盐酸纳呋拉啡在治疗瘙痒症中的应用与效果分析

Introduction: Nafurorapine hydrochloride is a selective kappa opioid receptor agonist and Japan's first oral antipruritic drug. It is suitable for hemodialysis patients who are resistant to existing treatments. As a new type of drug for treating pruritus, nalfuraphine hydrochloride's unique mechanism of action and good efficacy provide patients with new treatment options. Especially for patients with refractory pruritus, nalfuraphine hydrochloride has shown significant therapeutic effects and good safety, and is expected to improve patients' quality of life and sleep conditions.

Indications

It is mainly used to improve pruritus in hemodialysis patients, especially when the existing treatments are not effective. Additionally, it is used for refractory pruritus in patients with chronic liver disease and in peritoneal dialysis patients. On July 4, 2023, 3SBio’s nalfuraphine hydrochloride orally disintegrating tablets were approved for marketing by the China State Food and Drug Administration. They are used to improve pruritus in hemodialysis patients whose existing treatments are unsatisfactory. Currently officially on the market in China, it is the first and only selective opioid kappa receptor agonist approved by the China National Medical Products Administration for refractory pruritus in hemodialysis patients.

Efficacy analysis

In a phase III multicenter bridging study, 141 Chinese patients with refractory CKD-aP were randomly assigned to receive 5 μg, 2.5 μg nalfurapine hydrochloride or placebo orally for 14 times. The primary endpoint was the average decrease in mean visual analog scale (VAS) from baseline. Based on the primary endpoint analysis of the full analysis set (FAS), the difference in mean VAS decline between the 5 μg nalfuraphine hydrochloride group and the placebo group was 11.37 mm, and the difference in mean VAS decline between the 2.5 μg nalfuraphine hydrochloride group and the placebo group was 8.81 mm, but there was no statistical difference. Both differences were greater than 4.13mm, meeting the predetermined success criteria for Japan's pivotal clinical trials, which is at least 50% efficacy. For Chinese hemodialysis patients with refractory pruritus, oral administration of nalfurapine hydrochloride can effectively relieve pruritus with few adverse reactions.

Medication Guide

The recommended adult dose of nalfuraphine hydrochloride is 2.5 μg, taken once a day, after dinner or before going to bed. Patients can increase the dose under the guidance of a doctor according to symptoms, but 5 μg once a day is the maximum dose. Nafurafine hydrochloride can be placed on the tongue to soak with saliva, and gently crushed with the tongue. After it disintegrates, it can be swallowed with saliva alone. In addition, it can also be taken with water.