CN105078991A - Medicine composition for preventing and treating nausea and emesis after TACE operation as well as application thereof and package - Google Patents
Medicine composition for preventing and treating nausea and emesis after TACE operation as well as application thereof and package Download PDFInfo
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Abstract
The invention belongs to the technical field of biological medicine, and in particular relates to a medicine composition for preventing and treating nausea and emesis after TACE operation as well as an application thereof and a package. The medicine composition comprises antanacathartic used simultaneously, separately or sequentially with treatment effective dose and taken as a combined intervening measure, and non-invasive electrophotoluminescence. The package comprises a first packing unit and a second packing unit as well as an intervening measure, wherein the packing spaces of the first packing unit and the second packing unit are independent, the first packing unit contains antanacathartic, the second packing unit contains non-invasive electrophotoluminescence, and the intervening measure is combined to be applied to prevention and treatment of nausea and emesis after TACE operation. The clinical test result shows that the total effective rate used for stopping vomiting of the medicine composition and the package thereof is superior to that of the pure navoban stop vomiting group, the occurrence rate of acute and delayed emesis is obviously reduced, the appetite recovering and cacation state after the TACE operation are good, and the life quality is improved.
Description
Technical field
The invention belongs to biomedicine technical field, be specifically related to a kind ofly prevent and treat TACE postoperative nausea, the drug regimen of vomiting and application thereof, and package.
Background technology
Hepatic arterial infusion chemotherapy thromboembolism (TACE) is the main method of current advanced primary liver cancer and secondary liver cancer patient palliative therapy, but the side effect such as its Nausea and vomiting produced (CINV) seriously have impact on the quality of life of patient, serious vomiting can cause dehydration, Electrolyte imbalance, weak and lose weight, even bring out upper gastrointestinal massive hemorrhage and threat to life, significantly reduce the life quality of tumor patient and the compliance for the treatment of, and therapeutic outcome.The incidence rate of the nausea and vomiting of usual patient is difficult to determine; it is relevant with patient individual difference, chemotherapeutics kind and dosage and chemotherapy regimen and route of administration etc.; according to estimates 70% ~ 80% chemotherapy process in all live through nausea and vomiting, this reaction occupy chemotherapy adverse effect front three always.
Conventional acute, retardance, expection, sudden and be difficult to the feature controlling to describe vomiting clinically.Be the nausea and vomiting of prophylactic treatment each course for the treatment of to the Therapeutic Method of the best of expection property CINV, but sudden nausea and vomiting still happen occasionally.
The antiemetic used clinically at present comprises anti-parasympathetic nervous class medicine, Loratadine, dopamine receptor antagonist (as phenothiazine, phenyl propyl ketone, Benzoylamide), 5-hydroxytryptamine receptor antagonist and antagonists of neurokinine-1 receptor as Aprepitant.Studies have reported that, Navoban (Soz) causes acute nausea to chemotherapeutics such as cisplatin, the suppression ratio of vomiting is respectively 28.59% and 52.61%, but often undesirable to the curative effect of tardive vomiting.Therefore, find a kind of medicine of more preferably emesis and assembly packaging part thereof and become the problem that this area research worker comparatively pays close attention to.
Prior art related to the present invention has:
1.TakiuchiH,KawabeS,GotoM,etal.[Principlesofmanagingchemotherapy-inducednauseaandvomiting].GanToKagakuRyoho2006；33:19-23.
2.WiserW,BergerA.Practicalmanagementofchemotherapy-inducednauseaandvomiting.Oncology(WillistonPark)2005；19:637-45.
3. Zhang Wendong, Wang Xiuwen, Chen Zhendong, etc. multicenter II clinical trial phase of Navoban (Soz) control caused by chemotherapeutic medicines digestive tract reaction. cancer, 2007,08:870-873
4.LiangyueD,YijunG,ShuhuiH,etal.ChineseAcupunctureandMoxabustion.C.Youbang,H.Xinming,J.Weicheng,L.Sheng,Q.Maoliang,andY.Hiasaned.Beijing,China:ForeignLanguagesPress,1987.
5.SamuelsN.[Acupuncturefornausea:howdoesitwork？].Harefuah2003；142:297-300,316.
6.VickersAJ.Canacupuncturehavespecificeffectsonhealth？Asystematicreviewofacupunctureantiemesistrials.JRSocMed1996；89:303-11.
