CN102198089A - Application of lauromacrogol injection as medicament for treating internal hemorrhoid - Google Patents
Application of lauromacrogol injection as medicament for treating internal hemorrhoid Download PDFInfo
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- CN102198089A CN102198089A CN 201110130088 CN201110130088A CN102198089A CN 102198089 A CN102198089 A CN 102198089A CN 201110130088 CN201110130088 CN 201110130088 CN 201110130088 A CN201110130088 A CN 201110130088A CN 102198089 A CN102198089 A CN 102198089A
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Abstract
The invention belongs to the field of the medical application of a lauromacrogol injection, and particularly relates to application of a lauromacrogol injection as a medicament for treating internal hemorrhoid. Internal hemorrhoid is one of hemorrhoids, which occurs above the pectinate line of the anal canal and is a commonly encountered disease having the highest incidence rate among the hemorrhoids; for majorities of people, internal hemorrhoid bleeding is a disease difficult to deal with; and when the internal hemorrhoid bleeds too much, secondary anemia can be caused. In the invention, the lauromacrogol injection is injected into the hemorrhoid, so that an aseptic inflammation is produced and is then gradually fiberized, thus realizing the treatment of the internal hemorrhoid. The lauromacrogol injection can wrap veins and arterioles in the hemorrhoid, so that a protective layer can be formed at the peripheries of the veins and arterioles, thereby preventing weak blood vessels from bleeding due to damage caused by defecation and other factors; fiber textures can occlude blood vessel cavities, eliminate or lessen the expansion and congestion of the veins and atrophy the hemorrhoid; because of the fiberization process, a relaxed mucous membrane can be fixed on the muscular wall thereunder again through the fiber textures, thereby eliminating the symptom.
Description
Technical field
The invention belongs to polycinnamic alcohol injection medicinal application field, be specifically related to of the application of a kind of polycinnamic alcohol injection as treatment internal hemorrhoid medicine.
Background technology
Internal hemorrhoid is a kind of of hemorrhoid, and it is meant and occurs in more than the anal canal pectinate line, enlarges varicose by hemorrhoid angular vein clump under the mucosa and is formed softish vein group.Internal hemorrhoid is the highest commonly encountered diseases of sickness rate in all hemorrhoid, and the cause of disease mainly contains eating and drinking without temperance, and surfeit is drunk, and pungent raw food stimulates, irregular diet, and the sitting standing for a long time, the long journey of bearing a heavy burden, the chronic diarrhea chronic dysentery, prolonged constipation, gestation is produced, abdominal tumor compressing etc.The general symptom of internal hemorrhoid for have blood in stool, deviate from, pain, mucus flows out and pruritus etc.Internal hemorrhoid hemorrhage does not have pain, and minority has the sense of weigh down expanding, and deviates from incarceration when internal hemorrhoid or mixed hemorrhoid, edema, infection occur, when downright bad, pain is in various degree arranged then.Late period prolapsus of internal hemorrhoid, hemorrhoid piece and relaxation of anal sphincter often has secretions to flow out, and Internal hemorrhoid hemorrhage is because secretions stimulates, and around the anus pruritus discomfort is often arranged, even skin eczema occurs, and patient very feels bad.Internal hemorrhoid hemorrhage is that most people are difficult to the disease that tackles, Internal hemorrhoid hemorrhage more for a long time, but secondary anemia.
The hemorrhage medicine of treatment varicosis commonly used at present mainly contains natrium tetradecylsulfuricum, ethamolin and sodium morrhuate etc.The curative effect of natrium tetradecylsulfuricum equates with polycinnamic alcohol injection, but the incidence rate of side effect is apparently higher than polycinnamic alcohol injection; The ethamolin injection also renal failure can occur except that common complication takes place; Side effect such as chest pain, dark ulcer, heating then taking place after the sodium morrhuate injection easily, and want high than other sclerosing agents, also has cirso-to eliminate unconspicuous report.
