CN105205352A - Clinical evaluation method for primary liver cancer patient - Google Patents
Clinical evaluation method for primary liver cancer patient Download PDFInfo
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- CN105205352A CN105205352A CN201510513001.0A CN201510513001A CN105205352A CN 105205352 A CN105205352 A CN 105205352A CN 201510513001 A CN201510513001 A CN 201510513001A CN 105205352 A CN105205352 A CN 105205352A
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Abstract
The invention relates to a clinical evaluation method for a primary liver cancer patient. The method evaluates a clinical curative effect of primary liver cancer by a primary liver cancer traditional Chinese medicine curative effect patient self-reporting scale filled in by the patient in combination with the judgment of a doctor. The clinical evaluation method has the advantages that the primary liver cancer traditional Chinese medicine curative effect patient self-reporting scale used by the method provided by the invention has good reliability and validity, good practicability and applicability, and can be used for evaluating common symptoms of a liver cancer patient; and the scale introduces traditional Chinese medicine syndrome factors into the scale for evaluation in combination with a patient self-reporting concept, so that the measurement of own feeling of the primary patient is achieved, and the doctor can help judge the severity of the disease from the perspective of the patient, so as to well formulate the next treatment plan.
Description
[technical field]
The present invention relates to patient clinical therapeutic evaluation technical field, specifically, is a kind of clinical assessment method of Patients with Primary.
[background technology]
Primary carcinoma of liver (following abbreviation PLC) is one of modal malignant tumour in the whole world.China's liver cancer year number of the infected about 350,000, about have 320,000 people to die from this disease every year, the incidence of disease and case fatality rate all account for the second in tumour
[3].The male sex is multiple, and the ratio of men and women is 6:1, China onset of liver cancer rate male sex 35.2/10 ten thousand, and women is 13.3/10 ten thousand, and mortality ratio remains high, and it is over half that its number of the infected occupies the whole world
[4].More than 80% patient assessment time most cancer middle and advanced stage, Resection Rate is low, can excision person less than 20%, in postoperative 2 years of radical resection, recurrence rate reaches 62% ~ 82%, and prognosis is poor.
PLC has a strong impact on health and the life of Chinese.Along with medical science and technology is constantly brought forth new ideas, the method being used for the treatment of PLC at present has: the surgical interventions such as surgical resection, HAL (HAL), transcatheter hepatic arterial chemoembolization (HACE), freezing partly (argon helium knife) and transcatheter hepatic artery embolization chemotherapy (TACE), the non-operative treatment such as ethanol injection (PEI) in rind gall.Although the treatment technology of PLC is improved significantly, this extends the life span of patient to a certain extent, advanced liver cancer, is difficult to cure, and has large progress to the prolongation of life span is also difficult.Treatment is main with anti symptom treatment, and it is main for reducing misery.In order to prevent and resist tumor focus height recurrence with easily shift, patient usually undergos surgery, radiotherapy, chemotherapy, ablation, interventional therapy, seeds implanted treat.Patient not only will bear from (the puzzlement of multiple symptom of autologous tissue's organ lesion, as huge tumor compressing Glisson's capsule causes hepatalgia) and the misery brought of the various bad reactions of diagnosis and treatment, also to bear from many-sided pressure such as psychological, social simultaneously.
Previously under biomedical model instructs, clinical efficacy focuses on evaluates anatomy index, pathological hallmarks and biochemical indicator, comprises major fate's index and Minor consequence index.
1, major fate's index (PrimaryOutcome) is also known as endpoint (EndPoint), namely maximum to patient effect, the most directly, patient is concerned about most, want the clinical events avoided most, comprises disease end (as dead, disabled, afunction) and some important clinical events (as fractured)
[12].Endpoint often can represent by rate, as case fatality rate, cure rate, remission rate, recurrence rate, subsidiary reaction rate and survival rate etc.
[13], can reflect the real effect of intervening, bias is less, but usually needs the experimental study of large sample, long term follow-up to measure, and is subject to the interference of other non-intervention factors.
