In this letter,we discuss the topic of necessity of routine laboratory monitoring during isotretinoin treatment for acne.According to Park and colleagues,it is advisable to monitor the levels of triglycerides,alanine ...In this letter,we discuss the topic of necessity of routine laboratory monitoring during isotretinoin treatment for acne.According to Park and colleagues,it is advisable to monitor the levels of triglycerides,alanine aminotransferase,and aspartate aminotransferase every 5 to 6 months.Additionally,the levels of total cholesterol and low-density lipoprotein should be checked within the first two months of treatment.Isotretinoin is a commonly prescribed agent mainly used to treat acne.Despite its high effectiveness,it necessitates regular monitoring of laboratory parameters due to its side effect profile.Currently,there remains a lack of consensus on the appropriate frequency for monitoring these parameters during treatment with isotretinoin.This letter will provide insight into this complex and controversial topic.Based on existing literature,we concluded that the incidence of changes in lipid and liver aminotransferase levels during isotretinoin treatment for acne was low and likely clinically insignificant.For generally healthy people,we recommend testing lipid and liver profiles once at baseline and a second time at the peak dosage.However,frequent testing might still be beneficial in certain populations of patients.展开更多
BACKGROUND Isotretinoin is a widely prescribed drug for various dermatological conditions,especially acne.Blood tests are routinely performed to monitor its side effects.However,the optimal testing schedule remains co...BACKGROUND Isotretinoin is a widely prescribed drug for various dermatological conditions,especially acne.Blood tests are routinely performed to monitor its side effects.However,the optimal testing schedule remains controversial.AIM To evaluate the laboratory monitoring tests and schedules of patients with acne taking isotretinoin to determine the most efficient testing regimen.METHODS We retrospectively reviewed electronic medical records from the Dermatology Department of Dongguk University Ilsan Hospital from 2005 to 2020 for patients prescribed isotretinoin for acne who underwent monthly blood tests.RESULTS Aspartate aminotransferase(AST),alanine aminotransferase(ALT),and trigly-ceride(TG)levels significantly changed between 5 and 6 mo when the total prescription period and dose variables were considered altogether.The high-density lipoprotein level also significantly changed between 5 and 6 mo.However,low-density lipoprotein(LDL)and total cholesterol levels significantly changed between 1 and 2 mo.CONCLUSION We recommend testing AST,ALT,and TG levels once every 5 to 6 mo.We also suggest testing LDL and total cholesterol levels during the first and second months.展开更多
Isotretinoin(Accutane) is a treatment for severe acne that is resistant to other forms of treatment, including antibiotics and topical treatments. The prescription of this drug has been controversial ever since its in...Isotretinoin(Accutane) is a treatment for severe acne that is resistant to other forms of treatment, including antibiotics and topical treatments. The prescription of this drug has been controversial ever since its initial marketing in 1982. It is the only non-psychotropic drug in the Food and Drug Administration top 10 drugs found to be associated with depression. Recently, Bremner et al published an extensive review(until 2010) of the evidence for the association of retinoic acid(RA) with depression and suicide. Some patients who are admitted in psychiatric hospitals report a history of present or past treatment with isotretinoin. Then, the imputability of the molecule in the occurrence of disorders represents necessarily an important question for both professionals and their patients. This paper aims to specify the links between the drug and specific psychiatric disorders. A review of the literature related to isotretinoin, RA, vitamin A, depression, suicide, anxiety, bipolar disorder, psychosis, schizophrenia was performed. Many studies demonstrated an increased risk of depression, attempted suicide and suicide following isotretinoin treatment. However, isotretinoin may have an antidepressant impact, according to some dermatological papers. They consider treating acne with this efficient treatment could improve selfimage and make the patient feel better. Several studies showed that patients with bipolar disorder had an increased risk for a clinical exacerbation of symptoms undergoing treatment with isotretinoin. A few studies also seem to suggest a possible link between isotretinoin and psychosis. Nonetheless, studies point out a link between retinoid dysregulation and schizophrenia through modulation of dopamine receptors. From this review, we propose guidelines for isotretinoin prescription to healthcare professionals.展开更多
