CN104288407A

CN104288407A - Preparation method for nasopharynx cancer chemoradiotherapy assisting skin ointment

Info

Publication number: CN104288407A
Application number: CN201410608377.5A
Authority: CN
Inventors: 所俊强; 宋美芹; 邓小蕾; 迟玉华
Original assignee: Individual
Current assignee: Individual
Priority date: 2014-11-04
Filing date: 2014-11-04
Publication date: 2015-01-21

Abstract

The invention discloses a preparation method of a nasopharynx cancer chemoradiotherapy assisting skin ointment, and aims to solve the treatment problem of nasopharynx cancer. The preparation method is characterized by comprising the following steps: (1) extracting volatile oil from groundsel, acorus gramineus and polygonum multiflorum coarse powder for later use; (2) grinding Chinese honey locust and peach gum to form fine powder for later use; (3) conducting aqueous extraction on elsholtzia rugulosa, pungent litse flower, leycesteria formosa, rhizoma pinelliae (decocted in a bag), trifolium pratense, cassia twig and the dregs obtained in the step 1, and conducting vacuum concentration and drying to obtain a primary material; (4) heating sesame oil, adding pine needles to the heated oil, filtering the oil material, adding the primary material and the Chinese honey locust and peach gum powder to the oil material at 120 DEG C, cooling, spraying the volatile oil, mixing uniformly, and subpackaging to obtain the product. The clinical experiments show that the nasopharynx cancer chemoradiotherapy assisting skin ointment is synergetic with the chemotherapy, good in in curative effect, high in safety, and worthy of clinical application and popularization.

Description

A kind of preparation method of nasopharyngeal carcinoma aid in skin ointment

Technical field

The present invention relates to the field of Chinese medicines, be specifically related to a kind of preparation method of nasopharyngeal carcinoma aid in skin ointment.

Background technology

The sickness rate of malignant tumor is in recent years in sustainable growth trend, and chemotherapy and operative treatment, radiotherapy are the Main Means of current oncotherapy.Maximum tolerated dose chemotherapy (maximum tolerated dose, MTD) is the principal mode of classic chemotherapy, because toxic and side effects is heavier, needs the intermission of 2 ~ 3 weeks to be beneficial to the recovery of body tissue organ dysfunction, easily produce tumor drug resistance after each cycle chemotherapy.There is multiple theory such as tumor stem cell hypothesis can explain that tumor cell is insensitive or produce recurrence and the transfer that drug resistance or resistance cause tumor over the course for the treatment of to chemicotherapy at present, it is the balance of chemicotherapy toxicity and killing action at all, for " completely " killing off tumor cells, only have increasing to put (change) and treat dosage, but, this brings again the toxic and side effects being difficult to bear to patient, cause Endodontic failure.

Therefore, clinical cancer therapy takes chemoradiation therapy hypersitization medicine to carry out auxiliary treatment more in recent years, its object is to when not increasing toxic action, maximized increase killing action, reduce tumor drug resistance incidence rate, as the xeloda activated in selectivity tumor, Selective COX-2 inhibitor celecoxib, meloxicam etc.But said medicine is expensive, and its adverse effect of life-time service is high, causes patient compliance poor.

In recent years, Chinese medicine adjuvant therapy Therapy study mainly concentrates on righting and two aspects of getting rid of evils, the former is as medicine or Chinese medicine single components such as ginsenoside, ganoderan, the Radix Astragali, Radix Angelicae Sinensis, how to start with from air making-up and spleen enlivening, supplementing QI and nourishing YIN, protection normal cell, immune organ, reduce radiotherapy and chemotherapy medicine to the infringement of body; The latter is as hard masses softening and resolving, removing blood stasis medicine or Chinese medicine single components such as Venenum Bufonis, Fructus Bruceae, irisquinone, pocket clothing polysaccharide, and how starting with from " treating the poisonous disease with poisonous drugs ", toxic and side effects is large.And in prescription, two kinds of medicines with the use of, its effect produces conflicts, and affects the treatment.

Therefore, still lack a kind of not simple Chinese medicine of starting with from " killing " or " righting " angle or formula, Combined with Radiotherapy chemotherapeutic sensitivity uses.

