CN117414387A - 一种防治亚实性肺结节的中药组合物及其制备方法和应用 - Google Patents
一种防治亚实性肺结节的中药组合物及其制备方法和应用 Download PDFInfo
- Publication number
- CN117414387A CN117414387A CN202310984697.XA CN202310984697A CN117414387A CN 117414387 A CN117414387 A CN 117414387A CN 202310984697 A CN202310984697 A CN 202310984697A CN 117414387 A CN117414387 A CN 117414387A
- Authority
- CN
- China
- Prior art keywords
- parts
- chinese medicine
- traditional chinese
- medicine composition
- patients
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000003814 drug Substances 0.000 title claims abstract description 89
- 239000000203 mixture Substances 0.000 title claims abstract description 39
- 230000002685 pulmonary effect Effects 0.000 title claims abstract description 27
- 238000002360 preparation method Methods 0.000 title claims abstract description 8
- 238000011282 treatment Methods 0.000 claims abstract description 64
- 210000003038 endothelium Anatomy 0.000 claims abstract description 9
- 244000144725 Amygdalus communis Species 0.000 claims description 16
- 235000011437 Amygdalus communis Nutrition 0.000 claims description 16
- 241000132446 Inula Species 0.000 claims description 16
- 235000020224 almond Nutrition 0.000 claims description 16
- 244000303040 Glycyrrhiza glabra Species 0.000 claims description 15
- 235000006200 Glycyrrhiza glabra Nutrition 0.000 claims description 15
- 244000274050 Platycodon grandiflorum Species 0.000 claims description 15
- 235000006753 Platycodon grandiflorum Nutrition 0.000 claims description 15
- 241000239226 Scorpiones Species 0.000 claims description 15
- 240000007164 Salvia officinalis Species 0.000 claims description 13
- 241000264877 Hippospongia communis Species 0.000 claims description 11
- 241000112528 Ligusticum striatum Species 0.000 claims description 11
- 238000000034 method Methods 0.000 claims description 11
- 239000007787 solid Substances 0.000 claims description 9
- LPLVUJXQOOQHMX-QWBHMCJMSA-N glycyrrhizinic acid Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@@H]1C([C@H]2[C@]([C@@H]3[C@@]([C@@]4(CC[C@@]5(C)CC[C@@](C)(C[C@H]5C4=CC3=O)C(O)=O)C)(C)CC2)(C)CC1)(C)C)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O LPLVUJXQOOQHMX-QWBHMCJMSA-N 0.000 claims description 8
- 235000011477 liquorice Nutrition 0.000 claims description 8
- 240000004534 Scutellaria baicalensis Species 0.000 claims description 7
- 235000017089 Scutellaria baicalensis Nutrition 0.000 claims description 7
- 235000005412 red sage Nutrition 0.000 claims description 7
- 235000001453 Glycyrrhiza echinata Nutrition 0.000 claims description 6
- 235000017382 Glycyrrhiza lepidota Nutrition 0.000 claims description 6
- 235000005035 Panax pseudoginseng ssp. pseudoginseng Nutrition 0.000 claims description 6
- 235000003140 Panax quinquefolius Nutrition 0.000 claims description 6
- 235000017276 Salvia Nutrition 0.000 claims description 6
- 238000001035 drying Methods 0.000 claims description 6
- 235000008434 ginseng Nutrition 0.000 claims description 6
- 229940010454 licorice Drugs 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 241000132012 Atractylodes Species 0.000 claims description 5
- 244000088415 Raphanus sativus Species 0.000 claims description 5
- 235000006140 Raphanus sativus var sativus Nutrition 0.000 claims description 5
- 239000000284 extract Substances 0.000 claims description 5
- 239000000706 filtrate Substances 0.000 claims description 5
- 238000001914 filtration Methods 0.000 claims description 5
- 238000005303 weighing Methods 0.000 claims description 5
- 244000197580 Poria cocos Species 0.000 claims description 4
- 235000008599 Poria cocos Nutrition 0.000 claims description 4
- 244000150195 Cyperus longus Species 0.000 claims description 3
- 235000018109 Cyperus longus Nutrition 0.000 claims description 3
- 244000075634 Cyperus rotundus Species 0.000 claims description 3
- 235000005010 Scirpus paludosus Nutrition 0.000 claims description 3
- 235000006533 astragalus Nutrition 0.000 claims description 3
