CN102552473B - New application of Keke preparation - Google Patents
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Abstract
The invention discloses new application of a Keke preparation for treating cough due to pathogenic wind-heat in preparation of medicines for treating cold cough and cold and phlegm wet cough. A Chinese medicinal composition consists of 360 parts of ephedra, 360 parts of poppy capsule, 360 parts of liquorice, 360 parts of bitter almond, 112.5 parts of balloon flower, 112.5 parts of radish seed and 112.5 parts of gypsum. The Chinese medicinal composition can be prepared into oral formulations, including tablets, capsules, granules, an oral solution preparation, powder or pills. The invention overcomes the technical bias in the traditional pharmacy and medication, opens up the new application of the Chinese medicinal composition including Keke capsules and Keke tablets in the preparation of medicines for treating cold cough and cold and phlegm wet cough, and has good social and economic benefits.
Description
Technical field
The present invention relates to field of traditional Chinese medicine pharmacy, especially a kind of new purposes of the Chinese medicine composition that is used for the treatment of cough due to pathogenic wind-heat.
Background technology
Traditional Chinese Medicine is thought lung being a delicate viscus, is subject to exopathogen invasion and attack, if be subject to the invasion and attack of wind, cold, summer-heat, wet, dry, fiery six climate exopathogens, causes impairment of dispersing and descending function of the lung, and abnormal rising of lung-QI, causes cough.Cough has dividing of wind and cold and wind heat by pathogenic factor character.Cough due to wind and cold, how by the heresy invasion and attack of wind and cold, interior strongly fragrant lung qi, lung qi obstruction and causing, cardinal symptom is low voice speaking for cough, and the thin color of coughing up phlegm is white, aversion to cold, or have heating, and lossless, itching throat, nasal obstruction watery nasal discharge, or with headache general pain, arthralgia, thin white fur of tongue, floating and tense pulse.Wind and cold holds concurrently that productive cough due to phlegm-damp refers to that cough due to wind and cold has that expectorant is sticky concurrently, lack of appetite, loose stool, tongue greasy, rolling pulse or moisten cunning in vain.Cough due to pathogenic wind-heat, how because the heresy of wind heat is violated lung, impairment of purifying and descending function of the lung and causing, cardinal symptom is cough, coughs sound slightly high, yellowish thick sputum, coughs up phlegm not well, with fever and aversion to wind, headache sweating, dry throat and mouth, nose stream yellow thick nasal discharge, red tongue with thin and yellow fur, floating and rapid pulse etc.
By Herba Ephedrae, Pericarpium Papaveris, Radix Glycyrrhizae and Semen Armeniacae Amarum each 360 parts, the prescription of the each 112.5 parts of compositions of Radix Platycodonis, Semen Raphani and Gypsum Fibrosum derives from the recipe MAXINGSHIGAN TANG of Zhang Zhongjing " Treatise on Febrile and Miscellaneous Disease " treatment dyspnea and cough due to lung-heat.Descendant, on the basis of Maxing Ganshi Tang, according to " make mutually with material, abnormal smells from the patient is in harmony mutually ", changes its original intention, deposits it and becomes second nature, and adds Radix Platycodonis, Pericarpium Papaveris, Semen Raphani three taste medical materials, thereby has widened the scope of application.All medicines share plays that heat clearing away is eliminated the phlegm, effect of relieving cough and asthma altogether, and its indication is cough due to pathogenic wind-heat.
Above-mentioned prescription is developed into Chinese patent medicine KEKE JIAONANG by Guizhou Yibai Pharmaceutical Co., Ltd, records
in" Drug Standard of Ministry of Public Health of the Peoples Republic of China Traditional Chinese medicine historical preparation " (the 17th), and be put into nonprescription drugs.At present, domestic enterprise has gone out the Chinese patent medicine of the multiple dosage form such as cough-relieving tablets, cough-relieving syrup by changing formulation development according to this prescription.The cough-relieving tablets that for example Zhongshan Zhongzhi Pharmaceutical Group Co., Ltd produces according to above-mentioned prescription, obtains good effect.The present invention is referred to as cough stopping formulation the preparation of the various dosage forms of being made up of above-mentioned formula.
