The urgent need for effective cancer treatments,particularly for advanced and relapsed cases in which standard therapies are inadequate,has spurred the development of innovative therapeutic drugs1,2.Among the strategi...The urgent need for effective cancer treatments,particularly for advanced and relapsed cases in which standard therapies are inadequate,has spurred the development of innovative therapeutic drugs1,2.Among the strategies to expedite drug development,the use of single-arm trials(SATs)is emerging as a promising avenue with substantial potential to shorten drug approval timelines and accelerate market entry.展开更多
BACKGROUND Pregabalin is widely used to treat neuropathic pain associated with postherpetic neuralgia.To our knowledge,this is the first report on simultaneously occurring dose-related adverse drug reactions(ADRs)of b...BACKGROUND Pregabalin is widely used to treat neuropathic pain associated with postherpetic neuralgia.To our knowledge,this is the first report on simultaneously occurring dose-related adverse drug reactions(ADRs)of balance disorder,asthenia,peripheral edema,and constipation in an elderly patient after pregabalin.CASE SUMMARY A 76-year-old female with a history of postherpetic neuralgia was prescribed pregabalin(300 mg daily).After taking pregabalin for 7 d,the patient developed balance disorder,weakness,peripheral pitting edema(2+),and constipation.On days 8-14,the pregabalin dose was reduced to 150 mg/d based on creatinine clearance.The patient’s peripheral edema improved significantly with the disappearance of all other adverse symptoms.On day 15,the pregabalin dose was increased to 225 mg/d to relieve pain.Unfortunately,the symptoms mentioned earlier gradually reappeared after 1 wk of pregabalin treatment.However,the complaints were not as severe as when taking 300 mg/d pregabalin.The patient consulted her pharmacist by telephone and was advised to reduce the dose of pregabalin to 150 mg/d and add acetaminophen(0.5 g,q6h)to relieve pain.The patient’s ADRs gradually improved over the following week.CONCLUSION Older patients should be prescribed a lower initial dose of pregabalin.The dose should be titrated to the maximum tolerable dose to avoid dose-limiting ADR.Dose reduction and the addition of acetaminophen may help limit ADR and improve pain control.展开更多
Over the past two decades,China has introduced significant changes to drug regulations through regulatory innovations to accelerate drug review and approvals,keeping in line with the rapidly growing scientific innovat...Over the past two decades,China has introduced significant changes to drug regulations through regulatory innovations to accelerate drug review and approvals,keeping in line with the rapidly growing scientific innovation in drug research and development(R&D).In this study,we outlined the revolution of drug regulation in China since the establishment of the State Drug Administration in 1998.More particularly,we performed a comprehensive analysis of newly approved anticancer drugs in China from the year 2005 to May 2021,as a powerful illustration of how the revolution has changed the drug R&D landscape.Innovative drug development in China has boomed,benefiting in particular from pro-innovation policies as well as expedited program designations by the authority.We found a significant increase in the number of both imported and domestic new anticancer drugs from 2005 to 2021,with the emergence of drugs with novel mechanisms of action,including immune checkpoint inhibitors and cell therapy products.Drug lag has also been dramatically shortened by more than 70%for imported drugs in years 2016-2020 compared to years 2006-2010.Furthermore,we provide an insight into the potential approaches to further optimize the science-based and clinical value-based regulatory and R&D drug ecosystem in China.This review provides evidence of significant impacts of regulations and policies on drug R&D and suggests that the constantly adapting regulatory ecosystem will speed up drug development in China and worldwide.展开更多
基金supported by grants from the China Society for Drug Regulation(Grant No.2023-Y-Y-002)。
文摘The urgent need for effective cancer treatments,particularly for advanced and relapsed cases in which standard therapies are inadequate,has spurred the development of innovative therapeutic drugs1,2.Among the strategies to expedite drug development,the use of single-arm trials(SATs)is emerging as a promising avenue with substantial potential to shorten drug approval timelines and accelerate market entry.
文摘BACKGROUND Pregabalin is widely used to treat neuropathic pain associated with postherpetic neuralgia.To our knowledge,this is the first report on simultaneously occurring dose-related adverse drug reactions(ADRs)of balance disorder,asthenia,peripheral edema,and constipation in an elderly patient after pregabalin.CASE SUMMARY A 76-year-old female with a history of postherpetic neuralgia was prescribed pregabalin(300 mg daily).After taking pregabalin for 7 d,the patient developed balance disorder,weakness,peripheral pitting edema(2+),and constipation.On days 8-14,the pregabalin dose was reduced to 150 mg/d based on creatinine clearance.The patient’s peripheral edema improved significantly with the disappearance of all other adverse symptoms.On day 15,the pregabalin dose was increased to 225 mg/d to relieve pain.Unfortunately,the symptoms mentioned earlier gradually reappeared after 1 wk of pregabalin treatment.However,the complaints were not as severe as when taking 300 mg/d pregabalin.The patient consulted her pharmacist by telephone and was advised to reduce the dose of pregabalin to 150 mg/d and add acetaminophen(0.5 g,q6h)to relieve pain.The patient’s ADRs gradually improved over the following week.CONCLUSION Older patients should be prescribed a lower initial dose of pregabalin.The dose should be titrated to the maximum tolerable dose to avoid dose-limiting ADR.Dose reduction and the addition of acetaminophen may help limit ADR and improve pain control.
文摘Over the past two decades,China has introduced significant changes to drug regulations through regulatory innovations to accelerate drug review and approvals,keeping in line with the rapidly growing scientific innovation in drug research and development(R&D).In this study,we outlined the revolution of drug regulation in China since the establishment of the State Drug Administration in 1998.More particularly,we performed a comprehensive analysis of newly approved anticancer drugs in China from the year 2005 to May 2021,as a powerful illustration of how the revolution has changed the drug R&D landscape.Innovative drug development in China has boomed,benefiting in particular from pro-innovation policies as well as expedited program designations by the authority.We found a significant increase in the number of both imported and domestic new anticancer drugs from 2005 to 2021,with the emergence of drugs with novel mechanisms of action,including immune checkpoint inhibitors and cell therapy products.Drug lag has also been dramatically shortened by more than 70%for imported drugs in years 2016-2020 compared to years 2006-2010.Furthermore,we provide an insight into the potential approaches to further optimize the science-based and clinical value-based regulatory and R&D drug ecosystem in China.This review provides evidence of significant impacts of regulations and policies on drug R&D and suggests that the constantly adapting regulatory ecosystem will speed up drug development in China and worldwide.
