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Table of Contents
ORIGINAL ARTICLE
Year : 2020  |  Volume : 6  |  Issue : 3  |  Page : 307-323

Clinical evaluation on xiyanping injection in the treatment of bronchopneumonia in children based on meta-analysis


Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China

Date of Submission24-Dec-2019
Date of Acceptance01-May-2020
Date of Web Publication05-Sep-2020

Correspondence Address:
Prof. Yan-Ming Xie
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/wjtcm.wjtcm_29_20

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  Abstract 


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: A systematic 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: A total 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.

Keywords: Meta-analysis, pediatric bronchopneumonia, systematic review, xiyanping injection


How to cite this article:
Zhang C, Lyu J, Xie YM, Sun MH. Clinical evaluation on xiyanping injection in the treatment of bronchopneumonia in children based on meta-analysis. World J Tradit Chin Med 2020;6:307-23

How to cite this URL:
Zhang C, Lyu J, Xie YM, Sun MH. Clinical evaluation on xiyanping injection in the treatment of bronchopneumonia in children based on meta-analysis. World J Tradit Chin Med [serial online] 2020 [cited 2020 Sep 26];6:307-23. Available from: http://www.wjtcm.net/text.asp?2020/6/3/307/294387




  Introduction Top


Bronchopneumonia is an inflammation involving the bronchi and alveoli, which is the most common pneumonia in childhood. It is a common clinical infectious disease of the lower respiratory tract, mostly occurring in infants under 2 years old. The main clinical manifestations are cough, asthma, fever, and fixed wet rale of the lung, which often cause myocardial injury and cardiac insufficiency.[1],[2] If the treatment is not complete, it is easy to recurrence, causing various complications and seriously affecting the growth of children.[3] At present, there is no unified standard for the treatment of bronchopneumonia in children. At present, antitussive and expectorant drugs combined with antibiotics are mainly used to treat bronchopneumonia in children. Although the clinical symptoms can be quickly relieved, over-use of antibiotics will lead to drug resistance in children and affect the clinical effect.[4] Xiyanping injection (XYPI), a Chinese medicinal preparation, is an extract of Herba Andrographis, the main component of which is water-soluble andrographolide sulfonates, which has good effects of clearing away heat, relieving fever, resisting inflammation, resisting bacteria and virus, and can be used for bronchitis, tonsillitis, bacillary dysentery, etc.[5] A number of randomized controlled trials (RCTs) have shown that the use of XYPI based on routine treatment (RT) can improve therapeutic effectiveness and reduce adverse reactions. However, due to the lack of evidence-based medicine, there has been controversy over the effectiveness and safety of the treatment. Although a meta-analysis study was published in 2012,[6] the relevant literature has been updated. According to the Cochrane system evaluation method, this article referred to the revised PRISMA system evaluation and meta-analysis writing standard in 2009,[7] The pediatric statistics of 16 units in China showed that 93.7% of the 22,504 cases were hospitalized with bronchopneumonia, most of which were in infants and young children.[8] The published RCT study of XYPI in the treatment of bronchopneumonia in children was evaluated, to provide the more reliable evidence-based basis for the rational treatment of bronchopneumonia in children.


  Materials and Methods Top


Inclusion criteria and exclusion criteria

Inclusion criteria

(1) The types of studies included were RCTs; (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 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.

Exclusion criteria

(1) Exclusion if there are obvious errors in the research data or the full text cannot be obtained; (2) Other traditional Chinese medicine (such as Chinese patent medicine, Chinese medicine extract injection, decoction), acupuncture, auricular points, massage and other traditional Chinese medicine measures as an adjuvant therapy were excluded. Repeated articles retain the first one, and articles with duplicate data retain the most complete one.[9]

Outcome indicators

Primary outcome indicator: Total effective rate. Under the same evaluation criteria, total effective rate = (markedly effective cases + effective cases)/total cases × 100%. Markedly effective: The main clinical symptoms and signs of children were significantly relieved or disappeared after treatment, and the objective inflammatory indicators were significantly improved; Effective: The main clinical symptoms and signs of children were relieved after treatment, and the objective inflammatory indicators were improved.

