Objective To evaluate the clinical effectiveness and safety of gastrodin injection in the treatment of vertigo. Methods A multi-center, single-blind randomized controlled trial was designed to study 240 vertigo patients who were randomly allocated into the treatment and the control groups.Patients in the treatment group were treated with gastrodin injection 600 mg, intravenously guttae, daily for 7 days, while those in the control group were treated with betahistin 30 mg, intravenously guttae, daily for 7 days. All data were analyzed by SAS. CMH (Cochran’s and Mantel-Haenszel) method was used to compare the clinical effect between the two groups. Nonparametric statistics and t-test were used in baseline data analysis. Results ① The clinical effectivenes on vertigo: according to the intention-to-treat (ITT) analysis, the clinical control rate and effective rate in the treatment group (n=117) were 71.19% and 90.60%, respectively, while 54.17% and 77.50% were in the control group (n=120). A statistic significance difference was found between the two groups (P=0.005 and P=0.004 for control and effective rate respectively).According to the per-protocol population (PP) analysis, the clinical control rate and effective rate in the treatment group (n=116) were 72.41% and 91.38%, respectively, and were 54.70% and 77.78% in the control group (n=117). Statistic significance was found between the two groups (P=0.005 and P=0.004 respectively). ITT and PP analysis revealed similar results. ② The clinical effect on vestibular function: the clinical control rate and effective rate were 62.26% and 81.13% respectively in the treatment group (n=53), and were 42.37% and 76.27% in the control group (n=58). Statistic significance was found in the clinical control rate but was not found in the effective rates between the two groups (P=0.029 and P=0.504, respectively). ITT and PP analysis revealed the same results. ③ Adverse drug reactions (ADRs) were slight to moderate. ADRs rates were 8.33% in the treatment group (n=120) and 10.83% in the control group (n=120), respectively. No statistic significance was found between the two groups(P=0.538). Conclusions Gastrodin injection and betahistine injection are safe and effective drugs for vertigo; gastrodin injection is better than betahistine injection in relieving vertigo symptoms.
【摘要】 目的 研究天麻素注射液治疗椎-基底动脉供血不足（vertebrobasilar insufficiency，VBI）的疗效和安全性。 方法 检索CBM、CNKI、VIP、万方数据库，检索时间为各数据库建库至2010年5月，纳入天麻素注射液对比其他药物治疗VBI的随机对照试验（RCT），对纳入研究进行方法学质量评价后，采用RevMan 5.0软件进行Meta分析。 结果 纳入8个RCT，涉及受试者648例，均为C级文献，Meta分析结果显示:天麻素注射液对比丹参注射液治疗VBI，显效率和总有效率差异均有统计学意义[RR=1.63，95%CI （1.37，1.95）和RR=1.21，95%CI （1.12，1.30）]。 结论 基于当前证据，临床治疗VBI，天麻素注射液疗效优于丹参注射液，且安全性较好。【Abstract】 Objective To study the effectiveness and safety of gastrodine injection for vertebrobasilar insufficiency (VBI). Methods Databases of CBM, CNKI, VIP and Wanfang were searched from the time of the establishment till May 2010 and randomized controlled trials (RCT) of gastrodine injection compared with other positive drugs for VBI were included. Quality evaluation and meta-analysis by using RevMan 5.0 were performed. Results A total of 8 grade-C RCTs including 648 cases were gathered. The results of meta-analysis showed that the difference of excellent and effective rates between danshen injection and gastrodine injection for VBI were significant: RR=1.63, 95%CI (1.37, 1.95) and RR=1.21, 95%CI (1.12, 1.30). Conclusion Based on current evidence, compared with danshen injection, gastrodine injection is better and safer for VBI.