A Random Open And Control Clinical Study On Evaluating The Effectiveness And Security Of Pushen Capsule In Treating Hypertriglyceirdemia

Objective: To investigate the effectiveness and security of PuShen Capsule(PSC) intreating hypertriglyceridemia(HTG).Methods: Fifty cases of HTG were randomly divided2:1into an experimental group(n=33) and a control group (n=17). The experimental group was treated with four tablets ofPSC three times a day after meals. The control group was treated with one tabletof Acipimox Capsules two times a day, after breakfast and supper. With the exception ofregulating lipids, previous treatments remained unchanged. During the eight-weektreatment period the life-style, such as diet, etc. remained the same as before the treatment.We observed the index of curative effects such as TG、TC、LDL-C and HDL-C, as well asthe index of security such as routine blood tests, routine urine tests, liver function (ALT,AST), renal function (Scr, BUN), CK and Glu.Results:(1) After eight weeks, the level of TG of both two groups were lower thanbefore the treatment with statistical difference (P＜0.05).(2) After eight weeks, the level of TC、LDL-C of both two groups were lower thanbefore the treatment with statistical difference (P＜0.05)，but the level of HDL-C did notmake a significant change between the two groups compared with before the treatment.(3) The Tanzhuozue type of HTG is the biggest constituent ratio in both groups beforethe treatment. In the experimental group, after eight weeks, the severity of Tanzhuozuedeclined and the number of people with no symptoms increased compared with the dataPrior to the experiment with statistical difference (P＜0.05). In contrast, there was nostatistical difference compared with the beginning in the control group after eight weeks. Comparison between the two groups after the treatment has statistical difference (P＜0.05).(4) After eight weeks, PSC can significantly improve signs and symptoms of HTGincluding but not limited to numb and heavy limbs, impotence, palpitation and dark purpletongue with statistical difference (P＜0.05), while Acipimox Capsules have little impactwithout statistical difference (P＞0.05).(5) In the experimental group after eight weeks, the level of ALT、AST、BUN、Glu andCK has no statistical difference compared with levels Prior to treatment, while the level ofScr significantly declines. In the control group， the level of the aforesaid index had nostatistical difference from the start of treatment to the end of the treatment period. It alsohad no statistical difference compared with the experimental group.(6) There is significant difference between the two groups in incidence rate of adverseevents and general evaluation on security.Conclusion:(1) PSC is an effective drug in treating HTG, and have equivalentefficacy with Acipimox Capsules. It is also an effective drug in adjusting the level ofTC and LDL-C.(2) PSC offers prominent advantages over Acipimox Capsules on alleviating TCMsigns and symptoms.(3) PSC have great security without liver and renal toxicity. Furthermore, it can lowerthe level of Scr which indicates that it may improve renal function.(4) PSC have little side effect such as abdominal distension which can be alleviatedby itself.As a result, it has high treatment compliance.