摘要
ObjectiveTo systematically review the studies about Yiqing Capsules in the treatment of pharyngitis， tonsillitis， gingivitis， and oral ulcers with heat-toxin syndrome and clarify the advantages and therapeutic characteristics of Yiqing capsules， thus providing reference for the decision-making by relevant departments and clues for the clinical and basic research. MethodThe multi-criteria decision analysis （MCDA） model and CSC v2.0 were employed to comprehensively evaluate Yiqing capsules from multiple aspects. ResultThe serious adverse reactions in the spontaneous reporting system （SRS） monitoring data of Yiqing capsules included pruritus， rash， an ddiarrhea， all of which were relieved or cured， without aggravation or interhospital transfer for treatment. Literature data showed that the main clinical adverse reactions were abdominal pain， diarrhea， etc. Both acute toxicity and long-term toxicity tests showed good safety， and thus the safety of Yiqing capsules was rated as grade B. The results of Meta-analysis showed that Yiqing capsules used alone or in combination with other medicines outperformed Niuhuang Jiedu capsules or Western medicine in the treatment of pharyngitis， tonsillitis， gingivitis， and oral ulcers with heat toxin in terms of symptom alleviation， disappearance rate of main symptoms， and recurrence rate of aphtha. Pharmacological and pharmacodynamic studies showed that Yiqing capsules had antimicrobial， antiviral， and anti-inflammatory effects， with the effectiveness rated as grade B. The decision tree model was adopted to analyze the incremental cost-effectiveness ratio. With the threshold of 1 fold per capita GDP and the disappearing rate of pain in gingivitis as the indicator， Yiqing capsules had an economic advantage in the treatment of gingivitis due to heat-toxin compared with Niuhuang Jiedu capsules， and the incremental cost-effectiveness ratio was 0.39 yuan/%， which indicated acceptable cost， with the economy rated as grade B. Yiqing capsules can not only clear heat from Qi aspect but also purge blood fire， serving as the representative prescription of clearing and purging for heat-toxin syndrome. Considering the industrial service system and enterprise innovation， the comprehensive innovation of Yiqing capsules was rated as grade B. Generally， this product does not require personalized treatment plans and features convenient supply， storage， transportation， policy publicity， drug information standards， and easy operation for medical care and patients. The Chinese patent medicine information was complete and in line with national standards， and thus the suitability of Yiqing capsules was rated as grade A. With a low price and good availability and affordability， the accessibility of Yiqing capsules was rated as grade A. The Yiqing capsules prescription， Sanhuang Xiexin decoction， originated from ancient medical books， with rich real-world studies， and thus the traditional Chinese medicine characteristics of Yiqing capsules was rated as grade C. ConclusionThe clinical value of Yiqing capsules was rated as grade B from the "6+1" dimensions， suggesting that it could be conditionally converted into the relevant policy results of basic clinical drug management according to the procedure.
摘要
ObjectiveTo systematically review the existing evidence of Tongxiening（TXN） Granules in the treatment of diarrhea-predominant irritable bowel syndrome （IBS-D） with liver Qi invading spleen syndrome，and evaluate the clinical comprehensive value from the 6+1 dimension，providing references for national medical decision-making，drug clinical application promotion，pharmaceutical services，etc. MethodFollowing the relevant standards of the "Guidelines for the Management of Clinical Evidence and Value Evaluation of Drugs"， a combination of qualitative and quantitative approaches based on evidence-based medicine，questionnaire surveys，pharmacoeconomic evaluation，etc.，was employed. Multi-criteria decision analysis （MCDA） model was employed to comprehensively evaluate the clinical evidence and value of TXN Granules in the treatment of IBS-D with liver Qi invading spleen syndrome from the "6+1" dimensions of effectiveness，safety，economy，innovation，suitability，accessibility， and traditional Chinese medicine （TCM） characteristics Result① Safety： Based on the evaluation of known risks and adequacy of safety evidence， TXN granules were considered to have controllable risks with sufficient safety evidence. ② Effectiveness： Meta-analysis showed that TXN granules combined with probiotics could reduce the intestinal symptom score level of IBS-D patients ［mean difference （MD）=-2.29， 95% confidence interval （CI） （-3.20， -1.38）， P<0.01］， and TXN granules combined with conventional treatments （such as Bifidobacterium triple viable capsules，pinaverium bromide tablets，or trimebutine maleate tablets）effectively improved the comprehensive improvement rate of IBS-D patients ［relative risk （RR）=1.19， 95%CI （1.14，1.25）， P<0.01］. TXN granules significantly improved abdominal pain ［RR=1.99， 95%CI （1.62，2.44）， P < 0.01］ and diarrhea efficacy rate ［RR = 1.56， 95% CI （1.07，2.25）， P<0.05］ in IBS-D patients. TXN granules were comparable to pinaverium bromide tablets in reducing HAMA score ［MD = 0.29， 95% CI （-0.30， 0.88）， P=0.34］， HAMD score ［MD=0.35， 95%CI （-0.31，1.00），P=0.30］， and improving IBS-QOL score ［MD = 0.28， 95%CI （-1.70，2.26）， P=0.78］. Based on the quality of evidence and evidence value assessment of effectiveness， it was considered that there was sufficient evidence of effectiveness for this product. ③ Economy： TXN granules are a national medical insurance category B product. After 5 years of simulation with three kinds of Markov models， it was considered that TXN granules were the advantageous treatment option with stable results and good economy. ④ Innovation： TXN granules adhered to original innovation， conducting research and development from clinical application， product components， and production processes. They have obtained national TCM new drug certificates， first prizes