Objectives： To evaluate the efficacy and safety of Chinese herbal medicine Xingnaojing Injection（醒脑静注射液） for newborns with hypoxic ischemic encephalopathy（HIE）. Methods： Literature was identified by search...Objectives： To evaluate the efficacy and safety of Chinese herbal medicine Xingnaojing Injection（醒脑静注射液） for newborns with hypoxic ischemic encephalopathy（HIE）. Methods： Literature was identified by searching the Pub Med, EMBASE, Cochrane Library, Cochrane Central, and four Chinese literature databases from the establishment of database to October in 2013. Relevant reference lists were also screened. Two reviewers independently evaluated the methodological quality of included studies. We also conducted the meta-analysis. Results： Thirteen trials involving 1,169 patients were included. There was no trial reported death or disability at the end of follow-up period. Meta-analysis of 4 trials（n=371） showed that there was no significant difference in the reduction of mortality [risk ratios（RR）=0.48, 95% confidence intervals（CI, 0.21, 1.13）, P=0.09] between the Xingnaojing and control groups. Meta-analysis of 5 trials（n=359） showed that there was significant difference in reducing the major neurodevelopmental disability [RR=0.36, 95% CI（0.19, 0.66）, P=0.001]. Meta-analysis of 6 trials（n=447） showed that there was a significant difference in the author self-defined symptom improvement [RR=1.25, 95% CI（1.14, 1.37）, P〈0.01]. No fatal side-effects were reported. Conclusion： Based on the limited evidence, the routine use of Xingnaojing Injection for treatment of HIE in newborns is not recommended. Further well-conducted trials are justified.展开更多
In 2012,USA Food and Drug Administration（FDA） approved 39 new drugs,however,there are only two botanical drugs（one topical and one oral）approved by FDA since the publication of the FDA＇s industry guidelines for t...In 2012,USA Food and Drug Administration（FDA） approved 39 new drugs,however,there are only two botanical drugs（one topical and one oral）approved by FDA since the publication of the FDA＇s industry guidelines for the botanical drug product in June 2004.The approval shows the Western guideline can be used for herbal medicines,authors investigate current regulation on herbal medicine clinical research,identify challenges conducting clinical trials,and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area.Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials.Authors critically explore case study of the 1st FDA approved botanical drugs,Veregen（sinecatechins）,green tea leaves extract,a topical cream for perianal and genital condyloma.In consideration of current regulation environment in USA,based on the findings and analysis through the literature review and Veregen case study,authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considerina in a herbal medicine clinical trial.展开更多
Apocynaceae is a large family of tropical trees, shrubs and vines with most species producing white latex. Major metabolites of species are triterpenoids, iridoids, alkaloids and cardenolides, which are known for a wi...Apocynaceae is a large family of tropical trees, shrubs and vines with most species producing white latex. Major metabolites of species are triterpenoids, iridoids, alkaloids and cardenolides, which are known for a wide range of biological and pharmacological activities such as cardioprotective, hepatoprotective, neuroprotective, anti-inflammatory, anticancer and antimalarial properties. Prompted by their anticancer and antimalarial properties, the current knowledge on ten genera （Allamanda, Alstonia, Calotropis, Catharanthus, Cerbera, Dyera, Kopsia, Nerium, Plumeria and Vallaris） is updated. Major classes of metabolites are described using some species as examples. Species with antiproliferative （APF） and/ or antiplasmodial （APM） properties have been identified. With the exception of the genus Dyera, nine genera of 22 species possess APF activity. Seven genera （Alstonia, Calotropis, Catharanthus, Dyera, Kopsia, Plumeria and Vallaris） of 13 species have APM properties. Among these species, Alstonia angustiloba, Alstonia macrophylla, Calotropis gigantea, Calotropis procera, Catharanthus roseus, Plumeria alba and Vallaris glabra displayed both APF and APM properties. The chemical constituents of these seven species are compiled for assessment and further research.展开更多
It is estimated that 80% of the world population depends on traditional medicine for primary healthcare need. Trianthema portulacastrum Linn.（family： Aizoaceae） is a small perennial weed found in the Americas, Afri...It is estimated that 80% of the world population depends on traditional medicine for primary healthcare need. Trianthema portulacastrum Linn.（family： Aizoaceae） is a small perennial weed found in the Americas, Africa, India, and other regions of the world. This plant is used extensively in Indian traditional medicines and is also consumed as a vegetable throughout Asia for its perceived health benefits. Phytochemical analysis of T. portulacastrum reveals the presence of alkaloids, fl avonoids, terpenoids, saponins, and phenolic compounds. Emerging studies demonstrate that crude extracts as well as bioactive phytoconstituents of T. portulacastrum exhibit potent antioxidant, anti-infective, analgesic, and anti-infl ammatory activities. A growing number of in vitro and in vivo studies demonstrate various biological and pharmacological activities, including prevention and amelioration of hepatotoxicity, nephrotoxicity, hyperglycemia, hyperlipidemia, infectious diseases and cancer. This review aims to present and analyze available literature to understand the full potential of T. portulacastrum in health promotion and disease prevention. Current limitations and future directions of research on this medicinal and dietary plant are also critically discussed.展开更多
