Adverse drug reactions and adverse events of 33 varieties of traditional Chinese medicine injections on National Essential medicines List (2004 edition) of China: an overview on published literatures

Wang, Li; Yuan, Qingyu; Marshall, Gareth; Cui, Xue; Cheng, Lan; Li, Yuanyuan; Shang, Hongcai; Zhang, Boli; Li, Youping

doi:10.1111/j.1756-5391.2010.01073.x

Cited by 48 publications

(26 citation statements)

References 1 publication

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“…Our results suggest that the death numbers in clinics (Wang et al, 2004) are proportional to the severity of proarrhythmic risk of SHL, QKL and YZH found in this study. Currently, the adverse drug reactions caused by CHIs are thought to be attributed to allergic reactions and misuse in clinics (Li, 2010;Wang et al, 2010aWang et al, , 2010bZhang et al, 2010).…”

Section: Discussionmentioning

confidence: 99%

“…Almost all 109 CHIs induce ADR involving all human systems or organs, the most common of which are allergic reactions. Due to severe cases of ADR, including sudden death, and due to inappropriate use in some clinics, the SFDA has withdrawn four CHIs from the market and made warnings or changed specifications for three CHIs since 2006 (Wang et al, 2010a). CHIs are produced by more 400 Chinese pharmaceutical companies and made from Chinese herbs with little procedural standardization (different growth years, harvesting seasons, part of herbs, extraction procedure, etc.).…”

Section: Introductionmentioning

confidence: 99%

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Confirmation of a proarrhythmic risk underlying the clinical use of common Chinese herbal intravenous injections

Chen

Titch

Luo

et al. 2012

Journal of Ethnopharmacology

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Confirmation of a proarrhythmic risk underlying the clinical use of common Chinese herbal intravenous injections

Chen

Titch

Luo

et al. 2012

Journal of Ethnopharmacology

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“…Investigators of these studies might have underestimated possible adverse events. In addition, the safety of herbal patent injection itself has become a major concern to both national health authorities and the general public [59] . A standard reporting format for adverse drug reactions (ADR) has been developed [60] , and we suggest that improvement of the reporting of adverse events and ADRs of PBCRBS should be closely followed.…”

Section: Implications For Further Researchmentioning

confidence: 99%

Promoting blood circulation for removing blood stasis therapy for acute intracerebral hemorrhage: a systematic review and meta-analysis

Wei

Wan

et al. 2015

Acta Pharmacol Sin

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Aim: To conduct a systematic review and meta-analysis to assess the current evidence available regarding the promoting blood circulation and removing blood stasis (PBCRBS) therapy for Chinese patients with acute intracerebral hemorrhage (ICH). Methods: Six databases were searched from their inception to November 2013. The studies assessed in ≥4 domains with 'yes' were selected for detailed assessment and meta-analysis. The herbal compositions for PBCRBS therapy for acute ICH patients were also assessed.Results: From the 6 databases, 292 studies claimed randomized-controlled clinical trials (RCTs). Nine studies with 798 individuals were assessed in ≥4 domains with 'yes' by using the Cochrane RoB tool. Meta-analysis showed that PBCRBS monotherapy and adjuvant therapy for acute ICH could improve the neurological function deficit, reduce the volume of hematoma and perihematomal edema, and lower the mortality rate and dependency. Moreover, there were fewer adverse effects when compared with Western conventional medication controls. Xueshuantong Injection and Fufang Danshen Injection, Buyang Huanwu Decoction and Liangxue Tongyu formula, and three herbs (danshen root, sanqi and leech) were the most commonly used Chinese herbal patent injections, herbal prescriptions and single herbs, respectively. Conclusion: Despite the apparently positive findings, it is premature to conclude that there is sufficient efficacy and safety of PBCRBS for ICH because of the high clinical heterogeneity of the included studies and small number of trials in the meta-analysis. Further large sample-sizes and rigorously designed RCTs are needed.

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“…However, in this study, 11/21 (52.38%) hepatoprotectives were chemical drugs, which accounted for 51.64% of total DID, but 78.95% of total expenditure and 73.47% of all ADEs (Table 2 and 4). In general, TCMs were seemingly but not invariably safer and cheaper than chemical drugs [21,22] . Glycyrrhizin, as one of the oral TCMs, was widely used with 606.25 DID, only causing 3 ADEs, which indicated its safety in clinical therapy.…”

Section: Table 4: Constituent Ratios and Main Clinical Manifestation mentioning

confidence: 99%

Utilization and Safety of Hepatoprotective Drugs: A Retrospective Pharmacoepidemiology Study on Two Databases of China

Liu¹,

Zhao²,

Zhang³

et al. 2017

pharmaceutical-sciences

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Liu, et al.: Utilization and Safety of Hepatoprotective DrugsAdverse event reports related hepatoprotective drugs are increasing. This has important public health implications. Our study aims to investigate the safety of hepatoprotective drugs by combining safety reports with drug utilization data from 2012 to 2014. Utilization data were retrieved from the hospital drug information network of Yangtze River basin and expressed as defined daily doses per 10 000 inhabitants per day. Safety data were collected from the Hubei Adverse Event Reporting System and analysed according to patients' sex, age, occurrence time, route of administration, involved organs or systems, and so on. The relationship between utilization and adverse drug events was used to evaluate the safety of hepatoprotectives by graphical analysis with histogram plots. For the utilization, both consumption sum and dose per inhabitants per day increased from 2012 to 2014. Of the 21 hepatoprotectives, 52.38% were chemical drugs, which accounted for 78.95% of total expenditure and 51.64% of total dose per inhabitants per day. The top three hepatoprotectives were glycyrrhizin, hepatocyte growth-promoting factors, and marine. For the safety, chemical drugs were responsible for 673/916 adverse drug events (73.47%). The gastrointestinal system was most frequently damaged (331, 29.82%), followed by the skin and its appendages (324, 29.19%). Irrational use and intravenous administration were associated with an increased risk of adverse drug events, therefore, surveillance and educational strategies should be strengthened to promote the safety of hepatoprotective drugs. Of the 21 hepatoprotectives, glycyrrhizin, Heluoshugan and Bicyclol were preferable for clinical hepatoprotection, whereas Yinzhihuang, Kuhuang, and ribonucleic acid should be avoided. This parallel approach through spontaneous reporting and drug utilization analyses provided valuable information for the safety of hepatoprotectives, and this synergy should be encouraged to support future pharmacovigilance activities.

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Adverse drug reactions and adverse events of 33 varieties of traditional Chinese medicine injections on National Essential medicines List (2004 edition) of China: an overview on published literatures

Cited by 48 publications

References 1 publication

Confirmation of a proarrhythmic risk underlying the clinical use of common Chinese herbal intravenous injections

Confirmation of a proarrhythmic risk underlying the clinical use of common Chinese herbal intravenous injections

Promoting blood circulation for removing blood stasis therapy for acute intracerebral hemorrhage: a systematic review and meta-analysis

Utilization and Safety of Hepatoprotective Drugs: A Retrospective Pharmacoepidemiology Study on Two Databases of China

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