Efficacy of intramuscular injection of Xiyanping injection for the treatment of acute bronchitis in children: a multicenter, randomized, parallel-controlled clinical study / 中国当代儿科杂志

OBJECTIVES@#To study the efficacy and safety of Xiyanping injection through intramuscular injection for the treatment of acute bronchitis in children.@*METHODS@#A prospective study was conducted from December 2021 to October 2022, including 78 children with acute bronchitis from three hospitals using a multicenter, randomized, parallel-controlled design. The participants were divided into a test group (conventional treatment plus Xiyanping injection; n=36) and a control group (conventional treatment alone; n=37) in a 1:1 ratio. Xiyanping injection was administered at a dose of 0.3 mL/(kg·d) (total daily dose ≤8 mL), twice daily via intramuscular injection, with a treatment duration of ≤4 days and a follow-up period of 7 days. The treatment efficacy and safety were compared between the two groups.@*RESULTS@#The total effective rate on the 3rd day after treatment in the test group was significantly higher than that in the control group (P<0.05), while there was no significant difference in the total effective rate on the 5th day between the two groups (P>0.05). The rates of fever relief, cough relief, and lung rale relief in the test group on the 3rd day after treatment were higher than those in the control group (P<0.05). The cough relief rate on the 5th day after treatment in the test group was higher than that in the control group (P<0.05), while there was no significant difference in the fever relief rate and lung rale relief rate between the two groups (P>0.05). The cough relief time, daily cough relief time, and nocturnal cough relief time in the test group were significantly shorter than those in the control group (P<0.05), while there were no significant differences in the fever duration and lung rale relief time between the two groups (P>0.05). There was no significant difference in the incidence of adverse events between the two groups (P>0.05).@*CONCLUSIONS@#The overall efficacy of combined routine treatment with intramuscular injection of Xiyanping injection in the treatment of acute bronchitis in children is superior to that of routine treatment alone, without an increase in the incidence of adverse reactions.

Complex Network Analysis of Xiyanping Injection in Treatment of Bronchitis Based on Real World / 中国实验方剂学杂志

Objective:To explore the group modules of Chinese medicine and western medicine for the treatment of bronchitis patients with Xiyanping injection based on the real world to provide references for the clinical treatment of bronchitis with Chinese medicine and western medicine. Method:Medical records of 13 874 patients with bronchitis treated by Xiyanping injection were extracted from 29 hospital information systems （HISs） in China，and complex network analysis was carried out using Tabu Search algorithm to obtain the substructure and associated information of core drug combination of Xiyanping injection for the treatment of bronchitis and to analyze clinical medication protocols. Result:Medication protocols for the pathogens of bronchitis are listed below： Xiyanping injection + cefuroxime for bacterial infection. Xiyanping injection + interferon for viral infection. Xiyanping injection + azithromycin for mycoplasma infection. According to the clinical symptoms and complications of bronchitis， the appropriate medication protocols were as follows： Xiyanping injection + ambroxol + Feilike mixture + ibuprofen for uncomplicated bronchitis. Xiyanping injection + ipratropium bromide + budesonide + salbutamol for asthmatic bronchitis. Xiyanping injection + mannitol + furosemide + phenobarbital + gangliosides + immunoglobulin for bronchitis complicated with viral encephalitis. Xiyanping injection + creatine phosphate sodium + vitamin C for bronchitis complicated with viral myocarditis. The combined medication of Chinese medicine for the treatment of bronchitis was adopted based on its characteristics of traditional Chinese medicine. Conclusion:The data of this study were derived from the real world. The combined medications protocols of Xiyanping injection targeting the clinical symptoms and complications of bronchitis were extracted and summarized. However， it is necessary to formulate an individualized medication protocol according to the specific condition.

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.

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.

Theoretical basis and effect characteristics of andrographolide against COVID-19 / 中草药

