揉散法治疗急性乳腺炎初期的随机对照临床研究

背景：急性乳腺炎是乳腺的急性感染性疾病，大量抗生素治疗往往不能取得很好疗效，应积极寻找安全有效的非药物疗法。目的：验证揉散法治疗急性乳腺炎初期的临床疗效。设计、场所、对象和干预措施：采用多中心随机对照试验，将198例来自上海中医药大学附属岳阳中西医结合医院和龙华医院以及上海市杨浦区妇幼保健院的急性乳腺炎初期患者随机分为治疗组和对照组各99例。治疗组施以推拿揉散手法，对照组口服头孢拉定，均治疗5d。主要结局指标：观察乳腺局部肿块大小、症状体征积分等效应指标和不良反应。结果：治疗组总有效率为95．92％（94／98），对照组总有效率为80％（76／95），两组总有效率比较，差异有统计学意义（P〈0．05）；两组治疗前后肿块大小与症状体征积分差值比较，差异均有统计学意义（P〈0．05）。结论：揉散法治疗急性乳腺炎初期疗效确切，具有安全性和可重复性。

Kneading and dispersing manipulation in treatment of early-stage acute mastitis:a randomized controlled trial

Background： Acute mastitis is an acute infectious disease of breast. Antibiotic treatment is often unable to obtain a good effect, and we should actively look for a safe and effective non-drug therapy. Objective： To validate the clinical efficacy of kneading and dispersing manipulation in treatment of early-stage acute mastitis. Design, setting, participants and interventions： According to the multicenter randomized controlled trial design, 198 cases of acute mastitis from Yueyang Hospital of Integrated Traditional Chinese Medicine, Longhua Hospital, and Shanghai Yangpu Maternity and Child Health Hospital were randomly divided into treatment group and control group. There were 99 cases in each group. Patients,in the treatment group were only treated with manipulation, and cefradine was orally administered to patients in the control group.Main outcome measures： The local breast lump size, clinical symptoms and the adverse reactions in the two groups were observed before and after the treatment. Results： The total response rates in the treatment and control group were 95.92% （94/98） and 80% （76/95） respectively. There was a significant difference in the total response rate between the two groups （P〈0.05）. There were significant differences in the score of breast lump size, and the score of signs and symptoms between the two groups （ P 〈0. 05）. Conclusion： Kneading and dispersing manipulation has certain effects on early-stage acute mastitis, and the therapy is safe and repeatable.