CN114832078B - Traditional Chinese medicine composition for spleen deficiency and dampness retention type PPI (PPI-dependent gastroesophageal reflux disease) - Google Patents
Traditional Chinese medicine composition for spleen deficiency and dampness retention type PPI (PPI-dependent gastroesophageal reflux disease) Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for spleen deficiency and dampness resistance type PPI (PPI-dependent gastroesophageal reflux disease), which comprises the following raw materials in parts by weight: 17-22 parts of codonopsis pilosula, 13-16 parts of fried bighead atractylodes rhizome, 13-16 parts of poria cocos, 8-13 parts of dried orange peel, 7-11 parts of fingered citron, 7-11 parts of caulis perllae, 8-13 parts of rhizoma cyperi, 8-13 parts of ginger processed pinellia tuber, 7-11 parts of thunberg fritillary bulb, 5-7 parts of costustoot, 5-7 parts of honey-fried licorice root, 4-6 parts of fructus amomi (added later), 9-13 parts of fried chicken's gizzard-membrane and 26-32 parts of calcined cuttle bone. The traditional Chinese medicine composition can effectively treat PPI-dependent GERD patients, reduces the PPI usage rate, improves symptoms better than simple western medicine treatment, and has good clinical popularization significance.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for spleen deficiency and dampness resistance type Proton Pump Inhibitor (PPI) dependent gastroesophageal reflux disease.
Background
Gastroesophageal reflux disease (GERD) is a common disease of the digestive system and is characterized by symptoms of acid regurgitation, heartburn and the like in clinic. Western medicine treatment mainly takes measures of inhibiting gastric acid secretion, promoting gastric motility, performing surgical operations and the like (Wang Zhonggao, hu Zhiwei, gastroesophageal reflux disease and extra-esophageal reflux thereof: a major public health problem which is often overlooked [ J ], journal of clinical surgery, 2016, 24 (1): 5-11). Current treatments are more common with Proton Pump Inhibitors (PPIs). Most patients taking PPIs on demand can control reflux symptoms for a long period of time and effectively, but some patients still have the dependence of PPI long-term maintenance or PPI inadequate treatment. In addition, PPI can cause a variety of adverse reactions after long-term administration (Wang Yan, adverse reactions to proton pump inhibitors [ J ], J.Clin.Rev.Med., 2012, 36 (4): 91-92). The academic experience of the traditional Chinese medicine experts in the whole country inherits work to guide the teacher Chen Yongcan to master the traditional Chinese medicine, and considers how long the disease persists, the consumption of vital qi of the spleen and the stomach, the transportation and transformation disorder and the water-dampness are endogenous to the PPI-dependent GERD patients, so the patients are caused by the spleen deficiency and the dampness obstruction and the qi stagnation.
Disclosure of Invention
Aiming at the condition that a part of patients with gastroesophageal reflux disease have PPI dependence, the invention provides a traditional Chinese medicine composition for treating PPI dependence gastroesophageal reflux disease with spleen deficiency and dampness resistance.
The traditional Chinese medicine composition for the spleen deficiency and dampness resistance type PPI dependent gastroesophageal reflux disease comprises the following raw materials in parts by weight:
17-22 parts of codonopsis pilosula, 13-16 parts of fried bighead atractylodes rhizome, 13-16 parts of poria cocos, 8-13 parts of dried orange peel, 7-11 parts of fingered citron, 7-11 parts of caulis perllae, 8-13 parts of rhizoma cyperi, 8-13 parts of ginger processed pinellia tuber, 7-11 parts of thunberg fritillary bulb, 5-7 parts of costustoot, 5-7 parts of honey-fried licorice root, 4-6 parts of fructus amomi (added later), 9-13 parts of fried chicken's gizzard-membrane and 26-32 parts of calcined cuttle bone.
According to the invention, the dosage form of the traditional Chinese medicine composition is a conventional dosage form prepared from the traditional Chinese medicine composition and a pharmaceutically acceptable carrier or excipient.
Preferably, the dosage form is an oral dosage form, including tablets, capsules, powders, granules and the like.
The traditional Chinese medicine composition can effectively treat PPI-dependent GERD patients, reduces the PPI use rate, is superior to simple western medicine treatment in symptom improvement, and has good clinical popularization significance.
Detailed Description
The present invention will be described in further detail with reference to specific examples. It is to be understood that the following examples are illustrative of the present invention only and are not intended to limit the scope of the present invention.
Example 1
The traditional Chinese medicine composition for the spleen deficiency and dampness retention type PPI dependent gastroesophageal reflux disease comprises the following raw materials in parts by weight:
20 parts of codonopsis pilosula, 15 parts of fried bighead atractylodes rhizome, 15 parts of poria cocos, 10 parts of dried orange peel, 9 parts of fingered citron, 9 parts of caulis perllae, 9 parts of rhizoma cyperi, 9 parts of ginger processed pinellia tuber, 9 parts of thunberg fritillary bulb, 6 parts of costustoot, 6 parts of honey-fried licorice root, 4 parts of fructus amomi (added later), 12 parts of fried chicken's gizzard-membrane and 30 parts of calcined cuttle bone.
