泽泻丹明饮治疗高脂血症合并非酒精性脂肪肝痰湿证的临床研究OA

Objective To investigate the clinical efficacy and safety of Zexie Danming Yin(a dispensing granule mainly composed of Alismatis Rhizoma,Salviae Miltiorrhizae Radix et Rhizoma,Cassiae Semen,Curcumae Radix,Crataegi Fructus,etc.)in treating patients with hyperlipidemia complicated with nonalcoholic fatty liver disease(NAFLD)of phlegm-damp type.Methods A total of 120 patients with hyperlipidemia complicated with NAFLD of phlegm-damp type,who visited the Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital from June 2022 to August 2024 were enrolled as study subjects.The patients were randomly divided into control group and treatment group by random number table method,with 60 cases in each group.The control group received lifestyle intervention,while the observation group received lifestyle intervention combined with oral use of Zexie Danming Yin.The treatment duration was 24 weeks.The changes in lipid metabolism indicators[total cholesterol(TC),triglyceride(TG),low-density lipoprotein cholesterol(LDL-C),and high-density lipoprotein cholesterol(HDL-C)],liver parameters based on transient elastography[controlled attenuation parameter(CAP),and liver stiffness measurement(LSM)],and body mass index(BMI)were observed before and after treatment in both groups.The therapeutic effects on traditional Chinese medicine(TCM)syndrome,lipid improvement,and liver transient elastography were compared between the two groups,and the medication safety was evaluated.Results(1)Regarding exclusions and dropouts,3 cases in the treatment group and 2 cases in the control group were excluded or dropped out.Finally,57 cases were included in the treatment group and 58 cases in the control group.(2)In terms of efficacy,after 24 weeks of treatment,the total effective rates of TCM syndrome efficacy,lipid improvement efficacy,and liver transient elastography efficacy in the treatment group were 70.18%(40/57),70.18%(40/57),and 59.65%(34/57),respectively,while those in the control group were 50.00%(29/58),55.17%(32/58),and 44.83%(26/58),respectively.Inter-group comparison(by chi-square test)showed that the TCM syndrome efficacy in the treatment group was significantly superior to that in the control group(P＜0.05),while the lipid improvement efficacy and liver transient elastography efficacy showed a trend of being superior to the control group,but the differences were not statistically significant(P＞0.05).(3)Regarding lipid metabolism indicators,after treatment,the levels of TC,LDL-C,and TG in the treatment group were significantly decreased compared with those before treatment(P＜0.05 or P＜0.001),while the HDL-C level showed no significant difference before and after treatment(P＞0.05).In the control group,there were no significant changes in TC,LDL-C,TG,or HDL-C levels after treatment compared with those before treatment(P＞0.05).The reductions in TC and LDL-C levels in the treatment group were significantly greater than those in the control group,and the differences in the pre-and post-treatment changes between the groups were statistically significant(P＜0.01).(4)Regarding liver parameters based on transient elastography,after treatment,the CAP and LSM values in both groups were significantly decreased compared with those before treatment(P＜0.05 or P＜0.001),and the reductions in CAP and LSM values in the treatment group were significantly greater than those in the control group,with statistically significant differences in the pre-and post-treatment changes between the groups(P＜0.05).(5)Regarding BMI,after treatment,the BMI values in both groups were improved compared with those before treatment(P＜0.05 or P＜0.001),and the improvement in BMI in the treatment group was significantly greater than that in the control group,with a statistically significant difference in the pre-and post-treatment changes between the groups(P＜0.01).(6)Regarding safety,except for the urea level in the treatment group,there were no statistically significant differences in liver and kidney function indicators such as creatinine,urea,alanine aminotransferase,and aspartate aminotransferase between the two groups before and after treatment(P＞0.05).Conclusion The application of Zexie Danming Yin on the basis of conventional lifestyle intervention has a definite therapeutic effect in treating patients with hyperlipidemia complicated with NAFLD of phlegm-damp type.It can effectively improve fatty liver and blood lipid levels,and has high safety.