这项研究利用了一项前瞻性的,大样本,多中心,并注册医院重点专科方法监测热毒宁注射液的应用。共监测100249名14岁及以下接受热毒宁注射液治疗的青少年患者,导致83例不良事件,其中76例被归类为药物不良反应(ADR)。计算热毒宁注射液不良反应发生率为0.076%,表明ADR非常罕见。不良反应的主要症状为瘙痒,腹泻,腹痛,呕吐,高烧,呼吸困难,抽搐,和寒战。所有ADR病例均为首次报告,包括3例新的ADR病例和73例已知的ADR病例。ADR的类别为一般ADR。所有ADR的严重程度均为轻度。ADR患者中男性多于女性。一名患者有ADR病史,引起ADR的药物是布洛芬。在热毒宁注射液用量为5~10mL时,ADR发生人数最多。滴落速度为每分钟30滴或更少,溶剂类型为5%葡萄糖注射液。ADR患者最常见的表现是瘙痒,接着是腹泻,腹痛,呕吐,高烧,呼吸困难,抽搐,和寒战。72名患者(94.74%的ADR患者)停药,3例(占ADR患者的3.95%)给予吸氧。47例(61.84%的ADR患者)采用药物治疗,其中地塞米松使用最多(24例,46.15%的ADR患者)。76例ADR患者治愈或好转。当西医诊断为急性支气管炎和中医咳嗽时,ADR更容易发生,中医证型为风热证,联合用药是盐酸氨溴索和盐酸溴己新注射液,抗坏血酸/维生素C注射液。该结果为热毒宁注射液在14岁及以下青少年中的积极药物警戒提供了循证安全依据。
This study utilized a prospective, large-sample, multi-center, and registered key specialty approach of hospitals to monitor the application of Reduning Injection. A total of 100 249 adolescent patients aged 14 years and below who received Reduning Injection were monitored, resulting in 83 cases of adverse events, with 76 of them being classified as adverse drug reaction(ADR). The calculated incidence rate of ADR for Reduning Injection was 0.076%, indicating a very rare ADR. The main symptoms of ADR were pruritus, diarrhea, abdominal pain, vomiting, high fever, dyspnea, convulsion, and chills. All ADR cases were reported for the first time, including three new ADR cases and 73 known ADR cases. The categories of ADR was general ADR. All ADR was mild in severity. There were more males than females in ADR patients. One patient had a history of ADR, and the drug causing ADR was buprofen. The largest number of ADR cases occurred when the dosage of Reduning injection was 5-10 mL. The dropping speed was 30 drops or less per min, and the solvent type was 5% glucose injection. The most common manifestation of ADR patients was pruritus, followed by diarrhea, abdominal pain, vomiting, high fever, dyspnea, convulsions, and chills. 72 patients(94.74% of ADR patients) discontinued the drug, and three patients(3.95% of ADR patients) were given oxygen inhalation. 47 cases(61.84% of ADR patients) were treated with medication, of which dexamethasone was the most used(24 cases, 46.15% of ADR patients). 76 ADR patients were cured or improved. ADRs are more likely to occur when diagnosed with acute bronchitis by western medicine and cough by traditional Chinese medicine(TCM), TCM syndrome type is wind heat syndrome, and the combination medicine is ambroxol hydrochloride and bromhexine hydrochloride injection, ascorbic acid/vitamin C injection. This result provides an evidence-based safety basis for active pharmacovigilance of Reduning Injection in adolescents aged 14 years and below.