Acupoint sticking traditional Chinese medicine composition for treating AIDS combined with insomnia, acupoint sticking and preparation method thereof

Abstract

The application is suitable for the technical field of traditional Chinese medicine, and provides an acupoint sticking traditional Chinese medicine composition for treating AIDS combined with insomnia, an acupoint patch and a preparation method thereof, wherein the acupoint sticking traditional Chinese medicine composition is prepared from the following raw medicinal materials in parts by weight: 10-30 parts of angelica, 10-30 parts of astragalus, 20-50 parts of radix polygoni multiflori, 10-30 parts of albizia, 5-15 parts of cassia, 10-30 parts of acorus, 5-15 parts of evodia, 10-30 parts of radix paeoniae alba, 5-15 parts of mentha and 10-30 parts of semen platycladi. The application strictly follows the theory of traditional Chinese medicine to formulate the prescription, and the various medicinal materials are synergized by virtue of unique efficacy and meridian characteristics, combined with the meridians of traditional Chinese medicine, the theory of traditional Chinese medicine and modern pharmacology, and various acupoint selection methods are used to select acupoints, and the application adopts "one acupoint one medicine" to treat AIDS combined with insomnia by "waking up in the day and calming down at night", and the acupoint sticking operation is simple and low in cost.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to an acupoint pasting traditional Chinese medicine composition for treating AIDS combined with insomnia, an acupoint patch and a preparation method thereof. BACKGROUND

[0002] Insomnia, as a common type of sleep disorder in clinical practice, is mainly manifested in difficulty falling asleep, easy to wake up in the middle of the night, difficulty falling back to sleep after waking up, poor sleep quality and the like. Its incidence rate is increasing year by year with the acceleration of social rhythm. According to statistics of the World Health Organization, about 27% of the global population has sleep disorders, and the incidence rate of insomnia in China is as high as 30%. Long-term insomnia not only seriously reduces the quality of life, but also leads to a decrease in immunity, induces problems such as emotional cognitive disorder, memory decline, anxiety and depression, affects work efficiency and mental health, and even causes high blood pressure, coronary heart disease and even sudden death, which poses a significant threat to human health.

[0003] At present, the treatment of insomnia by western medicine mainly relies on drugs, including benzodiazepines, non-benzodiazepines, orexin antagonists and the like. Although these drugs have a certain effect on acute insomnia, they are not good for chronic insomnia, and long-term use is prone to cause adverse reactions such as drug dependence, addiction and withdrawal syndrome. Non-drug therapies such as cognitive behavioral therapy and repetitive transcranial magnetic stimulation can avoid drug dependence, but they have limitations such as complex operation, high cost and great difficulty in implementation, and are difficult to be widely applied.

[0004] Under this background, acupoint pasting of traditional Chinese medicine, as a non-invasive external treatment method guided by traditional Chinese medicine theory and combined with modern medical technology, opens up a new path for the treatment of insomnia with the advantages of simple operation, low price and sustained effect. Its mechanism of action involves multiple levels of synergistic effect, including local penetration of drug ingredients to exert drug efficacy, physiological regulation effect of acupoint stimulation, regulation of qi and blood through meridian system, and overall regulation through the synergy between drugs and acupoints. A large number of studies have confirmed that acupoint pasting of traditional Chinese medicine has positive effects in improving insomnia symptoms. However, it is worth noting that the group of patients with AIDS combined with insomnia has special characteristics. They are not only troubled by insomnia, but also have complex conditions such as immune system damage and great psychological pressure caused by AIDS. The existing acupoint pasting of traditional Chinese medicine does not fully consider these special factors, and it is difficult to accurately and effectively solve the problem of AIDS combined with insomnia, so it is urgent to develop a more targeted treatment plan. SUMMARY

[0005] The purpose of the embodiments of the present application is to provide an acupoint pasting traditional Chinese medicine composition for treating AIDS combined with insomnia, aiming to solve the problem that the existing acupoint pasting of traditional Chinese medicine is difficult to accurately and effectively solve the problem of AIDS combined with insomnia.

