CN110420326A - A kind of application mostly fragrant for pool - Google Patents
A kind of application mostly fragrant for pool Download PDFInfo
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- CN110420326A CN110420326A CN201910874493.4A CN201910874493A CN110420326A CN 110420326 A CN110420326 A CN 110420326A CN 201910874493 A CN201910874493 A CN 201910874493A CN 110420326 A CN110420326 A CN 110420326A
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- Prior art keywords
- pool
- fragrant
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- bladder cancer
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K41/00—Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
- A61K41/0057—Photodynamic therapy with a photosensitizer, i.e. agent able to produce reactive oxygen species upon exposure to light or radiation, e.g. UV or visible light; photocleavage of nucleic acids with an agent
- A61K41/0071—PDT with porphyrins having exactly 20 ring atoms, i.e. based on the non-expanded tetrapyrrolic ring system, e.g. bacteriochlorin, chlorin-e6, or phthalocyanines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
Abstract
The invention discloses a kind of applications mostly fragrant for pool.The invention discloses a kind of mostly for the fragrant application in the drug of the diagnosis of preparation photodynamic therapy or treatment bladder cancer of pool.Combine after TUR-BT operation mostly for the high risk sexual non-Myometrial involvement bladder cancer of the fragrant photodynamic therapy treatment of pool, it on the one hand can be after operation cuts off visible lesion, dynamic therapy is given simultaneously, a possibility that killing the tumour cell disseminated in latent lesion that may be present or surgical procedure, reducing postoperative recurrence；On the other hand, optical dynamic therapy can substitute completely, or at least be substantially reduced the number of BCG irrigation of bladder；Finally, with cystoscopy while carrying out when optical dynamic therapy is typically arranged at TUR-BT Follow-up After every time, do not increase the burden of doctor and patient additionally.
Description
Technical field
The present invention relates to a kind of applications mostly fragrant for pool.
Background technique
Photodynamic therapy (Photodynamic Therapy, PDT) is the photograph using photosensitizer in specific wavelength visible light
It penetrates down, generates cytotoxic substance, act on target tissue, generate a kind for the treatment of method of organizational effect.Photosensitizer can be absorbed
Photon, and transfer energy to oxygen molecule etc., rush brings it about chemical reaction, generates the cell toxicants substances such as singlet oxygen.It is photosensitive
One key property of agent is, it in pathological tissues preferential build and can generate specific biological effect, and just to surrounding
Normal tissue effect is smaller.Photodynamic therapy comes out the twentieth century eighties, and rapidly develop becomes a kind of tumour in recent years
The new technology of prevention and treatment is another after operation, radiotherapy, chemotherapy and the tumours traditional remedies such as immune just in research and development
Tumour new treatment.
PDT is a kind of medicine, tool joint technology, is related to administration and two steps of irradiation, and principle is by lesion part
Optical sensibilization selectively destroys the pathologic target tissue of tumour and other paraplasms, i.e., using specific emission wavelength
Light source implements light irradiation to the diseased region for absorbing photosensitizer, the photosensitizer being excited and oxygen molecule occur energy exchange and/or
Electronics transfer locally generates in pathological tissues and has cytotoxic active oxygen (reactive oxygen species, ROS),
These reactive oxygen species killing tumor cells lead to its apoptosis or necrosis.Photosensitizer is to generate with that can emit specific wavelength light source
Two fundamentals of PDT effect.