Since December 2019, coronavirus disease 2019 (COVID-19) has spread rapidly in China. National Health Commission of the People’s Republic of China and local departments have released a number of diagnosis and treatment plans for COVID-19. Some plans recommend Xiyanping Injection for the clinical treatment of COVID-19. The active component of the drug is the total sulfonate of andrographolide, which is a derivative of andrographolide. This paper summarized the pharmacological action and clinical application of andrographolide, and proposed that it has the functions of clearing heat and detoxification, anti-bacterial and anti-inflammatory, and definite therapeutic effect on respiratory system diseases including viral pneumonia and upper respiratory tract infection, and a large number of clinical data have been accumulated. Andrographolide has a potential antiviral effect on the treatment of COVID-19, and can reduce the level of inflammation in patients, improve respiratory symptoms, inhibit concurrent bacterial infection, and improve the body immunity. At the same time, it will not bring the immunosuppressive effect of hormone drugs, and the incidence of adverse reactions is low. In addition, Andrographolide has certain hepatoprotective effects and clinical value for treating cardiovascular diseases in clinical experience, suggesting that it may have some protective effects on drug-induced liver injury, heart injury and liver injury caused by durgs against COVID-19, but further clinical verification is needed. The pharmacological action and clinical application of andrographolide are summarized. This paper also analyzes the etiology, pathogenesis and dialectical treatment of COVID-19 from the perspective of traditional Chinese medicine, and points out that the treatment of COVID-19 with andrographolide is consistent with the theory of traditional Chinese medicine.

Analysis of clinical application characteristics of Xiyanping Injection in 194 873 cases in real world / 中国中药杂志

To analyze the clinincal application characteristics of Xiyanping Injection in real world. The data of the patients came from the hospital information systerm(HIS) of 29 tertiary hospitals in China from 2006 to 2016. It included three parts about basic information, Western medicine diagnosis information, and doctor advice information. The exploration was conducted for the characteristics of the patients and disease distribution as well as the therapeutic regimen. Apriori algorithm was adopted to establish the models, and Clementing 12.0 was used for a correlation analysis of the comprehensive therapeutic regimen of Xiyanping Injection. There were 194 873 cases in the study. The male to female ratio was 1.44∶1. The median age was 4 years old. The median daily dosage was 200 mg. 46.68% of the patients were administered with 250-500 mg, and 33.07% were 50-100 mg one day. 47.08% of the patients were administered for 4-7 d, and 32.65% of the patients were 1-3 d. In the doctor advice information, the most frequently types of Western medicine, traditional Chinese medicine were mucilagin, heat-clearing agent. Second generation cephalosporins, third generation cephalosporins, compound penicillin were the most common types of antibiotic. Interferon, nucleoside and nucleotide, human immunoglobulin were the most common types of antiviral drug. The mining association rules results were analyzed, finding the application of Xiyanping Injection in severe infectious diseases. To improve respiratory symptoms, Xiyanping Injection treaments were Budesonide + Ipratropium Bromide + Ambroxol. To severe pulmonary infection, the treaments were Dopamine + Ambroxine. To severe hand, foot and mouth disease, the treatments were Namefen + Mannitol. To pulmonary heart failure, the treatments were Dobutamine + Heparin. Based on the results of the real world HIS, we could provide clinical application the idea, and a reference for further excavation of the applicable diseases of Xiyanping Injection.

Antipyretic effect of Xiyanping injection on bacterial endotoxin lipopolysaccharide-induced fever in rabbits / 药学学报

This paper mainly studied the effect of Xiyanping injection on the bacterial endotoxin lipopolysaccharide (LPS)-induced fever in rabbits, preliminarily investigated the mechanisms, and provided pharmacological basis for the clinical application. The rabbit model of endotoxin-induced fever was established by using LPS as the inducer; The changes of rectal temperature were measured; The levels of prostaglandin E2 (PGE2), tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and phospholipaseA2 (PLA2) in the serum were measured; The levels of PGE2, cyclic adenosine monophosphate (cAMP), and arginine vasopressin (AVP) in cerebrospinal fluid as well as hypothalamus were detected. The animal welfare and experimental process are in accordance with the regulations of the Animal Ethics Committee of China Pharmaceutical University in this study. The results showed that Xiyanping injection (12.5, 25, and 50 mg·kg-1) could significantly reduce LPS-upregulated body temperature of rabbits, and the duration of action could reach 5.5-8.5 h. At the doses of 25 and 50 mg·kg-1, the antipyretic effect of Xiyanping injection was comparable to that of analgin injection (50 mg·kg-1). Furthermore, Xiyanping injection and analgin injection both reduced the levels of PGE2, IL-1β, TNF-α, and PLA2 in the serum of febrile rabbits to the varying degrees. In addition, Xiyanping injection also down-regulated the levels of PGE2, cAMP, and AVP in the hypothalamus, and PGE2 and cAMP in the cerebrospinal fluid. The level of AVP in the cerebrospinal fluid was up-regulated. This study indicated that Xiyanping injection could significantly improve the endotoxin-induced fever in rabbits, and mechanisms were closely related to the regulation of the levels of PGE2, TNF-α, IL-1β, PLA2, cAMP, and AVP in serum, hypothalamus, and cerebrospinal fluid.

