CN111840439A - Method for preparing traditional Chinese medicine medicated thread and method for treating high-position complicated anal fistula by using medicated thread - Google Patents

Method for preparing traditional Chinese medicine medicated thread and method for treating high-position complicated anal fistula by using medicated thread Download PDF

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CN111840439A
CN111840439A CN202010855436.4A CN202010855436A CN111840439A CN 111840439 A CN111840439 A CN 111840439A CN 202010855436 A CN202010855436 A CN 202010855436A CN 111840439 A CN111840439 A CN 111840439A
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thread
anal fistula
fistula
medicine
anal
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CN111840439B (en
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赵兵
唐学贵
吴至久
孔鹏飞
胡选亚
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Affiliated Hospital of North Sichuan Medical College
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3209Incision instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/241Lead; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/32Burseraceae (Frankincense family)
    • A61K36/324Boswellia, e.g. frankincense
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/32Burseraceae (Frankincense family)
    • A61K36/328Commiphora, e.g. mecca myrrh or balm of Gilead
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/889Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0031Rectum, anus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00818Treatment of the gastro-intestinal system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00893Material properties pharmaceutically effective

Abstract

The invention provides a method for preparing a traditional Chinese medicine medicated thread, which comprises the following steps: s1, crushing each medicinal material into medicinal powder and storing the medicinal powder separately for later use; s2, putting all the medicinal powder into a vessel according to the medicine proportion, adding purified water, and mixing uniformly to form a liquid medicine; s3, completely immersing the prepared flexible wire into the liquid medicine and sealing the vessel; s4, drying and disinfecting the soaked flexible wires for later use; in step S2, the medicine ratio is as follows: 6g of catechu, 8g of frankincense, 10g of myrrh, 8g of dragon's blood and 5g of litharge, wherein the respective mass errors of the five medicines are not more than +/-220 mg, and the added purified water is 210-216 ml; in step S3, the flexible wires are No. 7 mousse threads with 20 and 45cm lengths, the temperature of the mousse threads sealed and soaked in the liquid medicine is 25-27 ℃, and the soaking time is 69-71 hours. The medicinal line prepared by the invention has sufficient medicinal effect and obvious clinical comprehensive curative effect on anal fistula.

Description

Method for preparing traditional Chinese medicine medicated thread and method for treating high-position complicated anal fistula by using medicated thread
Technical Field
The invention relates to a medicated thread for treating anal fistula, in particular to a method for manufacturing a traditional Chinese medicine medicated thread for treating anal fistula.
Background
In medicine, anal fistula is an abnormal passage between the anorectum and the skin around the anus, and modern medicine considers that the cause of anal fistula can be divided into: infectivity and other factors. The infection factors mainly include anal gland infection and central gap infection, the anal gland infection is the main cause of anal fistula, about 85 percent, and the anal fistula caused by the central gap infection is mostly high anal fistula. At present, anal fistula is treated mainly by open placement, tube removal, incision and thread hanging drainage and combination of antibiotics, the curative effects are all strong and satisfactory, and the anal fistula has some corresponding negative effects on patients. For example, researchers in the field creatively design a surgical mode of incision, thread hanging and selective suture, which has better curative effect, but has the negative effects of large surgical injury, easy infection, anal morphological change and the like. In view of the above, medical workers have conducted a plurality of intensive studies on anal fistula treatment documents, and found that the curative effect of the traditional Chinese medicine 'medicated thread' on anal fistula, especially on high-level complex anal fistula, is remarkable, and some clinical treatment methods using the traditional Chinese medicine 'medicated thread' and the using method thereof as technical routes are designed, so that some progress is made, but the clinical treatment requirements on the clinical curative effect, the recurrence rate reduction, and the treatment complications and sequelae reduction are far from being met. For example, in the early eighties of the twentieth century, medical workers, through research on traditional Chinese medicine documents, particularly on traditional Chinese medicine external treatment documents, have recorded about "line therapy" in the hemorrhoid theory of "orthodox surgery", the line-boiling prescription: flos genkwa and wallflower, the original prescription is a treatment method for treating haemorrhoids prolapse and haemorrhage. Then according to the medicine compatibility theory, the traditional Chinese medicine property theory, the using principle of externally applied traditional Chinese medicine and toxic traditional Chinese medicine and the traditional Chinese medicine external treatment theory, the clinical practice is combined, under the guidance of the etiology and pathogenesis theory of anal fistula, the characteristics of externally applied medicines for the anus and the intestine are combined, and in clinical use, the lilac daphne flower bud is changed into the lilac daphne flower root on the basis of keeping the compatibility of the original formula, and in addition: the preparation method comprises the following steps of crushing each medicinal material into medicinal powder, respectively storing the medicinal powder separately for later use, putting all the medicinal powder into a vessel according to the medicine proportion, adding water, and uniformly mixing to form a liquid medicine; then, completely immersing the prepared medicated thread in the liquid medicine and sealing the vessel; boiling the medicinal liquid soaked with medicated thread with strong fire, evaporating to dry, taking out the medicated thread, spraying sanguis Draxonis powder, oven drying, and sterilizing. The traditional Chinese medicine line can reduce postoperative complications and sequelae to a certain extent on the aspect of anal fistula treatment, and has a good curative effect, but in the aspect of a preparation process, the soaked line needs to be directly dried by high temperature, and the liquid medicine is concentrated on the line as much as possible, so that at the high temperature, part of the medicine effect of the medicine is actually lost, most of the medicine is dried on the bottom or the inner wall of a container such as a pottery pot and the like, and the medicine is wasted, but if the medicine is not dried by distillation according to the existing method to fully blend the medicine into the line, the existing medicine formula cannot guarantee the curative effect. In addition, the dragon's blood is added after the medicated thread is fished out of the pot body, and the powdered dragon's blood is difficult to be uniformly distributed on the medicated thread, which also influences the stability of the curative effect of the medicated thread. Therefore, in terms of curative effect, the contradictory relationship between the medicated thread treatment process and the ratio of the medicated thread liquid exists, and the compatibility is difficult. Therefore, the comprehensive curative effect of the traditional Chinese medicine medicated thread for treating anal fistula is still worth being studied deeply, and further improvement and promotion are urgently needed.
