CN108305667A - Method of the evidential evaluation TNF-α as the biomarker of assessment Yoga curative effect - Google Patents
Method of the evidential evaluation TNF-α as the biomarker of assessment Yoga curative effect Download PDFInfo
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Abstract
The method of biomarker the invention discloses a kind of evidential evaluation TNF α as assessment Yoga curative effect comprising (1) formulate research evidence search strategy；(2) research evidence inclusion criteria exclusion criteria is formulated；(3) literature research data extracts；(4) document quality assessment；(5) standardized data is handled；(6) efficiency and value of the assessment TNF α as Yoga curative effect biomarker.The method of the present invention can reject uncorrelated research relative to single experimental study in a large amount of data, maximally utilise existing research evidence, the value of biomarker can synthetically be assessed, specify clinical meaning of the TNF α situations of change as assessment Yoga function and effect, it is time saving and energy saving.Method through the invention can be derived that the yoga exercise scheme of systematic science and best beneficiaries, and the auxiliary supplementary therapy for Yoga as disease provides concrete guide scheme.
Description
Technical field
The present invention relates to biotechnologies, and in particular to evidential evaluation TNF-α is as assessment Yoga curative effect
The method of biomarker.
Background technology
Yoga explicitly points out its meaning in adjuvant therapy of breast cancer in newest breast cancer guide.Yoga is also received
Enter to assist non-steroidal drug to treat the first-line treatment scheme of chronic Low Back Pain.At the same time, Yoga is also widely used for improving it
In the lapsing to of his chronic disease, including cardiovascular and cerebrovascular disease, metabolic disease, autoimmune disease and phrenoblabia
Deng.But clinical evidence is still short of at present, and the biological mechanism of Yoga effect is still indefinite, lacks effective and feasible finger
Mark assessment Yoga function and effect.According to current research, Yoga exists clear with the expression of inflammatory reaction and inflammatory mediator
Correlation.Yoga can be by regulating and controlling internal inflammatory reaction, and regulation and control patient mood, sleep, gyrus road recognize, are tired and swollen
The occurrence and development of tumor.TNF-α has more basic research branch at present as one of internal detectable most common inflammation index
It holds, TNF-α plays important in tissue fibrosis, the adjusting autoimmune response and fat cell metabolism etc. of modulate tumor
Effect.Existing relevant evidence shows that Yoga can regulate and control the expression variation of TNF-α at present simultaneously.
The expression that TNF-α can be adjusted about Yoga at present changes to which the clinical experimental study for influencing patient's prognosis has not
It is few, but TNF-α whether can as Yoga adjuvant treatment of diseases biological indicator it is still indefinite, TNF-α is as Yoga
The biomarker of curative effect is still not able to be applied, and being primarily due to single clinical test, often sample is smaller；Science
For the information of research without rational deep processing, utility value is very low；It is next bright that there is presently no a systematic researches
The relationship of true Yoga and TNF-α；To the same problem, the different laboratory in the whole world may be unfolded to study simultaneously, the object that is put to the test,
Sample size, the limitation of the factors such as area, experimental design may obtain inconsistent even contradictory conclusion.Due to above original
It will be huge, great shadow that cause, clinician and enterprise spend using the required knowledge accumulation of biomarker and time
Research and the application process of Yoga adjuvant treatment of diseases are rung.
In conclusion how to excavate and collect information, assessment and processing data in current data, clearly have
The biomarker for assessing Yoga curative effect of application value or potential using value has become one and is badly in need of asking for solution
Topic.
Invention content
A kind of biomarker the purpose of the present invention is to provide evidential evaluation TNF-α as assessment Yoga curative effect
The method of object.
The present invention also aims to provide application of the method in evaluating Yoga adjuvant treatment of diseases
To achieve the above object, present invention firstly provides a kind of evidential evaluation TNF-α as assessment Yoga curative effect
Biomarker method, include the following steps：
1, research evidence search strategy is formulated：
Clinical Evidence database is systematically retrieved comprehensively, including PubMed, Cochrane Library, Embase
And Web of Science databases search for the pertinent literature changed about yoga patients before and after intervention expression of tumor necrosis factor,
Ruling off is retrieved on November 8th, 2017.The search condition of document is：“TNF-α”and“yoga”or“yogic”or
“Asana”or“Pranayama”or“Dhyana”or“Dharana”or“Meditation”or“Tumor Necrosis
Factor alpha”or“Cachectin-TumorNecrosis Factor”or“Cachectin Tumor Necrosis
Factor”or“TNFalpha”or“TNF-alpha”or“Tumor Necrosis Factor”or“Tumor Necrosis
Factor Ligand Superfamily Member 2”or“Cachectin or TNF Superfamily,Member 2”。
Meanwhile the bibliography of all these researchs has been read, to find more related articles.