Summary of the invention
The purpose of this invention is to provide a kind of application that can effectively treat the lower polycinnamic alcohol injection of internal hemorrhoid and complication rate as treatment internal hemorrhoid medicine, the hemorrhage situation of avoiding the damage because of factors such as defecations to take place.
Technical scheme that the present invention adopts is:
A kind of polycinnamic alcohol injection is as the application of treatment internal hemorrhoid medicine.
Described internal hemorrhoid refers to the internal hemorrhoid part of I phase, II phase, III phase internal hemorrhoid and mixed hemorrhoid.
Described internal hemorrhoid is pointed out the internal hemorrhoid of blood and prolapsus.
The present invention has the following advantages:
The present invention injects polycinnamic alcohol injection and makes it produce aseptic inflammation in the blood stasis, and fibrosis gradually can hold vein and small artery in the hemorrhoid then, forms layer protective layer around it, make weak blood vessel avoid because of the damage of factors such as defecation hemorrhage; Fibrous tissue can make the lumen of vessels obturation, eliminates or alleviate venous expansion and congested, makes hemorrhoid body generation atrophy; Because fibrosis forms, can make lax mucosa borrow fibrous tissue to retighten on thereunder the flesh wall, to eliminate its symptom.
The specific embodiment
The present invention will be described in detail below in conjunction with the specific embodiment.
The prescription of polycinnamic alcohol injection of the present invention is:
Polidocanol 1g
Ethanol 5ml
Water for injection adds to 100ml.
The preparation method of polycinnamic alcohol injection involved in the present invention is: add the polidocanol of 1g in dispensing containers, add the ethanol of 5ml again, stirring is dissolved polidocanol fully, adds water for injection again to 100ml; Content is surveyed in sampling behind the stirring and evenly mixing, after pH is qualified, 0.05～0.3% amount of pressing the solution total amount adds needle-use activated carbon, logical Steam Heating is boiled, when being cooled to 45～50 ℃ again, with solution through the carbon removal of 0.45um filtering with microporous membrane, adsorption time was at 20～30 minutes, again with filtrate through the 0.22um filtering with microporous membrane when the solution clarity does not have foreign body, be filled in cillin bottle or the ampoule, seal.
The mechanism of action of polycinnamic alcohol injection is: polycinnamic alcohol injection is injected make it produce aseptic inflammation in the blood stasis, fibrosis gradually then, this fibrosis tissue can produce 2 kinds of important function: the one, hold vein and small artery in the hemorrhoid, form layer protective layer around it, make weak blood vessel avoid because of the damage of factors such as defecation hemorrhage; Fibrous tissue can make the lumen of vessels obturation, eliminates or alleviate venous expansion and congested, makes hemorrhoid body generation atrophy; Because fibrosis forms, can make lax mucosa borrow fibrous tissue to retighten on thereunder the flesh wall, to eliminate its symptom.
Polycinnamic alcohol injection is the internal hemorrhoid part of I phase, II phase, III phase internal hemorrhoid and mixed hemorrhoid as the indication of treatment internal hemorrhoid medicine, especially hemorrhage and prolapsus internal hemorrhoid is had better effect.Contraindication is the internal hemorrhoid that is associated with complication, as thrombosis, infect, fester etc.
Polycinnamic alcohol injection is as follows as the using method of treatment internal hemorrhoid medicine:
1, behind the routine disinfection drape, locates local anesthesia at 3,9 with 1% lignocaine.
2, patient gets lateral position, and anal is placed anoscope, observes blood stasis number, position and rectal mucosa, uses the 5ml syringe, 4-5 number elongated syringe needle, needle slope 30-45 that makes progress
, 0.5cm thrusts on the pectinate line, I phase internal hemorrhoid needle point reaches Submucosa is advisable, II, III phase internal hemorrhoid reach the blood stasis central part is advisable, mixed hemorrhoid only need be injected the internal hemorrhoid part.Be needled into back pumpback depletion of blood, can inject the 2-4ml polycinnamic alcohol injection, overflow with the hemorrhoid body that swollen to be canescence blister shape be standard.Syringe needle can not thrust dark in order to avoid thrust intestinal wall flesh layer; Can not thrust shallow, make the table shallow mucosa necrosis, cause pain.
