| PurposeTo observe the improvements of the outcome measures of the Patients with HAART-related hyperlipidemia who has taken chinese medicine granules, including syndromes of traditional chinese medicine (TCM), blood fat levels and the Atherosclerosis Index (AI). To discuss about the pre-scription characteristics and the mechanism of regulating lipid me-tabolism and objectively evaluate its efficacy and safety of the treatment. To establish a new kind of TCM mixture which is a safe and effective therapy for the treatment of HAART-related hyperlipidemia.MethodAccording to the inclusion criteria,60cases of Patients with HAART-related hyperlipidemia are chosen for by-self Pre-and Post-control observation. Patients are all aged18to70years old with TCM phlegm and blood stasis syndrome. Patients are treated with chinese medicine granules and HAART. Patients taking observation time was12weeks. The cases maintain the original lifestyle and diet during the observation period. To record the file values of blood lipid items (including TC, TG, LDL-C, HDL-C), arterioscleros index and other indicators, observ the improvements of clinical syndromes of TCM in patients before and after treatment. Meanwhile comparative safety indicators such as urine routine, liver function, kidney function, ECG, and possible adverse reactions are observed, and lipid levels were compared between two groups of different syndromes. After the clinical observation, organizing the data and making detailed statistical analysis.Results1An evaluation of the efficacy 1.1Comparison of efficacy of TCM symptomsAccording to clinical symptoms, the treatment group of58cases,2cases of clinical control (3.4%), markedly in5cases (8.6%), effective in41cases (70.7%), ineffective in10cases (17.2%), the total efficiency of82.7%. After8and12weeks of treatment, the subjects score of TCM symptoms are decreased compared with pre-treatment. Suggest that chinese medicine granules have a good effect on improving the TCM symptoms of the patients with HAART-related hyperlipidemia.1.2Evaluation Laboratory testsBased on laboratory test results, the treatment group of58cases,1case of clinical control (1.7%), markedly in3cases (5.2%), effective in39cases (67.2%), ineffective in15cases (25.9%) and the total efficiency of74.1%. Suggest that chinese medicine granules has a good effect on terms of improving the clinical symptoms of the Patients with HAART-related hyperlipidemia.1.3Lipid levels before and after the treatmentAfter12weeks of treatment, TC levels are decline compared with pre-treatment (p〈0.05); And HDL levels are significantly increases after8weeks of treatment (p〈0.05); While the change of TG and LDL levels did not reach statistical significance (P>0.05); Suggest that Chinese medicine granules have a good effect on changing TC and HDL levels of the patients with HAART-related hyperlipidemia.All the data (TC, TG, LDL, HDL) were compared between spleen phlegm-damp syndrome group and phlegm-stagnation syndrome group has not seen the remarkable difference (P>0.05); And there were significant difference in TC and HDL levels before and after treatment intra-group comparison (p〈0.05).1.4Arteriosclerosis index changes before and after Compared with pre-treatment, after eight weeks of treatment, there is a signi-ficant difference on reducing arteriosclerosis index (P〈0.05); Suggest that chinese medicine granules have a good effect on reducing the incidence of cardiovascular disease.2Safety evaluationDuring clinical observation, there is no obvious changes in the blood test, urine test, ECG test and biochemical examination are found in these cases after eight weeks of treatment. And there are no adverse reactions and side effects associated with the test are found. Suggest that chinese medicine granules is a safe and reliable preparation for hyperlipidemia.ConclusionClinical observation found that chinese medicine granules.can significantly improve the symptoms of TCM and improve the life quality of Patients, reduce TC level and arteriosclerosis index, and effectively increase HDL level. Adverse reactions and side effects associated with the test do not occur during the clinical observation, chinese medicine granules is a safe and effective traditional chinese medicines for the Patients with HAART-related hyperlipidemia. |