Expert consensus statement on Xiyanping Injection for respiratory system infectious diseases in clinical practice(adults) / 中国中药杂志

Xiyanping Injection is widely used in the treatment of respiratory infectious diseases. However,its package insert is still less instructive for physicians in understanding the specific clinical application of Xiyanping Injection. To discover potential clinical advantages of Xiyanping Injection,the team invited clinical experts of traditional Chinese medicine and western medicine from the field of respiratory diseases,pharmacists and methodologists of evidence-based medicine to compile the consensus. The consensus was based on a combination of clinical research evidence and expert experience,involving recommendations for clinical problems supported by clini-cal evidence as well as consensus suggestions for clinical problems with no clinical evidence. The consensus recommended the indication,timing of intervention,usage,dosage,course of treatment,combined medication of Xiyanping Injection used for adults,and introduced the safety and precautions of its clinical application. It is suitable for guiding clinical medical workers to rationally use Xiyanping Injection in the treatment of adult's respiratory infectious diseases.

Systematic evaluation and Meta-analysis on effictiveness and safety of Xiyanping Injection in treatment of acute bronchitis in children / 中国中药杂志

To evaluate the effectiveness and safety of Xiyanping Injection in the treatment of acute bronchitis in children. The research systematically retrieved four Chinese databases( namely CNKI,VIP,Wan Fang,Sino Med) and four English databases( namely EMbase,Cochrane Library,Medline,Clinical Trail.gov). The retrieval time ranged from the commencement of each database to April2019. According to pre-set inclusion criteria and exclusion criteria,randomized controlled trials( RCTs) of Xiyanping Injection in the treatment of acute bronchitis in children were screened out. The quality assessment of the included studies was performed using the " Cochrane Bias Risk Assessment" tool,and the Meta-quantitatively analysis on the included studies was performed using Rev Man 5.3 software. A total of 648 articles were retrieved,and 10 studies were finally included. Except for one multi-arm test,the total sample size was 1 260,including 630 cases in the test group and 630 cases in the control group. The overall quality of the included study was not high. The results of Meta-analysis showed that in terms of antipyretic time,Xiyanping Injection combined with routine therapy was superior to routine therapy in the shortening of fever time in children with acute bronchitis( MD =-0.94,95%CI[-1.18,-0.70],P<0.000 01); in the overall efficacy,Xiyanping Injection combined with routine therapy was superior to routine therapy( RR = 1. 34,95% CI[1.26,1.42],P<0.000 01) and Yanhuning Injection + routine therapy( RR = 1.28,95%CI[1.19,1.38],P<0.000 01); descriptive analysis showed that Xiyanping Injection was excellent in the overall efficacy in treating acute bronchitis in children. The differences between the two groups were statistically significant( P< 0.000 1). The adverse reactions included in the study were mild adverse reactions,with no impact on treatment. Based on the results of this study,Xiyanping Injection combined with routine therapy or other Western medicine had a certain effect on acute bronchitis in children,especially in improving the overall efficacy of acute bronchitis in children. No serious adverse reactions were observed. And in the time of fever,cough and cough disappearance time,lung voice loss time,Xiyanping Injection + routine therapy or Western medicine therapy was better than routine therapy or Western medicine therapy. However,the small size of included studies,the low quality of the included studies,and the existence of publication bias and the low quality of the evidence had impacts on the reliability of the conclusion. Therefore,more large-sample,multi-center,well-designed,rigorous randomized controlled trials with best case reports are required to further verify the efficacy and safety.

Effect of Xiyanping Injection combined with Azithromycin on mycoplasma pneumonia in children and observation of serum cytokines / 中草药

Objective: To observe the anti-inflammatory and anti-mycoplasma effects and safety of Xiyanping Injection on mycoplasma pneumonia in children, and to explore the mechanism of treatment of mycoplasma pneumonia, so as to provide a new basis for clinical treatment. Methods: A total of 72 children with mycoplasma pneumonia were randomly divided into treatment group and control group, 36 cases in treatment group and 36 cases in control group. The control group was treated with Azithromycin. The treatment group was treated with Xiyanping intravenous drip on the basis of the control group and observed for 7 to 11 d. The therapeutic effects of TCM syndromes, the disappearance time of fever and cough were compared between the two groups to detect serum levels of inflammatory factors. Results: After 7 to 11 d of treatment, the symptoms of the two groups were improved, and the marked efficiency of the treatment group was significantly better than that of the control group (P 0.05). There was no significant difference in serum IL-10, IL-2, IL-4, and IFN-γ between the two groups after treatment (P > 0.05). Conclusion: Xiyanping Injection combined with Azithromycin can significantly improve the clinical symptoms of mycoplasma pneumonia in children with wind-heat stagnation of lung syndrome and phlegm-heat obstruction of lung syndrome, and improve the curative effect of traditional Chinese medicine syndromes,with better safety and no obvious adverse reactions.

