Expert consensus guidelines on clinical use of Xiyanping injection for acute infectious diseases

Xiyanping injection, a traditional Chinese medicine injection made of andrographolide sulfonate, consisting of well-defined ingredients with antiviral, antibacterial, anti-inflammatory and antipyretic efficacy, has been widely used for treating infectious diseases of respiratory and digestive systems. However, its wide applications may easily lead to unreasonable clinical medication. In order to guide the precise clinical application and rational use of Xiyanping injection, experts in related fields conducted systematically literature review, evaluated and deliberated the application of Xiyanping injection in treating acute infectious diseases using evidence-based medicine method, and jointly drafted the consensus to summarize types of acute infectious diseases in children and adults that can be treated with Xiyanping injection, and recommend the intervention time, usage and dosage, course of treatment and combined medication of the injection. Besides, the consensus elucidates the safety, precautions and contraindications of the injection, so as to provide guidance for clinical use.

Clinical Evaluation on Xiyanping Injection in the Treatment of Bronchopneumonia in Children Based on Meta-Analysis

Objective:The aim of this study is to evaluate the effectiveness and safety of xiyanping injection(XYPI)in the treatment of children with bronchopneumonia.Methods:Asystematic and comprehensive search was conducted in the domestic and foreign electronic databases CNKI,SinoMed,VIP,WanFang DATA,PubMed,The Cochrane Library,Embase,Web of Science,Clinical‑Trials.gov,and the search date ended on May 30,2019.Inclusion criteria:(1)the types of studies included were randomized controlled trials;(2)the study participants were infants and children with a clear diagnosis of bronchopneumonia,without gender and ethnic restrictions;(3)the intervention test group was XYPI or the control group plus XYPI.The control group was routine treatment(RT)(basic treatment such as fever,cough and asthma,oxygen inhalation,anti‑infection,maintaining water,electrolyte balance,etc.)or other Western medicine or RT+other Western medicine treatment.Except for XYPI,the two groups were consistent in intervention measures.According to the Cochrane Handbook,5.1 evaluation standard and a meta‑analysis of the final included studies was performed using RevMan 5.3 software.Results:Atotal of 57 studies were included,with a total sample size of 8454 cases,of which 4255 were in the experimental group and 4199 were in the control group.Meta‑analysis results showed that(1)Total effective rate:XYPI group was better than the control group(relative risk[RRRT]=1.25,95%confidence interval[CI][1.15,1.36],P<0.00001;RRRT+RBVI=1.18,95%CI[1.09,1.29],P<0.0001;RR antibiotic=1.16,95%CI[1.09,1.24],P<0.00001,RRRT+antibiotic=1.22,95%CI[1.16,1.27],P<0.00001);antipyretic time:XYPI group was better than the control group(mean difference[MDRT]=−0.97,95%CI[−1.17,−0.76],P<0.00001;MDRT+antibiotic=−2.28,95%CI[−2.88,−1.67],P<0.00001;MDRT+RBVI=−1.51,95%CI[−1.81,−1.21],P<0.00001;cough disappearing time:XYPI group was better than the control group(MDRT=−1.37,95%CI[−1.74,−1.00],P<0.00001;MDRT+antibiotic=−1.71,95%CI[−2.04,−1.37],P<0.00001;MDRT+RBVI=−1.51,95%CI[−2.15,−0.86],P<0.00001);disappearance time of lung rales:XYPI group was better than the control group(MDRT=−1.11,95%CI[−1.35,−0.88],P<0.00001;MDRT+RBVI=−1.63,95%CI[−2.23,−1.03],P<0.00001).The difference was statistically significant;(2)Of the 57 studies(a total of 8454 cases),29 studies reported adverse reactions,of which 18 studies did not find adverse reactions,and 11 studies reported adverse reactions such as nausea,vomiting,and rash after medication in both groups.(3)The funnel chart indicated potential publication bias.Conclusion:Based on the existing clinical evidence,XYPI can have a certain effect on the treatment of children with bronchopneumonia,and it is not yet possible to conclude its safety evaluation.Moreover,due to the low quality of the included studies,this evidence is still used with cautious clinically.