from the China Association of Chinese Medicine for Science and Technology， and excellent awards for Chinese patents， providing sufficient innovative evidence in clinical， corporate， and industrial aspects. ⑤ Suitability： The information service of this drug is comprehensive. The questionnaire survey results showed that this drug was suitable for clinical doctors， nurses， pharmacists， and patients in terms of individual compliance， system， and management across multiple dimensions. The overall assessment showed sufficient evidence of suitability for this product. ⑥ Accessibility： The daily cost of TXN granules accounts for 2.43% of the median disposable daily income of urban residents and 9.26% of rural residents， which is moderate and reasonable compared to similar drugs. There is sufficient evidence of affordability， and it is sold nationwide covering all 31 provinces， municipalities， and autonomous regions， with full accessibility evidence and clear results. TCM characteristics： TXN granules originate from the prescription for treating diarrhea in Danxi's Experiential Therapy. They are derived from classical formulas and have undergone multiple clinical trials involving 5 000 cases since their launch， accumulating a certain amount of human use experience. Based on the principles of evaluating TCM characteristics， TXN granules highlight TCM characteristics. The comprehensive value measured using CSC V2.0 software is 0.83 points based on the results of “6+1” dimensions. ConclusionBased on the evaluation results of TXN granules in various dimensions and the comprehensive evaluation score， it is considered that there is sufficient clinical value evidence for TXN granules in treating IBS-D with liver Qi invading spleen syndrome， which can provide references for clinical decision-making and pharmaceutical management. It is suggested for future research to conduct network Meta-analysis， conduct horizontal comparisons of similar TCM treatments for IBS-D， improve the quality of evidence-based evidence， and fully leverage the clinical value advantages of TXN granules.
摘要
ObjectiveTo comprehensively evaluate the clinical value of Feilike mixture and provide a basis for the allocation of medical resources， rational drug use， and hospital procurement and supply of Chinese patent medicines. MethodWith the data from available studies and provided by drug manufacturers， the methods of evidence-based medicine， pharmacoeconomics， and health technology assessment were employed to construct a multi-criteria decision-making analysis framework from the "6+1" dimensions of safety， effectiveness， economy， innovation， suitability， accessibility， and characteristics of traditional Chinese medicine （TCM）. The clinical evidence and value evaluation software of Chinese patent medicine， CSCv2.0， was used to comprehensively evaluate the clinical value of Feilike mixture. ResultBased on the existing clinical evidence， the following results were obtained. ① Safety： Multi-sources of evidence showed that Feilike mixture had little known risk and sufficient evidence， with the safety rated as grade A， which indicated good safety. ② Effectiveness： The systematic review and Meta-analysis showed that Feilike mixture combined with conventional Western medicine in the treatment of bronchitis shortened the time to disappearance of cough compared with conventional Western medicine alone， with the evidence rated as grade B by the Grading of Recommendations Assessment， Development， and Evaluations （GRADE） system， which indicated high effectiveness. ③ Economy： From the perspective of health system， Feilike mixture combined with conventional Western medicine was more economical than conventional Western medicine alone， and the quality evaluation of pharmacoeconomics rated the economy as grade B. ④ Innovation： Feilike mixture combined with conventional Western medicine improved the clinical treatment effect and had innovation advantages compared with similar drugs. From the aspects of cultivation， identification of medicinal materials， and production， the sufficient supply and safety of medicinal materials can be ensured for Feilike mixture. This medicine was rated as grade B in terms of the medicinal material quality， preparation technology， and patents， which indicated good innovation. ⑤ Suitability： According to the results of the questionnaire survey， the usage of Feilike mixture was easy to be mastered and accepted by doctors and nurses， without special administration time， complex personalized treatment， and special technical and management requirements. It is convenient for patients to use， with convenient supply and storage， and weak influences of policy， publicity， and drug information. Therefore， the suitability of Feilike mixture was rated as grade B. ⑥ Accessibility： Among the similar Chinese patent medicines， Feilike mixture had a moderate price， high production capacity， wide sales coverage， wide coverage of hospitals， sustainable supply of medicinal materials， and low costs of treatment for acute bronchitis， with the accessibility rated as grade A. ⑦ TCM characteristics： Feilike mixture is composed of Scutellariae Radix， Peucedani Radix， Stemonae Radix， Gentianae Rhodanthae Herba， Scleromitrion diffusum， Firmiana platanifolia Radix， and Aster ageratoides， with reasonable compatibility. This formula is derived from the medical experience of Miao ethnic group， with rich experience in human use and the TCM characteristics rated as grade B. According to the evaluation results in the "6+1" dimensions， Feilike mixture was evaluated as class B， with a high clinical value. ConclusionAccording to the existing clinical evidence， compared with conventional Western medicine alone， Feilike mixture combined with conventional Western medicine demonstrates a high clinical value and prominent TCM characteristics in the treatment of acute bronchitis with phlegm-heat invading lung. It is suggested that it should be translated into the basic clinical drug management policy results according to the conditions.
