妊娠期妇女使用中成药的疗效及子代安全性评价
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摘要
目的:通过评价妊娠期妇女使用中成药的疗效及子代安全性,探讨建立中成药妊娠期循证医学证据体系的必要性。方法:选取2016年某院门诊使用中成药的妊娠期妇女纳入研究,随访周期为1年,从药品、患者年龄、妊娠情况、生产方式、新生儿情况等方面进行统计分析,与课题研究期间某院全部出生新生儿的数据为对照,统计两组之间是否存在显著性差异。结果:研究组入组患者720人,随访结果204人,分析结果显示研究组和研究亚组新生儿体质量、性别比例和流产情况与对照组无统计学差异。结论:本研究所涉及的10种中成药对妊娠期妇女使用总体上是安全的,个别品种出现的异常情况还需进一步研究。
OBJECTIVE To explore the necessity for establishing an evidence-based medicine system of Chinese patent medicines,by evaluating the efficacy and offspring safety of Chinese patent medicine in pregnant women.METHODS The pregnant women who used Chinese patent medicines in a hospital in 2016 were included in the study. The follow-up period was one year. The statistical analysis was made from the aspects of medicines,age,pregnancy,mode of production,and conditions of newborns. In comparison with the data of all newborn babies born in the hospital during the study period,significant difference between the two groups were examined.RESULTS A total of 720 patients was enrolled in the study groups and 204 of them were followed up. The results showed that there was no significant difference in weight,sex ratio and abortion between the study group and the control group.CONCLUSION The 10 Chinese patent medicines involved in this study are generally safe for pregnant women. The abnormal conditions of individual varieties need further study.
OBJECTIVE To explore the necessity for establishing an evidence-based medicine system of Chinese patent medicines,by evaluating the efficacy and offspring safety of Chinese patent medicine in pregnant women.METHODS The pregnant women who used Chinese patent medicines in a hospital in 2016 were included in the study. The follow-up period was one year. The statistical analysis was made from the aspects of medicines,age,pregnancy,mode of production,and conditions of newborns. In comparison with the data of all newborn babies born in the hospital during the study period,significant difference between the two groups were examined.RESULTS A total of 720 patients was enrolled in the study groups and 204 of them were followed up. The results showed that there was no significant difference in weight,sex ratio and abortion between the study group and the control group.CONCLUSION The 10 Chinese patent medicines involved in this study are generally safe for pregnant women. The abnormal conditions of individual varieties need further study.
引文
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[12] Xu CF,Lu XD.Preliminary study on the anti-early pregnancy mechanism of verbena officinalis[J].Acta Acad Med Nanjng (南京医科大学学报(自然科学版)),1998,18(6):504-508.
[13] Zhang XY.Practical obstetrics and gynecology(实用妇产科学) [M].2nd Ed.Beijing:People’s Health Publishing House,2007:153.
[2] Yi JM,Zeng Y,Xie WQ,et al.Investigation and analysis of pregnant women's cognition of safe medication[J].Chin Hosp Pharm J(中国医院药学杂志),2008,28(12):1124-1126.
[3] Broussard CS,Louik C,Honein MA,et al.Herbal use before and during pregnancy[J].Am J Obstet Gynecol,2010,202(5):443.
[4] Huang L,Luo SP,Luo XB,et al.Investigation and analysis of pregnancy contraindication in package inserts of 210 kinds of chinese patent medicines[J].China Pharm(中国药房),2017,28(16):2295-2300.
[5] Lv QX,Cui M,Li J.Influencing factors of neonatal birth weight in Jinshui district of Zhengzhou city[J].Chin J Women Children Health(中国妇幼卫生杂志),2013,4(5):38-39.
[6] Zhou M,Zhang X,Yan FX.Analysis of the clinical application of chinese patent medicine in the perinatology department from 2010 to 2013 [J].World J Integr Tradit West Med (世界中西医结合杂志),2015,10(4):514-516.
[7] Tan Y.Analysis of contraindications during pregnancy in drug instructions[J].J North Pharm (北方药学),2015,12(10):137.
[8] Miao XL,Cao D,Mu CM,et al.The effect of some Chinese herbs for breaking blood and activating blood circulation on abortion and stillbirth of mice in early pregnancy[J].Yunan J Tradit Chin Med Materia Med(云南中医中药杂志),2005,26(1):31-32.
[9] Li J,Wang YM,Bai Q,et al.Clinical analysis of 90 cases of nonspecific vulvovaginitis treated by honghe Fujie Lotion in early pregnancy[J].Chin Foreign Med Res (中外医学研究),2011,9(26):126-127.
[10] Xu CF,Lu XD.Preliminary Study on the anti-early pregnancy mechanism of verbena officinalis[J].Acta Acad Med Nanjing(南京医科大学学报(自然科学版)),1998,18(5):402-406.
[11] Xu CF,Lu XD,Zhou YD,et al.Isolation and purification of human choriotrophoblast cells in early pregnancy and the effect of verbena officinalis on the secretion of chorionic gonadotropin [J].J China Pharm Univ (中国药科大学学报),1998,29(2):145-148.
[12] Xu CF,Lu XD.Preliminary study on the anti-early pregnancy mechanism of verbena officinalis[J].Acta Acad Med Nanjng (南京医科大学学报(自然科学版)),1998,18(6):504-508.
[13] Zhang XY.Practical obstetrics and gynecology(实用妇产科学) [M].2nd Ed.Beijing:People’s Health Publishing House,2007:153.