| Part Ⅰ: Meta-analysis of the effect of Jianpiyishenhuazhuo method on clinical efficacy and insulin resistance in diabetic patients.Objective Meta-analysis was used to evaluate the clinical efficacy of Jianpiyishenhuazhuo method in the treatment of diabetes and its effect on insulin resistance in diabetic patients.Methods CNKI,Wanfang Data Knowledge Service Platform,VIP database,Sino Med,Embase data,Pub Med data and Web of Science data were searched by Internet.Published randomized controlled clinical trials of Jianpiyishenhuazhuo method for the treatment of diabetic patients from database establishment to February 15,2023 were included.Two reviewers analyzed and included all alone on the basis of the inclusion rule and exclusion rule.The data were statistically analyzed using Review Manager 5.4 and the “meta”software package in R software.Results A total of 24 randomized controlled clinical trials included 2057 patients which met the criteria in this study.The results showed that compared with the control group,the method of invigorating the spleen,tonifying the kidney and dissipating turbidity could improve the overall clinical response rate [RR = 1.29,95% CI(1.22;1.38),Z = 8.25,P < 0.01],improve fasting insulin level [SMD =-0.63,95% CI(-1.10;-0.16),Z =-2.64,P < 0.01],improve insulin resistance index [SMD =-0.69,95% CI(-1.23;-0.14),Z =-2.48,P < 0.01],and improve TCM syndrome score [RR = 1.36,95% CI(1.18;1.57),Z = 4.31,P < 0.01] in the treatment of diabetic patients.Conclusion The therapeutic effect of Jianpiyishenhuazhuo method on diabetic patients is remarkable,and the mechanism may be realized by improving the degree of insulin resistance.It is more useful to the treatment with conventional western medicine alone and is worthy of vigorous promotion.However,the whole study quality of the contained literatures is low,and multi-center,large-sample RCT studies are also needed to supplement to provide support.Part Ⅱ: To investigate the effect of Sanggehuazhuo decoction on insulin resistance and pancreatic injury in rats with impaired glucose regulation.Objective Under the lead of clinical experience,Sanggehuazhuo decoction was used to intervene the rat model of impaired glucose regulation by Jianpiyishenhuazhuo method to study the effect of Sanggehuazhuo decoction on insulin resistance and pancreatic injury in rats with impaired glucose regulation.Methods 10 of 60 healthy male Sprague Dawley rats were randomly selected as the normal control group(NC group)and fed with normal maintenance diet,and the other rats were fed with high-sugar and high-fat diet and intraperitoneal injection of streptozotocin solution to construct a rat model of impaired glucose regulation.The rats which were constructed successful were randomly divided into model group(IGR group),positive control group(AC group),low dose group(L group),medium dose group(M group)and high dose group(H group).Rats in group L,group M and group H were intragastrically administered with Sanggehuazhuo decoction at doses of 2.7 g/(kg· d),5.4 g/(kg· d)and 10.8g/(kg· d),respectively,group AC was administered with metformin suspension200 mg/(kg· d),group NC and group IGR were administered with ultrapure water2 ml/(kg· d)for 8 weeks.During the experiment,the mental status,activity,coat color,diet,urination and defecation,and the dynamic changes of body weight and blood glucose were looked carefully and recorded.At the end of gavage,serum was collected from rats for the detection of total cholesterol(TC),triglyceride(TG),high-density lipoprotein cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C),fasting insulin level(FINS),adiponectin level(ADPN),and calculated insulin resistance index(HOMA-IR),insulin sensitivity index(HOMA-IS);pancreatic tissues were separated and removed and soaked in 4% paraformaldehyde fixative for fixation,paraffin-embedded sections and hematoxylin-eosin HE staining were then performed in order to observe pancreatic histopathological changes and judgment of the degree of injury.Results1.General conditions: The rats of normal group generally fared well,moved as usual,had bright fur,and ate water and urinated normally.Rats in the IGR group had poor mental status,poor range of motion,decreased hair brightness,increased diet and drinking and increased urine and defecation volume;compared with the IGR group,rats in the other treatment groups had different degrees of improvement in general condition after drug intervention.2.Body weight results: Before modeling,the rats in each group were healthy rats,and there was no apparent difference in body weight(P > 0.05).Before drug