Secondary outcome indicators: fever abatement time, cough abatement time, lung rales abatement time, adverse reaction rate.

Literature retrieval

A comprehensive retrieval of four major Chinese databases: Chinese National Knowledge Infrastructure (CNKI), China Biology Medicine disc, CBMdisc (CBM), VIP, WanFang DATA, English database: PubMed, the Cochrane Library, Embase, Web of science, Clinical-Trials.gov for RCT papers on comparing XYPI in the treatment of bronchopneumonia in children was conducted. The retrieval time was from the establishment of database to May 2019. The key words mainly included “Xiyanping,” “Bronchopneumonia” and so on. Based on the combination of keywords and free words, literature selection is carried out according to the inclusion criteria and exclusion criteria, and supplemented by Google, Baidu, manual retrieval of conference papers, unpublished literature, and so on.

Literature screening and data extraction

The retrieved documents were imported into the document management software EndNote. After removing the repetitive literature, two researchers independently complete the literature screening and data extraction. Disputes were settled by discussion or determined by referring to a third party. After a preliminary screening of the titles and abstracts, and a full-text evaluation, the data were finally incorporated into the literature that meets the requirements of the study. Excel 2019 was used to construct a data extraction table to extract the data, including the first author, the year of publication, the characteristics of the study object, the specific content of the intervention, the sample size of the control group, the course of treatment, the outcome indicators and so on.

Quality evaluation of included studies

Two researchers independently completed the evaluation of the quality of the included research literature, with differences discussed or adjudicated by a third party. The “bias risk assessment” tool developed by Cochrane Collaborative Network's methodologists, editors and system reviewers was used to assess the bias risk in 7 aspects, and judgments of “low bias risk,” “high bias risk” and “uncertainty of bias risk” were made for each study result.[10]

Statistical methods

Meta-analysis was performed using RevMan 5.3 software (London, United Kingdom) in Cochrane collaboration network. When outcome indicators are binary data, relative risks (RR) effect quantities were used to express the value.[11] When the outcome index was a continuous variable, the mean difference (MD) or standardized MD were used to express the outcome index, and the 95% confidence interval (CI) and bilateral Z test P value were calculated respectively.[12],[13] Q test and I2 index test were used to test whether there was statistical heterogeneity in the effect quantity. When I2<50% and P >0.1, with no obvious heterogeneity, fixed-effect model was used. If I2 >50% and P < 0.05, with a certain degree of heterogeneity, the random effect model could be used in the normal distribution. When I2 = 75%–100%, the heterogeneity was obvious. The source of heterogeneity needs to be explored, and subgroup analysis and meta-regression were considered.[14] The number of inclusions is ≤10, except in the case of strong clinical heterogeneity, an inverted funnel diagram was drawn to identify publication bias.


  Results Top



  Literature Screening Results Top


A total of 363 literatures were obtained from the initial examination, and 67 literatures were screened out after EndNote duplicate check, reading the title and abstract of the literatures, and then 67 literatures were screened out, of which 67 literatures could not be affirmed. They were screened again after reading the full text. Finally, 57 literatures that met the research criteria were included, all of which were Chinese literatures. [Figure 1] shows the details of the screening process.
Figure 1: Flow diagram of study selection

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Basic features of included studies

The subjects of 57 RCTs were all infants or children with bronchopneumonia. The total number of samples was 8454, with 4255 cases in the experimental group, and 4199 cases in the control group. Among them, 2369 cases were treated with XYPI on the basis of RT. Sixty cases were treated only with XYPI. 1276 cases were treated with XYPI and antibiotics on the basis of RT. 200 cases were treated with XYPI and other western medicines on the basis of RT. The course of treatment was usually 7 days, with the shortest 3 days and the longest 14 days.