Record according to " Pharmacopoeia of People's Republic of China clinical application notice ", KEKE JIAONANG is clinical in the cough due to phlegm-heat accumulated in the lung or phlegm-damp heat-transformation, the disease that dyspnea with rapid respiration is breathed hard, and wind-cold affecting lung person should not use.This is also the generally understanding of current the world of medicine to KEKE JIAONANG (sheet) indication.Domestic have a document announcement, KEKE JIAONANG is to respiratory system commonly encountered diseases, cough that frequently-occurring disease causes, cough up phlegm, the symptom such as asthma, uncomfortable in chest, chest pain, itching throat has obvious curative effects, especially to coughing, expectorant, to breathe heavily three primary symptom effects remarkable, the above-mentioned symptom total effective rate that acute/chronic bronchitis, asthma etc. are caused reaches 76.2%.Its indication all points to cough due to pathogenic wind-heat's symptom, and the effect that can be used for the treatment of cough due to wind and cold to KEKE JIAONANG or cough-relieving tablets etc. is from having no report to some extent.
Summary of the invention
For expanding the application of Chinese medicine, research worker of the present invention is passed through long-term research and is groped, prove according to the Chinese medicine composition of the related formula preparation of KEKE JIAONANG (sheet) (being called for short " Chinese medicine composition " below), also be applicable to treat cough due to wind and cold, and there is good effect & Safety.
Thus, the object of the present invention is to provide the pharmaceutic usage of above-mentioned Chinese medicine composition.Specifically, by said composition for the preparation of the new application of productive cough due to phlegm-damp medicine of holding concurrently for the treatment of cough due to wind and cold's medicine and wind and cold.Each 360 parts by Herba Ephedrae, Pericarpium Papaveris, Radix Glycyrrhizae and Semen Armeniacae Amarum of the prescriptions of described Chinese medicine composition, the each 112.5 parts of compositions of Radix Platycodonis, Semen Raphani and Gypsum Fibrosum.The source of above Chinese crude drug is consistent with China pharmacopeia.
Described Chinese medicine composition can be made into and is applicable to oral dosage form, comprises tablet, capsule, granule, oral liquid, powder or pill.
For cough due to wind and cold, the present invention is by multicenter, random, double blinding, masculine parallel comparison clinical trial, result shows, with after above-mentioned Chinese medicine composition (tablet) treatment, curative effect index is coughed in the daytime before symptom score, the score of nocturnal cough's symptom, cough degree (VAS) are all treated and is had clear improvement; And can obviously improve clinical symptoms, the signs such as amount of expectoration, expectorant matter, heating, itching throat, aversion to cold, nasal obstruction watery nasal discharge, there is good clinical efficacy.With the comparison of Tongxuanlifei sheet matched group, difference not statistically significant.
With the comparison of masculine parallel comparison group, the improvement rate of coughing in the daytime after test group treatment is 89.0%, and the improvement rate of coughing in the daytime after treatment of control group is 93.8%, difference not statistically significant.Nocturnal cough's improvement rate 87.0% after test group treatment, nocturnal cough's improvement rate 89.3% after treatment of control group, difference not statistically significant.
Cough degree score improvement degree comparison after two groups of treatments, after test group treatment, the score of cough degree changes
Kind rate 86.4%, cough degree score improvement rate 93.8% after treatment of control group, difference not statistically significant.
The test group disappearance rate 35.8% of coughing in the daytime, the matched group disappearance rate 41.1% of coughing in the daytime; Test group nocturnal cough's disappearance rate 49.3%, matched group nocturnal cough disappearance rate 46.8%; Test group cough degree score disappearance rate 27.2%, matched group cough degree score disappearance rate 24.1%.Therapeutic effect difference not statistically significant.