3, annotate the complete syringe needle of extracting out with dry cotton ball compressing 2-3 minute, avoid hemorrhage and overflow of drug fluid.If inject second blood stasis, can continue said method, annotate to finish and fill in one of rectal suppository.
4, if several blood stasis are arranged, generally need the gradation injection, every injection in 7-10 days once, be no more than 3 blood stasis, until healing at every turn.
After the injection blood stasis is resetted, advised the patient flat 20 minutes for sleeping in, control stool 24 hours gives 1-2 days antibiotic prophylaxis and infects.Treatment back patient feels the slight discomfort that rises of weighing down of anus, need not to handle section's spontaneous remission after 30 minutes.
Below be the zoopery of polycinnamic alcohol injection as treatment internal hemorrhoid medicine:
Experiment one: pharmacological evaluation
1, polycinnamic alcohol injection makes varicosis fibrosis and hemostatic laboratory observation:
(1) material and method:
Laboratory animal: hybrid dog, body weight 10～12Kg, 33.
Experiment medicine: polycinnamic alcohol injection
Experimental technique: fasting is 24 hours before the test, and anesthesia hybrid dog is tightened with tourniquet at the vein two ends of dog, after with normal saline blood being washed out, injects polycinnamic alcohol injection 1～2ml, stagnates 30 seconds.Subsequently, the formalin fixed of injection 10% was that center 5mm amplitude is made tissue section strain with the polycinnamic alcohol injection injection site after 30 minutes.
Observed result: obvious edema appears in polycinnamic alcohol injection injection site immediately; Visible Submucosa cell infiltration after 3 days, edema disappears after 7 days; Submucosa cell infiltration degree alleviates, and extensively is obvious vasculitis and thrombosis, and fibroblast occurs, also the visible part fibrosis; Compare after 14 days with after 7 days, cell infiltration alleviates, the Submucosa fibrosis, and the tremulous pulse machineization can be oppressed cirso-, reaches the hemostatic purpose.The results are shown in Table 1.
Tissue system changes figure behind the table one injection polycinnamic alcohol injection
(2) conclusion: as can be known by above experiment, polycinnamic alcohol injection can make the varicosis fibrosis and the venous acute hemorrhage is had good haemostatic effect, better with hemorrhage again haemostatic effect to continuing hemostasis, therefore can think: polycinnamic alcohol injection is good sclerosing agent.
2, the observation experiment of thrombosis effect:
(1) material and method:
Laboratory animal: hybrid dog, body weight 10～12Kg, 33.
Experiment material: human blood
Experiment medicine: polycinnamic alcohol injection
Experimental technique: fasting is 24 hours before the test, and anesthesia is tightened the about 5cm in cutaneous vein two ends of dog down with tourniquet, with normal saline blood is washed out, and behind the injection polycinnamic alcohol injection 5ml, stagnates 30 seconds.After cleaning with normal saline, recover blood flow, through the time vein carried out histological examination.In addition, personnel selection hemodilution this product changes concentration and intravenous and recovers blood flow after dead time, observes the formation frequency of entirely shutting property thrombosis after a week.
Observed result: inject this product after 30 seconds, only the venous endothelial cell with this product contact portion disappears, and electron microscopic observation is to fibrin and hematoblastic calmness after 5 minutes.After 2 hours, with fibrin together erythrocyte occur accumulating, account for blood vessel tube wall over half after 6 hours and form thrombosis, after 24 hours, the thrombosis of the blood vessel that entirely shuts, and then after 4 weeks, organification appears in thrombosis, vein diameter is dwindled to be about and is injected preceding 1/2.
Experiment conclusion: by above experiment as can be known, polycinnamic alcohol injection can promote the formation of thrombosis, makes Submucosa organic changes such as plumpness occur organizing.As seen, polycinnamic alcohol injection is a kind of effective sclerosis medicine.
