CN105147811B - A kind of external medicine composition and preparation method thereof for preventing and treating hand-foot syndrome - Google Patents
A kind of external medicine composition and preparation method thereof for preventing and treating hand-foot syndrome Download PDFInfo
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Abstract
The invention discloses a kind of for preventing and treating the external medicine composition of hand-foot syndrome, the Chinese medicine composition is manufactured as follows: kuh-seng 12-18 parts by weight, lopseed 12-18 parts by weight, Radix Angelicae Sinensis 12-18 parts by weight, cortex dictamni 12-18 parts by weight, root of Dahurain angelica 8-12 parts by weight, radix paeoniae rubra 12-18 parts by weight, it is secondary that Radix Angelicae Sinensis, the root of Dahurain angelica, cortex dictamni one are reinstated into alcohol reflux extraction, merge alcohol extract, recycle ethyl alcohol, it is concentrated into clear cream, for use；Separately radix paeoniae rubra, kuh-seng, lopseed are added water to cook together, collecting decoction is concentrated into clear cream；Alcohol extracting clear cream is proposed clear cream with water to merge, continues to be concentrated into thick paste, proper auxiliary materials is added, external-applied ointment is made.The external medicine composition can effectively treat hand-foot syndrome.
Description
Technical field
The preparation side of the present invention relates to a kind of external medicine composition for preventing and treating hand-foot syndrome and the composition
Method and purposes, belong to tcm field.
Background technique
Malignant tumour is to endanger the important diseases of human life and health, and chemotherapy, targeted therapy are clinical most common treatments
Method.In recent years, Biological target therapy achieves unprecedented progress, and it is indispensable in oncotherapy that chemotherapy, which remains on,
Few means, but while targeted therapy, chemotherapy acquisition curative effect, relevant toxic side effect has also seriously affected treatment curative effect
And quality of life improves.Wherein, hand-foot syndrome is one of the toxic side effect that chemotherapy, targeted therapy are common in recent years, because it is straight
The quality of life that will affect patient is connect, patient is even resulted in and is not resistant to further treat, clinical efficacy reduces.Therefore, it finds
Curative effect is reliable, the treatment method of Small side effects and economy prevents and treats the toxic side effect with highly important clinical meaning.
Hand-foot syndrome (hand-foot syndrome, HFS) also known as slaps toe sensory deprivation erythema syndrome
(Palmer-planter Erythrodysesthesia Syndrome PPES), is the skin as caused by antineoplaston
Toxic reaction is more common in chemotherapeutics such as capecitabine, cytarabine, cyclophosphamide, docetaxel, vinorelbine, especially with card
His shore is trained to attach most importance to.Targeted therapy medicine such as Sorafenib, Sutent etc. can also cause hand-foot syndrome.The generation of HFS, not only
It affects the treatment, and has seriously affected the quality of life of patient.The typical clinical manifestations of hand-foot syndrome are that a kind of progressive adds
The cutaneous lesions of weight, hand are easier to be involved compared with foot.Onset symptoms are palm and vola pruitus, palm, finger tip and vola
Hyperemia then occurs referring to/toe end feeling of pain, hand/skin of foot erythema, tension, insensitive, numb, pachylosis, chap
It splits, small number of patients can have finger to cut finger sample skin injury, watery blood bubble occur, furfur, exudation, even festers at decortication, and can be secondary
Infection.Patient Ke Yin has an intense pain and can not walk, and serious person can lose part life processing capacity.Clinical response has certainly more
It is sex-limited, but can be recurred after being administered again.
The generation of hand-foot syndrome not only influences the effect of tumor patient antineoplaston, and the life daily to patient
Work causes huge puzzlement, directly reduces the quality of life of patient.The current treatment means of modern medicine are mainly with large dosage
VitB6, cox 2 inhibitor and part apply put on the skin urea frost etc. prevention and/or mitigate hand-foot syndrome severity, but without agree
Constant current modulation effect, while due to a lack of large-scale case curative effect evaluation, so can not also determine the validity of drug.At present it is most effective most
Direct treatment is to adjust the drug withdrawal of dosage or one to two weeks, waits the voluntarily alleviation of hand-foot syndrome symptom.At present both at home and abroad
Research be mostly prevent hand-foot syndrome, improve the symptomatic treatment of symptom.
