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中国药品带量采购政策下精神类药品不良反应的再评价。

Reevaluation of adverse drug reactions of psychiatric drugs under the chinese drug volume-based procurement policy.

机构信息

Wuxi Mental Health Center of Nanjing Medical University, Wuxi, Jiangsu, 214151, China.

Wuxi Tongren Rehabilitation Hospital, Wuxi, Jiangsu, 214151, China.

出版信息

BMC Health Serv Res. 2022 Mar 31;22(1):424. doi: 10.1186/s12913-022-07851-4.

Abstract

BACKGROUND

The "4 + 7" volume-based procurement is a "large group purchase" led by the Chinese government, with the aim of reducing the price of medicines by trading volume for price. Although the "4 + 7" drugs had passed the national consistency evaluation, the adverse drug reactions need to be further evaluated to ensure the safety of the "4 + 7" drugs with low prices. We aimed to analyze the occurrence characteristics and related influencing factors of adverse reactions of psychiatric drugs under the chinese drug volume-based procurement policy(4 + 7 policy), and provide references for clinical medication.

METHODS

137 cases of adverse drug reactions of four psychotropic drugs reported under the "4 + 7" policy in Wuxi Mental Health Center in 2020 were collected. The gender and age of patients, related "4 + 7" drugs, involving organs / systems, clinical manifestations, distribution of new / serious adverse reactions, clinic outcomes were analyzed.

RESULTS

Among the 137 cases of adverse drug reactions, the incidence of adverse drug reactions was the highest in patients aged 61-70 (25.38%). Mainly involved 4 "4 + 7" psychiatric drugs, of which olanzapine tablets caused the most adverse reactions (54, 39.24%). The adverse reactions mainly involved the digestive system, nervous system, cardiovascular system, blood and lymphatic system, among which the digestive system was the most common (61, 44.53%). A total of 8 cases (6.16%) of new and 26 cases of serious adverse reactions were reported, all of which led to the prolongation of disease course. Except for the transient side effects, most of that were improved or cured with no death, disability or teratogenicity after stopping or reducing the dose with symptomatic treatment.

CONCLUSION

Since more and more drugs will be included in "4 + 7" for clinic, clinical pharmacists should strengthen the publicity and training of the knowledge of "4 + 7" drugs, strengthen the monitoring of adverse drug reactions, and provide timely feedback to the clinic, in order to achieve early prevention, early identification, timely diagnosis and reasonable intervention of the adverse drug reactions under the context of "4 + 7" policy.

摘要

背景

“4+7”量价采购是以政府为主导的“大团购”,旨在以量换价降低药品价格。虽然“4+7”药品已通过国家一致性评价,但为确保低价“4+7”药品的安全性,仍需进一步评估其不良反应。本研究旨在分析中国药品集中采购政策(“4+7”政策)下精神类药物不良反应的发生特点及相关影响因素,为临床用药提供参考。

方法

收集 2020 年无锡市精神卫生中心上报的 137 例“4+7”政策下 4 种精神类药物的不良反应报告,分析患者的性别和年龄、相关“4+7”药物、累及器官/系统、临床表现、新/严重不良反应分布、临床结局。

结果

137 例不良反应报告中,61-70 岁患者的不良反应发生率最高(25.38%)。主要涉及 4 种“4+7”精神类药物,其中奥氮平片引起的不良反应最多(54 例,39.24%)。不良反应主要累及消化系统、神经系统、心血管系统、血液淋巴系统,其中消化系统最常见(61 例,44.53%)。共报告 8 例(6.16%)新的和 26 例严重的不良反应,均导致疾病病程延长。除一过性不良反应外,大部分经停药或减少剂量对症治疗后改善或治愈,无死亡、残疾或致畸。

结论

随着越来越多的药物被纳入“4+7”,临床药师应加强“4+7”药物知识的宣传和培训,加强不良反应监测,并及时向临床反馈,以实现“4+7”政策背景下不良反应的早期预防、早期识别、及时诊断和合理干预。

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