Aromatherapy composition for treating peripheral phlebitis via transdermal absorption, preparation and application thereof

Abstract

The present invention relates to the technical field of aromatherapy in traditional Chinese medicine, and specifically to an aromatherapy composition for treating peripheral phlebitis through transdermal absorption, and its preparation and application. The aromatherapy composition and its preparation of the present invention are used for transdermal treatment of peripheral superficial phlebitis through aromatherapy in traditional Chinese medicine, and the overall effective rate of 24h treatment is 100%, of which the cure rate is 55%, and the cure rate is 97.5% after 48h. The reduction of phlebitis grade is recorded as grade difference, and the sum of grade differences of 40 patients is 125. The treatment effect of peripheral superficial phlebitis is significantly superior to traditional and commonly used methods. Compared with traditional therapies, it can greatly shorten the treatment time, quickly relieve pain, reduce the incidence of complications, and has stable and reliable efficacy. Patients' compliance, comfort and acceptability during the treatment process are very good.

Description

Technical Field

[0001] The invention relates to the technical field of aromatherapy of traditional Chinese medicine, and in particular to an aromatherapy composition for treating peripheral phlebitis via transdermal absorption, and a preparation and application thereof. Background Art

[0002] Peripheral intravenous catheters are commonly used in hospitals for invasive procedures and intravenous drug administration. Phlebitis is the most common complication of peripheral intravenous catheters, which brings considerable pain to patients, affects the implementation of diagnosis and treatment plans, and even increases clinical workload and prolongs patients' hospitalization time.

[0003] In order to more accurately evaluate and treat phlebitis, the American Intravenous Nursing Society (INS) has developed a detailed grading standard, which divides phlebitis into five levels: Level 0, no symptoms; Level 1, redness at the infusion site, with or without pain; Level 2, pain at the infusion site accompanied by redness and / or edema; Level 3, pain at the infusion site accompanied by redness and / or edema, with cord-like formation and palpable nodules; Level 4, pain at the infusion site accompanied by redness and / or edema, with palpable cord-like veins > 2.5 cm and purulent exudation. This grading is based on the severity of the inflammatory response of phlebitis. Therefore, the severity of phlebitis can be quantified clinically based on this grading mechanism, which makes the evaluation of treatment effects more accurate and consensual.

[0004] Although there are many methods for treating phlebitis, such as the use of ichthyol glycerol, heparinoids, magnesium sulfate glycerol, hot compresses, elevation of the affected limb, topical gels or ointments, the current studies have problems such as small sample size, inconsistent efficacy evaluation time, and imprecise dosage units. Existing treatment methods are always unsatisfactory, such as: magnesium sulfate is slow to take effect and the nursing workload is large; Hirudoid needs to pay attention to skin irritation or allergies, and cannot be applied directly to the wound; the cost of hydrocolloid dressings is high, and the operation requires attention; although Jinhuangsan is cheap, the nursing workload is large, and wet compresses are not patient-friendly. In recent years, with the development of traditional Chinese medicine, there have also been some studies on the application of Chinese aromatherapy in clinical practice. No clear side effects have been found, and it is cheap and easy to operate. In clinical practice, the treatment of PVC-related phlebitis varies: pharmacological intervention (anticoagulants, anti-inflammatory drugs, vasodilators), phytotherapy products (chamomile, Panax notoginseng, aloe vera) and / or physical measures (cold and hot compresses). Most of the therapies used are local, and systemic administration is only occasionally used. Given the high incidence of phlebitis in clinical practice, it is crucial to analyze the treatment methods and their possible effects on the symptoms of PVC-related phlebitis. Recent literature meta-analysis suggests that there is currently no recognized gold standard for the treatment of peripheral phlebitis, and most studies in this area lack high-quality evidence for sample size, evaluation criteria and implementation methods, and follow-up time. In particular, there are no prospective, randomized, controlled studies on the commonly used treatment methods, drugs, or dressings for phlebitis. Summary of the invention

[0005] The purpose of the present invention is to fill the current research gap and provide an aromatherapy composition and a treatment plan for treating peripheral phlebitis through transdermal absorption, which has good efficacy, economy, strong applicability, simple clinical operation and is easy to promote, by using traditional Chinese medicine aromatherapy.