Summary of the invention

Technical assignment of the present invention is for above the deficiencies in the prior art, provides a kind of curative effect certainly and the preparation method of the little nasopharyngeal carcinoma aid in skin ointment of side effect.

The technical scheme that the present invention solves its technical problem is: a kind of pharmaceutical composition of chemotherapeutic sensitivity, it is characterized in that being prepared from by the crude drug of following weight proportion: play the flageolet at Elsholtzia regulosa 10 ~ 30 parts, Folium Elsholtziae cypriani 10 ~ 30 parts, night 3 ~ 10 parts, Pinellia leaven 6 ~ 9 parts, Radix Polygoni Multiflori 3 ~ 10 parts, Herba Trifolii Pratentis 6 ~ 12 parts, Herba Senecionis Scandentis 6 ~ 12 parts, 1 ~ 3 part, Fructus Gleditsia, Rhizoma Acori Graminei 6 ~ 12 parts, Ramulus Cinnamomi 1 ~ 5 part, Resina persicae 10 ~ 25 parts, 3 ~ 10 parts, Folium Pini, 50 parts, Oleum Sesami.

Chinese medicine of the present invention can be prepared from by following method:

(1) Herba Senecionis Scandentis, Rhizoma Acori Graminei, Radix Polygoni Multiflori coarse powder are extracted volatile oil with vapor distillation respectively, and mixing for standby use after collecting, medicinal residues are continued to employ;

(2) Fructus Gleditsia, Resina persicae are pulverized 100 mesh sieves, and become fine powder for subsequent use;

(3) Elsholtzia regulosa, Folium Elsholtziae cypriani, night are played the flageolet, Pinellia leaven (decocting a drug wrapped), Herba Trifolii Pratentis, Ramulus Cinnamomi and the mixing of step 1 gained medicinal residues add 3 times of water yields, decoct with water 2 times, each 30min, collecting decoction, leaves standstill and filters, get filtrate, concentrating under reduced pressure, spraying dry, draws just material;

(4) Oleum Sesami is heated to 160 DEG C, adds the Folium Pini of pulverizing, after 3min, oil plant is filtered, 120 DEG C time, add step 3 gained just expect and gained Fructus Gleditsia, Resina persicae fine powder in step 2, Keep agitation 5min, sprayed into by gained volatile oil in step 1 when being cooled to 60 DEG C, the subpackage that stirs forms.

Wherein said: Elsholtzia regulosa is the herb of labiate scabriculous Herba Moslae Elsholtzia rugulosa Hemsl..Acrid in the mouth; Bitter; Cool in nature.Merit can be induced sweat and be brought down a fever; Removing dampness for regulating stomach.

Folium Elsholtziae cypriani is the fragrant Elsholtzia cypriani(Pavol. of labiate weeds) leaf of C.Y.Wu et S.chow or stem and leaf.Acrid in the mouth; Cool in nature.Merit can be delivered in heat clearing away; Removing toxic substances preventing the attack (or recurrence) of malaria.

Night plays the flageolet, and for Caprifoliaceae to play the flageolet Leycesteria formosa Wall. night, is used as medicine with Herb.Nature and flavor are bitter, cool.Merit can removing blood stasis, dispels the wind, relievings asthma.

Pinellia leaven, the dry tuber powder for the aroid Rhizoma Pinelliae adds the herbal leaven that flour, Sucus Zingberis etc. are made.Bitter in the mouth is pungent, and property is put down.Merit can drying dampness to eliminate phlegm, and stopping nausea and vomiting by lowering the adverse flow of QI, dissolving lump and resolving mass, helps digestion long-pending, control and have loose bowels.

Radix Polygoni Multiflori, be the dried root of polygonum multiflorum thunb Polygonum multiflorum Thunb., nature and flavor are bitter, sweet, puckery, temperature.Return liver, the heart, kidney channel.Merit can nourishing the blood and yin; Removing toxic substances, eliminating carbuncle, loosening bowel to relieve constipation.

Herba Trifolii Pratentis is inflorescence and the wounded in the battle branch and leaf of leguminous plant Herba Trifolii Pratentis Trifolium pratense L..Sweet in the mouth; Bitter; Cold nature.Return lung meridian.Merit can clearing and antitussive; Mass dissipating and swelling eliminating.