- 239000008187 granular material Substances 0.000 claims description 3
- 230000002265 prevention Effects 0.000 claims description 3
- 239000002775 capsule Substances 0.000 claims description 2
- 239000002552 dosage form Substances 0.000 claims description 2
- 239000007788 liquid Substances 0.000 claims description 2
- 239000000843 powder Substances 0.000 claims description 2
- 241001061264 Astragalus Species 0.000 claims 1
- 244000131316 Panax pseudoginseng Species 0.000 claims 1
- 239000002671 adjuvant Substances 0.000 claims 1
- -1 decoctions Substances 0.000 claims 1
- 239000002674 ointment Substances 0.000 claims 1
- 210000004233 talus Anatomy 0.000 claims 1
- 208000024891 symptom Diseases 0.000 abstract description 28
- 206010062717 Increased upper airway secretion Diseases 0.000 abstract description 23
- 208000026435 phlegm Diseases 0.000 abstract description 23
- 239000008280 blood Substances 0.000 abstract description 21
- 230000000694 effects Effects 0.000 abstract description 21
- 208000011580 syndromic disease Diseases 0.000 abstract description 12
- 206010036790 Productive cough Diseases 0.000 abstract description 9
- 206010008479 Chest Pain Diseases 0.000 abstract description 8
- 230000001105 regulatory effect Effects 0.000 abstract description 8
- 230000001965 increasing effect Effects 0.000 abstract description 7
- 206010067484 Adverse reaction Diseases 0.000 abstract description 6
- 230000006838 adverse reaction Effects 0.000 abstract description 6
- 210000000582 semen Anatomy 0.000 abstract description 5
- 241000628997 Flos Species 0.000 abstract description 4
- 241000522620 Scorpio Species 0.000 abstract description 4
- 239000009490 scorpio Substances 0.000 abstract description 4
- 238000012216 screening Methods 0.000 abstract description 3
- 210000004369 blood Anatomy 0.000 description 18
- 210000004072 lung Anatomy 0.000 description 18
- 208000002193 Pain Diseases 0.000 description 15
- 210000000952 spleen Anatomy 0.000 description 11
- 241000287828 Gallus gallus Species 0.000 description 10
- 206010056342 Pulmonary mass Diseases 0.000 description 10
- 210000004185 liver Anatomy 0.000 description 10
- 235000009508 confectionery Nutrition 0.000 description 9
- 229940079593 drug Drugs 0.000 description 9
- 206010011224 Cough Diseases 0.000 description 7
- 230000001737 promoting effect Effects 0.000 description 7
- 238000012360 testing method Methods 0.000 description 7
- 230000008859 change Effects 0.000 description 6
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 6
- 240000004371 Panax ginseng Species 0.000 description 5
- 230000007812 deficiency Effects 0.000 description 5
- 210000002784 stomach Anatomy 0.000 description 5
- 241000212322 Levisticum officinale Species 0.000 description 4
- 206010058467 Lung neoplasm malignant Diseases 0.000 description 4
- 206010028980 Neoplasm Diseases 0.000 description 4
- 208000004880 Polyuria Diseases 0.000 description 4
- 238000003745 diagnosis Methods 0.000 description 4
- 208000035475 disorder Diseases 0.000 description 4
- 230000035619 diuresis Effects 0.000 description 4
- 230000006870 function Effects 0.000 description 4
- 230000002496 gastric effect Effects 0.000 description 4
- 239000001645 levisticum officinale Substances 0.000 description 4
- 201000005202 lung cancer Diseases 0.000 description 4
- 208000020816 lung neoplasm Diseases 0.000 description 4
- 230000003211 malignant effect Effects 0.000 description 4
- 235000019640 taste Nutrition 0.000 description 4
- 201000007100 Pharyngitis Diseases 0.000 description 3
- 241000207929 Scutellaria Species 0.000 description 3
- 206010047700 Vomiting Diseases 0.000 description 3
- 208000006673 asthma Diseases 0.000 description 3
- 230000017531 blood circulation Effects 0.000 description 3
- 210000001124 body fluid Anatomy 0.000 description 3
- 239000010839 body fluid Substances 0.000 description 3
- 230000006866 deterioration Effects 0.000 description 3
