ABSTRACT
This study systematically sorted out the existing studies about Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), and conducted comprehensive clinical evaluation through "6+1" dimensions of safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM) to embody the advantages and characteristics and clarify the precise clinical position of Tianshu Capsules. The value of each dimension was calculated via health technology assessment, the multi-criteria decision analysis(MCDA) mo-del and CSC v2.0 software. The results were graded into four levels of A, B, C, or D from high to low. According to the available studies, Tianshu Capsules had low and controllable risks, with the safety rated as A. The drug has obvious clinical significance in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), with the effectiveness rated as A. It has clear economic results, with the economy rated as B. The clinical innovation, service system innovation, and industrial innovation are all good, and thus the innovation of Tianshu Capsules is grade A. The drug can meet clinical medication demand of medical care and patients, and thus its suitability is grade A. In view of the reasonable drug price, affordability, and availability, the accessibility is grade A. The prescription originated from the Daxiong Pills recorded in the classic Comprehensive Recording of Sage-like Benefit. In clinical trials, 4 675 patients have used Tianshu Capsules, which indicates rich experience in human administration, and the characteristics of traditional Chinese medicine is grade B. The statutory drug information complies with national stan-dards, and the non-statutory information is standard and accurate. Based on the comprehensive evaluation results of various dimensions of evidence, the clinical value of Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals and syndrome of ascendant hyperactivity of liver Yang) is class A. According to the Comprehensive Clinical Evaluation Management Guidelines of Drugs(trial version 2021) issued by the National Health Commission of the People's Republic of China, we recommend that Tianshu Capsules treating migraine can be transformed into relevant policy results for clinical medication management according to procedures.
Subject(s)
Humans , Capsules , Liver , Medicine, Chinese Traditional , Migraine Disorders/drug therapy , SyndromeABSTRACT
Objective:To explore the group modules of Chinese medicine and western medicine for the treatment of bronchitis patients with Xiyanping injection based on the real world to provide references for the clinical treatment of bronchitis with Chinese medicine and western medicine. Method:Medical records of 13 874 patients with bronchitis treated by Xiyanping injection were extracted from 29 hospital information systems （HISs） in China，and complex network analysis was carried out using Tabu Search algorithm to obtain the substructure and associated information of core drug combination of Xiyanping injection for the treatment of bronchitis and to analyze clinical medication protocols. Result:Medication protocols for the pathogens of bronchitis are listed below： Xiyanping injection + cefuroxime for bacterial infection. Xiyanping injection + interferon for viral infection. Xiyanping injection + azithromycin for mycoplasma infection. According to the clinical symptoms and complications of bronchitis， the appropriate medication protocols were as follows： Xiyanping injection + ambroxol + Feilike mixture + ibuprofen for uncomplicated bronchitis. Xiyanping injection + ipratropium bromide + budesonide + salbutamol for asthmatic bronchitis. Xiyanping injection + mannitol + furosemide + phenobarbital + gangliosides + immunoglobulin for bronchitis complicated with viral encephalitis. Xiyanping injection + creatine phosphate sodium + vitamin C for bronchitis complicated with viral myocarditis. The combined medication of Chinese medicine for the treatment of bronchitis was adopted based on its characteristics of traditional Chinese medicine. Conclusion:The data of this study were derived from the real world. The combined medications protocols of Xiyanping injection targeting the clinical symptoms and complications of bronchitis were extracted and summarized. However， it is necessary to formulate an individualized medication protocol according to the specific condition.
ABSTRACT
At present, the value evaluation of Chinese patent medicines is in the exploratory stage, and a clinical value evaluation system that can reflect the characteristics of traditional Chinese medicine has not been established. This article investigates four universal drug value tools from abroad, namely, evidence rating matrix, cancer value label, patient-perspective value framework and multiple criteria decision analysis advance value framework. The evidence rating matrix is used to measure the benefits and risks of different treatment measures, and the net health benefit is used as the best estimate point to evaluate the value of treatment; the cancer value label is mainly used to weigh the economic value and innovative value of drug treatment programs of different anti-tumor drugs by matrix composed the ratio between the expected result and the cost; the patient-perspective value framework emphasizes the evaluation of the value of different healthcare intervention methods from the patient's perspective; multiple criteria decision analysis advance value framework measures the value of drugs or measures from multiple dimensions. Combined with the characteristics of the above universal drug value evaluation tools and the correlation research of domestic drug value evaluation, the paper proposes to analyze the characteristics of Chinese patent medicine value evaluation from the six dimensions of effectiveness, safety, innovation, economy, suitability and accessibility of Chinese patent medicine, and expounds the strategy of constructing Chinese patent medicine value evaluation tool, so as to provide reference for the drug value evaluation and decision-making application of Chinese patent medicine.