Herba Senecionis Scandentis is the aerial parts of feverfew Herba Senecionis Scandentis.Cold in nature, bitter in the mouth.Merit can heat-clearing and toxic substances removing, removing obstruction for relieving pain.

Fructus Gleditsia is the fruit of leguminous plant Fructus Gleditsia Gleditsia sinensis Lam..Nature and flavor are pungent, temperature.Return lung; Large intestine channel.Merit can expelling phlegm for arresting cough; Have one's ideas straightened out to lead to and close; Parasite killing eliminating stagnation.

Rhizoma Acori Graminei is the dry rhizome of acorus gramineus araceae plant Acorus tatarinowii Schott.Nature and flavor are pungent, bitter, temperature.GUIXIN, stomach warp.Merit can be whetted the appetite in removing dampness, eliminating phlegm of having one's ideas straightened out, refreshment Fructus Alpiniae Oxyphyllae.

Ramulus Cinnamomi is the dry twig of canella Cortex Cinnamomi Cinnamomum cassia Presl.Nature and flavor acrid, sweet, warm.GUIXIN, lung, urinary bladder channel.Merit can diaphoresis expelling pathogenic factors from muscles, promoting the flow of QI-blood by warming the meridian, supporing yang activating QI, the flat gas that spins.

Folium Pini is the dry needle of the Folium seu Strobilus Pini sibiricae in Pinaceae pine genus plant, Pollen pini thunbergii, Pinus tabuliformis, Pinus koraiensis, Pinus armandi Franch-P. Komavovii Lavl., pinus yunnanensis faranch, Pinus kesiya Royle ex Gordon var. langbianensis (A.Chev) Gaussen, Pinus massoniana Lamb etc.Merit can dispeiling pathogenic wind and removing dampness, killing parasites for relieving itching.

Resina persicae, for rosaceous plant peach tree does the resin of upper outflow.Merit can removing heat from blood and promoting blood circulation, benefiting qi for promoting granulation.

Oleum Sesami, the fatty oil that the mature seed milling process for Pedaliaceae plant sesame Sesamum indicum L. obtains.

Composition principle: maximum tolerated dose chemotherapy (maximum tolerated dose, MTD) is the balance of chemicotherapy toxicity and killing action at all.For " completely " killing off tumor cells, only have increasing to put (change) and treat dosage, but this brings again the toxic and side effects being difficult to bear to patient, cause Endodontic failure.In recent years, Chinese medicine adjuvant therapy Therapy study mainly concentrates on righting and two aspects of getting rid of evils, the former is as medicine or Chinese medicine single components such as ginsenoside, ganoderan, the Radix Astragali, Radix Angelicae Sinensis, how to start with from air making-up and spleen enlivening, supplementing QI and nourishing YIN, protection normal cell, immune organ, reduce radiotherapy and chemotherapy medicine to the infringement of body; The latter is as hard masses softening and resolving, removing blood stasis medicine or Chinese medicine single components such as Venenum Bufonis, Fructus Bruceae, irisquinone, pocket clothing polysaccharide, and how starting with from " treating the poisonous disease with poisonous drugs ", toxic and side effects is large.And in prescription, two kinds of medicines with the use of, its effect produces conflicts, and affects the treatment.Therefore, still lack a kind of not simple Chinese medicine of starting with from " killing " or " righting " angle or formula, Combined with Radiotherapy chemotherapeutic sensitivity uses.