Bladder cancer is one of most common malignant tumour of Urology Surgery, and in China, the disease incidence of bladder carcinoma in males is 7.3/
100000, women disease incidence is 2.0/10 ten thousand.According to tumour to the invasive depth of the bladder wall, bladder cancer is clinically divided into non-muscle layer
Invasive tumor and Myometrial involvement tumour.About 90% the above are Urothelium carcinomas in bladder cancer, wherein about 70% urinary tract
Cell carcinoma is non-Myometrial involvement bladder cancer (Non Muscle Invasive Bladder Cancer, NMIBC).At present
The treatment method of NMIBC mainly uses underwent transurethral resection of bladder tumor (TUR-BT), and postoperative auxiliary gives irrigation bladder
Treat drug (pirarubicin, epirubicin, mitomycin etc.) or immune drug (BCG vaccine).Simple TUR-BT is postoperative 10%
~67% patient can recur in 12 months, there is 24%~84% Patients on Recurrence in postoperative 5 years, may with newly swell tumor,
Tumour cell plantation or primary tumor resection are not exclusively related.There are two high for non-Myometrial involvement bladder cancer TUR-BT postoperative recurrence
The peak phase, respectively postoperative 100~200 days and postoperative 600 days.First peak period of postoperative recurrence is the same as tumour cell in art
Send out it is related, and postoperative bladder instillation to treat can substantially reduce due to caused by Tumor cell dissemination recurrence or disease into
Exhibition.Subset of patients can even be in progress as Myometrial involvement bladder cancer, therefore the postoperative carry out bladder instillation to treat of TURBT, pass through
The remaining tumour cell of surgical resection margins is eliminated, tumor recurrence rate is reduced, prevents or delay the progress of disease.It is clinical both at home and abroad at present
The gamma therapy that guide is recommended is TUR-BT operation joint BCG vaccine (BCG) bladder instillation to treat: TUR-BT starts after performing the operation 2 weeks
BCG irrigation of bladder is given, the first stage is the induction perfusion phase, is perfused 1 time, continuous 6 weeks, totally 6 times weekly；It is later maintenance perfusion
Phase distinguishes the 3rd, 6 and 12 months Shi Jinhang after surgery, continuous 3 weeks every time, is perfused 1 times a week, totally 9 times.Entire BCG perfusion is controlled
Treatment process needed for 1 year, and totally 15 times, although clinical efficacy has obtained more sufficient affirmative, perfusion therapy number is too many, suffers from
The satisfaction that person receives treatment receives larger challenge.
Part photosensitizer can selectively be distributed in bladder cancer tissues, and the light through specific wavelength is (such as 400nm or so
Blue light) irradiation after, mucous membrane of urinary bladder canceration position can issue be easier to observation fluorescence, it is very eye-catching under the blue background visual field, this
One characteristic is remarkably contributing to find the carcinoma in situ or minute lesion of the more difficult discovery under the common cystoscope white light visual field, improves doctor
To the complete resection rate of tumor tissues.On the other hand, after TUR-BT operation, full bladder is given immediately using the light source of appropriate wavelength
Irradiation can kill the small cancer nests that may be left after operation or latent lesion, greatly reduce the chance of tumor recurrence.
Numerous clinical reports show that the curative effect of optical dynamic therapy bladder cancer is satisfactory.The report such as Andreasp, passes through wing
The photodynamic therapy treatment relapsed or refractory transitional cell carcinoma of bladder of perfusion ALA in Guang, after 23.7 months, 51.6%
(16/32) patient is not recurred.McClellan etc. summarizes external more medical institutions, and more than totally 300 example clinical treatments are reported
Display is applied alone the complete remission rate of PDT treatment carcinoma in situ average up to 66%, and long term follow-up shows the time of tumor recurrence about
37-84 months after surgery, it is applied alone the complete remission rate of PDT treatment papillary carcinoma of bladder up to 54%, the median time of recurrence is
25-48 months.
Jocham etc. has carried out one in Germany and has compared with Intravesical BCG, and photodynamic therapy is for treating high-risk non-muscle layer
Multicenter, opening, the parallel control III clinical trial phase of invasive bladder cancer.Test incorporates 124 high-risk non-muscle layer leachings altogether
Lubricant nature bladder cancer patients, are divided into two groups, PDT treatment group 63, BCG treatment group 61.The intravenous injection of PDT treatment group
After Photofrin, cystoscopy bladder capacity is used within the 3rd day, PDT treatment is carried out to the bladder of 50-75% filling volume.BCG
Treatment group starts to be perfused for 2 weeks after surgery, and induction period is 6 weeks, weekly perfusion 1 time, and totally 6 times, then after surgery 3,6,12,18
With 24 months, each follow-up gives continuous perfusion in 3 weeks, 1 times a week.The progression free survival phase of PDT treatment group is 16.6
Month, the progression free survival phase of BCG treatment group is 24.9 months.Tumor recurrence rate and progression rates are respectively in 2 years of PDT treatment group
Recurrence rate and progression rates are respectively 48.7% and 22.1% in 2 years of 58.4% and 17.1%, BCG treatment group, but test and exist
Center effect, secondary efficacy index follow up time are too short, sample size is few and repeat curative effect of PDT treatment etc. one without research
A little problems need further to explore the curative effect of photodynamic therapy.