7.LeeA,DoneML.Theuseofnonpharmacologictechniquestopreventpostoperativenauseaandvomiting:ameta-analysis.AnesthAnalg1999；88:1362-9.
8.LeeA,DoneML.StimulationofthewristacupuncturepointP6forpreventingpostoperativenauseaandvomiting.CochraneDatabaseSystRev2004；3:CD003281.
9. horse is graceful, Wu Xi, and beam is flourishing. external acupuncture control Postoperativenauseaand vomiting present Research [J]. and Chinese acupuncture and moxibustion, 2010,30 (5): 407-411.
10.StreitbergerK,Friedrich-RustM,BardenheuerH,etal.Effectofacupuncturecomparedwithplacebo-acupunctureatP6asadditionalantiemeticprophylaxisinhigh-dosechemotherapyandautologousperipheralbloodstemcelltransplantation:arandomizedcontrolledsingle-blindtrial.ClinCancerRes2003；9:2538-44.。
Summary of the invention
The object of this invention is to provide a kind of control hepatic arterial infusion chemotherapy thromboembolism (TACE) postoperative nausea, the drug regimen of vomiting and application thereof, and package.
The drug regimen of control hepatic arterial infusion chemotherapy thromboembolism (TACE) postoperative nausea of the present invention, vomiting comprises the Bendectin for the treatment of effective dose and the electricity irritation of Noninvasive that supply simultaneously as Combination intervention measure, separate or use in order; Preferred Bendectin tropisetron in embodiments of the invention; The electricity irritation of described Noninvasive reaches stimulating acupoint in the mode exporting weak current.
Tropisetron described in the present invention can be used for the drug regimen medicine preparing control hepatic arterial infusion chemotherapy thromboembolism (TACE) postoperative nausea, vomiting;
In described drug regimen, include but not limited to other antiemetic, comprise anti-parasympathetic nervous class medicine, Loratadine, dopamine receptor antagonist (as phenothiazine, phenyl propyl ketone, Benzoylamide), 5-hydroxytryptamine receptor antagonist and antagonists of neurokinine-1 receptor as Aprepitant.
Invention also provides a kind of package packing the electricity irritation of Bendectin and Noninvasive, comprise the second packaging unit of packaging space the first packaging unit containing Bendectin independent of each other and the electricity irritation containing Noninvasive;
Wherein, described the first packaging unit containing Bendectin comprises the tropisetron of clinical effective dose, and the mode that described the second packaging unit containing the electricity irritation of Noninvasive comprises exporting weak current reaches the electricity irritation of the Noninvasive of stimulating acupoint.
The optional sub-acupuncture of method of stimulating acupoint of the present invention, electricity irritation, Neural stem cell or Acupressure.
In the present invention, in described package, also comprise description, specify in this description, described unit containing clinical effective dose tropisetron and the described unit reaching the electricity irritation of the Noninvasive of stimulating acupoint in the mode exporting weak current, as being united and applied in the intervening measure preventing and treating TACE postoperative nausea, vomiting.
Invention has been clinical trial, the electricity irritation of Bendectin tropisetron associating Noninvasive is on the impact test preventing and treating curative effect of TACE patients ' vomiting, observe associating electricity irritation P6 and combine Gongsun, hoku-bit prevents and treats curative effect to TACE patients ' vomiting, result shows, electric acupoint stimulation associating tropisetron anti-emesis treatment overall efficiency is adopted to be better than simple tropisetron emesis group, associating group after TACE acute stage antiemetic effect be better than simple Bendectin group, the patient of Combination intervention measure only takes Bendectin compared with other and does not accept electricity irritation meddler, it is acute, tardive vomiting incidence rate is obviously low, postoperative appetite recover and defecation in good condition, be beneficial to and improve the quality of living.
The invention provides control TACE postoperative nausea, the drug regimen of vomiting and the package of Combination intervention measure, comprising the Bendectin for the treatment of effective dose supplying simultaneously, separate or use in order and the electricity irritation of Noninvasive; When this drug regimen and package are for preventing and treating TACE postoperative nausea, vomiting, the curative effect being better than only taking Bendectin can be obtained, obviously can reduce incidence of vomiting, and postoperative appetite is recovered and defecation is in good condition, is beneficial to and improves the quality of living.
Advantage of the present invention is:
1. the intervening measure of electric acupoint stimulation associating tropisetron has good inhibition to constitutional/secondary liver cancer patient TACE postoperative nausea, vomiting, obviously can improve patient's appetite and tired symptom, improve the quality of living.
