CN111544488A - Application of Xuefu Zhuyu preparation as functional product for intervening postoperative chest pain - Google Patents

Abstract

The invention adopts the Xuefu Zhuyu preparation to intervene acute chest pain after thoracoscope surgery, can reduce the postoperative pain degree of patients, reduce the taking quantity of analgesic drugs, shorten the pain treatment time, improve the postoperative life quality of the patients and has no toxic or side effect.

Description

Application of Xuefu Zhuyu preparation as functional product for intervening postoperative chest pain

Technical Field

The invention belongs to the field of medicines, and particularly relates to an application of a Xuefu Zhuyu preparation as a functional product for intervening postoperative chest pain.

Background

In the prior art, the television thoracoscopic surgery has the advantages of small wound, quick postoperative recovery, short hospitalization time and the like, can diagnose the property of lung lesion and treat the lung lesion according to conditions, and has become a main treatment mode for diseases such as early non-small cell lung cancer and the like. However, complications such as chest pain, persistent cough, pleural effusion and the like often occur after thoracoscopy, which often affect the life quality of patients and are not beneficial to the recovery of patients. Postoperative chest pain is one of common complications, and clinical common pain relieving modes comprise epidural pain relieving, paraspinal block, patient self-control venous pain relieving, multi-mode pain relieving and the like, but various pain relieving modes have adverse reactions with different degrees, so that safety risks such as drug dependence and the like are easily caused, the life quality of a patient is influenced, and the rehabilitation of the patient is not facilitated. Therefore, more effective medicines are needed to be found to relieve the pain of patients and reduce the occurrence of adverse reactions.

The Xuefu Zhuyu Tang is originated from Yi Lin correction of Qing, Wang Qing ren, and has the curative effects of promoting qi circulation, activating blood circulation, removing blood stasis and relieving pain, and the Xuefu Zhuyu preparation commonly used in the market is decoction and capsule. The Xuefuzhuyu capsule is a dosage form conversion of Xuefuzhuyu decoction, the original formula consists of angelica, rehmannia root, peach kernel, safflower, bitter orange, red peony root, bupleurum, licorice, balloonflower root, chuanxiong rhizome and achyranthes root, the whole formula can promote the circulation of qi and blood circulation, remove blood stasis and relieve pain, and is a good formula for treating blood stasis in chest. In the formula, peach kernel is used for breaking blood and removing stasis and moistening dryness, and safflower is used for activating blood and removing stasis and relieving pain, and is used as monarch drug together; radix paeoniae rubrathe and rhizoma ligustici wallichii are used as ministerial drugs for promoting blood circulation and removing blood stasis, and radix achyranthis bidentatae is used for promoting blood circulation and removing blood stasis, and stimulating the menstrual flow and relieving pain; radix rehmanniae and angelica sinensis nourish blood and activate blood, benefit yin and clear heat, radix platycodi and fructus aurantii, promote blood circulation, relieve chest stuffiness and promote qi circulation, radix bupleuri soothes liver and relieves depression, and radix platycodi and fructus aurantii are used together to promote qi circulation and remove stagnation, which are all adjuvant drugs; balloonflower root, radix Platycodi carries the drugs to ascend and also acts as a guiding drug, while Licorice root, radix Glycyrrhizae coordinates the effects of other drugs in the recipe. The research shows that the product can protect the vascular endothelium, promote the angiogenesis of the ischemic region, improve the blood supply, promote the microcirculation reperfusion, relieve the edema of the ischemic region and the like. Moreover, a plurality of studies show that the capsule for removing blood stasis in the chest has good effect on chest stuffiness (heart stuffiness), rib fracture combined with blood chest, chest wall soft tissue contusion and other pains caused by coronary heart disease. However, there has been no study on the treatment of postoperative chest pain with the Xuefuzhuyu preparation.

