What are the international experiences of the medical service delivery model

2019-09-11 16:58


Methods: Using a randomized controlled double-blind study, patients diagnosed with hyperacidemia in our hospital from October 2014 to March 2015 were divided into experimental group and control group. Experimental group: lifestyle intervention combined with hydrogen-containing water (hydrogen water) conditioning, three cans a day; control group: lifestyle intervention combined with placebo water group, three cans a day. Record the patient’s age, gender, blood pressure, total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein, cholesterol, fasting blood glucose, blood uric acid, blood creatinine and urea and other laboratory examinations, self-feeling assessment and sub-health assessment .




Results: A total of 80 people were included in the study. After unblinding, the experimental group actually participated in 40 cases, completed 32 cases, and lost 8 cases (20.00%); the control group actually participated in 40 cases, completed 21 cases, and lost 19 cases (47.50%). ); A total of 53 people completed the research. Among them, 52 were males and 1 female, with an average age of 40.66±7.45 years old. There were no cases withdrawn from the study due to adverse reactions in either group. The loss rate of the control group was significantly higher than that of the experiment (χ2=6.7645, P=0.01). The effective rate, apparent rate and total effective rate of the experimental group were significantly higher than those of the control group. There was no statistical difference in the sub-health scores between the two groups before conditioning (t=0.3992, P=0.69), but there were significant differences after conditioning. The scores of the experimental group were significantly lower than those of the control group (t=2.6419, P=0.01) ). The diastolic blood pressure, total cholesterol and uric acid levels of the experimental group decreased significantly, especially the average level of uric acid before and after conditioning in the experimental group decreased by 66.69μmoL/L (t=3.3870, P=0.002), while there was no significant change before and after the control group.




Conclusion: Hydrogen has a certain therapeutic effect on hyperuricemia, and it can also improve patients' self-feeling symptoms.




Hyperuricemia is a metabolic disease caused by the disorder of purine metabolism in the human body, which causes the increase of uric acid in the blood. The daily production and excretion of uric acid in the body are approximately equal. One third of uric acid comes from food, and two thirds are synthesized by the body; one third is excreted from the intestines, and two thirds are excreted from the kidneys. More and more studies have confirmed that hyperuricemia is also one of the risk factors for cardiovascular disease. Clinically, there are few choices of drugs to correct hyperuricemia, and the side effects are large, and they are often adjusted through diet control and improvement of living habits. Recent studies have found that the oxidative damage caused by oxygen free radicals is closely related to the formation and aggravation of the body's metabolic dysfunction; hydrogen dissolved in water can selectively neutralize hydroxyl free radicals and nitrite anions, thereby producing a good antioxidant effect; There have been many studies that have found that hydrogen can have an impact on a variety of metabolic pathways. Hydrogen water is water in which hydrogen is dissolved. Studies at home and abroad have shown that hydrogen water has a certain conditioning effect on patients with high uric acid, but there is a lack of large samples of clinical controlled observation data. This study conducted a randomized controlled double-blind study on hyperuric acid populations, aiming to confirm the conditioning effect of hydrogen water on hyperuricemia.








1.1 Research subjects inclusion criteria: Blood tests between October 2014 and March 2015 showed that uric acid was above the normal range (male blood uric acid was higher than 416 μmol/L; female blood uric acid was higher than 357 μmol/L); the patient voluntarily signed and informed Consent form; not taking any medications. Exclusion criteria: taking uric acid lowering drugs, combined with severe liver and kidney dysfunction, cardiovascular disease, or tumors requiring routine medication that may affect uric acid levels; those who are unwilling to receive hydrogen water conditioning; those who have not completed the research steps according to the research design requirements or have not Those who accept the re-examination are regarded as missing; those who have adverse reactions and cannot tolerate them are regarded as withdrawal.




1.2 Materials Use the hydrogen water imported from Japan "Blessings of Fujiyama Town", and the hydrogen concentration in the water is 1.0-1.5ppm. Hydrogen water adopts vacuum positive pressure and double-layer steel tank packaging technology, which solves the problem of hydrogen leakage and ensures the stability of the concentration. Hydrogen water (200ml/tin) is provided by Beijing Mingcheng Jiaye Technology Development Co., Ltd. The placebo water is the same quality, the same packaged, undissolved hydrogen water produced by the original Japanese factory.




1.3 Methods The research subjects were randomly divided into experimental group and control group by blind method. Test group: lifestyle intervention combined with hydrogen water conditioning, three cans a day; control group: lifestyle intervention combined with placebo water group, three cans a day. The lifestyle interventions of the two groups are the same, including health education, supervision of lifestyle changes, such as alcohol restriction, low-purine diet, exercise, etc. Complete the collection of baseline data and the detection of relevant blood indicators within one week before the start of the hydrogen water conditioning; telephone follow-ups were carried out 4 weeks and 8 weeks after enrollment, and the drinking situation and adverse reactions were recorded. After 3 months, the questionnaire and related indicators should be retested within 1 week of stopping the water intervention.




1.3.1 Clinical data collection The age of the subjects (calculated based on the birth date of the ID card), smoking habits, and drinking habits are recorded in detail. Measure height, weight, blood pressure, and calculate body mass index (BMI=weight/height 2kg/m2). Smoking is defined as: smoking ≥10 cigarettes a day for more than 1 year. Drinking habits are divided into: never drinking, occasional drinking (<1 time a week, one drinking for men, equivalent to more than 30 grams of alcohol, and more than 15g for women), and regular drinking (≥1 time a week). The questionnaire records self-feeling symptoms, diet, sleep, and frequency of gout attacks. Those with no change in self-feeling or worsening symptoms are judged as invalid; those with a certain degree of improvement in self-feeling and no adverse reactions are judged as effective; those with obvious improvement in self-feeling, fewer gout attacks, and no adverse reactions are judged as markedly effective.




1.3.2 Determination of blood indicators Within 1 week of the beginning and end of the study, fasting for 12 h and collecting venous blood on an empty stomach the next morning. According to the quality control and testing standards of the Clinical Laboratory Department of the PLA General Hospital, the total cholesterol (TC), Triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), fasting blood glucose (FBG), blood uric acid (UA), blood Creatinine (serum creatinine, Cr) and urea.




1.3.3 Sub-health status assessment The sub-health status assessment adopts (SHSQ-25) questionnaire, which includes 25 questions in 5 dimensions, including fatigue symptoms, cardiovascular symptoms, gastrointestinal symptoms, immune symptoms and mental symptoms. Ask the most recent The frequency of occurrence of each discomfort symptom within 3 months; each question is assigned a value of 0 to 4 points according to the increase of the alternative answers (no, rarely, yes, often, almost always) respectively, and the total of the 25 questions The score is used as the sub-health state score value. The survey objects were entered through the touch screen system, and the questionnaire was completed under the guidance of uniformly trained investigators. Then, the computer automatically scored points according to the scoring program. Sub-health assessments were performed twice before enrollment and within 1 week after the end of the study.




1.4 Statistical processing The questionnaire data is encoded and quantified and then input into the computer, and statistical analysis is carried out with Stata 11.0 software. The Kolmogorov-Smirnov method was used for the normality test, and the classification data was expressed as the rate, and the independent sample t test and the χ2 test were used for analysis. P<0.05 indicated that the difference was statistically significant.








2.1 General clinical data of the research subjects According to the research design, 80 people were included in the study, 27 cases were missing, and 0 cases were withdrawn; a total of 53 people completed the study. Among them, 52 were males and 1 female, with an average age of 40.66±7.45 years old. The age distribution ranged from 21 to 62 years old. After unblinding, the experimental group actually participated in 40 cases, completed 32 cases, and lost 8 cases (20.00%); the control group actually participated in 40 cases, completed 21 cases, and lost 19 cases (47.50%). There was a significant difference in the loss rate between the two groups (χ2=6.7645, P=0.01). The loss of the two groups is shown in Table 1. There were no cases of loss in the first month, the loss increased in the second month, and the most lost in the third month. Among them, the loss ratio in the second and third months of the control group was higher than that of the experimental group. The main reasons for the loss are feeling invalid and unwilling to continue taking it; failing to take the test water on time due to changes in work or living place; losing contact or failing to recheck within 1 week due to business trips or going abroad after the test. There were no cases withdrawn from the study due to adverse reactions in either group. The comparison of baseline data between the two groups is shown in Table 2. Before the start of conditioning, there was no significant difference in the two groups except for blood uric acid in other indicators.












2.2 Comparison of the clinical efficacy of the two groups The clinical efficacy results of the two groups are shown in Table 3; the effective rate, apparent rate and total effective rate of the experimental group are significantly higher than those of the control group. The invalid ratio of the control group was significantly higher than that of the experimental group (χ2=12.0645, P=0.001).








2.3 Comparison of the sub-health assessment results of the two groups There was no statistical difference between the sub-health scores of the two groups before conditioning (t=0.3992, P=0.69), but there were significant differences after conditioning, and the score of the experimental group was significantly lower than the control Group (t=2.6419, P=0.01). The average difference of the experimental group before and after reached 8.16, and the difference between the before and after self-control was significant. The average difference between before and after the control group was only 0.81, and there was no difference between before and after the self-control. See Table 5.








2.4 The changes in the observed indicators before and after the two groups of conditioning. Compare the baseline indicator value with the re-examination value after 3 months. It can be seen that there is no significant change in the indicators of the control group. However, the diastolic blood pressure, total cholesterol and uric acid levels of the experimental group decreased significantly. See Table 4.