Experts consensus statement on Xiyanping Injection in clinical practice(children) / 中国中药杂志

Xiyanping Injection is a commonly used medicine in clinical treatment,which is recommended by many pediatric disease guidelines/consensus. However,the instraction is relatively simple and lack of guidance for clinical application,which affects the efficacy and brings safety risks. Therefore,more detailed clinical guidance is urgently needed. This consensus is formulated by clinical experts of traditional Chinese medicine and Western medicine in pediatrics. This consensus follows Manual for the clinical experts consensus of Chinese patent medicine which published by China Association of Chinese Medicine. The study identified clinical problems using clinical investigation,searched the literature based on PICO clinical problems,using GRADE system to carry out evidences evaluation,classification and recommendation,and adopted the nominal grouping method to reach expert consensus. The consensus combines evidence-based evidence with expert experience,sufficient evidence of clinical problems would lead to " recommendations",and clinical problems with insufficient evidence will lead to " consensus suggestions". This expert consensus recommends the indications,intervention time for treatment,route of drug administration,dose conversion,the indications of being used alone,suitability and taboos of medicine combination,and introduces the safety and clinical application,to provide reference for clinical using.

Meta-analysis on effectiveness and safety of Xiyanping Injection combined with antibiotics in treatment of CAP in adults / 中草药

To electronically search databases including PubMed, MEDLINE, Web of Science, CBM, CNKI, VIP, Wanfang Data for randomized controlled trials (RCTs) of Xiyanping Injection for adult community acquired pneumonia patients from inception to August, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then RevMan 5.3 software was used for data analysis. Seventeen RCTs involving 1924 patients with adult community acquired pneumonia were included. The results of meta-analysis showed that Xiyanping Injection combined with antibiotic group was superior to the antibiotic drugs group (RR = 1.20, 95% CI 1.15 to 1.25, P < 0.000 01) in treatment adults with community acquired pneumonia. At the same time, it can improve the symptoms of cough and shorten the duration of fever and the duration of hospitalization. In terms of safety, there were 26 cases of adverse reactions in the antibiotic group. The primary adverse reactions were gastrointestinal reaction, dizziness, rash, and phlebitis, and reactions were mild and self-healing. There are 30 adverse reactions cases in the combination group, and the types and levels of reaction are same as antibiotic group. Moreover, the current evidence showed that the combination of Xiyanping Injection and conventional antibiotic drugs in the treatment of community acquired pneumonia may significantly improve the curative effect compared with only antibiotics. Rare adverse reactions occurred and safety evaluation was acceptable. However, due to the low methodological quality of the enrolled studies, more clinical research is needed to further verify the results of this work.

Efficacy and safety of Xiyanping injection combined with azithromycin in treating mycoplasma pneumonia of children: Meta-analysis / 中国中药杂志

To systemically evaluate the safety and efficacy of Xiyanping injection combined with azithromycin in the treatment of mycoplasmal pneumonia in children. PubMed, Wanfang Data, CNKI, VIP and CBM were used to search for the clinical randomized controlled trials on Xiyanping injection combined with azithromycin in the treatment of mycoplasmal pneumonia in children from database establishment to July, 2017. The papers were screened according to the established inclusion and exclusion criteria, and then the quality of the included studies was evaluated to extract valid data for Meta-analysis by using Revman 5.3 software. A total of 31 clinical randomized controlled trials were included, involving 2 881 patients. Meta-analysis showed that as compared with azithromycin alone, the combination of azithromycin with azithromycin had obvious advantages in the total effective rate（OR=5.42,95%CI[3.98,7.38],<0.000 01）, fever clearance time（MD=-1.29,95%CI[-1.51,-1.08],<0.000 01）, cough disappearance time （MD=-1.72,95%CI[-1.99,-1.46],<0.000 01）, lung wet rales disappearance time（MD=-1.51,95%CI[-1.88,-1.14],<0.000 01）, chest X-ray recovery time（MD=-2.72,95%CI[-3.82,-1.63],<0.000 01）, shortening the hospital stay（MD=-1.88,95%CI[-2.26,-1.50],<0.000 01）, reducing the incidence of adverse reactions（MD=0.51,95%CI[0.33,0.79],=0.002）, and other aspects, with statistically significant difference. Based on the existing evidences, Xiyanping injection combined with azithromycin in the treatment of mycoplasmal pneumonia in children can significantly improve the overall clinical efficiency, shorten the hospital stay and reduce the incidence of adverse reactions. However, the clinical trials of existing small randomized controlled trials have low quality of methodology and require a large sample of high quality clinical trials for further validation.