Compared with prior art, the present invention has following characteristics:

1, get Elsholtzia regulosa in side, Folium Elsholtziae cypriani is monarch, Elsholtzia regulosa and Folium Elsholtziae cypriani 1:1 ratio collocation prescription become the basis of we, experiment proves that (specific experiment data are shown in specific embodiment part) Elsholtzia regulosa and Folium Elsholtziae cypriani geometric ratio decocting liquid assist 5-FU chemotherapy or adjuvant radiotherapy can obviously reduce tumor weight, improves tumour inhibiting rate.Its action pathway may be relevant to COX inhibitory action, but in experiment examination, Elsholtzia regulosa effect and dosage are clearly relevant, Elsholtzia regulosa and Folium Elsholtziae cypriani 1:2 ratio and then without above-mentioned potentiation

2, get in side and play the flageolet night, Herba Trifolii Pratentis, Herba Senecionis Scandentis, Radix Polygoni Multiflori coordinates monarch drug to start with from the poison blood, expelling wind and clearing away heat eliminating stagnation, but because night plays the flageolet, Herba Trifolii Pratentis, Herba Senecionis Scandentis drug effect is all invigorated blood circulation dynamic blood effect, under routine dose (15-30g/ day) have and promote blood vessel new role, and angiogenesis and tumor development closely bound up, so here using dosage is all improved, play the flageolet night 3 ~ 10g/ day, Herba Trifolii Pratentis 6 ~ 12g/ day, Herba Senecionis Scandentis 6 ~ 12g/ day, at this dose, namely medicine can keep the pharmacological action of former expelling wind and clearing away heat eliminating stagnation, again without the anxiety of dynamic blood,

3, get Pinellia leaven, Rhizoma Acori Graminei dampness sending down the abnormal ascending QI, eliminating phlegm of having one's ideas straightened out in side, contribute to antagonism radiotherapy and chemotherapy medicine to the damage of gastrointestinal, and the greasy side effect of taste that this two herbal medicine does not have other spleen reinforcing medicines, and Resina persicae there is nourishing to nourish blood effect;

4, medicine coordinates lifting: Fructus Gleditsia is had one's ideas straightened out to lead to and closes, the flat gas that spins of Ramulus Cinnamomi, although the medicine of the soaping agents contained in Fructus Gleditsia, single use can stimulate the secretion of gastric mucosa and reflexive promotion respiratory mucus, and then produce nauseous phlegm-dispelling functions, but coordinating the Ramulus Cinnamomi of low dose of (1 ~ 5 g/ day) to use can open entire by orderly and clearly mechanism of qi, reduce the nauseating sense of patient and gastrointestinal reaction, the warm DeGrain of Ramulus Cinnamomi under this dosage, can not cause yang-energy to cross Sheng and cause local blood circulation too fast and promote tumor growth;

5, Folium Pini, Resina persicae, Oleum Sesami contribute to medicine topical transdermal and absorb, and the viscosity of medicine, and Folium Pini can reduce medicine local excitation, prevents the generation of skin adverse reaction.

Detailed description of the invention

Below in conjunction with practical situation, the specific embodiment of the present invention is elaborated.

Embodiment 1, crude drug weight proportion: play the flageolet at Elsholtzia regulosa 20g, Folium Elsholtziae cypriani 20g, night 6g, Pinellia leaven 9g, Radix Polygoni Multiflori 6g, Herba Trifolii Pratentis 10g, Herba Senecionis Scandentis 10g, Fructus Gleditsia 3g, Rhizoma Acori Graminei 10g, Ramulus Cinnamomi 2g, Resina persicae 20g.

The preparation method of embodiment 1 is: played the flageolet at Elsholtzia regulosa, Folium Elsholtziae cypriani, night, Pinellia leaven (decocting a drug wrapped), Radix Polygoni Multiflori, Herba Trifolii Pratentis, Herba Senecionis Scandentis, Fructus Gleditsia, Rhizoma Acori Graminei, Ramulus Cinnamomi mixing and water adding decoct, filtrate is got after 30 minutes, medicinal residues add water continue decoction get filtrate after 20 minutes, twice filtrate merges, being divided into two parts of morning and evenings takes, and sooner or later respectively gets odd-numbered day dosage half amount Resina persicae molten every day and takes.

Embodiment 2, crude drug weight proportion: play the flageolet at Elsholtzia regulosa 10 parts, Folium Elsholtziae cypriani 10 parts, night 3 parts, Pinellia leaven 6 parts, Radix Polygoni Multiflori 3 parts, Herba Trifolii Pratentis 6 parts, Herba Senecionis Scandentis 6 parts, 1 part, Fructus Gleditsia, Rhizoma Acori Graminei 6 parts, Ramulus Cinnamomi 1 part, Resina persicae 10 parts, 3 parts, Folium Pini, 50 parts, Oleum Sesami.

