Jingmaiyan Granules Combined with External Application of Jinhuang Ointment in Treatment of Acute Stage Blood Heat Stasis Type Superficial Thrombophlebitis of Lower Extremities： A Randomized， Double-blind， Placebo-controlled Clinical Trial
10.13422/j.cnki.syfjx.20252192
- VernacularTitle:静脉炎颗粒联合金黄膏外敷治疗急性期血热瘀结型下肢血栓性浅静脉炎——一项随机、双盲、安慰剂对照临床试验
- Author:
Qiaoyilan LIANG
1
;
Hong CHEN
1
;
Weijing FAN
1
;
Hongshuo SHI
1
;
Fangfang WU
1
;
Guobin LIU
1
Author Information
1. Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine， Shanghai 201203，China
- Publication Type:Journal Article
- Keywords:
superficial thrombophlebitis of lower extremities;
acute stage;
blood heat stasis syndrome;
Jingmaiyan granules;
Jinhuang ointment
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(5):196-202
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the clinical efficacy and safety of Jingmaiyan granules （composed of Lonicerae Japonicae Flos， Sedi Herba， Paeoniae Radix Rubra， Moutan Cortex， Rhei Radix et Rhizoma Praeparata， and Glycyrrhizae Radix et Rhizoma） combined with external application of Jinhuang Ointment in treating acute-stage blood heat stasis type superficial thrombophlebitis （ST） of lower extremities， and to explore their effects on hemorheology and serum inflammatory factors. MethodsA randomized， double-blind， placebo-controlled clinical trial was conducted. A total of 124 patients with lower extremity ST were randomized into two groups（62 cases in each group）. The control group received external application of Jinhuang ointment and oral placebo treatment， while the observation group received external application of Jinhuang ointment and oral Jingmaiyan granules. Both groups were treated for 2 weeks. The clinical symptom scores， therapeutic efficacy of traditional Chinese medicine （TCM） syndrome， pain visual analog scale （VAS） scores， hemorheological indices ［including whole blood high-shear， medium-shear， and low-shear viscosity， as well as plasma viscosity （PV）］， and inflammatory factors ［C-reactive protein （CRP）， interleukin-6 （IL-6）， tumor necrosis factor-α （TNF-α）］ were compared before and after treatment. ResultsAfter 2 weeks of treatment， the total effective rate in the observation group （98.3%， 60/62） was significantly higher than that in the control group （83.8%， 52/62）， with a statistically significant difference （Z=3.512 1， P<0.05）. Compared with pre-treatment scores， the scores for skin color， skin temperature， swelling， pain， and cord or nodules were significantly reduced in both groups （P<0.05）， with more pronounced improvement in the observation group （P<0.05）. Additionally， compared with pre-treatment levels， the whole blood viscosity （low-， medium-， and high-shear） significantly improved in both groups after treatment （P<0.05）， with more marked improvement in the observation group （P<0.05）. Furthermore， the plasma viscosity， CRP， IL-6， and TNF-α levels were significantly reduced in both groups after treatment （P<0.05）， with more pronounced improvement observed in the observation group （P<0.05）. ConclusionThe combination of external application of Jinhuang ointment and oral Jingmaiyan granules effectively improves clinical symptoms， hemorheological abnormalities， and inflammatory responses in patients with acute stage blood heat stasis type ST of lower extremities. The treatment is safe and holds clinical promotion value.