" the Chinese urological diseases diagnoses and treatment guide " of urinary surgery branch, Chinese Medical Association publication (2014
Version) it mentions, photodynamic therapy (PDT) is the treatment method for being combined laser with photosensitizer using cystoscope.Tumour cell
After absorbing photosensitizer, singlet oxygen is generated under laser action, makes tumour cell degeneration necrosis.Carcinoma in situ of bladder, control bladder are swollen
Tumor bleeding, tumour multiple relapse are not resistant to situations such as operative treatment and can choose this therapy.TURBT postoperative recurrence and BCG are filled
Infusing treatment failure patient also can be selected photodynamic therapy.
It is mostly a kind of Porphyrin-Based Sensitizer for fragrant (Deuteporfin) is moored, with the first antitumor light for being approved listing in the whole world
Sensitizing drug Porfimer SodiumIt compares, is equally mostly a mixing porphyrin preparation for pool sweet smell, but by four structures
Specific photoactive substance is mixed in a certain ratio, and ingredient and structure are relatively sharp clear, and is eliminated part and needed in vivo
The derivative structure of metabolism for a long time, therefore while retaining original photodynamic activity, mostly for the pool fragrant time removed in vivo
Photofrin etc. compared to previous generation is obviously shortened, and the phase that is protected from light after medication was reduced to 15 days or so from 2~3 months；Separately
Outside, when with the light source activation of near ultraviolet band (400-450nm), it mostly can produce the red fluorescence of macroscopic for pool sweet smell, in conjunction with
Drug can be used for helping to find the carcinoma in situ for being easy to ignore under the white light visual field or help bladder in the characteristic of tumor tissue accumulation
The guide of neoplastic lesion tissue when cancer is performed the operation.
Injection replaces pool sweet smell to have 4 main components: MHD, DMD, MVD, HVD more.
Summary of the invention
The technical problem to be solved by the present invention is to overcome the few defects of the drug of existing treatment bladder cancer, and provide one
Kind application mostly fragrant for pool.The present invention can reduce a possibility that postoperative recurrence bladder cancer, and can reduce the burden of doctor and patient.
The present invention solves above-mentioned technical problem by the following technical programs.
The present invention provides a kind of mostly for fragrant the answering in the drug of the diagnosis of preparation photodynamic therapy or treatment bladder cancer of pool
With.
In the application, described is preferably mostly intravenous drip for fragrant administration mode is moored, and further preferably use can
The infusion pump of constant flow rate carries out intravenous drip.
In the application mostly for pool sweet smell in the drug of preparation joint photodynamic therapy diagnosing bladder cancer, described is more
It is preferably completed in 60 minutes for the fragrant administration of pool.
In the application mostly for pool sweet smell in the drug of preparation joint photodynamic therapy diagnosing bladder cancer, described is more
It is preferably 1~5mg/kg for the fragrant dosage of pool, further preferably 1~3mg/kg, most preferably 2mg/kg.The agent
Amount is calculated according to subject's weight.
In the application mostly for pool sweet smell in the drug of preparation joint photodynamic therapy diagnosing bladder cancer, the light
The light source peak wavelength of motivation therapy is preferably 380~440nm, further preferably 400~420nm.
In the application mostly for pool sweet smell in the drug of preparation joint photodynamic therapy diagnosing bladder cancer, it is preferable that
TUR-BT operation is completed in 2 hours after starting venoclysis.
In the application mostly for pool sweet smell in the drug of preparation joint photodynamic therapy treatment bladder cancer, described is more
Be preferably 2~20mg/kg for the fragrant dosage of pool, further preferably 2~10mg/kg, still more preferably for 5~
10mg/kg, most preferably 7.5mg/kg.The dosage is calculated according to subject's weight.
In the application mostly for pool sweet smell in the drug of preparation joint photodynamic therapy treatment bladder cancer, the light
The light source peak wavelength of motivation therapy is preferably 405~660nm, further preferably 532~660nm, still more preferably for
532~635nm, most preferably 635nm.
