[Meta-analysis on incidence of adverse drug reaction induced by Shuanghuanglian injection]

Abstract

To conducted a systematic review on the safety of Shuanghuanglian injection in clinical use. In this paper, data from Pubmed, Embase, the Cochrane Library, CNKI, VIP and WanFang Data were retrieved. After extracting information and evaluating research methodological quality according to inclusion and exclusion criteria, Meta-analysis was conducted by using R3.2.3 software. A total of 56 individual studies were included, in which 585 cases showed adverse reactions in a total of 11 001 patients with Shuanghuanglian injections. Meta-analysis showed that the total incidence of adverse reactions was 6.5% (95%CI 0.051 to 0.082). Subgroup analysis showed that the incidence of adverse reactions was 4.8% (95%CI (0.032 to 0.067) and 8.1% (95%CI 0.054 to 0.112) respectively in children and adults; 7.2% (95%CI 0.049 to 0.095) and 6.6% (95%CI 0.036 to 0.104) respectively in 5%-10% glucose injection and 0.9% sodium chloride injection; 6.3% (95%CI 0.047 to 0.082) and 7.0% (95%CI 0.044 to 0.099) respectively in powder injection and liquid injection; 5.8% (95%CI 0.043 to 0.075) and 8.9% (95%CI 0.049 to 0.140) respectively in cases with duration of ≤7 d and >7 d; 4.2%(95%CI 0.027 to 0.059) and 8.4% (95%CI 0.059 to 0.113) respectively in single use and combined medication. Three most frequent types of adverse reaction symptoms reported were in skin and mucosa, digestive system, and body temperature center, with an incidence of 4% (95%CI 0.03 to 0.04), 3% (95%CI 0.02 to 0.03), and 1% (95%CI 0.00 to 0.01), respectively. The systemic evaluation demonstrated that the occurrence of adverse reaction of Shuanghuanglian injection was related to age, menstruum, duration of medication and combined medication. Incidence of adverse reactions differed considerably among different damage types. From the study demonstrated above, this paper concludes that we should follow the principles of evidence-based medication of traditional Chinese medicine; use Shuanghuanglian injection singly instead of combination with other drugs in clinical use; use Shuanghuanglian injection strictly in accordance to instructions, especially for children and the elderly, whose weight should be calculated and considered in medication; intensively monitor the drug adverse reaction after use; assess the risks of adverse effects for long-term usage, and take corresponding safety measures to ensure safety.

Keywords: Meta-analysis; Shuanghuanglian injection; adverse drug reaction; incidence; subgroup analysis.