- 210000002216 heart Anatomy 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 230000007935 neutral effect Effects 0.000 description 3
- 231100000614 poison Toxicity 0.000 description 3
- 238000002203 pretreatment Methods 0.000 description 3
- 238000011160 research Methods 0.000 description 3
- 210000003296 saliva Anatomy 0.000 description 3
- 231100000331 toxic Toxicity 0.000 description 3
- 230000002588 toxic effect Effects 0.000 description 3
- 239000003440 toxic substance Substances 0.000 description 3
- 230000008673 vomiting Effects 0.000 description 3
- 208000004998 Abdominal Pain Diseases 0.000 description 2
- 206010000234 Abortion spontaneous Diseases 0.000 description 2
- 201000000736 Amenorrhea Diseases 0.000 description 2
- 206010001928 Amenorrhoea Diseases 0.000 description 2
- 208000006820 Arthralgia Diseases 0.000 description 2
- 241000045403 Astragalus propinquus Species 0.000 description 2
- 206010010774 Constipation Diseases 0.000 description 2
- 206010010904 Convulsion Diseases 0.000 description 2
- 241000721047 Danaus plexippus Species 0.000 description 2
- 208000005171 Dysmenorrhea Diseases 0.000 description 2
- 206010013935 Dysmenorrhoea Diseases 0.000 description 2
- 239000009636 Huang Qi Substances 0.000 description 2
- 208000019255 Menstrual disease Diseases 0.000 description 2
- 206010068319 Oropharyngeal pain Diseases 0.000 description 2
- 206010062237 Renal impairment Diseases 0.000 description 2
- 208000005392 Spasm Diseases 0.000 description 2
- 206010041956 Stasis syndrome Diseases 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 231100000540 amenorrhea Toxicity 0.000 description 2
- 230000001174 ascending effect Effects 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 235000019658 bitter taste Nutrition 0.000 description 2
- 208000005634 blind loop syndrome Diseases 0.000 description 2
- 201000011510 cancer Diseases 0.000 description 2
- 230000004087 circulation Effects 0.000 description 2
- 230000036461 convulsion Effects 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 230000004069 differentiation Effects 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 208000002173 dizziness Diseases 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
- 235000013305 food Nutrition 0.000 description 2
- 238000003384 imaging method Methods 0.000 description 2
- 230000001976 improved effect Effects 0.000 description 2
- 230000001939 inductive effect Effects 0.000 description 2
- 210000003734 kidney Anatomy 0.000 description 2
- 230000005977 kidney dysfunction Effects 0.000 description 2
- 208000019423 liver disease Diseases 0.000 description 2
- 230000005976 liver dysfunction Effects 0.000 description 2
- 230000003908 liver function Effects 0.000 description 2
- 201000007227 lymph node tuberculosis Diseases 0.000 description 2
- 208000015994 miscarriage Diseases 0.000 description 2
- 230000036961 partial effect Effects 0.000 description 2
- 230000002829 reductive effect Effects 0.000 description 2
- 238000012552 review Methods 0.000 description 2
- 208000000995 spontaneous abortion Diseases 0.000 description 2
- 230000006641 stabilisation Effects 0.000 description 2
- 238000011105 stabilization Methods 0.000 description 2
- 238000007619 statistical method Methods 0.000 description 2
- 238000005728 strengthening Methods 0.000 description 2
- 230000008961 swelling Effects 0.000 description 2
- 238000012353 t test Methods 0.000 description 2
- 239000003053 toxin Substances 0.000 description 2
- 231100000765 toxin Toxicity 0.000 description 2
- 230000002936 tranquilizing effect Effects 0.000 description 2
- PQGCEDQWHSBAJP-TXICZTDVSA-N 5-O-phosphono-alpha-D-ribofuranosyl diphosphate Chemical compound O[C@H]1[C@@H](O)[C@@H](O[P@](O)(=O)OP(O)(O)=O)O[C@@H]1COP(O)(O)=O PQGCEDQWHSBAJP-TXICZTDVSA-N 0.000 description 1
- 206010000060 Abdominal distension Diseases 0.000 description 1
- 206010000077 Abdominal mass Diseases 0.000 description 1
