieval was conducted by using multi-databases for meta-analysis on Ketoconazole associated hepato...Objective To evaluate the incidence of Ketoconazole associated hepatotoxicity and related factors Methods Literature retrieval was conducted by using multi-databases for meta-analysis on Ketoconazole associated hepatotoxicity. The data were collected with a standardized form. Overall estimation of incidence of hepatotoxicity for specific study type was calculated by using a DerSimonian-Laird random-effects model owing to the substantial differences among the studies. Results Totally 204 eligible studies were included in the analysis. The incidence of Ketoconazole associated hepatotoxicity was 3.6%-4.2%. The dosage and duration specific subgroup analyses did not show any significant difference among groups, while the age specific subgroup analysis showed the incidence in children and people aged 〉60 years was 1.4% (95% CI 0.5%-4.2%) and 3.2% (95% Cl: 1.1%-8.7%) respectively. Additionally, the incidence of the hepatotoxicity was higher in people who had oral administration of ketoconazole beyond the provisions of the usage instructions, and the incidence was 5.7% (95% CI: 4.5%-7.2%). Conclusion Ketoconazole associated hepatotoxicity was common. Off-label use might increase the risk of liver damage. Well-designed large sample studies are needed to identify the risk factors in future.展开更多
This paper describes a sensitive spectrophotometric method developed for determination of Ketoconazole (KC) in tablets based on amplification reactions. Ketoconazole was oxidized with periodate, resulting in formation...This paper describes a sensitive spectrophotometric method developed for determination of Ketoconazole (KC) in tablets based on amplification reactions. Ketoconazole was oxidized with periodate, resulting in formation of KC2t and iodate ions. After masking the excess periodate with molybdate, the iodate was treated with iodide to release iodine. The liberated iodine was transformed to ICl2 species and extracted as ion-pair with rhodamine 6G into toluene for spectrophotometric measurement at 535 nm. A linear calibration graph was obtained between 0.2136 mg/mL and 1.7088 mg/mL of Ketoconazole with a molar absorptivity of 5 105 mol L 1 cm 1. The procedure was successfully applied for the determination of ketoconazole in tablet formulation.展开更多
AIM: To study the long-term outcome of ketoconazole and tacrolimus combination in kidney transplant recipi-ents. METHODS: From 2006 to 2010, ketoconazole was given in 199 patients and was continued for at least 1 y...AIM: To study the long-term outcome of ketoconazole and tacrolimus combination in kidney transplant recipi-ents. METHODS: From 2006 to 2010, ketoconazole was given in 199 patients and was continued for at least 1 year or until graft failure (Group 1), while 149 patients did not receive any ketoconazole (Group 2). A combina-tion of tacrolimus, mycophenolate and steroid was used as maintenance therapy. High risk patients received basiliximab induction. RESULTS: Basic demographic data was similar be-tween the 2 groups. The 5-year cumulative incidence of biopsy-confrmed and clinically-treated acute rejection was signifcantly higher in Group 1 than in Group 2 (34% vs 18%, P = 0.01). The 5-year Kaplan-Meier estimated graft survival (74.3% vs 76.4%, P = 0.58) and patient survival (87.8% vs 87.5%, P = 0.93) were not different between the 2 groups. Multivariable analyses identifed ketoconazole usage as an independent risk of acute rejection (HR = 2.33, 95%CI: 1.33-4.07; P = 0.003) while tacrolimus dose in the 2nd month was protective (HR = 0.89, 95%CI: 0.75-0.96; P = 0.041). CONCLUSION: Co-administration of ketoconazole and tacrolimus is associated with significantly higher inci-dence of acute rejection in kidney transplant recipients.展开更多