Tcm syndrome curative effect treatment group cure rate is 21.4%, and obvious effective rate is 30.7%, and effective percentage is 41.7%, and cure rate and obvious effective rate are 52.1%, and total effective rate is 93.9%; Matched group cure rate is 18.8%, and obvious effective rate is 28.6%, and effective percentage is 46.4%, and cure rate and obvious effective rate are 47.4%, and total effective rate is 93.7%.Two groups of comparisons, no significant difference.
After two groups of treatments, the symptom of coughing up phlegm all has clear improvement, and test group amount of expectoration improvement rate is 74.5%, expectorant matter improvement rate is 73.6%, and matched group is 71.4%, expectorant matter improvement rate is 71.4%.Two groups are improved degree comparison, difference not statistically significant.
In therapeutic process, occur that part Blood of Patients, urine, feces routine, renal function, Electrocardiography result exceed the range of normal value that each center provides, according to the analysis of researcher and judgement, all do not think relevant with trial drug, meet drug safety requirement.
Above-mentioned clinical effectiveness proves, above-mentioned Chinese medicine composition is used for the treatment of cough, and the cough that for example acute tracheobronchitis, chronic bronchitis cause belongs to cough due to wind and cold, the wind and cold productive cough due to phlegm-damp of holding concurrently and has good clinical therapeutic efficacy and drug safety.
The present invention has overcome the technology prejudice of traditional pharmacy medication, has opened up the new purposes that above-mentioned Chinese medicine composition comprises that KEKE JIAONANG, cough-relieving tablets are held concurrently aspect productive cough due to phlegm-damp medicine at preparation treatment cough due to wind and cold and wind and cold, has good society and economic benefit.
The specific embodiment
The present embodiment 1 is by 480 routine clinical case multicenters, random, double blinding, masculine parallel comparison test, and according to optimal efficiency check clinical trial design, objective evaluation cough-relieving tablets treatment cough, belongs to the hold concurrently clinical efficacy of productive cough due to phlegm-damp of cough due to wind and cold, wind and cold.And by the observation of blood, urine, feces routine, darling renal function and adverse events, the safety of objective evaluation cough-relieving tablets.
One, clinical trial method: adopt optimal efficiency check, multicenter, random, double blinding, masculine parallel comparison clinical trial method.
Two, Clinical observation index: main effects index comprises the score of cough symptom (night in the daytime), cough degree (VAS).Secondary efficacy index comprises cough remission time, cough recurrent number; The simultaneous phenomenons such as expectoration; Tcm syndrome curative effect.
Three, test crowd and experimenter enter group situation:
Qualified experimenter's inclusion criteria, cough due to wind and cold's symptom is low voice speaking to cough, and the thin color of coughing up phlegm is white, aversion to cold, or have heating, and lossless, itching throat, nasal obstruction watery nasal discharge, or with headache general pain, arthralgia, thin white fur of tongue, floating and tense pulse is standard.The wind and cold productive cough due to phlegm-damp of holding concurrently, take cough due to wind and cold have that expectorant is sticky concurrently, lack of appetite, loose stool, tongue greasy, rolling pulse or moisten sliding as standard in vain.18 years old to 65 years old age.
Screen qualified experimenter with the pro rate of 3:1 to test group and matched group, observation patient is outpatient, strictly controls variable factor.Clinical trial is carried out in 6 hospitals simultaneously.Enter to organize altogether case 480 examples, wherein test group 360 examples, matched group 120 examples; Run counter to inclusion criteria case 8 examples, wherein test group 6 examples, matched group 2 examples; Come off or drop by the wayside case 23 examples, wherein test group 13 examples, matched group 10 examples; In qualified case, complete altogether and observe 449 examples, wherein test group 341 examples, matched group 108 examples.
Four, dosage regimen:
Test group: cough-relieving tablets, oral, 4 of 2+placebo (magneta colour), 2 times on the one.
