Recently, novel anti-androgens and inhibitors of androgen biosynthesis have been developed through the elucidation of mechanisms of castration resistance of prostate cancer. We believe that these new developments will...Recently, novel anti-androgens and inhibitors of androgen biosynthesis have been developed through the elucidation of mechanisms of castration resistance of prostate cancer. We believe that these new developments will improve hormonal therapy. On the other hand, there has been an increase in criticism of hormonal therapy, because hormonal therapy is supposed to induce adverse effects such as cardiovascular disease. In this review, we have introduced the Japanese experience of hormonal therapy, because we believe that there may be ethnic differences between Caucasians and Asian people in the efficacy and adverse effects of hormonal therapy. First, we showed that primary hormonal therapy can achieve long-term control of localized prostate cancer in some cases and that quality of life of patients receiving hormonal therapy is rather better than previously thought. Neoadjuvant and adjuvant hormonal therapy in cases undergoing radical prostatectomy or radiotherapy are very useful for high-risk or locally advanced prostate cancer. Further clinical trials are required to confirm the efficacy of neoadjuvant or adjuvant hormonal therapy. We showed that the death from cardiovascular dis- eases in Japanese patients receiving hormonal therapy was not higher than that in the general population. However; efforts should be made to decrease the adverse effects of hormonal therapy, because life-style change may increase the susceptibility to adverse effects by hormonal therapy even in Japan. Managements of endocrine and metabolic dysfunction, such as diabetes mellitus, are essential. New hormonal compounds such as selective androgen receptor modulators capable of specifically targeting prostate cancer are expected to be developed.展开更多
Background: Intravenous methylprednisolone pulse therapy has been used since the late 1960s for acute transplant rejection or severe renal involvement in systemic lupus erythematosus and primary glomerulonephritis. Ho...Background: Intravenous methylprednisolone pulse therapy has been used since the late 1960s for acute transplant rejection or severe renal involvement in systemic lupus erythematosus and primary glomerulonephritis. However, reports of serious adverse effects such as life-threatening cardiac arrhythmias and sudden death raise questions about its safety. Objective: To investigate the incidence of significant adverse effects associated with low-dose methylprednisolone pulse therapy (LDMPT) in pediatric patients. Methods: We retrospectively analyzed adverse effects during and after LDMPT in 68 patients (median age: 11.4 years;43% male) with various glomerular diseases who were admitted to Saitama Children’s Medical Center between April 2007 and December 2010. LDMPT consisted of pulse methylprednisolone (15-20 mg/kg;maximum 600 mg/d) for 3 consecutive days weekly for 2-3 weeks. Results: Although adverse effects occurred in 54 of 68 patients (79%), most were mild and transient. Transient glycosuria was noted in 46 patients (68%), hypertension in 6 (9%), elevated intraocular pressure in 6 (9%), hypokalemia in 5 (7%), and liver damage in 2 (3%). No late-onset adverse effects such as osteoporotic fractures, steroid diabetes mellitus, or short stature were observed. Conclusion: LDMPT appears to be relatively safe and well tolerated in children with various glomerular diseases.展开更多
Objective:To compare the differences in adverse effects and efficacy profile between bacillus Calmette-Guerin(BCG)Danish 1331 and BCG Moscow-I strain in management of non-muscle invasive bladder cancer.Methods:Clinica...Objective:To compare the differences in adverse effects and efficacy profile between bacillus Calmette-Guerin(BCG)Danish 1331 and BCG Moscow-I strain in management of non-muscle invasive bladder cancer.Methods:Clinical data of 188 cases of non-muscle invasive bladder cancer treated with BCG between January 2008 and December 2018 in our institute were collected prospectively and analysed retrospectively,and 114 patients who completed a minimum of 12 months of follow-up were analysed.Patient and tumor characteristics,strain of BCG,adverse effects,and tumor progression were included for analysis.Intravesical BCG was instilled in intermediate-and high-risk patients.Six weeks of induction BCG,followed by three weekly maintenance BCG at 3,6,12,18,and 24 months was advised in high-risk patients.Results:Overall 68 patients received BCG Danish 1331 strain and 46 patients received Moscow-I strain.Patient and tumor characteristics were well balanced between the two groups.The