CN104906539A - Traditional Chinese medicine combination for preventing and treating delayed nausea and vomiting caused by chemotherapy and application thereof - Google Patents
Traditional Chinese medicine combination for preventing and treating delayed nausea and vomiting caused by chemotherapy and application thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine combination for preventing and treating delayed nausea and vomiting caused by chemotherapy. The traditional Chinese medicine combination comprises, by weight, 20-25 parts of pinellia rhizoma prepared by ginger, 15-20 parts of cassia twigs, 10-15 parts of agastache rugosus, 10-15 parts of fructus amomi, 8-12 parts of fructus evodiae, 4-10 parts of inula flower, 4-6 parts of pericarpium citri reticulatae, 10-16 parts of ginger juice and 1-3 parts of menthol. The traditional Chinese medicine combination has the advantages of being rigorous in composition, easy to prepare, free of stimulus, low in cost, easy to operate and capable of being accepted by patients easily. The traditional Chinese medicine combination is combined with granisetron and dexamethasone for use, can well treat delayed nausea and vomiting and loss of appetite caused by cis-platinum, also can relieve the side effects, like constipation of patient, caused by the usage of the granisetron and dexamethasone, provides a novel way for delayed nausea and vomiting patients, fills the blank of treating the delayed nausea and vomiting through traditional Chinese medicine at home and abroad, and reaches the international leading level.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, be specifically related to a kind of Chinese medicine composition preventing and treating the delayed nausea and vomiting that chemotherapy causes.
Background technology
Delayed nausea and vomiting refers to the vomiting occurred after 24 hours in chemotherapy.Usually 48-72 hour is betided, after sometimes reaching 120 hours.Accept the patient that middle and high degree causes vomiting risk chemotherapy, delayed nausea and vomiting incidence rate is respectively 19%-33% and 49%-75%.Cisplatin is current clinical practice broad-spectrum anti-cancer drug widely, and have height and cause and tell risk, the patient of 70-80% there will be delayed nausea and vomiting.At present, lack the effective medicine suppressing vomiting clinically, 1st generation 5-HT3 receptor antagonist is about 28% to delayed nausea and vomiting control rate; 2nd generation 5-HT3 receptor antagonist palonosetron and dexamethasone conbined usage are confirmed the incidence rate that can reduce delayed nausea and vomiting by large quantity research, and it is 35%-41% to delayed nausea and vomiting control rate, and the incidence rate for the treatment of related reactions is 44%.5-HT3 receptor antagonist SM curative effect is unsatisfactory, and its untoward reaction such as constipation, abdominal distention allows patient be difficult to adhere to continuous use.The smooth effect to prevention delayed nausea and vomiting of the husky pyrrole of nk 1 receptor antagonist aprepitant, good fortune is by a large amount of clinical research confirmation, dos Santos etc. are by using the patient of nk 1 receptor antagonist to carry out systematic analysis to 8740 examples in 17 clinical trials, result display is 48% containing the scheme of nk 1 receptor antagonist to the control rate of delayed nausea and vomiting, but the also corresponding incidence rate adding severe infections, and itself can cause anorexia, nausea and vomiting after medication, the even side effect such as weakness, fatigue, constipation.The correlational study that antipsychotic drug is used for control lag nausea and vomiting also obtains certain progress, have been reported the antipsychotic drug such as display olanzapine, midazolam, gabapentin, nabilone and all have certain effect to delayed nausea and vomiting, but life-time service can increase the risk of type 2 diabetes mellitus patient hyperglycemia and hyperlipidemia, also likely increase the mortality risk of the related psychotic patients such as senile dementia.Glucocorticoid is clinical commonly used drug, associating 5-HT3 receptor antagonist and NK-1 antagonist can significantly improve the control rate of chemotherapy nausea and vomiting, play potentiation and improve to cause vomiting threshold value, the research of Roscoe etc. further confirms to add the control rate that obviously can increase delayed nausea and vomiting with dexamethasone in conventional preventing or arresting vomiting treatment, but the untoward reaction such as dexamethasone often has middle severe insomnia, dyspepsia, epigastric discomfort, restless, appetite increases, blood glucose raises, body weight increase and acne.
Summary of the invention
This deficiency of medicine of the delayed nausea and vomiting caused for well suppressing chemotherapy now, the invention provides a kind of Chinese medicine composition preventing and treating the delayed nausea and vomiting that chemotherapy causes, said composition take Chinese crude drug as raw material, and the delayed nausea and vomiting caused chemotherapy, inappetence have good prevention effect.