2, Minor consequence index (SecondaryOutcome) is also known as Substitute Indexes (SurrogateOutcome), under the infeasible prerequisite of the measurement of endpoint, as case fatality rate, its measurement may need to wait for for a long time, and Substitute Indexes now can be adopted to assess the effect of intervening measure
[13].Substitute Indexes is generally easy to measure, and mainly the simple biological indicator of finger, comprises laboratory Physico-chemical tests and sign, as reducing of alpha-fetoprotein or entity tumor volume.It is relevant with clinical endpoint final result to adopt Substitute Indexes that enough evidences must be had to support, and measurable disease outcome, if without strict validity Evaluation, use Substitute Indexes Estimating curative effect easily to produce bias, even cause serious consequence.In recent years, the evaluation of clinical of primary carcinoma of liver also becomes the Main Topics of insider gradually, clinical practice proves, traditional Chinese medicine obviously can reduce its recurrence rate or extend recurrence/transfer time in liver cancer treatment process, improve the allomeric function state of patient, improve its life quality, and extend the life cycle of patient to a certain extent.Traditional Chinese medical science Estimating curative effect then more pays close attention to the change of " patient " subjective symptoms, the i.e. improvement of tcm syndrome, but the evaluation of its treatment curative effect is under suspicion often, and the curative effect therefore how using the Method and kit for of science rationally to illustrate the traditional Chinese medical science needs the problem of solution at present badly.
TCM Therapeutic is different according to research purpose, is divided into pilot study and confirms Journal of Sex Research 2 class.Pilot study is the knowledge according to having obtained, and before a kind of research formally starts, carries out deep discussion to the design implementation process of this research, forms fixing research and form of therapy, final formation clinical research hypothesis.In Clinical Researches of New Drugs process, the I phase II phase is studied and belongs to pilot study type; Confirm that Journal of Sex Research is also referred to as confirmatory study, on the basis of pilot study, the hypothesis formed is carried out to the clinical research of the large sample of system, confirm that the result of pilot study is as each phase of new drug development with it, the III phase IV phase of clinical testing belongs to confirmation Journal of Sex Research, the most common to being randomized controlled trial (RCT).
The deficiency of current TCM Therapeutic: the first, the method for traditional Chinese medical science tradition summary clinical efficacy only stresses improvement and the disappearance of symptom, and the curative effect staying in case report and clinical case is summed up more, and the depth & wideth of Estimating curative effect is inadequate; The second, do not form the evaluation index that syndrome disease levies change, result of study is without comparability; 3rd, use for reference traditional doctor trained in Western medicine evaluation method to the therapeutic evaluation of Syndrome in TCM, result in its science evaluated and reduce; 4th, too pay attention to biological indicator, ignore psychiatric and socioeconomic impact, do not embody the general Quality of Life Scale of traditional Chinese medicine feature, the Quality of Life Scale of disease specific, the one side of neglect patients " people "; 5th, pay little attention to clinical research method, lack rigorous rational design, randomized controlled trial is few, and statistical method is relatively backward.
In sum, set up one and both meet modern scientific research rule and current international practice standard, traditional Chinese medicine self-character can be fully demonstrated again and be the method for estimating curative effect of colleague's recognition and acceptance both at home and abroad, become the significant problem that Development of Chinese Medicine is in the urgent need to address.
[summary of the invention]
The object of the invention is for deficiency of the prior art, a kind of practical impression by patient self is provided to combine with the judgement of doctor, the evaluation of clinical efficacy can be made more true, comprehensive, reliable, be more conducive to the clinical assessment method that doctor adjusts the Patients with Primary of therapeutic scheme in time.
For achieving the above object, the technical scheme that the present invention takes is: a kind of clinical assessment method of Patients with Primary, the method fills in primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient from report scale and in conjunction with doctor's judgement by patient, and assessment primary carcinoma of liver clinical efficacy, comprises the following steps:
A. patient is in hospital prerequisite for essential information, and medical personnel auxiliary under fill in primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient strictly according to the facts according to self truth in past two weeks oneself report scale;
B. medical personnel reclaim and arrange the primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient filled in and certainly report scale, and collect data, building database, carries out Data Quality Analysis, and is kept at by analysis result in the essential information of corresponding patient;
C. again fill in primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient when patient is hospitalized for treatment from reporting scale next time, finishing analysis is carried out to scale data, preserve analysis result;
D. the data results in step c and the data results in step b are contrasted, assessment clinical therapeutic efficacy.
Described primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient belongs to primary carcinoma of liver peculiar property scale, the standard that the patient filling in this scale need meet from report scale: the patient being diagnosed as Barcelona II phase and above primary carcinoma of liver by stages; Age is 18 ~ 80 years old; Carrying out anticancer or supportive treatment of suiting the medicine to the illness; There is clinical malaise symptoms; Possess certain word read ability, can understand to put question to and answer and keep to the point; Patient knows the inside story and agrees to filling in of this scale of voluntary participation.
