ABSTRACT
We evaluated the long-term safety of eight adult volunteers (male 7, female 1: average age 47.4 years) ingesting powdered foods containing Coix-seed Reactive Derivatives (CRD/2.2g/day or 4.4g/day) for 1 year 8 months to 5 years (average 2 years 9 months). Body weight, vital signs (blood pressure, pulse rate), peripheral blood test, blood biochemical test, etc. were observed. We also investigated the presence or absence of side effects. The results showed no notable changes in vital signs or blood test results. From the above, it was speculated that long-term intake of CRD would not pose a safety problem. We plan to continue the study by increasing the number of observation cases in the future.
ABSTRACT
Infantile hemangioma is the most common tumor in infancy,with an incidence of 4％-5％.According to the risk level,hemangioma is divided into 3 levels:high risk,medium risk and low risk.At present,the first-line treatment of high-risk hemangioma is oral propranolol (β-receptor blockers).It has been 10 years since infantile hemangioma was treated with propranolol for the first time,and propranolol has been the drug of first-choice in systematic treatment due to its high efficacy and good safety,but its long-term adverse effect needs further evaluation.
ABSTRACT
Once-daily tadalafil administration has been well established; however, studies about tadalafil once-daily treatment in the Chinese population are lacking. In this phase 4, postmarketing study, we ascertained the long-term safety and effectiveness of tadalafil 2.5 mg and 5.0 mg once daily in Chinese men with erectile dysfunction (n = 635). The primary endpoint of the study was safety at 12 months as assessed by the proportion of patients experiencing at least one treatment-emergent adverse event (serious or nonserious). The secondary endpoints included safety and effectiveness, measured by the International Index of Erectile Function-Erectile Function (IIEF-EF) domain scores. Similar adverse events to the known safety profile of tadalafil, such as nasopharyngitis, upper respiratory tract infection, headache, and dizziness, were detected. No new cardiovascular safety concerns were observed. After 3 months of treatment, significant increases in IIEF-EF domain scores were detected for both 2.5-mg (least squares [LS] mean change: 6.3; 95% confidence interval [CI]: 5.4-7.1; P < 0.001) and 5.0-mg (LS mean change: 7.4; 95% CI: 6.8-7.9; P < 0.001) tadalafil doses, and significance was maintained up to 12 months. In addition, approximately 40% of patients regained normal erectile function (IIEF-EF ≥26) following 1 year of tadalafil once-daily treatment. The findings in this study provide evidence for the extended effectiveness and tolerability of tadalafil, demonstrating no new safety concerns, in a Chinese population and make once-daily tadalafil administration a viable option for improving sexual performance and satisfaction in Chinese men with erectile dysfunction.
Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Young Adult , Asian People , Double-Blind Method , Erectile Dysfunction/drug therapy , Patient Safety , Phosphodiesterase 5 Inhibitors/therapeutic use , Product Surveillance, Postmarketing , Prospective Studies , Tadalafil/therapeutic use , Treatment OutcomeABSTRACT
Once-daily tadalafil administration has been well established; however, studies about tadalafil once-daily treatment in the Chinese population are lacking. In this phase 4, postmarketing study, we ascertained the long-term safety and effectiveness of tadalafil 2.5 mg and 5.0 mg once daily in Chinese men with erectile dysfunction (n = 635). The primary endpoint of the study was safety at 12 months as assessed by the proportion of patients experiencing at least one treatment-emergent adverse event (serious or nonserious). The secondary endpoints included safety and effectiveness, measured by the International Index of Erectile Function-Erectile Function (IIEF-EF) domain scores. Similar adverse events to the known safety profile of tadalafil, such as nasopharyngitis, upper respiratory tract infection, headache, and dizziness, were detected. No new cardiovascular safety concerns were observed. After 3 months of treatment, significant increases in IIEF-EF domain scores were detected for both 2.5-mg (least squares [LS] mean change: 6.3; 95% confidence interval [CI]: 5.4-7.1; P < 0.001) and 5.0-mg (LS mean change: 7.4; 95% CI: 6.8-7.9; P < 0.001) tadalafil doses, and significance was maintained up to 12 months. In addition, approximately 40% of patients regained normal erectile function (IIEF-EF ≥26) following 1 year of tadalafil once-daily treatment. The findings in this study provide evidence for the extended effectiveness and tolerability of tadalafil, demonstrating no new safety concerns, in a Chinese population and make once-daily tadalafil administration a viable option for improving sexual performance and satisfaction in Chinese men with erectile dysfunction.
ABSTRACT
OBJECTIVE: To optimize the chemotherapy regimen for one pediatric patient with retinoblastoma. METHODS: Clinical pharmacists provided advice to the physicians to develop targeted treatment programs and medication counseling to the patient's parents to improve the long-term safety of chemotherapy. RESULTS: The patient finished this cycle of chemotherapy safely, and took the physicians advice to receive surgical therapy in the future. CONCLUSION: Multiple chemotherapy-related long-term safety issues might significantly affect the future life of pediatric patients with retinoblastoma, which needs more attention.
ABSTRACT
A long-term safety study was conducted with astaxanthin derived from <i>Haematococcus pluvialis</i> algae extract. Fifteen healthy volunteers took 9 mg of astaxanthin daily for 12 weeks. Physiological (including doctor’s consultation), haematological, biochemical, and urinary markers were examined at weeks 0, 4, 8 and 12. No adverse effects or clinical changes were observed throughout the test period. It was concluded that a healthy adult can consume 9 mg of astaxanthin derived from <i>Haematococcus pluvialis</i> algae extract for 12 weeks without any safety concern.<br>