Disclosure of Invention
The invention aims to solve the problems that the traditional Chinese medicine medicated thread preparation method for treating anal fistula cannot sufficiently obtain the traditional Chinese medicine medicated thread with obvious curative effect in the prior art, and particularly, the comprehensive curative effect of the medicated thread prepared by the prior preparation method needs to be further improved and promoted when high-level complex anal fistula is treated.
In order to achieve the purpose, the invention adopts the following technical scheme:
a method for preparing a Chinese medicinal medicated thread comprises the following steps: s1, crushing each medicinal material into medicinal powder and storing the medicinal powder separately for later use; s2, putting all the medicinal powder into a vessel according to the medicine proportion, adding purified water, and mixing uniformly to form a liquid medicine; s3, completely immersing the prepared flexible wire into the liquid medicine and sealing the vessel; s4, drying and disinfecting the soaked flexible wires for later use; in step S2, the medicine ratio is as follows: 6g of catechu, 8g of frankincense, 10g of myrrh, 8g of dragon's blood and 5g of litharge, wherein the respective mass errors of the five medicines are not more than +/-220 mg, and the added purified water is 210-216 ml; in step S3, the flexible wires are No. 7 mousse threads with 20 and 45cm lengths, the temperature of the mousse threads sealed and soaked in the liquid medicine is 25-27 ℃, and the soaking time is 69-71 hours. The above process parameters need to be strictly controlled, and if the error range is exceeded, the efficacy of the mixed medicines may be linearly reduced, and the effective dose on the line is greatly influenced, so that the selection of the efficacy is difficult to grasp when the clinical line is used, the treatment effect and the dosage of the line cannot be evaluated, and the treatment based on syndrome differentiation is affected, so that the compliance is required.
When the medicated thread is prepared, preferably, each medicinal material is crushed into medicinal powder and then screened through a screen, the adopted screen is 80-100 meshes, and the medicinal powder passing through the screen is stored for later use.
In addition, the inside of the vessel is provided with an automatic stirring part which stirs during the soaking period of the mousse threads and all the mousse threads are not exposed out of the liquid level of the liquid medicine in the stirring process, so that the uniformity of the liquid medicine is fully improved, and the liquid medicine is guaranteed to be fully and uniformly soaked into each liquid medicine line as far as possible. In order to improve the effect, during actual manufacturing, a stirring shaft inserted into a vessel is arranged on the automatic stirring part, 20 cross rods are arranged on the stirring shaft along the radial direction of the stirring shaft, all the cross rods are not in the liquid medicine, multiple layers of cross rods are arranged along the axial direction of the stirring shaft, the adjacent two layers of cross rods are staggered with each other, so that the cross rods and the stirring shaft form a circular comb-shaped structure, and a mousse line is spirally wound on each cross rod along the length direction of the cross rod; the stirring shaft is horizontally arranged, the vessel can also integrally rotate, the rotating shaft of the vessel is coaxial with the stirring shaft, but the rotation direction of the vessel is opposite to that of the stirring shaft, and the rotating speed of the vessel is less than that of the stirring shaft. And more preferably, the stirring shaft and the vessel both intermittently rotate by 60 degrees and do not rotate simultaneously.