Chinese medicine has long history in China, has the advantage of overall regulation and control and multifactor adjustment, and the traditional Chinese medical science is for the understanding of vomiting, and its key is adverse rising of stomach-QI, stomach-QI being unable to descend normally.Chemotherapy causes taste impaired, and raw in phlegm-damp, adverse rising of stomach-QI, therefore the present invention is with invigorating the spleen and regulating the stomach, and QI invigorating is reduced phlegm, the principle research medicine of stopping nausea and vomiting by lowering the adverse flow of QI.
The present invention is according to large quantifier elimination and experiment, and obtain the Chinese medicine composition that can be good at the delayed nausea and vomiting suppressing chemotherapy to cause, concrete technical scheme is as follows:
A kind of Chinese medicine composition preventing and treating the delayed nausea and vomiting that chemotherapy causes, comprise the crude drug of following weight portion: Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 20-25 part, Ramulus Cinnamomi 15-20 part, Herba Pogostemonis 10-15 part, Fructus Amomi 10-15 part, Fructus Evodiae 8-12 part, Flos Inulae 4-10 part, Pericarpium Citri Reticulatae 4-6 part, Rhizoma Chuanxiong 4-6 part, Rhizoma Zingiberis Recens juice 10-16 part, Mentholum 1-3 part.
In above-mentioned Chinese medicine composition, preferably include the crude drug of following weight portion: Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 22 parts, Ramulus Cinnamomi 16 parts, Herba Pogostemonis 12 parts, Fructus Amomi 12 parts, Fructus Evodiae 10 parts, Flos Inulae 8 parts, Pericarpium Citri Reticulatae 5 parts, Rhizoma Chuanxiong 5 parts, Rhizoma Zingiberis Recens juice 14 parts, Mentholum 1 part.
Further, on the basis of above-mentioned raw materials medicine, Folium Perillae, Endothelium Corneum Gigeriae Galli and Fructus Hippophae three kinds of crude drug can also be added, increase curative effect.The crude drug formula of the medicine formed on this basis is (weight portion): Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 20-25 part, Ramulus Cinnamomi 15-20 part, Herba Pogostemonis 10-15 part, Fructus Amomi 10-15 part, Fructus Evodiae 8-12 part, Flos Inulae 4-10 part, Pericarpium Citri Reticulatae 4-6 part, Rhizoma Chuanxiong 4-6 part, Rhizoma Zingiberis Recens juice 10-16 part, Mentholum 1-3 part, Folium Perillae 8-10 part, Endothelium Corneum Gigeriae Galli 5-8 part, Fructus Hippophae 2-4 part.Preferably, crude drug formula is (weight portion): Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 22 parts, Ramulus Cinnamomi 16 parts, Herba Pogostemonis 12 parts, Fructus Amomi 12 parts, Fructus Evodiae 10 parts, Flos Inulae 8 parts, Pericarpium Citri Reticulatae 5 parts, Rhizoma Chuanxiong 5 parts, Rhizoma Zingiberis Recens juice 14 parts, Mentholum 1 part
,folium Perillae 9 parts, Endothelium Corneum Gigeriae Galli 6 parts, Fructus Hippophae 3 parts.
In Chinese medicine composition of the present invention, each crude drug coordinated, plays invigorating the spleen and regulating the stomach, stopping nausea and vomiting by lowering the adverse flow of QI, eliminating stagnation leads to stagnant effect, have good prevention effect to the nausea and vomiting that chemotherapy causes.Each crude drug effect is as follows:
The Rhizoma Pinelliae, has dehumidifying and reduces phlegm, effect of regulating the stomach and sending down the adverse rising QI to arrest nausea, and for abundant expectoration cough with asthma, phlegm retention vertigo and palpitation, dizziness due to wind-phlegm, syncope due to accumulation of phlegm is had a headache, and vomiting regurgitation, breast gastral cavity painful abdominal mass is vexed.
Ramulus Cinnamomi, has diaphoresis expelling pathogenic factors from muscles, promoting the flow of QI-blood by warming the meridian, supporing yang activating QI, effect of the flat gas that spins, for anemofrigid cold, and coldness and pain in the epigastrium, cold in blood amenorrhea, arthralgia.
Herba Pogostemonis, has removing dampness and is amusing, ward off dirty and in, expelling summer-heat, the effect delivered, for dampness taste, distension and fullness in the abdomen, hygropyrexia from the beginning of, vomit, have loose bowels, heat-damp in summer, fever with chills, fever with aversion to cold, chest distress etc.
Fructus Amomi, fragrant odour, is apt to into taste, has effect that warming the spleen and kidney, activating QI to stop vomiting, increasing appetite, appetizing, change are stagnant, help digestion, and effectively can treat the diseases such as stomachache distension, increased borborygmus and diarrhea, indigestion, vomiting clear water, thick fur be greasy.
