Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Haiyuncang Lane, Dongcheng District, Beijing, 100700, China.
Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Haiyuncang Lane, Dongcheng District, Beijing, 100700, China; Research Center of Clinical Epidemiology, Peking University Third Hospital, China.
J Ethnopharmacol. 2020 Mar 25;250:112424. doi: 10.1016/j.jep.2019.112424. Epub 2019 Nov 22.
Xiyanping injection (XYP), extraction of Andrographis paniculate (Andrographis paniculata (Burm. f.) Nees, chuan xin lian), is a Chinese patent medicine approved to treat bronchitis in China. In 2017, safety incidents associated with treatment of XYP began to emerge throughout China. However, the risk factors of severity of adverse reactions by XYP remain uncertain.
To determine risk factors for the severity of XYP-associated adverse drug reactions (ADRs).
We analyzed a total of 26,317 cases of ADRs linked to the use of XYP injection in the China National Adverse Drug Reaction Monitoring Information System from 2004 to 2017. Data were analyzed with respect to age, gender, ethnicity, previous ADRs, family history of ADRs, dosage specification, medication frequency specification, body weight, route of administration, herb-drug interactions (ribavirin, cefatriaxone, penicillin sodium, ambroxol hydrochloride, clindamycin, cefoxitin sodium, azithromycin, ceftazidime, amoxicillin sodium and clavulanate potassium, levofloxacin, cefazolin sodium pentahydrate, acyclovir) by univariate analysis and multivariate analysis. Propensity score matching was used to compare severity of (general or serious) ADRs.
We included 24,911 cases of general ADRs and 1406 cases of serious ADRs. Univariate analysis identified age (p < 0.001), body weight (p < 0.001), route of administration (p = 0.008), co-administration of XYP with ribavirin (p = 0.031) as risk factors of severity of ADRs. Multivariate analysis identified XYP + ribavirin combination (p = 0.048) and age (p < 0.001) as the independent risk factors. Upon propensity score matching, the variables were relatively balanced amongst the two groups of patients with general or severe ADRs, and the level of severity in patients who received treatment of XYP + ribavirin increased (p = 0.020).
Age and co-administration of ribavirin may be potential risk factors for the severity of XYP-associated ADRs. This reminds us to pay more attention to the safety of elderly medication. Minimizing the herb-drug-interaction effects of XYP and ribavirin is a viable treatment target for healthcare professionals in managing serious ADRs amongst patients receiving XYP injection.
喜炎平注射液（XYP）是穿心莲（Andrographis paniculata（Burm. f.）Nees，chuan xin lian）的提取物，是一种中国专利药品，在中国被批准用于治疗支气管炎。2017 年，与 XYP 治疗相关的安全事件开始在中国各地出现。然而，XYP 相关不良反应（ADR）严重程度的危险因素仍不确定。
确定与喜炎平注射液相关的不良反应严重程度的危险因素。
我们分析了 2004 年至 2017 年中国国家药品不良反应监测信息系统中与喜炎平注射液使用相关的 26317 例不良反应。使用单变量分析和多变量分析分别从年龄、性别、种族、既往不良反应史、不良反应家族史、剂量规格、用药频率规格、体重、给药途径、草药-药物相互作用（利巴韦林、头孢曲松、青霉素钠、盐酸氨溴索、克林霉素、头孢西丁钠、阿奇霉素、头孢他啶、阿莫西林钠和克拉维酸钾、左氧氟沙星、头孢唑林钠五水合物、阿昔洛韦）方面分析数据。采用倾向评分匹配比较（一般或严重）不良反应的严重程度。
我们纳入了 24911 例一般不良反应和 1406 例严重不良反应。单变量分析确定年龄（p<0.001）、体重（p<0.001）、给药途径（p=0.008）、喜炎平与利巴韦林联合使用（p=0.031）是不良反应严重程度的危险因素。多变量分析确定喜炎平与利巴韦林联合使用（p=0.048）和年龄（p<0.001）是独立的危险因素。在倾向评分匹配后，两组一般或严重不良反应患者的变量相对平衡，接受喜炎平与利巴韦林联合治疗的患者的严重程度增加（p=0.020）。
年龄和利巴韦林联合使用可能是喜炎平相关 ADR 严重程度的潜在危险因素。这提醒我们要更加关注老年人的用药安全。尽量减少喜炎平和利巴韦林的草药-药物相互作用是医护人员管理接受喜炎平注射液治疗的患者严重 ADR 的可行治疗目标。