摘要
ObjectiveTo comprehensively assess the clinical value of Duliang soft capsules in the treatment of migraine with wind-cold blood stasis syndrome， and to provide guidance for national medical decision-making， clinical drug promotion， and pharmaceutical services. MethodThe evaluation of Duliang soft capsules' clinical value was conducted in accordance with the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs （Trial Version， 2021） using a combination of qualitative and quantitative methods. Utilizing the CSC v2.0 software， this study conducted a comprehensive clinical evaluation of Duliang soft capsules across the "6+1" dimensions， including safety pre- and post-market launch， effectiveness in treating migraine， economy （cost-effectiveness）， and innovation， suitability， accessibility， and traditional Chinese medicine （TCM） characteristics in both its technology and clinical applications. ResultSafety： Duliang soft capsules were found to have good safety based on evidence from known adverse reactions （spontaneous reporting system （SRS） data， literature data， etc.）， pre-marketing toxicological research， and post-marketing drug monitoring. Effectiveness： A meta-analysis indicated that the combination of Duliang soft capsules and western medicine was more effective than Western medicine alone in the treatment of migraine. The product's effectiveness was rated as "Best" based on the quality and value of the evidence. Economy： Duliang soft capsules are moderately priced and categorized as a Type B medical insurance product. Economic research indicated that the combination of Western medicine and Duliang soft capsules was more cost-effective than Western medicine alone. The product's economy was rated as "Better". Innovation： Duliang soft capsules， with Angelicae Dahuricae Radix and Chuanxiong Rhizoma as the main components， hold one invention patent and have been awarded the China Patent Excellence Award. The pharmaceutical company has introduced innovative extraction （CO2 supercritical extraction technology） and formulation （soft capsule） processes. The product's innovation was rated as "Better". Suitability： A questionnaire survey on Duliang soft capsules showed that it was well-suited for both patients and healthcare professionals. The product received a comprehensive assessment of suitability through the "Evaluation of Chinese Patent Medicine Information Services". The product's suitability was rated as "Best". Accessibility： Duliang soft capsules are moderately priced， making them accessible and affordable. The product's accessibility was rated as "Good" based on evidence from these three aspects. TCM characteristics： The formulation of Duliang soft capsules can be traced back to WANG Qiu's Selected Formulas from the Praiseworthy Studio （Shi Zhai Bai Yi Xuan Fang） from the Song Dynasty， and it was documented in ZHANG Jiebin's The Complete Works of Zhang Jing-yue （Jing Yue Quan Shu） as "Duliangwan". The product has been extensively studied with over 2000 clinical cases since its market launch， and its TCM characteristics were rated as outstanding with sufficient evidence. ConclusionThe comprehensive clinical value evaluation of Duliang soft capsules demonstrated its high effectiveness， suitability， and accessibility， and outstanding TCM characteristics. The product's safety， economy， and innovation received good ratings. In summary， Duliang soft capsules exhibited significant clinical value and outstanding TCM characteristics， the evidence was sufficient， and the result was confirmed， providing crucial references for clinical decision-making and pharmaceutical management.
摘要
ObjectiveTo construct the evidence body for revision of safety information on package inserts of Chinese patent medicines in post-marketing by taking Xiaoke'an capsules as an example， so as to provide reference for the revision of instructions of Chinese patent medicines in post-marketing. MethodThe construction of the evidence body was guided by the theory of traditional Chinese medicine（TCM） and the Technical Guiding Principles for Revision of Safety Information Items in Instructions for TCMs After Marketing， and 8 categories and 25 specific items were taken as the main body of the evidence body， and information inclusion， integration， screening and improvement were carried out， then expert demonstrations were conducted， and finally modifications were made based on the opinions of the Center for Drug Evaluation to complete the revision of the safety information in the instructions of Xiaoke'an capsules. Result［Adverse reactions］ of Xiaoke'an capsules was revised to "monitoring data show that the following adverse reactions can be seen with this product：individual hypoglycemic reaction reports". ［Contraindications］ was revised to "contraindicated for those allergic to this product and its ingredients". ［Precautions］ was revised to "（1）pregnant women should use with caution， （2）elderly people should consult a physician， （3）people with spleen deficiency and dampness， spleen and stomach deficiency and cold， or those who eat less and have diarrhea should use with caution， （4）this product contains ginseng， should not be taken at the same time with TCM prescriptions or patent medicines containing veratrum and Wulingzhi， （5）pay attention to monitoring blood sugar during medication， （6）if any other discomfort occurs during medication， you should seek medical attention in time". The warning was revised to "use with caution by pregnant women， and pay attention to regular monitoring of blood sugar". ConclusionIn accordance with the content and process of the evidence body for the revision of safety information in the instructions， the revision of the safety information in the instructions of Xiaoke'an capsules has been completed， providing a strong basis for the rational and safe use of medication in the clinic.
