Comparative efficacy and safety of antiviral traditional Chinese medicine injections for viral pneumonia: a systematic review and network meta-analysis.

BACKGROUND: Viral pneumonia (VP) is becoming a persistent and pervasive burden of disease. Traditional Chinese medicine Injections (TCMIs) have been proved effective in the treatment of patients with VP, which are now widely used in China. The evidence of TCMIs for VP is evolving rapidly. This study aims to assess the comparative efficacy and safety of TCMIs to provide more evidence and sights for the treatment selection of VP. RESEARCH DESIGN AND METHODS: Seven databases were searched from their inception up to 16 March 2022. Only randomized controlled trials (RCTs) are included to compare the efficacy and safety of antiviral TCMIs for the treatment of viral pneumonia. Clinical efficacy and rate of adverse events were considered as primary outcomes. RESULTS: A total of 76 RCTs with eight TCMIs comprising 7925 patients were included in the NMA. According to NMA, Reduning Injection combined with conventional antiviral drugs (CAD) produced superior effects in the effective outcomes and reduced the adverse event incidence rate of VP. CONCLUSIONS: This study indicated that TCMIs combined with CAD was more effective and safer than CAD monotherapy and compared different TCMIs therapies, which provided guidance and reference for the selection of clinical treatment medication.

Xiyanping injection combined with acitretin for psoriasis vulgaris: A systematic review and meta-analysis.

Background: Psoriasis represents the chronic, recurrent and inflammatory disorder. The Traditional Chinese Medicine Xiyanping injection (XYP) is extensively applied in China for treating diverse inflammatory disorders, such as bronchitis, viral pneumonia or upper respiratory tract infection. XYP may offer a potential treatment for psoriasis vulgaris (PV). This study focused on analyzing whether XYP combined with acitretin was effective and safe. Methods: The present meta-analysis was carried out in line with guidelines of Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). This systematic review was registered in PROSPERO (CRD42022333273). Besides, relevant randomized controlled trials (RCTs) that compared XYP plus acitretin with acitretin alone for treating PV were searched from several databases from their inception till May 2022. In addition, this work utilized RevMan5.4 to conduct risk assessment as well as meta-analysis. Results: This meta-analysis selected altogether 10 RCTs including 815 subjects. Upon quality assessment, the RCTs mainly had low or unclear risk. According to our meta-analysis results, relative to acitretin monotherapy, XYP plus acitretin increased the total clinical effective rate, as evidenced by Psoriasis area and severity index score (PASI)-20, PASI-30 and PASI-60 in patients with PV [risk ratio (RR) = 1.23 Z = 4.87, p < 0.00001, 95% confidence interval (CI): 1.13-1.34; RR = 1.29, Z = 3.89, p = 0.009, 95% CI: 1.07 to 1.55; and RR = 1.31, Z = 3.89, p = 0.0001, 95% CI: 1.14-1.49]; the reduced levels of TNF-α, MCP-1 and RANTES, the alleviated side effects resulting from acitretin like itchiness (RR = 0.54, 95% CI: 0.4 to 0.74, Z = 3.94, p < 0.0001), and the increased levels of aminotransferases and dyslipidemia (RR = 0.5, 95%CI = 0.29, 0.86, p = 0.01; and RR = 0.41, 95% CI = 0.23, 0.75, p = 0.004). Conclusion: As suggested in the present meta-analysis, XYP combined with acitretin effectively and safely treats PV. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022333273, identifier PROSPERO 2022 CRD42022333273.

Combination effect of azithromycin with TCM preparation Xiyanping injection against Klebsiella pneumoniae infection in rats.

BACKGROUND: Klebsiella pneumoniae is known as one of the most principal opportunistic human pathogens. Although antibiotics such as the first-line agent azithromycin (AZM) usually are efficient for the treatment of K. pneumonia-related infections, growing threat from antibiotic resistance has become a major challenge. Various preparations based on traditional Chinese medicine (TCM) clinical experience have been developed to help combat such a global public health threat, including Xiyanping injection (XYP) that is made from the natural product andrographolide with potent heat-clearing and toxin-resolving functions. PURPOSE: The present study aimed to demonstrate the therapeutic potential, as well as the action of mechanism of AZM in combination with XYP against K. pneumonia infection in rats. METHODS: Pneumonia model of K. pneumoniae infection in rats was established and subjected to various treatments. The lung histopathological lesions were evaluated. ELISA and Griess techniques were used to determine the level of crucial cytokines. The protein expressions of MAPKs and NF-κB pathways were analyzed by Western blotting. RESULTS: The combination in vivo could significantly inhibit the proliferation of K. pneumoniae in lung, improve the pathological changes of lung and reduce inflammatory factors in lung homogenate and bronchoalveolar lavage fluid, mainly by inactivating MAPKs and NF-κB signaling pathways. Combination therapy caused one-fold increase in apparent distribution volume of AZM in rats after multiple dosing, along with a significant increase of AZM level in lungs but obvious decrease in livers. CONCLUSION: The combination therapy of AZM and XYP showed increased antibacterial and anti-inflammatory properties, indicating that it might be used to treat K. pneumoniae infection.