Fifty-seven RCTs described baseline conditions in both groups, 14 of which did not describe gender at baseline, and 10 did not describe age at baseline, but all reported no significant differences in gender, age, course of the disease, and severity of disease between the two groups, as detailed in [Table 1].
Table 1: Basic information included in the study

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Risk bias assessment for included study

Allocation hiding and blind methods were not described in 57 studies, and random grouping was described in 55 studies, of which four studies were described as random number tables,[21],[53],[59],[62] 4 studies were described as random grouping in order of attendance or hospitalization,[26],[34],[42],[64] none of the other studies described random embodiments, only randomization were mentioned, and three studies did not describe random grouping.[18],[27],[40] In two studies, there were missing cases, and the generation of missing data may be associated with real outcomes.[40],[41] One study did not fully report on the prestated outcome indicators.[42] The bias risk assessment included in the study is shown in [Figure 2].
Figure 2: Percentage of included study that produced the risks of bias

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Meta-analysis results

Total efficiency analysis

A total of 42 studies were included. The intervention measures of 14 studies were RT + XYPI VS RT,[18],[26],[28],[31],[36],[42],[43],[46],[48],[55],[56],[57],[63],[66] the intervention measures of 8 studies were RT + XYPI VS RT + RBVI,[15],[17],[22],[33],[49],[52],[69],[71] the intervention measures of 3 studies were RT + XYPI VS RT + antibiotic,[30],[39],[45] 10 studies were treated with RT + Antibiotic + XYPI VS RT + antibiotic,[16],[29],[34],[35],[41],[51],[61],[62],[65],[67] 7 studies were treated with antibiotic + XYPI VS antibiotic.[19],[20],[27],[37],[38],[44],[64] Combined analysis using random effects model (P < 0.00001, I2 = 74%), the results are shown in [Figure 3], suggesting that the total effective rate of RT combined with XYPI was better than RT (RR = 1.25, 95% CI [1.15, 1.36], P < 0.00001).
Figure 3: Forest plot of total effective rate

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On the basis of RT, the total effective rate of XYPI was better than that of RBVI (RR = 1.18, 95% CI [1.09, 1.29], P < 0.0001), but no significant difference was found between XYPI and antibiotic (RR = 1.07, 95% CI [1.88, 1.29], P = 0.51). The total effective rate of antibiotic combined with XYPI was higher than that of antibiotic alone (RR = 1.16, 95% CI [1.09, 1.24], P < 0.00001).

Analysis of antipyretic time

A total of 28 studies were included for meta-analysis. The intervention measures of 13 studies were RT + XYPI VS RT.[21],[26],[36],[42],[43],[46],[50],[54],[55],[56],[57],[63],[66] The intervention measures of 3 studies were RT + XYPI VS RT + RBVI.[17],[33],[69] The intervention measures of 9 studies were RT + antibiotic + XYPI VS RT + antibiotic.[16],[29],[32],[34],[51],[53],[62],[67],[68] The intervention measures of 3 studies were antibiotic + XYPI VS antibiotic.[19],[44],[64] The intervention measures of the four kinds of the study were analyzed by subgroup, and the heterogeneity was higher in each group (I2 ≥70%, P < 0.01). The random effect model was used to combine effect dose. As shown in [Figure 4], the rhomboid diagram was not intersected with ordinate. The addition of XYPI on the basis of RT can significantly reduce the fever time and antipyretic time of children with bronchial pneumonia, which was superior to RT (MD = −0.97, 95% CI [−1.17, −0.76], P < 0.00001); The antipyretic time of combined antibiotics and XYPI on the basis of RT was better than RT and antibiotic (MD = −2.28, 95% CI [−2.88, −1.67], P < 0.00001); The antipyretic time of RT combined with XYPI was better than that of RT combined with RBVI (MD = −1.51, 95% CI [−1.81, −1.21], P < 0.00001); The antipyretic time of XYPI was better than that of antibiotic (MD = −1.13, 95% CI [−1.90, −0.37], P = 0.004).
Figure 4: Forest plot of antipyretic time

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Analysis of disappearance time of cough