In the application mostly for pool sweet smell in the drug of preparation joint photodynamic therapy treatment bladder cancer, the light
The light dose of motivation therapy is preferably 5~75J/cm2, further preferably 5~50J/cm2, still more preferably for 15~
25J/cm2, most preferably 15J/cm2。
In the application mostly for pool sweet smell in the drug of preparation joint photodynamic therapy treatment bladder cancer, the light
The preferably spherical optical fiber of the optical fiber being connect in motivation therapy with laser.
In the application, the bladder cancer is preferably high risk sexual non-Myometrial involvement bladder cancer.
Without prejudice to the field on the basis of common sense, above-mentioned each optimum condition, can any combination to get the present invention it is each preferably
Example.
The reagents and materials used in the present invention are commercially available.
The positive effect of the present invention is that: combine after TUR-BT operation mostly high risk sexual for fragrant photodynamic therapy treatment is moored
Non- Myometrial involvement bladder cancer, on the one hand can be after operation cuts off visible lesion, while giving dynamic therapy, and killing may deposit
Latent lesion or surgical procedure in the tumour cell that disseminates, a possibility that reducing postoperative recurrence；On the other hand, light power is controlled
Treatment can substitute completely, or at least be substantially reduced the number of BCG irrigation of bladder；Finally, optical dynamic therapy is typically arranged at every time
It is carried out simultaneously when TUR-BT Follow-up After with cystoscopy, does not increase the burden of doctor and patient additionally.
Detailed description of the invention
Fig. 1 is to be given after 2mg/kg replaces pool fragrant more in embodiment 12 hours, tumour fluorescence figure of the patient 1 under the blue light visual field
Picture.
Fig. 2 is to be given after 2mg/kg replaces pool fragrant more in embodiment 12 hours, tumour fluorescence figure of the patient 2 under the blue light visual field
Picture.
Fig. 3 be given in embodiment 3 mostly for pool it is fragrant after, tumor image of the patient under the white light visual field.
Fig. 4 be given in embodiment 3 mostly for pool it is fragrant after, tumour fluorescence image of the patient under the blue light visual field.
Specific embodiment
The present invention is further illustrated below by the mode of embodiment, but does not therefore limit the present invention to the reality
It applies among a range.In the following examples, the experimental methods for specific conditions are not specified, according to conventional methods and conditions, or according to quotient
The selection of product specification.
Embodiment more than 1 is for the fragrant light power diagnosis of pool
The quasi- bladder cancer patients for receiving TUR-BT operation, intravenous drip mode is given mostly for pool sweet smell 2mg/ before operation starts
Kg, using can constant flow rate infusion pump, completion intravenous drip in 60 minutes.TUR-BT hand is completed in 2h after starting venoclysis
Art.Light source peak wavelength for exciting light power diagnosis is 400~420nm.TUR-BT hand is carried out under the first Conventional white visual field
Then art tumor resection is converted to the blue light visual field and observes the position (having red fluorescence instruction) of possible residual tumor, reconvert is extremely
White light is cut off under the visual field, is repeated several times, until not observing suspected tumor tissue under white light and the blue light visual field.
Combine after embodiment 2TUR-BT operation mostly for the fragrant photodynamic therapy of pool
Bladder cancer patients receive TUR-BT operation consent intravenous drip mode and give mostly for pool sweet smell 7.5mg/kg.Doctor carries out
After TUR-BT ocal resection, the 1h after the completion of mostly instiling for pool sweet smell is given with the laser of specific wavelength and is irradiated, laser
Selectable launch wavelength is 635nm.The optical fiber connecting with laser is spherical optical fibre.Light dose when PDT is 15J/
cm2.It is carried out after postoperative 3rd month more than the 2nd time for the fragrant optical dynamic therapy of pool.The 3rd is carried out respectively within postoperative 6th month and 12nd month
Secondary and the 4th replaces the fragrant optical dynamic therapy of pool more.3,6,12 month follow-ups after the test, do not recur.2 years after operation, also
Without recurrence.
