| Objective: According to the clinic observation and analysis, this article aims at objectively accessing the clinical efficacy and safety of the self-created prescription as well as further exploring its possible mechanism. Organized under the guidance of principle of invigorating the spleen,removing dampness and blood stasis, this formula especially suits the case of type 2 pre-diabetes.Methods: This study collected 90 patients(from May 2014 to October 2015) from the endocrinology department and VIP clinic of affiliated hospital of Shanxi University of Traditional Chinese Medicine and Hui Feng community hospital of Jiancaoping District in Taiyuan. These patients were diagnosed with type 2 pre-diabetes and belonged to deficiency in the spleen syndrome, specifically phlegm-dampness and blood stasis. Then,they were equally categorized into experimental group, herb medicine control group and western medicine control group at random, with 30 patients each. Patients among the experimental group were given the self-created prescription(one parcel, bid); patients among the herb medicine control group were given Shen Qi Jiang Tang Jiao Nang(3 pills,tid); and patients among the western medicine control group were given Metformin Hydrochloride Enteric-coated Tablets(250 mg, tid). The treatment lasted for three months and during this period the following parameters were recorded, including BMI, symptoms,fast plasma glucose(FPG), 2-hour postprandial blood glucose(2hPG),glycated hemoglobin(HbA1c), insulin release level, lipid, insulin resistance and so on. And then,these data were statistical analyzed by SPSS21.0.Results: 1. After three months, BMI, clinical symptom credits of patients in the experimental group show a big difference in comparison with condition before treatment(P<0.01). What's more, they demonstrate a significant difference compared with that of western medicine group.(P<0.05).And compared with western medicine group, clinical symptoms of experimental group such as languid, abdominal distention and anorexia, chest tightness, thirst without desire to drinking, sticky stool, frequent nocturia and tongue pictures are also significantly improved(P<0.05).2. After three months, fast plasma glucose(FPG), 2-hour postprandial blood glucose(2hPG), glycated hemoglobin(HbA1c), insulin resistance index(HOMA-IR) of patients in experimental group show a big difference in comparison with condition before treatment(P<0.01). Moreover, FPG, 2hPG, HOMA-IR of patients in experimental group demonstrate a significant difference compared with that of western medicine group(P<0.05). Also, HbA1 c, HOMA-IR of patients in experimental group are greatly improved compared with that of herb medicine group(P<0.05).3. After three months, total cholesterol(CHO), triglycerides(TG), high-density lipoprotein(HDL-L) and low-density lipoprotein(LDL-L) index of patients in experimental group show a big difference in comparison with condition before treatment and that ofwestern medicine group(P<0.01). Besides, they demonstrate a significant difference compared with that of herb medicine group(P<0.05). However, HDL-L index of patients in western medicine group don't reduce.(P>0.05).4. Security indicators(such as blood routine, liver and kidney parameters) show no big statistical difference in comparison with condition before treatment.Conclusion: It is significantly effective to treat type 2 pre-diabetes belonging to spleen deficiency with phlegm-dampness and blood stasis syndrome under the guidance of principle of invigorating the spleen, removing dampness and blood stasis. It contributes to decrease blood sugar, BMI index and lipid level and improve insulin resistance and relieve clinical symptoms. Besides, this method can delay the procedure of IGR to DM. Moreover,without serious side effects, this method may have a broad prospect in the area of TCM treating type 2 pre-diabetes and worth to be generalized. |
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