健脾利湿通络方联合涌泉穴艾灸治疗下肢静脉性水肿湿邪瘀阻证的随机对照研究
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上海市自然科学基金(23ZR1460300),上海市科学技术委员会医学创新研究专项(22Y11922700),上海市虹口区卫生健康委员会中医药科研项目(HKQGYQY-ZYY-2022-12).


Jianpi Lishi Tongluo decoction combined with Yongquan moxibustion in treatment of lower limb venous edema with damp pathogen and blood stasis syndrome: a randomized controlled trial
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Supported by Natural Science Foundation of Shanghai (23ZR146300), Medical Innovation Research Project of Science and Technology Commission of Shanghai Municipality (22Y11922700), and Traditional Chinese Medicine Scientific Research Project of Health Commission of Shanghai Hongkou District (HKQGYQY-ZYY-2022-12).

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    摘要:

    目的 观察健脾利湿通络方联合涌泉穴艾灸治疗慢性下肢静脉性水肿湿邪瘀阻证的临床疗效。方法 将符合纳入标准的70例慢性下肢静脉性水肿湿邪瘀阻证患者随机分为2组,每组35例。对照组采用艾灸涌泉穴治疗,试验组在对照组治疗方案的基础上服用健脾利湿通络方治疗。两组患者均治疗4周。统计两组患者的治疗总有效率,比较两组患者治疗前后中医证候积分、患肢症状及体征积分、患肢周径、血清炎症因子水平和安全性。结果 试验组共34例患者纳入最终结果统计,治疗总有效率为91.17%(31/34);对照组共33例患者纳入最终结果统计,治疗总有效率为69.70%(23/33)。试验组治疗总有效率高于对照组(P=0.026)。两组患者治疗后中医证候积分、患肢症状及体征积分、患肢髌骨下缘下15 cm处及胫骨内髁上缘上2 cm处周径、血清炎症因子(IL-6和TNF-α)水平均低于治疗前(均P<0.05),且治疗后试验组上述各指标(除胫骨内踝上2 cm处周径外)均低于对照组(均P<0.05)。治疗过程中,两组患者的肝、肾功能均未见明显异常,均未出现严重不良反应。结论 健脾利湿通络方联合涌泉穴艾灸治疗慢性下肢静脉性水肿能够明显改善患肢的症状、体征,减轻机体炎症反应。

    Abstract:

    Objective To observe the clinical effect of Jianpi Lishi Tongluo decoction combined with Yongquan moxibustion in the treatment of chronic lower limb venous edema (CLLVE) with damp pathogen and blood stasis syndrome. Methods Seventy CLLVE patients with damp pathogen and blood stasis syndrome were randomly divided into 2 groups, with 35 cases in each group. The control group received Yongquan moxibustion treatment, while the experimental group received Jianpi Lishi Tongluo decoction in addition to Yongquan moxibustion. Both groups were treated for 4 weeks. The total effective rate of the 2 groups was calculated, and the traditional Chinese medicine (TCM) symptom scores, symptoms and signs scores, limb circumferences, serum inflammatory factor levels and safety of the 2 groups were compared before and after treatment. Results A total of 34 patients were included in the experimental group, and the total effective rate was 91.17% (31/34). A total of 33 patients were included in the control group, and the total effective rate was 69.70% (23/33). The total effective rate of the experimental group was significantly higher than that of the control group (P=0.026). After treatment, both groups showed decreased TCM syndrome scores, symptom and sign scores of the affected limb, circumferences of the affected limb 15 cm below the lower edge of patella and 2 cm above the upper edge of tibial medial condyle, and levels of inflammatory factors (interleukin-6 and tumor necrosis factor-α) (all P<0.05). Moreover, the above indexes in the experimental group were significantly lower than those in the control group except for the circumference of the limb 2 cm above the upper edge of tibial medial condyle (all P<0.05). During the treatment, no abnormalities were observed in the liver or kidney functions for either group, and there were no serious adverse reactions. Conclusion Jianpi Lishi Tongluo decoction combined with Yongquan moxibustion can significantly improve symptoms and signs of affected limbs in CLLVE patients with damp pathogen and blood stasis syndrome and reduce systemic inflammation response.

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  • 收稿日期:2024-02-22
  • 最后修改日期:2024-04-27
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  • 在线发布日期: 2024-06-01
  • 出版日期: 2024-05-20
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