Meanwhile, based on the traditional Chinese medicine thread, the invention also provides a method for treating high-position complex anal fistula, which mainly changes the original five steps into four steps, namely: 1. look for the internal orifice of anal fistula, 2, incision selection, 3, anal fistula main pipe string medicine line, 4, anal fistula branch pipe string medicine line, and anal fistula main pipe string medicine line gymnastics does: one end of a No. 7 silk thread is tied on a medical thread which is a traditional Chinese medicine medical thread prepared by the method, the other end of the No. 7 silk thread is tied on a prepared rubber band, the rubber band and the medical thread are dragged to pass through a fistula under the guidance of a probe, meanwhile, the medical thread and the rubber band are kept to be wound together, a middle-bending hemostat is used for clamping the stretched rubber band close to muscles, the No. 7 silk thread and the medical thread are ligated together, and the automatic tightening of the medical thread hung on the anorectal ring is completed to cut the muscles until the muscles fall off.
Compared with the prior art, the invention has the following beneficial effects: the invention provides a brand new preparation method of a traditional Chinese medicine medicated thread for treating anal fistula and a corresponding improved treatment method of anal fistula, which changes the traditional formula and the medicated thread treatment method on the basis of the existing 'medicated thread' preparation process, adopts an original formula, combines a special medicated thread treatment process, integrates the traditional Chinese medicine theory and clinical innovation, improves the influence on the curative effect on the factors of medicine compatibility and the manufacturing process of the medicated thread, can better and fully obtain the medicated thread with excellent curative effect without fully integrating high-temperature steaming dry type medicines, is simpler and easier in process, thoroughly avoids the process defect that powder medicine (dragon blood) is difficult to uniformly adhere when finally adding in the prior art, obtains a medicated thread for treating anal fistula, particularly has obvious comprehensive curative effect for treating high-level complicated anal fistula, and uses the traditional Chinese medicine medicated thread provided by the invention, the one-time operation has high cure rate, few postoperative complications and sequelae, greatly reduced anus function damage and anus form damage degree, short treatment course, low recurrence rate and obvious and excellent comprehensive curative effect, and the whole preparation method is more scientific, reasonable, adjustable and controllable. In addition, the method of the invention does not need to evaporate the liquid medicine to dryness and concentrate, and has a basis for recycling.
Additional advantages, objects, and features of the invention will be set forth in part in the description which follows and in part will become apparent to those having ordinary skill in the art upon examination of the following or may be learned from practice of the invention.
Drawings
FIG. 1 is a schematic illustration of the dipping of a medicated thread in an embodiment of the present invention;
fig. 2 is a schematic diagram of a drying mode of the medicated thread.
Wherein, household utensils 1, admire silk thread 2, (mixing) shaft 3, horizontal pole 4, metal pole 5, fan 6.
Detailed Description
In order to make the technical means, the creation characteristics, the achievement purposes and the functions of the invention clearer and easier to understand, the invention is further explained by combining the drawings and the detailed implementation mode:
the embodiment describes a method for manufacturing a traditional Chinese medicine medicated thread, which is specifically carried out according to the following steps: firstly, each medicinal material is crushed into medicinal powder and the medicinal powder is respectively and independently stored for later use. Secondly, all the medicinal powder is put into a vessel according to the medicine proportion, and purified water is added into the vessel to be mixed evenly to form liquid medicine. Again, the prepared cord was completely immersed in the drug solution and the vessel was sealed. Finally, fishing out the soaked flexible wires, drying and sterilizing for later use. In particular, the ratio of the above drugs in this embodiment is as follows: 6g of catechu, 8g of frankincense, 10g of myrrh, 8g of dragon's blood and 5g of litharge, wherein the respective mass errors of the five medicines are not more than +/-220 mg, the added purified water is 210-216 ml, the adopted flexible cord is specially selected from No. 7 mousse threads with 20 and 45cm in length, the temperature of sealing and soaking the mousse threads in the liquid medicine is 25-27 ℃, and the soaking time is 69-71 hours. When the medicated thread is soaked, the medicated thread can be wound on a winding wheel, and then the medicated thread is wholly immersed into the liquid medicine, if the medicated thread is prevented from being scattered, the medicated thread is preferably extruded to a certain degree, and the space of a vessel is fully utilized, so that all the medicated thread is immersed below the liquid medicine level.
In addition, the invention does not adopt the existing concentration steaming drying type drying method, so the liquid medicine in the vessel after the medicated thread is fished out can be recycled, the recycling base is provided, and the liquid medicine can be added according to 74-78% of the medicine proportion after a batch of medicated thread is prepared according to the method every time, for example, the addition amount is as follows: 4.5g of catechu, 6.1g of frankincense, 7.7g of myrrh, 6.1g of dragon's blood and 3.8g of litharge, and the preparation method is repeated.