Embodiment more than 3 is for mooring fragrant light power diagnosis+mostly for mooring fragrant optical dynamic therapy bladder cancer
The quasi- bladder cancer patients for receiving TUR-BT operation, intravenous drip mode is given mostly for pool sweet smell 7.5mg/ before operation starts
Kg, using can constant flow rate infusion pump, completion intravenous drip in 60 minutes.It is completed first in 1h after the completion of starting venoclysis
Conventional TUR-BT operation.It is observed using KARL STORZ Fluorescence cystoscope.TUR-BT is carried out under the first Conventional white visual field
Then ocal resection is converted to the blue light visual field (for exciting the light source peak wavelength of light power diagnosis into 400~420nm)
The position (having red fluorescence instruction) of possible residual tumor is observed, cuts off, is repeated several times under reconvert to the white light visual field, until white
Suspected tumor tissue is not observed under light and the blue light visual field.
After the completion of bladder cancer patients ocal resection, is given and irradiated with the laser of specific wavelength at once, laser can
The launch wavelength selected is 635nm.The optical fiber connecting with laser is spherical optical fibre.Light dose when PDT is 15-30J/
cm2.It is carried out after postoperative 3rd month more than the 2nd time for the fragrant optical dynamic therapy of pool.The 3rd is carried out respectively within postoperative 6th month and 12nd month
Secondary and the 4th replaces the fragrant optical dynamic therapy of pool more.
Embodiment more than 4 is for the fragrant photodynamic therapy palliative treatment advanced bladder carcinoma of pool
The patient of TUR-BT operation or cystectomy art can not be carried out for bladder cancer advanced stage, operation consent gives intravenous drip
Mode, which is given, mostly to be given with the laser of specific wavelength and is irradiated, swashed for pool sweet smell 7.5mg/kg, the 1h after the completion of mostly instiling for pool sweet smell
The selectable launch wavelength of light device is 635nm.The optical fiber connecting with laser is spherical optical fibre.Full bladder irradiation is carried out, when PDT
Light dose be 15-30J/cm2.After the completion for the treatment of for the first time, respectively at 3rd month, the 6th month, the 9th month, the 12nd
Month carry out the 2nd time, the 3rd time, the 4th and the 5th replace the fragrant optical dynamic therapy of pool more.
Claims (2)
1. a kind of mostly for the fragrant application in the drug of the diagnosis of preparation photodynamic therapy or treatment bladder cancer of pool.
2. application as described in claim 1, which is characterized in that the bladder cancer is high risk sexual non-Myometrial involvement bladder
Cancer.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201910874493.4A CN110420326A (en) | 2019-09-17 | 2019-09-17 | A kind of application mostly fragrant for pool |
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| CN201910874493.4A CN110420326A (en) | 2019-09-17 | 2019-09-17 | A kind of application mostly fragrant for pool |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112336746A (en) * | 2020-10-23 | 2021-02-09 | 内蒙古科技大学包头医学院 | Perfusion chemotherapeutic medicine for bladder cancer and application thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108697800A (en) * | 2015-12-17 | 2018-10-23 | 光治疗Asa公司 | Photodynamic therapy for carcinoma of urinary bladder(PDT)Method |
-
2019
- 2019-09-17 CN CN201910874493.4A patent/CN110420326A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108697800A (en) * | 2015-12-17 | 2018-10-23 | 光治疗Asa公司 | Photodynamic therapy for carcinoma of urinary bladder(PDT)Method |
Non-Patent Citations (3)
| Title |
|---|
| B. HABERMEYER等: "Some activities of PorphyChem illustrated by the applications of porphyrinoids in PDT, PIT and PDI", 《PHOTOCHEM. PHOTOBIOL. SCI》 * |
| 陶纪宁等: "多替泊芬-光动力疗法肿瘤抑制效应的实验研究", 《中国激光医学杂志》 * |
| 马礼坤: "注射用多替泊芬在浅表性膀胱癌患者中的局部药代动力学和安全性临床研究", 《中国优秀硕士学位论文全文数据库 医药卫生科技辑》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112336746A (en) * | 2020-10-23 | 2021-02-09 | 内蒙古科技大学包头医学院 | Perfusion chemotherapeutic medicine for bladder cancer and application thereof |
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