Experiment two: acute toxicity testing is observed
Being clinical drug safety, is laboratory animal with the healthy mice, carries out the toxicity of this medicine and observes, and now its experimental technique and result is reported as follows:
(1) experiment purpose: polycinnamic alcohol injection drug administration by injection median lethal dose(LD 50) (LD is carried out in this experiment
50) mensuration, to observe its acute toxic reaction and death condition.
Laboratory animal: Kunming kind healthy mice, body weight 18～22g, male and female half and half.
Experimental technique and result: make preliminary experiment according to a conventional method earlier, find out the estimator of 0% and 100% lethal dose, so that the group amount and the metering of the formal experiment of decision.During formal test, select 50 of the healthy mices of body weight 20 ± 2g for use, male and female half and half are divided into 5 groups at random, and the polycinnamic alcohol injection 0.2ml/kg of a tail vein injection variable concentrations observed seven days after the administration, press Bliss method calculating LD
50, the results are shown in Table 2.
Table 2 result
Significance index: G=0.218828 X
50=2.133056 S
X=0.022295
G is less to be omitted.
The heterogeneous inspection: X
2=2.227081 X
2(0.05)=7.815 Sb=2.277468
Do not have heterogeneous
Regression equation: Y (Probit)=-15.35443+9.542384 * Log (D)
r=0.9420303
LD
50=135.8mg/kg
LD
50Average fiducial limit=± 19.4 mg/kg
95% fiducial limit interval=117.8～156.6 mg/kg
(2) conclusion: animal is taken place after the administration immediately lie down, dyspnea shows as frequency and accelerates, dehisces or ventral breathing, sometimes discontinuity occurring twitches, death mostly occurred after administration in 5 minutes, and dead animal performs an autopsy on sb, and the organic change of internal organs is not seen in perusal.Not Si Wang animal after the administration about 10 minutes above-mentioned poisoning symptom fade away, no abnormality seens such as the activity of animal after recovering, appetite, defecation, quilt hair are found, do not see the abnormal secretion thing in nose, eye, oral cavity, administration is mousetail purpling, blackout, swelling after one day, and the latter half of tail begins to dry up, come off in the time of 4～5 days.So should grasp dosage during clinical use, to acute severe cardiac disease of ZANG-organs is arranged, as endocarditis, myocarditis, heart failure and hypertension and heating, when acute pulmonary disease comprises dyspnea, as suitable careful usefulness of the patient of bronchial asthma or forbidding.
Below be the clinical case of polycinnamic alcohol injection as treatment internal hemorrhoid medicine:
One, data:
The First Affiliated Hospital of Kunming Medical School is treated internal hemorrhoid 85 examples, wherein patient's 55 examples of II degree, wherein male's 26 examples with polycinnamic alcohol injection under colonoscope, women's 29 examples, patient's 30 examples of III degree, male's 14 examples wherein, women's 16 examples, wherein the male is 46.9 years old the mean age, the women is 53.2 years old the mean age, effective 72 examples, invalid 11 examples, wherein 2 example nothings are followed up a case by regular visits to, and aggregate efficiency reaches 86.7%.
Two, observational technique:
(1) case is selected:
1) be II degree, III degree internal hemorrhoid patient, possess one of following two conditions:
1. internal hemorrhoid has hemorrhage; 2. influence work life or patient the anus discomfort is all arranged at every turn greatly after an action of the bowels.
2) go for sclerosing agent treatment under the colonic mirror certainly, patient agrees and signature.
3) eliminating has the internal hemorrhoid severe complication, the obvious obstacle of coagulation function, immunodeficiency and pregnant person is arranged.
4) get rid of other and be not suitable for being the colonoscope patient.
MethodsThe cases enrolled situation such as following table 3.
Polidocanol injection for curing internal hemorrhoid MethodsThe cases enrolled situation under table 3 colonoscope
5) treatment material:
Treatment group MethodsThe cases enrolled is mainly derived from the court's outpatient service and minority inpatient.
All treatment group patients all use polycinnamic alcohol injection.
Use Olympus CF-240I or CF-H260AZ/I colonoscope.
The scope injection needles is selected German ENDO-FLEX type pin for use, standby in addition usually many scope entry needle protective inoculation pin accidents.