In various treatment means, external treatment of tcm is thoroughly evil nearby through Topical administration, can guide drugs to illness station after skin absorption,
Lesion local application to alleviate symptom, played positive effect for treating gentle solution hand-foot syndrome.Common Chinese medicine
Outer treating method including applying the ointment outside, soup is smoked washes.Wherein, apply the ointment outside have Groomwell root oil, scorching enemy's oil (mainly by Asian puccoon, Radix Astragali, when
The composition such as return), moist exposed burn cream (coptis, Cortex Phellodendri, radix scutellariae, Asian puccoon, Rhizoma Chuanxiong, the root of Dahurain angelica, pearl, borax, borneol) etc..Washing lotion packet
Include: stilbene returns Tongluo Decoction (Radix Astragali, ramulus cinnamomi, Asian puccoon, pawpaw, turmeric, Radix Angelicae Sinensis, asarum, safflower, tag), dredging collateral and promoting blood circulation particle (old stork
Grass, monkshood, ramulus cinnamomi, safflower), (Cortex Phellodendri, Semen Coicis Semen Coicis, radix cyathulae, peach kernel, safflower, bush, stretches muscle at rhizoma atractylodis to four wonderful Huoxue San "s
Grass), Huangqi Guizhi Wuwu Tang (Radix Astragali, ramulus cinnamomi, Radix Angelicae Sinensis, caulis piperis futokadsurae, safflower, radix paeoniae rubra, Radix Paeoniae Alba), ingredient-modified Taohong Siwu decoction (peach kernel,
Safflower, Rehmannia glutinosa, Radix Angelicae Sinensis, Rhizoma Chuanxiong, ramulus cinnamomi, radix cyathulae, Radix Glycyrrhizae, jujube), Traditional Chinese medicine foot-bath side's (ramulus cinnamomi, Radix Aconiti, ginger, honeysuckle
Rattan, prepared fleece flower root, Flos Carthami, caulis trachelospermi) etc..Although the treatment hand-foot syndrome that these drugs can not be fully effective, in
Medicine external preparation will necessarily increasingly show its irreplaceable advantage in terms of improving chemotherapy toxic side effect.
Summary of the invention
The object of the present invention is to provide a kind of new external medicine compositions, can effectively prevent hand-foot syndrome.Simultaneously
The preparation method of the composition is provided.
What the object of the invention was achieved through the following technical solutions.
The present invention provides a kind of for preventing and treating the external medicine composition of hand-foot syndrome, and the effective component of the composition is
Made of the bulk pharmaceutical chemicals of following weight ratio: 12-18 parts of kuh-seng, 12-18 parts of lopseed, 12-18 parts of Radix Angelicae Sinensis, cortex dictamni 12-18
Part, 8-12 parts of the root of Dahurain angelica, 12-18 parts of radix paeoniae rubra.
It is exact, the composition of above-mentioned each bulk pharmaceutical chemicals are as follows: 15 parts of kuh-seng, 15 parts of lopseed, 15 parts of Radix Angelicae Sinensis, 15 parts of cortex dictamni,
10 parts of the root of Dahurain angelica, 15 parts of radix paeoniae rubra.
The party is monarch, heat-clearing and damp-drying drug, dispelling wind and arresting itching with kuh-seng；Minister is with cortex dictamni, lopseed dispelling wind and eliminating dampness, antipruritic analgesic,
Radix Angelicae Sinensis promoting blood circulation and stopping pain；Assistant is dispelled pathogenic wind and remove dampness with the root of Dahurain angelica, is relieved pain, radix paeoniae rubra promoting blood circulation, removing blood stasis and relieving pain, and heat-clearing and damp-drying drug is played altogether by full side, and wind-dispelling stops
Itch, the function of promoting blood circulation and stopping pain there is significant drug effect symptoms include skin to be chapped from the cold hand-foot syndrome caused by tumor chemotherapeutic drug, itch, pain
Bitterly.
Chinese medicine thinks that external treatment of tcm can be thoroughly evil nearby through Topical administration, can guide drugs to illness station after skin absorption, in lesion
Local application to alleviate symptom.Therefore, external preparation is preferentially made in the present invention, the specific steps are as follows:
1) Radix Angelicae Sinensis, the root of Dahurain angelica, cortex dictamni one are reinstated into alcohol reflux and extracts secondary, merging alcohol extract, recycling ethyl alcohol is concentrated into
Clear cream, for use；
2) separately radix paeoniae rubra, kuh-seng, lopseed are added water to cook together, collecting decoction is concentrated into clear cream；
3) alcohol extracting clear cream is proposed clear cream with water to merge, continues to be concentrated into thick paste；
4) proper auxiliary materials are added in thick paste, external-applied ointment is made.
