| Backgroud:In China and even in the world,the morbidity of glycolipid metabolic disease is increasing,while its effective control rate is still not ideal,which is a world problem.Professor Guo Jiao of Guangdong Pharmaceutical University focused on the clinical and Experimental Research on the prevention and treatment of glycolipid metabolic diseases by the combination of traditional Chinese and Western medicine for more than 30 years,established a new theory of "glycolipid metabolic diseases(Dan-Zhuo)",formulated a new comprehensive and integrated prevention and control strategy,created a new treatment method of "regulating liver,activating pivot and removing turbidity",and developed a representative prescription,Zhenzhu Tiaozhi Capsule(FTZ),which has been in clinical practice for many years and has the functions of lipid regulation,glucose reduction and anti-atherosclerotic plaque and other multiple effects,but its overall clinical effect characteristics need to be clarified from different angles of glycolipid metabolic disease,using the latest clinical evidence-based research methods,to carry out systematic research.Real-world research(RWS)is rooted in real clinical practice,people-oriented,without strict exclusion criteria,and observes the actual efficacy and adverse reactions of interventions in the process of real clinical practice.Its research mode is consistent with the basic idea of "holistic concept" and "syndrome differentiation and treatment" of TCM,which has great advantages in the study of the efficacy of TCM compound prescriptions.Therefore,this study takes hyperlipidemia,an important component of glycolipid metabolic disease,as an entry point,and uses real-world research methods to clarify the efficacy and effect characteristics of FTZ in the treatment of hyperlipidemia in real medical practice,so as to provide high-quality evidence-based evidence for the precise clinical application of FTZ and the profound interpretation of the scientific connotation of the innovative theory of "glycolipid metabolic Objective1.Through systematic literature review,reveal the current status of Chinese medicine in the treatment of hyperlipidemia,and clarify its advantages and disadvantages.2.Based on the real-world data,through their own pre-and post-control studies,case-control studies,reveal the efficacy and safety of FTZ in patients with hyperlipidemia in terms of blood lipids,TCM syndromes,constitution,quality of life,sleep quality,and explore its effect on combined diabetes,fatty liver,carotid atherosclerosis.The multi-level manifests the effect characteristics of FTZ in treating hyperlipidemia in the real world,provides evidence-based evidence for its clinical application,and provides an effective scheme for the comprehensive treatment of glycolipid metabolic diseases characterized by hyperlipidemia.Method1.Literature research: firstly,the clinical research literatures of hyperlipidemia treated by traditional Chinese medicine included in CNKI,Wanfang database and VIP from the establishment of the database to December 2019 were retrieved.Through the inclusion and exclusion criteria,the literatures finally included in the statistics were screened out,and the descriptive statistical analysis method was used to carry out the statistical analysis of the literatures finally included.2.Clinical research:(1)Obtain cases through the hospital information system,using "Zhenzhu Tiaozhi Capsule" as the search term,and retrieve outpatient or inpatient information including "Zhenzhu Tiaozhi Capsule".Patients who have taken FTZ and met the diagnosis of hyperlipidemia are regarded as the FTZ group,and(2)patients with hyperlipidemia from November 2011 to December 2019 are retrieved,and those who have not taken FTZ are regarded as the control group.(3)Processing data,standardizing data before entering data,and matching FTZ group and control group with PSM method.(4)Data analysis,using IBMSPSS25.0 software to analyze data,to explore the effect characteristics of FTZ in real medical practice.Result1.Literature research results: There are 360 literatures that meet the inclusion and exclusion criteria.Phlegm turbidity repression,phlegm and blood stasis,qi stagnation and blood stasis,liver and kidney yin deficiency,spleen and kidney yang deficiency are common syndromes of hyperlipidemia.The top 5 Chinese medicines for treating hyperlipidemia are hawthorn,Salvia miltiorrhiza,alisma,Polygonum multiflorum and cassia seed.Previous clinical studies have shown that TCM treatment of hyperlipidemia has great advantages in clinical efficacy and safety,but there are also generally low quality literature,mostly small samples of clinical observation,scientific and standardized large-sample RCT studies,real-world studies are still insufficient,in the future to strengthen the high-level evidence-based research.2.Clinical research results:(1)A total of 1171 patients who had taken FTZ were retrieved.Excluding duplicate data in general information,patients who did not meet the diagnosis of hyperlipidemia,patients with incomplete follow-up data,a total of 196 patients were included for statistical analysis.