Matched group: Tongxuanlifei sheet (Film coated tablets), oral, 2 of 4+placebo (blueness), 2 times on the one.7 days courses for the treatment of.
Wherein, test group cough-relieving tablets is produced and is provided by Zhong Shanzhongzhi Pharmaceutical group.It is write out a prescription by the each 360g of Herba Ephedrae, Pericarpium Papaveris, Radix Glycyrrhizae and Semen Armeniacae Amarum; The each 112.5g composition of Radix Platycodonis, Semen Raphani and Gypsum Fibrosum.Matched group Tongxuanlifei sheet is provided by Guangdong Boluo Pioneer Medicinal Group Co., Ltd., and this medicine is made up of Radix Platycodonis, Pericarpium Citri Reticulatae, Radix Peucedani, Herba Ephedrae, Semen Armeniacae Amarum etc.The function cold expelling that induces sweat, lung qi dispersing antitussive, for diseases such as cough due to wind and cold.For clinical generally acknowledged treatment cough due to wind and cold, the cough due to wind and cold nonprescription drugs of phlegm-damp of holding concurrently.
Five, drug combination requires:
During clinical trial, must not use anti-microbial type medicine; Must not use to cough is had therapeutical effect or cures mainly similar Chinese medicine decoction, Chinese patent medicine and Western medicine etc. to trial drug function; If in experimenter's therapeutic process, merge antibacterial the infected, to routine blood test WBC >=Upper Limit of Normal Value 20%, the experimenter more than 37.5 ℃ patient that generates heat, visual clinical setting takes the circumstances into consideration to add with antibiotic therapy, use oral or quiet of levofloxacin, as selected secondary or third-generation cephalosporin to levofloxacin allergy sufferers.If experimenter meets qualified subject enrollment standard, need in clinical trial, continue medication person and merge Other diseases, or treat and need because of the state of an illness, or treatment unsatisfactory curative effect, really need add with other medicines or treatment means person, answer title (or treatment means), dosage, medication number of times, administration time of medicine that itemized record are used etc.
Six, clinical trial step:
Main clinic symptoms, picture of the tongue, pulse condition, sign, auscultation of lung all need treatment before, treatment after the 3rd day, treatment after the 7th day each observed and recorded once.
Heating (oxter is more than 37 ℃), 1 body temperature of early, middle and late each mensuration every day, in measuring using 3 times, soprano is as body temperature on the same day.
Before the treatment of chest X line, check.
The inspection of routine blood test, routine urinalysis, stool routine examination, electrocardiogram, liver function (ALT), renal function (BUN, Cr) must be before treatment, the 7th day each detection once after treatment.
Seven, evaluation criterion:
(1) main effects index therapeutic evaluation:
The score of cough symptom, cough degree are carried out comparing before and after two groups of treatments, and add up improvement degree and the disappearance rate of symptom.
1. cough symptom point system is, cough symptom integral is divided into integration and night integration two parts in the daytime, and every part is all divided into 0-3 points 4 grades (in table 1) according to different light and heavy degrees.This score-system has reflected affected situation of cough frequency, intensity and quality of life.
table 1
| Score | In the daytime the symptom of coughing score | The score of nocturnal cough's symptom |
| 0 point | Without cough | Without cough |
| 1 point | Occasionally there is of short duration cough | While falling asleep, of short duration cough or idol have nocturnal cough |
| 2 points | Frequent cough, slight effect daily routines | Because of cough slight effect nighttime sleep |
| 3 points | Frequent cough, has a strong impact on daily routines | Because cough has a strong impact on nighttime sleep |
2. cough degree point system:
Inspection method: visual analogue scale (visual analogue scale, VAS) adopt linear gauge point-score, for the subjective cough of experimenter grading, prepare the Vertical surveyors' staff of 100mm, 0 dial compass is decided to be minimum without cough, 100mm dial compass is decided to be maximum and intolerable cough, allows experimenter think and can reflect that the horizontal part of cough does a labelling at him, scores as cough degree using mark reading.Numerical value is larger, represents that cough degree is heavier.
