Summary of the invention
The present invention does not have the problem of ideal medicine and curative effect method in order to solve radiation rectitis in the prior art, and a kind of enema of radiotherapy proctitis is provided.
The present invention adopts following technical scheme to realize:
A kind of enema of radiotherapy proctitis is made by the raw material of following weight ratio, Radix Notoginseng 3~6g, catechu 3~6g, Colla Corii Asini 5~10g, Pseudobulbus Bletillae (Rhizoma Bletillae) 10~30g, Radix Sanguisorbae 15~45g, Radix Et Rhizoma Rhei 6~9g, Herba Agrimoniae 15~30g.
A kind of enema of radiotherapy proctitis, the optimum weight ratio of its raw material is: Radix Notoginseng 3g, catechu 3g, Colla Corii Asini 6g, Pseudobulbus Bletillae (Rhizoma Bletillae) 15g, Radix Sanguisorbae 30g, Radix Et Rhizoma Rhei 6g, Herba Agrimoniae 15g.
The seven flavor medicine material, broken mistake 300 orders of superfine notoginseng powder, the catechu routine was pulverized 100 orders, and was standby; Colla Corii Asini adds 5 times of water moltens, and is standby; Pseudobulbus Bletillae (Rhizoma Bletillae) soaks 1h before extracting, adds 26 times in water, decocts 2 times, decoction total time 4h, merging filtrate, and concentrate under reduced pressure at low temperature to relative density is the clear paste of 1.05-1.10 (75 ℃), and is standby; Radix Sanguisorbae, Radix Et Rhizoma Rhei, Herba Agrimoniae close to be fried in shallow oil, and decocts with water 3 times, each 1.5h, and amount of water is followed successively by 12 times, 10 times, 8 times, and merging filtrate is concentrated into relative density and is the clear paste of 1.10-1.15 (75 ℃), and is standby.Merge above medicated powder and medicinal liquid, cross 100 mesh sieves, mixing adds water move to 1000ml, and is canned, every bottled 150ml, and sterilization, promptly.
Monarch drug in the Radix Sanguisorbae side of being among the we, the detoxifcation hemostasis; The Radix Et Rhizoma Rhei cooling blood for hemostasis, Herba Agrimoniae astringing to arrest bleeding, removing toxic substances and promoting subsidence of swelling; Pseudobulbus Bletillae (Rhizoma Bletillae) convergence, hemostasis, detumescence and promoting granulation, pseudo-ginseng blood-circulation-invigovating hemostasis, catechu putrefaction-removing granulation-promoting, the Colla Corii Asini hemostasis, all medicines share, and heat clearing away altogether becomes to detoxify, putrefaction-removing granulation-promoting, the merit of cooling blood for hemostasis, the stomachache, diarrhoea, mucosanguineous feces, tenesmus, the anus causalgia that are used for due to the radiation rectitis are weighed down diseases such as pain.
The present invention is brown to sepia suspendible liquid.Rectum retention enema administration, a 150ml, once-a-day, with before shaking up.After making the patient drain presence of residual feces, get lateral position, insert rectum 12~14cm, slowly push medicinal liquid with anal canal.Liied in bed 30 minutes after extracting anal canal.Ten days is a course of treatment, after three to four days, continues for second course of treatment at interval.Medicinal liquid injects down at room temperature (25~37 ℃).
Pharmacodynamic test of active extract of the present invention is summarized as follows:
One, method
Selecting rat for use is experimental animal, utilizes the heavy dose of pelvic cavity local irradiation of linear accelerator single, sets up the radiation rectitis animal model.
The treatment group is observed medicine: enema of the present invention, divide high, medium and low three dosage groups;
Western medicine group gives medicine: dexamethasone adds gentamycin;
The Chinese medicine matched group gives medicine: XILEI SAN.
Observe one week of treatment back execution all animals.Observe the general situation of animal, body weight, defecation situation, light microscopic and electron microscopic observation mucous membrane of rectum degree of injury, and detect mucous membrane of rectum IL-1 β mRNA with the RT-PCR method and express, detect mucous membrane of rectum NF-κ B with the SABC method and express, measure blood TAX with the RIA method
2, 6-keto-PGF
1 αAnd the LN level, carry out statistical procedures.
Two, result
Performance such as diarrhoea, mucopurulent bloody stool appear in the model group rat, become thin.Light microscopic is observed the structural deterioration of rectum crypts, a large amount of cell infiltration down, the congestion of blood vessel under the mucosa, the chief of a pit, and many kitchen ranges ulcer is observed the gland structure disorder under the Electronic Speculum, and surperficial fine hair destroys, epithelial cell shedding, large tracts of land ulcer.
The general situation of treatment group rat is improved, and remission such as suffer from diarrhoea, have blood in stool relatively has significant difference (P<0.05) with model group.Treatment group mucous membrane of rectum degree of injury significantly improves, and IL-1 β mRNA expresses and NF-κ B expresses significantly and reduces, with model group and in, western medicine group more all has significant difference (P<0.05).The treatment high dose group is better than low dose group.
Conclusion: utilize the local single fraction irradiation 20Gy of linear accelerator pelvic cavity, can successfully induce the rat radiation rectitis.The present invention can improve the general situation of irradiation back animal effectively; control is suffered from diarrhoea and is had blood in stool; improve the long mucosa injury of radiation rectitis rat; the protection intestinal mucosa; promote ulcer healing, the damage of downward modulation radiation rectitis rat mucous membrane of rectum, IL-1 β mRNA and NF-κ B expression; the reaction that reduces inflammation improves mucosa injury.Raise radiation rectitis rat 6-Kote-PGF
1 αLevel is reduced its TXB
2Level and TXB
2/ 6-Kote-PGF
1 αRatio improves local microcirculation, promotes ulcer healing.Anti-local fibrosis.Observe 1 week of treatment, the horizontal no difference of science of statistics of LN between each family.