A total of 38 studies were included. The intervention measures of 14 studies were RT + XYPI VS RT.[21],[26],[36],[42],[43],[46],[50],[54],[55],[56],[57],[63],[66],[70] The intervention measures of 9 studies were RT + XYPI + antibiotic VS RT + antibiotic.[16],[29],[32],[34],[51],[53],[62],[67],[68] The intervention measures of 3 studies were RT + XYPI VS RT + RBVI.[17],[33],[69] The intervention measures of 3 studies wereRT + XYPI VS RT + antibiotic.[30],[39],[45] The intervention measures of 3 studies were antibiotic + XYPI VS antibiotic.[19],[44],[64]

Subgroup analysis of the interventions in the five kinds of studies showed high heterogeneity among the groups. Random effect model was used to combine effect dose. The results are shown in [Figure 5], suggesting that combined with XYPI can significantly reduce the disappearance of cough in patients (MD = −1.37, 95% CI [−1.74, −1.00], P < 0.00001); Based on RT plus antibiotics, XYPI was better than RT plus antibiotics in shortening the cough disappearance time. The difference was statistically significant (MD = −1.71, 95% CI [−2.04, −1.37], P < 0.00001); On the basis of RT, XYPI was better than RBVI in shortening cough disappearing time (MD = −1.51, 95% CI [−2.15, −0.86], P < 0.00001).
Figure 5: Forest plot of cough display time

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On the basis of RT, XYPI was superior to antibiotics (MD = −1.12, 95% CI [−1.24, −1.01], P < 0.00001) in shortening the disappearance time of cough.

XYPI combined with antibiotics was superior to antibiotics (MD = −1.00, 95% CI [−1.41, −0.59], P < 0.00001) in shortening the disappearance time of cough.

Analysis of disappearance time of lung rales

A total of 29 studies were included. The intervention measures of 14 studies were RT + XYPI VS RT.[21],[26],[36],[42],[43],[46],[50],[54],[55],[56],[57],[63],[66],[70] The intervention measures of 3 studies were RT + XYPI VS RT + antibiotic.[30],[39],[45] The intervention measures of 3 studies were RT + XYPI VS RT + RBVI.[17],[33],[69] The intervention measures of 7 studies were RT + antibiotic + XYPI VS RT + antibiotic.[29],[34],[51],[53],[62],[67],[68] The intervention measures of 2 studies were antibiotic + XYPI VS antibiotic.[19],[44] The results of subgroup analysis are shown in [Figure 6], and the heterogeneity of each group was high. Random effect model was used. The results of meta-analysis showed that XYPI combined with RT was superior to RT in shortening the disappearance time of pulmonary rales (MD = −1.11, 95% CI [−1.35, −0.88], P < 0.00001).
Figure 6: Forest plot of lung rales disappearances

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On the basis of RT, XYPI was better than RBVI and antibiotic treatment in shortening the disappearance time of lung rales (MD = −1.63, 95% CI [−2.23, −1.03], P < 0.00001) (MD = −1.00, 95% CI [−1.28, −0.27], P < 0.00001). On the basis of RT combined with antibiotics, XYPI was added to reduce the disappearance time of lung rales, which was better than RT combined with antibiotics (MD = −2.11, 95% CI [−2.03, −1.91], P < 0.00001).

On the basis of antibiotic, XYPI was superior to antibiotic alone (MD = −2.07, 95% CI [−2.65, −1.50], P < 0.00001) in shortening the disappearance time of lung rales.