[0006] The application embodiment is implemented in the following manner: a point application Chinese medicinal composition for treating AIDS combined with insomnia is prepared from the following raw medicinal materials by weight:

[0007] Angelica 10-30 parts, Astragalus 10-30 parts, Caulis Polygoni Multiflori 20-50 parts, Albizia 10-30 parts, Cinnamon 5-15 parts, Acorus 10-30 parts, Evodia 5-15 parts, White Peony Root 10-30 parts, Mint 5-15 parts, and Platycladus Seed 10-30 parts.

[0008] Another object of the application embodiment is a point application for treating AIDS combined with insomnia, which is prepared from the point application Chinese medicinal composition for treating AIDS combined with insomnia described above.

[0009] Another object of the application embodiment is a preparation method of the point application for treating AIDS combined with insomnia described above, which comprises the following steps:

[0010] The raw medicinal materials are weighed according to the formula of the point application Chinese medicinal composition for treating AIDS combined with insomnia described above, and then are decontaminated, washed, dried, and pulverized respectively to obtain fine powders of the medicinal materials;

[0011] The fine powders of Angelica and Astragalus, Caulis Polygoni Multiflori and Albizia, Cinnamon and Acorus, White Peony Root and Mint are mixed respectively, and the fine powders of Evodia and Platycladus Seed are used separately, and then honey is added to each of them to prepare medicinal beads, which are placed in the center of the point application and are used to prepare point applications for Shenjue Acupoint, Neiguan Acupoint, Dazhui Acupoint, Sanyinjiao Acupoint, Yungquan Acupoint, and Shengmen Acupoint.

[0012] The point application Chinese medicinal composition for treating AIDS combined with insomnia provided by the application embodiment strictly follows the theory of traditional Chinese medicine, and selects Angelica, Astragalus, Caulis Polygoni Multiflori, Albizia, Cinnamon, Acorus, Evodia, White Peony Root, Mint, and Platycladus Seed as medicinal materials. These medicinal materials have unique functions and meridian properties, and are synergistic with each other to accurately treat different acupoints.

[0013] The point application for treating AIDS combined with insomnia provided by the application embodiment selects acupoints according to meridians, diseases, and syndromes, adopts the innovative “one acupoint one medicine” mode, and is applied to Shenjue, Neiguan, and Dazhui acupoints in the daytime to improve the daytime spirit of the patient, and is applied to Yungquan, Sanyinjiao, and Shengmen acupoints at night to help the patient sleep at night, and improves sleep in all directions. This point application is based on the theory of traditional Chinese medicine meridians, and uses the simple and low-cost point application to provide a safe, effective, and economical treatment scheme for patients with AIDS combined with insomnia. DETAILED DESCRIPTION

[0014] In order to make the purpose, technical scheme and advantages of the present application clearer, the present application will be further described in detail below with reference to the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and not used to limit the present application.

[0015] Traditional Chinese medicine acupoint sticking, as a non-invasive external treatment method guided by traditional Chinese medicine theory and integrated with modern medical technology, opens up a new path for insomnia treatment with the advantages of simple operation, low price and sustained effect. It achieves overall regulation through local drug penetration, acupoint stimulation physiological regulation, meridian qi and blood regulation and synergistic effect of drugs and acupoints, and has remarkable effect on improving insomnia. However, due to the special conditions such as immune system damage and high psychological pressure, the existing scheme is difficult to accurately respond to AIDS patients with insomnia, and targeted treatment scheme is urgently needed. The research idea of the acupoint patch (Riyue Anmian patch) for treating AIDS combined with insomnia provided in the present application is based on the theory of traditional Chinese medicine: acupoints are the gathering points of meridian qi and blood and the channels of qi movement, and stimulation can adjust yin and yang, dredge meridians and regulate qi and blood; traditional Chinese medicine acupoint sticking stimulates the flow of meridian qi and blood by combining drugs with acupoints. According to the “Riyue Pianwen Lüyan” “only when the smell is strong can it be effective”, fast-permeable drugs are selected, and since the lung governs the skin and the skin, and the lung belongs to the lung, the addition of drugs with pungent flavor can act on the interstices, and the regulation of yin and yang and the improvement of sleep are achieved by stimulating the defensive qi and regulating the circulation of drugs. Therefore, the present application combines the theory of traditional Chinese medicine meridians, traditional Chinese medicine and modern pharmacology, selects acupoints according to the meridians, diseases and syndromes, and matches the efficacy of different acupoints with traditional Chinese medicine, and uses “one acupoint one drug” combination to treat AIDS combined with insomnia.

