Efficacy of a Chinese Herbal Medicine Compound Zhangpi Ointment against Hydroxyurea-Induced Leg Ulcers: A Prospective, Randomized, Open-Label, Controlled Clinical Trial

Abstract EN

Objective.

The randomized controlled trial was to evaluate the efficacy of topical Chinese herbal Zhangpi Ointment for hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms.

Patients and Methods.

This single-center, prospective, randomized, open-label, controlled clinical trial conducted at Shanghai Ninth People’s Hospital enrolled 54 patients with hydroxyurea-induced leg ulcers.

Patients were randomly assigned to the control group (n = 27) treated with chlorhexidine dressing or the intervention group (n = 27) treated with the Zhangpi Ointment.

Finally, 26 patients in the control group and 23 patients in the intervention group completed 8 weeks of observation.

Results.

The rate of complete healing was 100% for the intervention group, which was significantly higher than that of the control group (96.15%) (P<0.05).

Furthermore, the intervention group achieved a significantly higher rate of wound healing (95.56%) than the control group (69.02%) at week 4 (P<0.01).

The intervention group took 34 ± 5 days to achieve complete healing while the control group took 41 ± 7 days (P < 0.01).

Moreover, grade 3/4 side effects were observed in neither group.

Conclusion.

The Zhangpi Ointment is effective in promoting the healing of hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms, providing a therapeutic option for a condition that is recalcitrant to conventional therapy.