2.5 Comparison of blood uric acid with the first time after taking hydrogen water for 3 months




2.6 Comparison of blood uric acid with the first time after taking placebo for 3 months




3 Discussion




Since 2007, Ohsawa is equivalent to "Nature Medicine" pointed out for the first time that inhalation of 2% hydrogen can significantly reduce cerebral ischemia reperfusion injury, and put forward the view that hydrogen has a selective antioxidant effect. In recent years, a large number of studies have found that hydrogen can protect the body through a variety of modes of action, and has significant preventive and therapeutic effects on various diseases. It is considered a new type of biologically active gas molecule, and it is even called the "fourth". Gas signal molecules". For example, the research results of Liu et al. showed that intraperitoneal injection of hydrogen saline can significantly reduce the cerebral infarction area and reduce edema in rats, and the expression of 8-hydroxydeoxy ornithine, interleukin-1β, and TNF-α in ischemic brain areas Obvious reduction. Studies have also found that hydrogen molecules are very effective in reducing weight, reducing insulin resistance, controlling blood sugar, improving lipid metabolism, controlling blood pressure, and preventing liver damage. As a new type of antioxidant, hydrogen has its unique advantages: firstly, hydrogen has relatively weak reducibility and selectivity. It only reacts with active and toxic reactive oxygen species, and does not react with active oxygen species that have important signal effects; secondly , Hydrogen itself has a simple structure, and the product that reacts with free radicals is also simple. For example, it reacts with hydroxyl free radicals to produce water. Excess hydrogen can be removed from the body through breathing without any residue and no toxic side effects to the body. With low molecular weight, it can pass through the blood-brain barrier and can diffuse freely to any position of the cell, even the nucleus and mitochondria; finally, the preparation of hydrogen is easy and low in price. Therefore, as a selective, non-toxic, non-residual, and inexpensive antioxidant substance, it has a good clinical application prospect. However, hydrogen is very easy to diffuse, making it difficult to control the hydrogen concentration and difficult to store. Hydrogen water is based on natural drinking water with hydrogen dissolved in it. The use of special canning materials can ensure that the concentration of hydrogen is 1.0-1.5ppm. Abroad, hydrogen water has been on the market for 14 years without any serious adverse events reported.




This study is a randomized, placebo-controlled, double-blind clinical study. Because hydrogen is colorless and tasteless, the placebo water and hydrogen-containing hydrogen water in the control group are packaged exactly the same, which can basically rule out the influence of psychological factors on the two groups. Although the two groups initially included the same number of studies, the dropout rate of the control group was significantly higher than that of the experimental group. Thus, it reflects the poor compliance of placebo water due to lack of curative effect. This can be further confirmed from the difference in effective and apparent efficiency between the two groups. Sub-health is an intermediate state between disease and health, and there is no recognized standard for judging it. A large number of studies have found that sub-health status is related to oxidative stress damage. This study does not focus on the evaluation of sub-health status. Mainly use the current internationally recognized sub-health questionnaire (SHSQ-25). The questionnaire covers 25 questions including fatigue symptoms, cardiovascular symptoms, gastrointestinal symptoms, immune symptoms and psychiatric symptoms. By comparing the evaluation scores of individuals before and after conditioning, the changes in self-feeling symptoms can be more objectively reflected. The results of the study showed that the sub-health assessment scores of the experimental group and the control group were the same at the baseline level, but after conditioning, the experimental component values decreased significantly, while the control group did not change significantly before and after, and finally the two groups showed significant differences . Therefore, it is believed that drinking hydrogen-rich water for 3 months does improve the subjects’ self-feeling symptoms.




Before the start of conditioning, there was no significant difference in the two groups except for blood uric acid in other indicators. There is a difference in uric acid levels between the two groups before conditioning, which may be related to the higher loss rate of the control group, which makes the data of many hyperuricemia patients not included in the final statistics. On the basis of the same lifestyle intervention, after taking 3 months of hydrogen water, the diastolic blood pressure, total cholesterol and uric acid levels of the experimental group decreased significantly; while the control group had no significant changes in various indicators. This suggests that hydrogen water can lower blood pressure, lower cholesterol, and lower uric acid. This was significantly lower than the diastolic blood pressure, total cholesterol and uric acid levels of the experimental group. The diastolic blood pressure, total cholesterol and uric acid levels of the experimental group decreased significantly. Back in 2008. Japanese scholar Ohasawa and others reported that drinking saturated hydrogen water for 6 months can reduce the body's oxidative stress level and prevent atherosclerosis in mice. However, the molecular mechanism has not been discussed in depth. A large number of studies have confirmed that blood pressure, blood lipids and uric acid are risk factors for atherosclerosis. This study shows that hydrogen-rich water (hydrogen water) can lower blood pressure, blood lipids and uric acid, which suggests that hydrogen may affect the levels of these risk factors to prevent atherosclerosis.