We investigated the prognostic value of some variables of effective ketoconazole treatment for metastatic castration-resistant prostate cancer (mCRPC). In total, 163 patients with mCRPC were eligible, receiving keto...We investigated the prognostic value of some variables of effective ketoconazole treatment for metastatic castration-resistant prostate cancer (mCRPC). In total, 163 patients with mCRPC were eligible, receiving ketoconazole 200-400 mg three times daily with replacement doses of prednisone. Progression-free survival (PFS) was calculated from the beginning of the ketoconazole therapy to the onset of disease progression. The prognostic value of different variables for PFS was assessed by Cox regression analysis. The median PFS was 2.6 months (0.5-8.6 months) for these patients. The serum testosterone level changed during therapy, which decreased when the prostate-specific antigen (PSA) declined; the serum testosterone level increased as the levels of PSA relapsed. The median PFS values for patients associated with different factors were the following: 1.4 and 3.5 months for a nadir PSA of ≥ 0.2 and 〈0.2 ng ml- 1, respectively (hazard rate (HR)=4.767, P〈0.001); 3.1 and 1.6 months for a baseline testosterone of ≥0.1 and 〈0.1 ng m1-1, respectively (HR=2.865, P=0.012); 2.8 and 1.9 months for a baseline haemoglobin of ≥ 120 and 〈120 g 1-1, respectively (HR= 1.605, P〈0.001); and 3.0 and 1.9 months for a PSA doubling time (PSADT) of ≥ 2.0 and 〈2.0 months, respectively (HR= 1.454, P=-0.017). A risk model was constructed according to the four factors that divided patients into three subgroups of low risk (0-1 factors), moderate risk (2 factors) and high risk (3-4 factors) with PFS values of 3.6, 3.0 and 1.4 months, respectively (HR=1.619, P〈0.001). A nadir PSA of ≥0.2 ng m1-1, a baseline testosterone of 〈0.1 ng m1-1, a baseline haemoglobin of 〈 120 g I- 1 and a PSADT of 〈2 months were associated with a poor PFS. This risk model could provide evidence to predict the survival benefit of ketoconazole therapy.展开更多
Background: Ketoconazole was introduced in 1981 as the first in a series of antifungal agents that are characterized by nitrogen-containing ring. Ketoconazole acts against many different kinds of fungi such as candida...Background: Ketoconazole was introduced in 1981 as the first in a series of antifungal agents that are characterized by nitrogen-containing ring. Ketoconazole acts against many different kinds of fungi such as candida, dermatophytes and as pergillus. Also oral ketoconazole had proved its effectiveness in the treatment of cutaneous Leishmaniasis. Objective: To evaluate the safety of oral ketoconazole in the treatment of different skin diseases like cutaneous Leishmaniasis (CL), tineacapitis, tineacorporis and tineaversicolor. Patients and Methods: This is a single, blinded, therapeutic, controlled study that was carried out in the Department of Dermatology, Baghdad Teaching Hospital, Baghdad, Iraq, during the time, January 2015 to July 2016. In total, 951 patients with acute cutaneous leishmaniasis, tineacapitis, tineacorporis and tineaversicolor were enrolled in this study. The diagnosis was confirmed by smear and histopathology. Patients were divided into two groups: 51 patients in Group 1;24 of them were treated with oral ketoconazole tablets 200 mg twice daily for 6 weeks and 27 of them were treated orally with a combination of zinc sulfate 10 mg/kg/day and ketoconazole for 6 weeks. All patients were seen regularly every 2 weeks for 6 weeks of treatment period, then monthly for the next three months as follow up period. Liver enzymes monitoring was done for every patient in this study every two weeks. Elevated liver enzymes were considered as features of hepatotoxicity in the examined patients. While group 2 included 900 patients and was divided into 3 subgroups: A: 600 patients with tineacapitis and tineacorporis, B: 100 patients with tineaversicolor, and C: 200 patients with CL. All patients in group 2 were treated with oral KC tablets 200 mg twice daily for 6 weeks. The dose of oral KC in children is 3.3 - 6.6 mg/Kg/day. All patients in group 2 were not investigated for ketoconazole biochemical side effects but watched for any clinical symptoms and signs of any side effects. Results: After six weeks, 951 patients had