median follow-up period was 42.5 months and 34.5 months in Danish 1331 and Moscow-I groups,respectively.Adverse events like dropout rate,antitubercular treatment requirement,and need of cystectomy were higher in Moscow-I group(n=31,67.4%)when compared to Danish 1331 strain(n=33,48.5%)(p=0.046).On direct comparison between Danish 1331 and Moscow-I strain,there was similar 3-year recurrence-free survival(80.0%vs.72.9%)and 3-year progression-free survival(96.5%vs.97.8%).Conclusion:Study results suggest no significant differences between Danish 1331 and Moscow-I strain in recurrence-free survival and progression-free survival,but a significantly higher incidence of moderate to severe adverse events in BCG Moscow-I strain.展开更多
Background: The aim of the research was to evaluate the association between CRP (C-reactive protein), troponin I, d-dimer, creatinine, glucose, GFR (glomerular filtration rate) and LDL-C (low-density lipoprotei...Background: The aim of the research was to evaluate the association between CRP (C-reactive protein), troponin I, d-dimer, creatinine, glucose, GFR (glomerular filtration rate) and LDL-C (low-density lipoprotein cholesterol) levels at the admission and the results of thrombolytic therapy. Materials and methods: 113 patients who underwent thrombolytic therapy for acute ischemic stroke in Pauls Stradins Clinical University Hospital from 01.01.2015 to 01.01.2016 were studied retrospectively. Blood samples were collected in the emergency department. The neurological status was estimated using the NIHSS (National Institute of Health Stroke Scale). The efficacy of thrombolytic therapy was assessed by comparing NIHSS score at the admission and after treatment. Afterward all patients were divided into three groups-the major improvement (NIHSS 〉 4), minor improvement (NIHSS ≤ 4) and without any clinical effect. Results: Only the median levels of GFR were significantly (p = 0.015) lower in patients who did not have any clinical improvements after thrombolytic therapy as compared to patients with the major or minor improvements (60.0, IQR (interquartile range) 42.4-72.3 mL/min/1.73m2; 83.2, IQR 65.3-98.3 mL/min/1.73m2 and 75.9, IQR 59.2-94.6 mL/min/1.73m2). Based on the ROC (receiver operating characteristic) curve, the optimal cut-off value of GFR level as an indicator for prediction of worsen clinical outcome after thrombolytic therapy was projected to be 61.65 mL/min/1.73m2, which yielded a sensitivity of 71.4% and a specificity of 24.5%, the area under the curve was 0.788 (95% CI (confidence interval), 0.648-0.928). According Spearman rank correlation test was founded statistically significant indirect correlation between GFR level and NIHSS score after treatment (r = -0.410, p = 0.020) in patients with severe stroke (NIHSS 〉 14). Conclusions: GFR level lower than 61.65 mL/min/1.73m2 at the admission could predict as a worse outcome, especially in patients with severe stroke.展开更多
Adverse drug reactions (ADRs) are an important clinical problem and contribute significantly to mortality and morbidity. Scant data on the safety of drug use in children are usually available at the time of marketing ...Adverse drug reactions (ADRs) are an important clinical problem and contribute significantly to mortality and morbidity. Scant data on the safety of drug use in children are usually available at the time of marketing authorization, due to the limited number of trials performed in the paediatric population. Few studies monitored the incidence of ADRs in Italian hospitalized children, that cannot be compared for methodological reasons. A 6-month prospective observational study was, therefore, conducted on the paediatric wards of five hospitals in the Campania Region, Italy. Data were collected on all patients admitted to the wards during the study period through a structured questionnaire administered to the mothers and through a hospital chart review. Of the 752 patients enrolled, 86.2% were exposed to one or more drugs during hospitalization. The therapeutic class most prescribed was systemic antibacterial agents (47%). Six ADRs occurred during hospitalization (incidence 0.9%;95% CI 0.2% - 1.7%). In addition, one child was admitted to a hospital for an ADR. Five out of seven ADRs occurred in girls. The skin was the most affected organ. The medications implicated were amoxicillin, acyclovir, ibuprofen, ceftriaxone, paracetamol, and ranitidine. According to the Naranjo probability criteria, six ADRs were probably, and one possibly, related to the suspected drug. In conclusion, this study reveals that ADRs may be under-reported in children hospitalized in the Campania Region. Consequently, healthcare personnel should be alert to the possibility of ADRs. More accurate reporting of ADRs in children would result in safer use of drugs in such patients.展开更多