Scoring criteria.
Nothing (0 point): score 0 for nothing cough.
Slightly (1 point): score 1～3 for slight cough.
Moderate (2 points): score 4～6 for moderate cough.
Severe (3 points): score 7～10 for severe cough.
(2) secondary efficacy index therapeutic evaluation.
1. cough remission time:
Patient reaches in the daytime and≤1 point of nocturnal cough's symptom score or 1 grade that declines, and continues 48 hours persons, is called " alleviation ".Record patient in the observation period and reach the time that cough is alleviated.Be in the daytime and≤1 point of nocturnal cough's symptom score (note: what the score of cough symptom was assessed is patient's status of cough of first 24 hours) if the cough symptom of patient's diary card is scored continuous two days, " cough remission time " is designated as one day after.For example, on the 5th day and the 6th day patient's diary card in the daytime and the score of nocturnal cough's symptom all≤1 point, the remission time of coughing is designated as " 6 days ".
2. cough recurrent number:
Patient's cough reaches after above " alleviation " standard, occurs in the daytime again or >=2 points of nocturnal cough's symptom score or 1 grade that rises, and gets rid of respiratory tract infection person occurs again, is called " recurrence ".Record patient in the observation period and occur number of times and the order of severity that cough is recurred.
3. the simultaneous phenomenon such as expectoration.
1) amount of expectoration.
Nothing (0 point): without coughing up phlegm.
Slightly (1 point): expectoration 10-50ml round the clock.
Moderate (2 points): expectoration 51-100ml round the clock.
Severe (3 points): expectoration > 100ml round the clock.
2) expectorant matter.
Nothing (0 point): without coughing up phlegm.
Slightly (1 point): the thin color of expectorant matter is white.
Moderate (2 points): in expectorant matter or matter sticky, more easily bring up.
Severe (3 points): thick sputum, brings up effort.
4. heating: without 0 point of heating meter; 1 point of 37～38 ℃ of meter of axillaty temperature.
5. itching throat: without 0 point of meter, have 1 point of meter.
6. aversion to cold: without 0 point of meter, have 1 point of meter.
7. nasal obstruction watery nasal discharge: without 0 point of meter, have 1 point of meter.
8. a general pain: without 0 point of meter, have 1 point of meter.
9 lack of appetite: without 0 point of meter, have 1 point of meter.
10 loose stools: without 0 point of meter, have 1 point of meter.
11. tcm syndrome criterions of therapeutical effect.
1) recovery from illness: tcm syndrome clinical symptoms all disappears, after treatment, total score value is 0 point, therapeutic index is 100%.
2) effective: tcm syndrome clinical symptoms is obviously improved, 75%≤therapeutic index < 100%.
3) effective: tcm syndrome clinical symptoms is improved, 30%≤therapeutic index < 75%.
4) invalid: tcm syndrome clinical symptoms is without improvement, therapeutic index < 30%.
Note: tcm syndrome therapeutic index=(the front total score value of tcm syndrome symptom of the rear total score value/treatment of tcm syndrome symptom of the total score value-treatment of tcm syndrome symptom before treatment) × 100%.
Main tcm syndrome scoring value=cough score+cough of symptom degree (amount of expectoration, expectorant matter)+heating+itching throat+aversion to cold+nasal obstruction watery nasal discharge+general pain+lack of appetite+loose stool of scoring+cough up phlegm.
(3) safety evaluatio: laboratory checking index (blood, urine, feces routine, the heart, hepatic and renal function) and clinicing symptom observation (general and local untoward reaction).
1. evaluation criterion.
One-level: safety, without any untoward reaction; Safety indexes checks without abnormal.
Secondary: safer, there is mild adverse effects, do not need to do any processing and can continue administration; Safety indexes checks without abnormal.
Three grades: have safety issue, have moderate untoward reaction, or safety indexes has mile abnormality, after processing, can continue administration.
Level Four: because serious adverse reaction is ended test; Or safety indexes inspection is obviously abnormal.