completed the treatment. In the first group (51 patients), only two out 27 patients (7.4%) from the combined group showed elevated liver enzymes while the ketoconazole treated group showed no increase in liver enzymes, hence only 3.9% showed elevated liver enzymes that went to normal during follow up. In the second group (900 patients) there were no clinical symptoms and signs in favor of hepatic toxicity or other related organs. Conclusion: Ketoconazole has been used tremendously in treating of different skin diseases including fungal and Leishmania infection but without side effects, accordingly this drug seems safe to be used in treatment of different skin diseases whether adults or children.展开更多
BACKGROUND Guatemala is a developing country in Central America with limited health resources.In order to expand successful renal transplant care to children and adolescents at the lowest possible cost,our pediatric r...BACKGROUND Guatemala is a developing country in Central America with limited health resources.In order to expand successful renal transplant care to children and adolescents at the lowest possible cost,our pediatric renal transplant clinic uses a post-transplant tacrolimus-sparing strategy via inhibition of CYP3A4.AIM To study the safety,efficacy and the associated cost reduction of ketoconazole in combination with tacrolimus in this pediatric population.METHODS A retrospective chart review was carried out among the cohort of pediatric renal transplant recipients treated at the Foundation for pediatric renal patients(Fundación para el Niño Enfermo Renal-FUNDANIER),a pediatric tertiary care renal transplant center in Guatemala City,Guatemala.Patient charts were reviewed to ascertain the number of transplant recipients who were transitioned from tacrolimus based immunosuppression to combination therapy with ketoconazole and tacrolimus.Twenty-five post-transplant patients that used ketoconazole combined with tacrolimus were identified.Anthropometric,clinical and laboratory data was collected from patient charts before and after the transition.RESULTS Of the 25 patient charts reviewed 12(48%)patients were male and the average patient age was 13 years.Twenty-four(96%)transplants were from living donors.There was a non-significant difference between the mean tacrolimus doses six months and two months prior to ketoconazole:-0.10±0.04(95%CI:0.007,-0.029),P=0.23.However,the difference between the mean tacrolimus doses six months prior to ketoconazole initiation and six months after ketoconazole addition was significant:0.06±0.05(95%CI:-0.034,-0.086)P<0.001.All tacrolimus doses were reduced by 45%after the addition of ketoconazole.Therapeutic levels of tacrolimus ranged between 6.8-8.8 ng/mL during the study period and patients demonstrated an increase in estimated glomerular filtration rate.The combination of tacrolimus and ketoconazole resulted in a 21%reduction in cost.CONCLUSION Patients experienced an effective dose-reduction of tacrolimus with the administration of ketoconazole.There was no relevant variations in tacrolimus serum levels,number of rejections,or significant liver toxicity.The strategy allowed a cost reduction in pediatric immunosuppressive therapy.展开更多
Ketoconazole has been widely used as an antifungal drug ketoconazole shampoo. The aim of this research was to study and to that is formulated as tablets, cream and over-the-counter standardize an UV (ultraviolet spec...Ketoconazole has been widely used as an antifungal drug ketoconazole shampoo. The aim of this research was to study and to that is formulated as tablets, cream and over-the-counter standardize an UV (ultraviolet spectrophotometric) method, potentiometry and a HPLC (high performance liquid chromatographic) method for the determination ofketoconazole in commercially available tablets. These three methods were compared and discussed with respect to their sensitivity, selectivity and ready-applicability in routine analytical work. Absorption spectra and spectrophotometric determinations were carried out on the UV spectrophotometer. Investigated