- 208000021959 Abnormal metabolism Diseases 0.000 description 1
- 206010061623 Adverse drug reaction Diseases 0.000 description 1
- 206010002383 Angina Pectoris Diseases 0.000 description 1
- 206010003445 Ascites Diseases 0.000 description 1
- 206010003598 Atelectasis Diseases 0.000 description 1
- 206010007247 Carbuncle Diseases 0.000 description 1
- 206010008190 Cerebrovascular accident Diseases 0.000 description 1
- 206010008469 Chest discomfort Diseases 0.000 description 1
- 206010051625 Conjunctival hyperaemia Diseases 0.000 description 1
- 206010012735 Diarrhoea Diseases 0.000 description 1
- 206010013647 Drowning Diseases 0.000 description 1
- 208000030453 Drug-Related Side Effects and Adverse reaction Diseases 0.000 description 1
- 208000000059 Dyspnea Diseases 0.000 description 1
- 206010013975 Dyspnoeas Diseases 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 206010015137 Eructation Diseases 0.000 description 1
- 206010017553 Furuncle Diseases 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- 235000017443 Hedysarum boreale Nutrition 0.000 description 1
- 235000007858 Hedysarum occidentale Nutrition 0.000 description 1
- 206010019468 Hemiplegia Diseases 0.000 description 1
- 208000031361 Hiccup Diseases 0.000 description 1
- 208000015817 Infant Nutrition disease Diseases 0.000 description 1
- 206010023126 Jaundice Diseases 0.000 description 1
- 241000207923 Lamiaceae Species 0.000 description 1
- 238000000585 Mann–Whitney U test Methods 0.000 description 1
- 206010027514 Metrorrhagia Diseases 0.000 description 1
- 208000019695 Migraine disease Diseases 0.000 description 1
- 208000016285 Movement disease Diseases 0.000 description 1
- 206010067482 No adverse event Diseases 0.000 description 1
- 206010030113 Oedema Diseases 0.000 description 1
- 101800000628 PDH precursor-related peptide Proteins 0.000 description 1
- 206010033557 Palpitations Diseases 0.000 description 1
- 208000002151 Pleural effusion Diseases 0.000 description 1
- 241001619461 Poria <basidiomycete fungus> Species 0.000 description 1
- 244000018633 Prunus armeniaca Species 0.000 description 1
- 235000009827 Prunus armeniaca Nutrition 0.000 description 1
- 208000007123 Pulmonary Atelectasis Diseases 0.000 description 1
- 206010067171 Regurgitation Diseases 0.000 description 1
- 235000004789 Rosa xanthina Nutrition 0.000 description 1
- 241000220222 Rosaceae Species 0.000 description 1
- 206010040007 Sense of oppression Diseases 0.000 description 1
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- 206010042674 Swelling Diseases 0.000 description 1
- 206010043376 Tetanus Diseases 0.000 description 1
- 241000130764 Tinea Species 0.000 description 1
- 208000002474 Tinea Diseases 0.000 description 1
- 206010067197 Tinea manuum Diseases 0.000 description 1
- 208000025865 Ulcer Diseases 0.000 description 1
- 206010047513 Vision blurred Diseases 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000000172 allergic effect Effects 0.000 description 1
- 208000002399 aphthous stomatitis Diseases 0.000 description 1
- 229940107666 astragalus root Drugs 0.000 description 1
- 208000010668 atopic eczema Diseases 0.000 description 1
- 208000027687 belching Diseases 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 235000021152 breakfast Nutrition 0.000 description 1
- 230000001914 calming effect Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 238000000546 chi-square test Methods 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 208000016508 combined lung carcinoma Diseases 0.000 description 1
- 238000013170 computed tomography imaging Methods 0.000 description 1
- 230000001276 controlling effect Effects 0.000 description 1
- 230000000994 depressogenic effect Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000001784 detoxification Methods 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 230000029087 digestion Effects 0.000 description 1
- 208000001848 dysentery Diseases 0.000 description 1