Clinical research of Qingfei Oral Liqulid and Xiyanping Injection in treatment of children with human bocavirus pneumonia / 中草药

Objective To observe the clinical effect of Qingfei Oral Liqulid and Xiyanping Injection in the treatment of children with human bocavirus pneumonia. Methods Children with human bocavirus pneumonia (59 cases) were randomly divided into treatment group and control group. The cases in the treatment group were treated with Qingfei Oral Liqulid and Xiyanping Injection, and those in the control group were given Ambroxol and Clenbuterol oral solution and Ribavirin injection. The comprehensive efficacy, before and after treatment of primary symptoms scores, secondary symptoms scores, and total scores of symptoms were observed. Results The treatment group had superior comprehensive efficacy over the control group (P < 0.05). Both groups had reduced scores for primary symptoms and secondary symptoms and total scores for symptoms after treatment (P < 0.05). The decreases in the scores for primary symptoms and secondary symptoms and the total scores for symptoms after treatment were larger in the treatment group than those in the control group (P < 0.05). Conclusion Qingfei Oral Liqulid and Xiyanping Injection had definitive efficacy in the treatment of human bocavirus pneumonia in children.

Clinical effect of Xiyanping injection combined with bifidobacterium in the treatment of infantile virus diarrhea / 中国基层医药

Objective To explore the clinical effect of Xiyanping injection combined with bifidobacterium in the treatment of infantile virus diarrhea.Methods 80 cases of infantile virus diarrhea were selected,they were randomly divided into control group and research group according to the digital table,40 cases in each group.The control group received intravenous drip ribavirin treatment,the research group received treatment of intravenous drip Xiyanping injection combined with bifidobacterium at the same time.The symptoms disappear time(time of diarrhoea,antifebrile time),length of hospital stay and clinical curative effect were observed and compared between the two groups.Results The indicator of symptoms disappear time (time of diarrhoea,antifebrile time) and length of hospital stay of the research group were (2.19 ±0.43)d,(1.75 ±0.36)d,(4.13 ±0.85)d,respectively,which were shorter than those of the control group [(4.89 ± 0.61) d,(3.68 ± 0.52) d,(7.91 ± 1.13) d],the differences were statistically significant(t =22.89,19.30,16.90,all P ＜ 0.01).The total effective rate of the research group was 97.5％,which was significantly higher than 72.5％ of the control group (x2 =24.5,P ＜ 0.01).Conclusion Xiyanping injection combined with bifidobacterium in the treatment of infantile virus diarrhea has significantly shorter antidiarrheal time,antifebrile time,length of hospital stay than ribavirin,the clinical curative effect is distinct,which is worthy of clinical popularization and application.

Study on Signal Detection of Xiyanping Injection-induced Urticaria Based on BCPNN Warning Technology / 中国药房

OBJECTIVE:To explore and analyze signals of Xiyanping injection-induced urticaria from spontaneous reporting system database of Jiangxi province. METHODS:The continuous ADR report monitoring data were collected from spontaneous re-porting system of Jiangxi province,and established database. Bayesian confidence propagation neural network(BCPNN) method was used to calculate information component,IC value of Xiyanping injection-induced urticaria. The year-to-year changes of IC val-ue and its interval were analyzed. RESULTS:A total of 328324 ADR reports were collected in Jiangxi province during 2004-2016. The IC value of Xiyanping injection-induced urticaria detected by BCPNN method was 1.10(the lower limit of IC value was 0.65, and upper limit was 1.54),i.e. there was signal and the IC value ranged from-0.87 to 1.65. CONCLUSIONS:The results of BCPNN method suggest that urticaria is a warning signal of Xiyanping injection. The risk is increasing gradually,and prediction precision increase with the addition of report quantity.