Embodiment 3, crude drug weight proportion: play the flageolet at Elsholtzia regulosa 20 parts, Folium Elsholtziae cypriani 20 parts, night 6 parts, Pinellia leaven 9 parts, Radix Polygoni Multiflori 6 parts, Herba Trifolii Pratentis 10 parts, Herba Senecionis Scandentis 10 parts, 3 parts, Fructus Gleditsia, Rhizoma Acori Graminei 10 parts, Ramulus Cinnamomi 2 parts, Resina persicae 20 parts, 9 parts, Folium Pini, 50 parts, Oleum Sesami.

Embodiment 4, crude drug weight proportion: play the flageolet at Elsholtzia regulosa 30 parts, Folium Elsholtziae cypriani 30 parts, night 10 parts, Pinellia leaven 9 parts, Radix Polygoni Multiflori 10 parts, Herba Trifolii Pratentis 12 parts, Herba Senecionis Scandentis 12 parts, 3 parts, Fructus Gleditsia, Rhizoma Acori Graminei 12 parts, Ramulus Cinnamomi 5 parts, Resina persicae 25 parts, 10 parts, Folium Pini, 50 parts, Oleum Sesami.

The Chinese medicine of embodiment 2 ~ 4 can be prepared from by following method:

The efficient combination of said medicine, coordinates mutually, effectively reach the object of chemotherapeutic sensitivity, and side effect is less.Experiment and clinical data sufficient proof based on the above results, interrelated data is as follows.

One, square foundation zoopery.

1. materials and methods.

1.1 laboratory animals: Kunming mouse, body weight 20 ± 2g, male and female half and half.

1.2 tumor strain: H ₂₂the strain of hepatic ascites tumor, is provided by institute of materia medica of Beijing Chinese Academy of Sciences.

1.3 medicine.

1.3.1 5-fluorouracil (5-FU) injection, becomes 1g/L with front normal saline dilution.

1.3.2 the preparation of Elsholtzia regulosa and Folium Elsholtziae cypriani equal proportion (1:1) proportioning medicine: take Elsholtzia regulosa and each 250g of Folium Elsholtziae cypriani, mixing and water adding decocts, filtrate is got after 30 minutes, medicinal residues add water continue decoction get filtrate after 20 minutes, twice filtrate merges, concentrating under reduced pressure becomes clear paste to preserve, and uses front normal saline dilution, is equivalent to 0.5g crude drug/ml after dilution.

1.3.2 the preparation of Elsholtzia regulosa and the low ratio of Folium Elsholtziae cypriani (1:2) proportioning medicine: take Elsholtzia regulosa 125g and Folium Elsholtziae cypriani 250g, mixing and water adding decocts, filtrate is got after 30 minutes, medicinal residues add water continue decoction get filtrate after 20 minutes, twice filtrate merges, concentrating under reduced pressure becomes clear paste to preserve, and uses front normal saline dilution, is equivalent to 0.375g crude drug/ml after dilution.

1.4 modelings, grouping and processing method.

1.4.1 modeling: aseptically extract well-grown H ₂₂the tumor liquid of liver cancer mouse, becomes 2 × 10 with normal saline dilution ⁷the cell suspension of individual/ml, 0.2ml/, mouse hind leg subcutaneous vaccination.

1.4.2 chemotherapy grouping and processing method: mice was divided into 4 groups at random in the 2nd day after tumor strain is inoculated, often organizes 10, be respectively: matched group, 5-FU group, 5-FU+ equal proportion group, the low ratio group of 5-FU+.Matched group gives normal saline gavage every day, and remaining three groups give 5-FU 0.01g/kg lumbar injection, every day 1 time, continuous 3d, drug withdrawal 1d, then successive administration 2d.5-FU+ equal proportion group gives 8g(crude drug)/kg equal proportion decoction gavage, every day 1 time, continuous 15d.5-FU+ low ratio group gives 6.25g(crude drug)/kg low ratio decoction gavage, every day 1 time, continuous 15d.Put to death mice in the 16th day, get tumor and weigh, calculate tumour inhibiting rate and Increasing Efficiency.