Clinical effectiveness of the present invention is summarized as follows:
One, method
Adopt completely random, positive drug parallel control clinical trial method.Selected 63 routine qualified cases are divided into the test combinations matched group at random as study subject, and two groups of case ratios are 1: 1.Test group is used enema of the present invention (each 150ml, every day 1 time, retention enema).Matched group uses mixed liquor of gentamicin (each 150ml, every day 1 time, retention enema), the course of treatment: 4 weeks.Observe and treat back radiation rectitis curative effect at 2 weekend, traditional Chinese medical science disease curative effect, individual event symptom curative effect, disease condition curative effect, radiation injury curative effect, intestinal mirror mucosa infection curative effect, hemoglobin are improved curative effect, positive cloudy curative effect, the safety analysis of changeing of fecal occult blood.
Two, result
1, among therapeutic evaluation: PP (the meeting the scheme data set) crowd, the radiation rectitis curative effect of enema, traditional Chinese medical science disease curative effect, disease condition curative effect, radiation injury curative effect, intestinal mirror mucosa infection curative effect, individual event symptom (mucosanguineous feces, stomachache, tenesmus) curative effect obviously are better than matched group.The total effective rate of test group radiotherapy proctitis, traditional Chinese medical science disease, disease condition, radiation injury, intestinal mirror mucosa is respectively 93.94%, 96.97%, 90.91%, 90.91%, 93.94%, matched group be respectively 66.67%, 86.67%, 86.67%, 60.00%, 33.33% (P<0.05), and suffer from diarrhoea, anus weighs down between pain causalgia group relatively no difference of science of statistics (P>0.05).Treat relatively no difference of science of statistics (P>0.05) of back hemoglobin counting for two groups, rent but have alternately with the time between group, the treatment group has the better trend of improving hemoglobin, between the positive negative conversion rate group of fecal occult blood significant difference (P<0.05) is arranged relatively.
2, safety analysis
During the clinical trial, untoward reaction and toxic and side effects all do not take place in two foots.
Three, conclusion
Enema of the present invention can significantly be alleviated clinical symptoms such as mucosanguineous feces, diarrhoea, stomachache, tenesmus, anus causalgia bob pain; Improve the fecal occult blood positive, intestinal mirror mucosa infection and radiation injury; Can improve patients ' life quality; Relapse rate is low, and curative effect is reliable, and effect is stable, has no side effect, and is the comparatively satisfied medicine of radiotherapy proctitis.
The specific embodiment
Embodiment is used for illustrating of the present invention, rather than it is imposed any restrictions.
Embodiment 1: the enema of radiotherapy proctitis, make Radix Notoginseng 3g, catechu 3g, Colla Corii Asini 6g, Pseudobulbus Bletillae (Rhizoma Bletillae) 15g, Radix Sanguisorbae 30g, Radix Et Rhizoma Rhei 6g, Herba Agrimoniae 15g by the raw material of following weight ratio.
The seven flavor medicine material, broken mistake 300 orders of superfine notoginseng powder, the catechu routine was pulverized 100 orders, and was standby; Colla Corii Asini adds 5 times of water moltens, and is standby; Pseudobulbus Bletillae (Rhizoma Bletillae) soaks 1h before extracting, adds 26 times in water, decocts 2 times, decoction total time 4h, merging filtrate, and concentrate under reduced pressure at low temperature to relative density is the clear paste of 1.05-1.10 (75 ℃), and is standby; Radix Sanguisorbae, Radix Et Rhizoma Rhei, Herba Agrimoniae close to be fried in shallow oil, and decocts with water 3 times, each 1.5h, and amount of water is followed successively by 12 times, 10 times, 8 times, and merging filtrate is concentrated into relative density and is the clear paste of 1.10-1.15 (75 ℃), and is standby.Merge above medicated powder and medicinal liquid, cross 100 mesh sieves, mixing adds water move to 1000ml, and is canned, every bottled 150ml, and sterilization, promptly.
Embodiment 2: the enema of radiotherapy proctitis, make Radix Notoginseng 4g, catechu 3g, Colla Corii Asini 8g, Pseudobulbus Bletillae (Rhizoma Bletillae) 18g, Radix Sanguisorbae 24g, Radix Et Rhizoma Rhei 7g, Herba Agrimoniae 18g by the raw material of following weight ratio.Processing method is with embodiment 1.
Embodiment 3: the enema of radiotherapy proctitis, make Radix Notoginseng 6g, catechu 5g, Colla Corii Asini 10g, Pseudobulbus Bletillae (Rhizoma Bletillae) 30g, Radix Sanguisorbae 45g, Radix Et Rhizoma Rhei 9g, Herba Agrimoniae 30g by the raw material of following weight ratio.Processing method is with embodiment 1.
Embodiment 4: the enema of radiotherapy proctitis, make Radix Notoginseng 5g, catechu 6g, Colla Corii Asini 5g, Pseudobulbus Bletillae (Rhizoma Bletillae) 10g, Radix Sanguisorbae 15g, Radix Et Rhizoma Rhei 8g, Herba Agrimoniae 25g by the raw material of following weight ratio.Processing method is with embodiment 1.