2, research evidence is formulated to be included in and exclusion criteria：
Inclusion criteria
(1) english literature；(2) full text article；(3) original research；(4), there are control in randomized controlled trial and cohort study
Group, smallest sample amount are 15；(5) it is included in population ages ＞ 18 years old；(6) the intervention situation for being included in research is all that Yoga group compares it
His exercise group, at least 3 weeks intervention times；(7) outcome evaluation is TNF-α in serum or blood plasma, test method in strict accordance with
The instruction of equipment manufacturers.
Exclusion criteria：
(1) incomplete data；(2) publication repeated；(3) zooscopy, mail, expert opinion, case report, body
The article of outer experiment.
The article being wherein included in solves difference with consensus through discussion by two researcher's independent evaluations.
3, research data extracts：
Form is extracted using normal data, it is ensured that research money by the information that two researchers extract from each experiment respectively
The result of material extraction and quality evaluation is with uniformity, and the 3rd researcher is transferred to determine when at sixes and sevens.
4, experimental study quality evaluation：
Randomized controlled trial carries out document quality assessment using Cochrane offset risk assessment tools, and cohort study uses
Newcastle-Ottawa scale scales carry out document quality assessment, include the comparativity and knot of patient's selection, research group
The assessment of fruit；
5, standardized data is handled：
Using standardization statistics strategy, merge measurement index, extraction data are counted using 12.0 softwares of Stata
Analysis；Standardization Strategies include mainly：Mate analyses, heterogeneous analysis, subgroup analysis, sensitivity analysis, publication bias assessment；
6, efficiency and value of the assessment TNF-α as Yoga curative effect biomarker.
Preferably, the retrieval type of the database in the step 2 is " TNF-α " and " yoga " or " yogic " or
“Asana”or“Pranayama”or“Dhyana”or“Dharana”or“Meditation”or“Tumor Necrosis
Factor alpha”or“Cachectin-Tumor Necrosis Factor”or“Cachectin Tumor Necrosis
Factor”or“TNFalpha”or“TNF-alpha”or“Tumor Necrosis Factor”or“Tumor Necrosis
Factor Ligand Superfamily Member 2”or“Cachectin or TNF Superfamily,Member 2”。
Preferably, step (5) Central Asia group analysis include intervene type, the health status of participant, participant control
Treat situation, the regional or national situation of participant, Yoga intervention duration, yoga exercises time and frequency.
Further, the biomarker the present invention also provides evidential evaluation TNF-α as assessment Yoga curative effect
Application of the method for object in evaluating yoga exercise effect.
Preferably, yoga exercise crowd with obvious effects includes cancer patient, chronic back pain patient and high-risk occupation
Person.
Preferably, the crowd of the yoga exercise best results is cancer patient being treated.
Preferably, the cancer patient includes patient with breast cancer and straight colorectal cancer patients.
Preferably, the time of effective yoga exercise and frequency are：Total time is more than or equal to 8 weeks, exercise time weekly
More than or equal to 180min, for total exercise frequency more than or equal to 3 times, each exercise time is more than or equal to 60min weekly.
Advantageous effect
The method of the present invention can reject uncorrelated research relative to single experimental study in a large amount of data, maximum
Existing research evidence is utilized to limit, can synthetically assess the value of biomarker, specifies that TNF-α situation of change is used as and comments
The clinical meaning for estimating Yoga function and effect, compared with traditional research method, this method can at faster speed, less manpower
The application value that biomarker is improved with financial resources, the evidence of molecular level is provided for the effect of Yoga, facilitates research people
Member, doctor and enterprise's application.Method through the invention can be derived that the yoga exercise scheme of systematic science and best beneficiary
Group, the auxiliary supplementary therapy for Yoga as disease provide concrete guide scheme.
Description of the drawings
Fig. 1 sensitivity analyses；
Fig. 2 publication bias is analyzed.
Specific implementation mode
The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention..Unless otherwise specified, embodiment
Used in the conventional means that are well known to those skilled in the art of technological means.