Fructus Evodiae, has dispersing cold for relieving pain, stopping nausea and vomiting by lowering the adverse flow of QI, effect of supporing yang antidiarrheal, and for headache due to JUE YIN disorder, colic of cold type is suffered from abdominal pain, the disturbance of lower legs due to pathogenic cold and dampness, abdominal pain during menstruation, abdominal distention, vomiting acid regurgitation, Diarrhoea.
Flos Inulae, has stomach function regulating sending down the abnormal ascending QI, expectorant, row water, effect of preventing or arresting vomiting, and for cough due to wind and cold, phlegm retention stores knot, and chest and diaphragm painful abdominal mass is vexed, dyspnea and cough with excessive sputum, vomiting eructation, epigastric oppression and rigidity.
Pericarpium Citri Reticulatae, has regulating qi-flowing for strengthening spleen, and effect of drying dampness to eliminate phlegm, for fullness in the epigastrium and chest. lack of appetite and vomiting, cough with copious phlegm.
Rhizoma Chuanxiong, has blood-activating and qi-promoting, effect of wind-expelling pain-stopping, and for menoxenia, amenorrhea dysmenorrhea ， mass in the abdomen is suffered from abdominal pain, the twinge of the breast side of body, tumbling and swelling, headache.
Rhizoma Zingiberis Recens, has the cold expelling that induces sweat, warming middle-JIAO to arrest vomiting, effect of preventing phlegm from forming and stopping coughing, and for anemofrigid cold, gastrofrigid vomiting, cold-phlegm is coughed.
Mentholum
,for aromatic drug, remedium corrigens and carminative, produce refrigerant sense to alleviate discomfort and pain for skin or mucosa.
Folium Perillae, has the cold expelling that induces sweat, effect of relieving QI stagnancy in the stomach, and for anemofrigid cold, cough vomiting and nausea, vomiting during pregnancy, fish Eriocheir sinensis is poisoning.
Endothelium Corneum Gigeriae Galli, has invigorating the stomach and promoting digestion, and effect of arresting seminal emission, does not disappear for food stagnation, vomiting dysentery, infantile malnutrition, the enuresis, seminal emission.
Fructus Hippophae, has eliminating phlegm and stopping cough, relieving dyspepsia, effect of promoting blood circulation to remove blood stasis, and for cough with copious phlegm, dyspepsia, abdominal pain due to retention of food, blood stasis amenorrhea, falls and flutter congestive edema.
Chinese medicine composition of the present invention is external used medicine.Because oral Chinese medicine mouthfeel is very not good, considers that patient can not tolerate oral Chinese medicine treatment when there is digestive tract reaction, therefore have studied external used medicine of the present invention, preferably, make unguentum.
The preparation method of Traditional Chinese medicine composition paste of the present invention, comprises the following steps:
(1) Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Ramulus Cinnamomi, Herba Pogostemonis, Fructus Amomi, Fructus Evodiae, Flos Inulae, Pericarpium Citri Reticulatae, Rhizoma Chuanxiong, Mentholum, Folium Perillae (if any), Endothelium Corneum Gigeriae Galli (if any), Fructus Hippophae (if any) is got, be ground into the micropowder of 300 ~ 320 microns respectively, for subsequent use;
(2) adopt steam distillation to extract the Fructus Amomi of pulverizing, obtain Fructus Amomi volatile oil, for subsequent use;
(3) fresh ginger is squeezed the juice, make Rhizoma Zingiberis Recens juice, for subsequent use;
(4) by the Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) of pulverizing, Ramulus Cinnamomi, Herba Pogostemonis, Fructus Evodiae, Flos Inulae, Pericarpium Citri Reticulatae, Rhizoma Chuanxiong, Mentholum, Folium Perillae (if any), Endothelium Corneum Gigeriae Galli (if any), Fructus Hippophae (if any), the Fructus Amomi volatile oil of step (2) and the Rhizoma Zingiberis Recens juice mix homogeneously of step (3), add Mel furnishing pasty state, obtain unguentum.
In above-mentioned steps (2), be soaked in water Fructus Amomi 0.5-1h, then adds Fructus Amomi quality 96-100 water doubly, adopts steam distillation method to extract 8-10h.
In above-mentioned steps (3), directly squeeze the juice and can obtain Rhizoma Zingiberis Recens juice after fresh ginger is cleaned.
