Objective To evaluate the efficacy and safety of traditional Chinese medicine(TCM)compounds for the treatment of functional dyspepsia(FD).Methods The Pub Med,Embase,Cochrane Library,Web of Science,Chinese Biomedical D...Objective To evaluate the efficacy and safety of traditional Chinese medicine(TCM)compounds for the treatment of functional dyspepsia(FD).Methods The Pub Med,Embase,Cochrane Library,Web of Science,Chinese Biomedical Database(CBM),Wanfang Data,China National Knowledge Infrastructure(CNKI),and China Science and Technology Journal Database(VIP)were searched to collect randomized,double-blind,and placebo-controlled trials of FD treated with TCM compounds.The search duration was from the establishment of the database to March 2,2021.After two researchers independently screened the literature,extracted the data,and evaluated the bias risk included in the study,they used Rev Man 5.4 software for meta-analysis.Results A total of 23 clinical trials were included,including 2898 patients.Meta-analysis showed that the overall remission rate of FD treated with TCM compounds was significantly higher than that of placebo(73.8%vs.46.2%)[RR=1.50,95%CI(1.29,1.76),P<0.00001].Among the single symptoms,TCM compounds were superior to the placebo in improving epigastric pain[MD=﹣0.99,95%CI(﹣1.37,﹣0.61),P<0.00001],epigastric burning sensation[MD=﹣0.32,95%CI(﹣0.59,﹣0.05),P=0.02],postprandial fullness discomfort[MD=﹣1.59,95%CI(﹣1.96,﹣1.21),P<0.00001],and early satiety symptoms[MD=﹣0.93,95%CI(﹣1.32,﹣0.54),P<0.00001].Compared with the placebo,TCM compounds treatment can obviously improve TCM syndrome in patients with FD[MD=﹣5.58,95%CI(﹣7.55,﹣3.61),P<0.00001],gastric emptying rate[MD=12.22,95%CI(8.90,15.55),P<0.00001],and helped to improve patients’quality of life[MD=11.27,95%CI(0.10,22.43),P=0.05].No severe adverse events were reported between the two groups[RR=1.34,95%CI(0.91,1.96),P=0.14].Conclusion Our results showed that TCM compounds treatment could significantly alleviate FD symptoms,improve gastric emptying in FD patients,and help to improve their quality of life.No severe adverse reactions have been reported in clinical applications.Due to the limitation of the quantity and quality of the included studies,the above conclusions need to be verified by more high-quality studies.展开更多
OBJECTIVE: To assess the safety and effectiveness of Dengzhanxixin injection(DZI) extracted from Dengzhanxixin(Herba Erigerontis Breviscapi) and identify its potential risks.METHODS: A series of studies were conducted...OBJECTIVE: To assess the safety and effectiveness of Dengzhanxixin injection(DZI) extracted from Dengzhanxixin(Herba Erigerontis Breviscapi) and identify its potential risks.METHODS: A series of studies were conducted on the production process, quality standards, and pharmacology. Postmarketing clinical studies and literature reviews including adverse reactions(ADR),adverse events(ADE), case analysis and systematic reviews were also conducted. Data from the hospital information system and spontaneous reporting system were analyzed.RESULTS: The acute toxicity test indicated that the Lethal Dose 50 test( LD 50) dosage was 250 times more than the clinical maximum daily dosage(6mg/kg). In long-term toxicity tests, rats experi-enced renal tubular damage at 480 mg/kg. However, the dose of 120 mg/kg is safe and non-toxic,which is 40 times above the clinical daily maximum. Beagles had increased serum creatinine at160 mg/kg. In a prospective study, 15 962 cases experienced 16 ADR/ADE. The rate of ADR/ADE was0.1002%. ADR symptoms included rash(16.00%),chills(16.00%), and fever(16.00%).CONCLUSION: There is significant evidence that DZI is safe and effective in a clinical setting.展开更多
基金funding support from the National Natural Science Foundation of China Project(No.81820108033)the Project of Wangjing Hospital,China Academy of Chinese Medical Sciences(No.WJYY2020-18)。
文摘Objective To evaluate the efficacy and safety of traditional Chinese medicine(TCM)compounds for the treatment of functional dyspepsia(FD).Methods The Pub Med,Embase,Cochrane Library,Web of Science,Chinese Biomedical Database(CBM),Wanfang Data,China National Knowledge Infrastructure(CNKI),and China Science and Technology Journal Database(VIP)were searched to collect randomized,double-blind,and placebo-controlled trials of FD treated with TCM compounds.The search duration was from the establishment of the database to March 2,2021.After two researchers independently screened the literature,extracted the data,and evaluated the bias risk included in the study,they used Rev Man 5.4 software for meta-analysis.Results A total of 23 clinical trials were included,including 2898 patients.Meta-analysis showed that the overall remission rate of FD treated with TCM compounds was significantly higher than that of placebo(73.8%vs.46.2%)[RR=1.50,95%CI(1.29,1.76),P<0.00001].Among the single symptoms,TCM compounds were superior to the placebo in improving epigastric pain[MD=﹣0.99,95%CI(﹣1.37,﹣0.61),P<0.00001],epigastric burning sensation[MD=﹣0.32,95%CI(﹣0.59,﹣0.05),P=0.02],postprandial fullness discomfort[MD=﹣1.59,95%CI(﹣1.96,﹣1.21),P<0.00001],and early satiety symptoms[MD=﹣0.93,95%CI(﹣1.32,﹣0.54),P<0.00001].Compared with the placebo,TCM compounds treatment can obviously improve TCM syndrome in patients with FD[MD=﹣5.58,95%CI(﹣7.55,﹣3.61),P<0.00001],gastric emptying rate[MD=12.22,95%CI(8.90,15.55),P<0.00001],and helped to improve patients’quality of life[MD=11.27,95%CI(0.10,22.43),P=0.05].No severe adverse events were reported between the two groups[RR=1.34,95%CI(0.91,1.96),P=0.14].Conclusion Our results showed that TCM compounds treatment could significantly alleviate FD symptoms,improve gastric emptying in FD patients,and help to improve their quality of life.No severe adverse reactions have been reported in clinical applications.Due to the limitation of the quantity and quality of the included studies,the above conclusions need to be verified by more high-quality studies.
基金Supported by National Science and Technology Major Projects for"Major New Drugs Innovation and Development":Study on Key Technologies of Postmarketing Evaluation for Chinese Medicine(No.2009ZX09502-030)
文摘OBJECTIVE: To assess the safety and effectiveness of Dengzhanxixin injection(DZI) extracted from Dengzhanxixin(Herba Erigerontis Breviscapi) and identify its potential risks.METHODS: A series of studies were conducted on the production process, quality standards, and pharmacology. Postmarketing clinical studies and literature reviews including adverse reactions(ADR),adverse events(ADE), case analysis and systematic reviews were also conducted. Data from the hospital information system and spontaneous reporting system were analyzed.RESULTS: The acute toxicity test indicated that the Lethal Dose 50 test( LD 50) dosage was 250 times more than the clinical maximum daily dosage(6mg/kg). In long-term toxicity tests, rats experi-enced renal tubular damage at 480 mg/kg. However, the dose of 120 mg/kg is safe and non-toxic,which is 40 times above the clinical daily maximum. Beagles had increased serum creatinine at160 mg/kg. In a prospective study, 15 962 cases experienced 16 ADR/ADE. The rate of ADR/ADE was0.1002%. ADR symptoms included rash(16.00%),chills(16.00%), and fever(16.00%).CONCLUSION: There is significant evidence that DZI is safe and effective in a clinical setting.