Described primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient comprises elemental from report scale: exercise question, introductory remark, filling explanation and entry number, the object that described introductory remark is filled in for illustration of scale and meaning.
Described primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient is made up of 30 issue entry from report scale, is divided into four dimensions, and described problem is about the physiology in the past two weeks of patient, psychology, society and treatment situation; The wherein satisfaction of 1 ~ 9 be physiological reaction dimension, 10 ~ 19 be sensory symptoms dimension, 20 ~ 24 be physiology functional disturbance relevant dimension, 25 ~ 29 to be social relationships dimension, 30 be patient for treatment, wherein the satisfaction of patient for treatment does not include statistical study in.
The invention has the advantages that:
1, the primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient that the inventive method uses reports that scale is the reliability and validity by the research of a large amount of clinical investigations, statistical study, examination scale certainly, and it is revised, the reliability and validity of scale is again examined to be formed, evaluation of clinical curative effect can be widely used in, reference is provided for doctor understands the topic that patient pays close attention to most, provide foundation for traditional Chinese and western medicine better exchanges, and be next step therapeutic scheme and instruct clinical application to provide fundamental basis.
2, the primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient that the inventive method uses has good reliability and validity from report scale, and practicality and applicability better, can in order to assess the common sympton of liver cancer patient; Tcm syndrome key element is introduced in scale and is evaluated by this scale, in conjunction with patient from reporting concept, be the measurement to primary patient self impression, doctor can be made to help to judge the order of severity of disease from the angle of patient, thus formulate next step treatment plan better.
3, the practical impression of patient self combines with the judgement of doctor by the inventive method, the evaluation of clinical efficacy can be made more true, comprehensive, reliable, be more conducive to doctor and adjust therapeutic scheme in time.
[embodiment]
Below in conjunction with specific embodiment, the inventive method is described in detail.
The inventive method is mainly for the PATIENT POPULATION meeting following standard: the patient being diagnosed as Barcelona II phase and above primary carcinoma of liver by stages; Age is 18 ~ 80 years old; Carrying out anticancer or supportive treatment of suiting the medicine to the illness; There is clinical malaise symptoms; Possess certain word read ability, can understand to put question to and answer and keep to the point; Patient knows the inside story and agrees to filling in of this scale of voluntary participation.
The patient meeting above-mentioned standard in prerequisite of being in hospital for essential information, and medical personnel auxiliary under, read over explanations of filling in a form, fill in primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient strictly according to the facts according to past two weeks self truth interior and certainly report scale.The primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient filled in is reclaimed by medical personnel from report scale and arranges, and collect data, building database, carries out Data Quality Analysis, and is kept at by analysis result in the essential information of corresponding patient.These information contrast being used for receiving the homogeneous data after treating with the later stage, thus pass judgment on result for the treatment of.
Patient after completing starting stage treatment on when being once hospitalized for treatment, again fill in primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient from reporting scale by medical personnel auxiliary, the mode same before taking of scale data carries out finishing analysis, preserves analysis result.The scale data that this time data results chance and patient fill in first contrast, doctor judges in conjunction with oneself subjective research according to data results again, final assessment clinical therapeutic efficacy, this assessment result is taked to treat the important referential data of developing programs further to patient using as doctor.
The primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient that patient fills in this embodiment reports that scale complete scale form is as follows certainly:
Above scale illustrates the most suitable answer of selection by patient according to filling in a form, and beats " √ " in corresponding " ".The scale entry that the inventive method uses is multiple-choice question, survey feedback with reference to quasi scoring system, expert advice and the examination to Patients with Primary in the past and consider formulation standards of grading, entry divides 1 ~ 5 grade of scoring, " from nothing ", " not having " are designated as 0 point, " seldom ", " very light " are designated as 1 point, " sometimes ", " moderate " be designated as 2 points, and " often ", " heavier " are designated as 3 points, and " always ", " very heavy " are designated as 4 points.Positivity entry is oppositely scored, and mark is lower, and entire patient's situation is better.Medical personnel then add up according to above-mentioned standard when collecting scale laggard row data analysis.When carrying out curative effect evaluation, before and after contrast therapy, the TOP SCORES of result filled in by scale, and doctor, can using scoring as Primary Reference data when summing up result for the treatment of.
