| Qingre Jiangzhuo treatment is one of basic therapies intreating type2diabetes, obesity, hyperlipidemia. Obese type2diabetes has the basic pathogenesis of "zhongman neire", and is of "pidan" category. Obesity, type2diabetes, hyperlipidemia belong to metabolic syndrome, included to "Gaozhuo disease"Objective:Research the effectiveness of Qingre Jiangzhuo treatment in treating type2diabetes: This study search from ancient literature about definition of "gao","zhuo"related to metabolic diseases, provided the basis theory of "Gaozhuo disease". Through real world research method, observinig outpatient, study the function and characteristics of Qingre Jiangzhuo treatment in treatment of reducing blood glucose, weight loss, regulating blood lipids. Based on the Qingre Jiangzhuo treatment and Dahuang Huanglian Xiexin formula, we set a formula named Jiangtang tiaozhi formula. We assess the effectiveness of Jiangtang tiaozhi formula, through randomized, controlled clinical study of the treatment of obese type2diabetes with hyperlipidemia (gastrointestinal excess heat syndrome).Methods:1. This study used "gao","zhuo" as key words to search the discussion of "gaozhuo disease" in ancient literature through electronic books, looking for record about the"gao" and "zhuo"(metabolic disease). Then classified and summarized symptoms, etiology, pathogenesis, disease definition from the preliminary literature.2. Based on real-world approach, cored to clinical outpatient, this study recorded the whole process of treatment, and established inclusion criteria, but didn’t set up exclusion criteria. We sorted out data from professor Tong’s outpatients in2013, included183cases of patients with type2diabetes,678clinic times, and those including patients took Qingre Jiangzhuo prescription at least for three months. According to the patient’s basic information, diabetic duration, concomitant medications, blood glucose, glycosylated, the main symptoms, this study analyses the effectiveness and characteristics of Qingre Jiangzhuo treatment in type2diabetes.3. Based on the theory of controlling weight, blood glucose, glycolipids, the approach of Qingre Jiangzhuo as the core, and using Dahuang Huanglian Xiexin decoction as the basic formula, this study screened from formed effective medical records, composed Jiangtang Tiaozhi formula. Using community screening methods, we screened onset overweight type2diabetes patients with hyperlipidemia. We used randomized, positive-controlled, open-label clinical study design, divided participants into treatment group (Jiangtang Tiaozhi formula) and the control group (metformin tablets), and intervened obese type2diabetes patients with hyperlipidemia. After4weeks of screening and24weeks intervention, we assessed the effect of glycosylated hemoglobin, blood glucose, blood lipids, insulin resistance, weight-loss, waistline-reduction, hipline-reduction and other main symptoms. Through evidence-based medicine approach, this research evaluated the function of traditional Chinese medicine in blood glucose reduction, weight-loss, regulating blood lipids.Results:1. Preliminary analysis from historical medicine records:(1)"Gao zhuo" theory was put forward in the "The Inner Canon of Huangdi", enriched in the Ming and Qing Dynasties.(2)The definition of "gao","zhuo" in later dynasties was same as in the "The Inner Canon of Huangdi".Gao means over-fat diets, zhuo means disorders of qi moving caused by spleen and stomach complaints. Gao and zhuo are etiology, pathology products, but also can be used to explain the pathogenesis.(3)Diabetes is closely related with "gao" and "zhuo". For example, Chen pengchen and Ye tianshi both propose this idea.(4)The "gaozhuo’"s pathogenesis, etiology, and main symptoms were proposed in ancient times.