Xiyanping Injection in Treatment of Viral Pneumonia in Children: A Meta-analysis of Random Control Trials

Objective To evaluate the efficacy and safety of Xiyanping Injection in the treatment of viral pneumonia in children. Methods We searched several databases, including Pub Med, CNKI, VIP and Wanfang Data（January— June, 2014）. The references of all selected studies were also retrieved to collect the relevantly randomized controlled trials（RCTs） on Xiyanping Injection for viral pneumonia in children. Two authors screened the literatures in accordance with the inclusive criteria, extracted the data and assessed the methodological quality of the included studies. We used Rev Man 5.2 software for meta-analysis. Results Meta-analysis on the 10 included RCTs showed that the effective rates of defervescing and vanishing of the rashes and cough in the Xiyanping Injection group were better than those in the Ribavirin Injection group. There was no significant difference between the two groups in the incidence of adverse drug reaction. Conclusion The existing research indicated that Xiyanping Injection is a secure and efficient scheme for viral pneumonia in children. Because of the poor quality of present researches, these results should be verified by strictly-designed and large-scale sample RCTs.

Evaluation on Common Hand, Foot and Mouth Disease Treated by Integrative Traditional Chinese Medicine and Western Medicine

Objective To evaluate the efifcacy and safety of traditional Chinese medicine (TCM) combined with Western medicine in the treatment of patients with common hand, foot and mouth disease (HFMD) by conducting a prospective, controlled, and randomized trial. Methods A total of 452 patients with common HFMD were randomly assigned to receive Western medicine alone (n=220) or combined with TCM (Reduning or Xiyanping injections) (n=232). The primary outcome was the incidence rate of rash/herpes disappearance within 5 days, while secondary outcomes included the incidence rate for fever, cough, lethargy, agitation, and vomiting clearance within 5 days. Results The rash/herpes disappearance rate was 45.5% (100/220) in Western medicine therapy group, and 67.2% (156/232) in TCM and Western medicine combined therapy group, with significant difference (P<0.001). Moreover, TCM remarkably increased the incidence rate of secondary disappearance, which was 56.4%in Western medicine therapy group and 71.4%in TCM and Western medicine combined therapy group (P=0.001). No drug-related adverse events were observed. Conclusions It’s suggested that the integrative TCM and Western medicine therapy achieved a better therapeutic efficacy. TCM may become an important complementary therapy on relieving the symptoms of HFMD.

Effect of Integrated Chinese and Western Medicine Therapy on Severe Hand, Foot and Mouth Disease: A Prospective, Randomized, Controlled Trial

Objective: To evaluate the efficacy and safety of Chinese medicine(CM) plus Western medicine(WM) in the treatment of pediatric patients with severe hand, foot and mouth disease(HFMD) by conducting a prospective, controlled, and randomized trial. Methods: A total of 451 pediatric patients with severe HFMD were randomly assigned to receive WM therapy alone(224 cases, WM therapy group) or CM [Reduning Injection(热毒宁注射液) or Xiyanping Injection(喜炎平注射液)] plus WM therapy(227 cases, CM plus WM therapy group) for 7–10 days, according to a web-based randomization system. The primary outcome was fever clearance time, which was presented as temperature decreased half-life time. The secondary outcomes included the rate of rash/herpes disappearance within 120 h, as well as the rate for cough, runny nose, lethargy and weakness, agitation or irritability, and vomiting clearance within 120 h. The drug-related adverse events were also recorded. Results: The temperature decreased half-life time was 40.4 h in the WM therapy group, significantly longer than 27.2 h in the CM plus WM therapy group(P<0.01). Moreover, the rate for rash/herpes disappearance within 120 h was 43.6%(99/227) in the CM plus WM therapy group, significantly higher than 29.5%(66/224) in the WM therapy group(P<0.01). In addition, the rate for cough, lethargy and weakness, agitation or irritability disappearance within 120 h was 32.6%(74/227) in the CM plus WM therapy group, significantly higher than 19.2%(43/224) in the WM therapy group(P<0.01). No drug-related adverse events were observed during the course of the study. Conclusions: The combined CM and WM therapy achieved a better therapeutic efficacy in treating severe HFMD than the WM therapy alone. Reduning or Xiyanping Injections may become an important complementary therapy to WM for relieving the symptoms of severe HFMD.