- 230000007717 exclusion Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000001815 facial effect Effects 0.000 description 1
- 230000001605 fetal effect Effects 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 239000001947 glycyrrhiza glabra rhizome/root Substances 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 230000023597 hemostasis Effects 0.000 description 1
- 241000411851 herbal medicine Species 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 206010022437 insomnia Diseases 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 230000003907 kidney function Effects 0.000 description 1
- 230000002147 killing effect Effects 0.000 description 1
- 239000004922 lacquer Substances 0.000 description 1
- 210000002429 large intestine Anatomy 0.000 description 1
- 210000001165 lymph node Anatomy 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 208000004396 mastitis Diseases 0.000 description 1
- 230000005906 menstruation Effects 0.000 description 1
- 230000006371 metabolic abnormality Effects 0.000 description 1
- 206010027599 migraine Diseases 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000001613 neoplastic effect Effects 0.000 description 1
- 210000005036 nerve Anatomy 0.000 description 1
- 230000024121 nodulation Effects 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 244000045947 parasite Species 0.000 description 1
- 244000052769 pathogen Species 0.000 description 1
- 230000008506 pathogenesis Effects 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 230000007170 pathology Effects 0.000 description 1
- 210000003516 pericardium Anatomy 0.000 description 1
- 230000000737 periodic effect Effects 0.000 description 1
- 206010036067 polydipsia Diseases 0.000 description 1
- 230000003449 preventive effect Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 235000019633 pungent taste Nutrition 0.000 description 1
- 238000010791 quenching Methods 0.000 description 1
- 244000132619 red sage Species 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 230000002441 reversible effect Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 208000013220 shortness of breath Diseases 0.000 description 1
- 210000000813 small intestine Anatomy 0.000 description 1
- 208000024794 sputum Diseases 0.000 description 1
- 210000003802 sputum Anatomy 0.000 description 1
- 238000000528 statistical test Methods 0.000 description 1
- 230000004206 stomach function Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
- 235000019605 sweet taste sensations Nutrition 0.000 description 1
- 230000001360 synchronised effect Effects 0.000 description 1
- 230000035922 thirst Effects 0.000 description 1
- 230000017423 tissue regeneration Effects 0.000 description 1
- 206010044008 tonsillitis Diseases 0.000 description 1
- 208000004371 toothache Diseases 0.000 description 1
- 229940126680 traditional chinese medicines Drugs 0.000 description 1
- 230000008736 traumatic injury Effects 0.000 description 1
- 238000011269 treatment regimen Methods 0.000 description 1
- 230000010415 tropism Effects 0.000 description 1
- 231100000397 ulcer Toxicity 0.000 description 1
- 210000003932 urinary bladder Anatomy 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/34—Campanulaceae (Bellflower family)
- A61K36/346—Platycodon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/57—Birds; Materials from birds, e.g. eggs, feathers, egg white, egg yolk or endothelium corneum gigeriae galli
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/63—Arthropods
- A61K35/64—Insects, e.g. bees, wasps or fleas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/63—Arthropods
- A61K35/646—Arachnids, e.g. spiders, scorpions, ticks or mites
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/236—Ligusticum (licorice-root)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/537—Salvia (sage)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/89—Cyperaceae (Sedge family)