摘要
ObjectiveTo systematically review the existing studies on Xueshuantong for injection（lyophilized） in the treatment of acute cerebral infarction（ACI）， and to clarify the clinical value of Xueshuantong for injection（lyophilized） through comprehensive clinical evaluation， so as to promote clinical rational drug use and relevant policy transformation. MethodEvidence of Xueshuantong for injection（lyophilized） in terms of safety， effectiveness， economy， innovation， suitability， accessibility， traditional Chinese medicine（TCM） characteristics（6+1 dimensions） and information service was comprehensively collected. Evidence-based medicine， questionnaire survey， health technology assessment， pharmacoeconomic evaluation and other research methods were used， and the multi-criteria decision analysis model was used to measure each dimension， in order to comprehensively evaluate the clinical value of Xueshuantong for injection（lyophilized）. ResultSpontaneous reporting system， Meta-analysis of adverse reactions， and active safety monitoring study showed that the main adverse reactions of Xueshuantong for injection（lyophilized） were rash， pruritus， chest tightness， headache， dizziness and other general adverse reactions， the incidence of serious adverse reactions was judged to be rare， the known risk was small， the evidence was sufficient， and the safety evaluation was grade A. The results of Meta-analysis showed that Xueshuantong for injection（lyophilized） combined with conventional treatment for ACI was superior to conventional treatment in terms of improving neurological deficit score， improving daily activity score and clinical efficacy， and the effectiveness evaluation was grade B. The results of pharmacoeconomic evaluation showed that Xueshuantong for injection（lyophilized） combined with conventional treatment was relatively economic compared with conventional treatment alone， with the total clinical effective rate as the effect parameter， but the incremental effect was not significant， the economic evaluation was grade B. In addition to ACI and unstable angina of coronary heart disease， the drug also had good clinical efficacy in central retinal vein occlusion， and had a wider range of indications and awarded 16 patents， and its innovation evaluation was grade B. The suitability of medical personnel and patients was good without special technical and management requirements， and the suitability was evaluated as grade B. Xueshuantong for injection（lyophilized） had reasonable price， good affordability， certain prescription restrictions and general availability， the accessibility evaluation was grade B. Since the drug is an injection of effective parts of TCM， no grade evaluation of its TCM characteristics is conducted. The legal and non-legal information evaluation results of Xueshuantong for injection（lyophilized） showed that all the information was complete and in accordance with the requirements of national standards. Based on the grade scores of the 6 dimensions， the clinical comprehensive evaluation of Xueshuantong for injection（lyophilized） in the treatment of ACI was calculated as category B by CSC 2.0. ConclusionThe clinical value of Xueshuantong for injection（lyophilized） is good， and it is suggested that it can be directly translated into relevant policy outcomes for basic clinical medication management.
摘要
ObjectiveTo comprehensively evaluate the clinical value of Jintiange Capsules （JCs） in the treatment of osteoporosis （OP） and clarify the intrinsic advantages and clinical treatment characteristics of JCs， providing references for relevant departments of national health and medicine decision-making and the basis and clues for clinical and basic in-depth research. MethodBased on evidence-based medical evidence， this study integrated quantitative and qualitative methods and combined with questionnaires， official website data， human experience， pharmacoeconomic evaluation， and other research methods. From the effectiveness， safety， economy， innovation， suitability， accessibility， and traditional Chinese medicine （TCM） characteristics of the '6+1' dimension， the clinical evidence and value of JCs in the treatment of OP were comprehensively evaluated， forming the 'clinical evidence and value evaluation index'. The comprehensive evaluation of clinical value was based on the multi-criteria decision analysis framework. The expert meeting method was used to empower each dimension and value index. The clinical evidence and value evaluation software of Chinese patent medicine （CSC v2.0） was used to calculate the total value score， and the clinical advantages of JCs were comprehensively evaluated. ResultBased on randomized controlled clinical studies and systematic review， data analysis of spontaneous reporting system （SRS）， case reports， non-clinical safety studies， etc.， serious adverse drug reactions （ADRs） were reported after the launch of this product monitored by SRS， mainly involving abnormal liver function and adverse reactions of cardiovascular system. Therefore， the safety evidence adequacy of this product should be further improved， and the safety evaluation was Grade B. Meta-analysis showed that JCs were superior to the control group in improving the total clinical effective rate， improving bone mineral density， reducing visual analogue scale （VAS） score， and shortening fracture healing time. Combined with Grading of Recommendations Assessment， Development and Evaluation （GRADE） evidence evaluation， the comprehensive evaluation of effectiveness was Grade A. Pharmacoeconomic evaluation showed that JCs combined with calcium carbonate D3 tablets were more cost-effective than calcium carbonate D3 tablets alone in patients with OP. Compared with Gushukang capsules， JCs had more cost-effectiveness advantages， but the sample size included in the study was small， and the results needed to be verified by further studies. Combined with the results of the Comparative Assessment of Structure Prediction （CASP） evaluation list， the comprehensive economic evaluation was Grade B. JCs were the only bionic medicine of tiger bone in China with all intellectual property rights， with 3 national invention patents. Its process preparation and fingerprint detection had obvious technical advantages. It had innovative advantages in the supply base equipment， medicine resource management， production technology， and other aspects. Thus， its innovative comprehensive evaluation was Grade A. JCs were in capsule dosage form， which was relatively convenient for storage and transportation. The dosage form was suitable for indications， and the usage was easy for patients to grasp and accept. The statutory information and non-statutory information met the national standards. The comprehensive evaluation of suitability was Grade A. JCs did not contain toxic ingredients， had no restrictions on origin and prescription， and had abundant resources of original medicinal materials. The affordability of JCs in the treatment of OP was good in urban areas （14.97%） but not in rural areas （39.76%）. The price was higher than that of similar Chinese patent medicines， and the comprehensive evaluation of availability was Grade B. JCs had a reasonable proportion of natural animal bones， and their composition was basically the same as that of natural tiger bones. After marketing， more than 2 000 cases of real-world clinical research evidence was accumulated， and the comprehensive evaluation of TCM characteristics was Grade B. CSC v2.0 software was used for quantitative synthesis of the '6+1' dimension， and the comprehensive clinical value of JCs in the treatment of OP was Grade A. ConclusionJCs have good clinical value in the treatment of OP， and the TCM characteristics are prominent. It is suggested that JCs can be directly transformed into the related policy results of basic clinical drug management according to procedures.