Incidence of adverse reactions

A total of 25 studies were included. The intervention measures of 11 studies were RT + XYPI VS RT.[21],[26],[28],[31],[42],[43],[48],[54],[57],[63],[66] The intervention measures of 5 studies were RT + XYPIVS RT + RBVI.[17],[22],[49],[52],[69] The intervention measures of 7 studies were RT + antibiotics + XYPI VS RT + antibiotic.[34],[35],[51],[53],[61],[65],[67] The intervention measures of 2 studies were antibiotic + XYPI VS antibiotic.[38],[44] After the heterogeneity test (I2 = 0%, P = 0.62), the homogeneity between the groups was good. The fixed-effect model analysis was used. As shown in [Figure 7], the results showed that on the basis of the RT + antibiotic, the incidence of adverse reactions for combined with XYPI was lower than RT + antibiotic, and the difference was statistically significant (RR = 0.33, 95% CI [0.18, 0.61], P = 0.0004).
Figure 7: Forest plot of adverse reaction rate

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Adverse reactions

Twenty-nine studies reported adverse events.[17],[21],[22],[25],[26],[28],[31],[34],[35],[38],[40],[42],[43],[44],[45],[49],[51],[52],[53],[54],[57],[58],[60],[61],[63],[65],[66],[67],[69] Among them, 18 studies reported no adverse events,[21],[22],[25],[26],[28],[31],[35],[42],[43],[45],[49],[54],[57],[58],[63],[65],[67],[69] 11 studies reported adverse reactions such as nausea, vomiting, and rash after drug administration of the two groups.[17],[34],[38],[40],[44],[51],[52],[53],[60],[61],[66] There were no serious adverse reactions and liver and kidney dysfunction in both groups. The adverse reactions are shown in [Table 2].
Table 2: Summary of advice actions

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Publication bias analysis

The total effective rate, fever abatement time, cough abatement time, lung rale abatement time and adverse reaction rate of children with bronchopneumonia whose number of studies was more than or equal to 10 were analyzed by publication bias, As shown in [Figure 8], [Figure 9], [Figure 10], [Figure 11], [Figure 12], both studies were asymmetrically distributed, indicating that there may be potential publication bias due to the fact that positive results may be more easily published. The reason may be that the positive results were easier to publish. The included studies were all in Chinese, and there was a certain language publication bias.
Figure 8: Funnel plot of total effective rate

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Figure 9: Funnel plot of antipyretic time

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Figure 10: Funnel plot of cough display time

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Figure 11: Funnel plot of lung sound disappearances

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Figure 12: Funnel plot of adverse reaction rate

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  Discussion Top


Efficacy of XYPI in treating infantile bronchopneumonia

Fifty-seven RCTs were included in this study. There were 8454 cases of bronchopneumonia in children. The results of the meta-analysis showed that the effect of XYPI on bronchopneumonia in children was better than that of single RT, and it could shorten the time of fever, cough, and lung rales in children with bronchopneumonia, and the difference was statistically significant. On the basis of RT, the effect of XYPI was better than RBVI or antibiotic. The effect of XYPI combined with antibiotics was better than that of XYPI combined with antibiotics. The effect of XYPI combined with antibiotics was better than that of antibiotics alone, and the incidence of adverse reactions was low. Bronchopneumonia is the most common pneumonia in pediatrics. Hundreds of thousands of children die of pneumonia every year in our country, which has become an important public health problem in our country.[72] RT generally includes antipyretic, antitussive and antiasthmatic, oxygen inhalation, anti-infection, maintenance of water and electrolyte balance and other basic treatment, antibiotic antibacterial, and antiviral therapy.[73] But antibiotics have certain side effects, and with the wide use of antibiotics, bacterial resistance also gradually increased, resulting in a large number of drug-resistant bacteria and conditioned pathogens caused by refractory pneumonia, and sensitive antibiotics often failed to treat.[74]

Chinese traditional medicines such as traditional Chinese medicine decoction and Chinese patent medicine have a relatively small side effect. According to the study, XYPI is widely used in the treatment of bronchopneumonia in children, As a pure Chinese medicinal preparation, it has the effects of heat-clearing and detoxifying, anti-cough and anti-dysentery, which is used in the treatment of bronchitis, tonsillitis, bacillary dysentery. The therapeutic mechanism is related to the main component of sulfide of andrographolide.