This case report describes a case of ulcerative colitisthe onset of which occurred after the use of isotreti-noin for acne treatment. Our patient, a healthy maleyoung adult, after several months of isotretinoin use,de...This case report describes a case of ulcerative colitisthe onset of which occurred after the use of isotreti-noin for acne treatment. Our patient, a healthy maleyoung adult, after several months of isotretinoin use,developed gastrointestinal disorders and after thoroughmedical workup was diagnosed with ulcerative colitis.The literature regarding a possible correlation betweenisotretinoin use and ulcerative colitis is scarce. Never-theless, recent epidemiological studies have shed morelight on this possible association.展开更多
AIM: To investigate the frequency and severity of depression and/or anxiety in isotretinoin(ITT)-treated subjects and in a non-ITT control group. METHODS: Sixty consecutively-admitted non-psychiatric outpatients with ...AIM: To investigate the frequency and severity of depression and/or anxiety in isotretinoin(ITT)-treated subjects and in a non-ITT control group. METHODS: Sixty consecutively-admitted non-psychiatric outpatients with acne were assigned to either ITT at a fixed dose of 30 mg/d(n = 36) or "other treatment" group(OT; n = 24). The Zung depression or anxiety scales(with cut-off points), two locally developed scales for depression(Ge Depr) and anxiety(Ansilet)(without cut-off points) and clinical global impression scales of acne severity were administered at baseline and at weeks 6 and 12 of treatment. Data was analyzed with the chi-squared test and covariance analysis. RESULTS: Gender distribution, age, marital status and education level did not differ between both treatment groups. The frequency of depression, as defined by the Zung scale cut-off points was similar in the ITT and in the non-ITT groups: Weeks 6 and 12: 8.3% in both groups, P = 0.9. The frequency of anxiety was similar in the groups as well: Week 6: ITT = 8.3%; OT = 0.0%, P > 0.05; week 12: ITT = 11.1%, OT = 4.2%, P > 0.05. The scores in both scales' sets did not differ between the treatment groups at any evaluation time point(P> 0.05). Five ITT-treated subjects(13.8%) and two from the OT-treated group(8.3%) developed clinically significant anxiety and/or depression during treatment(P > 0.05). CONCLUSION: Our study confirms the safety of ITT regarding psychological side effects in regular dermatological patients. Susceptible subjects may exist but their identification requires additional strategies.展开更多
The development of facile and rapid quantification of biologically active biomolecules such as isotretitoin in therapeutic drugs contained in many generic formu- lations is necessary for determining their efficiency a...The development of facile and rapid quantification of biologically active biomolecules such as isotretitoin in therapeutic drugs contained in many generic formu- lations is necessary for determining their efficiency and their quality to improve the human health care. Isotretritoin finds its applications in the maintenance of epithelial tissues. Different processes to date such as normal phase HPLC, or gas chromatrography am- ong others are able to separate and quantify isote- troin. However, the extraction is quite complex and in the case of HPLC, the analysis requires long retention times. In such context, an isocratic reversed- phase high-performance liquid chromatography (HP- LC) technique coupled with an UV-vis detector is described here for easy separation and quantification of 13-cis-retinoic (isotretinoin) from soft gelatin capsule formulations. The isotretinoin was extracted from three different commercial drug samples with tetrahydrofuran (THF) solvent by a procedure that can be completed in less than 10 minutes. Subsequent separation and quantification were accomplished in less than 5 minutes under isocratic reversed-phase conditions on a Lichrospher RP18 column and a mobile phase consisting of 0.01% TFA/acetonitrile (15/85, v/v) at a flow rate of 1.0 mL/min. Isotretoin was detected for the three samples via its UV-vis absorbance at 342 nm. The method was validated and the results showed good linearity, precision and accuracy for sensitive and selective quantitative determination of isotretinoin in the different pharmaceutical formulations. We found that the average isotretinoin content in two of the three commercial pro- ducts fell outside the 90-110% United States Pha- rmacopeia specifications. Consequently, the facile extraction and the precise method for the biomole- cule quantification open up tremendous possibilities in improving the quality control of drugs which can exist as different generic brands.展开更多