concentrations that ranged from 0.003 mg·dm^-3 to 0.02 mg·dm^-3. The absorbance was measured at 224 nm. In potentiometric titrations, glass and saturated (KCI) calomel electrodes were used to determine the end point of the titration. HPLC analyses of ketoconazole were carried in the presence ofeconazole as internal standard. It was concluded that the described methods are simple, fast and reliable for the identification of ketoconazole in pharmaceutical preparations. The preparation of the samples was easy, the excipients did not interfere with the active substance in the methods, so they can be used in routine quality control analysis.展开更多
【目的】观察加味蛇黄膏(由蛇床子、黄柏、花椒等中药组成)治疗面部脂溢性皮炎的临床疗效。【方法】将72例面部脂溢性皮炎患者随机分为观察组和对照组,每组各36例。2组患者均给予口服阿伐斯汀胶囊、维生素B6片治疗,在此基础上,观察组给...【目的】观察加味蛇黄膏(由蛇床子、黄柏、花椒等中药组成)治疗面部脂溢性皮炎的临床疗效。【方法】将72例面部脂溢性皮炎患者随机分为观察组和对照组,每组各36例。2组患者均给予口服阿伐斯汀胶囊、维生素B6片治疗,在此基础上,观察组给予加味蛇黄膏外用治疗,对照组给予2%酮康唑乳膏外用治疗,疗程均为4周。观察2组患者治疗前后临床症状积分、皮肤病生活质量指数(dermatology life quality index,DLQI)评分的变化情况,并评价2组患者的临床疗效和安全性。【结果】(1)治疗4周后,观察组的总有效率为88.89%(32/36),对照组为72.22%(26/36),组间比较,观察组的疗效明显优于对照组,差异有统计学意义(P<0.05)。(2)治疗后,2组患者的红斑、鳞屑、油脂、皮疹面积、瘙痒程度等临床症状积分均较治疗前明显降低(P<0.05),且观察组治疗后的各项临床症状积分均明显低于对照组,差异均有统计学意义(P<0.05)。(3)治疗后,2组患者的DLQI评分均较治疗前明显降低(P<0.05),且观察组患者治疗后的DLQI评分明显低于对照组,差异有统计学意义(P<0.05)。(4)治疗期间,2组患者均无明显不良反应发生,具有较高的安全性。【结论】在常规西药治疗基础上联合加味蛇黄膏外用治疗面部脂溢性皮炎疗效确切,可有效缓解患者临床症状,提高患者生活质量。展开更多
文摘Objective:To investigate the clinical efficacy and safety of Chuzhi Shengfa Tablets combined with ketoconazole shampoo and Chuzhi Shengfa Tablets combined with 5%minoxidil foam in the treatment of male androgenetic alopecia.Methods:From July 2022 to July 2023,120 male patients with androgenetic alopecia were selected from our Department of Dermatology and randomly divided into Control Group 1,Control Group 2,Observation Group 1,and Observation Group 2,with 30 patients in each group.Control Group 1 was treated with ketoconazole shampoo,Control Group 2 with 5%minoxidil foam,Observation Group 1 with ketoconazole shampoo combined with Chuzhi Shengfa Tablets,and Observation Group 2 with 5%minoxidil foam combined with Chuzhi Shengfa Tablets.Hair density,hair diameter,scalp oil secretion(using oil secretion scoring),and adverse reactions were compared before and after treatment across the four groups.Results:After treatment,hair density and hair diameter significantly increased in all four groups compared to before treatment,while scalp oil secretion scores significantly decreased(P<0.05).The improvements in Observation Groups 1 and 2 were significantly better than those in Control Groups 1 and 2(P<0.05).No significant differences in the incidence of adverse reactions were observed among the four groups(P>0.05).Conclusion:Chuzhi Shengfa Tablets combined with ketoconazole shampoo and Chuzhi Shengfa Tablets combined with 5%minoxidil foam are both effective and safe for treating male androgenetic alopecia.These combinations can significantly improve hair growth and are worthy of clinical promotion.
文摘Related substances in pharmaceutical formulations are associated with their safety, efficacy and stability. However, there is no overall study already published on the assessment of related substances in the Compound Ketoconazole and Clobetasol Propionate Cream. In this work, a reliable HPLC-TOF-MS qualitative method was developed for the analysis of related substances in this preparation with a quick and easy extraction procedure. Besides the active pharmaceutical ingredients, two compounds named ketoconazole impurity B′ optical isomer and ketoconazole impurity E were identified. Furthermore, a new HPLC method for qualitative and quantitative assessment on related substances and degradation products, which were found in the stability test, was established and validated. The single standard to determine multi-components method was applied in the quantitative analysis, which was an effective way for reducing cost and improving accuracy. This study can provide a creative idea for routine analysis of quality control of the Compound Ketoconazole and Clobetasol Propionate Cream.
