Abstract
Objective To evaluate the efficacy,safety and economy of traditional Chinese patent medicines for opening orifices in the treatment of stroke.Methods The search time was set from January 2015 to November 2024,and the Chinese database(China Journal Full-text Database,Chinese Journal Full-text Database,Wanfang Data Knowledge Service Platform,China Biomedical Literature Database)and foreign language database(PubMed)were searched.Clinical research literature on the treatment of stroke with open-body Chinese patent medicines such as Angong Niuhuang Pill,Annao Pill,Suhexiang Pill and Niuhuang Qingxin Pill was collected.Two researchers screened the literature according to inclusion and exclusion criteria,and then carried out data extraction and evaluated the quality of the literature.Meta-analysis was performed using R 4.1.3 software to evaluate the clinical efficacy and safety.Based on the efficacy and safety data,TreeAge Pro 2020 software was used to further evaluate its economy.Results After retrieval,there was only one literature on stroke for Niuhuang Qingxin Pills,which was excluded.Eventually,40 clinical studies were included,involving a total of 3,767 stroke patients for meta-analysis.The results showed that compared with basic treatment,Angong Niuhuang Pills[90.71%vs.74.05%,RR=1.224 9,95%CI(1.163 2～1.289 8),P＜0.000 1],Anao Pills[93.67%vs.76.71%,RR=1.203 4,95%CI(1.115 0～1.298 9),P＜0.000 1],Suhexiang Pills[94.20%vs.77.94%,RR=1.206,95%CI(1.149 3～1.265 8),P＜0.000 1],all of which could significantly improve the total effective rate of stroke treatment;Compared with the basic treatment,both Angong Niuhuang Pill[MD=-3.255,95%CI(-5.537 7～-0.972 4),P=0.002 5]and Anao Pill[MD=-3.48,95%CI(-5.32～-1.65),P＜0.01]could significantly reduce the NIHSS score.Suhexiang Pills[MD=-2.45,95%CI(-2.68～-2.22),P=0.29]could reduce the NIHSS score to a certain extent,but there was no statistically significant difference.Compared with basic treatment,Angong Niuhuang Pill[90.11%vs.71.38%,RR=1.258,95%CI(1.097 2～1.442 5),P=0.001 0]and Annao Pill[92.34%vs.79.23%,RR=1.165 4,95%CI(1.086 8～1.249 7),P＜0.000 1]and Suhexiang Pills[90.80%vs.74.60%,RR=1.217 5,95%CI(1.121 2～1.322 1),P＜0.000 1]could both improve the cognitive function of patients.Compared with the basic treatment,Annao Pills[95.95%vs.79.53%,RR=1.167 4,95%CI(1.045 8～1.303 1),P=0.005 8]could significantly relieve the depressive state of patients,and no reports were made on other drugs.The adverse reactions of the other three groups of drugs were relatively mild.Generally,no treatment was required and the safety was good.Network meta-analysis and SAS software were used to indirectly compare the therapeutic effects of the three groups.The results indicated that the total effective rate of Angong Niuhuang Pill in the treatment of stroke,the effective rate of improving cognitive function,and the incidence of adverse reactions were similar among Angong Niuhuang Pill,Suhexiang Pill,and Anao Pill,with no statistical difference(P＞0.05).The cost-effectiveness analysis results showed that compared with the basic treatment,the ICER values of the three groups of drugs were ICER Annao Pills vs.Basic treatment=-2 386.7,ICER Basic treatment vs.Angong Niuhuang Pill=1 405.5,ICER SuXianghe Pill vs.The basic treatment=5 177.2,that is,Anao Pills have an absolute economic advantage.The results of the minimum cost analysis method show that the order of pharmacoeconomic advantages among the three groups is Annao Pill＞Angong Niuhuang Pill＞Suhexiang Pill,and Annao Pill still has the greatest economic advantage.Conclusion Compared with basic treatment,Angong Niuhuang Pill,Anao Pill and Suhexiang Pill can all significantly improve the clinical efficacy of stroke treatment and enhance the cognitive function of patients.However,Annao Pill has the effect of improving the depressive state after stroke.Economic evaluations suggest that Annao Pills are more economical due to their low price per pill.关键词
开窍剂/脑卒中/安宫牛黄丸/苏合香丸/安脑丸/药物经济学Key words
Resuscitation agent/Stroke/Angong Niuhuang pill/Suhexiang pill/Annao Pill/Pharmacoeconomics分类
医药卫生