When using Drug therapy delayed nausea and vomiting of the present invention, adopt the method for Chinese medicine patch umbilicus associating ear acupoint pressing.The traditional Chinese medical science pastes umbilicus and auricular therapy has long history.The cave of Qizhong is SHENJUE acupoint, SHENJUE acupoint be conception vessel want cave, for clinical preventing or arresting vomiting wants cave, through with taste, there is invigorating the spleen and regulating the stomach, preventing or arresting vomiting, eliminating stagnation lead to stagnant merit.Medicine of the present invention is affixed on umbilical part, and existing acupoint stimulation effect, is absorbed effective ingredient by skin histology again, plays obvious pharmacodynamics effect, thus has double treatment effect." ear person, the institute of assembled channels is poly-also ", the twelve regular channels all on lead in ear, each internal organs of whole body all link in ear, stimulate the ear acupoint can useful effect in whole body meridian, the function of adjustment body.
Chinese medicine patch umbilicus Therapeutic Method is as follows: unguentum of the present invention is covered on umbilical part, fixes with medical film, and within every 24 hours, change the drug of topical application, each medication is about 5g.
Ear acupoint Therapeutic pressing method is as follows: master point: under Stomach duodenum, large intestine, sympathetic, Shenmen, cortex.Adjunct acupuncture points: hyperactive liver-QI attacking the stomach person joins liver; Weakness of the spleen and stomach person joins spleen.With the alcohol disinfecting auricle of 75%, with Wang Anyi by being pressed on the corresponding acupuncture point chosen, with immobilization with adhesive tape.Relatively press Wang Anyi with thumb, forefinger, feel sour, swollen with patient, bitterly, until the rubescent heating of auricle is advisable.Advise patient to press voluntarily, 3 ~ 5 minutes, each every cave, every day 5 ~ 6 times, within every 3 days, two ears replace rotation.
Institute gets in the ear acupoint: " stomach " regulating the stomach and sending down the adverse rising QI to arrest nausea, " large intestine ", " duodenum " transporting and transforming nutrients from foodstuff, stomach function regulating sending down the abnormal ascending QI; " Shenmen " tranquillizing and allaying excitement preventing or arresting vomiting; " sympathetic " regulating plant function of nervous system, alleviates the nausea and vomiting produced because of vagal excitation; " under cortex " regulates cerebral cortex irritability and action of enterogastric function; According to dialectical insufficiency of the spleen, add spleen cave, get its invigorating the spleen and benefiting QI, and middle preventing or arresting vomiting; Belch, pantothenic acid then add liver cave with dispersing the stagnated liver-QI for regulating the stomach, dredge smooth mechanism of qi.All caves are share and are jointly reached dredging through gas, invigorating the spleen and regulating the stomach, the object of stopping nausea and vomiting by lowering the adverse flow of QI.
Research finds, better effects if when said medicine of the present invention and granisetron and dexamethasone drug combination.Therefore; the present invention also protects above-mentioned the Chinese medicine composition associating granisetron and the application of dexamethasone in the medicine preparing the delayed nausea and vomiting that treatment chemotherapy causes that prevent and treat the delayed nausea and vomiting that chemotherapy causes; wherein; the above-mentioned Chinese medicine composition preventing and treating the delayed nausea and vomiting that chemotherapy causes is unguentum, and granisetron and dexamethasone are ejection preparation.
When adopting Chinese medicine patch umbilicus of the present invention in conjunction with ear acupoint pressing associating granisetron and dexamethasone in treatment, effectively can control the delayed nausea and vomiting caused by cisplatin, and can improve the appetite of patient, difference has statistical significance.
The present invention also protects a kind of drug regimen for the treatment of the delayed nausea and vomiting that chemotherapy causes; comprise external used medicine and injectable drug; described external used medicine is above-mentioned Traditional Chinese medicine composition paste of preventing and treating the delayed nausea and vomiting that chemotherapy causes, and described injectable drug is granisetron and dexamethasone.
The present invention has the following advantages:
1, the present invention alleviates vomiting medicine from the research of traditional Chinese medical science angle, plays invigorating the spleen and regulating the stomach, stopping nausea and vomiting by lowering the adverse flow of QI, eliminating stagnation lead to stagnant effect, have good prevention effect to the delayed nausea and vomiting that chemotherapy causes by the mode of external.Prescription of the present invention is rigorous, and preparation is simple, non-stimulated, cheap, easy and simple to handle, patient is easy to accept, have potential applicability in clinical practice widely, the treatment for Chemotherapy on Patient with Tumor delayed nausea and vomiting provides a kind of new thinking, can create higher Social benefit and economic benefit.
2, the present invention adopts the Therapeutic Method that Chinese medicine patch umbilicus and the ear acupoint press, dredging can be reached through gas, QI and blood regulating, regulate the effect of gastrointestinal, effectively can alleviate the nausea and vomiting of patients undergoing chemotherapy, improve appetite, reach the effect of inner disease outer treat, add the compliance of patient, improve the toleration of patient to chemotherapy, significantly improve the quality of life of patient.
