| 杜楠楠;万华;冯佳梅;瞿文超;邵士珺;孙佳晔;吴雪卿.托里消毒散与柴胡清肝汤干预热盛肉腐证化脓性非哺乳期乳腺炎初期的随机对照研究[J].,2024,44(1):37-43 |
| 托里消毒散与柴胡清肝汤干预热盛肉腐证化脓性非哺乳期乳腺炎初期的随机对照研究 |
| Comparison of Clinical Efficacy of Tuoli Xiaodu Powder and Chaihu Qinggan Decoction in Treatment of Non-puerperal Mastitis patients with Intense Heat Induced Flesh Decay Syndrome at Early Stage of Abscess：A Randomized Controlled Trial |
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| DOI：10.7661/j.cjim.20231016.336 |
| 中文关键词: 化脓性非哺乳期乳腺炎初期 托里消毒散 柴胡清肝汤 热盛肉腐证 随机对照试验 中药复方 |
| 英文关键词:non-puerperal mastitis at the early stage of abscess Tuoli Xiaodu Powder Chaihu Qinggan Decoction intense heat induced flesh decay syndrome randomized controlled trial Chinese herbal compound |
| 基金项目:上海市卫生健康委员会科研课题计划项目（No.202040254） |
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| 中文摘要: |
| 目的 观察托里消毒散与柴胡清肝汤治疗热盛肉腐证化脓性非哺乳期乳腺炎（NPM）的临床疗效及对相关血清免疫炎症指标的影响。方法 采用随机、对照、单盲研究方法，将72例热盛肉腐证化脓性NPM初期患者采用区组随机分为试验组和对照组，每组36例，试验组内服托里消毒散治疗，对照组内服柴胡清肝汤治疗，疗程均为28天。入组第1~28天，每14天清晨抽取空腹血，测量肿块大小，记录脓肿形成及皮肤破溃程度。结果 试验组治疗第14天较对照组脓肿范围更大，脓肿表面溃破数量及程度更严重（P＜0.05）；治疗28天，试验组肿块缩小程度、红细胞沉降率（ESR）下降水平优于对照组（P＜0.05）。化脓性NPM初期患者免疫功能紊乱，表现为血清免疫球蛋白G（IgG）、补体（C）4、T淋巴细胞亚群CD3+和CD4+、调节T淋巴细胞（Treg）以及CD19+B淋巴细胞（CD19+）异常升高，C3、活化人类白细胞Ⅱ类抗原DR（HLA-DR）T淋巴细胞以及自然杀伤（NK）细胞异常降低，两组治疗后异常指标水平均趋于正常，试验组对HLA-DR T细胞的调节作用更强（P＜0.05）。结论 与柴胡清肝汤比较，托里消毒散在促进化脓性NPM初期肿块缩小、抗炎及免疫调节方面作用更好。 |
| 英文摘要: |
| Objective To compare the clinical efficacy of Tuoli Xiaodu Powder （TLXDP） and Chaihu Qinggan Decoction （CHQGD） in the treatment of non-puerperal mastitis （NPM）patients with intense heat induced flesh decay syndrome （IHIFDS） at the early stage of abscess and their effects on the levels of relevant serum inflammatory indices. Methods A randomized， controlled， single-blind study method was used. Seventy-two early stage NPM patients with IHIFDS at the outpatient clinic were randomly assigned to the test group and the control group， 36 in each group. Patients in the test group took TLXDP and those in the control group took CHQGD. The treatment course lasted for 28 days. Fasting blood was collected at early morning on the first，14th and
28th day of grouping. The size of the mass was also measured， and the degree of abscess formation and skin breakdown were recorded as well. Results The number and extent of abscess cavities were greater in the test group on the 14th day of treatment， and the number and extent of surface ulceration of abscesses were more severe （P＜0.05）. On the 28th day of treatment the masses in the test group were significantly smaller than those in the control group （P＜0.05）. Post-treatment abnormally increased erythrocyte sedimentation rate （ESR） decreased to a better level in the test group than in the control group （P＜0.05）. Immune dysfunction in early stage NPM patients was manifested by abnormally increased immunoglobulin G （IgG）， complement 4 （C4）， CD3+ T lymphocytes （CD3+）， CD4+ T lymphocytes （CD4+）， regulatory T cells （Treg）， and CD19+B lymphocytes （CD19+）， and abnormally decreased complement 3 （C3）， human leucocyte antigen DR （HLA-DR），and natural killer cell （NK）. All abnormal parameters tended to be normal after treatment. The regulatory effect on HLA-DR T cells was stronger in the test group （P＜0.05）. Conclusion Compared with CHQGD， TLXDP was better in promoting mass reduction， anti-inflammation， and immunomodulation in the treatment of early stage NPM. |
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