文摘Objective To evaluate the incidence of Ketoconazole associated hepatotoxicity and related factors Methods Literature retrieval was conducted by using multi-databases for meta-analysis on Ketoconazole associated hepatotoxicity. The data were collected with a standardized form. Overall estimation of incidence of hepatotoxicity for specific study type was calculated by using a DerSimonian-Laird random-effects model owing to the substantial differences among the studies. Results Totally 204 eligible studies were included in the analysis. The incidence of Ketoconazole associated hepatotoxicity was 3.6%-4.2%. The dosage and duration specific subgroup analyses did not show any significant difference among groups, while the age specific subgroup analysis showed the incidence in children and people aged 〉60 years was 1.4% (95% CI 0.5%-4.2%) and 3.2% (95% Cl: 1.1%-8.7%) respectively. Additionally, the incidence of the hepatotoxicity was higher in people who had oral administration of ketoconazole beyond the provisions of the usage instructions, and the incidence was 5.7% (95% CI: 4.5%-7.2%). Conclusion Ketoconazole associated hepatotoxicity was common. Off-label use might increase the risk of liver damage. Well-designed large sample studies are needed to identify the risk factors in future.
文摘This paper describes a sensitive spectrophotometric method developed for determination of Ketoconazole (KC) in tablets based on amplification reactions. Ketoconazole was oxidized with periodate, resulting in formation of KC2t and iodate ions. After masking the excess periodate with molybdate, the iodate was treated with iodide to release iodine. The liberated iodine was transformed to ICl2 species and extracted as ion-pair with rhodamine 6G into toluene for spectrophotometric measurement at 535 nm. A linear calibration graph was obtained between 0.2136 mg/mL and 1.7088 mg/mL of Ketoconazole with a molar absorptivity of 5 105 mol L 1 cm 1. The procedure was successfully applied for the determination of ketoconazole in tablet formulation.
文摘AIM: To study the long-term outcome of ketoconazole and tacrolimus combination in kidney transplant recipi-ents. METHODS: From 2006 to 2010, ketoconazole was given in 199 patients and was continued for at least 1 year or until graft failure (Group 1), while 149 patients did not receive any ketoconazole (Group 2). A combina-tion of tacrolimus, mycophenolate and steroid was used as maintenance therapy. High risk patients received basiliximab induction. RESULTS: Basic demographic data was similar be-tween the 2 groups. The 5-year cumulative incidence of biopsy-confrmed and clinically-treated acute rejection was signifcantly higher in Group 1 than in Group 2 (34% vs 18%, P = 0.01). The 5-year Kaplan-Meier estimated graft survival (74.3% vs 76.4%, P = 0.58) and patient survival (87.8% vs 87.5%, P = 0.93) were not different between the 2 groups. Multivariable analyses identifed ketoconazole usage as an independent risk of acute rejection (HR = 2.33, 95%CI: 1.33-4.07; P = 0.003) while tacrolimus dose in the 2nd month was protective (HR = 0.89, 95%CI: 0.75-0.96; P = 0.041). CONCLUSION: Co-administration of ketoconazole and tacrolimus is associated with significantly higher inci-dence of acute rejection in kidney transplant recipients.
文摘We investigated the prognostic value of some variables of effective ketoconazole treatment for metastatic castration-resistant prostate cancer (mCRPC). In total, 163 patients with mCRPC were eligible, receiving ketoconazole 200-400 mg three times daily with replacement doses of prednisone. Progression-free survival (PFS) was calculated from the beginning of the ketoconazole therapy to the onset of disease progression. The prognostic value of different variables for PFS was assessed by Cox regression analysis. The median PFS was 2.6 months (0.5-8.6 months) for these patients. The serum testosterone level changed during therapy, which decreased when the prostate-specific antigen (PSA) declined; the serum testosterone level increased as the levels of PSA relapsed. The median PFS values for patients associated with different factors were the following: 1.4 and 3.5 months for a nadir PSA of ≥ 0.2 and 〈0.2 ng ml- 1, respectively (hazard rate (HR)=4.767, P〈0.001); 3.1 and 1.6 months for a baseline testosterone of ≥0.1 and 〈0.1 ng m1-1, respectively (HR=2.865, P=0.012); 2.8 and 1.9 months for a baseline haemoglobin of ≥ 120 and 〈120 g 1-1, respectively (HR= 1.605, P〈0.001); and 3.0 and 1.9 months for a PSA doubling time (PSADT) of ≥ 2.0 and 〈2.0 months, respectively (HR= 1.454, P=-0.017). A risk model was constructed according to the four factors that divided patients into three subgroups of low risk (0-1 factors), moderate risk (2 factors) and high risk (3-4 factors) with PFS values of 3.6, 3.0 and 1.4 months, respectively (HR=1.619, P〈0.001). A nadir PSA of ≥0.2 ng m1-1, a baseline testosterone of 〈0.1 ng m1-1, a baseline haemoglobin of 〈 120 g I- 1 and a PSADT of 〈2 months were associated with a poor PFS. This risk model could provide evidence to predict the survival benefit of ketoconazole therapy.
文摘Background: Ketoconazole was introduced in 1981 as the first in a series of antifungal agents that are characterized by nitrogen-containing ring. Ketoconazole acts against many different kinds of fungi such as candida, dermatophytes and as pergillus. Also oral ketoconazole had proved its effectiveness in the treatment of cutaneous Leishmaniasis. Objective: To evaluate the safety of oral ketoconazole in the treatment of different skin diseases like cutaneous Leishmaniasis (CL), tineacapitis, tineacorporis and tineaversicolor. Patients and Methods: This is a single, blinded, therapeutic, controlled study that was carried out in the Department of Dermatology, Baghdad Teaching Hospital, Baghdad, Iraq, during the time, January 2015 to July 2016. In total, 951 patients with acute cutaneous leishmaniasis, tineacapitis, tineacorporis and tineaversicolor were enrolled in this study. The diagnosis was confirmed by smear and histopathology. Patients were divided into two groups: 51 patients in Group 1;24 of them were treated with oral ketoconazole tablets 200 mg twice daily for 6 weeks and 27 of them were treated orally with a combination of zinc sulfate 10 mg/kg/day and ketoconazole for 6 weeks. All patients were seen regularly every 2 weeks for 6 weeks of treatment period, then monthly for the next three months as follow up period. Liver enzymes monitoring was done for every patient in this study every two weeks. Elevated liver enzymes were considered as features of hepatotoxicity in the examined patients. While group 2 included 900 patients and was divided into 3 subgroups: A: 600 patients with tineacapitis and tineacorporis, B: 100 patients with tineaversicolor, and C: 200 patients with CL. All patients in group 2 were treated with oral KC tablets 200 mg twice daily for 6 weeks. The dose of oral KC in children is 3.3 - 6.6 mg/Kg/day. All patients in group 2 were not investigated for ketoconazole biochemical side effects but watched for any clinical symptoms and signs of any side effects. Results: After six weeks, 951 patients had completed the treatment. In the first group (51 patients), only two out 27 patients (7.4%) from the combined group showed elevated liver enzymes while the ketoconazole treated group showed no increase in liver enzymes, hence only 3.9% showed elevated liver enzymes that went to normal during follow up. In the second group (900 patients) there were no clinical symptoms and signs in favor of hepatic toxicity or other related organs. Conclusion: Ketoconazole has been used tremendously in treating of different skin diseases including fungal and Leishmania infection but without side effects, accordingly this drug seems safe to be used in treatment of different skin diseases whether adults or children.
