Description for medicine or protocol of treatment in detail:
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1. Components of swelling relieving pain plaster :
Artemisia scoparia, menthol, water vine.
2. Traditional Chinese medicine powder :
White mustard, asarum, ginger, mirabilite, calamus, Chuanxiong.
3. Treatment plan :
( 1 ) Preparation of paste
1. Test drugs :
The raw materials of swelling relieving pain paste and powder were provided by Yabao Pharmaceutical Group Co., Ltd. Specification : 0.4 g / patch, 2 mL / branch ; usage : acupoint application. Storage method : sealed, room temperature storage.
2. placebos
The placebo patch was prepared by Yabao Pharmaceutical Group Co., Ltd. According to the color and odor of Xiaozhongzhitong patch, the artemisia seed cake, liquid and powder of traditional Chinese medicine were prepared by caramel and excipients to form the placebo patch with the same color, shape and odor as Xiaozhongzhitong patch, without the effective components of traditional Chinese medicine, and the specifications, usage and preservation methods were consistent with those of the test drugs.
( 2 ) Screening before grouping
1. Compliance with diagnostic criteria and inclusion criteria ;
2. Signing of an informed consent ;
3. Perfect basic information : general information, diagnosis and treatment history of postherpetic neuralgia, past medical history and other existing medical history, surgical history, allergic history, etc.
4.Perfect baseline examination : physical examination and blood routine, urine routine, stool routine, liver and kidney function, electrocardiogram before enrollment.
( 3 ) Group treatment
In this study, a randomized controlled design was used to strictly follow the diagnostic criteria and the inclusion criteria of research design for postherpetic neuralgia. A total of 134 patients with postherpetic neuralgia who were willing to participate in this study and the screening results were positive were selected. The treatment methods were Xiaozhong Zhitong plaster + Chinese medicine powder or placebo plaster + placebo powder .
After the patients were enrolled, the informed consent was signed, and the researchers trained the patients for 3 days in application storage, use methods, possible adverse reactions and corresponding treatment methods. The patients also joined the WeChat communication group of the subjects, and the SDP operation videos were regularly shared within the group. The subjects needed to upload the daily medication in the form of video cards to the WeChat communication group. Ensure accurate positioning of patients, familiar with the application process and methods, improve patient compliance.
1. Acupoint selection
According to the national standard of the People 's Republic of China 's name and location of acupoints ' GB / T12346-2006, Sanyinjiao and Shenque acupoints were selected ; according to the People ' s Health Press ' 13th Five-Year ' planning textbook ' meridian acupoints ' selected Ashi points.
Sanyinjiao point : in the medial leg, medial malleolus tip3inches, posterior tibial medial edge.
Shenque point : in the umbilical area, umbilical center.
Ashi point : press or other reaction point positioning, select two.
2.Intervention measures
The patients in the experimental group and the control group were given health knowledge education of postherpetic neuralgia, including low salt diet, light diet, regular work and rest, smoking cessation and alcohol restriction, moderate exercise, etc. The experimental group was treated with Xiaozhong Zhitong paste + Chinese medicine fine powder acupoint application, and the control group was treated with placebo paste + placebo fine powder acupoint application.
3.Sticking process
3.1 Process of outpatient application
( 1 ) Preparation before modulation
Xiaozhong Zhitong Patch, Xiaozhong Zhitong Patch placebo patch, Chinese medicine powder, placebo Chinese medicine powder, medical disinfection cotton swab, 75 % medical alcohol / iodophor disinfectant, 5ml disposable syringe, dispensing bowl, dispensing spoon, palm scale ( model : XSZC-01 ) ; manufacturer : Kaifeng Group Co., Ltd. ), sealed bags.
( 2 ) Ding point : in turn to find Sanyinjiao point ( bilateral ), Ashi point ( 2 ), Shenque point.
( 3 ) Application method
① Dispensing powder
Dosage of each point : Sanyinjiao ( unilateral amount ) asarum, white mustard 0.25 g, Ashi ( unilateral amount ) galanga, mirabilite 0.25 g, Shenque Shichangpu, Chuanxiong 0.25 g. The powder was stored in a 50g brown bottle and labeled as ' group A asarum ', ' group A white mustard ', ' group A galanga ', ' group A mirabilite ', ' group A calamus ', ' group A Rhizoma Chuanxiong ', ' group B asarum ', ' group B white mustard ', ' group B galanga ', ' group B mirabilite ', ' group B Rhizoma Chuanxiong '. ( A group or B group is the test group powder or control group powder. )
Put two kinds of powder for each hole in the same sealed bag in advance. Taking ' Ashi point ' as an example, brown bottles marked with ' group A galange ', ' group A mirabilite ' or ' group B galange ' and ' group B mirabilite ' were selected and weighed by palm scale. Each 0.25 g powder was loaded into a sealed bag called ' Ashi point ' and mixed. The cave ahead.