During the experiment, specifically, a batch of traditional Chinese medicine medicated thread is prepared according to the method, and the preparation process parameters of the medicated thread are as follows:
group number Catechu Olibanum (Boswellia carterii) Myrrha Dragon's blood Lithargyrum Purified water Temperature of Duration of time
1 5.82 8.1 10.11 7.88 4.83 215 25.5 70
2 5.78 7.9 9.91 7.98 4.99 212 25.8 70.5
3 6.12 7.78 10.15 8.2 5.1 210 26.3 69.8
4 5.89 8.12 9.78 8.11 5.13 215 25 70
5 6 8 10.1 7.78 4.98 213 26 69
6 6.11 7.89 9.87 7.88 4.78 212 25.8 69.7
7 6.22 7.96 10.15 8.15 4.89 215 25.8 70.5
8 6.05 8.22 10.12 8.05 4.88 216 26.3 70.3
9 5.88 7.89 9.97 8.22 5.05 214 26.5 70.8
10 5.99 8.18 10 7.99 5.11 210 26.9 71
11 6.15 8.20 10.22 8.08 5.22 213 27 70
In the above examples, the flexible wires in each group are 20 # 7 mousse threads with a length of 45cm, each medicine unit is g, the purified water unit is ml, and the temperature and the time are respectively the soaking temperature and the soaking time of the mousse threads.
In order to objectively and specifically illustrate the beneficial effects of the invention, the medicated thread is prepared according to the preparation method of the medicated thread provided by the invention and then put into clinical test for verification, and the specific method comprises the following steps:
(1) a subject: 360 patients with high complex anal fistula (non-acute infection phase).
(2) The source of the cases is: all cases were hospitalized in the anorectal department of the third-class hospital of three research centers, and were randomly tested for inclusion of single blindness according to the national Chengdu conference high-level complex anal fistula diagnosis standard and exclusion standard in 1992.
(3) Diagnostic criteria (criteria established by the Chengdu anorectal conference in 1992):
high-level complex anal fistula refers to more than two external orifices and branches of fistula, and the main pipeline of the anal fistula has one or more than two internal orifices passing through the deep part of the external sphincter.
(4) Inclusion criteria were:
the anal fistula patient with high complexity accords with the diagnosis standard.
② has good compliance to the observation and treatment of researchers.
(5) Exclusion criteria:
i, eliminating specific infection;
II, excluding patients with serious systemic complications (such as diabetes, cardiovascular and cerebrovascular diseases, hematopathy, infectious diseases, tumor patients, patients with liver and kidney insufficiency, and mental patients);
III, removing patients with scar constitution;
excluding patients under 18 years of age, pregnant or lactating women;
v, excluding the patients who are not healed after anal fistula radical treatment operation in the hospital;
and VI, excluding the patients with acute infection.
(6) And (3) estimating the number of samples: estimating the total sample number by using the counting data sample, and using the formula:
Figure BDA0002646262070000051
wherein p ise、pcThe effective rates of the test group and the control group are respectively, if the sample contents of the test group and the control group are set to be equal, k is 1,
Figure BDA0002646262070000052
alpha is 0.05 and beta is 0.10 (formula is compiled from Wangmang Jialiang, clinical epidemiology and scientific research design, measurement and evaluation, Shanghai science and technology Press, 2001: 145) pe=89.03%、pc75.13%, two-sided test was taken. Estimation of the number of samples one skilled in the art can also use other existing statistical calculation models to calculate, and the estimation of the number of samples in this embodiment is only one of the feasible methods.
(7) And (3) random grouping: the simple random division method uses SAS software package to produce random number on computer, fills in random distribution card, notes serial number, groups and puts in opaque and sealed envelope.
(8) Blind method: the study adopts a single blind design, the subjects do not know their own grouping, and three separations, namely, the implementer, the recorder and the analyst, are implemented to avoid human factors.
(9) Comparison: the test group (observation group) and the control group of the embodiment adopt a comparable control, namely the traditional Chinese medicine medicated thread adopts the medicated thread prepared by the method, and the medicated thread of the control group adopts a traditional Chinese medicine medicated thread with a currently available curative effect, and the preparation method of the traditional medicated thread mainly comprises the steps of taking 6g of daphne genkwa roots, 3g of walleye, 3g of brucea javanica kernels, 3g of croton kernels and 3g of schizonepeta carbons, smashing, putting white cotton threads with the diameter of 0.5mm and the length of 2 feet into an earthenware pot, adding 200ml of water, sealing, soaking at a constant temperature of 20 ℃ for 24 hours, then burning the liquid medicine with strong fire, taking out the undried medicated thread concentrated with the medicines, spreading 6g of dragon's blood powder, and drying for later use.
(10) Multi-center: this study employed multiple centers, namely: the three research centers cooperate with affiliated hospitals of Chuanbei medical college, national hospitals of Yangtze county, and central hospitals of Nanxi city. The total number of samples was equally distributed among three study centers, 120 per study center.
(11) The specific treatment method comprises the following steps:
preparation before the conventional operation of anorectal department.
② the anesthesia is performed on the points Yashu.