In above-mentioned steps, conventionally used concentration of alcohol is 75%-95%, is advisable with 95%；Each reflux extracting time
For 1-2 hour；Amount of water when water decocts is advisable with covering all bulk pharmaceutical chemicals, is decocted 2-3 times, 1-1.5 hours each；
The auxiliary material is the customary adjuvant of external-applied ointment, including matrix and preservative etc..
Beneficial effect
For the effect for proving drug of the present invention, inventor uses perspective random double blind test researching and designing, in China
Gate of Pervasive Peace hospital of medical courses in general institute, Beijing Tumour Hospital, Cancer Hospital of Chinese Academy of Medical Sciences, China TCM Academy of Sciences Xiyuan Hospital
Carry out the clinical research for the treatment of HFS.Test group enters group 72, and control group enters group 72.Test group uses 1 institute of the embodiment of the present invention
Paste processed, is applied to brothers' affected part of warm water foam washing, each 5g, 2 times a day；Control group using matrix ointment (lanolin, it is all
Intellectual circle etc.) smear warm water foam washing brothers' affected part, each 5g, 2 times a day.Two groups of observing times are 2 weeks.
The following are the main contents of experiment:
1 data and method
1.1 Clinical design
Using random, double blind, control design, by Chinese department of traditional Chinese medicine institute and Beijing Tumour Hospital, Chinese department of traditional Chinese medicine institute
Xiyuan hospital, Beijing Tumour Hospital, Cancer Hospital of Chinese Academy of Medical Sciences collaboration are completed, and case is mainly derived from this Beijing and complete
State carrys out various regions the tumor patient of this four hospital admissions, and drug early period is used to treat the cure-remarkable-effectiveness rate of hand-foot syndrome according to the present invention
77%, the cure-remarkable-effectiveness rate that the past document report control group treats hand-foot syndrome is 46%, calculates case load, warp using SPSS software
It calculates, n=59, it is contemplated that influence lost to follow-up also needs to add 20% sample size again, therefore at least needs 72 pairs of observation, is included in disease altogether
Example 144, wherein test group 72, control group 72.
1.2 case selection
1.2.1 diagnostic criteria
1.2.1.1 Western medicine diagnostic criteria
Diagnosing tumor standard reference Department of Medical Administration of Ministry of Health of the People's Republic of China " Chinese common cancer diagnosis and treatment specification ",
Staging scale is referring to " NCCN clinical practice guideline (Chinese version) first edition in 2012 ": HFS grade scale is formulated anti-referring to NCI
Tumour medicine is acute and subacute toxicity reacts indexing standard.
Hand-foot syndrome NCI grade scale:
Level-one: (such as feeling of numbness, picotement are burnt with cacesthesia for slight skin change or dermatitis (such as erythema, furfur)
Sense), but do not influence daily routines；
Second level: if preceding skin change is with pain, slight effect daily routines, skin surface is complete；
Three-level: ulcerative dermatitis or skin change seriously affect daily life with severe pain, hence it is evident that disorganization
(such as furfur, bubble, bleeding, oedema)
1.2.1.2 tcm diagnosis standard
Syndrome of qi deficiency: shortness of breath sound is low, spiritlessness and weakness；Few gas or lazy speech；Spontaneous perspiration；Tongue nature is light fat or print with teeth；Weak pulse
(weak, soft, moisten), or have a dizzy spell, dynamic then all diseases are aggravated.
Syndrome of blood deficiency: pale or sallow complexion, eyelid, lip, tongue nature, the color of onyx are light white, dizzy, or see dim eyesight, two
Xerophtalmia, palpitaition, dreaminess, amnesia, mind is tired, even brothers are numb or menstruation quantity is few, color is light, menostasis of delaying, the thin nothing of arteries and veins
Power.
Syndrome of spleen deficiency: loss of appetite receives few, abdominal fullness and distention, after food it is swollen very；Diarrhea with loose stool, limbs burnout, spiritlessness and weakness, few gas
Lazyness speech；Sallow complexion；Or fat or edema, pale tongue with white fur, arteries and veins are slow or weak.
Have three, assertive evidence often deposit together by same syndrome of qi deficiency, yin deficiency syndrome or yang deficiency syndrome.
Yin deficiency syndrome: dysphoria in chestpalms-soles；Swallow dry dry；Tongue is red or less fur, without tongue fur；Thready rapid pulse；
Secondary card: it fires in the afternoon；Just it ties or urinates short red；Night sweat.
Have main symptom three, secondary card one.This card often saves as together syndrome of deficiency of both qi and yin with syndrome of qi deficiency.