② Application operation
A. Preparation of drug paste : Uncovering the anti-tumescence and pain paste backing note, using5ml syringe to extract about2 / 3of the anti-tumescence and pain liquid, from the center to the surrounding spiral evenly sprayed to artemisia seed paste, the edge of about2mm drying range, to prevent the loss of liquid. Open the sealed bag marked ' Ashi point ', pour its powder into the prepared small bowl, and add about 1 / 3 of the remaining swelling analgesic solution, single direction rotation stirring, modulation for half flow paste. The prepared slurry was placed in the center of the patch sprayed with good solution and evenly spread to the wet area of the patch for further use.
B. Skin cleaning and disinfection : 75 % medical alcohol / iodophor disinfectant was dipped into the disinfection cotton swab to wipe Sanyinjiao acupoint and its surrounding parts, on the one hand, it can play a role in local disinfection and remove skin debris on the surface of the skin, in order to prevent sticky ; on the other hand, alcohol / iodophor can be used to remove the skin surface sebum to facilitate the absorption of drug ingredients in the patch and accelerate the onset time.
C. Patching fixed method : the modulation of the drug paste is aligned to the acupoint, gently pull the edge of the film, maintain appropriate elasticity, from bottom to top acupoint application, to avoid the drops of the slurry. Select the corresponding points of powder in Shenque acupoint with the same operation steps.
D. Application time : Ashi point ( 2 ), Shenque point, once a day, 6-8 hours each time. Sanyinjiao ( bilateral ), once a week, 30min each time.
3 Course of treatment : 2 weeks for a course of treatment, a total of 2 courses of treatment.
4. Notes
( 1 ) The subjects need to go to the outpatient operation in the first two weeks of the treatment period, and train the application operation process and standardize the operation steps. After 2 weeks of application, the patients apply Ashi point ( 2 points ) and Shenque point at home. Sanyinjiao ( bilateral ) was operated at the clinic at each follow-up.
( 2 ) Protect the application site and ensure the close contact between the patch and the skin to prevent the patch from falling in advance ;
( 3 ) Due to the characteristics of acupoint application, local skin can appear red tide, burning, prickle, itching and skin pigmentation reactions, some patients can also appear small blisters, few may appear large blisters. After acupoint application, if the local skin appears red tide, burning, prickle, itching, small blisters and pigmentation, etc., belongs to the normal response of the therapy, generally do not need special treatment ; a small number of patients with large blisters need to contact the doctor of the research group in the hospital, or to the nearby hospital. The doctor uses disinfection needles to break the bottom of the blister, drains the liquid, and after disinfection, uses sterile gauze for external use to prevent infection. For self-broken blisters, avoid scratching, can be applied scald ointment, wanhua oil, erythromycin ointment to protect the wound. If a very small number of patients have skin infection, they need to be in hospital in time for treatment.
( 4 ) Diet mainly light, avoid cold and spicy, high protein and stimulating food, such as milk, fruit, fried food, etc., so as not to affect the curative effect ;
( 5 ) Apply according to the doctor s advice according to the course of treatment.
5. Record of adverse reactions
Before and after the application, the patients could observe whether there were any abnormal reactions such as redness and swelling, rash, ulceration, blisters and itching on the skin at the coating site. If abnormal reactions occur, they should be reflected to the researchers in time to take relevant intervention measures.
6. Combined medication
( 1 ) In addition to prescribed medications, no other medications for postherpetic neuralgia shall be used during the trial, and analgesics may be taken when the pain is serious, subject to truthful records ;
( 2 ) The drug name ( or other therapy ), usage, dosage and time should be recorded in detail in order to analyze and report when summarizing the drugs or other treatments that must be continued to be used before the beginning of the test, i. e., those that have combined diseases or symptoms ( except symptoms of this disease ) ;
( 3 ) Any combined disease after the start of the test should be recorded in the adverse event table in detail as adverse events ; the drugs used were recorded in the ' combined medication ' table.
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