1.4.3 radiotherapy grouping and processing method: mice was divided into 4 groups at random in the 2nd day after tumor strain is inoculated, often organizes 10.Be respectively: matched group, combination radiotherapy group, radiotherapy+equal proportion group, radiotherapy+low ratio group.Matched group gives normal saline gavage, and remaining three groups start to add radiotherapy in administration on the 7th day, basic crack 8Gy/d, every day 1 time, continuous 3d, dosage escalation, 8,9,10Gy.Radiotherapy+equal proportion group gives 8g(crude drug)/kg equal proportion decoction gavage, every day 1 time, continuous 15d.Radiotherapy+low ratio group gives 6.25g(crude drug)/kg low ratio decoction gavage, every day 1 time, continuous 15d.Put to death mice in the 16th day, get tumor and weigh, calculate tumour inhibiting rate and Increasing Efficiency.

1.5 statistical method results adopt SPSS 16.0 to carry out statistical analysis, and measurement data t checks.

2 results.

2.1 couples of H ₂₂the potentiation of tumor-bearing mice chemotherapy.

Matched group, 5-FU group, 5-FU+ equal proportion group, the tumor of the low ratio group of 5-FU+ is heavily respectively 2.46 ± 0.78g, 1.39 ± 0.51g, 0.98 ± 0.31g, 1.25 ± 0.42g, 5-FU group, 5-FU+ equal proportion group, 5-FU+ is low, and ratio group is all obviously better than matched group, its tumour inhibiting rate is respectively 43.50%, 60.16%, 49.19%, 5-FU+ equal proportion group compares with 5-FU group, its tumor is heavy obviously to be reduced, tumour inhibiting rate obviously increases (P<0.05), and the low ratio group of 5-FU+ compares with 5-FU group, then group difference does not have statistical significance (P>0.05).Therefore, can find out that Elsholtzia regulosa and Folium Elsholtziae cypriani equal proportion (1:1) proportioning medicine are to mice H ₂₂the 5-FU treatment of hepatocarcinoma has potentiation, and Increasing Efficiency is 29.50%.

2.2 couples of H ₂₂the potentiation of tumor-bearing mice radiotherapy.

Matched group, combination radiotherapy group, radiotherapy+equal proportion group, the tumor of radiotherapy+low ratio group is heavily respectively 2.38 ± 0.86g, 1.44 ± 0.46g, 0.97 ± 0.38g, 1.21 ± 0.39g, combination radiotherapy group, radiotherapy+equal proportion group, radiotherapy+low ratio group is all obviously better than matched group, its tumour inhibiting rate is respectively 39.50%, 59.24%, 49.16%, radiotherapy+equal proportion group compares with combination radiotherapy group, its tumor is heavy obviously to be reduced, tumour inhibiting rate obviously increases (P<0.05), and radiotherapy+low ratio group compares with combination radiotherapy group, then group difference does not have statistical significance (P>0.05).Therefore, can find out that Elsholtzia regulosa and the low ratio of Folium Elsholtziae cypriani (1:2) proportioning medicine are to mice H ₂₂the radiotherapy in the treatment of hepatocarcinoma has potentiation, and Increasing Efficiency is 32.64%.

Two, Clinical controlled trial.

1 object and method.

1.1 object.

1.1.1 case selection: in January, 2011 ~ 2013 are diagnosed as Nasopharyngeal Carcinoma Patients 89 example year February, all make a definite diagnosis through histopathologic examination, and Ka Shi scoring >65 divides, and before treatment, surrounding hemogram, hepatic and renal function, electrocardiogram etc. check without radiotherapy contraindication.Wherein man 61 example, female 28 example, age 26 ~ 67(42.6 ± 8.5) year.Pathological: scale cancer 78 falls, adenocarcinoma 7 example, undifferentiated carcinoma 4 example.By stages by International Union Against Cancer (UICC) staging scale in 1989: III phase 49 example, IV phase 40 example.

1.1.2 divide into groups: be divided into matched group 30 example, decoction group 30 example and ointment group 29 example.Before three groups of patient treatments sex, the age and by stages on compare, no significant difference (P>0.05), has comparability.