摘要
ObjectiveTo explore the comprehensive clinical value of Qianlieping capsules in the treatment of chronic prostatitis with damp-heat stasis syndrome， and to provide evidence for the decision-making of clinical basic drug management. MethodBased on the "Guidelines for Comprehensive Clinical Evaluation of Drugs （Trial Version 2021）"， this study systematically reviewed the existing research on the treatment of chronic prostatitis with damp-heat stasis syndrome by Qianlieping capsules. Based on evidence-based medicine， clinical epidemiology， clinical medicine， evidence-based pharmacy， pharmacoeconomics， health statistics， health technology assessment， and other disciplines， the multi-criteria decision analysis model （MCDA） and CSC 2.0 software were used. The six dimensions of safety， effectiveness， economy， innovation， suitability， and accessibility of drugs， as well as traditional Chinese medicine（TCM） characteristics， were comprehensively evaluated qualitatively and quantitatively. ResultIn terms of safety， based on the spontaneous reporting system （SRS） of the National Center for ADR Monitoring， safety literature analysis， pharmacological and toxicological experiment report， and other evidence， the safety grade of Qianlieping capsules was evaluated as grade A， with good safety. In terms of effectiveness， based on the results of pharmacological and pharmacodynamic studies and Meta-analysis， and combined with the value and quality of the evidence for efficacy， the final efficacy grade of Qianlieping capsules was rated as B. In terms of economy， Qianlieping capsules was a class B drug of national medical insurance. Compared with those of similar Chinese patent medicines， the average daily cost of Qianlieping capsules was moderate， and there was no related cost increase during the administration process. Economic research showed that Qianlieping capsules combined with α-receptor blockers were more economical than α-receptor blockers alone. Based on the quality evaluation of economic evidence and the value evaluation of economic evidence， the economic grade of Qianlieping capsules was rated as B. In terms of innovation， Qianlieping capsules were a combination of cold and warm drugs， focusing on clearing heat， detoxifying， removing blood stasis， and relieving pain， with non-toxic medicinal materials. They obtained a number of invention patents. The enterprise service system was perfect， and the quality standard was higher than the international and Chinese standards. The innovation grade of Qianlieping capsules was rated as B. In terms of suitability， the results of the questionnaire survey showed that it had relatively good suitability for clinicians， nurses， pharmacists， and patients who used Qianlieping capsules. The information on Chinese patent medicines was complete and met the requirements of national standards. The suitability grade of Qianlieping capsules was rated as A. In terms of accessibility， Qianlieping capsules were moderately priced and affordable， with sufficient resources of medicinal materials， no shortage of medicinal materials， and good availability. The accessibility grade of Qianlieping capsules was rated as B. In terms of TCM medicine characteristics， the prescription of Qianlieping capsules was derived from Danshen Huoxue Decoction. The original prescription was used for the treatment of chronic prostatitis with blood stasis syndrome. The whole formula was recorded in The Complete Compendium of Fine Formulas （《良方大全》） published by Beijing Publishing Group Co.， Ltd. in 1991 and has been used for more than 30 years. The formula was a combination of warm and cold drugs， attacking pathogens without hurting healthy Qi. The grade of TCM characteristics of Qianlieping capsules was rated as B. ConclusionBased on the above "6+1" dimensions， the comprehensive evaluation result of Qianlieping capsules in the treatment of chronic prostatitis with damp-heat and blood stasis syndrome is grade B， and it is recommended to convert it into the relevant policy results of basic clinical drug management according to the conditions.
摘要
OBJECTIVE To evaluat e the cost-effectiveness of Keluoxin capsule combi ned with chemical medicine in the treatment of diabetic kidney disease （DKD）from the perspective of the whole society. METHODS Six-state Markov model with 1 year cycle and 40 years time horizon was constructed by means of secondary literature review ，medical record analysis of sample hospital and clinical expert consultation. The cost-effectiveness of Keluoxin capsule combined with chemical medicine versus chemical medicine alone for DKD was evaluated by taking the quality-adjusted life year （QALY）as the output index ，setting the discount rate as 5％，and taking one time domestic gross domestic product （GDP）per capita in 2020 of China as the judgement threshold of incremental cost-effectiveness ratio （ICER）. RESULTS Within 40 years，Keluoxin capsule combined with chemical medicine group spent 8 644.09 yuan per capita more than chemical medicine alone group ，and gained more 0.143 QALYs；ICER was 60 460.25 yuan/QALY，which was less than one times GDP per capita of China in 2020（72 447 yuan）. The results of sensitivity analysis showed that the annual days of using Keluoxin capsule ，the health utility value of DKD at early stage had a great influence on the results of cost-effectiveness analysis. The results of probabilistic sensitivity analysis suggested that the basic analysis results of this study were robust. CONCLUSIONS At the current price level ，Keluoxin capsule combined with chemical medicine is more cost-effective to treat DKD than chemical medicine alone. The dosage of Keluoxin capsule and health utility value should be paid attention in specific decision- bjmu.edu.cn making scenarios.