2. in the Combination intervention measure described in, electric acupoint stimulation is likely by regulating blood samples of patients gut hormone level to play control TACE postoperative nausea, vomiting effect.
For the ease of understanding, below will be described in detail the present invention by specific embodiment.It is important to note that these descriptions are only exemplary descriptions, do not form limitation of the scope of the invention.According to the discussion of this description, many changes of the present invention, to change concerning one of ordinary skill in the art be all apparent.
Detailed description of the invention
Embodiment 1
The crossover control experiment of electric acupoint stimulation associating tropisetron control TACE postoperative nausea, vomiting,
1) random packet, crossover contrast clinical research:
Meet the experimenter of person's standard, be diagnosed as patient 74 example of primary hepatocarcinoma or secondary liver cancer through histology or cytolgical examination during being in December, 2012 in April ,-2014, all row liver interventional therapys, being divided into treatment group according to accepting order for medical treatment at random with patient assessment's order, entering people's crossover matched group (A group and B group) at random with computer random number method; Wherein, A group: first use electric acupoint stimulation, namely liver gets involved period 1 employing electric acupoint stimulation+Shu Outing, the 2nd cycle alone Shu Ou booth; B group: first do not adopt electric acupoint stimulation, namely liver gets involved period 1 alone Shu Ou booth, and the 2nd cycle adopted electric acupoint stimulation+Shu Outing; A group and each 37 examples of B group, two groups of experimenter's ordinary circumstance no significant differences (P) 0.05);
Constitutional or the secondary liver cancer patient of the hepatic arterial infusion chemotherapy scheme of inclusion criteria based on oxaliplatin 200mg scheme will be met, after acquisition basic document, allly enter to organize patient's interventional procedure first 30 minutes intravenous drip 5-hydroxytryptamine receptor antagonist (i.e. tropisetron 6mg) emesis:
A group:
First time is when getting involved: preoperative and 5 days after operation electric acupoint stimulation+conventional emesis (tropisetron 6mg)
A. the location at acupuncture point: the location of Neiguan acupoint: to be positioned on rasceta 2 cun, between Tendon palmaris longus and flexor carpi radialis muscle tendon.The location of Gongsun point: in medial border of foot, the front lower place of first metatarsal basilar part, dorso-ventral boundary of the hand place; Point Hegu: thumb first joint band is just to the tiger's jaw limit of another hands, and thumb flexing is pressed, finger tip indication place;
B. patient is advised to get comfortable posture, seat or dorsal position, with moistening cotton swab acupuncture point, the anode of electric stimulus generator and negative electrode are fixed respectively, two Electrode connection are in electric stimulus generator (the G9805-C low-frequency electronic pulse therapeutic instrument that Shanghai Medical Electric Instrument Factory physical therapy subsidiary factory produces);
C. select continuous wave mode to be produced on acupuncture point by electric current to continue to stimulate;
D. stimulus frequency: 4 hertz;
E. stimulus intensity: carry out between the stimulation period of rule to acupuncture point at acusector, sensation according to patient adjusts intensity in time, be limited (patient feels that the stimulus intensity of acusector can reduce gradually along with the time) with the maximum intensity that can bear, stimulate after 10 minutes and carry out an intensity adjustment;
F. stimulus duration: 30 minutes;
G. treatment time: electric stimulating time is before interventional procedure 1 ~ 2 hour first, and the morning 7 every day, point ~ 11 were carried out thereafter;
When second time gets involved: scheme when preoperative conventional emesis (tropisetron 6mg) was got involved with B group first time;
B group
First time is when getting involved: preoperative conventional emesis (tropisetron 6mg) interventional procedure first 30 minutes intravenous drip 5-hydroxytryptamine receptor antagonist (tropisetron 6mg) emesis;
Second time is when getting involved: preoperative and 5 days after operation electric acupoint stimulation+conventional emesis (tropisetron 6mg) was got involved with A group first time time scheme, wherein, first time gets involved and intervention for the second time interval time is 1 month;
Before electronic stimulation first in 24 hours, electricity irritation first and TACE complete and record following information for postoperative 5th day:
1. the classification of nausea and vomiting: Nausea and vomiting is assessed respectively according to NCICTC-AE3.0 version, each point of 5 grades;
The classification of feeling sick, 1 grade: loss of appetite, dietary habit does not change; 2 grades: oral cavity intake reduces, and does not have obvious weight loss, dehydration or applies bad; Need venous transfusion <24 hour; 3 grades: the calorie that oral cavity is taken in or fluid low; Need venous transfusion, gavage or TNP >=24 hour; 4 grades: life-threatening consequence; 5 grades: dead;
The classification of vomiting: show effect 1 time in 1 grade: 24 hours; Show effect 2-5 time in 2 grades: 24 hours; Need venous transfusion <24 hour; Show effect >=6 hours in 3 grades: 24 hours; Need venous transfusion or TPN >=24 hour; 4 grades: life-threatening consequence; 5 grades: dead;
2. appetite improves situation (according to CTCAEv3.0): appetite calibration: feed normal (-), loss of appetite, dietary habit does not change (I level), oral cavity intake changes, but without obvious weight loss or malnutrition situation, needs direct oral cavity to supplement the nutrients (II level), body weight is caused obviously to decline or malnutrition, need venous transfusion, gavage or TPN (III level), threat to life (IV level);
3. the details of drug combination (be mainly antiemetic and vomiting side reaction medicine may be had);
4.KPS scoring and vital sign (blood pressure, pulse);
5. quality of life: use M.D.Anderson Self-reporting inventory (theM.D.AndersonSymptomInventory, MDASI); Patients Diary's situation;
6. before Intraarterial Chemotherapy and Intraarterial Chemotherapy 5 days afterwards each once;
7. test in laboratory: gather the preoperative and TACE fasting blood 2-3ml in postoperative 5th day early morning of patient TACE, adopt the change of the gut hormone content such as serum measured by radioimmunoassay gastrin, motilin, vasoactive intestinal peptide; (appended by detection method reference medicine box, description measures).
Carry out curative effect evaluation:
Evaluation criterion according to NCICTCV.3.0 nausea and vomiting:
According to nausea and vomiting classification: control (CR) 0 grade of degree completely; Part controls (PR) 1 grade; Slight control (MR) 2 grades; Do not control (F) 3-5 level;
The evaluation of appetite behavior: appetite calibration: control (CR) 0 grade completely; Part controls (PR) 1 grade; Slight control (MR) 2 grades; Do not control (F) 3-5 level;
To control to add part controlling calculation effective percentage (CR+PR) completely.
Carry out secondary efficacy evaluation:
Every symptom score in M.D.Anderson Self-reporting inventory (MDASI) is calculated and assessed, carries out calculating and assessing according to symptom score in Patients Diary.
Application SASV8 software carries out statistical analysis, two groups of nausea and vomiting control effects compare employing in groups the rank test (Wilcoxon method) of comparing of two samples with P < 0.05 for difference has statistical significance SAS9.1.3 software to carry out the statistical disposition of data.
Result shows
(1) ordinary circumstance, the aspect such as sex, age, KPS scoring, tumor type, chemotherapy regimen of two groups of patients is harmonious good (P>0.105);
(2) therapeutic evaluation of emesis, nausea is alleviated
The overall emesis effective percentage of electric acupoint stimulation associating tropisetron anti-emesis treatment and simple tropisetron emesis group is respectively 89.1% and 86.3%, two medicines acute stage (namely after chemotherapy the 1st day) and effective remission rate (CR+PR) of period of delay (after chemotherapy 2 ~ 5 days) after chemotherapy are respectively 80%, 77.1%, 97.1,94.3%, 97.1% and 68.6%, 68.6%, 80%, 91.4%, 94.3%, two groups of comparing differences existing for 1-3 days remarkable significant difference (P<0.05) (as shown in table 2) after chemotherapy.
A table 2 liang group therapeutic scheme antiemetic effect compares (n=70)
Electric acupoint stimulation associating tropisetron anti-emesis treatment (associating emesis group) and simple tropisetron emesis group (simple emesis group) are respectively 77.1% ~ 94.3% and 77.1% ~ 97.1% to nauseating improvement rate in 1st ~ 5 days, complete remission rate is respectively 80% and 77.1%, two groups of comparing difference not statistically significants (P>0.05) (as shown in table 3).
Table 3 liang group to chemotherapy cause nausea improve comparison (%)
(3) to make the life better quality evaluation
Electric acupoint stimulation associating tropisetron treatment and simple tropisetron group are to other Quality Of Well Being Indexs, comprise pain, tired, appetite, breathe hard, worried improvement rate is as shown in table 4, result shows, the treatment of electricity irritation associating anti-emesis treatment more simple tropisetron, has statistical significance (P<0.05) improving the difference in tired and appetite.