- A61K36/8905—Cyperus (flatsedge)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Mycology (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Microbiology (AREA)
- Insects & Arthropods (AREA)
- Tropical Medicine & Parasitology (AREA)
- Animal Husbandry (AREA)
- Zoology (AREA)
- Neurosurgery (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
本发明提供一种防治亚实性肺结节的中药组合物及其制备方法和应用。所述中药组合物包括桔梗、旋覆花、生甘草、黄芩、杏仁、丹参、川芎、蜂房、全蝎、鸡内金。该中药组合物根据中医药理论和辨证论治的理论进行中药组方筛选,配方严谨,针对中医辨证为痰瘀互结证的亚实性肺结节患者,具有调气祛瘀化痰,解毒攻坚散结的功效,可有效抑制肺结节进展,减少肺结节数目增多的趋势,明显改善患者咳痰、胸闷等临床症状,并且无明显的药物相关不良反应。
Description
技术领域
本发明属于中医药技术领域,具体包含一种防治亚实性肺结节的中药组合物及其制备方法和应用。
背景技术
“治未病”是我国传统医学一直倡导的原则,是控制肿瘤最有效对策,也是最具有成本效益的措施,亚实性肺结节处于“易检难治”的等待观察状态,其恶性风险高,依旧缺乏有效抑制亚实性肺结节进展、缩小结节大小的治疗方法或者药物。因此,在治未病理念指导下,研发针对预防中高危肺结节的药物,对于早期有效预防肺癌发生、肿瘤治疗关口前移具有重要价值,进而降低患者病死率、延长患者生存时间具有重要意义。
发明内容
针对现有技术存在的上述问题,本发明的第一个目的在于提供一种防治亚实性肺结节的中药组合物。该中药组合物在治疗亚实性肺结节(SSN)方面疗效显著,可有效抑制肺结节进展,减少肺结节数目增多的趋势,明显改善患者咳痰、胸闷等临床症状,并且无明显的药物相关不良反应。
本发明的第二个目的在于提供一种制备如上所述的中药组合物的制备方法。
本发明的第三个目的在于提供一种包含如上所述的中药组合物的药物。
本发明的第四个目的在于提供一种利用如上所述的中药组合物在制备防治亚实性肺结节的药物中的应用。
为实现上述第一个目的,本发明所采用的技术方案包括:
本发明公开一种防治亚实性肺结节的中药组合物,所述中药组合物包括桔梗、旋覆花、生甘草、黄芩、杏仁、丹参、川芎、蜂房、全蝎、鸡内金。
中医理论认为,肺脏气机升降紊乱下的津血代谢失常,逐渐演变为“湿、痰、瘀、毒”等病理产物为肺结节及早期肺癌发生的基本病机,肺失宣降则见咳嗽、胸闷;肺主治节,津液运行失调,凝聚成痰,则见咳痰;宣降失调,气机阻滞则见胸胁不舒或胀痛,肺朝百脉,调节全身血液运行,其失调导致血瘀,则见刺痛,甚者见唇紫,舌质暗,故治疗应兼顾“调气”与“解毒”。
本方中重用桔梗、旋覆花为君药,桔梗宣肺祛痰、利咽排脓,旋覆花降气化痰、行气利水。二药相合,升降并用,共奏化痰排脓之功;杏仁、丹参、川芎为臣,杏仁化痰兼降气逆,丹参活血化瘀,《本草便读》中记载:“丹参,功同四物,能祛瘀以生新,善疗风而散结。”川芎被称为“血中之气药”能够行气开郁、活血止痛。三药共为臣药,辅助君药祛瘀化痰;痰瘀既成,便不断胶结增长,日久逐渐成形,并易化热生毒,故佐以蜂房、全蝎、鸡内金消坚散结;生甘草清热解毒。全方药物配伍得当,气血同调,升降并用,共奏调气祛瘀化痰、解毒攻坚散结之功。
本发明配方中所采用的药材的功能主治如下:
桔梗:味苦、辛,性平,归肺经,具有宣肺祛痰、利咽、排脓、能浮而治上焦、升提肺气,为众药之舟楫也。
旋覆花:性味甘,微温,冷利,入肺、肝、胃经,治疗胸中痰结、胁下胀满、咳喘、呃逆、唾如胶漆、心下痞鞕、噫气不除、大腹水肿。
生甘草:味甘,性平,归心、肺、脾、胃经,具有补脾益气、清热解毒、祛痰止咳的功效。
黄芩:为唇形科、黄芩属植物,性味苦、寒,入心、肺、胆、大肠经,用于泻实火、除湿热、止血、安胎、治壮热烦渴、肺热咳嗽、湿热泻痢、黄疸、目赤肿痛、胎动不安、痈肿疔疮。
杏仁:是蔷薇科杏的种子,味苦,性微温,归肺、大肠经,降气止咳平喘,润肠通便,用于咳嗽气喘、胸满痰多、血虚津枯、肠燥便秘。
丹参:性味苦,微温,入心、肝经,用于活血祛瘀、安神宁心、排脓、止痛,治心绞痛、月经不调、痛经、经闭、血崩带下、癥瘕、积聚、瘀血腹痛、骨节疼痛、惊悸不眠、恶疮肿毒。
川芎:辛,温,归肝、胆、心包经,活血行气,祛风止痛,用于胸痹心痛、胸胁刺痛、跌扑肿痛、月经不调、经闭痛经、癥瘕腹痛、头痛、风湿痹痛。
蜂房:性平,味甘,归胃经,具有祛风、攻毒、杀虫、止痛的功效,常用于疮疡肿毒、乳痈、瘰疬、皮肤顽癣、鹅掌风、牙痛、风湿痹痛。
全蝎:性味辛、平,归肝经,具有息风镇痉、攻毒散结、通络止痛的功效,用于小儿惊风、抽搐痉挛、中风口歪、半身不遂、破伤风、风湿顽痹、偏正头痛、疮疡、瘰疬。
鸡内金:性味甘、寒,归脾、胃、小肠、膀胱经,用于消积滞、健脾胃,治食积胀满、呕吐反胃、泻痢,疳积、消渴、遗溺、喉痹乳蛾、牙疳口疮。
黄芪:甘、温,归脾、肺经,具有补气升阳、益卫固表、托毒生肌、利水消肿的作用,用于治疗脾肺气虚和中气下陷之证。
茯苓:味甘、淡,性平,归心、肺、脾、肾经,具有利水渗湿、健脾和胃、宁心安神的功效。
人参:味苦,性甘,微温,归心、肺、脾、肾经,属于补气药物,具有大补元气、补脾益肺、生津止渴、安神益智的功效。
白术:性苦、甘、温,无毒,归脾、胃经,具有补气健脾、燥湿利水、止汗、安胎的功效。
莱菔子:味辛、甘、性平,具有消食除胀,降气化痰的功效。
香附:性味辛、微苦、微甘、平,归肝、脾、三焦经,具有消解郁闷、调经止痛的功效。
进一步,按重量份数计,所述中药组合物包括桔梗10-20份、旋覆花10-20份、生甘草6-10份、黄芩3-10份、杏仁6-10份、丹参6-15份、川芎6-15份、蜂房6-9份、全蝎1-3份、鸡内金10-30份。
进一步,当治疗亚实性肺结节并伴有肺脾气虚的患者时,可以按照如下组方进行配制:按重量份数计,所述中药组合物包括桔梗10-20份、旋覆花10-20份、生甘草6-10份、黄芩3-10份、杏仁6-10份、丹参6-15份、川芎6-15份、蜂房6-9份、全蝎1-3份、鸡内金10-30份、生黄芪15-30份、茯苓10-20份、人参10-15份、白术10-15份。
进一步,当治疗亚实性肺结节并伴有肝郁气滞的患者时,可以按照如下组方进行配制:按重量份数计,所述中药组合物包括桔梗10-20份、旋覆花10-20份、生甘草6-10份、黄芩3-10份、杏仁6-10份、丹参6-15份、川芎6-15份、蜂房6-9份、全蝎1-3份、鸡内金10-30份、莱菔子10-20份、香附10-15份。
进一步,按重量份数计,所述中药组合物包括桔梗20份、旋覆花15份、生甘草6份、黄芩10份、杏仁10份、丹参15份、川芎10份、蜂房6份、全蝎3份、鸡内金20份。
进一步,当治疗亚实性肺结节并伴有肺脾气虚的患者时,按重量份数计,所述中药组合物包括桔梗20份、旋覆花15份、生甘草6份、黄芩10份、杏仁10份、丹参15份、川芎10份、蜂房6份、全蝎3份、鸡内金20份、生黄芪15份、茯苓12份、人参10份、白术12份。
进一步,当治疗亚实性肺结节并伴有肝郁气滞的患者时,按重量份数计,所述中药组合物包括桔梗20份、旋覆花15份、生甘草6份、黄芩10份、杏仁10份、丹参15份、川芎10份、蜂房6份、全蝎3份、鸡内金20份、莱菔子10份、香附10份。
为实现上述第二个目的,本发明所采用的技术方案包括:
本发明公开一种制备如上所述的中药组合物的制备方法,包括如下步骤:
按照处方量称取各中药成分,加水煎煮,过滤,滤液浓缩成浸膏,干燥后即得。
为实现上述第三个目的,本发明所采用的技术方案包括:
本发明公开一种包含如上所述的中药组合物的防治亚实性肺结节的药物。
进一步,所述药物还包括药学上可接受的辅料。
进一步,所述药物的剂型选自片剂、煎剂、颗粒剂、胶囊剂、散剂、口服液、汤剂或膏剂。
为实现上述第四个目的,本发明所采用的技术方案包括:
本发明公开一种利用如上所述的中药组合物在制备防治亚实性肺结节的药物中的应用。
本发明有益效果:
本发明公开一种防治亚实性肺结节的中药组合物。该中药组合物根据中医药理论和辨证论治的理论进行中药组方筛选,配方严谨,针对中医辨证为痰瘀互结证的亚实性肺结节患者,具有调气祛瘀化痰,解毒攻坚散结的功效,可有效抑制亚实性肺结节进展,预防早期肺癌,减少肺结节数目增多的趋势,明显改善咳嗽、咳痰、气短、胸胁痞满不舒或胀痛、刺痛、唇紫、舌暗红苔白腻、脉细涩或滑等中高危肺结节患者的临床症状,并且无明显的药物相关不良反应。
具体实施方式
为了更清楚地说明本发明,下面结合优选实施例对本发明做进一步的说明。应当明确,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其它实施例,都属于本发明保护的范围。
实施例1
所述中药组合物的组方如下:
桔梗20g、旋覆花15g、生甘草6g、黄芩10g、杏仁10g、丹参15g、川芎10g、蜂房6g、全蝎3g、鸡内金20g。
