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目的:制备乳癖康巴布剂,观察其临床疗效与不良反应。方法:根据长期临床经验方改变剂型制成乳癖康巴布剂;将63例乳腺囊性增生患者随机分为观察组33例和对照组30例,观察组乳癖康巴布剂、对照组乳癖消贴膏分别1帖/天,14天为1疗程,疗程3个月,比较两组患者的临床疗效及毒副作用、过敏反应情况。结果:该制剂制备工艺可行,质量符合药典要求,观察组与对照组有效率分别为93.9%与73.3%两组有显著性差异(P<0.05),两组均无毒副作用,观察组有1例皮肤轻微过敏反应,对照组有9例过敏反应,其中3例起泡严重过敏反应。结论:乳癖康巴布剂制备工艺简单,其治疗乳腺囊性增生病临床疗效显著,无毒副作用,过敏反应发生率低。
OBJECTIVE: To prepare Lactopapumab agent and observe its clinical efficacy and adverse reactions. Methods: According to the long-term clinical experience, the formula was changed to formulate Lactopacamine; 63 cases of breast cystic hyperplasia were randomly divided into observation group (33 cases) and control group (30 cases). The observation group was Rupi Kangbbu agent and control group. The creams were given 1 post/day for 14 days and 1 course for 14 days. The treatment duration was 3 months. The clinical efficacy, side effects and allergic reactions of the two groups were compared. Results: The preparation process was feasible and the quality was in accordance with pharmacopoeia requirements. The observation group and the control group were 93.9% and 73.3% respectively. There was a significant difference between the two groups (P<0.05). There was no toxic or side effect in the two groups. The observation group had 1 Cases of skin allergic reactions, 9 cases of allergic reactions in the control group, of which 3 cases of severe allergic foaming. Conclusion: The preparation technology of Rupiangkangbubu is simple, and its clinical curative effect for treating cystic hyperplasia of the breast is significant, with no toxic and side effects, and the incidence of allergic reactions is low.