Step three, operation:
i, searching an internal opening, and determining the internal opening of the anal fistula by methods such as dyeing, probe detection and the like. Firstly, placing one piece of physiological saline gauze in the rectum under the leaf-separating anoscope, and taking the mixture with the volume ratio of 1: 1 and hydrogen peroxide to form a mixed solution, wherein the mixed solution is selected according to needs and generally does not exceed 4 ml. The injection needle is slowly injected into the fistula from the outer opening (the farthest outer opening) under the condition of tightly pressing the outer opening (the gauze is held by hands to press the outer opening), and is properly used as the fistula running area to be kneaded and pressed to promote the penetration. If the gauze is taken out and dyed, the position of the inner opening is the position of the inner opening, namely, the dyeing agent infiltrates into the anus through the fistula from the outer opening, and the white gauze is dyed when the dyeing agent enters the anus through the inner opening, namely the position of the inner opening of the anal fistula. The stain blocking the fistula lumen can not pass smoothly or can not be retained when meeting large pus cavity or cavity stain, which causes the inner orifice not to be colored. The inner opening can be searched by a probe with a hook under the leaf separating mirror or cut open from the outer opening under the guidance of the probe, and then the probe is used for probing and cutting while probing.
And II, selecting an incision, namely selecting the incision position according to the position relationship between the outer opening and the inner opening, firstly knowing the relationship between the running direction of the fistula and the anal sphincter, after the anal fistula main pipe (namely the fistula directly communicated with the inner opening) is cleared, radially cutting the skin on the main fistula communicated with the inner opening and the lower part of the skin of a small part of the external sphincter, trimming the incision to form an open drainage incision with a wide upper part and a narrow lower part, then keeping the anal canal rectum ring without cutting, and extending the spherical head silver probe from the incision to the anal fistula inner opening in the anus through the anal canal rectum ring and keeping the anal fistula inner opening in a pipeline for waiting for treatment.
III, hanging the medical thread on the anal fistula main pipe, tying one end of a No. 7 silk thread on the prepared traditional Chinese medicine medical thread (hereinafter referred to as medical thread) on the observation group, tying the other end on a probe penetrating through the anal fistula main pipe, drawing out the probe gently, leading the medical thread out to the other end of the anal fistula, and tying the knot to form a temporary virtual hanging thread. Here, as a control group for verifying the efficacy of the contrast observation group, the traditional Chinese medicine medicated thread connected to one end of the number 7 silk thread is replaced with a medicated thread prepared by combining six traditional Chinese medicines such as lilac daphne root, osbeckia chinensis, brucea javanica kernel and the like to form a control in the operation.
And IV, hanging a medical line on the anal fistula branch pipe, probing a probe into a drainage cut after cutting along the anal fistula branch pipe from an anal fistula external orifice, cutting off the anal fistula external orifice and expanding wound, trimming an inlet and an outlet at two ends of the probe, penetrating and knotting the medical line on the same main pipe, and hanging the medical line as a suspension line.
V, anal fistula is responsible for cutting string, 3 days after anal fistula is responsible for hanging the pencil, treat anal fistula is responsible for hanging the pencil and take off, when lumen grow drainage is unobstructed, with 7 # silk thread one end system in the pencil, the other end system is on the rubber band that prepares, drag the rubber band to passing the fistula, keep pencil and rubber band to twine together simultaneously, cushion the direction in order to change string cutting tissue stress on the muscle that the skin was opened outside after folding into three with mulberry paper this moment, then tighten up pencil and rubber band and press on mulberry paper, press the rubber band of stretching near the muscle with the well curved hemostatic forceps, ligate together with 7 # silk thread together with the pencil, accomplish the automatic tight line of anal canal rectum ring string pencil and cut the muscle until droing.
Fourthly, after operation, antibiotics are reasonably used after the operation, and the wound is changed to be healed.
(12) And (3) observation period: the observation period for all patients was 30 days.
The observation indexes are as follows:
self-sensing: bleeding, pain, itching, secretions.
② the curative effect standard (the seventh anorectal meeting of the Chengdu nationwide in 1992 is established):
i, healing: the symptoms and physical signs disappear, and the wound is completely healed;
II, effect is shown: the symptoms disappear, the physical signs are improved, and the wound is not healed;
III is effective: symptoms and signs are improved, and wounds are not healed;
IV symptoms, signs, and wound healing were not improved or improved, but there was incomplete healing and exudate spillage.
(13) Follow-up: the follow-up visit period is 6 months, and the follow-up visits are performed respectively at 3 rd and 6 th months after discharge. Including anal morphology and anal functional assessment.
(14) Statistical treatment: all data from the experiments were statistically analyzed in the SPSS19.0 software package.
After the medicine is taken strictly according to the test mode, 360 patient samples are observed, and the curative effect standard is evaluated by adopting the standard established in the seventh anorectal meeting of Chengdu nationwide in 1992:
i, healing: the symptoms and physical signs disappear, and the wound is completely healed;
II, effect is shown: the symptoms disappear, the physical signs are improved, and the wound is not healed;
III is effective: symptoms and signs are improved, and wounds are not healed;
IV symptoms, signs, and wound healing were not improved or improved, but there was incomplete healing and exudate spillage.