A kind of method of the biomarker of embodiment 1, evidential evaluation TNF-α as assessment Yoga curative effect, according to
It is secondary to follow the steps below：
1, research evidence search strategy is formulated：
Using PubMed, Library, Embase and Web ofScience database search about yoga patients before and after intervention
The pertinent literature of the variation of expression of tumor necrosis factor, retrieval ruling off on November 8th, 2017.The search condition of document
It is:“TNF-α”and“yoga”or“yogic”or“Asana”or“Pranayama”or“Dhyana”or“Dharana”or
“Meditation”or“Tumor Necrosis Factor alpha”or“Cachectin-Tumor Necrosis
Factor”or“Cachectin Tumor Necrosis Factor”or“TNFalpha”or“TNF-alpha”or“Tumor
Necrosis Factor”or“Tumor Necrosis Factor Ligand Superfamily Member 2”or
“Cachectin or TNF Superfamily,Member 2”.Meanwhile the bibliography of all these researchs has been read, with
Find more related articles.
2, research evidence is formulated to be included in and exclusion criteria：
Inclusion criteria：
(1) english literature；(2) full text article；(3) original research；(4), there are control in randomized controlled trial and cohort study
Group, smallest sample amount are 15；(5) it is included in population ages ＞ 18 years old；(6) the intervention situation for being included in research is all that Yoga group compares it
His exercise group, at least 3 weeks intervention times；(7) outcome evaluation is TNF-α in serum or blood plasma, test method in strict accordance with
The instruction of equipment manufacturers.
Exclusion criteria：
(1) incomplete data；(2) publication repeated；(3) zooscopy, mail, expert opinion, case report, body
The article of outer experiment.
The article being wherein included in solves difference with consensus through discussion by two researcher's independent evaluations.
3, research data data are extracted
Form is extracted using normal data, it is ensured that research money by the information that two researchers extract from each experiment respectively
The result of material extraction and quality evaluation is with uniformity, and the 3rd researcher is transferred to determine when at sixes and sevens.The data packet of extraction
Include the first authors title, publish year, research institute country, research population the case where, sample size, follow up time, do weekly
Number, the TNF-α (average ± standard deviation) lacked in pre- frequency, research process.
For any research for having several parts of publications, all reports all concentrate in together.For some publications,
In the publication without the information reported or only shown in the graph, investigator contacts author and finds the data lost.3rd is ground
The person of studying carefully bears the quality of research of paper very important responsibility, including distribution concealment, blinding and integrality.
4, experimental study quality evaluation
Randomized controlled trial carries out document quality assessment using Cochrane offset risk assessment tools, and cohort study uses
The Newcastle-Ottawa scale scales of improvement carry out document quality assessment, including patient's selection, study group
Three factors such as assessment of comparativity and result.The Research Literature quality being included in is all fine.
5, standardized data is handled
Data Management Analysis is carried out using 12.0 softwares of Stata.
(1) influence of the Yoga to TNF-α is assessed using continuous variable, due to the difference of TNF-α measurement method, as a result made
It is indicated with standard mean difference (SMD).
(2) I is used2Statistic carrys out heterogeneous size between evaluation studies.Work as I2When between 0-20%, show between research
Without heterogeneity；Work as I2When between 20-50%, then it is assumed that there are moderate heterogeneities；Work as I2=>When 50%, it will be considered existing
It is apparent heterogeneous.
(3) the additional uncertainty that changeability is brought between the research under fully considering different intervention effects, using random
Effect model (i-v is heterogeneous) carries out data analysis.
(4) validity to TNF-α as the biomarker of Yoga curative effect carries out subgroup analysis.
(5) sensitivity analysis is by assessing individual event research or single influence of the factor for Meta analysis results, to weigh
As a result reliability.
(5) possibility of publication bias is assessed by building the crater blasting of each test effect size in standard error
Property.The asymmetry of crater blasting is assessed by using Begg tests, and it is p value that will significantly issue deviation definition<0.1.
6, value of the TNF-α as the biomarker of assessment Yoga curative effect is evaluated according to analysis of statistical results.
By the result of study of TNF-α and Yoga relationship that standardized data is handled：
(1) 6 independent experiments, including 240 participants are included in research altogether, and each quality of research is preferable, has evaluated Yoga
Interference situation, health status, treatment, life countries and regions, the fortune of influence and the crowd of exercise to TNF-α change level
Relationship between the parameters such as dynamic Time And Frequency.