3, adopt the delayed nausea and vomiting that Chinese medicine patch umbilicus of the present invention and ear acupoint pressing associating granisetron and dexamethasone can effectively control caused by cisplatin, and can improve the appetite of patient, effect is better.
4, the present invention is by external application Chinese medicine and granisetron and dexamethasone conbined usage, can be good at delayed nausea and vomiting, inappetence that treatment cisplatin causes, also the use of granisetron and dexamethasone can be alleviated to side effect such as the constipation that patient causes, and medicine of the present invention directly pastes umbilicus treatment, without the need to oral or injection, avoid oral administration and increase the weight of GI irritation, compliance is good, for delayed nausea and vomiting patient provides a kind of new way, and filled up a blank of domestic and international Chinese medicine delayed nausea and vomiting, be the leading level in the world.
Detailed description of the invention
Below by detailed description of the invention, the present invention is further detailed.If no special instructions, following raw material medicaments is weight portion.
embodiment 1
Pharmaceutical formulation of the present invention is as follows: Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 22 parts, Ramulus Cinnamomi 16 parts, Herba Pogostemonis 12 parts, Fructus Amomi 12 parts, Fructus Evodiae 10 parts, Flos Inulae 8 parts, Pericarpium Citri Reticulatae 5 parts, Rhizoma Chuanxiong 5 parts, Rhizoma Zingiberis Recens juice 14 parts, Mentholum 1 part.
Said medicine is made unguentum, and method is as follows:
(1) get Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Ramulus Cinnamomi, Herba Pogostemonis, Fructus Amomi, Fructus Evodiae, Flos Inulae, Pericarpium Citri Reticulatae, Rhizoma Chuanxiong, Mentholum, be ground into 300 ~ 320um(micron respectively) micropowder, for subsequent use;
(2) Fructus Amomi of pulverizing is added water soaking 0.5h, then add the water of Fructus Amomi quality 96 times, adopt extraction by steam distillation 8-10h, obtain Fructus Amomi volatile oil, for subsequent use;
(3) squeeze the juice after fresh ginger being cleaned, filter extracting juice, obtain Rhizoma Zingiberis Recens juice, for subsequent use;
(4) Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) pulverized, Ramulus Cinnamomi, Herba Pogostemonis, Fructus Evodiae, Flos Inulae, Pericarpium Citri Reticulatae, Rhizoma Chuanxiong, Mentholum and the Fructus Amomi volatile oil of step (2), the Rhizoma Zingiberis Recens juice of step (3) are mixed, add Mel furnishing pasty state, obtain unguentum.
embodiment 2
Pharmaceutical formulation of the present invention is as follows: Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 20 parts, Ramulus Cinnamomi 20 parts, Herba Pogostemonis 10 parts, Fructus Amomi 15 parts, Fructus Evodiae 8 parts, Flos Inulae 10 parts, Pericarpium Citri Reticulatae 4 parts, Rhizoma Chuanxiong 6 parts, Rhizoma Zingiberis Recens juice 10 parts, Mentholum 3 parts.
Preparation method is with embodiment 1.
embodiment 3
Pharmaceutical formulation of the present invention is as follows: Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 25 parts, Ramulus Cinnamomi 15 parts, Herba Pogostemonis 15 parts, Fructus Amomi 10 parts, Fructus Evodiae 12 parts, Flos Inulae 4 parts, Pericarpium Citri Reticulatae 6 parts, Rhizoma Chuanxiong 4 parts, Rhizoma Zingiberis Recens juice 16 parts, Mentholum 1 part.
Preparation method is with embodiment 1.
embodiment 4
Pharmaceutical formulation of the present invention is as follows: Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 22 parts, Ramulus Cinnamomi 16 parts, Herba Pogostemonis 12 parts, Fructus Amomi 12 parts, Fructus Evodiae 10 parts, Flos Inulae 8 parts, Pericarpium Citri Reticulatae 5 parts, Rhizoma Chuanxiong 5 parts, Rhizoma Zingiberis Recens juice 14 parts, Mentholum 1 part, Folium Perillae 9 parts, Endothelium Corneum Gigeriae Galli 6 parts, Fructus Hippophae 3 parts.
