含毒改型中药制剂金匮肾气片用量评价与监管

Evaluation and Supervision of Dosage on Modification of Dosage Form for Jinkui Shenqi Tablet with Poisonous Ingredients

关键词:  金匮肾气片  含毒中药材  附子  用量评价

Key words:  Jinkui Shenqi tablet  poisonous ingredients  monkshood  evaluation of dosage

摘要:

目的 通过对含毒性中药材“附子”的金匮肾气片的用量评价，促进其合理应用。方法 收集2014年1月—6月就诊单用金匮肾气片处方的患者91例，对其不同性别、各年龄段的用药情况，包括每日频次，每次剂量、日用药量、总用量、使用天数及复诊用药情况进行评价。结果 每日剂量>2.16 g有60例(65.93%)，75~89岁男性(20例)明显多于女性(10例)，其中男性(15例)的日剂量(3.19±1.24)g，超过2.16 g，有显著性差异(P<0.05)。复诊患者32例，用药量占91例的40.82%；仅4例(12.50%)用法用量正确。结论 开发中成药应用在线监测系统，及时干预应用过程中存在的用量问题，从而促进其合理应用。

Abstract:

OBJECTIVE To promote the rational use of Jinkui Shenqi tablet through the evaluation of the medication of such a tablet which contains poisonous ingredient of monkshood. METHODS In a bid to ensure the consistence between the patients’ dosages and pharmaceutical instructions, collected a total of 91 outpatient prescriptions from January to June in 2014. The varieties of medication including patients’ genders, age, dosages were analyzed by DDDs, drug utilization index (DUI), daily dose, the total dosage, medication period and further consultation with doctor. RESULTS Sixty cases (65.93%) took more medicine at 2.16 g per dose. Among these cases, 20 were male from 75 to 89 years old, which outnumbered female only 10 cases. And 15 male took medicine at (3.19±1.24)g per day, much higher than 2.16 g per day, which meantsignificant differences (P<0.05). The number of subsequent visit patients was 32. They took 40.82% of total medicine consumed by all 91 patients. Only four cases (12.50%) featured correct usage and dosage. CONCLUSION To develop the monitoring system online and timely solve the usage problems in the course of application, so as to promote the rational use of Jinkui Shenqi tablet.