[0016] Its treatment drug thinking is also based on this: daytime wakefulness selects Shenque, Neiguan and Dazhui points. Shenque point belongs to Ren Channel, and is applied with Angelica (blood tonic and blood circulation) and Astragalus (qi and yang tonic), which can warm yang and tonify deficiency, and regulate qi and blood; Neiguan point belongs to Pericardium Channel and connects Yin and Yang channels, and is matched with Shouwuteng (blood nourishing and spirit calming) and Hehuanpi (depression relieving and spirit calming) to relieve daytime restlessness; Dazhui point is the gathering place of Yangqi of Du Channel, and is matched with Rougui (warming Yang and unblocking meridians) and Shichangpu (opening orifices and waking up), which can ascend Yang, clear brain, open orifices and calm spirit. Nighttime sleep selection includes Yongquan, Sanyinjiao and Shengmen points. Yongquan point is the well point of Foot-Shaoyin Kidney Channel, and is matched with Wuzhuyu (warming kidney and dispelling cold) to treat “deficiency of yang and disturbance of heart and kidney” type insomnia; Sanyinjiao is a three-channel intersection point, and is matched with Shaoyao (nourishing blood and soothing liver) and Bohe (cooling) to nourish yin, clear fire and help sleep; Shengmen point is the original point of Hand-Shaoyin Heart Channel, and is matched with Baiziren (moistening heart and nourishing blood, calming spirit and benefiting intelligence) to benefit heart and calm spirit.

[0017] Specifically, the acupoint sticking traditional Chinese medicine composition for treating AIDS combined with insomnia provided by the embodiments of the present application is made of the following raw materials by weight:

[0018] Angelica 10-30 parts, Astragalus 10-30 parts, Caulis Polygoni Multiflori 20-50 parts, Albizia 10-30 parts, Cinnamon 5-15 parts, Acorus 10-30 parts, Evodia 5-15 parts, White Peony Root 10-30 parts, Mint 5-15 parts, and Platycladus 10-30 parts.

[0019] Preferably, the acupoint application traditional Chinese medicine composition is made of the following raw medicinal materials by weight:

[0020] Angelica 20 parts, Astragalus 20 parts, Caulis Polygoni Multiflori 35 parts, Albizia 15 parts, Cinnamon 10 parts, Acorus 20 parts, Evodia 10 parts, White Peony Root 20 parts, Mint 10 parts, and Platycladus 20 parts.

[0021] The application also provides an acupoint patch for treating AIDS combined with insomnia, which is prepared from the acupoint application traditional Chinese medicine composition for treating AIDS combined with insomnia.

[0022] Meanwhile, the application also provides a preparation method of the acupoint patch for treating AIDS combined with insomnia, which comprises the following steps:

[0023] The raw medicinal materials are weighed according to the above-mentioned formula of the acupoint application traditional Chinese medicine composition for treating AIDS combined with insomnia, and then are crushed after being removed of impurities, washed and dried to obtain fine powder of each medicinal material;

[0024] The fine powder of Angelica and Astragalus, the fine powder of Caulis Polygoni Multiflori and Albizia, the fine powder of Cinnamon and Acorus, and the fine powder of White Peony Root and Mint are mixed respectively, and the fine powder of Evodia and Platycladus is used alone, and then honey is added to each of them to make medicinal beads, which are placed in the center of the application patch to make acupoint patches corresponding to Shenjue acupoint, Neiguan acupoint, Dazhui acupoint, Sanyinjiao acupoint, Yongquan acupoint and Shengmen acupoint.