摘要
ObjectiveTo evaluate the efficacy and safety of An'erning granules in the treatment of community-acquired pneumonia in children. MethodA randomized， double-blind， single-simulation， placebo-controlled trial was designed in this study. The children were randomly assigned into an observation group （An'erning granules combined with ceftriaxone sodium） and a control group （An'erning granules placebo combined with ceftriaxone sodium） according to the ratio of 2∶1. The disease cure rate was taken as the main indicator of efficacy， and the safety of An'erning granules was observed. ResultA total of 206 children （137 in the observation group and 69 in the control group） were included in this study. Before treatment， the age， sex， body height， body weight， diagnosis time of pneumonia， and symptom and sign scores had no significant differences between the two groups. After 8 days of continuous medication， the observation group［70.80%（97/137）］ had higher cure rate than the control group［56.52%（39/69）］（χ2=4.17，P<0.05） and total effective rate of chest X-ray ［97.98%（97/99）］ than the control group［86.27%（44/51）］ （χ2=12.98，P<0.01）. The observation group was superior to the control group in the alleviation of TCM syndrome under the condition of 0-3 g dose stratification on day 3 of medication （P<0.01）. The recovery time， time to complete fever abatement， time to fever abatement and expectoration alleviation， rate of conversion to severe case， and reduction in the frequency of antibiotic use showed no significant differences between the two groups. In terms of safety， 13 and 7 adverse events occurred in the observation group and control group， respectively， which were relieved or disappeared after drug withdrawal or symptomatic treatment and showed no significant difference between the two groups. ConclusionIntravenous drip of ceftriaxone sodium combined with An'erning granules is effective in the treatment of community-acquired pneumonia in children. It can accelerate the absorption of pulmonary inflammation， alleviate the clinical symptoms in a short time for young children or the children with mild symptoms， and is safe in clinical application.
摘要
ObjectiveTo evaluate the efficacy and safety of An'erning granules in the treatment of community-acquired pneumonia in children. MethodA randomized， double-blind， single-simulation， placebo-controlled trial was designed in this study. The children were randomly assigned into an observation group （An'erning granules combined with ceftriaxone sodium） and a control group （An'erning granules placebo combined with ceftriaxone sodium） according to the ratio of 2∶1. The disease cure rate was taken as the main indicator of efficacy， and the safety of An'erning granules was observed. ResultA total of 206 children （137 in the observation group and 69 in the control group） were included in this study. Before treatment， the age， sex， body height， body weight， diagnosis time of pneumonia， and symptom and sign scores had no significant differences between the two groups. After 8 days of continuous medication， the observation group［70.80%（97/137）］ had higher cure rate than the control group［56.52%（39/69）］（χ2=4.17，P<0.05） and total effective rate of chest X-ray ［97.98%（97/99）］ than the control group［86.27%（44/51）］ （χ2=12.98，P<0.01）. The observation group was superior to the control group in the alleviation of TCM syndrome under the condition of 0-3 g dose stratification on day 3 of medication （P<0.01）. The recovery time， time to complete fever abatement， time to fever abatement and expectoration alleviation， rate of conversion to severe case， and reduction in the frequency of antibiotic use showed no significant differences between the two groups. In terms of safety， 13 and 7 adverse events occurred in the observation group and control group， respectively， which were relieved or disappeared after drug withdrawal or symptomatic treatment and showed no significant difference between the two groups. ConclusionIntravenous drip of ceftriaxone sodium combined with An'erning granules is effective in the treatment of community-acquired pneumonia in children. It can accelerate the absorption of pulmonary inflammation， alleviate the clinical symptoms in a short time for young children or the children with mild symptoms， and is safe in clinical application.
摘要
ObjectiveTo analyze factors related to the suspected allergic reaction of elememe emulsion injection based on hospital information system. MethodData on cases that used elememe emulsion injection were collected from the information systems of 60 first-class hospitals nationwide. The nested case-control design method was adopted. Finally， 30 cases were included in the suspected allergy group and 120 cases in the control group. SAS 9.3 was employed for descriptive analysis of the gender， age， occupation， admission route， conditions of patients at the admission， and the diagnosis with frequency and percentage. The factors affecting the occurrence of suspected allergic reaction were analyzed by conventional logistic regression and propensity score weighted logistic regression. In the case that the number of independent variables was larger than the sample number， MCP （minimax concave penalty） was used to screen the key variables and the conditions of patients at admission， conditions of patients during hospitalization， hospital stay， diagnostic information， and medication information were compared between two groups. ResultThe male-to-female ratio was about 2∶1 in both groups and most of the patients were 46-65 years old. Patients in the control group were mainly "professional and technical personnel"， and the majority in the suspected allergy group were "business and service personnel" and "clerks and related personnel". They were mainly admitted at the outpatient and conditions of patients were average at the admission. Compared with the control group， suspected allergy group showed severe conditions during the hospitalization， short average hospital stay， large proportion with intravenous infusion， and low cure rate and effective rate. The results of logistic regression analysis showed no statistical difference in conditions of patients at admission， hospital stay， combined diseases， medicine dosage， and treatment course. ConclusionThe suspected allergic reaction of elememe emulsion injection mainly occurs in the first administration with rapid onset even with the dose lower than the commonly used one. The occurrence is related to the intravenous infusion and the severe conditions of patients during hospitalization and has nothing to do with the conditions of patients at admission， hospital stay， treatment course， use of other medicines， and diagnostic information. In summary， it is mainly related to the constitution and immune status of patients.