All the data obtained by the test are statistically analyzed and processed by an SSPS19.0 software package to obtain the following curative effect comparison statistical table:
table 1-evaluation of clinical efficacy of the observation and control groups:
group of N (case) Recovery method Show effect Is effective Invalidation Total effective rate
Observation group 180 157(87.22%) 11(6.11%) 8(4.44%) 4(2.22%) 97.78%
Control group 180 131(72.78%) 15(8.33%) 13(7.22%) 21(11.67%) 88.33%
Note: compared with the control group, the difference has statistical significance, and P is less than 0.05.
According to the statistical analysis results in table 1, it can be seen that: the effective rate of the whole treatment of the medicated thread group is obviously higher than that of the control group.
TABLE 2 comparison of postoperative rehabilitation indexes for the observed and control groups: (
Figure BDA0002646262070000081
d):
Group of n Length of stay (sky) Time to heal wound (Tian)
Observation group 180 14.18±3.58 28.17±3.61
Control group 180 19.36±1.96 33.43±4.23
Note: the difference was statistically significant, P <0.05, when compared to the control group.
Description of the drawings: the average hospitalization days and wound healing time of the patients in the medicated thread group are obviously lower than those in the control group.
Table 3-comparison of postoperative pain levels in the observation and control groups:
Figure BDA0002646262070000082
note: the difference was statistically significant, P <0.05, when compared to the control group.
Description of the drawings: the pain of the patients in the medicated thread group was significantly less in the first three weeks after surgery than in the control group.
Table 4-comparison of anal function before treatment n (%) for the observed and control groups:
group of Is normal The loose stool cannot be controlled Leakage of liquid Air leakage
Observation group (n 180) 86(47.78%) 73(40.56%) 98(54.44%) 82(45.56%)
Control group (n ═ 180) 83(46.11%) 76(42.22%) 91(50.56%) 89(49.44%)
Note: the difference was statistically significant, P >0.05, when compared to the control group.
Description of the drawings: the anus function before the operation of the observation group and the control group is not different integrally.
Table 5-comparison of anal functional recovery after treatment of the observation and control groups n (%):
group of Is normal The loose stool cannot be controlled Leakage of liquid Air leakage
Observation group (n 180) 173(96.11%) 0(0.00%) 2(1.11%) 5(2.78%)
Control group (n ═ 180) 152(84.44%) 5(2.78%) 13(7.22%) 15(8.33%)
Note: the difference was statistically significant, P <0.05, when compared to the control group.
Description of the drawings: compared with the postoperative anus function of the control group, the anal function recovery of the medicated thread group is obviously better than that of the control group.
The data obtained by the scientific, rigorous and detailed experimental control show that the traditional Chinese medicine medicated thread prepared by the method provided by the invention has good comprehensive curative effect on anal fistula patients while fully utilizing medicinal materials, and has great progress compared with the traditional Chinese medicine medicated thread.
In addition, as specific implementation details, each medicinal material is crushed into medicinal powder and then screened through a screen, the screen is 80-100 meshes, the medicinal powder passing through the screen is stored for later use, the medicinal powder with the size can be fully mixed in 210-216 ml of purified water, and on the premise of the medicine proportioning of the medicinal composition, the medicinal powder has a reasonable size of the water consumption so as to be fully contacted with a medicinal line, and the medicinal powder does not need to be dried by distillation to enable the medicine to be soaked to reach the standard. Similarly, in order to improve the above effect, an automatic stirring component is arranged inside the vessel, the automatic stirring component stirs during the soaking period of the mousse threads, and all the mousse threads 2 can not be exposed out of the liquid level of the liquid medicine during the stirring process, and the liquid medicine can be further soaked and blended with the mousse threads 2.
In order to improve the stirring effect and fully and uniformly mix the liquid medicine, in particular, the automatic stirring part in the embodiment is provided with a stirring shaft 3 inserted into the vessel 1, 20 cross rods 4 are arranged on the stirring shaft 3 along the radial direction, the cross rods 4 are completely immersed in the liquid medicine, a plurality of layers of the cross rods 4 are arranged along the axial direction of the stirring shaft 3, the adjacent two layers of the cross rods 4 are staggered with each other, so that the cross rods 4 and the stirring shaft 3 form a circular comb-shaped structure, and each cross rod 4 is spirally wound with a mousse line 2 used in the invention along the length direction thereof so as to soak the liquid medicine line. The stirring shaft 3 is horizontally arranged, the vessel 1 can integrally rotate, the rotating shaft of the vessel 1 is coaxial with the stirring shaft 3, but the rotation direction of the vessel 1 is opposite to that of the stirring shaft 3, and the rotating speed of the vessel 1 is less than that of the stirring shaft 3. Furthermore, (mixing) shaft 3 and household utensils 1 equal intermittent type nature rotate 60 degrees, and the two is not rotatory simultaneously, so, two differential antiport more is favorable to the liquid medicine environment of horizontal pole 4 contact different positions and stage nature remixing liquid medicine for the pencil on every horizontal pole 4 all contacts under similar liquid medicine concentration environment as far as possible and soaks. In addition, the stirring shaft 3 is horizontally installed instead of vertically installed, because when horizontally installed, all the cross rods 4 on the stirring shaft 3 can be contacted under the environment of relatively uniform concentration of the liquid medicine, and when vertically installed, the cross rods 4 on the upper portion of the stirring shaft 3 are located on the upper layer of the liquid medicine, the concentration of the liquid medicine which is relatively easy to contact is slightly lower, however, for all the liquid medicine lines, the possibility of inconsistent medicine effect due to uneven concentration of the liquid medicine is greatly improved, and the batch manufacturing and clinical efficacy evaluation of the liquid medicine lines are affected.