[0025] Specifically, the step of mixing the fine powder of Angelica and Astragalus, the fine powder of Caulis Polygoni Multiflori and Albizia, the fine powder of Cinnamon and Acorus, and the fine powder of White Peony Root and Mint respectively, using the fine powder of Evodia and Platycladus alone, adding honey to each of them to make medicinal beads, and placing the medicinal beads in the center of the application patch to make acupoint patches corresponding to Shenjue acupoint, Neiguan acupoint, Dazhui acupoint, Sanyinjiao acupoint, Yongquan acupoint and Shengmen acupoint comprises the following steps:

[0026] The fine powder of Angelica and Astragalus is mixed uniformly, honey is added to make medicinal beads, and the medicinal beads are placed in the center of the application patch to obtain Shenjue acupoint day patch.

[0027] The fine powder of Caulis Polygoni Multiflori and Albizia is mixed, honey is added to make medicinal beads, and the medicinal beads are placed in the center of the application patch to obtain Neiguan acupoint day patch.

[0028] The fine powder of Cinnamon and Acorus is mixed, honey is added to make medicinal beads, and the medicinal beads are placed in the center of the application patch to obtain Dazhui acupoint day patch.

[0029] Mix fine powders of white peony root and peppermint, add honey to make medicinal beads, and place them in the center of the patch to apply to the Sanyinjiao acupoint at night.

[0030] Mix fine powdered Evodia rutaecarpa with honey to make medicinal beads, place them in the center of the patch, and apply to the Yongquan acupoint at night.

[0031] Mix finely powdered cypress seeds with honey to make medicinal beads, place them in the center of the patch, and apply to the Shenmen acupoint at night.

[0032] Preferably, the drying process controls the moisture content of the medicinal materials to below 5%.

[0033] Preferably, the fine powder of the medicinal material after pulverization is passed through a 100-mesh sieve.

[0034] Preferably, the weight ratio of honey to the corresponding medicinal powder is 3:4. That is, the weight ratio of the total fine powder of Angelica sinensis and Astragalus membranaceus, the total fine powder of Polygonum multiflorum vine and Albizia julibrissin bark, the total fine powder of Cinnamomum cassia and Acorus tatarinowii, the total fine powder of Paeonia lactiflora and Mentha haplocalyx, the fine powder of Evodia rutaecarpa, and the fine powder of Platycladus orientalis seed to honey is 4:3.

[0035] Preferably, the diameter of the medicine bead is 1-2 cm.

[0036] The following are examples of the acupoint patch traditional Chinese medicine composition for treating AIDS complicated with insomnia, the acupoint patch and its preparation method. Unless otherwise specified, the experimental methods used in the following examples are conventional methods; the materials and reagents used are commercially available unless otherwise specified.

[0037] Additionally, it should be noted that the values ​​given in the following embodiments are as accurate as possible. However, those skilled in the art will understand that due to unavoidable measurement errors and experimental issues, each number should be understood as an approximation rather than an absolutely accurate value.

[0038] Example 1

[0039] In this embodiment, a traditional Chinese medicine composition for treating AIDS complicated with insomnia is prepared from the following raw materials: 20 parts Angelica sinensis, 20 parts Astragalus membranaceus, 35 parts Polygonum multiflorum, 15 parts Albizia julibrissin, 10 parts Cinnamomum cassia, 20 parts Acorus tatarinowii, 10 parts Evodia rutaecarpa, 20 parts Paeonia lactiflora, 10 parts Mentha haplocalyx, and 20 parts Platycladus orientalis.

[0040] In this embodiment, the preparation method of the acupoint patch for treating AIDS complicated with insomnia is as follows:

[0041] Day paste. Take the above-mentioned proportions of Angelica 20 parts, Radix Astragali 20 parts, crush and mix, pass through a 100 mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Shenjue point of the patient in the morning, keep for 6-8 hours, once a day; take the above-mentioned proportions of Caulis Polygoni Multiflori 35 parts, Cortex Albiziae 15 parts, crush and mix, pass through a 100 mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Neiguan point of the patient in the morning, keep for 6-8 hours, once a day; take the above-mentioned proportions of Cinnamomum 10 parts, Acorus 20 parts, crush and mix, pass through a 100 mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Dazhui point of the patient in the morning, keep for 6-8 hours, once a day.