Standby diameter 30mm endoscopic dilation air bag.
After reaching, uses injection process rare norepinephrine liquid flushing
6) Therapeutic Method:
1. prepare identical before the treatment with preparation before the colonoscope diagnosis and treatment.
2. all patients all do the total colectomy inspection, have polyp etc. to handle accordingly earlier, do internal hemorrhoid treatment at last.
3. according to the order of severity and the size of hemorrhoid, grasp dose of medicament flexibly and injection is counted, how at 10-15ml, the 8-10 point.
When 4. injecting, first left lateral position, horizontal position again, right arm reclining when keeping pin, make not overbending of scope front end, and the biopsy hole is better at lower position again.
5. every inject pin after, with the about 30-60 of stylophore or camera lens compressing pin mouth second.
6., give carbazochrome salicylate 5mg, tid behind the treatment group injectable drug; Lactulose 15ml, tid; Ciprofloxacin 0.5, bid; Continuous three days.
7) follow up a case by regular visits to:
1. treat and began to follow up a case by regular visits to tracking in back second day, write down hemorrhage, complication such as anus is uncomfortable, crissum pain, defecation situation, heating, stomachache.
2. follow up a case by regular visits to respectively at the 1st day, the 3rd day, the 6th day, 2 weeks and carrying out in 3 weeks, and record has or not complication, requires patient to make the intestinal mirror after three months and checks, and is particularly suitable for the patient of internal hemorrhoid treatment postoperative under intestinal mirror polypectomy+mirror.
(2) internal hemorrhoid treatment matched group:
1) mucosa ring cutting stitching art 30 examples on department of general surgery's same time hemorrhoid,
2) simple traditional Chinese medical herbal treatment 20 examples, the each patient takes the Chinese medicine preparation of traditional treatment internal hemorrhoid, and wrap a continuous week every day one.MethodsThe cases enrolled situation such as following table 4.
Table 4 traditional Chinese medical herbal treatment internal hemorrhoid MethodsThe cases enrolled situation
3) Therapeutic Method:
1. select at random to take Chinese medicine compound preparation treatment internal hemorrhoid person voluntarily, all do colonoscope before being selected in and make a definite diagnosis II, III degree internal hemorrhoid, other inclusion criteria is identical with the treatment group.
2. the each patient takes one week of Chinese medicine continuously, and the 8th day begins to follow up a case by regular visits to after the drug withdrawal, calculates the 1st day in the 8th day, and it is identical with the treatment group to follow up a case by regular visits to content.
(3) therapeutic outcome and discussion:
1) therapeutic outcome: have hemorrhage or influence work life patient for II degree, III degree internal hemorrhoid, colon soft lens direct-view injection polycinnamic alcohol injection treatment down is very effective.Patient does not generally need to be in hospital, and medical expense is more cheap than surgical operation, uses relieving constipation, anti-inflammation drugs a couple of days behind the injection of sclerosing agent to get final product.The polycinnamic alcohol injection injection for curing, internal hemorrhoid disappears fully, and onset is very fast, and as suitable operation, complication is gently lacked.Compare with the hard mirror treatment of rectum internal hemorrhoid in theory, its advantage is: colonoscope is a soft lens, can not oppress internal hemorrhoid, as suitable operation, get a clear view, varicosis and internal hemorrhoid expose clear, help accurate, capacity injection of sclerosing agent, seance just makes the internal hemorrhoid complete obiteration.
1. Follow-up results such as following table 5.
Polidocanol injection for curing internal hemorrhoid is followed up a case by regular visits to three months results under table 5 colonoscope
* compare p evident in efficacy＜0.01 with the treatment by Chinese herbs group
Followed up a case by regular visits to three months after the * treatment, symptom does not have and is improved as invalidly, and symptom obviously is improved as effectively.The treatment group has 20 example check intestinal mirrors, and scope shows that 20 examples all internal hemorrhoid disappear; The treatment by Chinese herbs group has 5 routine symptoms obviously to be improved as effectively, has no significant change but check intestinal mirror internal hemorrhoid, and patient treats from going for the scope injection of sclerosing agent afterwards, during the observation that this 5 example is included the treatment group at present in is followed up a case by regular visits to.
