Objective

2

To evaluate the clinical efficacy and safety of topical

Zhihuang Xiaoyu Zhitong Plaster

（栀黄消瘀止痛膏， ZXZP） combined with channel sinews acupuncture in the treatment of acute closed soft tissue injury （ACSTI）.

Methods

2

A total of 114 patients with ACSTI were randomly divided into control group and treatment group. The control group received channel sinews acupuncture alone， while the treatment group received a combination of ZXZP and channel sinews acupuncture. Both groups were treated continuously for one week. The visual analogue scale （VAS） scores， tenderness， swelling， ecchymosis， functional impairment scores， and total traditional Chinese medicine （TCM） syndrome scores were assessed before and after treatment. The hemorheological parameters including whole blood high-shear viscosity， whole blood low-shear viscosity， plasma viscosity， hematocrit， and fibri-nogen were measured. Serum inflammatory factors， including interleukin-6 （IL-6）， tumor necrosis factor-alpha （TNF-α）， and prostaglandin E

2

（PGE

2

）， were also evaluated. The time to relief of pain， swelling， and functional impairment， as well as overall clinical efficacy， were compared between groups. Adverse events during treatment were recorded.

Results

2

One pa

tient in the treatment group withdrew， leaving 56 patients in the treatment group and 57 in the control group for final analysis. After treatment， both groups showed significant reductions in VAS scores， tenderness， swelling， ecchymosis， functional impairment scores， total TCM syndrome scores， whole blood high-shear and low-shear viscosity， plasma viscosity， hematocrit， fibrinogen， and serum IL-6， TNF-α， and PGE

2

levels （

P

＜0.05）. Between-group comparison revealed that the treatment group had lower values for all the above indicators than the control group （

P

＜0.05）. The treatment group also demonstrated shorter time to relief of pain， swelling， and functional impairment （

P

＜0.05）. The overall effective rate of the treatment group （53/56， 94.64%） was higher than that of the control group （43/57， 75.44%，

P

＜0.05）. The incidence of adverse reactions in the treatment group （4/56， 7.14%） was not significantly different from the control group （5/57， 8.77%，

P

＞0.05）.

Conclusion

2

Topical application of ZXZP combined with channel sinews acupuncture can significantly alleviate swelling and pain， reduce inflammatory factors levels and hemorheological abnormalities in patients with ACSTI. This combined therapy demonstrates superior clinical efficacy and good safety compared with channel sinews acupuncture alone.