| Objective:To investigate the clinical curative effect and safety of ShanYin Capsule inPatients with hyperlipemia through clinical trial study, and to establish thesubstructure of directions to clinical medication.Methods:According to《Principle to clinical research of the traditional Chinese medicinetherapia to hyperlipemia》, adopted randomization, double blindness, positivemedicine control of equal rank method was used in this trial selected 60 suitable caseswhom were parted two groups at random, patients in trial group was treated withShanYin Capsule, while control group was treated with ZhiBiTuo Capsule. 28 dayswas a course of treatment. We observed the curative effect of HLP, record thesymptoms' change of TCM and signs' of HLP, lever of TC,TG,HDL-C,LDL-C andthe change of weight was observed before and after treatment meanwhile.1. Select patientsThe patient won't be brought into clinical examination unless he consistent withthe following 4 conditions.1.1 The symptoms Correspond with the diagnostic criteria which this projectestablishes and the symptoms of phlegm muddy repressing, and accepting theinformed consent.1.2 Essential hyperlipide.1.3 Although the patient had taken medicine to hyperlipemia, he hasdiscontinuated for above two weeks.1.4 The age was among 18～65.2. Delete patients:According with the following anyone conditions, the patient can't be broughtinto clinical examination.2.1 The age was below 18 or above 65.2.2 Pregnancy or women in lactation; hypersensitiveness constitution or hypersens-itiveness to this drug.2.3 One suffered acute myocardial infarction; cerebrovascular accident; Severitytrauma; major operation etc in half of one year.2.4 Hamilial hypercholesterolemia or hyperlipemia revoked by nephroticsyndrome; hypothyroidism; arthrolithiasis; acute or chronicity liver and gall disease;urophthisis etc.2.5 Hyperlipemia revoked by medicine such as dibenzothiazine;β-block agent;adrenal cortical steroid; some contraceptives etc. Patients were taking liquemine;medicine to thyropathy or other medicine which could effects lipid metabolism.Patients had accepted any other measure to subdue blood-fat.2.6 Combinning with severity primary disease such as liver,kidney orhematopoietic system disease; psychotic.3. Grouping principle:240 suitable cases were parted two groups: the ratio between trail group andcontrol group is 1:14. Treatment project:Treat group was treated with ShanYin Capsule, 3 pills, third daily. Control groupwas treated with ZhiBiTuo Capsule, 3 pills, third daily.28 days was a course of treatment.5. Observation index:5.1 Therapeutic efficiency observation: the curative effect of HLP, record thesymptoms' change of TCM and signs'of HLP, lever of TC,TG,HDL-C,LDL-C andthe change of weight.5.2 Safety observation: the blood-routine, the urine-routine, the stool-routine,electr-ocardiogram, liver function, kidney function.Results:1. ShanYin Capsule has significant effects in symptom remission, theeffective rate of treat group was 87.61％, while the control group's was76.09％, there was no statistically significant difference betweenthem(p＞0.05). 2. The blood fats curative effect between treat group and control group, theeffective rate of treat group was 65.49％, while the control group's was58.97％, there was no statistically significant difference betweenthem(p＞0.05).3. The accumulated points of symptom of traditional Chinese medicinewere both statistically significant degraded (p＜0.05), but there was nostatistically significant difference between this two group (p＞0.05).4. In group comparison, the difference has no statistically significance(p＞0.05).The change of lever of TC,TG,LDL-C,HDL-C has nostatistically significant difference in group comparison(p＞0.05).5. Safety analysis: There was no untoward reactions in both treat group andcontrol group in the clinical test.Conclusions:In this clinical trial, it was confirmed that the ShanYin Capsule was effective andsafe prescription in curing hyperlipemia (syndrome of stagnation of phlegm andsludging of Blood). It's curative effect has reached the ZiBiTuo. The effectiveness ofcompound Chinese traditional medicine Capsule is worth of deep research. |
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