Disclosure of Invention

Aiming at the problems in the prior art, the invention adopts the blood stasis removing preparation to intervene on acute chest pain after thoracoscope surgery, thereby relieving the postoperative pain degree of a patient, reducing the taking amount of analgesic, shortening the pain treatment time, improving the postoperative life quality of the patient and having good safety.

The invention discloses an application of a blood stasis removing preparation as a functional product for intervening postoperative chest pain.

Wherein the functional product is a product or potential substance which can produce beneficial effects of treatment, alleviation, inhibition and the like on the occurrence and development of postoperative chest pain; the functional product can be a single preparation, or can be a composition containing effective dose of preparation components, and the composition can comprise a pharmaceutically acceptable carrier.

Wherein the blood stasis removing preparation is one of blood stasis removing decoction, blood stasis removing capsule, blood stasis removing soft capsule, blood stasis removing oral liquid, blood stasis removing pill, blood stasis removing tablet, and blood stasis removing granule; and is preferably a blood stasis removing capsule.

The blood stasis removing prescription comprises QIANDIHUA prescription, TAOHONGSIWU decoction prescription, radix Platycodi and Achyranthis radix.

The traditional Xuefu Zhuyu decoction is prepared by adding water into 11 medicinal materials, and carrying out soaking, first decoction and second decoction. In the decocting process, attention is paid to the first decocting and the second decocting of special medicines, the conversion of mild fire and strong fire is needed, the traditional Chinese medicines are continuously stirred, the bottom pasting and the overflow of liquid medicine are prevented, the operation is complicated, volatile components in the liquid medicine are easy to lose, common family decocting can only decoct 40-70% of effective components, medicinal resources cause a large amount of recessive waste, and the clinical curative effect of the medicines is reduced.

The preparation method of XUEFUZHUYU Capsule comprises pulverizing half amount of parched semen Persicae, radix Angelicae sinensis, radix Paeoniae Rubra, fructus Aurantii parched with bran, rhizoma Ligustici Chuanxiong and bupleuri radix into fine powder, sieving, and mixing; decocting the rest five materials such as Carthami flos and the rest parched semen Persicae in water for three times, filtering the decoctions, mixing the filtrates, concentrating into soft extract, mixing with the above powder, granulating, drying, pulverizing, sieving, and making into capsule (from Chinese pharmacopoeia). In the preparation of the Xuefu Zhuyu capsule, the Sini san prescription medicinal materials and the medicinal materials with volatile components are prepared by adopting a medicinal material crushing mode, and compared with a decoction decocting mode, the clinical characteristics of rapid effect taking of the Sini san are kept, and the loss of the volatile active components is reduced. The medicinal materials of the peach-red four-ingredient decoction are prepared by adopting a decoction and concentration mode, so that the peach-red four-ingredient decoction has the same effects of nourishing blood and activating blood as the decoction. Compared with decoction, the Xuefuzhuyu capsule has the characteristics of quick response and high curative effect.

The preparation of the Xuefu Zhuyu capsule is guided by the theory of traditional Chinese medicine, the quality standard of single traditional Chinese medicine decoction pieces is established in each link of extraction, separation, concentration, drying, granulation and encapsulation of the pharmaceutical technology according to the standard processing standard, the quality detection is carried out, the nature, taste, meridian tropism and efficacy of the original traditional Chinese medicine decoction pieces are retained, the pesticide residue of the traditional Chinese medicine decoction pieces is removed, and the heavy metal content is strictly controlled. Compared with decoction, the Xuefuzhuyu capsule has the advantages of guaranteed quality and small side effect. Clinical observation shows that the Xuefuzhuyu capsule has obvious curative effect, basically consistent with the traditional decoction, even superior to the traditional decoction.

Wherein the operation type is thoracoscopic operation.

Wherein, the disease corresponding to the thoracoscopic surgery is one of early non-small cell lung cancer and small cell cancer.

Namely, the invention discloses application of a Xuefuzhuyu capsule as a medicine for intervening postoperative chest pain.