2. the record of adverse events, untoward reaction and method for reporting:
Adverse events (Adverse Event) definition: patient or clinical trial experimenter accept the bad medical events occurring after a kind of medicine, but might not have cause effect relation with treatment.
Serious adverse events (Serious Adverse Event) definition: refer to that " adverse drug reaction report and monitoring management way " refers to occur in the reaction that causes one of following infringement situation because taking medicine: cause death; Carcinogenic, teratogenesis, cause birth defect; Dangerous and can cause the permanent or significant disability of human body to life; Organ dysfunction is produced to permanent damage; Cause being in hospital or hospital stays prolongation.
Adverse events record
The adverse events that duration of test is occurred, its kind, degree, time of occurrence, persistent period, treatment measures, processing process and lapsing to etc. should be recorded in to CRF, and considering complication, on the basis of drug combination, evaluate the dependency of itself and trial drug, and by doctor's itemized record.Should carry out follow up survey to the case because of adverse events, untoward reaction drug withdrawal, its result of itemized record.
Safety detects index (routine blood test, routine urinalysis, stool routine examination, electrocardiogram, liver function, renal function) if appearance is abnormal in treatment, after treatment, between must be in due course, check, record faithfully, and comprehensively analyze with situations such as experimenter's morbidity, treatments, relevant with trial drug to determine whether.
The criterion of adverse events and trial drug relation
Determine whether adverse events and trial drug exist cause effect relation, the standard (Gao Dongchen etc. " ADRs monitoring guide ", Chinese Medicine science and technology publishing house version in 1996) that can work out according to Ministry of Public Health adverse drug reaction supervision center judges.A judgement point Pyatyi: cause effect relation judgement point certainly, probably, possible, suspicious and impossible.
Untoward reaction grading standard:
Light: slight reaction, symptom does not develop, generally without treatment;
In: ADR symptom is obvious, and vitals and tissue have certain damage, easily recovers;
Heavy: vitals damage, disable, teratogenesis, carcinogenic, threat to life, can cause sequela, or cause client need hospitalization, and inpatient need extend hospital stay.
Eight, statistical analysis technique:
This test adopts two groups of comparisons of optimal efficiency check.Each continuous variable carries out test of normality if desired.According to the character of clinical testing data (metering, classification and ranked data), select suitable statistical analysis technique.X2 check or accurate probabilistic method for group data.Measurement data meets normality and homogeneity of variance claimer two sample averages are relatively checked with t; The relatively Wilcoxon rank tests of backlog demand person's two sample averages, relatively match rank test with Wilcoxon before and after self.The Wilcoxon rank test (correction) of two sample comparisons for ranked data.The significance level of statistical test is 0.05.Center effect analysis adopts Cochran-Mantel-Haenszel method.There is lack of uniformity if affect the Clinical symptoms of main effects index between group in baseline, adopt chromatographic analysis organize between curative effect comparison.Independent variable (or covariant), dependent variable are that quantitative variable adopts covariance analysis; Independent variable, dependent variable are that qualitative variable adopts Logistic regression analysis.Main Analysis type comprises that ITT analyzes (intention-to-treat analysis, ITT) and complys with scheme experimenter and analyze (per-protocol subjects analysis, PPA).
Nine, clinical efficacy result:
(1) curative effect index analysis: the score of cough symptom, cough degree
In the daytime minimizing value before and after the symptom of coughing score test, test group mean is that 1.49 ± 0.78(divides); Matched group mean is that 1.50 ± 0.70(divides).Difference comparison between group, difference not statistically significant.And compare before and after treatment, difference has significant.
Minimizing value before and after nocturnal cough's symptom score test, test group mean is that 1.40 ± 0.82(divides); Matched group mean is that 1.35 ± 0.71(divides).Difference comparison between group, difference not statistically significant.And compare before and after treatment, difference has significant.