Effect of integrated Chinese and Western medicine therapy on severe hand, foot and mouth disease: A prospective, randomized, controlled trial / 中国结合医学杂志

<p><b>OBJECTIVE</b>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.</p><p><b>METHODS</b>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 ( ) or Xiyanping Injection ()] 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.</p><p><b>RESULTS</b>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.</p><p><b>CONCLUSION</b>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. (Registration No. NCT01145664).</p>

Clinical Study of Xiyanping Injection for Treatment of Children with Acute Suppurative Tonsillitis / 广州中医药大学学报

Objective To investigate the effectiveness and safety of Xiyanping Injection for the treatment of children with acute suppurative tonsillitis, so as to provide evidence for the prevention and treatment of pediatric acute suppurative tonsillitis with traditional Chinese medicine. Methods Two hundred children with acute suppurative tonsillitis were randomly divided into treatment group and control group, 100 cases in each group. The control group was given routine western medicine treatment, and the treatment group was given Xiyanping Injection based on the treatment for the control group. The treatment lasted for 5 days. The clinical outcomes covered the course of disease, the overall efficacy, adverse reaction, and time for the subsiding of fever, sore throat, swollen tonsils and purulent secretion, as well as the changes of white blood cell count, hyper-sensitivity C reactive protein, alanine aminotransferase, creatinine and creatine kinase levels before and after treatment. Results (1) After treatment, the total effective rate of the treatment group was 97.0% and that of the control group was 87.0%, the difference being significant (P 0.05). No adverse reactions of rash, nausea, vomiting, diarrhea, chest distress, shortness of breath, or drug fever were found in the two groups. Conclusion Xiyanping Injection is effective and safe for the treatment of children with acute suppurative tonsillitis by increasing the total efficiency, reducing the time for the subsiding of fever, sore throat, swollen tonsils and purulent secretion, shortening hospitalization time, and decreasing white blood cell count and hyper-sensitivity C reactive protein level. No obvious hepato-renal function damage occurred during the medication.

Antibacterial Activity in vitro of Xiyanping Injection Combined with 7 Kinds of Antibiotics / 中国药师

Objective: To study the antibacterial activity in vitro of Xiyanping injection combined with cefoxitin, cefuroxime, ceftriaxone, cefmenoxime, amikacin, levofloxacin and meropenem against staphylococcus aureus, escherichia coli, klebsiella pneumoniae, pseudomonas aeruginosa and acinetobacter bauman.Methods: Minimum inhibitory concentration (MIC) of the 7 kinds of antimicrobial agents used individually or combined with Xiyanping injection on germs were determined respectively on 96 plates by using the agar dilution method and the checkerboard method.Fractional inhibitory concentration index (FICI) was calculated to evaluate the antibacterial activity of Xiyanping injection combined with the 7 kinds of antimicrobial agents in vitro.Results: MIC of Xiyanping injection combined with cefoxitin was the same as that of cefoxitin used individually on escherichia coli.MIC of levofloxacin combined with Xiyanping injection showed no difference with that of levofloxacin used individually on klebsiella pneumoniae.Besides, Xiyanping injection could increase the MIC of the other antimicrobial agents on germs.Conclusion: Xiyanping injection combined with antimicrobial agents on staphylococcus aureus, escherichia coli, klebsiella pneumoniae shows antagonistic and irrelevant relationship.

Systematic review of medication safety of Xiyanping injection in conformity with indications of package inserts / 中国中药杂志

To systematically review the medication safety of Xiyanping injection in conformity with indications of package inserts. Eight databases at home and abroad were searched for studies on the safety of Xiyanping injection. Literature screening, quality assessment, data extraction and analysis were performed according to internationally recognized inclusion and exclusion criteria. There were 118 clinical studies included, and 94 studies were finally studied, including 70 randomized controlled trials and eight non-randomized controlled trials, involving 16 case reports, and 4 716 patients treated with Xiyanping injection, with 148 adverse drug reactions(ADR) and no adverse event(AE). Among them, 15 cases reported serious adverse drug reactions, including 1 vegetative state, 4 allergic shock and other general cardiovascular damages. Diarrhea was the most commonly reported ADR among the 133 general adverse reactions, accounting for 30.12%, which was followed by rash. Most of the studies adopted the dosage set forth in package inserts. Some current evidences showed that irrational combined administration and use of Xiyanping may cause some ADRs. Because the most of studies didn't report the medication process and patient conditions, we can't infer the relations between the ADR and the age or solvent. Clinicians shall judge the causality according to relevant provisions and standards, and report ADRs, so as to provide more evidences for evaluating the safety of the drug.