| Objective: Traditional Chinese medicine(TCM)is a commonly used drugs for pregnant women in China.There is currently a lack of data on the safety of Chinese medicine and Chinese herbal medicines used during pregnancy.The purpose of this study was to investigate the situation of the use of Chinese patent medicines and Chinese herbal medicines in the pregnancy woman consulted on drugs,and to follow up the safety of Chinese patent medicines and Chinese herbal medicines during pregnancy.Finally,to provide evidence for guiding the rational use of traditional Chinese medicine by pregnant women.Methods:(1)The literature of the animal developmental toxicity test of TCM was published from the establishment of the database to December 31,2019 were searched by through computational and manual,and the literature that meet inclusion and exclusion criteria was included,and data extraction and analysis were performed.The data was systematic analysis of the toxicity of traditional Chinese medicine to the mother and the teratogenicity of the embryo.(2)From January 2017 to December 2020,the pregnant woman in the outpatient department of Sichuan Provincial People’s Hospital,who has been exposed to Chinese patent medicines and Chinese herbal medicines were collected.And the pregnancy outcome and newborn situation of pregnant women were followed up through We Chat and telephone.The medication use profile of Chinese patent medicines and Chinese herbal medicines during pregnancy were first analyzed,and the influence of pregnancy with contraindicated Chinese medicine exposure group and pregnancy with caution or unclear Chinese medicine exposure group on pregnancy outcome and newborn birth were evaluated.(3)With berberine as the specific research drug,pregnant women exposed to berberine in early pregnancy were considered as the research group.According to the exposure group,patients who were not exposed to berberine were randomly matched as the control group.The two groups of patients were followed up to analyze the correlation between berberine exposure in early pregnancy and pregnancy outcomes and neonatal condition.Results:(1)Finally,29 articles involving 25 kinds of traditional Chinese medicines were included,mainly animal experiments on embryo-fetal developmental toxicity.Studies have found that realgar,cinnabar,senecio extracts,safflower Ruyi pills,Cyclovirobuxine D injection,astragaloside IV can reduce the number of live births in animals.And realgar,cinnabar,safflower Ruyi pills,ginkgolide B,Zishengyutai pill and wogonin can delay the development of animal bones.(2)A total of 254 pregnant women were enrolled during the observation period,each of them used 2 kinds of Chinese patent medicines and 12 kinds of Chinese herbal medicine per person.And about46.89% Of pregnant women have taken medicine during the teratogenic sensitive period.Approximately,39.76% of pregnant women have used contraindicated Chinese medicine.The main reason for pregnant women to take Chinese patent medicines and Chinese herbal medicine was cold.Finally,the effective follow-up rate was 94.88%.175 pregnant women gave birth successfully,the spontaneous abortion rate was 7.05%,and selective termination pregnancy rate was 9.13%.Compared with the non-exposure group,pregnant women exposed to pregnancy contraindicated Chinese medicines had no significant differences in live birth rate,premature birth rate and birth weight of fetuses(P>0.05).(3)The live birth rate of the berberine-exposed group in early pregnancy was lower than that of the non-exposed group,but the difference was not statistically significant(P>0.05).The gestational age and weight of the fetuses in the berberine exposure group were not significantly different from those in the control group(P>0.05).Conclusion:(1)The research on the in vivo developmental toxicity of contraindicated Chinese medicines for pregnancy should be strengthened,and attention should be paid to the teratogenicity of pregnancy contraindicated traditional Chinese medicine and its toxicity to the mother.(2)There is an urgent need to improve the information on the medications used during pregnancy in Chinese herbal medicines in my country,and establish a more practical grading system for the safety of traditional Chinese medicines during pregnancy based on evidence-based data.(3)The pregnant women’s awareness of pregnancy contraindicated traditional Chinese medicines should be strengthened to reduce accidental exposure.(4)Berberine exposure in early pregnancy does not increase the incidence of spontaneous abortion,premature delivery and low birth weight infants. |
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