Minimizing value before and after cough degree (VAS) scoring test, test group mean is 4.19 ± 2.10(cm); Matched group mean is 4.13 ± 2.13(cm).Difference comparison between group, difference not statistically significant.And compare before and after treatment, difference has significant.
In the daytime the improvement degree comparison of coughing after two groups of treatments, difference not statistically significant.In the daytime improvement rate 89.0%(307/345 coughs after test group treatment), the improvement rate of coughing in the daytime after treatment of control group 93.8%(105/112).After two groups of treatments, nocturnal cough improves degree comparison, difference not statistically significant.Nocturnal cough's improvement rate 87.0%(300/345 after test group treatment), nocturnal cough's improvement rate 89.3%(100/112 after treatment of control group).Cough degree score improvement degree comparison after two groups of treatments, difference not statistically significant.Cough degree score improvement rate 86.4%(298/345 after test group treatment), cough degree score improvement rate 93.8%(105/112 after treatment of control group).
In the daytime cough after two groups of treatments, nocturnal cough, the comparison of cough degree score disappearance rate, no significant difference.The test group disappearance rate 35.8% of coughing in the daytime, the matched group disappearance rate 41.1% of coughing in the daytime; Test group nocturnal cough's disappearance rate 49.3%, matched group nocturnal cough disappearance rate 46.8%; Test group cough degree score disappearance rate 27.2%, matched group cough degree score disappearance rate 24.1%.
(2) secondary efficacy index analysis
Tcm syndrome curative effect comparison: tcm syndrome curative effect treatment group cure rate is 21.4%, and obvious effective rate is 30.7%, and effective percentage is 41.7%, and cure rate and obvious effective rate are 52.1%, and total effective rate is 93.9%; Matched group cure rate is 18.8%, and obvious effective rate is 28.6%, and effective percentage is 46.4%, and cure rate and obvious effective rate are 47.4%, and total effective rate is 93.7%.Two groups of comparisons, no significant difference.
Cough remission time, the comparison of cough recurrent number curative effect: cough remission time comparison after two groups of treatments, no significant difference.Test group cough remission time is 3.90 ± 2.08(days), matched group cough remission time is 4.05 ± 1.77(days).Cough recurrent number comparison after two groups of treatments, no significant difference.Test group cough recurrent number is 0.02 ± 0.13(time), matched group cough recurrent number is 0.01 ± 0.10(days).
(amount of expectoration, the expectorant matter) symptom of coughing up phlegm after two groups of treatments all has clear improvement, test group amount of expectoration improvement rate is 74.5%(257/345), expectorant matter improvement rate is 73.6%(254/345), matched group is 71.4%(80/112), expectorant matter improvement rate is 71.4%(80/112).But two groups are improved degree comparison, difference not statistically significant.Test group amount of expectoration disappearance rate is 52.7%, expectorant matter disappearance rate is 53.4%; Heating disappearance rate is 82.1%, itching throat disappearance rate is 67.4%, aversion to cold disappearance rate is 95.2%, nasal obstruction watery nasal discharge disappearance rate is 95.6%, a general pain disappearance rate is 94.8%, lack of appetite disappearance rate is 76.5%, loose stool disappearance rate is 83.8% disappearance rate.Matched group amount of expectoration disappearance rate is 49.5%, expectorant matter disappearance rate is 48.5%; Heating disappearance rate is 77.8%, itching throat disappearance rate is 63.8%, aversion to cold disappearance rate is 94.5%, nasal obstruction watery nasal discharge disappearance rate is 87.5%, a general pain disappearance rate is 76.7%, lack of appetite disappearance rate is 77.8%, loose stool disappearance rate is 83.3% disappearance rate.After a general pain test group treatment, transference cure rate, higher than matched group, is treated rear clinical symptom disappearance rate comparisons, no significant difference for two groups.