Example 2
The traditional Chinese medicine composition for the spleen deficiency and dampness retention type PPI dependent gastroesophageal reflux disease comprises the following raw materials in parts by weight:
17 parts of codonopsis pilosula, 16 parts of fried bighead atractylodes rhizome, 16 parts of poria cocos, 8 parts of dried orange peel, 7 parts of fingered citron, 11 parts of caulis perllae, 8 parts of rhizoma cyperi, 8 parts of ginger processed pinellia tuber, 11 parts of thunberg fritillary bulb, 7 parts of costustoot, 7 parts of honey-fried licorice root, 6 parts of fructus amomi (added later), 13 parts of fried chicken's gizzard-membrane and 32 parts of calcined cuttle bone.
Example 3
The traditional Chinese medicine composition for the spleen deficiency and dampness resistance type PPI-dependent gastroesophageal reflux disease comprises the following raw materials in parts by weight:
22 parts of codonopsis pilosula, 13 parts of fried bighead atractylodes rhizome, 13 parts of poria cocos, 13 parts of dried orange peel, 11 parts of fingered citron, 7 parts of caulis perllae, 13 parts of rhizoma cyperi, 13 parts of ginger-processed pinellia tuber, 7 parts of thunberg fritillary bulb, 5 parts of costustoot, 5 parts of honey-fried licorice root, 5 parts of fructus amomi (added later), 9 parts of fried chicken's gizzard-membrane and 26 parts of calcined cuttle bone.
Example 4 clinical experiments
1. Clinical case data:
a total of 84 patients with PPI-dependent GERD were treated and divided into an observation group and a control group, in which:
observation group 42 cases: 19 men and 23 women; age 33-61 years, mean age (38.9 ± 6.6) years; the disease course is 6-10 months, and the average disease course (6.7 +/-4.5) months; the average total integral of TCM syndrome (22.45 + -3.58) points.
42 cases of the control group: 24 men and 18 women; age 29-65 years, mean age (41 ± 5.7 years); the course of disease is 7-12 months, and the average course of disease (7.1 +/-5.2) months; the average total integral of TCM syndrome (21.64 + -3.20).
The general data of two groups of patients are compared, and the data are suggested to be comparable (P is more than 0.05). The rabeprazole sodium enteric-coated tablets (Jiangsu Haison pharmaceutical industry, inc.) are taken by patients before the group, and 10mg of the rabeprazole sodium enteric-coated tablets are taken by the patients half an hour before breakfast and supper.
2. Diagnostic criteria:
the Western diagnostic standard refers to the consensus of Chinese gastroesophageal reflux disease experts in 2014, namely Chenhu, hou Xiaohua, shouximab, and the like, and 2014, the consensus of Chinese gastroesophageal reflux disease experts in 2014 [ J ]. The J of Chinese digestion, 2014, 34 (10): 649-661).
The traditional Chinese medicine syndrome differentiation standard refers to the consensus opinions of traditional Chinese medicine diagnosis and treatment experts for gastroesophageal reflux disease (2017) (Zhang Shengsheng, zhu Sheng, wang Hongwei, and the like), and the consensus opinion of traditional Chinese medicine diagnosis and treatment experts for gastroesophageal reflux disease (2017) [ J ] is Chinese J & W.J.digestive J.2017, 25 (5): 321-326).
Syndrome of spleen deficiency with dampness obstruction: the main symptoms are: (1) acid regurgitation after meal; (2) heartburn. The secondary symptoms are as follows: (1) discomfort with fullness; (2) chest distress; (3) no desire to eat; (4) tired and weak; (5) loose stool and difficult defecation. Tongue pulse: (1) pale or red tongue with thin, white and greasy (or yellow and greasy) coating; (2) the pulse is thready, slippery and rapid.
The diagnosis is in accordance with 2 main symptoms and 2 or more secondary symptoms, and then combines with tongue pulse.
3. Inclusion criteria were:
1. the standard of the traditional Chinese medicine and the western medicine is met; 2. there are significant typical GERD symptoms for more than 6 months, and over 3 months accumulated depending on PPI drug treatment. Patients with serious cardiovascular and cerebrovascular diseases, metabolic diseases and other basic diseases are excluded, and patients with gastrointestinal hemorrhage, ulcer or tumor are also excluded.