A simple, precise and accurate high performance thin layer chromatographic method has been developed for the simultaneous estimation of Isotretinoin and Erythromycin in pharmaceutical gel. The separation was carried o...A simple, precise and accurate high performance thin layer chromatographic method has been developed for the simultaneous estimation of Isotretinoin and Erythromycin in pharmaceutical gel. The separation was carried out on Merck TLC aluminum sheets of silica gel 60 F254, (20 × 10 cm) with 250 μm thickness using toluene: DMSO: methanol (6.5:0.2:2.5, v/v/v) as a mobile phase. HPTLC separation of the two drugs followed by densitometric measurement of their spots at 340 nm for Isotretinoin before derivatization and 410 nm for Erythromycin after derivatization with 10% H2SO4 and heating at 100°C for 15 min. The drugs were satisfactorily resolved with RF values of 0.38 ± 0.02 and 0.55 ± 0.02 for Isotretinoin and Erythromycin, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (30-150 ng spot-1 for Isotretinoin and 1200-6000 ng spot-1 for Erythromycin), precision (intra-day RSD 0.62-0.79% and inter-day RSD 0.43-0.71 % for Isotretinoin and intra-day RSD 0.47-1.71 % and inter-day RSD 0.42-1.49 % for Erythromycin), accuracy (98.91 ± 0.92 % for Isotretinoin and 99.27 ± 0.72 % for Erythromycin), and specificity, in accordance with ICH guidelines.展开更多
Background: Both 30% supramolecular salicylic acid (SA) and isotretinoin erythromycin gel (IEG) have proven efficacy with good safety profiles in the treatment of acne vulgaris. Objectives: This study compared the cli...Background: Both 30% supramolecular salicylic acid (SA) and isotretinoin erythromycin gel (IEG) have proven efficacy with good safety profiles in the treatment of acne vulgaris. Objectives: This study compared the clinical efficacy and safety of 30% SA peeling and IEG in the treatment of moderate-to-severe acne vulgaris. Methods: Patients with moderate-to-severe acne vulgaris were randomized into 3 groups of 30 persons each, and treated with SA peel, or IEG, or SA combine with IEG (SA + IEG group). Evaluation of acne was done by effective rate and individual lesion counts. And the adverse effects and recurrence were recorded. Results: The SA + IEG group was better in clinical efficacy and treating noninflammatory and inflammatory lesions than that of single treatment group (P 0.05). Conclusion: 30% SA combined with IEG had a significant effect in the treatment of moderate-to-severe acne lesions.展开更多
Background: Recurrent aphthous ulcer (RAS) is a common oral disease where its etiopathogenesis is not well elucidated. There was no effective curative therapy for this disease. Isotretinoin has been recently used in t...Background: Recurrent aphthous ulcer (RAS) is a common oral disease where its etiopathogenesis is not well elucidated. There was no effective curative therapy for this disease. Isotretinoin has been recently used in the treatment of Behcet’s disease. Objectives: To evaluate the efficacy and safety of isotretinoin in treating RAS and the long term remission of RAS. Patients and Methods: This single-blind controlled therapeutic study conducted in Department of Dermatology-Baghdad Teaching Hospital during February 2011-January 2012. Thirty patients with typical RAS were included in this work. Detailed history and full examination were done for all patients. They were given isotretinoin 20 mg orally once daily for three months to be seen on Day 14 firstly and then monthly to be assessed using the oral clinical manifestation index (OCMI). After isotretinoin was stopped three months later, patients were given placebo therapy for another 3 months. Results: The results of 30 treated patients were as follows: 17 (56.67%) males and 13 (43.33%) females with male to female ratio was 1.3:1. Their ages ranged from 12 - 60 (35.33 ± 12.06) years. The OCMI before isotretinoin therapy ranged from 7 - 17 (13.13 ± 2.55), while after therapy the mean started to decline to a lower level within the first 14 days (P = 0.103), and continued to decline significantly until the end of the first month of therapy (P = 0.023). Then the OCMI declined very significantly until the end of fourth month of therapy (P < 0.001). After that the mean started to increase until the end of the 5 months (with placebo) but it remained statistically significant compared with the baseline of mean of OCMI before treatment (P = 0.046). Then it continued to increase to become not significant at the end of 6 months of therapy (P = 0.107). Conclusion: Isotretinoin is an effective therapeutic and prophylactic promising remedy in treatment of RAS.展开更多
