An Observational Study on the Safety of Long-term Intake of Coix-seed Reactive Derivatives (CRD) in Adults / 日本補完代替医療学会誌

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.

Short-and long-term safety of oral propranolol in the treatment of infantile hemangioma / 中华皮肤科杂志

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.

Evaluation of the long-term safety and effectiveness of tadalafil once daily in Chinese men with erectile dysfunction: interim results of a multicenter, randomized, open-label trial / 亚洲男科学杂志(英文版)

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.

Evaluation of the long-term safety and effectiveness of tadalafil once daily in Chinese men with erectile dysfunction: Interim results of a multicenter, randomized, open-label trial / 亚洲男科学杂志(英文版)

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.

Pharmaceutical care for long-term safety multiple chemotherapy in a retinoblastoma patient / 中国药学杂志

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.

A Safety Study on the Long-Term Consumption of Astaxanthin in Healthy Human Volunteers / 日本補完代替医療学会誌

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>