(2)Among 196 people,the middle-aged and elderly(45-74 years old),overweight and abdominal obese were the main groups.Complicated with hypertension,fatty liver,diabetes mellitus,atherosclerotic vascular disease,hyperuricemia,coronary heart disease or more accounted for 97.96%,of which combined with four or more metabolic diseases accounted for 50%.(3)The effective rates of FTZ treatment alone after 1 month,3 months and 6 months were66.15%,82.22% and 85.28%,respectively.After treatment,TC and LDL-C decreased significantly compared with before treatment(P < 0.05,P < 0.01).(4)Patients rebounded significantly after discontinuation of other lipid-lowering drugs and before discontinuation.During the 1-6 months after discontinuation of FTZ,27.27%-35.71% patients’ blood lipids could be effectively controlled.(5)The efficiency of FTZ combined with western medicine after 2 weeks and 1 month of treatment was 82.35% and 85%,respectively;after 2 weeks of treatment,TC,LDL-C and HDL-C had significant difference compared with before treatment(P < 0.05),and after 1month of treatment,TC and HDL-C had significant difference before and after treatment(P < 0.05)(6)In terms of TCM symptoms and constitution,FTZ can significantly improve the TCM symptoms of patients,especially to eliminate or improve the symptoms such as upset,lumbar acid,insomnia,dry mouth and pharynx,while the symptoms of fatigue,fatigue,cold limbs,frequent nocturia can be eliminated or effectively alleviated by FTZ treatment for 6 months,with an effective rate of more than 70%.FTZ can also improve the TCM constitution of patients,especially in young and middle-aged patients.(7)In terms of patients’ quality of life and sleep status,the total scores of patients’ quality of life after FTZ treatment were significantly higher than before,with a statistically significant difference(P < 0.05);after FTZ treatment,patients’ total scores of sleep time,sleep disorders and sleep quality were significantly lower than before treatment,with a statistically significant difference(P < 0.005,P < 0.01).(8)For patients with hyperlipidemia and diabetes mellitus,2h PG decreased significantly after 1 month of treatment compared with before treatment(P < 0.01).(9)For patients with hyperlipidemia and fatty liver,the fat attenuation parameter(FAP)was significantly decreased after treatment compared with before treatment(P <0.05).(10)The left carotid intima-media thickness(IMT)tended to decrease compared with that before treatment,but there was no statistical difference.(11)Both the FTZ group and the conventional treatment group could significantly reduce the level of TC and LDL-C(P < 0.05,P < 0.01),and there was no statistical difference between the groups after treatment.There was no significant difference in total effective rate between the two groups.＿In terms of safety,there were no obvious adverse reactions in FTZ group,while in the control group,after treatment,there were 2 cases with ALT more than 3 times the normal upper limit and 1 case with AST more than 3 times the normal upper limit.Discussion1.FTZ has clear lipid-regulating effect,which can significantly reduce the levels of cholesterol and low-density lipoprotein.With the prolongation of medication time,its efficacy tends to be stable.Compared with the conventional treatment group,there was no significant difference in the total effective rate of lipid lowering.For patients who take statin and other Western medicines with poor lipid-lowering effect,the combination of FTZ can improve the clinical efficacy.2.FTZ not only reduces lipid,but also takes into account the function of lowering blood glucose and reducing the attenuation index of liver fat.In addition,FTZ can also improve patients’ TCM symptoms,regulate TCM constitution,and improve patients’ quality of life and sleep.3.FTZ has good safety and no toxic side effects in clinical application. |
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