摘要
ObjectiveTo further assess the safety of clinical application of Shujin Jianyao pills after marketing and find its potential risk factors as early as possible， to obtain the real world medication situation of Shujin Jianyao pills and its incidence of adverse reactions and clinical characteristics， and to explore the factors affecting the occurrence of adverse drug reactions （ADR）. MethodIn this study， prospective， large-sample， multi-center and intensive whole-hospital monitoring with continuous registration was carried out， combined with telephone follow-up visits 2-4 weeks after the end of medication， for whole treatment course monitoring among patients. In addition， the three-level quality control was strictly implemented in the monitoring process. The study used a proprietary electronic data management system for data management， and SAS 9.4 and R software were used for statistical analysis. ResultFrom May 2018 to July 2020， the study completed the safety monitoring of 3 033 patients taking Shujin Jianyao pills in 30 clinical departments of 25 hospitals in China. A total of 36 ADR cases （49 times） were confirmed by expert assessment on data and supervision quality and expert interpretation of ADR. ConclusionAccording to the World Health Organization （WHO）， the symptoms of adverse reactions were mainly classified into occasional adverse reactions （0.1%≤ADR<1%： abdominal distension， oral ulcer， dry mouth， constipation） and rare adverse reactions （0.01%≤ADR<0.1%： loss of appetite， rash， fatigue， increased ALT， increased creatinine， dizziness， stomachache， stomach distension， liver discomfort， pruritus， dysphoria， acid regurgitation， numbness in mouth， abdominal pain， sore throat， earache， tinnitus）. Moreover， through the synthetic minority oversampling technique （SOMTE） combined with logistic regression， the following factors might affect ADR： taking Shujin Jianyao pills for 1-14 days， aged 46-65， 66-80 and 81 and above as well as combined use of atorvastatin， cobamamide， calcitriol capsules， Gushukang capsules， glucosamine， nifedipine， methylcobalamin， metformin， Tenghuang Jiangu pills， Bugu tablets， and diclofenac sodium sustained-release tablets. This study provided a real world basis for the safety and standardized use of Shujin Jianyao pills in clinical practice.
摘要
Objective:To evaluate the clinical effect of Salviae Miltiorrhizae and Ligustrazine Hydrochloride injection on coronary heart disease in real world.Methods:Took the patients data with coronary heart disease of 24 tertiary-class A hospitals’ information system from October 2006 to December 2015 as the research targets. The patients injected by Salviae Miltiorrhizae and Ligustrazine Hydrochloride injection were selected as the observation group, and who were not injected were selected as the control group with ratio of 1:1, the same number on gender, similar age (+5 years difference) and similar condition upon hospitalization. Taking medication efficacy as the outcome evaluation index, the 30 confounding factors in this study were controlled by propensity scores, including hospital admission, co-morbidity, co-medication, occupation, cost category, and total hospitalization costs. Comparative analysis of the effect of Salviae Miltiorrhizae and Ligustrazine Hydrochloride injection on the clinical outcome of coronary heart disease by classical logistic regression and logistic regression weighted by propensity score.Results:30 confounding factors were identified and balanced, and 7 confounding factors were most affected factors that included clopidogrel bisulfate tablets, occupation, inosine tablets, levocarnidine injection, cerebroprotein hydrolysate injection, nitroglycerin and insulin. Both methods of logistic regression demonstrated that patients receiving parenterally administered Salviae Miltiorrhizae and Ligustrazine Hydrochloride injection had improved outcomes compared to those who did not receive the drug ( P<0.05). Conclusions:The study suggestes that the Salviae Miltiorrhizae and Ligustrazine Hydrochloride injection is a potential advantageous therapy in the treatment of coronary heart disease. However, a large amount of unknown confounding variable should be taken into account. Consider this research is a retrospective study, and the results need to be further verified by prospective studies.
摘要
Objective:To analyze the effect of Maixuekang Capsule on the treatment outcome of coronary heart disease (CHD) by propensity score.Methods:Based on the electronic medical record database of 22 large-scale tertiary hospitals nationwide, this study matched the coronary heart disease patients using and not using Maixuekang capsule according to a certain standard (1∶1). After matching, there were 2 464 cases in the patients group (group A) and the patients group (group B). In the database, the recombination of " recovery" and " improvement" is defined as effective treatment, and " invalid" , " death" and " other" are combined as ineffective treatment population. The effectiveness of the two groups after the re combination is compared by propensity score.Results:The results of χ 2 test showed that the difference between the two groups was statistically significant ( P<0.05) without controlling the confounding factors, and the treatment effect of group A was better than that of group B. In order to further observe the difference between the two groups, three logistic regression analysis methods were used to analyze, which showed that the regression coefficient was >0, and there was statistical significance ( P<0.01). Conclusions:The therapeutic effect of Maixuekang capsule on coronary heart disease is higher than that of patients without the drug.