4. The treatment method comprises the following steps:
the orally administered rabeprazole sodium enteric-coated tablets in the observation group are orally administered half an hour before 10mg of dinner, and the traditional Chinese medicine composition in the embodiment 1, the embodiment 2 or the embodiment 3 is added, and the daily dosage is as follows: 17-22g of codonopsis pilosula, 13-16g of fried bighead atractylodes rhizome and poria cocos, 8-113g of dried orange peel, 7-11g of fingered citron and caulis perllae, 8-13g of rhizoma cyperi and rhizoma pinelliae preparata, 7-11g of thunberg fritillary bulb, 5-7g of elecampane and honey-fried licorice root, 4-6g of fructus amomi (added later), 9-13g of fried chicken's gizzard-membrane and 26-32g of calcined cuttle bone. One dose is taken every day by decocting with water, and the decoction is taken twice in the morning and at night.
The rabeprazole sodium enteric-coated tablets were orally administered to the control group at a constant dose (10 mg before breakfast and supper), and 5mg of mosapride citrate tablets (gastrointestinal prokinetic agent, yabao pharmaceutical Co., ltd.) were added and orally administered three meals.
Both groups were administered continuously for 8 weeks, followed by 12 weeks after withdrawal.
5. The statistical method comprises the following steps:
and (3) extracting data in the result, performing statistics by SPSS 19.0 software, analyzing, and respectively performing corresponding test on the metering data, the counting data and the grade data, wherein P is less than 0.05, and the statistical difference is obtained.
6. The curative effect standard is as follows:
1. the traditional Chinese medicine syndrome judgment curative effect standard is as follows: refer to the guidelines for clinical research of new Chinese drugs (trial) (Zheng Xiaoyu), the guidelines for clinical research of new Chinese drugs (trial) [ M ]. Beijing, china pharmaceutical science and technology press, 2002). The major symptoms are respectively counted as 0, 2, 4 and 6 according to the non-, light-, medium-and heavy-weights; the secondary symptoms are scored as 0, 1, 2 and 3 points. And (3) healing: the curative effect index is more than or equal to 95 percent; the effect is shown: the curative effect index is 70-94%; the method has the following advantages: the curative effect index is 30-69%; and (4) invalidation: the curative effect index is less than 30%.
2. PPI dosing at the end of the 12-week follow-up period: stopping medicine: no PPI treatment is required; the medicine is reduced by more than 50 percent: the PPI utilization rate is less than or equal to 1 time/day; the drug is reduced by 50 percent as follows: the dosage is less than 2 times per day when the dosage is less than 1 time per day; keeping unchanged: the dosage is the same as before stopping taking the medicine.
7. As a result:
the results of the overall effective comparison of the two traditional Chinese medicine syndrome scores are shown in table 1.
TABLE 1 comparison of clinical efficacy of the two groups
Note: compared with the control group, # P < 0.05.
The results of the comparison of the scores of the syndromes before and after the two groups of treatments are shown in Table 2.
TABLE 2 comparison of Chinese medicine syndrome scores before and after treatment
Note: p < 0.05 compared to pre-treatment; compared with the control group, # P < 0.05.
The results of the comparison of the PPI dosing in the two groups are shown in table 3.
TABLE 3 comparison of PPI dosing in two groups
Note: compared with the control group, # P < 0.05.
The clinical observation results show that the traditional Chinese medicine composition can effectively treat PPI-dependent GERD patients, reduce the PPI use rate, and improve symptoms better than simple western medicine treatment.
It will be readily understood by those skilled in the art that the Chinese medicinal composition of the present invention can be prepared into various conventional dosage forms with pharmaceutically acceptable carriers or excipients, and preferably oral dosage forms including tablets, capsules, powders, granules, etc., as will be apparent.
In conclusion, the traditional Chinese medicine composition has a good curative effect on the PPI-dependent GERD with the syndrome of spleen deficiency and dampness retention, and has a good clinical popularization significance.
Claims (4)
1. A traditional Chinese medicine composition for spleen deficiency and dampness resistance type PPI-dependent gastroesophageal reflux disease is characterized in that the traditional Chinese medicine composition comprises the following raw material medicines in parts by weight:
17-22 parts of codonopsis pilosula, 13-16 parts of fried bighead atractylodes rhizome, 13-16 parts of poria cocos, 8-13 parts of dried orange peel, 7-11 parts of fingered citron, 7-11 parts of caulis perllae, 8-13 parts of rhizoma cyperi, 8-13 parts of ginger processed pinellia tuber, 7-11 parts of thunberg fritillary bulb, 5-7 parts of costustoot, 5-7 parts of honey-fried licorice root, 4-6 parts of fructus amomi, 9-13 parts of fried chicken's gizzard-membrane and 26-32 parts of calcined cuttle bone.
2. The traditional Chinese medicine composition of claim 1, wherein the dosage form of the traditional Chinese medicine composition is a conventional dosage form prepared from the traditional Chinese medicine composition and a pharmaceutically acceptable carrier or excipient.
3. The traditional Chinese medicine composition of claim 2, wherein the dosage form is an oral dosage form.
4. The composition of claim 3, wherein the dosage form is a tablet, capsule, powder, or granule.
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