1.2 method.

1.2.1 Therapeutic Method:

Matched group takes conventional radiotheraphy+FP scheme chemotherapy: 1. Radiation treatment plans: primary tumor first face neck combines wild DT 36Gy, after change ears before wild or wild to DT 70 ~ 74 Gy before adding nose; Metastatic Lymph Nodes first face neck combines wild DT 36 Gy, after change full neck tangent line Dm 23 Gy, then make local dose to DT 64 Gy to there being lymph node region to add electron beam; 2. FP scheme chemotherapy: 5-fluorouracil 750 mg/m ², 1st ~ 3 days; Cisplatin 30 mg/m ², 1 ~ 3d, in radiotherapy pre-induction 2 cycles (14d is 1 cycle);

Decoction group is on matched group scheme basis, and before chemotherapy starts, 1 thoughtful radiotherapy terminates with gained decoction oral in the embodiment of the present invention 1,2 times/d;

Ointment group, on matched group Radiation treatment plans basis, starts first 1 week with gained decoction oral in the embodiment of the present invention 1,2 times/d to radiotherapy from chemotherapy; Starting front 1 thoughtful radiotherapy from radiotherapy terminates with gained ointment in the embodiment of the present invention 3 at radiotherapy position local topical, and it is 1 time/d that radiotherapy starts medication in first 1 week, and radiation period medication is 2 times/d, and medication and radiotherapy in the treatment interval are at more than 1h;

3 groups of radiation therapy session terminate rear evaluation curative effect.

1.2.2 criterion of therapeutical effect: with reference to WHO standard evaluation curative effect in " Radiation Oncology ", be divided into CR(completed tumor regression), PR(tumor partial regression >=50%), NC(tumor regression <50%, or unchanged), PD(tumor increase >=25% or there is new focus), effective percentage=(CR+PR)/total case load.

1.2.3 1 year is followed up a case by regular visits to, record local recurrence and metastasis situation.

1.2.4 statistical analysis: SPSS 16.0 carries out statistical analysis.Measurement data t checks, enumeration data χ ²inspection.

2 results.

2.1 3 groups of Comprehensive Clinical comparitive study: see the following form,

Group	Number of cases	CR	PR	NC	PD	Effective percentage
							Matched group	30	2	9	12	7	36.67%
Decoction group	30	5	15	7	3	66.67%
							Ointment group	29	3	16	,6	4	65.52%

Decoction group effective percentage is apparently higher than matched group (χ ²=5.41, P<0.05), ointment group effective percentage is apparently higher than matched group (χ ²=4.91, P<0.05).Result shows, pharmaceutical composition disclosed in this invention has the effect of chemicotherapy potentiation, and chemotherapy adopts oral intervention, the effect that adopts ointment external to intervene before radiotherapy and in radiotherapy and omnidistance decoction oral effect suitable (P>0.05).

In 2.2 one years, local recurrence and metastasis situation compare: three groups of patient's local relapse and metastasis incidence rate situation are matched group 33.3%(10/30), 30.0%(9/30), decoction group 10.0%(3/30), 13.33%(4/30), ointment group 13.8%(4/29), 13.8%(4/29).Decoction group local relapse is starkly lower than matched group (χ ²=4.81, P<0.05).Overall recurrence and the rate of transform compare, and decoction group and ointment group are all lower than matched group (χ ²=5.71, P<0.05; χ ²=4.05, P<0.05).

2.3 radiotherapy local skin toxicity incidence rates compare: decoction group (10/30), ointment group (7/29) are all lower than matched group (18/30), and difference has statistical significance (P<0.05, P<0.01).

3. conclusion.

This result of study shows, take the oral and ointment group external effective percentage of decoction group of the present invention apparently higher than matched group, show that prescription of the present invention has good gain effect for radiotherapy, and the untoward reaction of radiotherapy local skin a situation arises is starkly lower than matched group, illustrate that pharmaceutical composition prepared by the inventive method has the advantage that untoward reaction is comparatively light, safety is higher in radiotherapy potentiation, local attenuation.

Claims

1. a preparation method for nasopharyngeal carcinoma aid in skin ointment, is characterized in that, is made up of following steps: