CN118903309A - Application of compound PIANZAIHUANG buccal tablet in preparing medicine for preventing and/or treating laryngopharyngeal reflux disease - Google Patents

Abstract

The invention provides a novel application of a compound PIANZAIHUANG buccal tablet in treating laryngopharynx reflux diseases, and belongs to the field of biological medicines. The invention discovers for the first time that the compound pian zaihuang lozenge can effectively treat the laryngopharynx reflux disease, and has wide application prospect in preparing medicines for preventing and/or treating the laryngopharynx reflux disease.

Description

Use of compound Pien Tze Huang lozenges in the preparation of drugs for preventing and/or treating laryngopharyngeal reflux disease

Technical Field

The invention belongs to the field of biomedicine, and in particular relates to use of compound Pien Tze Huang lozenges in preparing medicines for preventing and/or treating laryngopharyngeal reflux disease.

Background Art

Laryngopharyngeal reflux disease (LPRD) is a general term for chronic inflammation and signs such as pharyngeal edema and ulcers caused by the reflux of gastric contents (such as pepsin, deoxycholic acid, etc.) to the area above the upper esophageal sphincter. The main symptoms include hoarseness, sore throat and chronic cough. Severe LPRD may cause malignant tumors in the throat, and LPRD is related to the occurrence of diseases such as asthma, allergic rhinitis and chronic otitis media with effusion. Western medicine believes that LPRD is related to factors such as the destruction of anti-reflux function, neuroinflammation, and lifestyle and diet. At present, the main clinical treatment methods are oral proton pump inhibitors (PPI), H2 receptor inhibitors H2RA, prokinetic drugs and surgery to relieve patients' LPRD symptoms. However, taking the above drugs has the disadvantages of long cycles, easy recurrence, and difficult to cure patients. Therefore, new LPRD treatment methods need to be developed.

Compound Pien Tze Huang Lozenges are a Chinese patent medicine composed of Wedelia officinalis, Sarcandra chinensis, Scrophularia ningpoensis, Radix Ophiopogonis, Licorice, Menthol and Pien Tze Huang, a national secret formula drug, which has the effect of clearing away heat and detoxifying and has been used clinically for a long time. However, there are no reports on the use of Compound Pien Tze Huang Lozenges for the treatment of laryngopharyngeal reflux disease.

Summary of the invention

The purpose of the present invention is to provide a new use of the compound Pien Tze Huang lozenge in treating laryngopharyngeal reflux disease.

The invention provides use of compound Pien Tze Huang lozenges in preparing medicine for preventing and/or treating laryngopharyngeal reflux disease.

Furthermore, the drug is a drug for improving laryngopharyngeal reflux symptoms.

Furthermore, the drug is a drug that reduces the reflux symptom index score.

Furthermore, the compound Pien Tze Huang lozenge is a preparation prepared with Wedelia chrysanthemum, Sarcophagnum recutita, Scrophularia ningpoensis, Ophiopogon japonicus, Licorice, menthol and Pien Tze Huang as active ingredients, and with mannitol, dextrin, pregelatinized starch, corn protein, magnesium stearate, aspartame and film coating premix as auxiliary materials.

Furthermore, the compound Pien Tze Huang lozenge is a commercially available product purchased from Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd.

The present invention also provides the use of the compound Pien Tze Huang lozenges in combination with a proton pump inhibitor in the preparation of a medicine for preventing and/or treating laryngopharyngeal reflux disease.

Furthermore, the proton pump inhibitor is an oral proton pump inhibitor.

Furthermore, the oral proton pump inhibitor is oral rabeprazole sodium.

Furthermore, the oral rabeprazole sodium is rabeprazole sodium enteric-coated capsules.

Furthermore, the mass ratio of the compound Pien Tze Huang lozenge to the proton pump inhibitor is (200-300):1.

Furthermore, the mass ratio of the compound Pien Tze Huang lozenge to the proton pump inhibitor is 250:1.

Furthermore, the compound Pien Tze Huang lozenge and the proton pump inhibitor are administered simultaneously or separately.

The present invention firstly finds that compared with the use of PPI alone, the combined use of compound Pien Tze Huang lozenges and PPI drugs can more significantly improve the symptoms of LPRD patients, and there is a statistical difference. The present invention firstly finds that compound Pien Tze Huang lozenges can effectively treat laryngopharyngeal reflux disease, and has broad application prospects in the preparation of drugs for preventing and/or treating laryngopharyngeal reflux disease.

Obviously, according to the above contents of the present invention, in accordance with common technical knowledge and customary means in the art, without departing from the above basic technical ideas of the present invention, other various forms of modification, replacement or change may be made.

The above contents of the present invention are further described in detail below through specific implementation methods in the form of examples. However, this should not be understood as the scope of the above subject matter of the present invention being limited to the following examples. All technologies realized based on the above contents of the present invention belong to the scope of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a flowchart of the treatment plan.

Figure 2 shows the changing trends of RSI scores in the control group and the combined treatment group.

DETAILED DESCRIPTION

The raw materials and equipment used in the present invention are all known products, which are obtained by purchasing commercially available products.

Compound Pien Tze Huang lozenges were purchased from Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd.

Example 1: Effect of Compound Pien Tze Huang Lozenges in Treating Laryngopharyngeal Reflux Disease

1. Research subjects

This study was designed as a prospective randomized controlled trial. The subjects were patients who presented with throat discomfort, had a reflux symptom index score (RSI) >13 points, and had a positive salivary pepsin test. The specific inclusion criteria included: (1) age ≥18 years; (2) had one or more symptoms in the laryngopharyngeal reflux symptom scale and an overall RSI >13 points; (3) had a salivary pepsin test (Peptest) index greater than 16 ng/ml; (4) had no contraindications to the use of PPI drugs or Pien Tze Huang, such as gastrointestinal malignancies, severe liver function abnormalities, and pregnancy or lactation; and (5) agreed to be included in the study and could cooperate with the treatment and follow-up.

The scoring method of the Reflux Symptom Index (RSI) is shown in Table 1 below (referenced by the Laryngology Group of the Editorial Committee of the Chinese Journal of Otolaryngology-Head and Neck Surgery, the Laryngology Group of the Otolaryngology-Head and Neck Surgery Branch of the Chinese Medical Association, and the Expert Consensus on the Diagnosis and Treatment of Laryngopharyngeal Reflux Disease (2015)).

Table 1 Reflux Symptom Index Scoring Scale

The exclusion criteria for this study are as follows: (1) symptoms before treatment and the presence of allergic rhinitis, sinusitis, tonsillitis or other upper respiratory tract diseases assessed by electronic nasopharyngolaryngoscope; (2) pregnant or lactating women; and (3) those who do not agree to be included in the study or cannot guarantee cooperation with the full course of treatment and follow-up.

In addition, patients withdrew from the study and their data were no longer included in the final analysis due to the following circumstances during the follow-up period, including: (1) those who were lost to follow-up or unable to cooperate with the follow-up; (2) those who could not continue drug treatment due to various discomforts; (3) those who failed to take medication regularly; and (4) those who developed acute upper respiratory tract infection or allergies during treatment.

2. Treatment plan

All patients were randomly assigned to the combined treatment group and the control group according to the random number table method. Both groups were given PPI drugs, specifically rabeprazole sodium enteric-coated capsules (dosage form: 20 mg/tablet, Shandong Jichuan Pharmaceutical Co., Ltd.), 20 mg orally, once a day. The combined treatment group was given compound Pien Tze Huang lozenges (dosage form: 0.5 g/tablet, Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd.), 1 g orally, 5 times a day.

3. Treatment results

A total of 51 patients were included in this study, including 26 in the control group and 25 in the combined treatment group. During the follow-up, 2 patients gave up treatment, including 1 patient in the control group who gave up treatment due to dizziness and discomfort after 3 days of medication, and 1 patient in the combined treatment group who gave up treatment due to nausea and other discomfort after 1 week of medication. In addition, 1 and 2 patients in the control group and combined treatment group were lost to follow-up, respectively. Therefore, the number of patients in the two groups included in the final analysis was 24 (control group) and 22 (combined treatment group) (see Figure 1). There was no significant difference in the baseline data between the two groups (see Table 2).

Table 2. Comparison of baseline data between the control group and the combined treatment group

Compared with the RSI before treatment, the RSI values of the two groups of patients decreased significantly one week after treatment (P<0.001). The comparison of RSI scores at different follow-up time points is shown in Table 3 and Figure 2. At the end of the 1st to 3rd week of follow-up, the RSI scores of the combined treatment group were lower than those of the control group, and there was a significant difference between the two (P<0.05).

Table 3. Comparison of RSI between the control group and the combined treatment group at different time points

4. Conclusion

The above studies show that in the treatment of LPRD patients, the combination of PPI drugs with compound Pien Tze Huang lozenges can help control symptoms more quickly and better. Therefore, compound Pien Tze Huang lozenges are expected to become a new and effective means of clinical treatment of LPRD.

The present invention discloses the evaluation of the therapeutic effect of two groups of LPRD patients after taking PPI alone and taking compound Pien Tze Huang lozenges on the basis of PPI alone, and compares the reflux symptom index score (RSI) of the included LPRD patients taking PPI alone and taking the combined drugs. It is clear that compared with taking PPI alone, the combined use of compound Pien Tze Huang lozenges and PPI drugs can more significantly improve the symptoms of LPRD patients, and there is a statistical difference in the first to third weeks. This increases the clinical indications of compound Pien Tze Huang lozenges and provides a new clinical medication idea for the treatment of LPRD.

In summary, the present invention discovers for the first time that the compound Pien Tze Huang lozenges can effectively treat laryngopharyngeal reflux disease, and has broad application prospects in the preparation of drugs for preventing and/or treating laryngopharyngeal reflux disease.

Claims (10)

1. Application of compound PIANZAIHUANG buccal tablet in preparing medicine for preventing and/or treating laryngopharyngeal reflux disease is provided.

2. The use according to claim 1, wherein the medicament is a medicament for improving symptoms of laryngopharyngeal reflux.

3. The use according to claim 1, wherein the medicament is a medicament that reduces the reflux symptom index score.

4. The use according to any one of claims 1-3, wherein the compound pian zaihuang lozenge is a preparation prepared by taking wedella, glabrous sarcandra herb, figwort root, dwarf lilyturf tuber, liquorice, menthol and pian zaihuang as active ingredients and taking mannitol, dextrin, pregelatinized starch, zein, magnesium stearate, aspartame and film coating premix as auxiliary materials.

5. The compound PIANZAIHUANG buccal tablet and proton pump inhibitor can be used in combination for preparing medicine for preventing and/or treating laryngopharyngeal reflux diseases.

6. The use according to claim 5, wherein the proton pump inhibitor is an oral proton pump inhibitor.

7. The use according to claim 6, wherein the oral proton pump inhibitor is oral sodium rabeprazole.

8. The use according to any one of claims 5 to 7, wherein the mass ratio of the compound pian zaihuang buccal tablet to the proton pump inhibitor is (200-300): 1.

9. The use of claim 8, wherein the mass ratio of the compound pian zaihuang lozenge to the proton pump inhibitor is 250:1.

10. The use according to claim 5, wherein the compound pian zaihuang buccal tablet and the proton pump inhibitor are administered simultaneously or separately.