Objective:To observe the clinical efficacy of point application with De Huang(Rhizome Rhei Crude)powder at Shenque(CV 8)plus moxa-salt hot compress on the umbilicus for preventing gastrointestinal adverse reactions af...Objective:To observe the clinical efficacy of point application with De Huang(Rhizome Rhei Crude)powder at Shenque(CV 8)plus moxa-salt hot compress on the umbilicus for preventing gastrointestinal adverse reactions after chemotherapy for non-Hodgkin lymphoma(NHL).Methods:A total of 60 cases with NHL under chemotherapy were divided into two groups by hospitalization order,with 30 cases in each group.The control group was treated with routine nursing and the observation group was additionally given point application with Da Hueng(Rhizome Rhei Crude)powder plus moxa-salt hot compress on the umbilicus,to compare the effect in preventing gastrointestinal adverse reactions after chemotherapy between the two groups.Results:The occurrence rates of constipation,nausea,vomiting and poor appetite on the second day and fifth day after chemotherapy were obviously lower in the observation group than those in the control group,with statistically significant differences between the two groups(all P〈0.05).Conclusion;The point application with De Hueng(Rhizome Rhei Crude)powder at Shenque(CV 8)plus maxa-salt hot compress on the umbilicus can produce more significant efficacy in preventing the gastrointestinal adverse reactions after chemotherapy for NHL than routine nursing.Moreover,it is simple and easy to be used and popularized.展开更多
Immune-checkpoint inhibitor-mediated colitis(IMC)is an increasingly recognized adverse event in cancer immunotherapy,particularly associated with immune checkpoint inhibitors(ICIs)such as anti-cytotoxic T-lymphocyte a...Immune-checkpoint inhibitor-mediated colitis(IMC)is an increasingly recognized adverse event in cancer immunotherapy,particularly associated with immune checkpoint inhibitors(ICIs)such as anti-cytotoxic T-lymphocyte antigen-4 and anti-programmed cell death protein-1 antibodies.As this revolutionary immunotherapy gains prominence in cancer treatment,understanding,diagnosing,and effectively managing IMC becomes paramount.IMC represents a unique challenge due to its immune-mediated nature and potential for severe complications.However,a precise picture of IMC pathophysiology is currently unavailable.Therefore,we aimed to summarize the existing data while acknowledging the need for further research.This comprehensive review explores the mechanisms underlying ICIs,gastrointestinal adverse effects,and,in particular,IMC’s incidence,prevalence,and features.Our review also emphasizes the importance of recognizing IMC’s distinct clinical and histopathological features to differentiate it from other forms of colitis.Furthermore,this paper highlights the urgentneed for evolving diagnostic methods,therapeutic strategies,and a multidisciplinary approach to effectively manage IMC.展开更多
文摘Recently, novel anti-androgens and inhibitors of androgen biosynthesis have been developed through the elucidation of mechanisms of castration resistance of prostate cancer. We believe that these new developments will improve hormonal therapy. On the other hand, there has been an increase in criticism of hormonal therapy, because hormonal therapy is supposed to induce adverse effects such as cardiovascular disease. In this review, we have introduced the Japanese experience of hormonal therapy, because we believe that there may be ethnic differences between Caucasians and Asian people in the efficacy and adverse effects of hormonal therapy. First, we showed that primary hormonal therapy can achieve long-term control of localized prostate cancer in some cases and that quality of life of patients receiving hormonal therapy is rather better than previously thought. Neoadjuvant and adjuvant hormonal therapy in cases undergoing radical prostatectomy or radiotherapy are very useful for high-risk or locally advanced prostate cancer. Further clinical trials are required to confirm the efficacy of neoadjuvant or adjuvant hormonal therapy. We showed that the death from cardiovascular dis- eases in Japanese patients receiving hormonal therapy was not higher than that in the general population. However; efforts should be made to decrease the adverse effects of hormonal therapy, because life-style change may increase the susceptibility to adverse effects by hormonal therapy even in Japan. Managements of endocrine and metabolic dysfunction, such as diabetes mellitus, are essential. New hormonal compounds such as selective androgen receptor modulators capable of specifically targeting prostate cancer are expected to be developed.