Concomitant Medication Use With Xiyanping Injection and the Risk of Suspected Allergic Reactions: A Nested Case-Control Study Based on China's National Medical Insurance Database.

Introduction: Xiyanping injection (XYP), a type of Traditional Chinese Medicine, is widely used and often applied in combination with other medications in treating bronchitis, tonsillitis, and bacillary dysentery in China. In recent years, an elevated risk of allergic reactions has been observed following XYP, but whether concomitant medication use contributes to this risk is still unknown. Objective: This study aims to investigate the association between the concomitant use of XYP and the 25 most frequently co-applied medications with suspected allergic reactions for China's patients receiving XYP. Methods: A nested case-control study was conducted using the sampling data from 2015 China's Urban Employees Basic Medical Insurance and Urban Residents Basic Medical Insurance database. Four anti-allergic marker drugs were used to evaluate suspected allergic reactions. Univariate analyses and multivariable conditional logistic regression were conducted, and results were reported as odds ratios (ORs) with a 95% confidence interval (CI). Sensitivity analyses were performed on the expanded sample by including those prescribed with anti-allergic marker drugs on the same day as XYP and then stopped XYP on the next day. Results: Out of 57,612 participants with XYP prescription, we obtained 949 matched case-control pairs. Multivariable conditional logistic regression revealed that seven concomitant medications including gentamicin [OR = 4.29; 95% CI (2.52, 7.30)], cefoperazone-sulbactam [OR = 4.26; 95% CI (1.40, 13.01)], lidocaine [OR = 2.76; 95% CI (1.79, 4.25)], aminophylline [OR = 1.73; 95% CI (1.05, 2.85)], ribavirin [OR = 1.54; 95% CI (1.13, 2.10)], potassium chloride [OR = 1.45; 95% CI (1.10, 1.91)], and vitamin C [OR = 1.32; 95% CI (1.03, 1.70)] were associated with increased risk, while cefathiamidine [OR = 0.29; 95% CI (0.16, 0.51)] was associated with reduced risk. Sensitivity analysis on 2,438 matched pairs revealed similar findings. Conclusion: Increased risks for suspected allergic reactions were found for the concomitant use of XYP with seven medications. Our data suggest that gentamicin, cefoperazone-sulbactam, lidocaine, and ribavirin should be applied with precautions for patients receiving XYP, and further studies on drug interactions and allergy mechanisms are warranted.

Herb-Drug Interaction Between Xiyanping Injection and Lopinavir/Ritonavir, Two Agents Used in COVID-19 Pharmacotherapy.

The global epidemic outbreak of the coronavirus disease 2019 (COVID-19), which exhibits high infectivity, resulted in thousands of deaths due to the lack of specific drugs. Certain traditional Chinese medicines (TCMs), such as Xiyanping injection (XYPI), have exhibited remarkable benefits against COVID-19. Although TCM combined with Western medicine is considered an effective approach for the treatment of COVID-19, the combination may result in potential herb-drug interactions in the clinical setting. The present study aims to verify the effect of XYPI on the oral pharmacokinetics of lopinavir (LPV)/ritonavir (RTV) using an in vivo rat model and in vitro incubation model of human liver microsomes. After being pretreated with an intravenous dose of XYPI (52.5 mg/kg) for one day and for seven consecutive days, the rats received an oral dose of LPV/RTV (42:10.5 mg/kg). Except for the t1/2 of LPV is significantly prolonged from 4.66 to 7.18 h (p < 0.05) after seven consecutive days pretreatment, the pretreatment resulted in only a slight change in the other pharmacokinetic parameters of LPV. However, the pharmacokinetic parameters of RTV were significantly changed after pretreatment with XYPI, particularly in treatment for seven consecutive days, the AUC0-∞ of RTV was significantly shifted from 0.69 to 2.72 h µg/mL (p < 0.05) and the CL exhibited a tendency to decrease from 2.71 L/h to 0.94 L/h (p < 0.05), and the t1/2 of RTV prolonged from 3.70 to 5.51 h (p < 0.05), in comparison with the corresponding parameters in untreated rats. After administration of XYPI, the expression of Cyp3a1 protein was no significant changed in rats. The in vitro incubation study showed XYPI noncompetitively inhibited human CYP3A4 with an apparent Ki value of 0.54 mg/ml in a time-dependent manner. Our study demonstrated that XYPI affects the pharmacokinetics of LPV/RTV by inhibiting CYP3A4 activity. On the basis of this data, patients and clinicians can take precautions to avoid potential drug-interaction risks in COVID-19 treatment.

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.

