Improving reporting of adverse events and adverse drug reactions following injections of Chinese materia medica.
Improving reporting of adverse events and adverse drug reactions following injections of Chinese materia medica.
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DOI：
10.1111/j.1756-5391.2010.01055.x
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发表时间：
2010-02-01
影响因子：
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通讯作者：
Song, Li
中科院分区：
文献类型：
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作者：
Bian, Zhao-Xiang;Tian, Hao-Yao;Song, Li
背景技术背景：中药注射剂不良事件（AE）和不良反应（ADR）报告日益普遍，报告质量备受关注。结果：按检索策略共纳入210篇文献，其中175篇报道了黄芪注射液单一或多例不良反应/事件（I类报告）。有7份报告来自地区或国家ADR监测中心（II类报告），28份总结报告来自单个医院或医疗中心（III类报告）。210篇文献均在标题中提及“不良反应"、“安全性”或相关含义词语，但199篇文献无摘要。这些文章未充分报告患者人口统计学特征。I类文献中仅有97例（43.11%）提及患者是否有过敏史，而II类文献中有128例（56.89%）和III类文献中有14例（50%）未提及患者过敏史。仅有3篇文献（3/210，1.43%）提及了中医证型，均为I型。没有一篇论文明确指出患者ADR/AE的类型和级别。大多数论文没有报道CM注射程序的细节，如制药公司，产品序列号或药物的有效期。ADR/AE的发生时间和管理数据也不充分reported.Conclusion和Recommendations：目前的报告格式在临床CM注射剂的ADR/AE是不规范的。因此，CM注射后ADR/AE的许多基本信息缺失。应制定ADR的标准报告格式，并应包括以下内容：（1）提及不良反应和安全性的标题;（2）结构化摘要，包括患者和所治疗疾病、所用药物、特定ADR/AE、医生对ADR/AE的反应和管理结果的充分信息;（3）患者的人口统计学特征（性别、年龄等）; (4)患者的临床特征（疾病、证候等）;（5）患者的过敏史;（6）基于中医理论的诊断和证候;（7）CM干预的详细信息（药物生产商、系列号、有效日期、剂量、给药途径、剂量、滴速等）; (8)合并用药;（9）ADR/AE发生的时间和症状;（10）ADR/AE的类型和分级;（11）受ADR/AE影响的生理系统;（12）ADR/AE的具体治疗和预后;（13）ADR/AE的因果证据;（14）ADR/AE的任何其他可能性。此外，应建立ADR/AE登记制度。
BACKGROUND: While reporting of adverse drug events (AE) and adverse drug reactions (ADR) following Chinese materia medica (CM) injection is becoming more common, the reporting quality is of concern.METHODS: A checklist about the reporting quality of AE/ADR was set up, and the ADR/AE reporting of Herba Houttuyniae injection was chosen as an example. Electronic databases Chinese Journal Net (1994-2009) and Chinese Science and Technological Journal Net (VIP) (1989-2009) were searched for target literature.RESULTS: Based on our search strategy, 210 articles were included, with 175 articles reporting single or several cases of ADR/AE following Herba Houttuyniae injection (type I report). There were seven reports from regional or national ADR monitoring centers (type II report), and 28 summary reports from a single hospital or medical center (type III report). All 210 papers mentioned "adverse effect,""safety" or related meaning words in their titles, but 199 articles did not have abstract. Patient demographic characteristics were not fully reported in these articles. In type I articles, only 97 cases (43.11%) mentioned whether patients had or did not have a history of allergies, whereas 128 cases (56.89%) in type II papers and 14 (50%) type III papers, did not mention allergic history of patients. Only three articles (3/210, 1.43%), all of them type I, mentioned the syndrome type in Chinese medicine. None of the papers gave clear indications of the type and grade of ADR/AE of patients. Most papers did not report details of the CM injection procedure, such as the drug company, product serial number, or the drug's validity period. Data about the occurrence time and management of ADR/AE was also inadequately reported.CONCLUSION AND RECOMMENDATIONS: The current reporting format of ADR/AE in clinical CM injections is not standardized. Much fundamental information of ADR/AE following CM injection is therefore missing. A standard reporting format for ADR should be developed, and should include the following: (1) a title mentioning adverse effects and safety; (2) a structured abstract including adequate information about the patient and the disease treated, the drug used, the specific ADR/AE, physician response to the ADR/AE, and result of management; (3) demographic characteristic of the patients (gender, age, etc.); (4) clinical characteristics of patients (disease, syndrome, etc); (5) allergic history of patients; (6) diagnosis and syndrome based on Chinese medicine theory; (7) detailed information about the CM intervention (the manufacturer of the drug, series number, valid dates, dosage, route of administration, menstruum, dripping speed, etc.); (8) concomitant drug use; (9) time and symptoms of ADR/AE; (10) type and grading of ADR/AE; (11) physiological systems affected by ADR/AE; (12) specific treatment and prognosis for ADR/AE; (13) evidence of the cause and effect of ADR/AE; and (14) any other possibility of ADR/AE. Also, a ADR/AE registration system should be established.