In order to stabilize the medicated thread and dry the medicated thread without influencing the drug effect, the taken mousse thread 2 is naturally dried in a ventilation environment at 25-27 ℃, which is more favorable for protecting the drug effect than the existing method of boiling the medicated thread by high temperature and decocting the medicated thread by slow fire, and the medicated thread is not favorable for drying when being too high or too low. Further, when the silk threads 2 are ventilated and dried, two ends of each silk thread 2 are tied to two metal rods 5 which are erected in parallel, all the silk threads 2 are arranged in parallel and located in the same vertical plane, a fan 6 which blows air towards the silk threads 2 is arranged in the direction perpendicular to the silk threads 2, the air speed of the fan 6 is 5-6 m/s, the quality of finished medicine threads can reach the best quality by combining the drying conditions, and the medicine effect after the medicine is fused with the silk threads 2 is the most sufficient.
Finally, the invention also provides a method for treating high complex anal fistula by using the traditional Chinese medicine medicated thread prepared by the method, which is different from the existing medicated thread treatment method in that the original five steps are changed into four steps, namely, the step of cutting and hanging the thread of the original V-shaped anal fistula main pipe is not independently implemented, and the original step of hanging the thread of the original III-shaped anal fistula main pipe is changed into a new step III: one end of a No. 7 silk thread is tied on a medical thread which is a traditional Chinese medicine medical thread prepared by the method, the other end of the No. 7 silk thread is tied on a prepared rubber band, the rubber band and the medical thread are dragged to pass through a fistula under the guidance of a probe, meanwhile, the medical thread and the rubber band are kept to be wound together, a middle-bending hemostat is used for clamping the stretched rubber band close to muscles, the No. 7 silk thread and the medical thread are ligated together, and the automatic tightening of the medical thread hung on the anorectal ring is completed to cut the muscles until the muscles fall off. The traditional Chinese medicine medicated thread prepared by the invention is adopted, so that the operation steps can be deleted and improved when high-level complex anal fistula is treated based on the excellent comprehensive curative effect, the complexity of the operation is reduced compared with the original medicated thread treatment method, the operation progress is accelerated, the curative effect of the traditional Chinese medicine medicated thread is better matched with that of the improved traditional Chinese medicine medicated thread, a better curative effect method is provided for clinical treatment of the high-level complex anal fistula, and the clinical treatment system of the anal fistula is enriched and further perfected.
Finally, the above embodiments are only for illustrating the technical solutions of the present invention and not for limiting, although the present invention has been described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions may be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all of them should be covered in the claims of the present invention.

Claims (8)

1. A method for preparing a Chinese medicinal medicated thread comprises the following steps: s1, crushing each medicinal material into medicinal powder and storing the medicinal powder separately for later use; s2, putting all the medicinal powder into a vessel according to the medicine proportion, adding purified water, and mixing uniformly to form a liquid medicine; s3, completely immersing the prepared flexible wire into the liquid medicine and sealing the vessel; s4, drying and disinfecting the soaked flexible wires for later use; the method is characterized in that: in step S2, the medicine ratio is as follows: 6g of catechu, 8g of frankincense, 10g of myrrh, 8g of dragon's blood and 5g of litharge, wherein the respective mass errors of the five medicines are not more than +/-220 mg, and the added purified water is 210-216 ml; in step S3, the flexible wires are No. 7 mousse threads with 20 and 45cm lengths, the temperature of the mousse threads sealed and soaked in the liquid medicine is 25-27 ℃, and the soaking time is 69-71 hours.
2. The method for preparing the traditional Chinese medicine thread according to claim 1, which is characterized in that: in step S1, each medicinal material is crushed into medicinal powder and then screened through a screen mesh, the adopted screen mesh is 80-100 meshes, and the medicinal powder passing through the screen mesh is stored for later use.
3. The method for preparing the traditional Chinese medicine thread according to claim 1, which is characterized in that: the automatic stirring part is arranged in the vessel and is used for stirring during the soaking period of the mousse threads, and all the mousse threads cannot be exposed out of the liquid level of the liquid medicine during the stirring process.