(5)The treatment of "gaozhuo"was proposed in old times. For example, Zhao Xianke suggested treating with spleen and stomach, Shen Yuan agreed using reduce heat, and Li Yongcui accounted move liver qi, remove sperm and heat.2. Findings from outpatient observation about Qingre Jiangzhuo approach in real-world research:(1) Qingre Jiangzhuo approach can effectively reduce blood glucose in patients with type2diabetes, cholesterol, body weight, and the main symptoms. Intervention in three months, six months later, Qingre Jiangzhuo approach can effectively reduce type2diabetic population glycosylated hemoglobin, fasting blood glucose, postprandial blood glucose; able to reduce total cholesterol triglycerides, low-density lipoprotein, increased high-density lipoprotein in type2diabetic patients with hyperlipidemia; reduce body mass index in obesity and overweight patients. Therefore, preliminary studies have shown that Qingre Jiangzhuo approach has effect on hypoglycemic, weight loss, lipids. Meanwhile, Qingre Jiangzhuo approach can effectively relieve fatigue, constipation, insomnia, then sticky smelly stool, irritability, sweating which are the main symptoms in type2diabetes gastrointestinal heat and intestinal damp and heat.(2)Qingre Jiangzhuo approach has the main herbs of huanglian, zhimu, shengjiang/ganjiang, shengdahuang/jiudahuang, hongqu, xiyangshen, huangqin, tianhuafen, banxia, and so on. Huanglian can reduce stomach and intestinal heat, it is the most bitter and cold herb, and has the most frequently using in this study. Xiyangshen, tianhuafen, gegen are also used more frequently to supplement qi and yin, dahuang is used for moving stool; shengjiang and ganjiang were served with bitter cold herbs to reduce their drawbacks; banxia and gualouren were for zhuo which has typical symptoms of greasy tongue, tianma, xiakucao, gouteng, baishao were for liver heat and windy; hongqu, danshen, heye, wancansha were for reducing blood lipids; yinchen, wuweizi, shengshanzha, honghua, chishao, sani can move blood and reduce zhuo in treating fatty liver disease; danshen, sanqi, chishao can protect vascular for prevention of diabetic complications.(3)Huanglian is the corn herb of Qingre Jiangzhuo approach to treat type2diabetes, and its dose was associated with a variety of factors. Qingre Jiangzhuo approach was based on dahuang huanglian xiexin formula, and huanglian was the king of Qingre Jiangzhuo approach. Its dose range was from1to45g from the experience of professor Tong Xaolin. From this real-world study, we found that so many factors influent the dose of huanglian, like age, duration of diabetes, BMI, fasting blood glucose, glycosylated hemoglobin values, other medicine, therapeutic purposes and so on. Look forward to further study of expanding the samples, research the correlation between factors and the dose of huanglian for the treatment of type2diabetes.3.clinical study of treating type2diabetes with obesity and hyper lipids (gastrointestinal heat syndrome) with Jiangtang tiaozhi formula results showed that: Jiangtang tiaozhi formula was used for type2diabetes with obesity and hyper lipids (gastrointestinal heat syndrome) patients. Our study shows that Jiangtang tiaozhi formula can reduce glycosylated hemoglobin0.39%in12-week, and using this added herbs formula can reduce HbAlc0.46%in24-week. This study also shows Jiangtangtiaozhi fomula can reduce fasting blood glucose, postprandial blood glucose, waistline, but the effect on triglycerides is weak which may be the reason that this study was only a part of participants in our hospital (total number of cases450cases).Conclusions:1.Gaozhuo disease theory began from "The Inner Canon of Huangdi", was more plenty in the Ming and Qing Dynasties, which was closely related to Diabetes, the ancient books presented its etiology, pathogenesis and treatment method.2. Qingre Jiangzhuo approach is one of the basic treatment of type2diabetes, which can effectively reduce type2diabetes patients’s glycated hemoglobin, fasting glucose, body mass index, triglycerides, total cholesterol and other indicators.3. Huanglian is the main herb of Qingre Jiangzhuo approach, and its dosage is related with patient’s age, duration of diabetes, combined with hypoglycemic drugs, treatment purposes, glycated hemoglobin, body mass index and other factors.4. Jiangtang tiaozhi formula has the comprehensive function of treating type2diabetes with obesity and hyper lipids (gastrointestinal heat syndrome) population, reducing high blood sugar and weight-loss.But its effect of reducing triglycerides is weak. |
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