(2) whole subgroup analysis result：The group for comparing Yoga group and other intervention forms, under the expression of Yoga group TNF-α
Drop.Yoga variant (SMD compared with other intervening measures：0.67；95% confidence interval：0.34-0.99, P-value<
0.05), group difference has moderate heterogeneity (I2=32.7%, p=0.191), as shown in table 2.
(3) result of subgroup analysis：
1) intervene type
Subgroup analysis is carried out according to the intervention of control group, is divided into Non-exercise：Yoga group (participate in yoga exercise) and
Group of giving up doing exercise (not participating in any exercise), Other-exercise：Yoga group (participating in yoga exercise) and other forms exercise group
(exercise for participating in the other forms in addition to Yoga).Result of study shows Yoga group compared with group of giving up doing exercise, TNF-α expression drop
It is low, heterogeneity statistically significant (5 experiments, 194 participants between group；SMD：0.69,95%CI：0.29-1.10, P-
value<0.05；I2=43.2%, p=0.134), and the expression of TNF-α is not united between Yoga group and other forms exercise group
Meter learns difference (1 experiment, 46 participants；SMD：0.51,95% confidence interval CI：- 0.08-1.11, P-value>0.05).
2) health status of participant
Subgroup analysis is carried out according to the health status of participant, is divided into cancer, chronic back pain, high-risk occupation and healthy person.
Result of study shows that Yoga has cancer patient the potential benefit for reducing TNF-α expression, and the heterogeneity between group is statistically significant
(3 experiments, 130 participants；SMD：0.68,95% confidence interval CI：0.33-1.04, P-value<0.05；I2=
0.0%, p=0.683)；Yoga has chronic back pain patient the potential benefit for reducing TNF-α expression, the heterogeneity between group to have system
Meter learns meaning (1 experiment, 43 people；SMD：1.17 95%CI：0.52-1.82, P-value<0.05)；Yoga is to high-risk occupation
Participant has the potential benefit for reducing TNF-α expression, the heterogeneity between group statistically significant (1 experiment, 37 people；SMD：
0.82,95%CI：0.15-1.49, P-value<0.05).And in healthy person without find significant effect (1 experiment, 30
Name participant；SMD：- 0.08,95%CI：- 0.79-0.64, P-value>0.05).
3) treatment of participant
Subgroup analysis is carried out according to the treatment of participant.Compared to other treatment situation, Yoga is to carrying out phase
The participant for closing treatment can be substantially reduced TNF-α expression, the heterogeneity between group statistically significant (2 experiments, 84 ginsengs
With person；SMD：0.78,95%CI：0.33-1.22, P-value<0.05；I2=0.0%, p=0.599).
4) the regional or national situation of participant
Subgroup analysis is carried out according to participant location or country.Result of study shows the development pair of country
The expression of TNF-α does not influence, and the heterogeneity between group is statistically significant.
5) intervene the duration
Subgroup analysis is carried out according to the time of intervention.Result of study shows that intervention time is more than that can become apparent from reduction in 8 weeks
TNF-α is expressed, the heterogeneity between group statistically significant (3 experiments, 126 participants；SMD：0.82,95%CI：0.43-
1.20 P-value<0.05；I2=7.3%, p=0.340).
6) practice periods and frequency
Subgroup analysis is carried out according to the time of practice and frequency.Result of study show for a long time practice (>=180 minutes/
Week) reduction TNF-α expression can be become apparent from, heterogeneity statistically significant (3 experiments, 152 participants between group；SMD：
0.73,95%CI：0.40-1.06, P-value<0.05；I2=0.0%, p=0.687).In addition, every time motion continuation when
Between be more than can become apparent within 60 minutes reduce TNF-α expression (in 1 experiment, 69 participants；SMD：0.83,95%CI：0.34-
1.33 P-value<0.05) duration, moved every time is similar (=60min), the heterogeneity statistically significant (4 between group
Item time experiment, 156 participant SMD：0.62,95%CI：0.12-1.11, P-value<0.05；I2=56.4%, p=
0.076).However, not had obvious effects in the exercise routine of short time.About the frequency of movement, result of study shows more
High-frequency practice, which can become apparent from, reduces TNF-α expression, and the heterogeneity between group is statistically significant, tempers 3 frequencies weekly
(3 experiments, 126 participants；SMD：0.82,95%CI：0.43-1.20, P-value<0.05；I2=7.3%, p=
0.340), (2 are tested frequency of the practice more than 3 times, 84 participants weekly；SMD：0.78,95%CI：0.33-1.22, P-
value<0.05；I2=0.0%, p=0.599).