按照上述组方称取桔梗、旋覆花、生甘草、黄芩、杏仁、丹参、川芎、蜂房、全蝎和鸡内金,加水煎煮,过滤,滤液浓缩成浸膏,干燥制粒即得,命名为调气解毒方。
实施例2
当治疗亚实性肺结节并伴有肺脾气虚的患者时,所述中药组合物的组方如下:
桔梗20g、旋覆花15g、生甘草6g、黄芩10g、杏仁10g、丹参15g、川芎10g、蜂房6g、全蝎3g、鸡内金20g、生黄芪15g、茯苓12g、人参10g、白术12g。
按照上述组方称取桔梗、旋覆花、生甘草、黄芩、杏仁、丹参、川芎、蜂房、全蝎、鸡内金、生黄芪、茯苓、人参、白术,加水煎煮,过滤,滤液浓缩成浸膏,干燥制粒即得。
实施例3
当治疗亚实性肺结节并伴有肝郁气滞的患者时,所述中药组合物的组方如下:
桔梗20g、旋覆花15g、生甘草6g、黄芩10g、杏仁10g、丹参15g、川芎10g、蜂房6g、全蝎3g、鸡内金20g、莱菔子10g、香附10g。
按照上述组方称取桔梗、旋覆花、生甘草、黄芩、杏仁、丹参、川芎、蜂房、全蝎、鸡内金、莱菔子、香附,加水煎煮,过滤,滤液浓缩成浸膏,干燥制粒即得。
临床试验
1临床资料
1.1研究对象
本次临床试验的研究病例为2022年1月-2022年6月间就诊于中国中医科学院广安门医院肿瘤科防癌门诊的SSN(5-8mm)痰瘀互结证型患者。
1.2诊断标准
1.2.1西医诊断标准
西医诊断标准:根据《肺结节诊治中国专家共识(2018年版)》中SSN诊断标准:影像学表现为局灶性、类圆形、密度增高的亚实性肺部阴影,可为孤立性或多发性,不伴肺不张、肺门淋巴结肿大和胸腔积液。
1.2.2中医证候诊断标准
中医诊断标准:参照《中药新药临床研究指导原则》、《中医内科学》等相关内容结合临床实践综合制定亚实性肺结节痰瘀互结证诊断标准:
主症:①咳痰;②唇甲紫暗;
次症:①胸闷;②头晕目眩;③呕吐痰涎;④胃脘满闷;⑤刺痛;
舌脉:舌色紫暗、苔滑腻、脉沉涩或弦滑。
凡满足主症2个,次症≥1个;或主症≥1个,次症≥2个。结合舌脉,即可诊断为痰瘀互结证。
1.3纳入标准
①性别不限,年龄18-85岁;②符合指南诊断SSN标准的患者,中医辨证属痰瘀互结证;③SSN(5mm-8mm)指南推荐随访观察;④未进行过手术的患者;⑤自愿参加本研究,签署知情同意书。
1.4排除标准
①合并肺癌及其他肿瘤疾病的患者;②肝肾功能不全的患者;③孕妇及哺乳期的患者;④病历资料不全的患者;⑤对所服用中药过敏的患者;⑥参加其他临床研究者。
1.5脱落和剔除标准
①患者出现严重不良事件,停止试验者;②拒绝接受随访的患者;③由于各种原因无法联系到的患者;④资料不全而影响最终评价的患者;⑤受试者要求退出研究。
2研究内容和方法
本研究已在国际传统医学临床注册平台注册(注册号:ITMCTR2022000072)、中国中医科学院广安门医院伦理委员会审查(伦理批件号:2022-149-KY),采用实用性随机对照设计,收集2022年1月-2022年6月符合纳入条件的SSN患者,填写病例报告表,建立Excel数据库,对患者的基线资料、病史资料、用药情况以及检查检验等信息进行汇总,符合纳入标准的SSN患者采用实用性随机对照试验(pRCT)中基于患者偏好的随机对照试验(PRPP)方法,首先询问患者对所接受的干预措施有无明显的偏好,当入组患者有明显偏好时,可按照患者的意愿分组而不采用随机;当患者无明显偏好时,将患者按就诊顺序进行编号,采用随机数字表法分为调气解毒方组(以下简称治疗组)和对照组,共纳入74例患者,观察两组患者24周结节最大直径、数目变化,评价治疗前后结节变化情况以及每12周观察患者中医证候积分、药物不良反应等方面的不同变化。
2.1治疗方案
(1)对照组:依据临床指南推荐,SSN(5-8mm)6个月影像CT定期随访观察。
(2)治疗组:在定期随访观察的基础上,给予实施例1制备的处方颗粒治疗,每次1袋,每日2次,早晚饭后温水送服。
2.2观察指标
2.2.1主要疗效指标
治疗前后采用同一医院CT测量两组患者肺结节最大直径和数目作为主要疗效指标,并依据中国中医科学院广安门医院肿瘤科制定的《中医药早期肺癌筛查与防治方案》中目标结节变化判定临床疗效:有效率=SSN(显效+有效)例数/总例数×100%。
显效:目标结节完全吸收,复查LDCT目标结节不可见。
有效:目标结节部分吸收,复查目标结节可见,未见目标结节进展指征且符合以下条件之一:(1)目标结节平均直径5-9mm,平均直径较治疗前减少≥30%;(2)目标结节CT值减低;(3)目标结节实性成分减少。
稳定:目标结节稳定,目标结节不符合进展或完全吸收或部分吸收指征认定为目标结节稳定。
恶化:目标结节进展,符合以下条件之一可认定为目标结节进展:(1)目标结节平均直径5-9mm,平均直径较前增加≥30%;(2)目标结节CT值增大;(3)目标结节实性成分平均直径增加>1.5mm;(4)目标结节出现分叶、毛刺、胸膜凹陷征、血管集束征等恶性征象;
注:结节平均直径是指结节实性部分的最大长径和垂直于最大长径的最长短径(最大短径)之和除以2。
2.2.2次要疗效指标
中医证候评分:参考《中药新药临床研究指导原则》拟定中医证候积分量表,将咳痰、唇甲紫暗等主症根据症状轻重各分为4个等级,分别记录为重度(6分)、中度(4分)、轻度(2分)、无(0分);将胸闷、头晕目眩、呕吐痰涎、胃脘满闷、刺痛等次症根据症状轻重各分为4个等级,分别记录为重度(3分)、中度(2分)、轻度(1分)、无(0分),对治疗前后2组患者中医证候积分的变化情况进行观察记录。
2.2.3安全性指标
详细记录治疗过程中患者肝、肾功能异常、胃肠道反应等和治疗相关的不良反应发生情况。
2.2.4随访时间及方式
通过门诊复查及网络平台、电话询问等方式进行随访,随访时间自患者入组后开始,每12周随访临床症状、血常规、肝肾功能等,并于第24周后进行CT影像学评价,发现结节恶化或者手术即研究结束,随访截止时间为2023年1月20日。
2.3统计学方法
统计分析采用SPSS26.0软件,用均值±标准差描述计量资料,用频数、百分数描述计数资料。计量资料的组间比较采用成组t检验(正态、方差齐)或Wilcoxon秩和检验(非正态、方差不齐),组内比较采用配对t检验(正态)或Wilcoxon符号秩和检验(非正态);计数资料采用卡方检验或Fisher精确概率法。所有的统计分析检验均采用双侧假设检验,假设检验水准均取α=0.05,即P<0.05被认为检验的差异有统计学意义。
3结果
3.1基线资料
3.1.1病例完成情况
本研究共入组SSN患者74例,治疗组及对照组各37例,其中治疗组脱落2例(治疗期间自行停药),对照组脱落3例(1例患者不配合检测,2例患者自行退出)最终治疗组35例,对照组34例,共69例患者完成了治疗及随访,如表1所示。
表1患者完成研究情况表
3.1.2基线资料比较
本研究共纳入受试者69例,其中治疗组35例和对照组34例。两组患者基线资料比较差异无统计学意义(P>0.05),具有可比性(参见表2)。
表2两组患者人口学资料及临床特征
3.2疗效分析
3.2.1主要疗效分析
(1)治疗前后SSN最大直径变化情况
如表3所示,治疗组与对照组组间比较:两组SSN最大直径的基线分布差异无统计学意义(P>0.05),具有可比性。24周后,对照组同治疗组相比,SSN最大直径显著增长(P<0.05),且治疗组治疗前后SSN最大直径差值显著优于对照组(P<0.05)。
治疗组与对照组组内比较:治疗组24周后SSN最大直径较前显著降低(P<0.05),而对照组SSN最大直径较前显著增加,差异具有统计学意义(P<0.05)。
表3两组患者治疗前后结节最大直径比较(mm)
组别 | 治疗组 | 对照组 | t | P |
治疗前 | 6.74±1.27 | 6.75±1.26 | -0.449 | 0.655 |
治疗后 | 5.80±1.59* | 7.32±1.63*△ | -3.937 | 0.000 |
差值 | -0.94±1.26 | 0.57±1.18△ | -5.156 | 0.000 |
注:与本组治疗前比较,*P<0.05;与对照组组间比较,△P<0.05。
(2)治疗前后SSN数目变化情况:
如表4所示,治疗组与对照组组间比较:两组治疗前SSN数目的基线分布差异无统计学意义(P>0.05),具有可比性。24周后,对照组结节数目显著多于治疗组,差异具有统计学意义(P<0.05),但两组治疗前后结节数量差值比较无统计学差异(P>0.05)。
治疗组与对照组组内比较:治疗组SSN数目治疗前后差异无统计学意义(P>0.05),而对照组SSN数目显著增加,治疗前后差异有统计学意义(P<0.05)。
表4两组患者治疗前后结节数目比较
组别 | 治疗组 | 对照组 | t | P |
治疗前 | 1.83±1.10 | 2.41±1.50 | -1.847 | 0.069 |
治疗后 | 1.80±1.13 | 2.62±1.46*△ | -2.607 | 0.011 |
差值 | 0.00±0.82 | 0.21±0.54 | -1.156 | 0.256 |
注:与本组治疗前比较,*P<0.05;与对照组组间比较,△P<0.05。
(3)两组患者整体疗效比较:
根据结节大小、CT值、实性成分、恶性征象等综合判定临床疗效,如表5、表6所示,治疗组与对照组组间比较,治疗组临床疗效总有效率为22.9%,对照组总有效率为2.9%,两组经经秩和检验,Z=-3.268,P=0.01,差异具有统计学意义,说明治疗组的临床疗效优于对照组。