Syndrome of blood stasis: there is the syndrome of pain, lump, bleeding, hemostasis color arteries and veins sign etc..Its pain feature is shouting pain, sore spot
Tenderness, it is fixed do not move, often hypnalgia very；Hemostasis color arteries and veins sign mainly has darkish complexion or cyanosis of the lips and nails or subcutaneous purple plague purpura, or
There is Filamentous red thread in scaly dry skin, a symptom of blood stasis or venous engorgement on abdomen or skin or tongue has a purple dot, sublingual vessel varicose, arteries and veins it is mostly thin puckery or
Knot, generation, acrotism etc..
Blood-heat syndrome: fever aggravated at night or hectic fever, thirsty, flushing is vexed, and insomnia, dysphoria is not peaceful, even frenzied, refreshing mistake is raved
Language, or see that various bleeding color depths are red or macula appears, or be sore carbuncle, tongue is deep red, rapid and swift pulse etc..
Yin deficiency syndrome: body is thin, and dryness of the mouth and throat, hectically flushed cheeks are dysphoria in chestpalms-soles, hectic fever, night sweat, oliguria with yellow urine, stool is dry
Knot, red tongue with a little fluid or less fur, thready rapid pulse.
1.3 test medications and drug distribution
1.3.1 medication is tested
Test group: the made ointment of the embodiment of the present invention 1, each 5g are once in the morning and once at night applied to the affected part of warm water cleaning.
Control group: matrix ointment (lanolin, vaseline etc.), each 5g are once in the morning and once at night applied to the trouble of warm water cleaning
Place.
Two groups are respectively intervened 14 days.
1.3.2 drug distributes
Patient will be randomized into test group and control group in 1:1 ratio, observe doctor according to medicine number sequence dispensing, no
Drug must be selected, number must not be destroyed, which remains unchanged during the whole test process.
1.3.3 drug is checked
When each follow-up, observation doctor records the Quantity of drugs that patient receives, takes and give back in detail, tested to determine
The compliance of person's medication, and recorded in time in case report form, and determine whether the patient continues to participate in test.If patient
Evaluation is taken medicine by scheme rule every time, and is reached and answered the 80% of dosage, then it is assumed that the patient compliance is good.
1.3.4 the regulation of drug combination
1. during test, the drug of other treatment hand-foot syndromes must not be used.
2. merge the other drugs that must take of other diseases and treatment method, enter still to maintain after group original treatment method but
It must be recorded in detail in drug combination table.
2. the therapeutic evaluation of medication after two weeks
The symptom of 1 hand-foot syndrome of table improves situation
As shown in Table 1, after treatment 2 weeks, each symptom of hand-foot syndrome and total score are on a declining curve, in the group of test group
More variant statistically significant (P < 0.05), drug of the present invention is effective to treatment hand-foot syndrome after illustrating medication 2 weeks
's.The symptom of test group improve situation better than control group, test group and control group in insensitive, feeling of numbness, picotement, burn
Sense, erythema, swelling, dry furfur, ulcer, pain symptom and total score improve aspect, statistically significant (the P < of group difference
0.05)。
Specific embodiment
Embodiment 1: the preparation of external-applied ointment of the present invention
Prescription: kuh-seng 150g, lopseed 150g, Radix Angelicae Sinensis 150g, cortex dictamni 150g, root of Dahurain angelica 100g, radix paeoniae rubra 150g
Preparation method: adding the alcohol reflux of 5 times of amounts 95% to extract twice Radix Angelicae Sinensis, the root of Dahurain angelica, cortex dictamni, and 1.5 hours for the first time, the
Secondary 1 hour, merge alcohol extract, recycles ethyl alcohol, be concentrated into clear cream, for use.8 times of amount water are added to decoct radix paeoniae rubra, kuh-seng, lopseed
Twice, it decocting 1.5 hours every time, second of decoction 1 hour, collecting decoction is concentrated into clear cream, merge with above-mentioned alcohol extracting clear cream,
Continue to be concentrated into thick paste.In thick paste be added matrix and appropriate preservative etc., stirring, placement, it is filling to get.
Embodiment 2: the typical case that the present invention applies
Case one: Chen, male, 53 years old, Beijing people from Shijingshan
The state of an illness: patient suffers from colon cancer with lymphatic metastasis, and histological type is gland cancer, and T3N1M0 takes orally the 3rd period of Xeloda
There is hand-foot syndrome, severe pain seriously affects daily life with blister, decortication, ulcer, inconvenient walking, and HFS is classified as III
Grade.Previously there is diabetes B history 3 years, glycemic control is stablized, and fasting blood-glucose is looked into before treatment for 7.87mmol/L, outside non-diabetic
All neurotrosises and diabetes.