Ten, safety results:
(1) lab testing
After two groups of tests, all there are part Blood of Patients, urine, feces routine, renal function, Electrocardiography result to exceed the range of normal value that each center provides, researcher has carried out explanation, analysis and cause effect relation judgement, be mainly: 1, after treatment, exceptional value approaches normal value critical level, researcher is thought normally or extremely without clinical meaning; 2, after treatment before abnormal and treatment relatively, alleviate, less without significant change or amplitude of variation; 3, extremely may be due to due to patient physiological, pathologic condition etc. after treatment.Thereby be not judged as relevant with trial drug.
(2) adverse events/reaction is observed
There is adverse events in test group totally 5 examples, wherein 2 examples are slight hepatic injury (ALT slightly raises), and 1 routine cause effect relation is judged as possibility, 1 example is suspicious.There is suspicious untoward reaction in 2 examples, slight dizzy, the 1 routine mild skin pruritus of 1 example.There is not adverse events in matched group.
11, sum up
Can judge from above-mentioned clinical test results, it is suitable with the effect of positive drugs compared Tongxuanlifei sheet that cough-relieving tablets is used for the treatment of the effect of productive cough due to phlegm-damp of holding concurrently of cough due to wind and cold or wind and cold, no significant difference.Therefore, we think that cough-relieving tablets can be for the preparation for the treatment of cough due to wind and cold and the wind and cold productive cough due to phlegm-damp medicine of holding concurrently, and its curative effect is good, and safety indexes meets medication requirement.
Can know by inference according to Chinese traditional medicine principle, the Chinese medicine composition such as oral formulations KEKE JIAONANG, cough-relieving syrup, decoction that comes from the different dosage form of same prescription also has the hold concurrently effect of productive cough due to phlegm-damp for the treatment of cough due to wind and cold and wind and cold and can be used for equally preparation treatment cough due to wind and cold and the wind and cold purposes of productive cough due to phlegm-damp medicine of holding concurrently.
Claims (3)
1. a purposes for the nasal obstruction watery nasal discharge that Chinese medicine composition causes at preparation alleviation wind and cold productive cough due to phlegm-damp and the medicine of a general pain, each 360 parts by Herba Ephedrae, Pericarpium Papaveris, Radix Glycyrrhizae and Semen Armeniacae Amarum of this Chinese medicine compositions, the each 112.5 parts of compositions of Radix Platycodonis, Semen Raphani and Gypsum Fibrosum.
2. purposes as claimed in claim 1, is characterized in that, the dosage form of described Chinese medicine composition is to be applicable to oral dosage form.
3. purposes as claimed in claim 2, is characterized in that, described applicable oral dosage form is tablet, capsule, granule, oral liquid, powder or pill.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110414604.7A CN102552473B (en) | 2011-11-15 | 2011-12-13 | New application of Keke preparation |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110361319 | 2011-11-15 | ||
| CN201110361319.3 | 2011-11-15 | ||
| CN201110414604.7A CN102552473B (en) | 2011-11-15 | 2011-12-13 | New application of Keke preparation |
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| CN102552473A CN102552473A (en) | 2012-07-11 |
| CN102552473B true CN102552473B (en) | 2014-05-14 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1557431A (en) * | 2004-01-18 | 2004-12-29 | 贵州益佰制药股份有限公司 | Cough resisting prescription and its preparing process |
| CN1733112A (en) * | 2004-12-02 | 2006-02-15 | 贵州益佰制药股份有限公司 | Cough stopping preparation and process for preparing the same |
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2011
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1557431A (en) * | 2004-01-18 | 2004-12-29 | 贵州益佰制药股份有限公司 | Cough resisting prescription and its preparing process |
| CN1733112A (en) * | 2004-12-02 | 2006-02-15 | 贵州益佰制药股份有限公司 | Cough stopping preparation and process for preparing the same |
Non-Patent Citations (2)
| Title |
|---|
| 中智牌克咳片临床应用征文;征文通知;《中国处方药》;20100930(第102期);6 * |
| 征文通知.中智牌克咳片临床应用征文.《中国处方药》.2010,(第102期),6. |
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| CN102552473A (en) | 2012-07-11 |
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