[0006] The present invention selects Chinese medicine aromatherapy transdermal technology as the main research object for the treatment of peripheral phlebitis, which is based on the previous research on the therapeutic effect of Chinese medicine on peripheral phlebitis, and the clear anti-infection and anti-inflammatory effects of Chinese medicine aromatherapy technology in recent clinical use. The research on the pharmacological effects of Chinese medicine aromatherapy technology is becoming increasingly clear, and it is most commonly used in the control and treatment of superficial inflammation. Domestic and foreign studies have shown that Chinese medicine aromatherapy substances have the effect of inhibiting the growth of various bacteria and fungi, and significantly reduce patient symptoms and shorten the course of disease in the treatment of superficial infections. Therefore, the use of Chinese medicine aromatherapy transdermal technology to treat peripheral phlebitis is based on a full study of aromatherapy substances and has a clear scientific basis.

[0007] A first aspect of the present invention provides an aromatherapy composition for treating peripheral phlebitis, comprising myrrh essential oil, lavender essential oil, tea tree essential oil, cypress essential oil, and frankincense essential oil in a volume ratio of 1:1:1:1:1.

[0008] Furthermore, the myrrh essential oil, lavender essential oil, tea tree essential oil, cypress essential oil and frankincense essential oil are all 100% pure essential oils. Commercially available single essential oil products can be selected.

[0009] A second aspect of the present invention provides an aromatherapy preparation for treating peripheral phlebitis, which is prepared from myrrh essential oil, lavender essential oil, tea tree essential oil, cypress essential oil, and frankincense essential oil in a volume ratio of 1:1:1:1:1, and coconut oil is used as the solvent, which is prepared in a solute:solvent volume ratio of 1:5.

[0010] The third aspect of the present invention provides a use of the aromatherapy composition as described above in the preparation of a medicament for treating peripheral phlebitis via transdermal absorption.

[0011] A fourth aspect of the present invention provides a use of the aromatherapy preparation as described above in the preparation of a drug for treating peripheral phlebitis via transdermal absorption.

[0012] Furthermore, the aromatherapy preparation for treating peripheral phlebitis is applied directly to the phlebitis site 4 times a day, 0.1 ml / cm each time. 2 , treatment course 3d.

[0013] The present invention has the advantages that:

[0014] 1. The aromatherapy composition and preparation of the present invention are used to treat peripheral superficial phlebitis through transdermal treatment with Chinese aromatherapy. The overall effective rate of 24h treatment is 100%, of which the cure rate is 55%, and the cure rate is 97.5% at 48h. The reduction in phlebitis grade is recorded as a grade difference, and the sum of the grade differences of 40 patients is 125. The results indicate that the present invention has obvious advantages over traditional and commonly used methods in the treatment of peripheral superficial phlebitis. Chinese aromatherapy is not only suitable for a wide range of people, but also significantly reduces the workload of clinical nursing due to its inherent high safety, convenient operation, and good patient acceptance. This excellent applicability has greatly broadened the treatment ideas and brought a more comprehensive treatment plan to patients.

[0015] 2. Compared with traditional therapies, it can significantly shorten the treatment time by 30%-50%, thereby quickly and significantly improving the patient's symptoms and improving their quality of life.

[0016] 3. After receiving treatment, the pain level of the patients began to decrease significantly within 2 hours, and continued to decline at the following 4 hours, 6 hours, 12 hours, 24 hours and 48 hours. Finally, the pain of all patients dropped to level 0, that is, they were completely pain-free. This reflects the significant advantages of the present invention in terms of rapid pain relief, and further verifies the stability and reliability of its efficacy through inter-group comparison and self-comparison before and after treatment.

[0017] 4. The nursing satisfaction rate is 100%. This high satisfaction rate not only reflects the patients' high recognition of the treatment effect, but also reflects the comfort and acceptability of Chinese aromatherapy during the treatment process, and further reflects the important role of this invention in improving the overall treatment experience of patients.

[0018] 5. During the entire observation period of the experiment, no infection occurred, which fully proved the safety of transdermal treatment with aromatherapy of traditional Chinese medicine. The results of inter-group comparison also further consolidated this conclusion, indicating that the present invention has a significant advantage in reducing the incidence of complications.

[0019] 6. The patients' compliance during the treatment process was also very good, which not only provided a strong guarantee for the smooth progress of the research, but also reflected the patients' trust and acceptance of Chinese aromatherapy from one aspect.

[0020] This innovative therapy of the present invention is expected to rapidly and significantly improve the symptoms of phlebitis patients, thereby improving the quality of life of patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1-15 This is a comparison chart of the effects before and after medication of No. 1-15 in Table 1. DETAILED DESCRIPTION

[0022] The specific implementation methods provided by the present invention are described in detail below in conjunction with examples.

[0023] Example 1: Aromatherapy composition preparation of the present invention

[0024] Myrrh essential oil, lavender essential oil, tea tree essential oil, cypress essential oil, and frankincense essential oil are prepared in a volume ratio of 1:1:1:1:1. Coconut oil is used as the solvent, and it is prepared in a volume ratio of solute: solvent of 1:5. After that, it is stored in a brown bottle and protected from light.

[0025] Example 2: Clinical Trial

[0026] Clinical trials are conducted to verify the actual effectiveness of Chinese aromatherapy in treating phlebitis, including pain relief, inflammation control, and improvement of quality of life.

[0027] 1. Research subjects

[0028] 1.1 Case selection

[0029] Patients with peripheral phlebitis who were hospitalized in our hospital from January 2023 to September 2024 were selected, and 40 cases of grade 3-4 peripheral phlebitis were included.

[0030] 1.2 Inclusion criteria

[0031] (1) The patient agrees to participate in the clinical trial and has signed the informed consent form.

[0032] (2) Age ≥ 18 years

[0033] (3) Phlebitis caused by peripheral intravenous infusion in non-chemotherapy patients

[0034] (4) Able to complete phlebitis treatment observation during this hospitalization.

[0035] 1.3 Exclusion criteria

[0036] (1) Treatment of allergies to drugs or aromatherapy substances

[0037] (2) Chemotherapy-induced phlebitis and phlebitis after central catheter implantation

[0038] (3) Patients with incomplete data that affect the outcome

[0039] (4) Phlebitis in the affected limb after modified radical mastectomy for breast cancer

[0040] (5) Patients with diabetes and peripheral vascular disease

[0041] 1.4 Rejection, shedding and termination test criteria:

[0042] (1) Patients who were found to have serious adverse events or reactions during the trial and were unable to continue the trial were excluded.

[0043] (2) Patients who withdraw from the trial on their own or are unable to complete the entire trial, which affects the evaluation of efficacy, should be considered as dropouts.

[0044] (3) For all cases of withdrawal from the trial, the reasons for withdrawal, the handling of adverse events and follow-up records should be recorded in detail and objectively and properly resolved.

[0045] 2. Experimental Methods

[0046] 2.1 Treatment methods

[0047] The aromatherapy composition of the present invention is administered for transdermal treatment, directly applied to the phlebitis site, 4 times / day, 0.1 ml / cm each time 2 , 3 days of treatment. Compliance education, daily follow-up, follow-up form: on-site inspection, WeChat follow-up.

[0048] The aromatherapy composition of the present invention comprises the following components: myrrh essential oil, lavender essential oil, tea tree essential oil, cypress essential oil and frankincense essential oil, which are prepared in a volume ratio of 1:1:1:1:1; coconut oil is selected as a solvent, which is prepared in a volume ratio of solute: solvent of 1:5, and then packed in a brown bottle for storage in the dark.

[0049] 2.2 Observation indicators:

[0050] 2.2.1 Main outcomes:

[0051] Effect evaluation: ① Cured: completely cured, phlebitis rating 0, after treatment, the symptoms of redness, swelling, heat and pain in the affected area disappear, and the blood vessels become soft and regain elasticity; ② Effective: Phlebitis is downgraded, the symptoms of redness, swelling, heat and pain in the affected area are slightly relieved or the blood vessels become slightly soft after intervention, but the phlebitis rating is 1 or above; ③ Ineffective: the symptoms of the affected area do not change after intervention, or even worsen. Total effective rate = (number of cured cases + number of effective cases) / total number of cases × 100%. Sum of grade differences: the number of phlebitis downgrades is the grade difference, and the sum of all grade differences for each treatment is statistically analyzed.

[0052] 2.2.2 Secondary outcomes:

[0053] 2.2.1 Pain severity score: Numerical rating scale (NRS) was used to evaluate the pain severity 2h, 4h, 6h, 12h, 24h, and 48h after phlebitis occurred; 0 was painless, 1-3 was mild (no impact on sleep), 4-6 was moderate (between moderate and severe), 7-9 was severe (unable to fall asleep or wake up with pain), and 10 was severe (unbearable). Inter-group comparison and self-comparison before and after treatment were performed.

[0054] 2.2.2 Patient satisfaction evaluation and inter-group comparison. Satisfaction is divided into four levels: very satisfied, satisfied, basically satisfied, and dissatisfied. Nursing satisfaction = (number of very satisfied patients + number of satisfied patients + number of basically satisfied patients) / total number of cases * 100%.

[0055] 2.2.3 Complications: The incidence of infection was recorded and compared between groups.

[0056] 2.2.4 Other indicators: hospitalization time, cost, etc. Compare between groups. Observe and record various changes in patients' conditions and adverse reactions to drugs, and deal with complications in a timely manner.