Said medicine is made unguentum, and method is as follows:
(1) get Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Ramulus Cinnamomi, Herba Pogostemonis, Fructus Amomi, Fructus Evodiae, Flos Inulae, Pericarpium Citri Reticulatae, Rhizoma Chuanxiong, Mentholum, Folium Perillae, Endothelium Corneum Gigeriae Galli, Fructus Hippophae, be ground into 300 ~ 320um(micron respectively) micropowder, for subsequent use;
(2) Fructus Amomi of pulverizing is added water soaking 0.5h, then add the water of Fructus Amomi quality 96 times, adopt extraction by steam distillation 8-10h, obtain Fructus Amomi volatile oil, for subsequent use;
(3) squeeze the juice after fresh ginger being cleaned, filter extracting juice, obtain Rhizoma Zingiberis Recens juice, for subsequent use;
(4) Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) pulverized, Ramulus Cinnamomi, Herba Pogostemonis, Fructus Evodiae, Flos Inulae, Pericarpium Citri Reticulatae, Rhizoma Chuanxiong, Mentholum, Folium Perillae, Endothelium Corneum Gigeriae Galli, Fructus Hippophae and the Fructus Amomi volatile oil of step (2), the Rhizoma Zingiberis Recens juice of step (3) are mixed, add Mel furnishing pasty state, obtain unguentum.
embodiment 5
Pharmaceutical formulation of the present invention is as follows: Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 20 parts, Ramulus Cinnamomi 20 parts, Herba Pogostemonis 10 parts, Fructus Amomi 15 parts, Fructus Evodiae 8 parts, Flos Inulae 10 parts, Pericarpium Citri Reticulatae 4 parts, Rhizoma Chuanxiong 6 parts, Rhizoma Zingiberis Recens juice 10 parts, Mentholum 3 parts, Folium Perillae 8 parts, Endothelium Corneum Gigeriae Galli 8 parts, Fructus Hippophae 2 parts.
Preparation method is with embodiment 4.
embodiment 6
Pharmaceutical formulation of the present invention is as follows: Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 25 parts, Ramulus Cinnamomi 15 parts, Herba Pogostemonis 15 parts, Fructus Amomi 10 parts, Fructus Evodiae 12 parts, Flos Inulae 4 parts, Pericarpium Citri Reticulatae 6 parts, Rhizoma Chuanxiong 4 parts, Rhizoma Zingiberis Recens juice 16 parts, Mentholum 1 part, Folium Perillae 10 parts, Endothelium Corneum Gigeriae Galli 5 parts, Fructus Hippophae 4 parts.
Preparation method is with embodiment 4.
Below by clinical research experimental verification unguentum of the present invention and using method thereof to the therapeutic effect of the delayed nausea and vomiting that cisplatin chemotherapy causes.
clinical research
one, object of study
Screen 320 routine tumor patients to test from Shandong Province medicine academy of sciences affiliated hospital, patient's inclusive criteria is: the clinical employing of tumor patient contains the chemotherapy regimen of cisplatin, cisplatin dose > 70mg/m
2,, being divided into application in 3 days, 21 days is a chemotherapy cycles.Without intestinal obstruction in patient, without vomiting medical history, without plaster allergies.In patient, male 163 example, women 157 example; 20 ~ 74 years old age, average 50.0 years old; Pulmonary carcinoma 89 example, gastric cancer 71 example, the esophageal carcinoma 45 example, breast carcinoma 68 example, ovarian cancer 23 example, cervical cancer 8 example, G. cephalantha 9 example, other malignant tumor 7 examples.
two, research method
, random packet
Patient is adopted Stochastic Equilibrium pairing, crossover control design.All patients all give the systemic chemotherapy containing cisplatin in two cycles, use the delayed nausea and vomiting that medical treatment chemotherapy causes while chemotherapy.The delayed nausea and vomiting that all patients all adopt two kinds of emesis schemes to cause to treat chemotherapy two chemotherapy cycles, a chemotherapy cycles uses external application Chinese medicine of the present invention to combine western medicine delayed nausea and vomiting, another chemotherapy cycles only uses western medicine, the medication order Stochastic choice of patient.And will the chemotherapy cycles of external application Chinese medicine of the present invention associating western medicine be used to be designated as treatment group according to the medication of patient is different, the chemotherapy cycles of only western medicine is designated as matched group, and often organizing be all 320 people.
, treatment
Western medicine method: routine gives granisetron and dexamethasone, administration continuous days is consistent with corresponding chemotherapy regimen natural law, and in chemotherapy first half hr iv instillation granisetron 3mg, dexamethasone 5 mg, every day 1 time, terminates to the course for the treatment of.
Chinese medicine associating western medicine method: granisetron and dexamethasone, usage is the same; The unguentum of Application Example 1 pastes umbilicus cooperation ear acupoint Therapeutic pressing simultaneously.
Unguentum subsides umbilicus method is as follows: clean point skin before medication, stick to umbilical part by the unguentum of embodiment 1, then fix with medical film, changed dressings once every 24 hours, each unguentum consumption is about 5g.