The above is only the preferred embodiment of the present invention; it should be pointed out that for those skilled in the art, under the prerequisite not departing from the inventive method; can also make some improvement and supplement, these improve and supplement and also should be considered as protection scope of the present invention.
Claims (4)
1. a clinical assessment method for Patients with Primary, is characterized in that, the method fills in primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient from report scale and in conjunction with doctor's judgement by patient, and assessment primary carcinoma of liver clinical efficacy, comprises the following steps:
A. patient is in hospital prerequisite for essential information, and medical personnel auxiliary under fill in primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient strictly according to the facts according to self truth in past two weeks oneself report scale;
B. medical personnel reclaim and arrange the primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient filled in and certainly report scale, and collect data, building database, carries out Data Quality Analysis, and is kept at by analysis result in the essential information of corresponding patient;
C. again fill in primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient when patient is hospitalized for treatment from reporting scale next time, finishing analysis is carried out to scale data, preserve analysis result;
D. the data results in step c and the data results in step b are contrasted, assessment clinical therapeutic efficacy.
2. the clinical assessment method of a kind of Patients with Primary according to claim 1, it is characterized in that, described primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient belongs to primary carcinoma of liver peculiar property scale, the standard that the patient filling in this scale need meet from report scale: the patient being diagnosed as Barcelona II phase and above primary carcinoma of liver by stages; Age is 18 ~ 80 years old; Carrying out anticancer or supportive treatment of suiting the medicine to the illness; There is clinical malaise symptoms; Possess certain word read ability, can understand to put question to and answer and keep to the point; Patient knows the inside story and agrees to filling in of this scale of voluntary participation.
3. the clinical assessment method of a kind of Patients with Primary according to claim 1, it is characterized in that, described primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient comprises elemental from report scale: exercise question, introductory remark, filling explanation and entry number, the object that described introductory remark is filled in for illustration of scale and meaning.
4. the clinical assessment method of a kind of Patients with Primary according to claim 1, it is characterized in that, described primary carcinoma of liver Efficacy of Traditional Chinese Medicine patient is made up of 30 issue entry from report scale, be divided into four dimensions, described problem is about the physiology in the past two weeks of patient, psychology, society and treatment situation; The wherein satisfaction of 1 ~ 9 be physiological reaction dimension, 10 ~ 19 be sensory symptoms dimension, 20 ~ 24 be physiology functional disturbance relevant dimension, 25 ~ 29 to be social relationships dimension, 30 be patient for treatment, wherein the satisfaction of patient for treatment does not include statistical study in.
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| CN201510513001.0A CN105205352A (en) | 2015-08-20 | 2015-08-20 | Clinical evaluation method for primary liver cancer patient |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110706762A (en) * | 2019-08-30 | 2020-01-17 | 昆明医科大学 | AIDS discrimination multidirectional parallel measurement method based on medical institution |
| CN111584095A (en) * | 2020-04-21 | 2020-08-25 | 中国人民解放军海军军医大学 | Auxiliary support system for participating in treatment decision of primary liver cancer patient |
| CN113707272A (en) * | 2021-08-02 | 2021-11-26 | 复旦大学附属中山医院 | Evaluation model for suitable population for interventional therapy of radial artery access liver cancer and construction method |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110706762A (en) * | 2019-08-30 | 2020-01-17 | 昆明医科大学 | AIDS discrimination multidirectional parallel measurement method based on medical institution |
| CN111584095A (en) * | 2020-04-21 | 2020-08-25 | 中国人民解放军海军军医大学 | Auxiliary support system for participating in treatment decision of primary liver cancer patient |
| CN113707272A (en) * | 2021-08-02 | 2021-11-26 | 复旦大学附属中山医院 | Evaluation model for suitable population for interventional therapy of radial artery access liver cancer and construction method |
| CN113707272B (en) * | 2021-08-02 | 2024-02-02 | 复旦大学附属中山医院 | Model for evaluating suitable crowd for interventional therapy of radial artery access liver cancer and construction method |
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Application publication date: 20151230 |