[0057] 3. Experimental results

[0058] 3.1 Primary outcomes

[0059] After treatment, 39 cases were cured, 40 cases were effective, and 0 cases were ineffective. The overall effective rate of 24h treatment was 100%, of which the cure rate was 55% and the cure rate was 97.5% at 48h. The reduction in phlebitis grade was recorded as a grade difference. The sum of the grade differences of 40 patients was 125. The use of grade difference indicators can quantify the treatment effect, which is more accurate than simply using the cure rate or the effective rate. These quantitative indicators not only intuitively demonstrate the significance of the treatment effect, but also provide valuable reference data for subsequent research. The experimental results show that the Chinese medicine aromatherapy transdermal technology has obvious advantages over traditional and commonly used methods in the treatment of peripheral superficial phlebitis.

[0060] Compared with traditional therapies (generally 3-7 days of treatment), the present invention can significantly shorten the treatment time by 30%-70%, thereby rapidly and significantly improving the patient's symptoms and improving their quality of life.

[0061] 3.2 Secondary Outcomes

[0062] Table 1

[0063]

[0064] Table 1 and Figure 1-15 The content presented is a demonstration of the therapeutic effects of some cases. Although only partial data are shown, from the detailed changes in various indicators recorded in Table 1, as well as the comparison charts before and after medication, we can still clearly observe the significant therapeutic effect of Chinese aromatherapy transdermal treatment in peripheral superficial phlebitis.

[0065] In the in-depth study of the clinical effect of Chinese aromatherapy transdermal treatment of peripheral superficial phlebitis, the experimental data of the present invention provide encouraging preliminary evidence. First, regarding the pain level score, the internationally recognized numeric rating scale (NRS) was used for accurate evaluation. The results showed that after treatment, the pain level of all 40 patients began to decrease significantly within 2 hours, and continued to maintain a downward trend at the subsequent 4 hours, 6 hours, 12 hours, and 24 hours observation points. Finally, the pain of all patients within 48 hours was reduced to 0 points, that is, a completely pain-free state was achieved. This result not only reflects the significant advantages of Chinese aromatherapy in rapid pain relief, but also further verifies the stability and reliability of its efficacy through inter-group comparison and self-comparison before and after treatment.

[0066] Secondly, in terms of patient satisfaction evaluation, the present invention adopts a four-level satisfaction evaluation system, and the results show that all 40 patients participating in the experiment expressed "very satisfied". This high satisfaction not only reflects the patients' high recognition of the treatment effect, but also reflects the comfort and acceptability of Chinese aromatherapy during the treatment process. Through calculation, the nursing satisfaction rate is 100%, which further reflects the important role of the present invention in improving the overall treatment experience of patients.

[0067] In addition, regarding the record of complications, the present invention pays special attention to infection, a common and serious potential risk. It is gratifying that no infection occurred in the 40 patients during the entire observation period of the experiment, which fully proves the safety of transdermal treatment of Chinese aromatherapy. The results of inter-group comparison also further consolidated this conclusion, indicating that this therapy has a significant advantage in reducing the incidence of complications.

[0068] Finally, it is worth mentioning that the compliance of the 40 patients during the treatment process was also very good. This not only provides a strong guarantee for the smooth progress of the study, but also reflects from one aspect the patients' trust and acceptance of Chinese aromatherapy.

[0069] In summary, the above experimental results strongly support the clinical application value of the Chinese medicine aromatherapy composition of the present invention in transdermal treatment of peripheral superficial phlebitis.

[0070] The preferred embodiments of the present invention have been specifically described above, but the present invention is not limited to the embodiments. Those skilled in the art may make various equivalent modifications or substitutions without violating the spirit of the present invention. These equivalent modifications or substitutions are all included in the scope defined by the claims of this application.

Claims

1. An aromatherapy composition for treating peripheral phlebitis, characterized in that: It is composed of myrrh essential oil, lavender essential oil, tea tree essential oil, cypress essential oil and frankincense essential oil in a volume ratio of 1:1:1:1:

1.

2. The aromatherapy composition according to claim 1, characterized in that The myrrh essential oil, lavender essential oil, tea tree essential oil, cypress essential oil and frankincense essential oil are all 100% pure essential oils.

3. An aromatherapy preparation for treating peripheral phlebitis, characterized in that: The essential oil is prepared with myrrh essential oil, lavender essential oil, tea tree essential oil, cypress essential oil and frankincense essential oil in a volume ratio of 1:1:1:1:1; coconut oil is used as the solvent and is prepared in a volume ratio of solute: solvent of 1:

5.

4. Use of the aromatherapy composition according to claim 1 or 2 in the preparation of a medicament for treating peripheral phlebitis via transdermal absorption.

5. Use of the aromatherapy preparation according to claim 3 in the preparation of a medicament for treating peripheral phlebitis via transdermal absorption.

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