文摘In this letter,we discuss the topic of necessity of routine laboratory monitoring during isotretinoin treatment for acne.According to Park and colleagues,it is advisable to monitor the levels of triglycerides,alanine aminotransferase,and aspartate aminotransferase every 5 to 6 months.Additionally,the levels of total cholesterol and low-density lipoprotein should be checked within the first two months of treatment.Isotretinoin is a commonly prescribed agent mainly used to treat acne.Despite its high effectiveness,it necessitates regular monitoring of laboratory parameters due to its side effect profile.Currently,there remains a lack of consensus on the appropriate frequency for monitoring these parameters during treatment with isotretinoin.This letter will provide insight into this complex and controversial topic.Based on existing literature,we concluded that the incidence of changes in lipid and liver aminotransferase levels during isotretinoin treatment for acne was low and likely clinically insignificant.For generally healthy people,we recommend testing lipid and liver profiles once at baseline and a second time at the peak dosage.However,frequent testing might still be beneficial in certain populations of patients.
基金Supported by the Dongguk University Research Program(2021).
文摘BACKGROUND Isotretinoin is a widely prescribed drug for various dermatological conditions,especially acne.Blood tests are routinely performed to monitor its side effects.However,the optimal testing schedule remains controversial.AIM To evaluate the laboratory monitoring tests and schedules of patients with acne taking isotretinoin to determine the most efficient testing regimen.METHODS We retrospectively reviewed electronic medical records from the Dermatology Department of Dongguk University Ilsan Hospital from 2005 to 2020 for patients prescribed isotretinoin for acne who underwent monthly blood tests.RESULTS Aspartate aminotransferase(AST),alanine aminotransferase(ALT),and trigly-ceride(TG)levels significantly changed between 5 and 6 mo when the total prescription period and dose variables were considered altogether.The high-density lipoprotein level also significantly changed between 5 and 6 mo.However,low-density lipoprotein(LDL)and total cholesterol levels significantly changed between 1 and 2 mo.CONCLUSION We recommend testing AST,ALT,and TG levels once every 5 to 6 mo.We also suggest testing LDL and total cholesterol levels during the first and second months.
文摘Isotretinoin(Accutane) is a treatment for severe acne that is resistant to other forms of treatment, including antibiotics and topical treatments. The prescription of this drug has been controversial ever since its initial marketing in 1982. It is the only non-psychotropic drug in the Food and Drug Administration top 10 drugs found to be associated with depression. Recently, Bremner et al published an extensive review(until 2010) of the evidence for the association of retinoic acid(RA) with depression and suicide. Some patients who are admitted in psychiatric hospitals report a history of present or past treatment with isotretinoin. Then, the imputability of the molecule in the occurrence of disorders represents necessarily an important question for both professionals and their patients. This paper aims to specify the links between the drug and specific psychiatric disorders. A review of the literature related to isotretinoin, RA, vitamin A, depression, suicide, anxiety, bipolar disorder, psychosis, schizophrenia was performed. Many studies demonstrated an increased risk of depression, attempted suicide and suicide following isotretinoin treatment. However, isotretinoin may have an antidepressant impact, according to some dermatological papers. They consider treating acne with this efficient treatment could improve selfimage and make the patient feel better. Several studies showed that patients with bipolar disorder had an increased risk for a clinical exacerbation of symptoms undergoing treatment with isotretinoin. A few studies also seem to suggest a possible link between isotretinoin and psychosis. Nonetheless, studies point out a link between retinoid dysregulation and schizophrenia through modulation of dopamine receptors. From this review, we propose guidelines for isotretinoin prescription to healthcare professionals.