[0042] Night paste. Take the above-mentioned proportions of Evodia 10 parts, crush, pass through a 100 mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Yongquan point of the patient before going to bed, keep for 6-8 hours, once a day; take the above-mentioned proportions of Radix Paeoniae Alba 20 parts, Mentha 10 parts, crush and mix, pass through a 100 mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Sanyinjiao point of the patient before going to bed, keep for 6-8 hours, once a day; take the above-mentioned proportions of Platycladus 20 parts, crush, pass through a 100 mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Shengmen point of the patient before going to bed, keep for 6-8 hours, once a day.

[0043] The weight ratio of honey to the total amount of corresponding fine powder of medicinal materials is 3:4.

[0044] Example 2

[0045] In this embodiment, a kind of acupoint paste of traditional Chinese medicine composition for treating AIDS combined with insomnia is prepared from the following raw medicinal materials: Angelica 30 parts, Radix Astragali 30 parts, Caulis Polygoni Multiflori 50 parts, Cortex Albiziae 20 parts, Cinnamomum 15 parts, Acorus 30 parts, Evodia 20 parts, Radix Paeoniae Alba 30 parts, Mentha 15 parts, Platycladus 30 parts.

[0046] The weight ratio of the traditional Chinese medicine composition and honey is 4:3.

[0047] In this embodiment, the preparation method of acupoint paste for treating AIDS combined with insomnia is as follows:

[0048] Day paste. Take the above-mentioned proportions of Angelica 30 parts, Radix Astragali 30 parts, crush and mix, pass through a 100 mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Shenjue point of the patient in the morning, keep for 6-8 hours, once a day; take the above-mentioned proportions of Caulis Polygoni Multiflori 50 parts, Cortex Albiziae 20 parts, crush and mix, pass through a 100 mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Neiguan point of the patient in the morning, keep for 6-8 hours, once a day; take the above-mentioned proportions of Cinnamomum 15 parts, Acorus 30 parts, crush and mix, pass through a 100 mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Dazhui point of the patient in the morning, keep for 6-8 hours, once a day.

[0049] Night paste. Take the above-mentioned proportions of Evodia 20 parts, crush, pass through a 100 mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Yongquan point of the patient before going to bed, keep for 6-8 hours, once a day; take the above-mentioned proportions of Radix Paeoniae Alba 30 parts, Mentha 15 parts, crush and mix, pass through a 100 mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Sanyinjiao point of the patient before going to bed, keep for 6-8 hours, once a day; take the above-mentioned proportions of Platycladus 30 parts, crush, pass through a 100 mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Shengmen point of the patient before going to bed, keep for 6-8 hours, once a day.

[0050] Above, the weight ratio of honey to the total amount of corresponding medicinal powder is 3:4.

[0051] Example 3

[0052] In this embodiment, a kind of acupoint paste of traditional Chinese medicine composition for treating AIDS combined with insomnia is prepared from the following raw medicinal materials: Angelica 10 parts, Radix Astragali 10 parts, Caulis Polygoni Multiflori 20 parts, Cortex Albiziae 9 parts, Cinnamomum 5 parts, Acorus 10 parts, Evodia 5 parts, Radix Paeoniae Alba 10 parts, Mentha 5 parts, Platycladus 10 parts.

[0053] In this embodiment, the preparation method of acupoint paste for treating AIDS combined with insomnia is as follows:

[0054] Day paste. Take the above-mentioned proportions of angelica 10 parts, radix astragali 10 parts, crush and mix, pass through a 100-mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Shenjue point of the patient in the morning, keep for 6-8 hours, once a day; take the above-mentioned proportions of Shouwuteng 20 parts, huanghua skin 9 parts, crush and mix, pass through a 100-mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Neiguan point of the patient in the morning, keep for 6-8 hours, once a day; take the above-mentioned proportions of cinnamon 5 parts, shichangpu 10 parts, crush and mix, pass through a 100-mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Dazhui point of the patient in the morning, keep for 6-8 hours, once a day.

