Preclinical safety assessment of antipyrine combined with lidocaine hydrochloride as ear drops.

This study was designed to assess the preclinical toxicity of antipyrine combined with lidocaine hydrochloride ear drops (ALED) and support the clinical trials of ALED in clinical settings in China. All the experiments including acute toxicity in rodents, skin sensitization toxicity in guinea pigs, skin irritation toxicity in rabbits and chronic toxicity in rats were performed according to China Food and Drug Administration guidelines. The maximum tolerated dose (MTD) of ALED administration for mice and rats was over (400 g antipyrine plus 100 g lidocaine hydrochloride)/kg and (240 g andtipyrine plus 60 g lidocaine hydrochloride)/kg, respectively. No obvious skin sensitization toxicity and skin irritation toxicity were observed. The main changes concentrated in chronic toxicity study in rats. For the chronic toxicity, rats were administrated once a day for 28 consecutive days, and a 14-day recovery period was followed. The side effects of ALED included decreased dietary intake in male rats, increased proportion of reticulocytes, decreased or even inversed granulocyte:erythrocyte ratio, fluctuated alanine aminotransferase and aspartate aminotransferase, and slightly increased relative weight of liver. Conclusively, blood system (especially erythrocyte system) and digestive system, including liver and gastrointestinal tract, might be the toxic targets of ALED.

[Assessment of methodology and report quality of systematic evaluation and meta-analysis of acupuncture-moxibustion in China].

OBJECTIVE: To assess the methodology and report quality of systematic evaluation and Meta-analysis of acupuncture and moxibustion in China. METHODS: Retrieve CBM, CNKI, WF and VIP database, collect data from the information system established by Epidata 2.1, assess the methodology and report quality by using the QQAQ and QUOROM, calculate the percentage of adequate rate. RESULTS: Thirty-eight reviews, including twenty six systematic evaluation and twelve Meta-analyses, met the enrolled criteria. Twenty-two kinds of diseases and six diseases systems were included. The methodology quality scores were generally low (3.34 +/- 1.44). The causes of the problems were insufficient literature resource, bias in data collections and inaccurate merging methods. The report quality was relatively low in abstracts, methods, trial flow, introduction and data merging. CONCLUSION: The amount of literatures on systematic evaluation and Meta-analysis of acupuncture is gradually increasing from 2002. However, the quality control is not ideal. It is important to improve the methodology and report quality.