It should be noted that, although many studies have shown that the xuefu zhuyu capsule has good effect on chest impediment (heart impediment), rib fracture and blood chest, chest wall soft tissue contusion and other pains caused by coronary heart disease, the pathogenesis of each is different. Wherein, chest obstruction: is a heart disease formed by myocardial ischemia caused by factors such as coronary atherosclerosis, spasm and the like, and the typical symptom of angina pectoris is the insufficient oxygen supply of myocardium caused by myocardial ischemia; chest pain due to chest fracture or soft tissue contusion: is the periosteal stretch pain caused by bone injury due to non-operative trauma. And, thoracoscopic postoperative chest pain: is due to surgical trauma to structures such as the chest wall, pleura, etc. during thoracoscopy. Thus, although the surface appears to be chest pain, thoracoscopic post-operative chest pain is not at the same pathogenesis as chest pain caused by obstruction of the chest, chest fracture or soft tissue contusion. Namely, the application of the Xuefuzhuyu preparation as a functional product for intervening postoperative chest pain is also the result obtained by the applicant after a large number of experiments.

The invention has the following beneficial effects:

(1) at present, central or narcotic analgesics and nerve tissue operation are used as main treatment means for various postoperative analgesia of thoracoscopes and the like, adverse reactions are large, and safety risks such as drug dependence are easily caused; the Xuefuzhuyu capsule has no obvious adverse reaction and no dependence; the capsule not only can effectively relieve postoperative pain of patients, but also has definite efficacy of soothing liver and relieving depression, and can effectively relieve tension moods such as anxiety, depression and the like of the patients after operation;

(2) the new application of the classic famous prescription of Xuefu Zhuyu decoction preparation in the modern clinical treatment of postoperative pain and other symptoms such as endoscope and the like is created;

(3) the medicine breaks through the medical problems of poor curative effect, great side effect and the like of western medicines for clinically treating chest pain and cough after thoracoscopy operation at present and provides a brand new treatment approach of a blood stasis removing preparation for clinic.

Detailed Description

Unless defined otherwise, technical terms used in the following examples have the same meanings as commonly understood by one of ordinary skill in the art to which the present invention belongs. The test reagents used in the following examples, unless otherwise specified, are all conventional biochemical reagents; the experimental methods are conventional methods unless otherwise specified. The present invention will be described in detail with reference to examples.

1 data and method

1.1 sources of cases

92 patients diagnosed with non-small cell lung cancer in situ and acute chest pain of qi stagnation and blood stasis syndrome in stage I and II a after thoracoscopic lung resection in Beijing university Hospital in thoracic surgery in 11 months to 12 months in 2019 in 2018.

1.2 diagnostic criteria

(1) Western diagnostic criteria: refer to NCCN clinical practice guideline for non-small cell lung cancer, 2 nd edition 2018. The TNM staging criteria used was International Association for The Study of Lung cancer (IASLC), published in 2015 as International Lung cancer staging (8 th edition). The standard of acute pain diagnosis refers to "consensus of pain management experts in perioperative period of thoracic surgery in China (2018 edition)".

(2) The traditional Chinese medicine diagnosis standard is as follows: the diagnosis of qi stagnation and blood stasis refers to the syndrome part of Chinese medicine clinical diagnosis and treatment terms (GB/T16751.2-1997) and the diagnosis and treatment of Chinese medicine syndrome, which are issued by the State administration of technology supervision. Compound syndrome judgment standard: the syndrome differentiation is performed on the single syndrome, and the syndrome differentiation is performed on the principle that the single syndrome is the syndrome.

1.3 inclusion and exclusion criteria

1.3.1 inclusion criteria

Receiving a patient with or without mediastinal lymph node resection of a sub-lobe, a compound lobe or a whole lung of a thoracoscope; secondly, the pathological diagnosis after the operation is primary lung cancer stage I, II A or precancerous lesion; ③ the patient has no chest pain before operation and pain after operation within 3 months; fourthly, the age is more than 18 years old; and fifthly, voluntarily taking part in clinical trials, signing an informed consent and contacting follow-up visits.