摘要
Traditional Chinese medicine (TCM) syndromes have a certain genetic background. It is of great significance to study the essence of syndromes, and through genetic polymorphism research, the objectification of TCM syndromes can be realized. There are multiple relationships between genetic polymorphisms and TCM syndromes:including the relationship between internal factors and external manifestations, the relationship between macrocosmic view and microcosmic view, and the relationship between objectivity and subjectivity. This article reviews the current research progress on the correlation between genetic polymorphism and TCM syndromes in order to provide some ideas for the objectification of syndromes.
摘要
This paper was aimed to understand the clinical features of traditional Chinese medicine (TCM) through the analysis of relevant information among fracture patients treated by the Cervus and Cucumis Polypeptide Injection (CCPI).The study was conducted among fracture patients treated by CCPI in the hospital information systems (HIS) among 26 national triple-A hospitals from 2003 to 2014.The general information,TCM syndrome and solar term of morbidity were analyzed.The results showed that the number of patients from 45-64 years old were the most,accounting for 39.84％.Among them,the number of male patients from 18-44 years old was the most,accounting for 43.38％;the number of female patients from 45-64 year old was the most,accounting for 44.33％.The main TCM syndrome of admission and discharge was qi stagnation and blood stasis,which accounted for 60.53％ and 53.08％,respectively.Beginning of Summer (7th solar term) and Rain Water (2nd solar term) were solar terms with the most patients,which accounted for 5.26％ and 5.24％,respectively.It was concluded that the majority of fractures patients treated with CCPI were the elderly.The syndrome of qi stagnation and blood stasis was the most.The hospital admission of most patients was at the Beginning of Summer and Rain Water.It provided theoretical basis to pay attention on TCM syndrome differentiation in the treatment of clinical fractures.The treatment should be adapted to the characteristics of the disease itself,the change of solar terms,and dialectical medication.
摘要
Objective To study the real world of bicyclol tablets in the treatment of viral hepatitis and its influence on platelets.Methods The hospital information system (HIS) was selected from 18 Triple-A hospitals in China on patients with bicyclol tablets information as exposed group (2 690 cases),patients with unused bicyclol tablet (2 690 cases) as an exposed group,an exception occurs of platelet as an index of the ending.Results The incidence of abnormal platelet difference in two groups before the treatment were not statistically significant.The incidence of abnormal platelet reduce between two groups have statistical significance,can be thought of exposure of abnormal lower rate (11.75%)lower than that of non exposed group(15.17%) (P<0.01).Conclusion Bicyclol piece have signficantly curative effect on the treatment of viral hepatitis.It shows more safety,and less impact on platelets.It is worth to be used in clinical practice.
摘要
This study was aimed to analyze the clinical application of Fufang Kushen (FFKS) injection in treating colonic malignant tumors in the real world based on the hospital information system (HIS) database,in order to provide references for clinical application of FFKS injection.The electronic medical records were extracted from 3328 patients with colonic malignant tumors using FFKS injection from 22 large-scale triple-A hospitals nationwide based on the data warehouse of HIS established by the Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences.The descriptive analysis of frequency and rate was made on general characteristics,diagnostic characteristics,dosage and characteristics of medication information,characteristics of drug combination,characteristics of discharge outcome and etc.The results showed that the average age of patients treated with FFKS injection for colonic malignant tumors was 61.85 years old,with more males than females.Patients were mainly hospitalized from the department of digestology and oncology.The single dose of medication was usually 10-20 ml.The main course of treatment was 4-7 days.Common clinical medications in combination included Tropisetron injection,thymus peptide injection,oxaliplatin injection,fluorouracil,leucovorin injection and etc.The total efficiency was 39.78％ based on the discharge outcomes.It was concluded that the population characteristics of using FFKS injection to treat colonic malignant tumors were clear and in line with the general rule of colonic malignant tumors.The clinical dosage and scope of FFKS injection in the real world of colonic malignant tumors treatment basically meet the medication instruction.The clinical drug combination type is more extensive.
摘要
This study was aimed to explore the death rule of viral hepatitis patient according to the 24-calendar cycle and time.Information of 40 681 inpatients diagnosed as viral hepatitis from 20 triple-A hospitals in China were collected from December 2003 to August 2011.The death rule of viral hepatitis patient according to the 24-calendar cycle and time was analyzed.It is the first time to put traditional Chinese medicine (TCM) concept of time into survival ending.Its mechanism was explained from the aspects of both TCM and modern medicine.It provided a reference method to combine TCM theory and clinical practice.The results showed that among 40 681 patients,36 547 patients had treatment ending.Among them,386 patients were dead,with the total death rate of 1.06％;308 patients were diagnosed as viral hepatitis B,which was about 79.79％ of the whole dead patients.The proportion of the death time is focused on the Great Heat and the Cold Dew,which is about 6.67％ and 6.4％,respectively.And the percentage of death in the winter is lowest,which is about 3％.The highest percentage of death in one day is Shen-Shi (from 3 pm to 5 pm,23.82％) and You-Shi (from 5 pm to 7 pm,21.78％).It was concluded that the death rule of viral hepatitis patient was at the highest percentage in summer and autumn;that of the spring was the second;and that of the winter was the lowest.In one day,the highest percentage of death lies in Jin-Shi (from 3 pm to 7 pm).