intervention,that is,after successful modeling,compared with the NC group,the weight of rats of the other five modeled groups was significantly increased(P < 0.01),and there was no obvious discrepancy between the five modeled groups(P > 0.05),with comparability.After 8 weeks of drug intervention,the body weight of AC group,M group and H group decreased to some extent compared with IGR group(P < 0.05 or P < 0.01),and the difference of body weight of H group was not significant compared with AC group(P > 0.05).3.Blood glucose results: The rats in each group were healthy rats before model establishment,and there was no significant difference in fasting blood glucose and 2h postprandial blood glucose(P > 0.05).After successful modeling,that is,before drug intervention,the fasting blood glucose and2 h postprandial blood glucose of rats in the five modeled groups were rised compared with those that is in the NC group(P < 0.01),and the fasting blood glucose and 2h postprandial blood glucose of rats in the IGR group had been increasing.After 8 weeks of drug intervention,the fasting blood glucose and2 h postprandial blood glucose of rats in the four groups were decreased to different extents compared with those in the IGR group(P < 0.01),and the blood glucose differences between groups M and H were not significant compared with those in the AC group(P > 0.05),suggesting that groups M,H and AC had similar effects in lowering blood glucose.4.Blood lipid results: The experimental results showed that the blood lipid levels of rats in the five modeled groups were obviously different from those in the NC group(P < 0.01),indicating that IGR rats were accompanied by dyslipidemia.The total cholesterol levels of the four treatment groups decreased to different extents compared with the IGR group(P < 0.05 or P< 0.01);the triglyceride levels of the AC,M,and H groups were significantly different compared with the IGR group(P < 0.01).The level of high density lipoprotein in AC group and H group was significantly different from that in IGR group(P < 0.01).The low-density lipoprotein levels of AC and H groups were significantly different from those of IGR group(P < 0.05).Among them,between group H and group AC,there was no obvious difference in blood lipid levels(P > 0.05),suggesting that group H and group AC had similar effects in reversing blood lipids.5.Evaluation of insulin resistance: The experimental results showed that there were significant differences in fasting insulin level,adiponectin level,insulin resistance index and insulin sensitivity index between the five modeled groups and the NC group(P < 0.01),suggesting that IGR rats were accompanied by insulin resistance.Compared with IGR group,the fasting insulin level and adiponectin level in AC group and H group were significantly different(P < 0.01),and the insulin resistance index and insulin sensitivity index in AC group,L group,M group and H group were significantly different(P < 0.01).Compared with AC group,fasting insulin level and adiponectin level in L group,M group and H group had different degrees of callback(P < 0.05 or P < 0.01),and there was no obvious difference in insulin resistance index and insulin sensitivity index in H group(P > 0.05).6.Staining results: HE staining results indicated that there was no distinct pathological variation in the pancreatic tissue of rats in the NC group under microscopic observation;the pancreas of rats in the IGR group revealed more serious pathological changes;compared with the IGR group,the islet histomorphology of rats in the AC,H,and M groups was significantly improved,and the overall degree of lesions was milder than that of rats in the IGR group.Conclusion1.Sanggehuazhuo decoction can ameliorate the general condition of rats with impaired glucose regulation,effectively regulate glucose and lipid metabolism,relieve the degree of insulin resistance,and reduce the pathological damage of pancreatic tissue.It is suggested that Sanggehuazhuo decoction can reduce insulin resistance index by decreasing FINS level and increasing APDN level It is speculated that can reduce the insulin resistance index and enhance insulin sensitivity by reversing FINS and APDN levels,thereby improving insulin resistance,protecting pancreatic function and treating early diabetes.2.High dose of Sanggehuazhuo decoction can more effectively improve glucose metabolism,lipid metabolism,insulin resistance and pancreatic injury in rats with impaired glucose regulation than medium and low doses,and its efficacy is slightly inferior to metformin. |
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