[0055] Night paste. Take the above-mentioned proportions of wuzhuyi 5 parts, crush, pass through a 100-mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Yongquan point of the patient before going to bed, keep for 6-8 hours, once a day; take the above-mentioned proportions of baishao 10 parts, bose 5 parts, crush and mix, pass through a 100-mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Sanyinjiao point of the patient before going to bed, keep for 6-8 hours, once a day; take the above-mentioned proportions of baiziren 10 parts, crush, pass through a 100-mesh screen, mix the powder with the corresponding proportion of honey, and make medicine beads with a diameter of 1-2 cm. Place the prepared medicine beads in the center of the paste, and place the paste on the Shenmen point of the patient before going to bed, keep for 6-8 hours, once a day.

[0056] Above, the weight ratio of honey to corresponding fine powder of medicinal materials is 3:4.

[0057] The above-mentioned prepared acupoint paste for treating AIDS combined with insomnia (Yueyue Anmian paste) is subjected to relevant tests, as follows:

[0058] 1. Object and method

[0059] 1.1 Research design

[0060] Research time: June 2023-December 2024.

[0061] Research object: HIV / AIDS patients with insomnia.

[0062] Research method: Randomized controlled method.

[0063] 72 cases of HIV / AIDS patients with insomnia were included, and Ruyi sleep patch was used for intervention, with a course of 48 weeks. During the treatment, 8 patients dropped out, and finally 64 cases of subjects were included, 33 cases in the treatment group and 31 cases in the control group.

[0064] 1.2 Study subjects

[0065] 1.2.1 Diagnostic criteria: The diagnostic criteria refer to the diagnostic criteria of AIDS and HIV infection diagnosis standard (WS293-2008) and AIDS diagnosis and treatment guidelines (2011 edition).

[0066] According to the diagnostic criteria of Chinese adult insomnia diagnosis and treatment guidelines, the diagnostic criteria are as follows: ① Difficulty falling asleep, easy to wake up, or wake up and can't sleep again, early morning wake up; ② Daytime drowsiness and body weakness; ③ Less than 5 hours of sleep for more than 1 month.

[0067] 1.2.2 Inclusion criteria

[0068] Meet the diagnostic criteria:

[0069] (1) Age 18-65 years old, male and female;

[0070] (2) Meet the diagnostic criteria of AIDS and insomnia in Chinese and Western medicine at the same time;

[0071] (3) Accepting antiviral therapy, and HIV-RNA < 20 cp / ml, CD4 > 200 cell / mm 3 ;

[0072] (4) Voluntarily participate in this study, sign the informed consent form.

[0073] 1.2.3 Exclusion criteria

[0074] Those who meet the inclusion criteria but have one of the following conditions are excluded:

[0075] (1) Do not meet the diagnostic criteria of AIDS insomnia in Chinese and Western medicine;

[0076] (2) With moderate or severe infection, severe heart, liver, kidney and other primary diseases;

[0077] (3) Serious illness, or with persistent disturbance of consciousness, cannot cooperate;

[0078] (4) Dependence on tranquilizers;

[0079] (5) With obvious suicidal tendency assessed by specialist;

[0080] (6) Alcohol abuse or drug abuse;

[0081] (7) With pregnancy intention or in pregnancy or lactation period;

[0082] (8) Local infection or severe skin damage at acupoint;

[0083] (9) Poor compliance or fear;

[0084] (10) Participate in other clinical trials, which have an impact on this study.

[0085] The study complies with the Declaration of Helsinki, and all patients sign the informed consent form before entering the treatment, and fully understand the purpose, procedure and possible risks and benefits of participating in this study.

[0086] 1.3 Intervention

[0087] This study is divided into treatment group and control group.

[0088] Treatment group: ART + Riyue Anmian Paste.

[0089] Control group: ART.

[0090] Western medicine antiviral therapy: Zidovudine (AZT) + Tenofovir (TDF) + Lamivudine (3TC) + Nevirapine (NVP) or Efavirenz (EFV), or TDF + 3TC + Lopinavir ritonavir (Lpv / r), according to the specific circumstances of patients (such as viral load, immune system status, comorbidity and tolerance to specific drugs, etc.) to develop individualized medication regimen.

[0091] Riyue Anmian Paste is provided by China Academy of Chinese Medical Sciences, and is prepared according to the method of Example 1, 1 paste per acupoint, 1 time / day.