4. The method for preparing the traditional Chinese medicine thread according to claim 1, which is characterized in that: in the step S4, naturally drying the fished mousse line in a ventilation environment at 25-27 ℃; when the silk threads are ventilated and dried, two ends of each silk thread are tied to two metal rods which are erected in parallel relatively, all the silk threads are arranged between the silk threads in parallel and located in the same vertical plane, a fan blowing air towards the silk threads is arranged in the direction perpendicular to the silk threads, and the air speed of the fan is 5-6 m/s.
5. A method for treating high complexity anal fistula, which is characterized by comprising the following four steps in sequence:
i, searching an anal fistula inner opening;
II, selecting a cut;
III, hanging a medical thread on a main anal fistula pipe, tying one end of a No. 7 silk thread to the medical thread prepared by the method for preparing the traditional Chinese medicine medical thread according to any one of claims 1 to 4, tying the other end of the No. 7 silk thread to a prepared rubber band, dragging the rubber band and the medical thread to pass through a fistula under the guidance of a probe, simultaneously keeping the medical thread and the rubber band to be wound together, clamping the stretched rubber band by a middle-bending hemostat close to muscles, and ligating the No. 7 silk thread together with the medical thread to finish automatic tightening of the anal canal rectum ring-hung medical thread and cut the muscles until the muscles fall off;
and IV, hanging a medicine line on the anal fistula branch pipe.
6. The method of claim 5, wherein the step of treating the high complexity anal fistula comprises: determining the internal opening of the anal fistula by a dyeing method; firstly, placing one piece of physiological saline gauze in the rectum under the leaf separation anoscope, and taking the mixture with the volume ratio of 1: 1, mixing the methylene blue with hydrogen peroxide to form a mixed solution, slowly injecting the mixed solution into the fistula from an outer opening by using an injection needle under the condition that the gauze is held by hands to press the outer opening, and kneading and pressing a fistula walking area to promote the permeation of the mixed solution; taking out the gauze and obtaining the position of the inner opening if dyeing; when the anal fistula internal orifice is determined by a dyeing method, if the fistula lumen blocks the coloring agent and passes unsmoothly, or the coloring agent cannot be retained in a large pus cavity or a cavity to cause the internal orifice not to be colored, at the moment, the internal orifice is searched by a probe with a hook under a leaf-separating mirror or is cut from the external orifice under the guidance of the probe, then the probe is explored, and the detection is carried out while cutting.
7. The method of claim 5, wherein the step of treating the high complexity anal fistula comprises: for the incision selection, the incision position is selected according to the position relationship between the outer opening and the inner opening, the relationship between the fistula walking direction and the anal sphincter is firstly known, after the anal fistula main pipe (namely, the anal fistula main pipe directly communicated with the inner opening) is cleared, the skin above the main fistula of the anal fistula main pipe communicated with the inner opening and the lower part of the external sphincter skin are radially cut, the incision is trimmed to form an open drainage incision with a wide upper part and a narrow lower part, then the anal canal rectal ring is kept without cutting, and a spherical head silver probe penetrates through the anal canal rectal ring from the incision to reach the anal fistula inner opening in the anus and is kept in the pipeline for treatment.
8. The method of claim 5, wherein the step of treating the high complexity anal fistula comprises: the specific operation of the anal fistula branch pipe drug-hanging line is as follows: and (3) probing the probe into the drainage incision after incision from the anal fistula external orifice along the anal fistula branch pipe, excising the anal fistula external orifice and expanding the wound, trimming the inlet and the outlet at the two ends of the probe, and passing and knotting the medical thread as the main pipe of the anal fistula main pipe to tie the medical thread to be used as a suspended thread.
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CN113198091A (en) * 2021-04-15 2021-08-03 上海中医药大学附属龙华医院 Medicated thread manufacturing system and medicated thread manufacturing method
CN113440202A (en) * 2021-06-29 2021-09-28 川北医学院附属医院 Thread hanging structure for anal fistula disease treatment and elastic thread preparation method thereof
CN115814008A (en) * 2023-02-22 2023-03-21 江西中医药大学附属医院 Traditional Chinese medicine medicated thread for treating perianal abscess and application

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CN112472762A (en) * 2020-12-17 2021-03-12 川北医学院附属医院 A Chinese medicinal medicated thread for treating pyocutaneous disease, and its preparation method
CN113198091A (en) * 2021-04-15 2021-08-03 上海中医药大学附属龙华医院 Medicated thread manufacturing system and medicated thread manufacturing method
CN113198091B (en) * 2021-04-15 2022-11-22 上海中医药大学附属龙华医院 Medicated thread manufacturing system and medicated thread manufacturing method
CN113440202A (en) * 2021-06-29 2021-09-28 川北医学院附属医院 Thread hanging structure for anal fistula disease treatment and elastic thread preparation method thereof
CN113440202B (en) * 2021-06-29 2022-09-27 川北医学院附属医院 Thread hanging structure for anal fistula disease treatment and elastic thread preparation method thereof
CN115814008A (en) * 2023-02-22 2023-03-21 江西中医药大学附属医院 Traditional Chinese medicine medicated thread for treating perianal abscess and application

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