表5两组患者治疗后影像学特征比较
表6两组患者治疗前后疗效比较
组别 | n | 显效 | 有效 | 稳定 | 恶化 | 有效率(%) |
治疗组 | 35 | 0(0) | 8(22.9) | 25(71.4) | 2(5.7) | 22.9* |
对照组 | 34 | 0(0) | 1(2.9) | 23(67.6) | 10(29.4) | 2.9 |
注:与对照组比较,*P<0.05。
3.2.2次要疗效分析
两组患者治疗前后中医证候积分比较
如表7所示,治疗12周后,治疗组患者中医证候量表总分、胃脘满闷症状较前均显著改善(P<0.05),且中医证候量表总分、唇甲紫暗症状改善情况明显优于对照组(P<0.05)。
治疗24周后,治疗组患者中医证候量表总分、胃脘满闷、咳痰、胸闷症状较前显著改善(P<0.05),且中医证候量表总分、咳痰、唇甲紫暗、胸闷等症状改善情况明显优于对照组(P<0.05),其他症状变化虽无统计学差异,但整体呈稳定及减轻趋势。
对照组患者的中医证候量表总分趋于增加,治疗前后分数差异有统计学意义(P<0.01),在单项症状方面,患者12周、24周后唇甲紫暗症状加重(P<0.05)。
表7两组治疗前后中医证候积分比较
注:与治疗前比较,*P<0.05;与治疗12周比较,△P<0.05;与对照组组间比较,**P<0.05。
3.3两组患者实验过程中不良事件发生情况
如表8所示,治疗过程中,治疗组中出现1例患者肝功能异常(ALT升高),对照组未发生不良事件。治疗组与对照组的不良反应发生率比较,经Fisher精确概率法检验,差异无统计学意义(P>0.05)。
表8两组不良反应发生率比较
注:Fisher精确概率法,无统计量。
综上,对于亚实性肺结节患者,调气解毒方可有效抑制结节进展,降低患癌风险,改善患者的临床症状,提高生活质量,且安全可行。
显然,本发明的上述实施例仅仅是为清楚地说明本发明所作的举例,而并非是对本发明的实施方式的限定,对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动,这里无法对所有的实施方式予以穷举,凡是属于本发明的技术方案所引伸出的显而易见的变化或变动仍处于本发明的保护范围之列。
Claims (10)
1.一种防治亚实性肺结节的中药组合物,其特征在于,所述中药组合物包括桔梗、旋覆花、生甘草、黄芩、杏仁、丹参、川芎、蜂房、全蝎、鸡内金。
2.根据权利要求1所述的中药组合物,其特征在于,按重量份数计,所述中药组合物包括桔梗10-20份、旋覆花10-20份、生甘草6-10份、黄芩3-10份、杏仁6-10份、丹参6-15份、川芎6-15份、蜂房6-9份、全蝎1-3份、鸡内金10-30份。
3.根据权利要求2所述的中药组合物,其特征在于,按重量份数计,所述中药组合物还包括生黄芪15-30份、茯苓10-20份、人参10-15份、白术10-15份。
4.根据权利要求2所述的中药组合物,其特征在于,按重量份数计,所述中药组合物还包括莱菔子10-20份、香附10-15份。
5.根据权利要求1所述的中药组合物,其特征在于,按重量份数计,所述中药组合物包括桔梗20份、旋覆花15份、生甘草6份、黄芩10份、杏仁10份、丹参15份、川芎10份、蜂房6份、全蝎3份、鸡内金20份。
6.如权利要求1-5任一项所述的中药组合物的制备方法,其特征在于,包括如下步骤:
按照处方量称取各中药成分,加水煎煮,过滤,滤液浓缩成浸膏,干燥后即得。
7.一种防治亚实性肺结节的药物,其特征在于,包括如权利要求1-5任一项所述的中药组合物或者如权利要求6所述的制备方法制备得到的中药组合物。
8.根据权利要求7所述的药物,其特征在于,所述药物还包括药学上可接受的辅料。
9.根据权利要求7所述的药物,其特征在于,所述药物的剂型选自片剂、煎剂、颗粒剂、胶囊剂、散剂、口服液、汤剂或膏剂。
10.如权利要求1-5任一项所述的中药组合物在制备防治亚实性肺结节的药物中的应用。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202310984697.XA CN117414387A (zh) | 2023-08-07 | 2023-08-07 | 一种防治亚实性肺结节的中药组合物及其制备方法和应用 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202310984697.XA CN117414387A (zh) | 2023-08-07 | 2023-08-07 | 一种防治亚实性肺结节的中药组合物及其制备方法和应用 |
Publications (1)
Publication Number | Publication Date |
---|---|
CN117414387A true CN117414387A (zh) | 2024-01-19 |
Family
ID=89527263
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202310984697.XA Pending CN117414387A (zh) | 2023-08-07 | 2023-08-07 | 一种防治亚实性肺结节的中药组合物及其制备方法和应用 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN117414387A (zh) |
-
2023
- 2023-08-07 CN CN202310984697.XA patent/CN117414387A/zh active Pending
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN101874874B (zh) | 一种治疗幽门螺旋菌相关性慢性胃炎的中药制剂及其制备方法 | |
CN108785422B (zh) | 一种治疗急性乳腺炎的中药组合物及其制备方法 | |
CN110833609A (zh) | 一种治疗消化不良的中药组合物 | |
CN111588757A (zh) | 一种治疗慢性阻塞性肺疾病稳定期的中药组合物及制备方法 | |
CN114224998B (zh) | 一种治疗脾肾阳虚型功能性消化不良的中药组合物、制剂与应用 | |
CN115252753A (zh) | 治疗失眠的中药组合物及其应用 | |
US10857186B2 (en) | Traditional Chinese medicine composition for treating acute stage of cerebral infarction | |
CN117414387A (zh) | 一种防治亚实性肺结节的中药组合物及其制备方法和应用 | |
CN112294940A (zh) | 一种用于治疗肿瘤的中药组合物及其应用 | |
CN101732469B (zh) | 一种中药组合物在制备治疗失音症药物中的应用 | |
CN110755501A (zh) | 一种治疗糖尿病周围神经病变的中药组合物 | |
CN1903347A (zh) | 一种治疗消化道疾病的药物组合物及其制备方法和应用 | |
CN114732889B (zh) | 一种治疗支气管哮喘急性发作期痰浊阻肺证的中药组合物、中药口服制剂 | |
CN115624586B (zh) | 一种治疗激素依赖性哮喘的中药组合物以及应用 | |
CN108465084A (zh) | 一种治疗冠心病的中药 | |
CN112138105B (zh) | 一种治疗支气管扩张症肺脾气虚、痰湿阻肺证的中药组合物及其应用 | |
CN115154535B (zh) | 一种改善动脉粥样硬化的中药复方及其制备方法 | |
CN102805795B (zh) | 一种治疗急性胸胁部软组织损伤的中药组合物及其应用 | |
CN114569690B (zh) | 一种治疗幽门螺旋杆菌感染性胃炎的中药组合物 | |
CN117180379B (zh) | 一种治疗气虚毒滞型桥本甲状腺炎的中药组合物及其应用 | |
CN115869375B (zh) | 一种清热疏风的中药组合物及其制备方法和应用 | |
CN116407595B (zh) | 一种治疗三阴性乳腺癌的中药组合物及其中药制剂和应用 | |
CN101167915B (zh) | 治疗慢性浅表性胃炎的中药组合物及其制备方法 | |
CN115040565A (zh) | 一种降肌酐的灌肠中药及其制备方法和应用 | |
CN104758749A (zh) | 一种治疗肝癌的中药组合物 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PB01 | Publication | ||
PB01 | Publication | ||
SE01 | Entry into force of request for substantive examination | ||
SE01 | Entry into force of request for substantive examination |