Treatment: it gives 1 gained ointment of the embodiment of the present invention and applies outside, twice daily.
Effect: follow-up after 14 days, can normal walking, private prosecution is in addition to feeling of numbness and picotement, no significant discomfort symptom,
Skin surface is complete, without obvious ulcer.HFS classification drops to I grade.
Case two: paying certain, male, and 54 years old, Pekinese
The state of an illness: malignant tumor of liver and Lung metastases find 3 months, take orally targeted drug sotan 2 months, daily 50mg, it is rear because
Serious hand-foot skin reaction is discontinued, when entering group, patient's foot bottom skin ulcer, and decortication, oozing of blood, severe pain, difficulty in walking, sternly
Ghost image rings the antineoplaston and daily life quality of patient.Hand-foot skin reaction is classified as III level.
Treatment: it gives 1 gained ointment of the embodiment of the present invention and applies outside, twice daily.
Effect: pain improves obvious after patient tells medication 3 days, pays a return visit after 14 days, and hand-foot skin significant reaction mitigates, classification
Drop to 1 grade.
Case three: Xiao, female 57 years old
The state of an illness: part row left breast cancer modified skinsuture of in August, 2010, pathology: invasive ductal carcinoma, ER (+), PR (+),
HER-2(-).In August, 2011 finds liver M, row taxol+4 period of capecitabine chemotherapy, and hand-foot syndrome occurred in the 4th period,
Start to treat within 2 months 2013, start oral the 6th period of capecitabine when treatment, patient brothers are dry and cracked, and decortication is with foot especially
It writes.It is classified as II grades.
Treatment: it gives 1 gained ointment of the embodiment of the present invention and applies outside, twice daily.
Effect: after patient treats 14 days, symptom improves obviously, and classification drops to 0 grade.
Case four: Hu, female, 60 years old, Haidian District Beijing people
The state of an illness: making a definite diagnosis breast cancer for 2011, and the right breast modified radical mastectomy of row, specific pathology is unknown, and postoperative row taxol+
5 period of capecitabine chemotherapy, now in chemotherapy.It is dry and cracked to start finger skin when treatment, vola redness, burn feeling, hand-foot syndrome
It is classified as I grades.
Treatment: it gives 1 gained ointment of the embodiment of the present invention and applies outside, twice daily.
Effect: further consultation after treatment 14 days, hand-foot syndrome symptom is unobvious, and classification drops to 0 grade.
Case five: Mr. Li, female, 39 years old, people from Hebei
The state of an illness: discovery malignant tumor of colon in 2012, in October, 2012 row colon carcinectomy, postoperative 1 year and a half check hair
Existing hepatic metastases, row taxotere+Xeloda chemotherapy, now in chemotherapy.When entering group, patient's ulcer of sole is more, and pain relieving ointment is posted on surface
Medicine, sharp ache influence the implementation of the antitumor scheme of patient, and cause great inconvenience to the daily life of patient, start to control
Hand-foot syndrome is classified as III level when treatment.
Treatment: giving 1 gained ointment of the embodiment of the present invention and apply outside, and patient embrocates after adhering to warm water foam washing affected part daily, and 14
Further consultation after it, effect are preferable.Hand-foot syndrome drops to I grades.
Claims (4)
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| CN108938759B (en) * | 2017-05-25 | 2021-08-13 | 四川省中医药科学院 | A kind of medicine or daily chemical composition for treating hand-foot syndrome and preparation method and use thereof |
| CN107158116A (en) * | 2017-07-24 | 2017-09-15 | 甘肃瀛海堂医药有限公司 | A kind of external medicine composition for treating the tinea manuum |
| CN108888728A (en) * | 2018-09-28 | 2018-11-27 | 昆明市中医医院 | A kind of Chinese herbal fumigation and washing formula for treating hand-foot syndrome |
| CN112370497A (en) * | 2020-12-08 | 2021-02-19 | 安徽医科大学第一附属医院 | Traditional Chinese medicine compound ointment for treating hand-foot skin reaction caused by TKIs (Total TKIs inhibitors) and preparation method thereof |
| CN115337341B (en) * | 2021-05-12 | 2023-04-07 | 江苏省中医院 | Traditional Chinese medicine composition for resisting hand-foot syndrome as well as preparation method and application thereof |
| CN116440215B (en) * | 2023-04-13 | 2025-02-11 | 中国中医科学院广安门医院 | A Chinese medicine composition for treating hand-foot syndrome and its preparation method and application |
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