文摘This case report describes a case of ulcerative colitisthe onset of which occurred after the use of isotreti-noin for acne treatment. Our patient, a healthy maleyoung adult, after several months of isotretinoin use,developed gastrointestinal disorders and after thoroughmedical workup was diagnosed with ulcerative colitis.The literature regarding a possible correlation betweenisotretinoin use and ulcerative colitis is scarce. Never-theless, recent epidemiological studies have shed morelight on this possible association.
文摘AIM: To investigate the frequency and severity of depression and/or anxiety in isotretinoin(ITT)-treated subjects and in a non-ITT control group. METHODS: Sixty consecutively-admitted non-psychiatric outpatients with acne were assigned to either ITT at a fixed dose of 30 mg/d(n = 36) or "other treatment" group(OT; n = 24). The Zung depression or anxiety scales(with cut-off points), two locally developed scales for depression(Ge Depr) and anxiety(Ansilet)(without cut-off points) and clinical global impression scales of acne severity were administered at baseline and at weeks 6 and 12 of treatment. Data was analyzed with the chi-squared test and covariance analysis. RESULTS: Gender distribution, age, marital status and education level did not differ between both treatment groups. The frequency of depression, as defined by the Zung scale cut-off points was similar in the ITT and in the non-ITT groups: Weeks 6 and 12: 8.3% in both groups, P = 0.9. The frequency of anxiety was similar in the groups as well: Week 6: ITT = 8.3%; OT = 0.0%, P > 0.05; week 12: ITT = 11.1%, OT = 4.2%, P > 0.05. The scores in both scales' sets did not differ between the treatment groups at any evaluation time point(P> 0.05). Five ITT-treated subjects(13.8%) and two from the OT-treated group(8.3%) developed clinically significant anxiety and/or depression during treatment(P > 0.05). CONCLUSION: Our study confirms the safety of ITT regarding psychological side effects in regular dermatological patients. Susceptible subjects may exist but their identification requires additional strategies.
文摘The development of facile and rapid quantification of biologically active biomolecules such as isotretitoin in therapeutic drugs contained in many generic formu- lations is necessary for determining their efficiency and their quality to improve the human health care. Isotretritoin finds its applications in the maintenance of epithelial tissues. Different processes to date such as normal phase HPLC, or gas chromatrography am- ong others are able to separate and quantify isote- troin. However, the extraction is quite complex and in the case of HPLC, the analysis requires long retention times. In such context, an isocratic reversed- phase high-performance liquid chromatography (HP- LC) technique coupled with an UV-vis detector is described here for easy separation and quantification of 13-cis-retinoic (isotretinoin) from soft gelatin capsule formulations. The isotretinoin was extracted from three different commercial drug samples with tetrahydrofuran (THF) solvent by a procedure that can be completed in less than 10 minutes. Subsequent separation and quantification were accomplished in less than 5 minutes under isocratic reversed-phase conditions on a Lichrospher RP18 column and a mobile phase consisting of 0.01% TFA/acetonitrile (15/85, v/v) at a flow rate of 1.0 mL/min. Isotretoin was detected for the three samples via its UV-vis absorbance at 342 nm. The method was validated and the results showed good linearity, precision and accuracy for sensitive and selective quantitative determination of isotretinoin in the different pharmaceutical formulations. We found that the average isotretinoin content in two of the three commercial pro- ducts fell outside the 90-110% United States Pha- rmacopeia specifications. Consequently, the facile extraction and the precise method for the biomole- cule quantification open up tremendous possibilities in improving the quality control of drugs which can exist as different generic brands.
