| 摘要: |
| ［摘要］ 目的 分析南虎凝胶剂治疗类风湿关节炎（RA）的临床疗效，鉴定其有效成分。方法 应用Franz扩散装置，以雌性裸鼠皮为屏障，75%乙醇溶液为接收介质，采用薄层色谱法鉴定南虎凝胶剂透皮吸收液中的有效成分。招募2017年5月至2021年12月南方医科大学中西医结合医院收治的RA患者60例，采用随机数字表法将其分为空白凝胶组、南虎凝胶组和扶他林组，各20例，分别于患者肿胀最显著的关节（单关节）外涂空白凝胶、南虎凝胶剂和扶他林乳膏，每次0.5～1.0 g（据关节周径调整），按摩1～2 min，1次/d，连续治疗7 d。比较三组临床疗效、起效时间、视觉模拟量表（VAS）评分、关节周径和炎症指标。记录治疗期间不良反应发生情况。结果 薄层色谱法鉴别结果提示，南虎凝胶剂中的大黄素、南蛇藤素、没药挥发油可透过皮肤发挥治疗作用。在治疗后，南虎凝胶组VAS评分显著低于扶他林组和空白凝胶组（P<0.05），起效时间显著快于扶他林组和空白凝胶组（P<0.05）。南虎凝胶组、扶他林组和空白凝胶组的临床总有效率分别为90.00%、80.00%和70.00%，差异有统计学意义（P<0.05）。在治疗前、治疗后，三组关节周径以及红细胞沉降率（ESR）、C反应蛋白（CRP）水平比较差异均无统计学意义（P>0.05）。三组在治疗期间均未观察到药物相关不良反应发生。结论 南虎凝胶剂可有效缓解RA患者的临床症状，具有安全性好、起效快的优点，大黄素、南蛇藤素、没药挥发油是其主要有效成分。 |
| 关键词: 南虎凝胶剂 透皮吸收液 有效成分 类风湿关节炎 临床疗效 |
| DOI：10.3969/j.issn.1674-3806.2025.07.09 |
| 分类号: |
| 基金项目:国家自然科学基金项目（编号：82304926）；广东省中医药局科研项目（编号：20213010，20251256） |
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| Analysis on clinical efficacy of Nanhu gel in treatment of rheumatoid arthritis and identification of its active ingredients |
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YUAN Yi1,2, WANG Yuyu1, WANG Jin1, ZHAO Xiaofeng1, ZUO Fangfang1, XUAN Ya′nan1, CHEN Ensheng1, XIAO Changhong1,2, LIU Qiang2
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1.Department of Rheumatology, Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine, Guangzhou 510315, China; 2.School of Traditional Chinese Medicine, Southern Medical University, Guangzhou 510315, China
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| Abstract: |
| ［Abstract］ Objective To analyze the clinical efficacy of Nanhu gel in treatment of rheumatoid arthritis(RA) and to identify its active ingredients. Methods Using Franz diffusion devices with female nude mouse skin as the barrier and 75% ethanol solution as the receiving medium, thin-layer chromatography(TLC) was employed to identify active ingredients in the transdermal absorption solution of Nanhu gel. Sixty RA patients admitted to Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine from May 2017 to December 2021 were recruited and randomly divided into blank gel group, Nanhu gel group and Votalin(diclofenac sodium) group using random number table method, with 20 patients in each group. Blank gel, Nanhu gel, and Votalin cream were topically applied to the most significantly swollen joints(single joint) in the patients of each group, 0.5-1.0 g per time(adjusting the dosage according to the joint circumference), massaging the joints where the medicine was applied for 1 to 2 minutes, once daily, for 7 consecutive days. The clinical efficacy, the onset time of the medication, Visual Analogue Scale(VAS) scores, joint circumference and inflammatory indicators were compared among the three groups. The occurrence of adverse reactions in the three groups during the treatment period was recorded. Results The results of TLC identification suggested that emodin, celastrol and myrrh essential oil in Nanhu gel could exert therapeutic effects through permeating the skin. After the treatment, the VAS scores in the Nanhu gel group were significantly lower than those in the Votalin group and the blank gel group(P<0.05), and the onset time of the medication in the Nanhu gel group was significantly faster than that in the Votalin group and the blank gel group(P<0.05). The total clinical effective rates in the Nanhu gel group, the Votalin group and the blank gel group were 90.00%, 80.00% and 70.00%, respectively, and the differences were statistically significant among the three groups(P<0.05). There were no statistically significant differences in the joint circumference, erythrocyte sedimentation rate(ESR) and C-reactive protein(CRP) levels among the three groups before and after treatment(P>0.05). No drug-related adverse reactions were observed in the three groups during the treatment period. Conclusion Nanhu gel can effectively relieve the clinical symptoms of RA patients and has the advantages of good safety and rapid onset of action. Emodin, celastrol and myrrh essential oil are its main active ingredients. |
| Key words: Nanhu gel Transdermal absorption solution Active ingredients Rheumatoid arthritis(RA) Clinical efficacy |
