| Purpose:To summarize the application of clinical outcome indicators in the randomized controlled trial(RCT)of Chinese medicine for the prevention and treatment of Mycoplasma pneumoniae pneumonia(MPP)in children,analyze its problems and propose solutions.To evaluate the long-term clinical efficacy of TCM for MPP in children and further improve the TCM system evaluation system and life-cycle respiratory health management programme for MPP.Material and method:The children’s MPP literature published between September 1,2017 and September 1,2022 was searched through China Knowledge Network,Wanfang,VIP,CBM,Cochrane library,Pub Med.Information on the number of subjects included in the literature,inclusion criteria,selection of TCM evidence and clinical outcome indicators,frequency of use,and combinations of use were extracted for analysis.Children diagnosed with MPP at the Affiliated Hospital of Liaoning University of Chinese Medicine from September 2017 to September 2018 were selected for the study.According to their previous treatment methods,they were divided into the observation group(Internal and external treatment plan+Xiyanping injection)with the control group(Internal and external treatment plan),and another healthy physical examination children were selected as the normal group.Collect the information on gender,age,allergy history,past history,regimen,and TCM constitution of the included children and correlate with the immunoglobulin,T-lymphocyte subsets,and serum immunoglobulin E(Ig E)results.Results:1.A total of 128 papers were included in the study.Ninety of the included papers detailed Western and Chinese diagnostic criteria(70.31%),21 papers included only Western diagnostic criteria(16.41%)and the remaining 17 papers did not include reference guidelines or criteria used for diagnosis(13.28%).Fifty papers reported TCM evidence(39.06%),with phlegm-heat occluding the lung being the most common.The clinical outcome indicators were divided into six categories of indicator domains in the study:clinical efficacy assessment(138 times,12.23%),symptoms and signs(270 times,23.94%),Chinese medical evidence(75 times,6.65%),physical and chemical test(454 times,40.25%),economic assessment(26 times,2.30%)and safety event(165 times,14.63%).The results of the use of a combination of clinical outcome indicators show:three papers used only category 1 indicators(2.34%),15 used category 2 indicators(11.72%),42 used category 3 indicators(32.81%),45used category 4 indicators(35.16%),22 used category 5 indicators(17.19%)and 1 used category 6 indicators(0.78%).A total of 8 papers in the study dealt with prognostic follow-up and only 1 paper had a statistically significant follow-up result.2.In this study,information on 53 subjects who had participated in the previous subjects was collated and telephone calls were made,and a total of 36 patients agreed to participate in this follow-up study.The follow-up shedding rate for this study was 32.08%.A total of 51 study subjects were included in the study,36 in the disease group(19 in the observation group and17 in the control group)and 15 in the normal group.Studies have found that children are prone to recurrent coughing,anorexia,constipation and night sweats,with coughing being the main symptom in the largest number of children.Children with Mycoplasma pneumoniae(MP),influenza virus,and novel coronavirus infections were included during the follow-up period,and there was no significant correlation between their disease status and pathogen infection(P>0.05);there was no significant correlation between children in the observation and control groups for MP,influenza virus,and novel coronavirus infections(P>0.05).The top 2 TCM constitutions included in the ranking of children were,in order,yin-deficiency constitution(22.13%)and qi-stagnation constitution(14.42%).Comparisons between groups revealed that the distribution of yin-deficiency constitution was statistically significant between the disease group and the normal group,and between the observation group and the control group(P<0.05),while the distribution of the remaining constitutions was not statistically significant(P>0.05).The distribution of abnormal indicators in each group was found to be abnormal in all groups.The levels of immunoglobulin A(Ig A),immunoglobulin G(Ig G),and immunoglobulin M(Ig M)were higher in children in the disease group than in the normal group,and the differences between Ig G levels were statistically significant(P<0.05);the levels of CD3~+%,CD4~+%,and CD4~+/CD8~+were higher in the disease group than in the normal group,and the levels of CD8~+%and CD19~+%were higher than in the normal group,but the difference between the groups was not statistically significant((P>0.05).The differences in the distribution of total serum Ig E between children in the disease group and the normal group were not statistically significant(P>0.05).The levels of Ig A,Ig G and Ig M in the observation group were lower than those in the control group,but the differences between the two groups were not statistically significant(P>0.05).The differences in the expression levels of CD3~+%,CD4~+%,CD8~+%and CD19~+%between the children in the observation group and the control group were not statistically significant(P>0.05),among which the differences between the expression levels of CD4~+/CD8~+were statistically significant(P<0.05)and there was no significant correlation between the distribution of serum total Ig E and the choice of treatment protocol(P>0.05).Correlation analysis showed that Ig G distribution was negatively correlated with children’s age;abnormal humoral immunity was correlated with yang-deficiency constitution and gentleness constitution,abnormal cellular immunity was correlated with gentleness constitution,yang-deficiency constitution and wetness-heat constitution,and abnormal serum total Ig E was correlated with phlegm-wetness constitution and special-diathesis constitution.Conclusion:1.In the study,we searched the RCT on the prevention and treatment of MPP in children with Chinese medicine included in domestic and international databases,and collated and analyzed the use of clinical outcome indicators,and found that most of the RCT had deficiencies such as irregular selection of outcome indicators and few outcome indicators with Chinese medicine characteristics.A standardized core set of indicators for Chinese medicine(COS-TCM)should be established.Its establishment will facilitate researchers to correctly select appropriate outcome indicators according to the study objectives,effectively reduce study heterogeneity,improve the quality of study results and provide a higher level of data evidence for clinical diagnosis and treatment.2.By detecting the number of T lymphocyte subsets and immunoglobulin levels in children with MPP,MP infection may cause long-term immune damage to the body of children.By comparing the observation group(Internal and external treatment plan+Xiyanping injection)with the control group(Internal and external treatment plan),the observation group’s diagnosis and treatment plan has the effect of maintaining the balance of CD4~+/CD8~+.It suggests that the observation group’s diagnosis and treatment plan can alleviate the cellular immune damage caused by MP infection in children to a certain extent.The TCM constitutions of children with MPP are mostly yin-deficiency constitution and qi-stagnation constitution.Gentleness constitution and yang-deficiency constitution are closely related to humoral and cellular immune indicators. |
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