Table 4 liang group therapeutic scheme is on the impact (n=70, %) of other Quality Of Well Being Indexs
(4) safety analysis two groups of untoward reaction are compared (n=74), and constipation 12 example (34.3%), abdominal discomfort 5 example (14.3%) appear in therapeutic alliance group patient; There is constipation 15 example (42.9%), abdominal discomfort 4 example (11.4%) in monotherapy group patient.Two groups of adverse reaction rate no significant differences, equal complete incidence graph after anti symptom treatment.
5) Combination intervention measure prevents and treats TACE postoperative nausea, vomits and test the impact of gut hormone
Gather and TACE preoperative into group experimenter liver TACE postoperative 1st day, 5th day early morning fasting blood 2-3ml, adopt enzyme to exempt from method and measure serum 5-HT, gastrin, motilin, the change of the gut hormone content such as vasoactive intestinal peptide, get the capable trial test of part experimenter serum and detect (n=16), analysis result shows electricity irritation or after playing alleviation chemotherapy by change gut hormone content, patient feels sick, the therapeutical effect (as shown in table 5) of symptoms of emesis, two groups of experimenters the 1st day 5-HT level after TACE comparatively all obviously raises (P<0.05) before TACE, all after TACE, the serum 5-HT level of the 5th day all obviously declines, statistical significance (P<0.05) is had with the 1st day comparing difference after TACE, wherein, Combination intervention group is to the decline effect of serum 5-HT compared with monotherapy group, and more remarkable (P=0.038), points out electric acupoint stimulation or play the synergism strengthening tropisetron antiemetic effect by suppressing the rising of serum 5-HT.
Serum 5-HT level before and after table 5 treatment compares (
pg/ml)
Experimental result shows, electric acupoint stimulation associating tropisetron emesis intervening measure overall efficiency is better than simple tropisetron emesis group, combine group after TACE acute stage antiemetic effect be better than simple Bendectin group; Combine group and can improve tired and appetite; The electric acupoint stimulation intervening measure of wherein combining or play the synergism strengthening tropisetron antiemetic effect by suppressing the rising of serum 5-HT; The present invention has low cost, untoward reaction advantage little, easy and simple to handle.
Claims (7)
1. prevent and treat a drug regimen for Nausea and vomiting after transarterial chemoembolization, it is characterized in that, to comprise as Combination intervention measure for simultaneously, separately or the Bendectin for the treatment of effective dose used in order and the electricity irritation of Noninvasive.
2., by drug regimen according to claim 1, it is characterized in that, described Bendectin is tropisetron.
3., by drug regimen according to claim 1, it is characterized in that, the electricity irritation of described Noninvasive is that the mode exporting weak current reaches stimulating acupoint.
4. by drug regimen according to claim 1, it is characterized in that, in described drug regimen, also comprise anti-parasympathetic nervous class medicine, Loratadine, dopamine receptor antagonist, 5-hydroxytryptamine receptor antagonist and antagonists of neurokinine-1 receptor.
5. pack a package for the electricity irritation of Bendectin and Noninvasive, it is characterized in that, it comprises the second packaging unit of packaging space the first packaging unit containing Bendectin independent of each other and the electricity irritation containing Noninvasive; Described the first packaging unit containing Bendectin comprises the tropisetron of clinical effective dose, and the mode that described the second packaging unit containing the electricity irritation of Noninvasive comprises exporting weak current reaches the electricity irritation of the Noninvasive of stimulating acupoint.
6., by package according to claim 5, it is characterized in that, the method for described stimulating acupoint is selected from acupuncture, electricity irritation, Neural stem cell or Acupressure.
7. by package according to claim 5, it is characterized in that, in described package, also comprise description, specify in this description, described unit containing clinical effective dose tropisetron and the described unit reaching the electricity irritation of the Noninvasive of stimulating acupoint in the mode exporting weak current, as being united and applied in the intervening measure preventing and treating TACE postoperative nausea, vomiting.
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Cited By (1)
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| CN114984172A (en) * | 2021-03-01 | 2022-09-02 | 中国人民解放军海军军医大学第一附属医院 | A topical Chinese medicinal composition for stopping emesis, its preparation method and antiemetic bandage |
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| CN114984172B (en) * | 2021-03-01 | 2023-04-28 | 中国人民解放军海军军医大学第一附属医院 | Anti-emetic traditional Chinese medicine composition for external application, preparation method and anti-emetic binding belt |
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Application publication date: 20151125 |