文摘BACKGROUND Guatemala is a developing country in Central America with limited health resources.In order to expand successful renal transplant care to children and adolescents at the lowest possible cost,our pediatric renal transplant clinic uses a post-transplant tacrolimus-sparing strategy via inhibition of CYP3A4.AIM To study the safety,efficacy and the associated cost reduction of ketoconazole in combination with tacrolimus in this pediatric population.METHODS A retrospective chart review was carried out among the cohort of pediatric renal transplant recipients treated at the Foundation for pediatric renal patients(Fundación para el Niño Enfermo Renal-FUNDANIER),a pediatric tertiary care renal transplant center in Guatemala City,Guatemala.Patient charts were reviewed to ascertain the number of transplant recipients who were transitioned from tacrolimus based immunosuppression to combination therapy with ketoconazole and tacrolimus.Twenty-five post-transplant patients that used ketoconazole combined with tacrolimus were identified.Anthropometric,clinical and laboratory data was collected from patient charts before and after the transition.RESULTS Of the 25 patient charts reviewed 12(48%)patients were male and the average patient age was 13 years.Twenty-four(96%)transplants were from living donors.There was a non-significant difference between the mean tacrolimus doses six months and two months prior to ketoconazole:-0.10±0.04(95%CI:0.007,-0.029),P=0.23.However,the difference between the mean tacrolimus doses six months prior to ketoconazole initiation and six months after ketoconazole addition was significant:0.06±0.05(95%CI:-0.034,-0.086)P<0.001.All tacrolimus doses were reduced by 45%after the addition of ketoconazole.Therapeutic levels of tacrolimus ranged between 6.8-8.8 ng/mL during the study period and patients demonstrated an increase in estimated glomerular filtration rate.The combination of tacrolimus and ketoconazole resulted in a 21%reduction in cost.CONCLUSION Patients experienced an effective dose-reduction of tacrolimus with the administration of ketoconazole.There was no relevant variations in tacrolimus serum levels,number of rejections,or significant liver toxicity.The strategy allowed a cost reduction in pediatric immunosuppressive therapy.
文摘Ketoconazole has been widely used as an antifungal drug ketoconazole shampoo. The aim of this research was to study and to that is formulated as tablets, cream and over-the-counter standardize an UV (ultraviolet spectrophotometric) method, potentiometry and a HPLC (high performance liquid chromatographic) method for the determination ofketoconazole in commercially available tablets. These three methods were compared and discussed with respect to their sensitivity, selectivity and ready-applicability in routine analytical work. Absorption spectra and spectrophotometric determinations were carried out on the UV spectrophotometer. Investigated concentrations that ranged from 0.003 mg·dm^-3 to 0.02 mg·dm^-3. The absorbance was measured at 224 nm. In potentiometric titrations, glass and saturated (KCI) calomel electrodes were used to determine the end point of the titration. HPLC analyses of ketoconazole were carried in the presence ofeconazole as internal standard. It was concluded that the described methods are simple, fast and reliable for the identification of ketoconazole in pharmaceutical preparations. The preparation of the samples was easy, the excipients did not interfere with the active substance in the methods, so they can be used in routine quality control analysis.
文摘【目的】观察加味蛇黄膏(由蛇床子、黄柏、花椒等中药组成)治疗面部脂溢性皮炎的临床疗效。【方法】将72例面部脂溢性皮炎患者随机分为观察组和对照组,每组各36例。2组患者均给予口服阿伐斯汀胶囊、维生素B6片治疗,在此基础上,观察组给予加味蛇黄膏外用治疗,对照组给予2%酮康唑乳膏外用治疗,疗程均为4周。观察2组患者治疗前后临床症状积分、皮肤病生活质量指数(dermatology life quality index,DLQI)评分的变化情况,并评价2组患者的临床疗效和安全性。【结果】(1)治疗4周后,观察组的总有效率为88.89%(32/36),对照组为72.22%(26/36),组间比较,观察组的疗效明显优于对照组,差异有统计学意义(P<0.05)。(2)治疗后,2组患者的红斑、鳞屑、油脂、皮疹面积、瘙痒程度等临床症状积分均较治疗前明显降低(P<0.05),且观察组治疗后的各项临床症状积分均明显低于对照组,差异均有统计学意义(P<0.05)。(3)治疗后,2组患者的DLQI评分均较治疗前明显降低(P<0.05),且观察组患者治疗后的DLQI评分明显低于对照组,差异有统计学意义(P<0.05)。(4)治疗期间,2组患者均无明显不良反应发生,具有较高的安全性。【结论】在常规西药治疗基础上联合加味蛇黄膏外用治疗面部脂溢性皮炎疗效确切,可有效缓解患者临床症状,提高患者生活质量。