基金Supported by the National Natural Science Foundation of China(No.81373381)
文摘Objectives： To evaluate the efficacy and safety of Chinese herbal medicine Xingnaojing Injection（醒脑静注射液） for newborns with hypoxic ischemic encephalopathy（HIE）. Methods： Literature was identified by searching the Pub Med, EMBASE, Cochrane Library, Cochrane Central, and four Chinese literature databases from the establishment of database to October in 2013. Relevant reference lists were also screened. Two reviewers independently evaluated the methodological quality of included studies. We also conducted the meta-analysis. Results： Thirteen trials involving 1,169 patients were included. There was no trial reported death or disability at the end of follow-up period. Meta-analysis of 4 trials（n=371） showed that there was no significant difference in the reduction of mortality [risk ratios（RR）=0.48, 95% confidence intervals（CI, 0.21, 1.13）, P=0.09] between the Xingnaojing and control groups. Meta-analysis of 5 trials（n=359） showed that there was significant difference in reducing the major neurodevelopmental disability [RR=0.36, 95% CI（0.19, 0.66）, P=0.001]. Meta-analysis of 6 trials（n=447） showed that there was a significant difference in the author self-defined symptom improvement [RR=1.25, 95% CI（1.14, 1.37）, P〈0.01]. No fatal side-effects were reported. Conclusion： Based on the limited evidence, the routine use of Xingnaojing Injection for treatment of HIE in newborns is not recommended. Further well-conducted trials are justified.
文摘In 2012,USA Food and Drug Administration（FDA） approved 39 new drugs,however,there are only two botanical drugs（one topical and one oral）approved by FDA since the publication of the FDA＇s industry guidelines for the botanical drug product in June 2004.The approval shows the Western guideline can be used for herbal medicines,authors investigate current regulation on herbal medicine clinical research,identify challenges conducting clinical trials,and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area.Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials.Authors critically explore case study of the 1st FDA approved botanical drugs,Veregen（sinecatechins）,green tea leaves extract,a topical cream for perianal and genital condyloma.In consideration of current regulation environment in USA,based on the findings and analysis through the literature review and Veregen case study,authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considerina in a herbal medicine clinical trial.
文摘Apocynaceae is a large family of tropical trees, shrubs and vines with most species producing white latex. Major metabolites of species are triterpenoids, iridoids, alkaloids and cardenolides, which are known for a wide range of biological and pharmacological activities such as cardioprotective, hepatoprotective, neuroprotective, anti-inflammatory, anticancer and antimalarial properties. Prompted by their anticancer and antimalarial properties, the current knowledge on ten genera （Allamanda, Alstonia, Calotropis, Catharanthus, Cerbera, Dyera, Kopsia, Nerium, Plumeria and Vallaris） is updated. Major classes of metabolites are described using some species as examples. Species with antiproliferative （APF） and/ or antiplasmodial （APM） properties have been identified. With the exception of the genus Dyera, nine genera of 22 species possess APF activity. Seven genera （Alstonia, Calotropis, Catharanthus, Dyera, Kopsia, Plumeria and Vallaris） of 13 species have APM properties. Among these species, Alstonia angustiloba, Alstonia macrophylla, Calotropis gigantea, Calotropis procera, Catharanthus roseus, Plumeria alba and Vallaris glabra displayed both APF and APM properties. The chemical constituents of these seven species are compiled for assessment and further research.
文摘It is estimated that 80% of the world population depends on traditional medicine for primary healthcare need. Trianthema portulacastrum Linn.（family： Aizoaceae） is a small perennial weed found in the Americas, Africa, India, and other regions of the world. This plant is used extensively in Indian traditional medicines and is also consumed as a vegetable throughout Asia for its perceived health benefits. Phytochemical analysis of T. portulacastrum reveals the presence of alkaloids, fl avonoids, terpenoids, saponins, and phenolic compounds. Emerging studies demonstrate that crude extracts as well as bioactive phytoconstituents of T. portulacastrum exhibit potent antioxidant, anti-infective, analgesic, and anti-infl ammatory activities. A growing number of in vitro and in vivo studies demonstrate various biological and pharmacological activities, including prevention and amelioration of hepatotoxicity, nephrotoxicity, hyperglycemia, hyperlipidemia, infectious diseases and cancer. This review aims to present and analyze available literature to understand the full potential of T. portulacastrum in health promotion and disease prevention. Current limitations and future directions of research on this medicinal and dietary plant are also critically discussed.
