新疆紫草颗粒剂与汤剂对药物流产效果影响的比较性研究

目的:比较新疆紫草颗粒剂与紫草汤剂对米非司酮配伍米索前列醇药物流产效果的影响,及不良反应。方法:将648例妊娠38-45　d、要求终止妊娠的妇女,随机分成3组,各组在米非司酮配伍米索前列醇药物流产时分别加服紫草颗粒剂或安慰剂或紫草汤剂,对3组的流产效果、出血时间、月经恢复时间等及不良反应进行观察。结果:紫草颗粒剂组和汤剂组的完全流产率(97.74%、97.70%)、平均出血时间(12.0±4.1　d、12.7±3.8　d)均无显著性差异(P均>0.05),且均显著优于安慰剂组(91.90%、14.3±4.8　d)(P均<0.05)。3组药物流产后月经恢复时间均无显著性差异。但紫草汤剂服用时有明显异味。结论:　紫草颗粒剂祛除了紫草的异味,服用方便,对其提高药物流产疗效与紫草汤剂相同,有必要进一步探讨。

Comparative Study on Effects of Arnebia Euchroma (Royle) Johnst Granula and Decoction Forms on Medical Abortion with Mifepristone and Misoprostol

Objective: To compare the effects and side-effect of 2 dosage-forms (granula and decoction) of Arnebia Euchroma (royle) Johnst (Arnebia EJ in short below) on medical abortion with mifepristone and misoprostol. Methods: A Total of 648 women, with 38-45 d pregnancy and willing to terminate pregnancy with mifepristone and misoprostol, were randomly divided into 3 groups. The 3 groups were respectively given granula of Arnebia EJ, placebo granula, or decoction of Arnebia EJ during their medical abortion. The abortion results, bleeding duration, menstruation recovery and side-effects were observed. Results: The complete abortion rates of granula group and decoction group (97.70%, 97.74%) were not significantly different (P>0.05), and the average bleeding duration of the 2 groups (12.7±3.8 d, 12.0±4.1 d) were not significantly different either (P>0.05). The 2 groups above were superior to the placebo group in complete abortion rate and bleeding duration (P<0.05 respectively). The menstruation recovery was not significantly different among the 3 groups (P>0.05). The decoction of Arnebia EJ caused significantly more nausea and vomiting than other groups (P<0.05). Conclusion: The granula form did not have the odor of Arnebia EJ, and caused much less nausea and vomiting compared with the decoction form. The granula and decoction forms were just as effective in improving the results of medical abortion. There- fore it is necessary to conduct further studies on the granula form of Arnebia EJ.