To observe the clinical efficacy and safety of emedastine difumarate sustained-release capsules in conjunction with tacrolimus ointment for treating elderly patients with skin pruritus.

The senile patients with pruritus who were treated in our hospital were divided into control group and treatment group according to the treatment methods. The control group was treated with tacrolimus ointment twice a day on the basis of conventional treatment for 6 consecutive weeks. The treatment group, on the basis of the control group, orally administered 2 mg of emestine fumarate sustained-release capsules after breakfast or before going to bed, twice a day for 6 consecutive weeks. The clinical efficacy of patients, evaluation of itching degree, the levels of eosinophils (EOS), histamine and immunoglobulin E (IgE), levels of inflammatory response indicators recurrence situation, and safety were compared between two groups.

A total of 122 cases were included in this study, including 59 cases in the control group and 63 cases in the treatmnet group. The total effective rates of treatment in the treatmnet group and the control group were 92.06% (58 cases/63 cases) and 76.27% (45 cases/59 cases), respectively; the pruritus degree scores were (2.35±0.48) and (2.64±0.52) points, respectively; the EOS were (208.07±33.69) and (225.61±34.82) ×10⁶·L^-1 respectively; the histamine was (0.79±0.13) and (1.25±0.21) ng·mL^-1, respectively; the IgE was (42.07±6.56) and (45.17±6.08) ng·mL^-1, respectively; the monocyte chemoattractant protein-1 was (279.77±39.14) and (298.52±47.64) pg·mL^-1, respectively; the eosinophil chemoattractant was (44.77±6.21) and (47.96±7.45) pg·mL^-1, respectively; the interleukin-6 was (6.56±1.07) and (7.13±1.08) pg·mL^-1, respectively; the tumor necrosis factor -α was (5.91±0.69) and (6.24±0.89) pg·mL^-1, respectively, and the recurrence rates were 11.11% and 25.42%, respectively. The comparison of above indicators showed that there were statistically significant differences between the two groups (P<0.05, P<0.01, P<0.001). The adverse reactions in the control group included a burning sensation on the skin and rosacea, while those in the treatmnet group included a burning sensation on the skin, rosacea, drowsiness, headache, dizziness and tinnitus. The adverse reaction rates of the control group and the treatmnet group were 11.86% and 19.05%, without tatistically significant difference (P>0.05).

Emedastine difumarate sustained-release capsules combined with tacrolimus ointment can alleviate patients′ pruritus symptoms, reduce inflammatory response, regulate immune function, improve efficacy and reduce the risk of recurrence without increasing adverse reactions.