文摘A simple, precise and accurate high performance thin layer chromatographic method has been developed for the simultaneous estimation of Isotretinoin and Erythromycin in pharmaceutical gel. The separation was carried out on Merck TLC aluminum sheets of silica gel 60 F254, (20 × 10 cm) with 250 μm thickness using toluene: DMSO: methanol (6.5:0.2:2.5, v/v/v) as a mobile phase. HPTLC separation of the two drugs followed by densitometric measurement of their spots at 340 nm for Isotretinoin before derivatization and 410 nm for Erythromycin after derivatization with 10% H2SO4 and heating at 100°C for 15 min. The drugs were satisfactorily resolved with RF values of 0.38 ± 0.02 and 0.55 ± 0.02 for Isotretinoin and Erythromycin, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (30-150 ng spot-1 for Isotretinoin and 1200-6000 ng spot-1 for Erythromycin), precision (intra-day RSD 0.62-0.79% and inter-day RSD 0.43-0.71 % for Isotretinoin and intra-day RSD 0.47-1.71 % and inter-day RSD 0.42-1.49 % for Erythromycin), accuracy (98.91 ± 0.92 % for Isotretinoin and 99.27 ± 0.72 % for Erythromycin), and specificity, in accordance with ICH guidelines.
文摘Background: Both 30% supramolecular salicylic acid (SA) and isotretinoin erythromycin gel (IEG) have proven efficacy with good safety profiles in the treatment of acne vulgaris. Objectives: This study compared the clinical efficacy and safety of 30% SA peeling and IEG in the treatment of moderate-to-severe acne vulgaris. Methods: Patients with moderate-to-severe acne vulgaris were randomized into 3 groups of 30 persons each, and treated with SA peel, or IEG, or SA combine with IEG (SA + IEG group). Evaluation of acne was done by effective rate and individual lesion counts. And the adverse effects and recurrence were recorded. Results: The SA + IEG group was better in clinical efficacy and treating noninflammatory and inflammatory lesions than that of single treatment group (P 0.05). Conclusion: 30% SA combined with IEG had a significant effect in the treatment of moderate-to-severe acne lesions.
文摘Background: Recurrent aphthous ulcer (RAS) is a common oral disease where its etiopathogenesis is not well elucidated. There was no effective curative therapy for this disease. Isotretinoin has been recently used in the treatment of Behcet’s disease. Objectives: To evaluate the efficacy and safety of isotretinoin in treating RAS and the long term remission of RAS. Patients and Methods: This single-blind controlled therapeutic study conducted in Department of Dermatology-Baghdad Teaching Hospital during February 2011-January 2012. Thirty patients with typical RAS were included in this work. Detailed history and full examination were done for all patients. They were given isotretinoin 20 mg orally once daily for three months to be seen on Day 14 firstly and then monthly to be assessed using the oral clinical manifestation index (OCMI). After isotretinoin was stopped three months later, patients were given placebo therapy for another 3 months. Results: The results of 30 treated patients were as follows: 17 (56.67%) males and 13 (43.33%) females with male to female ratio was 1.3:1. Their ages ranged from 12 - 60 (35.33 ± 12.06) years. The OCMI before isotretinoin therapy ranged from 7 - 17 (13.13 ± 2.55), while after therapy the mean started to decline to a lower level within the first 14 days (P = 0.103), and continued to decline significantly until the end of the first month of therapy (P = 0.023). Then the OCMI declined very significantly until the end of fourth month of therapy (P < 0.001). After that the mean started to increase until the end of the 5 months (with placebo) but it remained statistically significant compared with the baseline of mean of OCMI before treatment (P = 0.046). Then it continued to increase to become not significant at the end of 6 months of therapy (P = 0.107). Conclusion: Isotretinoin is an effective therapeutic and prophylactic promising remedy in treatment of RAS.