[0092] 1.4 Statistical method

[0093] This experiment uses R software for statistical analysis, and the measurement index is expressed by mean and standard deviation. The difference value of measurement index before and after treatment is calculated, and the difference value conforms to normal distribution, which is tested by paired t test, and the difference value does not conform to normal distribution, which is tested by Wilcoxon rank sum test. Hypothesis test uses two-sided test, and gives test statistic and corresponding P value, and P <0.05 is considered as significant statistical significance.

[0094] 2. Results analysis

[0095] 2.1 General data

[0096] 72 subjects were randomly divided into treatment group and control group, 36 cases in treatment group, 36 cases in placebo group. During the treatment, 8 patients dropped out, finally 64 cases were included in the analysis, 33 cases in treatment group, 31 cases in control group. Among them, 25 cases of male and 8 cases of female in treatment group, the average age was (55.28±12.29) years old; 21 cases of male and 10 cases of female in control group, the average age was (53.23±10.80) years old. The characteristics of gender, age and treatment duration of the two groups were not significantly different (P>0.05), which had good comparability.

[0097] 2.2 efficacy index

[0098] a. Symptom and sign score;

[0099] b. Pittsburgh sleep quality index;

[0100] c. Self-rating anxiety scale;

[0101] d. Quality of life scale.

[0102] 3. Results and conclusions

[0103] 3.1 symptom and sign score analysis

[0104] The results showed that the symptom and sign scores of the two groups of patients were significantly decreased (P<0.05), and the improvement degree of the treatment group was significantly superior to that of the control group (P<0.05). See Table 1.

[0105] Table 1 Analysis of symptom and sign scores of patients in two groups

[0106]

[0107] Note: ^: compared with the same group before treatment, P<0.05; *: compared with treatment group after treatment, P<0.05.

[0108] 3.2 Pittsburgh sleep quality index analysis

[0109] After treatment, the Pittsburgh sleep quality index scores of the two groups of patients were significantly lower than those before treatment (P<0.05), and the decrease in the treatment group was significantly greater than that in the control group (P<0.05). See Table 2.

[0110] Table 2 Analysis of Pittsburgh sleep quality index of patients in two groups

[0111]

[0112] Note: ^: compared with the same group before treatment, P<0.05; *: compared with treatment group after treatment, P<0.05.

[0113] 3.3 Self-rating Anxiety Scale analysis

[0114] After treatment, the self-rating anxiety scores of the two groups of patients showed significant reduction relative to before treatment (P<0.05), and the reduction in the treatment group was significantly greater than that in the control group (P<0.05). See Table 3.

[0115] Table 3 Self-rating Anxiety Scale analysis of the two groups of patients

[0116]

[0117] Note: ^: compared with the same group before treatment, P<0.05; *: compared with the treatment group after treatment, P<0.05.

[0118] 3.4 Quality of Life Scale analysis

[0119] After treatment, the quality of life scores of the two groups of patients showed significant improvement relative to before treatment (P<0.05), and the scores of the patients in the treatment group were significantly higher than those in the control group (P<0.05). See Table 4.

[0120]

[0121] Note: ^: compared with the same group before treatment, P<0.05; *: compared with the treatment group after treatment, P<0.05.

[0122] In summary, the Riyue'anmian Paste combined with ART can effectively reduce the symptom score, Pittsburgh Sleep Quality Index, and self-rating anxiety score of HIV / AIDS patients with insomnia, and can effectively improve the quality of life of patients, with definite curative effect.

[0123] The above-described embodiments only express several embodiments of the present application, and the description is relatively specific and detailed, but it should not be understood as limiting the scope of the patent of the present application. It should be noted that for ordinary skilled persons in the art, without departing from the concept of the present application, several modifications and improvements can be made, which are all within the protection scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

[0124] The above-described only the preferred embodiments of the present application, and does not limit the present application, any modification, equivalent replacement and improvement made within the spirit and principles of the present application, should be included in the protection scope of the present application.

