Injection of insulin with needle free syringe can bring better injection feeling treatment effect to diabetic patients, the patients do have subcutaneous induration after insulin injection, the risk of hypoglycemia has increased. " Recently, at the 79th Annual Meeting of the American Diabetes Society held in San Francisco, USA, Professor Ji Linong, director of the Department of Endocrinology, Peking University People's Hospital, shared with participants a research conclusion called "free research" led by him.
According to reports, this study is a prospective, multicenter, randomized, open, parallel group, with insulin pen as the control, to evaluate the effectiveness safety of the new insulin needle free syringe as the drug carrier for the control of blood glucose in patients with type 2 diabetes. The free study is also the first study to take HbA1c as the main therapeutic index to evaluate blood glucose control, to explore the effectiveness safety of insulin injection without needle. There are 10 top three hospitals in China, 427 patients are enrolled, with a span of 112 days. This study is a large-scale comparison of needle free injection in the world carried out in accordance with international standard clinical research methods The study of insulin treatment insulin injection.
According to IDF data statistics of 2017, China has become the country with the most widespread prevalence of diabetes. The number of adults with diabetes (20-79 years old) has reached 114 million, it is estimated that the number of diabetes patients in the world will reach at least 300 million by 2025.
In the treatment of diabetes, insulin is one of the most effective drugs to control blood sugar. Patients with type 1 diabetes need to rely on insulin to maintain their life, insulin must be used to control hyperglycemia reduce the risk of diabetic complications. Type 2 diabetes mellitus (T2DM) patients still need to use insulin to control hyperglycemia reduce the risk of diabetic complications when the effect of oral hypoglycemic drugs is good the use of oral drugs is taboo. Especially in patients with a long course of disease, insulin treatment may be the most important even necessary measures to control blood sugar.
"However, there are some problems in the clinical use of traditional insulin injection with needle." For example, the traditional way of injection of insulin with needle has certain influence on patients' psychology. Some patients are unwilling to receive insulin treatment because of fear of needle pain, because they can't inject insulin on time according to the doctor's order, which leads to poor blood glucose control, increases the probability of complications. In addition, the repeated use of injection needles will also affect the accuracy of insulin injection increase the chance of subcutaneous induration.
The emergence of needle free injection technology has brought good news for those patients who need long-term insulin treatment.
According to Zhang Yuxin, general manager of Beijing fast Shure Medical Technology Co., Ltd. (hereinafter referred to as fast Shure), needle free injection is to use the principle of pressure jet to complete the hypodermic injection of liquid medicine. That is to say, the pressure generated by the pressure device inside the needle free syringe pushes the liquid medicine in the drug pipe to pass through the micropores to form a liquid medicine column, so that the liquid medicine can instantly penetrate the skin of the human body reach the subcutaneous layer, the liquid medicine is absorbed in the subcutaneous layer in a dispersion shape with a diameter of 3.5 cm.
"We have replaced the needle with pressure. This kind of jet is very fast (the flow rate is generally greater than 100 m / s), the depth of entering the body is generally more than 4 mm ~ 6 mm. The stimulation to nerve endings is very small, so it does have obvious tingling like a needle syringe." Zhang Yuxin said.
But what are the differences between diabetic patients who need insulin injection those who don't have needles? In order to answer this question, relevant scholars at home abroad have done relevant research, confirmed that compared with needle injection, needle free injection does improve the pharmacodynamics pharmacokinetics of quick acting insulin, improve postprandial blood glucose control of early diabetic patients, insulin absorption is faster.
Previous short-term clinical studies have shown that compared with insulin injection with needle, insulin injection without needle can increase the absorption rate of short-term quick acting insulin, making the hypoglycemic effect of insulin in vivo more close to the physiological characteristics of insulin hypoglycemic, said jilinong. However, because patients need to be treated with insulin at home for a long time, it still needs a long-term study whether insulin injection without needle is as safe effective as insulin injection with needle, among which glycosylated hemoglobin is the gold index to evaluate blood glucose control.
In view of this, jilinong led to carry out "free research" in 10 research centers nationwide. Patients included in this study with type 2 diabetes need to meet the following conditions: subjects who have been diagnosed with type 2 diabetes, who have been treated with insulin (premixed basal) subcutaneous injection, who are taking oral hypoglycemic drugs life interventions, who plan to start insulin therapy due to poor blood glucose control; subjects aged 18-75 Years old; the time of insulin injection / oral hypoglycemic drugs before admission ≥ 3 months; HbA1c between 7.5% 11%; BMI ≤ 32kg / m2.
A total of 427 patients who needed insulin therapy were randomly divided into two groups: those who received insulin injection with needle those who did . "We set the main efficacy index as the change value of HbA1c relative to the baseline at the 16th week of treatment, took the changes of blood glucose of SMBG, the rate of reaching the standard of HbA1c after treatment, the quality of life questionnaire, the change of insulin dosage the satisfaction of the subjects as the secondary efficacy index." Ji said.
The final results showed that the decrease of HbA1c in the group without insulin injection was inferior to that in the group with insulin injection