The situation of 2. treatment group complication sees Table 6.
The situation of 83 routine complication is organized in table 6 treatment
* the person that do not have blood in stool all is less than 5ml whole every days, 2 routine fever patients merge flu.
* two examples are lost because of going abroad and are visited.
2) discuss: through TC, be chief complaint, the age surpasses 50 years old person, getting rid of digestive tract tumor simultaneously, finds obvious internal hemorrhoid person, as long as one of two conditions are arranged: 1. Internal hemorrhoid hemorrhage for having blood in stool; 2. patient has sense of discomfort at every turn greatly after an action of the bowels and influences life and work.Solicit the patient and agree, can stand polycinnamic alcohol injection treatment under the capable internal hemorrhoid mirror.Once find polyp or early stage intestinal cancer, also can carry out handling under the scope, as EMR or EST at once.Check according to three months rear sections of this clinical observation group patient's intestinal mirror: the result is most patients' internal hemorrhoid complete obiteration, shows injection polycinnamic alcohol injection treatment internal hemorrhoid under the colonoscope, may play the radical cure effect.
Claims (3)
1. a polycinnamic alcohol injection is as the application for the treatment of the internal hemorrhoid medicine.
2. polycinnamic alcohol injection according to claim 1 is characterized in that as the application of treatment internal hemorrhoid medicine:
Described internal hemorrhoid refers to the internal hemorrhoid part of I phase, II phase, III phase internal hemorrhoid and mixed hemorrhoid.
3. polycinnamic alcohol injection according to claim 1 and 2 is characterized in that as the application of treatment internal hemorrhoid medicine:
Described internal hemorrhoid is pointed out the internal hemorrhoid of blood and prolapsus.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103768090A (en) * | 2014-02-19 | 2014-05-07 | 南通大学附属医院 | Medicine for interventional treatment of uterine myoma |
| RU2532013C1 (en) * | 2013-04-17 | 2014-10-27 | Федеральное государственное бюджетное учреждение "Государственный научный центр колопроктологии" Министерства здравоохранения Российской Федерации | Method for minimally invasive treatment of internal haemorrhoid |
| CN107530359A (en) * | 2015-02-27 | 2018-01-02 | 约翰·丹尼尔·杜巴克 | The reduction of adipose tissue |
| CN114159388A (en) * | 2021-12-17 | 2022-03-11 | 陕西天宇制药有限公司 | Application of lauromacrogol injection in preparation of medicine for treating bronchial cyst |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2532013C1 (en) * | 2013-04-17 | 2014-10-27 | Федеральное государственное бюджетное учреждение "Государственный научный центр колопроктологии" Министерства здравоохранения Российской Федерации | Method for minimally invasive treatment of internal haemorrhoid |
| CN103768090A (en) * | 2014-02-19 | 2014-05-07 | 南通大学附属医院 | Medicine for interventional treatment of uterine myoma |
| CN103768090B (en) * | 2014-02-19 | 2015-11-25 | 南通大学附属医院 | A kind of medicine of Uterine Fibroids by Intervention Therapy |
| CN107530359A (en) * | 2015-02-27 | 2018-01-02 | 约翰·丹尼尔·杜巴克 | The reduction of adipose tissue |
| CN110339159A (en) * | 2015-02-27 | 2019-10-18 | 约翰·丹尼尔·杜巴克 | The reduction of adipose tissue |
| CN107530359B (en) * | 2015-02-27 | 2020-02-18 | 10X生物有限责任公司 | Reduction of adipose tissue |
| US11065210B2 (en) | 2015-02-27 | 2021-07-20 | 10Xbio, Llc | Reduction of adipose tissue |
| CN114159388A (en) * | 2021-12-17 | 2022-03-11 | 陕西天宇制药有限公司 | Application of lauromacrogol injection in preparation of medicine for treating bronchial cyst |
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Application publication date: 20110928 |