文摘Background: Intravenous methylprednisolone pulse therapy has been used since the late 1960s for acute transplant rejection or severe renal involvement in systemic lupus erythematosus and primary glomerulonephritis. However, reports of serious adverse effects such as life-threatening cardiac arrhythmias and sudden death raise questions about its safety. Objective: To investigate the incidence of significant adverse effects associated with low-dose methylprednisolone pulse therapy (LDMPT) in pediatric patients. Methods: We retrospectively analyzed adverse effects during and after LDMPT in 68 patients (median age: 11.4 years;43% male) with various glomerular diseases who were admitted to Saitama Children’s Medical Center between April 2007 and December 2010. LDMPT consisted of pulse methylprednisolone (15-20 mg/kg;maximum 600 mg/d) for 3 consecutive days weekly for 2-3 weeks. Results: Although adverse effects occurred in 54 of 68 patients (79%), most were mild and transient. Transient glycosuria was noted in 46 patients (68%), hypertension in 6 (9%), elevated intraocular pressure in 6 (9%), hypokalemia in 5 (7%), and liver damage in 2 (3%). No late-onset adverse effects such as osteoporotic fractures, steroid diabetes mellitus, or short stature were observed. Conclusion: LDMPT appears to be relatively safe and well tolerated in children with various glomerular diseases.
基金We thank Dr. Neha Sanwalka for the support with the statisticalanalysis and Dr. Meenal Hastak and Dr. Bijal Kulkarnifor their continued support and in discussion of pathologicalaspects of disease.
文摘Objective:To compare the differences in adverse effects and efficacy profile between bacillus Calmette-Guerin(BCG)Danish 1331 and BCG Moscow-I strain in management of non-muscle invasive bladder cancer.Methods:Clinical data of 188 cases of non-muscle invasive bladder cancer treated with BCG between January 2008 and December 2018 in our institute were collected prospectively and analysed retrospectively,and 114 patients who completed a minimum of 12 months of follow-up were analysed.Patient and tumor characteristics,strain of BCG,adverse effects,and tumor progression were included for analysis.Intravesical BCG was instilled in intermediate-and high-risk patients.Six weeks of induction BCG,followed by three weekly maintenance BCG at 3,6,12,18,and 24 months was advised in high-risk patients.Results:Overall 68 patients received BCG Danish 1331 strain and 46 patients received Moscow-I strain.Patient and tumor characteristics were well balanced between the two groups.The median follow-up period was 42.5 months and 34.5 months in Danish 1331 and Moscow-I groups,respectively.Adverse events like dropout rate,antitubercular treatment requirement,and need of cystectomy were higher in Moscow-I group(n=31,67.4%)when compared to Danish 1331 strain(n=33,48.5%)(p=0.046).On direct comparison between Danish 1331 and Moscow-I strain,there was similar 3-year recurrence-free survival(80.0%vs.72.9%)and 3-year progression-free survival(96.5%vs.97.8%).Conclusion:Study results suggest no significant differences between Danish 1331 and Moscow-I strain in recurrence-free survival and progression-free survival,but a significantly higher incidence of moderate to severe adverse events in BCG Moscow-I strain.
文摘Background: The aim of the research was to evaluate the association between CRP (C-reactive protein), troponin I, d-dimer, creatinine, glucose, GFR (glomerular filtration rate) and LDL-C (low-density lipoprotein cholesterol) levels at the admission and the results of thrombolytic therapy. Materials and methods: 113 patients who underwent thrombolytic therapy for acute ischemic stroke in Pauls Stradins Clinical University Hospital from 01.01.2015 to 01.01.2016 were studied retrospectively. Blood samples were collected in the emergency department. The neurological status was estimated using the NIHSS (National Institute of Health Stroke Scale). The efficacy of thrombolytic therapy was assessed by comparing NIHSS score at the admission and after treatment. Afterward all patients were divided into three groups-the major improvement (NIHSS 〉 4), minor improvement (NIHSS ≤ 4) and without any clinical effect. Results: Only the median levels of GFR were significantly (p = 0.015) lower in patients who did not have any clinical improvements after thrombolytic therapy as compared to patients with the major or minor improvements (60.0, IQR (interquartile range) 42.4-72.3 mL/min/1.73m2; 83.2, IQR 65.3-98.3 mL/min/1.73m2 and 75.9, IQR 59.2-94.6 mL/min/1.73m2). Based on the ROC (receiver operating characteristic) curve, the optimal cut-off value of GFR level as an indicator for prediction of worsen clinical outcome after thrombolytic therapy was projected to be 61.65 mL/min/1.73m2, which yielded a sensitivity of 71.4% and a specificity of 24.5%, the area under the curve was 0.788 (95% CI (confidence interval), 0.648-0.928). According Spearman rank correlation test was founded statistically significant indirect correlation between GFR level and NIHSS score after treatment (r = -0.410, p = 0.020) in patients with severe stroke (NIHSS 〉 14). Conclusions: GFR level lower than 61.65 mL/min/1.73m2 at the admission could predict as a worse outcome, especially in patients with severe stroke.