Subject(s)
Humans , China , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Nonprescription DrugsABSTRACT
To analyze the clinincal application characteristics of Xiyanping Injection in real world. The data of the patients came from the hospital information systerm(HIS) of 29 tertiary hospitals in China from 2006 to 2016. It included three parts about basic information, Western medicine diagnosis information, and doctor advice information. The exploration was conducted for the characteristics of the patients and disease distribution as well as the therapeutic regimen. Apriori algorithm was adopted to establish the models, and Clementing 12.0 was used for a correlation analysis of the comprehensive therapeutic regimen of Xiyanping Injection. There were 194 873 cases in the study. The male to female ratio was 1.44∶1. The median age was 4 years old. The median daily dosage was 200 mg. 46.68% of the patients were administered with 250-500 mg, and 33.07% were 50-100 mg one day. 47.08% of the patients were administered for 4-7 d, and 32.65% of the patients were 1-3 d. In the doctor advice information, the most frequently types of Western medicine, traditional Chinese medicine were mucilagin, heat-clearing agent. Second generation cephalosporins, third generation cephalosporins, compound penicillin were the most common types of antibiotic. Interferon, nucleoside and nucleotide, human immunoglobulin were the most common types of antiviral drug. The mining association rules results were analyzed, finding the application of Xiyanping Injection in severe infectious diseases. To improve respiratory symptoms, Xiyanping Injection treaments were Budesonide + Ipratropium Bromide + Ambroxol. To severe pulmonary infection, the treaments were Dopamine + Ambroxine. To severe hand, foot and mouth disease, the treatments were Namefen + Mannitol. To pulmonary heart failure, the treatments were Dobutamine + Heparin. Based on the results of the real world HIS, we could provide clinical application the idea, and a reference for further excavation of the applicable diseases of Xiyanping Injection.
Subject(s)
Child, Preschool , Female , Humans , Male , China , Drugs, Chinese Herbal , Therapeutic Uses , Injections , Medicine, Chinese Traditional , Respiratory Tract Infections , Drug TherapyABSTRACT
BACKGROUND: Osteonecrosis of the femoral head is one of the common forms of senile degenerative osteoarthropathy. The hip preservation surgery techniques that are currently commonly used include femoral head fenestration, debridement and bone grafting through an anterior approach, and debridement and impaction bone grafting with fibula support through a lateral approach with subtrochanter drilling. These two techniques cause great trauma to the patients, and surgery costs are high. Femoral head collapse occurs easily after surgery. The course inhibition of necrosis of the femoral head and repair effect are not ideal. OBJECTIVE: This study hopes to develop a new repair method that can make up for the shortcomings of conventional hip preservation surgery. We will observe the therapeutic effect of fenestration and debridement combined with percutaneous minimally invasive fibula implantation. This low-cost procedure for senile osteonecrosis of the femoral head should have little intraoperative trauma. We will determine if it also prevents postoperative femoral head collapse. METHODS: This is a prospective, multicenter, non-randomized, controlled, clinical trial. Seventy patients (117 hips) with senile degenerative osteonecrosis of the femoral head will be recruited from the Hebei Provincial Youfu Hospital and the Third Hospital of Hebei Medical University, Shijiazhuang, China. The patients will be allocated into three groups according to the repair method. (1) Patients in the drilling debridement group will undergo conventional debridement and impaction bone grafting with fibula support through a lateral approach with subtrochanter drilling. (2) Patients in the fenestration debridement group will undergo conventional femoral head fenestration, debridement, and bone grafting through an anterior approach. (3) Patients in the combination repair group will undergo fenestration, debridement, and impaction bone grafting combined with percutaneous minimally invasive fibula implantation. Each group will include 39 hips. Follow-up will be conducted for 12 months. The primary outcome measure is the incidence of femoral head collapse on the affected side at 12 months after surgery. The secondary outcome measures are intraoperative blood loss, operation time, hospital costs, and Harris hip score for hip function before surgery and 6 and 12 months after surgery and the incidence of adverse reactions at 6 and 12 months after surgery. DISCUSSION: Our results can verify whether the effect of fenestration and debridement combined with percutaneous minimally invasive fibula implantation is better than those of the other two types of conventional hip preservation techniques in the treatment of senile osteonecrosis of the femoral head. In addition, we will validate whether the combined method clearly inhibits postoperative femoral head collapse and improves hip function. This trial has been approved by the Ethics Committee of Third Hospital of Hebei Medical University of China(approval number:KE2016-011-1).The study protocol will be conducted in accordance with the Declaration of Helsinki,formulated by the World Medical Association. Written informed consent will be obtained from all participants. This trial was designed in January 2014. Ethics approval was done in December 2014. The recruitment of subjects will begin in June 2018. Samples and data will be collected from June 2018 to June 2019. Outcome measures will be analyzed in August 2019. This trial will be completed in December 2019. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. This trial had been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR1800015124).