RESUMO
Objective:To study the clinical efficacy of Chaihu Shugansan on non-alcoholic fatty liver（NAFLD） patients with liver stagnation and spleen deficiency syndrome and its effect on intestinal flora. Method:The study was a single-center， randomized，single-blind， placebo-controlled clinical study involving 80 patients with NAFLD treated from January 2019 to January 2020 at our hospital. They were divided into two groups （Chaihu Shugansan group，<italic>n</italic>=40） and control group （placebo group，<italic>n</italic>=40）. The two groups of patients were given lifestyle intervention as the basic protocol. The treatment group was orally given Chaihu Shugansan，and the control group was orally given placebo. The drugs were given twice in the morning and evening， 1 dose/time. Patients were followed up for 12 weeks. Before and after treatment，the efficady on liver steatosis was observed by abdominal ultrasound and transient elastography （Fibroscan）， levels of alanine aminotransferase（ALT），aspartate aminotransferase（AST），glutamyl transpeptidase（<italic>γ</italic>-GT），high density lipoprotein cholesterol（HDL-C），low density lipoprotein cholesterol（LDL-C），total cholesterol（TC），triglyceride（TG），interleukin（IL）-6，IL-1<italic>β</italic>，Toll-like receptor-4（TLR-4） in peripheral blood mononuclear cells（PBMCs） and intestinal flora were also detected. Result:There were 37 patients in the treatment group and 35 patients in the control group who finally completed the study protocol. The total effective rate of NAFLD in the treatment group（81.08%，30/37） was higher than that in the control group （68.57%，24/35）（<italic>Z</italic>=2.67，<italic>P</italic><0.05）. The treatment group was superior to the control group in reducing the levels of BMI，ALT，AST，TC，LDL-C，TG，<italic>γ</italic>-GT and increasing the level of HDL-C（<italic>P</italic><0.05）. The levels of pro-inflammatory cytokines（TNF-<italic>α</italic>，IL-1<italic>β</italic> and IL-6），the values of Controlled Attenuation Parameter（CAP），Liver Stiffness Measurement（LSM） and expression of TLR4 were down-regulated in the treatment group （<italic>P</italic><0.01）. In addition，the treatment group showed increase in the abundance of beneficial bacteria （<italic>Bifidobacterium</italic> and <italic>Lactobacillus</italic>） and inhibited the abundance of pathogenic bacteria （<italic>Enterobacter </italic>and<italic> Enterococcus</italic>） in the gut（<italic>P</italic><0.01）. Conclusion:In addition to the lifestyle intervention，Chaihu Shugansan can improve lipid metabolism and liver function，regulate intestinal flora and inhibit the level of inflammatory factors in patients with NAFLD.
RESUMO
The Aspongopus chinensis is an insect of the genus Hemiptera, which can be used both as a medicinal and as a gourmet in the folk. It has a long history as a drug, which has the effect of regulating Qi and relieving pain, and warming the Yang. It is mainly used to treat stomach cold and pain, liver and stomach pain, kidney deficiency and impotence, and waist and knee pain. Modern pharmacological studies have shown that A. chinensis has a variety of pharmacological activities. For example, it can be used to fight tumors, improve reproductive damage, and antibacterial, anti-oxidation, anti-coagulation, anti-ulcer, anti-fatigue and so on. The chemical constituents of A. chinensis currently reported mainly include odorous components, vitamins, fatty acids and proteins, amino acids, and other nutrients, as well as nucleosides and dopamines. This study summarizes and analyzes the related research literatures of A. chinensis in China and abroad, and provides a reference for its further development and research from the aspects of chemical composition, pharmacological action and clinical application.