文摘Adverse drug reactions (ADRs) are an important clinical problem and contribute significantly to mortality and morbidity. Scant data on the safety of drug use in children are usually available at the time of marketing authorization, due to the limited number of trials performed in the paediatric population. Few studies monitored the incidence of ADRs in Italian hospitalized children, that cannot be compared for methodological reasons. A 6-month prospective observational study was, therefore, conducted on the paediatric wards of five hospitals in the Campania Region, Italy. Data were collected on all patients admitted to the wards during the study period through a structured questionnaire administered to the mothers and through a hospital chart review. Of the 752 patients enrolled, 86.2% were exposed to one or more drugs during hospitalization. The therapeutic class most prescribed was systemic antibacterial agents (47%). Six ADRs occurred during hospitalization (incidence 0.9%;95% CI 0.2% - 1.7%). In addition, one child was admitted to a hospital for an ADR. Five out of seven ADRs occurred in girls. The skin was the most affected organ. The medications implicated were amoxicillin, acyclovir, ibuprofen, ceftriaxone, paracetamol, and ranitidine. According to the Naranjo probability criteria, six ADRs were probably, and one possibly, related to the suspected drug. In conclusion, this study reveals that ADRs may be under-reported in children hospitalized in the Campania Region. Consequently, healthcare personnel should be alert to the possibility of ADRs. More accurate reporting of ADRs in children would result in safer use of drugs in such patients.
文摘Objective:To observe the clinical efficacy of point application with De Huang(Rhizome Rhei Crude)powder at Shenque(CV 8)plus moxa-salt hot compress on the umbilicus for preventing gastrointestinal adverse reactions after chemotherapy for non-Hodgkin lymphoma(NHL).Methods:A total of 60 cases with NHL under chemotherapy were divided into two groups by hospitalization order,with 30 cases in each group.The control group was treated with routine nursing and the observation group was additionally given point application with Da Hueng(Rhizome Rhei Crude)powder plus moxa-salt hot compress on the umbilicus,to compare the effect in preventing gastrointestinal adverse reactions after chemotherapy between the two groups.Results:The occurrence rates of constipation,nausea,vomiting and poor appetite on the second day and fifth day after chemotherapy were obviously lower in the observation group than those in the control group,with statistically significant differences between the two groups(all P〈0.05).Conclusion;The point application with De Hueng(Rhizome Rhei Crude)powder at Shenque(CV 8)plus maxa-salt hot compress on the umbilicus can produce more significant efficacy in preventing the gastrointestinal adverse reactions after chemotherapy for NHL than routine nursing.Moreover,it is simple and easy to be used and popularized.
基金Supported by the European Union-NextGenerationEU,through the National Recovery and Resilience Plan of the Republic of Bulgaria,No.BG-RRP-2.004-0008.
文摘Immune-checkpoint inhibitor-mediated colitis(IMC)is an increasingly recognized adverse event in cancer immunotherapy,particularly associated with immune checkpoint inhibitors(ICIs)such as anti-cytotoxic T-lymphocyte antigen-4 and anti-programmed cell death protein-1 antibodies.As this revolutionary immunotherapy gains prominence in cancer treatment,understanding,diagnosing,and effectively managing IMC becomes paramount.IMC represents a unique challenge due to its immune-mediated nature and potential for severe complications.However,a precise picture of IMC pathophysiology is currently unavailable.Therefore,we aimed to summarize the existing data while acknowledging the need for further research.This comprehensive review explores the mechanisms underlying ICIs,gastrointestinal adverse effects,and,in particular,IMC’s incidence,prevalence,and features.Our review also emphasizes the importance of recognizing IMC’s distinct clinical and histopathological features to differentiate it from other forms of colitis.Furthermore,this paper highlights the urgentneed for evolving diagnostic methods,therapeutic strategies,and a multidisciplinary approach to effectively manage IMC.