1.3.2 exclusion criteria

The diagnosis standard of primary bronchogenic carcinoma is met, and the patients are treated by radiotherapy, chemotherapy, targeted therapy and traditional Chinese medicine; ② patients with mental diseases such as obnubilation and communication impairment; ③ patients with serious cardiovascular, hepatic, renal and cerebrovascular diseases; fourthly, the clinical data is incomplete.

1.4 intervention methods

1.4.1 grouping method

Using a computer to generate a random number sequence, the patient is assigned a ratio of 1: the ratio of 1 was divided into a control group and a test group.

1.4.2 methods of administration

Test groups: based on conventional treatment of western medicine, the capsule (HONGHUA tablet, produced in Tianjin Hongrentang pharmacy) is taken 2 times a day, 1 time 6 capsules are taken, and the capsule is continuously taken for 2 weeks from the 3 rd day after operation. If the patient's pain is evident, pain medication is given on demand and the medication name and dosage are recorded in detail. Control group: postoperative conventional analgesic treatment (where pain is evident, NSAIDs such as lymeprol, opioid analgesics such as tylosin, are administered on demand) is not intervened. The patient's pain score, analgesic name and dosage were recorded for 2 weeks starting on day 3 post-surgery. The treatments of two groups of patients except for pain treatment, such as cough treatment, basic disease treatment, etc., are not limited.

1.5 evaluation index

Patients were recorded on the follow-up visit with a digital grading score for pain (numerical rating Scale NRS), a Visual Analogue score for cough (Visual Analogue Scale VAS), the name, frequency, and quantity of analgesic and antitussive taken, and a quality score for life (EORTC QLQ-C30version3) before intervention, on days 3, 7, 10, and 14. NRS pain was graded as: the grading standard of pain degree is as follows: 0 minute: no pain; 1-3 points of: mild pain; 4-6 points: moderate pain; 7-9 min: severe pain; 10 min: severe pain. VAS cough was rated as: 1-3 points of: mild cough; 4-6 points: moderate cough; 7-10 min: severe cough. The EORTC QLQ-C30 score of quality of life is divided into 15 fields such as body function, role function, emotional function and the like, the higher the score of the function field is, the better the quality of life is, the higher the score of the symptom field is, and the worse the quality of life is.

1.6 statistical methods

Performing statistics by using SPSS 22.0 statistical software, wherein the measured data are all represented by means +/-standard deviation (x +/-s), the data are subjected to a t test, and the data which do not conform to the normality and the variance homogeneity are subjected to a rank sum test; the measurement data of the same observation index is measured for multiple times at different time points, repeated measurement variance analysis is adopted, differences exist when P is less than 0.05, and significant differences exist when P is less than 0.01.

2 results

2.1 general data

The study included 92 patients, 2 patients who dropped off, and 90 complete data, of which 44 in the control group and 46 in the Chinese medicinal treatment group. Wherein the male is 30 cases, the female is 60 cases, the age range is 28-73 years, and the average age is 57.19 + -9.99 years. Through statistical treatment, the comparative difference of the age, the operation position, the sex, the smoking history, the tumor type, the taking of the analgesic, the quantity of the antitussive and the quality of life score of two groups of patients has no statistical significance and is comparable.

2.2 results of the study

TABLE 1 comparison of NRS pain score and VAS cough score in two groups

Note: the overall analysis uses two-factor repeated measures analysis of variance. The fine comparison among the groups is LSD-t test, and the significance marks a and b are respectively compared with the test group and the control degree at the same time point, and P is less than 0.05. The time fine comparison is compared with a difference t test, a significance mark t is compared with a first time point in the group, P is less than alpha ', alpha' is a test level corrected by Bonferroni which is 0.05/n, and n is the number of fine comparisons in the time dimension.

