Search

OBJECTIVE: To evaluate risks of Japanese Kampo medicine and its effects on risk assessment of pregnancy of traditional Chinese medicine ( TCM) in China by analyzing risks of Japanese Kampo medicine on pregnancy and lactation in drug instructions, so as to provide reference for further development of the risk assessment of pregnancy and lactation of TCM in China. METHODS: According to the Pharmaceuticals and Medical Devices Agency (PMDA) platform, 148 kinds of Japanese Kampo medicine related drug instructions were collected and sorted out, the related statements during pregnancy and lactation were analyzed, and the Japanese Kampo medicine and TCM components with drug risks were evaluated. Additionally, potential risks of pregnancy and lactation of Japanese Kampo medicine were evaluated with Pharmacopoeia of the People's Republic of China (Volume 1, 2020 edition), Pharmacovigilance of Traditional Chinese Medicine, Theory on the Nature of Traditional Chinese Medicine. Based on Japanese Kampo components during pregnancy, the risk assessment of 505 Chinese patent medicines during pregnancy was carried out to analyze the effects on the pregnancy risk of Chinese patent medicines. RESULTS: Of the 148 kinds of Japanese Kampo medicines, there were 39 with risks on pregnancy. The risk components of TCM in pregnancy included Radix rhei et rhizome, Cortex Moutan, Aconiti lateralis radix praeparata, Persicae semen, Achyranthis bidentatae radix, mirabilite and Carthami flos, mainly due to their own toxicity and effects on abortion and premature delivery. Among the lactation-risk Kampo medicines, there were 18 medicines that were prone to cause diarrhea in newborns due to the presence of Radix rhei et rhizome. According to the evaluation of Chinese classics, there were 93 kinds of potential risks of Japanese Kampo medicines. Based on Japanese Kampo risk components, a total of 59 kinds of 505 TCM had potential risks during pregnancy, accounting for 17. 1% of the 345 unlabeled contraindicated drugs during pregnancy. CONCLUSIONS: Risks of Japanese Kampo medicine on pregnancy and lactation are evaluated based on TCM components. The methods of risk statements on special populations of Kampo medicine can provide a reference for development of TCM in China. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To analyze and discuss the clinical trial methodology of tocolysis through analysis of the series of studies on assessment of perinatal outcome after sustained tocolysis in early labor (APOSTEL), so as to provide references for further research on tocolysis drugs in China. METHODS: Factors such as study type, exclusion criteria, outcome indicators, sample size and drug regimen in series of studies of APOSTEL were analyzed. Based on main results and conclusions of APOSTEL, the methodological design of clinical research on tocolysis drugs was analyzed and discussed. RESULTS: The series of studies of APOSTEL were designed as prospective and randomized controlled trials, the design of test was different from the guidelines in China in the diagnosis of pregnancy cycle, contraction intensity and cervical length. Patients were included with diagnosis of intermediate cervical length and fibronectin test. Exclusion criteria were used to exclude clinical indications of urgent delivery, neonates with congenital malformations and drug contraindications. In terms of the calculation of the expected number of participants, there was an improvement in the absolute proportion of national research applications, while international research was calculated based on relative proportion. Drug regimen of the experimental group and control group was mostly similar to the national guidelines, and the regimen design of drug delay therapy could be used as the reference. CONCLUSIONS: Referring to the series of studies of APOSTEL can further improve the relevant clinical design, and carry out design and implementation of high-quality clinical trials on tocolysis drugs for premature delivery according to the national conditions [ABSTRACT FROM AUTHOR]

Copyright of Evaluation & Analysis of Drug-Use in Hospitals of China is the property of Evaluation & Analysis of Drug-Use in Hospitals of China Editorial Board and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Evaluation & Analysis of Drug-Use in Hospitals of China is the property of Evaluation & Analysis of Drug-Use in Hospitals of China Editorial Board and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Evaluation & Analysis of Drug-Use in Hospitals of China is the property of Evaluation & Analysis of Drug-Use in Hospitals of China Editorial Board and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)