| [Objective]Type 2 diabetes is a common and frequently-occurring disease worldwide, the incidence rate increased year after year, has become a serious hazard to human health of major diseases. Diabetes Control and Complications trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS) two large-scale clinical trial research shows that incipient Type 2 Diabetes remaining 50 percent of theβ-cell function. If trying to let the remaining 50 per cent of theβ-cell function fully play its role, we must start insulin therapy as soon as possible. Insulin glargine is a convenient, safe and effective alternative formulations of insulin. In the clinical, incipient Type 2 Diabetes with Deficient Qi and Yin combined blood stasis both the most common symptoms are most prominent.The purpose of this study is to observe and verify the clinical effect of a combination treatment of traditional Chinese medicine and western medicine for incipient Type 2 Diabetes having the pattern of "Deficient Qi and Yin combined blood stasis" . Meanwhile, concerns on improving treatment safety and promoting patients' compliance. This study also provides a optimized and reasonable treatment protocols to reduce the incidence of hypoglycemia and a better treatment to promote patients' compliance.[Method]According to the WHO diagnose and traditional Chinese Medicine dialectical standard, 90 incipient T2DM patients were chosen from in-and-out patients coming from endocrinology department in the Chinese medical hospital of GuangDong Province from October of 2006 to October of 2007. These selected patients were randomly divided into 3 groups (Group A, B, C). After 2 weeks' foundational diabetic treatment, Group A was given insulin glargine(Lai Deshi) and Metformin in addition (30 patients, 3 patients dropped out); Group B was given premixed insulin HUMALOG 25 and Metformin additionally; Group C was given insulin glargine(Lai Deshi), Metformin and a traditional Chinese medicine recipe nourishing Qi-Yin and activating Blood additional(30 patients, 2 patients dropped out), and all of the three groups separately received each kind of treatment mentioned above for 3 months. Sex, age, weight index of patients in each group were measured statistically, and there were no significant difference(P>0. 05), which meant the comparison between groups. Observation indexes include clinical syndromes, fasting plasma glucose (FPG), 2h plasma glucose (2hPG), glycosylated hemoglobin (HbAlc), fasting C peptide, blood coagulation, blood lipid. The incidence of hypoglycemia, integration calculating worry of using insulin and patients' compliance were compared. Meanwhile, the change of general physical examination items such as three routine tests (Blood Routine Test, Urine Routine Test, Stool Routine Test), Hepatic and Renal Function, Electrical Cardiogram were observed before and after treatment.[Results]After 3 months' treatment, clinical symptom, FPG, 2hPG, FINS, HbAlc,fasting c peptide, blood lipid and blood coagulation improve parentally comparing with pre- treatment (P<0. 01 or P<0. 05). Variation of observation indexes in C group pre-and-post treatment has significant difference comparing with A and B groups. In terms of the incidence of hypoglycemia, integration calculating worry of using insulin and patients' compliance, A and C groups have significant difference comparing with B group.The safety indexes demonstrated no evident differences before and after the treatment, and no adverse side effects were reported.[Conclusion]In this study, the combination treatment of Traditional Chinese Medicine and Western Medicine includes basic insulin treatment and a traditional Chinese medicine recipe nourishing Qi-and-Yin and activating blood. For incipient Type 2 Diabetes having the pattern of "Deficient Qi and Yin combined blood stasis" , this combination treatment can obviously improve patients' clinical syndrome, improve hypercoagulability and hyperlipidemia status as well as decrease FPG, 2hPG, HbAlc, raise the level of fasting C peptide, thus improve patients' living quality. When the method was used clinically, no adverse effect was reported. Therefore, the clinical use of qi-reinforcing and yin nourishing,blood activating Chinese medicine is safe.
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