NRS pain score comparison: the score of the test group from the 3 rd day of treatment and the ratio before the treatment have statistical significance (P is less than 0.05), the score of the control group from the 7 th day of treatment and the ratio before the treatment have statistical significance (P is less than 0.05), and the pain score of the test group is obviously lower than that of the control group from the 3 rd day, the 10 th day and the 14 th day and has statistical significance (P is less than 0.05). Comparison of VAS cough scores: the cough scores at the 10 th day and the 14 th day of the test group have statistical significance (P is less than 0.05) compared with the pretreatment ratio, the scores at the 3 rd day, the 10 th day and the 14 th day of the control group have statistical significance (P is less than 0.05) compared with the pretreatment ratio, and the scores of the two types of cough scores of the test group are lower than those of the control group. See table 1.

TABLE 2 comparison of the amounts of analgesic and antitussive in the two groups of treatment

The analgesics taken by two groups of patients before treatment are tyler tablets, in the treatment process, 2 patients are added with the pain relieving tablets, the antitussives are all suhuang antitussive capsules before treatment, and for convenience of statistics, the number of the analgesics taken by the patients in the study is counted as daily dose, such as 3 times in 1 day, 1 time in 1 tablet, 3 tablets in total, and 2 tablets in 1 day, 2 times in 1 time in 1 tablet and 2 tablets in total. The results show that: no patient took the analgesic on the 10 th and 14 th days of treatment in the test group, a small amount of patient took the analgesic in the control group, and the amount of the analgesic taken at each time point in the test group is less than that taken in the control group in the treatment process. The two groups of antitussives have no obvious difference in quantity (P is more than 0.05). See table 2.

TABLE 3 comparison of the results of the two groups of analgesia

The analgesic effect is as follows: the test group has higher significant efficiency (89.13%) than the control group (50%), the total effective rate (93.48%) is higher than the control group (79.55%), and the comparison of the two groups has statistical significance (P is less than 0.05). See table 3.

TABLE 4 comparison of cough relieving results in two groups

The cough relieving effect is as follows: the test group has higher significant efficiency (36.96%) than the control group (22.73%), and higher total effective rate (78.26%) than the control group (65.91%), but the total effective rate is relatively not statistically significant (P is more than 0.05). See table 4.

TABLE 5 comparison of quality of life before and after treatment of the two groups

Note: a is comparison between groups, P is less than 0.05; b is the comparison of time points, P is less than 0.05; c is the comparison of the interaction between groups and time P <0.05

The dry prognosis, body function, role function, cognitive function, emotional function, social function, insomnia, diarrhea, fatigue, short breath, constipation, and economic difficulty of the test group are all obviously better than those of the control group (P is less than 0.05). See table 5.

Discussion of 3

The research shows that the Xuefuzhuyu capsule is obviously superior to a control group in the aspects of relieving the pain after thoracoscope surgery, reducing the dosage of analgesics of patients, shortening the pain treatment time and improving the life quality of the patients, has obvious curative effect and is worthy of clinical popularization and application.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims (5)

1. The application of the Xuefu Zhuyu preparation in the aspect of the functional product for intervening postoperative chest pain.

2. The use according to claim 1, wherein the functional product is a product or potential substance capable of producing a therapeutic, palliative, inhibitory, etc. beneficial effect on the development, progression of post-operative chest pain; the functional product can be a single preparation, or can be a composition containing effective dose of preparation components, and the composition can comprise a pharmaceutically acceptable carrier.

3. The use of claim 2, wherein the Xuefuzhuyu preparation is one of Xuefuzhuyu decoction, Xuefuzhuyu capsule, Xuefuzhuyu software capsule, Xuefuzhuyu oral liquid, Xuefuzhuyu pill, Xuefuzhuyu tablet and Xuefuzhuyu granule.

4. Use according to claim 1, wherein the type of surgery is thoracoscopic surgery.

5. The use of claim 1, wherein the thoracoscopic surgery-associated condition is one of early stage non-small cell lung cancer and small cell lung cancer.