[Analysis of clinical application characteristics of Xiyanping Injection in 194 873 cases in real world].

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.

Risk factors associated with the severity of adverse drug reactions by Xiyanping injection: A propensity score-matched analysis.

ETHNOPHARMACOLOGICAL RELEVANCE: Xiyanping injection (XYP), extraction of Andrographis paniculate (Andrographis paniculata (Burm. f.) Nees, chuan xin lian), is a Chinese patent medicine approved to treat bronchitis in China. In 2017, safety incidents associated with treatment of XYP began to emerge throughout China. However, the risk factors of severity of adverse reactions by XYP remain uncertain. AIM OF THE STUDY: To determine risk factors for the severity of XYP-associated adverse drug reactions (ADRs). MATERIALS AND METHODS: We analyzed a total of 26,317 cases of ADRs linked to the use of XYP injection in the China National Adverse Drug Reaction Monitoring Information System from 2004 to 2017. Data were analyzed with respect to age, gender, ethnicity, previous ADRs, family history of ADRs, dosage specification, medication frequency specification, body weight, route of administration, herb-drug interactions (ribavirin, cefatriaxone, penicillin sodium, ambroxol hydrochloride, clindamycin, cefoxitin sodium, azithromycin, ceftazidime, amoxicillin sodium and clavulanate potassium, levofloxacin, cefazolin sodium pentahydrate, acyclovir) by univariate analysis and multivariate analysis. Propensity score matching was used to compare severity of (general or serious) ADRs. RESULTS: We included 24,911 cases of general ADRs and 1406 cases of serious ADRs. Univariate analysis identified age (p â€‹< â€‹0.001), body weight (p â€‹< â€‹0.001), route of administration (p â€‹= â€‹0.008), co-administration of XYP with ribavirin (p â€‹= â€‹0.031) as risk factors of severity of ADRs. Multivariate analysis identified XYP â€‹+ â€‹ribavirin combination (p â€‹= â€‹0.048) and age (p â€‹< â€‹0.001) as the independent risk factors. Upon propensity score matching, the variables were relatively balanced amongst the two groups of patients with general or severe ADRs, and the level of severity in patients who received treatment of XYP â€‹+ â€‹ribavirin increased (p â€‹= â€‹0.020). CONCLUSIONS: Age and co-administration of ribavirin may be potential risk factors for the severity of XYP-associated ADRs. This reminds us to pay more attention to the safety of elderly medication. Minimizing the herb-drug-interaction effects of XYP and ribavirin is a viable treatment target for healthcare professionals in managing serious ADRs amongst patients receiving XYP injection.

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.

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.

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.

[Systematic evaluation and Meta-analysis on effictiveness and safety of Xiyanping Injection in treatment of acute bronchitis in children].

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.

[Experts consensus statement on Xiyanping Injection in clinical practice(children)].

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.

[Expert consensus statement on Xiyanping Injection for respiratory system infectious diseases in clinical practice(adults)].

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.

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.

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.

[Efficacy and safety of Xiyanping injection combined with azithromycin in treating mycoplasma pneumonia of children: Meta-analysis].

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],P<0.000 01）, fever clearance time（MD=-1.29,95%CI[-1.51,-1.08],P<0.000 01）, cough disappearance time （MD=-1.72,95%CI[-1.99,-1.46],P<0.000 01）, lung wet rales disappearance time（MD=-1.51,95%CI[-1.88,-1.14],P<0.000 01）, chest X-ray recovery time（MD=-2.72,95%CI[-3.82,-1.63],P<0.000 01）, shortening the hospital stay（MD=-1.88,95%CI[-2.26,-1.50],P<0.000 01）, reducing the incidence of adverse reactions（MD=0.51,95%CI[0.33,0.79],P=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.

Andrographolide sulfonate reduces mortality in Enterovirus 71 infected mice by modulating immunity.

Outbreaks of hand, foot and mouth disease (HFMD), which is caused by Enterovirus 71 (EV71), have erupted in recent years. Andrographolide sulfonate (Trade name: Xiyanping injection) has been recommended to treat severe HFMD in China because of its conventional antithermic and antitoxic activities, but its actual mechanism has not been revealed clearly until now. To explore its therapeutic efficacy and mechanism, a Xiyanping injection treatment mouse model was established. Based on the therapeutic model, routine clinical parameters and histopathologic changes were investigated, in the same time, viral loads, immune cells, inflammatory molecules and cell signaling pathways were determined. Xiyanping injection treatment protected mice from lethal EV71 challenge in a therapeutic regimen-dependent manner, which may mostly depend on its direct immunomodulatory activities on neutrophil and T lymphocyte. Reduced inflammatory molecular production of neutrophil and elevated T lymphocyte activity may result from its marked inhibition of some signaling pathways. Taken together, Xiyanping injection was an effective treatment for severe HFMD by improving hosts' immunity.

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 ( ) 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. 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. CONCLUSION: 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).