Claims

1. An acupoint sticking traditional Chinese medicine composition for treating AIDS combined with insomnia, characterized in that, The acupoint pasting traditional Chinese medicine composition is composed of six kinds of drugs for time-sharing pasting corresponding to specific acupoints, including Shenjue acupoint daytime pasting drug, Neiguan acupoint daytime pasting drug, Dazhui acupoint daytime pasting drug, Sanyinjiao acupoint night pasting drug, Yunguan acupoint night pasting drug and Shengmen acupoint night pasting drug; The raw material composition of each acupoint pasting drug in parts by weight is as follows: The Shenjue acupoint daytime pasting drug is composed of Angelica 10-30 parts and Astragalus 10-30 parts; The Neiguan acupoint daytime pasting drug is composed of Caulis Polygoni Multiflori 20-50 parts and Albizia 10-30 parts; The Dazhui acupoint daytime pasting drug is composed of Cinnamon 5-15 parts and Acorus 10-30 parts; The Sanyinjiao acupoint night pasting drug is composed of White Peony Root 10-30 parts and Mint 5-15 parts; The Yunguan acupoint night pasting drug is composed of Evodia Rutaecarpa Fine Powder 5-15 parts; The Shengmen acupoint night pasting drug is composed of Platycladus Fine Powder 10-30 parts.

2. The acupoint sticking traditional Chinese medicine composition for treating AIDS combined with insomnia according to claim 1, characterized in that, The raw material composition of each acupoint pasting drug in parts by weight is as follows: The Shenjue acupoint daytime pasting drug is composed of Angelica 20 parts and Astragalus 20 parts; The Neiguan acupoint daytime pasting drug is composed of Caulis Polygoni Multiflori 35 parts and Albizia 15 parts; The Dazhui acupoint daytime pasting drug is composed of Cinnamon 10 parts and Acorus 20 parts; The Sanyinjiao acupoint night pasting drug is composed of White Peony Root 20 parts and Mint 10 parts; The Yunguan acupoint night pasting drug is composed of Evodia Rutaecarpa Fine Powder 10 parts; The Shengmen acupoint night pasting drug is composed of Platycladus Fine Powder 20 parts.

3. An acupoint patch for treating AIDS combined with insomnia, characterized in that, The acupoint paste is prepared from the acupoint pasting traditional Chinese medicine composition for treating AIDS combined with insomnia according to claim 1 or 2.

4. The preparation method of the acupoint patch for treating AIDS combined with insomnia according to claim 3, characterized in that, It comprises: The acupoint pasting traditional Chinese medicine composition for treating AIDS combined with insomnia according to claim 1 or 2 is prepared by weighing each raw material drug according to the formula, removing impurities, washing, drying and then crushing to obtain fine powder of each medicinal material; After mixing Angelica fine powder and Astragalus fine powder evenly, honey is added to make medicine beads, which are placed in the center of the pasting paste to obtain Shenjue acupoint daytime pasting; After mixing Caulis Polygoni Multiflori fine powder and Albizia fine powder, honey is added to make medicine beads, which are placed in the center of the pasting paste to obtain Neiguan acupoint daytime pasting; After mixing Cinnamon fine powder and Acorus fine powder, honey is added to make medicine beads, which are placed in the center of the pasting paste to obtain Dazhui acupoint daytime pasting; After mixing White Peony Root fine powder and Mint fine powder, honey is added to make medicine beads, which are placed in the center of the pasting paste to obtain Sanyinjiao acupoint night pasting; Evodia Rutaecarpa fine powder is mixed with honey to make medicine beads, which are placed in the center of the pasting paste to obtain Yunguan acupoint night pasting; Platycladus fine powder is mixed with honey to make medicine beads, which are placed in the center of the pasting paste to obtain Shengmen acupoint night pasting.

5. The preparation method of the acupoint patch for treating AIDS combined with insomnia according to claim 4, characterized in that, The water content of the medicinal material is controlled to be less than 5% after drying treatment.

6. The preparation method of the acupoint patch for treating AIDS combined with insomnia according to claim 4, characterized in that, The fine powder of the crushed medicinal material is passed through a 100-mesh sieve.

7. The preparation method of the acupoint patch for treating AIDS combined with insomnia according to claim 4, characterized in that, The weight ratio of honey to corresponding medicinal material fine powder is 3:

4.

8. The preparation method of the acupoint patch for treating AIDS combined with insomnia according to claim 4, characterized in that, The diameter of the medicine beads is 1-2 cm.

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