Ear acupoint pressing method is as follows: master point: under Stomach duodenum, large intestine, sympathetic, Shenmen, cortex.Adjunct acupuncture points: hyperactive liver-QI attacking the stomach person joins liver; Weakness of the spleen and stomach person joins spleen.With the alcohol disinfecting auricle of 75%, with Wang Anyi by being pressed on the corresponding acupuncture point chosen, with immobilization with adhesive tape.Relatively press Wang Anyi with thumb, forefinger, feel sour, swollen with patient, bitterly, until the rubescent heating of auricle is advisable.Advise patient to press voluntarily, 3 ~ 5 minutes, each every cave, every day 5 ~ 6 times, within every 3 days, two ears replace rotation.
, the observation of curative effect and judgement
Observe from each cycle chemotherapy first day, Continuous Observation 5 days, record patient nausea and vomiting and appetite situation, and evaluate according to following standard.
According to WHO grade scale, nausea and vomiting is divided into IV grade, 0 grade: without nausea and vomiting; I level: slight nothing vomiting of feeling sick, does not affect feed; II grade: vomit 1 ~ 2 every day, do not affect normal feed and life; III level: vomit 3 ~ 5 every day, the normal feed of impact and life, need treatment; IV level: unmanageable vomiting, every day, more than 5 times, needs bed.
According to scoring of QOL indices appetite is designated as 1 ~ 5 point, 1 point: take food hardly; 2 points: appetite is less than normal 1/2; 3 points: appetite is normal 1/2; 4 points: appetite is less slightly; 5 points: appetite is normal.
According to above standard, nausea and vomiting curative effect judging standard is: 0 grade, I level is effective; II grade is effective; III grade, IV level is invalid.Appetite improves the standard of curative effect evaluation: 4 points, 5 are divided into effective; 3 are divided into effectively; It is invalid to be divided into for 1 point, 2.Effective percentage is calculated divided by total number of cases with effective and effective case load.
three, statistical method
All data input SPSS17.0 software is analyzed, and data mean ± standard deviation (`x ± s) represents, calculating chart compares employing x
2inspection, two-stage cross-over design data variance analysis.P<0.05 is for there being statistical significance, and P<0.01 is for there being remarkable statistical significance, and p>0.05 is not statistically significant.
four, clinical effectiveness
1,320 routine patients all complete two cycle chemotherapy on schedule, observe from chemotherapy first day, Continuous Observation 5 days, from second day, the control rate of (namely after end of chemotherapy 24h) nausea and vomiting and appetite improvement rate treatment group were higher than matched group, and difference has statistical significance (P < 0.05).Show that treatment group can better control the generation of the delayed nausea and vomiting caused by cisplatin compared with matched group, and the appetite situation of patient can be improved.Concrete outcome is in table 1, table 2.
2, untoward reaction:
Matched group: 5 examples of having a headache (1.56%), dizzy 0 example (0%), abdominal distention 37 example (11.56%), constipation 106 example (33.1%).
Treatment group: 0 example of having a headache (0%), dizzy 0 example (0%), abdominal distention 21 example (6.56%), constipation 58 example (18.12%).
This shows, adopt the mode of Chinese medicine of the present invention and Western medicine therapeutic alliance to reduce the untoward reaction using Western medicine to cause merely, especially constipation incidence rate reduces greatly (
p<0.05).
five, conclusion
Above-mentioned clinical study results shows, Chinese medicine composition associating granisetron of the present invention and dexamethasone effectively can control the delayed nausea and vomiting caused by cisplatin, and can improve the appetite of patient, and difference has statistical significance.Use Chinese medicine patch umbilicus of the present invention can significantly improve the curative effect of granisetron and dexamethasone in treatment delayed nausea and vomiting in conjunction with the method that the ear acupoint presses, and the untoward reaction that the use that can reduce granisetron and dexamethasone causes patient, decrease the generation of side effect.
further, following clinical trial is carried out to unguentum prepared by above-described embodiment 1,2,4,5
one, object of study
Screen 180 routine tumor patients to test from Shandong Province medicine academy of sciences affiliated hospital, patient's inclusive criteria is: the clinical employing of tumor patient contains the chemotherapy regimen of cisplatin, cisplatin dose > 70mg/m
2,, being divided into application in 3 days, 21 days is a chemotherapy cycles.Without intestinal obstruction in patient, without vomiting medical history, without plaster allergies.In patient, male 100 example, women 80 example; 20 ~ 74 years old age, average 48.1 years old; Pulmonary carcinoma 40 example, gastric cancer 32 example, the esophageal carcinoma 31 example, breast carcinoma 55 example, ovarian cancer 10 example, cervical cancer 5 example, G. cephalantha 2 example, other malignant tumor 5 examples.
two, research method
Patient is adopted Stochastic Equilibrium pairing, crossover control design.All patients all give the systemic chemotherapy containing cisplatin in four cycles, and the Therapeutic Method using Chinese medicine to combine Western medicine while chemotherapy prevents and treats the delayed nausea and vomiting that chemotherapy causes.