Some studies have reported that andrographolide total lactones (andrographolide A, B, propion, butyrin), andrographolide glycosides, dehydrated andrographolide, etc., are made into andrographolide vulcanization, and the introduction of hydrophilic groups can enhance anti-infection and relieving fever, which is easy to dissolve, reduce absorption or avoid allergic reactions, with dual effects of antibacterial and antiviral.[75] Andrographis paniculata is a plant of the genus Andrographis family, and traditional Chinese medicine theory believes that it has the effects of clearing heat and detoxifying, cooling blood, and reducing swelling.[76] Andrographolide is a plant of the Chinese medicine acanthaceae family, which is a diterpene lactone compound, and has a very good anti-respiratory effect on the human body. It is known as a “natural antibiotic.”[77] Studies show that andrographolide specifically inhibits DNA biosynthesis in S. aureus cells in a dose-dependent manner, and inhibits S. aureus biofilm formation. Considering its antibacterial activity, andrographolide is expected to be a leader in the development of new antibacterial drugs.[78]

Safety of xiyanping injection in the treatment of infantile bronchopneumonia

Fifty-seven RCTs (8454 samples) were enrolled in this study, 29 of which reported adverse reactions. Both groups developed nausea, vomiting, and pruritus after treatment, but no liver or kidney dysfunction was found. The outcome of adverse reactions was not described in both groups, and the correlation with XYPI was not evaluated in all studies. Therefore, XYPI in children with bronchopneumonia should not be considered as safe but should be further validated by reasonable sample size and rigorous clinical safety monitoring test.

Significance and deficiencies of research

In this study, 57 RCTs were analyzed quantitatively by meta-analysis. The results showed that the effective rate and symptom improvement time of XYPI and RT were better than those of RT alone, and the combination of antibiotics and XYPI was also better than that of antibiotics alone. The effective rate of RT combined with XYPI was better than RBVI. Because there is no expert consensus on the treatment of bronchopneumonia in children, and the abuse of antibiotics has a certain impact on the health of children. Therefore, evidence-based treatment of traditional Chinese medicine has a good reference for the treatment of this disease. The results of this study can provide reference and the evidence-based basis for the clinical treatment of children with bronchopneumonia and the development of subsequent consensus of experts. The shortcoming of this study is that the methodology quality of the included 57 RCTs included is low. Blindness and distributive hiding were not mentioned in any of the 57 studies. For randomization, only four studies were described as random number tables. Four studies were described as randomized in the order of attendance or hospitalization. None of the other randomized implementations were described, and only the word “randomized” was mentioned. Therefore, the RCT included in this study may not avoid the bias of choice in grouping patients and measurement bias in outcome evaluation. In addition, only 2 RCT reports reported on withdrawal and lost cases, but none of them were included in the final statistical analysis, which has some influence on the authenticity of the results.

Recommendations for follow-up studies

In view of the low quality of the general methodology of RCTs included in this study, it is suggested that follow-up RCT studies should be carried out: (1) Formulate random sequence generation and random hiding schemes, implement strict blind methods, perform overall quality control of clinical trials, and report the number and causes of withdrawal and loss of follow-up, and standardization of the overall implementation process of the study; (2) Outcome indications should avoid single comprehensive curative effect judgment index, such as total effective rate; (3) Standardize the monitoring and reporting of adverse drug reactions and evaluate the safety of clinical application of Chinese patent medicine.


  Conclusions Top


The results of this study show that XYPI has a certain effect in treating bronchopneumonia in children, and has certain advantages in shortening the time of fever reduction, cough disappearance, and lung snoring disappearance. However, the existing evidence has not yet reached a conclusion on the safety evaluation of XYPI. The research results can provide a reference for the clinical treatment of children with bronchopneumonia, but due to the low quality of the included research in methodology, large-scale, multi-center, rigorously designed clinical trials are still needed to further verify its effectiveness, and prospective hospital centralized monitoring research is carried out to further evaluate its safety.

Financial support and sponsorship

National Key R&D Program of China (2018YFC1707400); Funding for Basic Scientific Research Business Expenses of Central-Level Non-Profit Research Institutes (Z0597).

Conflicts of interest

There are no conflicts of interest.



 
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