龙虎人丹治疗晕动病(湿浊中阻证)的多中心临床研究

目的评价龙虎人丹治疗晕动病(湿浊中阻证)的有效性和安全性。方法纳入符合标准的360例晕动病(湿浊中阻证)患者,采用区组随机化方法分为A组(216例):龙虎人丹+仁丹模拟剂+盐酸倍他司汀片模拟剂;B组(72例):龙虎人丹模拟剂+仁丹+盐酸倍他司汀片模拟剂;C组(72例):龙虎人丹模拟剂+仁丹模拟剂+盐酸倍他司汀片。观察各组治疗后晕动病发生率、呕吐症状出现时间,以及治疗前后中医证候总分和湿浊中阻证候病情程度构成比的变化。结果①晕动病发生率:A组为51.90%(109/210),B组为71.83%(51/71),C组为47.76%(32/67),差异有统计学意义。②呕吐症状出现时间:因用药后仅A组出现1例,无法比较3组间的差异。③治疗后中医证候总分以及湿浊中阻证候病情程度构成比,3组比较差异有统计学意义。A组与B组比较差异有统计学意义。A组较B组中医证候总分下降更明显,与C组相当,且A组较B组更能改善湿浊中阻证候病情程度均成比。结论龙虎人丹在治疗晕动病方面具有一定疗效,能改善湿浊中阻临床症状和体征。

Multi-center clinical study on the treatment of vertigo (dampness turbidity resistance syndrome) by Longhu Rendan

Objective To assess the efficacy and safety of Longhu Rendan(LHRD) in the treatment of motion sickness(dampness turbidity resistance syndrome). Methods A total of 360 eligible patients were assigned into group A(n=216), group B(n=72) and group C(n=72) with block randomization method. Patients in group A received LHRD plus matched placebo of Rendan plus matched placebo of Betahistine Hydrochloride Tablets. Patients in group B received matched placebo of LHRD plus Rendan plus matched placebo ofBetahistine Hydrochloride Tablets. Patients in group C received matched placebo of LHRD plus matched placebo of Rendan plus Betahistine Hydrochloride Tablets. The incidence of motion sickness after treatment, the time of occurrence of vomiting symptoms, and the change of the ratio of the total score of TCM syndrome and the degree of disease in the wet turbidity before and after treatment were observed. Results After treatment, the incidence of motion sickness in group A, B and C were 51.90%(109/210), 71.83%(51/71) and 47.76%(32/67), respectively, and there was difference among three groups. After treatment, only one case of vomiting was found in group A, and the difference of the appearance time of vomiting symptom in the three groups could not be compared. The difference of TCM syndrome score and the constituent ratio of dampness turbidity resistance syndrome among three groups was significant. The control group was given shallow sedation and airway management with early goal-oriented sedation. At the same time, the ambroxol sputum is used to support the gastrointestinal nutrition, and the Bacillus subtilis enteric capsule can prevent the intestinal bacteria from shifting. Conclusion Longhu Rendan has a certain effect on motion sickness, and could improve the clinical symptoms and signs of dampness and turbidity blocking.