The each chemotherapy cycles of each patient is all according to the Therapeutic Method treatment delay nausea and vomiting of above-mentioned Chinese medicine associating Western medicine, different unlike the Chinese medicine composition used in each chemotherapy cycles, 4 chemotherapy cycles use the Chinese medicine composition of embodiment 1,2,4,5 respectively, the use order Stochastic choice of Chinese medicine composition.
The chemotherapy cycles of the Chinese medicine composition using embodiment 1,2,4,5 is designated as embodiment 1 group, embodiment 2 groups, embodiment 4 groups, embodiment 5 groups by the difference of the Chinese medicine composition used according to patient respectively, and often organizing is all 180 people.
three, clinical effectiveness
Observe from each cycle chemotherapy first day, Continuous Observation 5 days, and according to above-mentioned identical standard, patients ' vomiting situation is recorded and evaluated.Result is as follows:
Claims (10)
1. prevent and treat the Chinese medicine composition of the delayed nausea and vomiting that chemotherapy causes for one kind, it is characterized in that the crude drug comprising following weight portion: Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 20-25 part, Ramulus Cinnamomi 15-20 part, Herba Pogostemonis 10-15 part, Fructus Amomi 10-15 part, Fructus Evodiae 8-12 part, Flos Inulae 4-10 part, Pericarpium Citri Reticulatae 4-6 part, Rhizoma Chuanxiong 4-6 part, Rhizoma Zingiberis Recens juice 10-16 part, Mentholum 1-3 part.
2. Chinese medicine composition according to claim 1, is characterized in that the crude drug comprising following weight portion: Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 22 parts, Ramulus Cinnamomi 16 parts, Herba Pogostemonis 12 parts, Fructus Amomi 12 parts, Fructus Evodiae 10 parts, Flos Inulae 8 parts, Pericarpium Citri Reticulatae 5 parts, Rhizoma Chuanxiong 5 parts, Rhizoma Zingiberis Recens juice 14 parts, Mentholum 1 part.
3. Chinese medicine composition according to claim 1, is characterized in that the crude drug also comprising following weight portion: Folium Perillae 8-10 part, Endothelium Corneum Gigeriae Galli 5-8 part, Fructus Hippophae 2-4 part.
4. Chinese medicine composition according to claim 1, is characterized in that the crude drug also comprising following weight portion: Folium Perillae 9 parts, Endothelium Corneum Gigeriae Galli 6 parts, Fructus Hippophae 3 parts.
5. Chinese medicine composition according to claim 1 and 2, is characterized in that: it is external used medicine.
6. Chinese medicine composition according to claim 1 and 2, is characterized in that: dosage form is unguentum.
7. the Chinese medicine composition preventing and treating the delayed nausea and vomiting that chemotherapy causes according to claim 1 and 2, is characterized in that preparation method comprises the following steps:
(1) get Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Ramulus Cinnamomi, Herba Pogostemonis, Fructus Amomi, Fructus Evodiae, Flos Inulae, Pericarpium Citri Reticulatae, Rhizoma Chuanxiong, Mentholum, be ground into the micropowder of 300 ~ 320 microns respectively, for subsequent use;
(2) adopt steam distillation to extract the Fructus Amomi of pulverizing, obtain Fructus Amomi volatile oil, for subsequent use;
(3) fresh ginger is squeezed the juice, make Rhizoma Zingiberis Recens juice, for subsequent use;
(4) by the Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) of pulverizing, Ramulus Cinnamomi, Herba Pogostemonis, Fructus Evodiae, Flos Inulae, Pericarpium Citri Reticulatae, Rhizoma Chuanxiong, Mentholum, the Fructus Amomi volatile oil of step (2) and the Rhizoma Zingiberis Recens juice mix homogeneously of step (3), add Mel furnishing pasty state, obtain unguentum.
8. Chinese medicine composition according to claim 7, is characterized in that: in step (2), and be soaked in water Fructus Amomi 0.5-1h, then adds Fructus Amomi quality 96-100 water doubly, adopts steam distillation method to extract 8-10h.
9. Chinese medicine composition according to claim 7, is characterized in that: fresh ginger adopts following methods to squeeze the juice: directly squeeze the juice after being cleaned by fresh ginger.
10. treat the drug regimen of the delayed nausea and vomiting that chemotherapy causes for one kind, it is characterized in that: comprise external used medicine and injectable drug, the Chinese medicine composition of preventing and treating delayed nausea and vomiting that chemotherapy cause of described external used medicine according to any one of claim 1-4, described injectable drug is granisetron and dexamethasone.
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