It is specific that the results are shown in Table 1：
The result of 1 aggregate analysis of table and subgroup analysis
(4) sensitivity analysis shows that the reliability of each research is all fine, as shown in Figure 1, the publication bias of every research
Possibility very little (P=0.550), shows the confidence level of result, as shown in Figure 2.
It can prove that TNF-α situation of change has clinic as assessment Yoga function and effect according to the above analysis of statistical results
Meaning, TNF-α can be as the biomarkers of evaluation Yoga curative effect.Meanwhile we also obtain being benefited for yoga exercise effect
Crowd has cancer patient, chronic back pain patient and high-risk duty dealer.The time of effective yoga exercise and frequency are：Total time is more than
Equal to 8 weeks, exercise time was more than or equal to 180min weekly, and total exercise frequency is more than or equal to 3 times weekly, and each exercise time is big
In equal to 60min.
Although above the present invention is described in detail with a general description of the specific embodiments,
On the basis of the present invention, it can be made some modifications or improvements, this will be apparent to those skilled in the art.Cause
This, these modifications or improvements, belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.
Claims (8)
1. it is evidential evaluation TNF-α as assess Yoga curative effect biomarker method, which is characterized in that including with
Lower step：
(1) research evidence search strategy is formulated：
Clinical Evidence database is systematically retrieved comprehensively, including PubMed, Cochrane Library, Embase and
Web ofScience databases；The bibliography of research is included in retrieval；
(2) it formulates and is included in and exclusion criteria：
Be included in research and design, study population, research type, publication language, sample size, intervention time these aspect limit
System；
(3) research data extracts：
Form is extracted using normal data, it is ensured that research data is carried by the information that two researchers extract from each experiment respectively
It takes with uniformity with the result of quality evaluation, the 3rd researcher is transferred to determine when at sixes and sevens；
(4) experimental study quality evaluation：
Randomized controlled trial carries out document quality assessment using Cochrane offset risk assessment tools, and cohort study uses
Newcastle-Ottawa scale scales carry out document quality assessment, include the comparativity and knot of patient's selection, research group
The assessment of fruit；
(5) standardized data is handled：
Using standardization statistics strategy, merge measurement index, it is for statistical analysis to extraction data using 12.0 softwares of Stata；
Standardization Strategies include mainly：Mate analyses, heterogeneous analysis, subgroup analysis, sensitivity analysis, publication bias assessment；
(6) efficiency and value of the assessment TNF-α as Yoga curative effect biomarker.
2. the method for biomarker of the evidential evaluation TNF-α as described in claim 1 as assessment Yoga curative effect,
It is characterized in that, the retrieval type of the database in the step (2) is " TNF-α " and " yoga " or " yogic " or " Asana "
or“Pranayama”or“Dhyana”or“Dharana”or“Meditation”or“Tumor Necrosis Factor
alpha”or“Cachectin-Tumor Necrosis Factor”or“Cachectin Tumor Necrosis Factor”
or“TNFalpha”or“TNF-alpha”or“Tumor Necrosis Factor”or“Tumor Necrosis Factor
Ligand Superfamily Member 2”or“Cachectin or TNF Superfamily,Member 2”。
3. the method for biomarker of the evidential evaluation TNF-α as described in claim 1 as assessment Yoga curative effect,
It is characterized in that, step (5) Central Asia group analysis includes intervening type, the health status of participant, the treatment feelings of participant
Duration, yoga exercises time and frequency are intervened in condition, the regional or national situation of participant, Yoga.
4. side of the evidential evaluation TNF-α as the biomarker for assessing Yoga curative effect as described in claim 1-3
Application of the method in evaluating yoga exercise effect.
5. application as claimed in claim 4, which is characterized in that yoga exercise crowd with obvious effects includes that cancer is suffered from
Person, chronic back pain patient and high-risk duty dealer.
6. application as claimed in claim 5, which is characterized in that the crowd of the yoga exercise best results is being treated
Cancer patient.
7. application as claimed in claim 6, which is characterized in that the cancer patient includes that patient with breast cancer and straight colon cancer are suffered from
Person.
8. application as claimed in claim 4, which is characterized in that the time of effective yoga exercise and frequency are：Total time
More than or equal to 8 weeks, exercise time was more than or equal to 180min weekly, and total exercise frequency is more than or equal to 3 times weekly, when taking exercise every time
Between be more than or equal to 60min.
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Application publication date: 20180720 |