Prospective Trial Of Aidi Injection Combined With Intraluminal Brachytherapy By I-125 Seeds In Treatment Of Malignant Obstructive Jaundice

BackgroundMost malignant obstructive jaundice are unresectable when diagnosed.The surgery ratio is low.Biliary stent implantation has already become one of the alleviative treatment of the malignant obstructive jaundice,which will effect the therapeutic efficacy,because the stent will become restenosis in some patients after the 3-6months in the clinical practice observation.The high infect rate and restenosis has seriously affected the clinical effect.There has been many tries to resolve the Stent' s restenosis.However to this day,no effective method has been discovered.The tumor' s growth is the major reason to the restenosis.Positive treatments to the primary tumor are required.It' s crucial to raise the forward effect.I-125 seeds which were made in China recently has the characteristic of low dose rate and persistent irradiation, which can redeem the insufficiency of the irradiation and be the permanent radiation source.It is hoped to decrease the restenosis of the stent by applying the I-125 seeds in the bile duct.The unite use of TCM can raise the patient' s immunity and reduce the infect rate,and can raise the patient' s toleration to intervention.PurposeTo observe the TCM zhenghou' s change in the front and the back of the intervention and instruct the TCM diagnosis and treatment.To evaluate the effect of the aidi injection in treatment of the malignant jaundice with deficiency of vital energy,poison and blood stasis syndrom.To evaluate the effect of the aidi injection' s in raising the patient' s immunity and reduce the infect rate.To evaluate the feasibility of the applying the I-125 seeds in the bile duct with home-made catheter.To evaluate the effect of the I-125 seeds in the bile duct to prevent and cure the Stent' s restenosis.To find the best Chinese and Western Medicine solution to treat the malignant obstructive jaundice.To find an effective solution to resolve the Stent' s restenosis and raise the effect,extend the patient' s lifetime,improve the patient' s Quality of Life.MethodWe use control experiment,Prospective Trial.There are thirty eight malignant obstructive jaundice patients in hospital 10th,2005-4th,2008.We put the 19 cases into the treatment group(biliary stent implantation + intraluminal brachytherapy by I-125 seeds) and another 19 cases into the antitheses group(biliary stent implantation).8 cases in the treatment group and 11 cases in the antitheses group use aidi injection.And to valuate the TCM zhenghou' s change,liver function,KPS score,CEA,the infect rate,the infect duration,survival rate and median survival time in the two group in the front and the back of the intervention.ResultAll the patient' s jaundice,abdominal pain,feel thirsty and bitter,be disturbed and fretful Score are soar before the intervention.And the above-mentioned Biaoshi syndrome reduce one week after the intervention.The differents have statistics significance(P＜0.05).The Benxu syndrome such as short of breath,don' t want talk,out of strength,abdominal distension reduce after the intervention.The differents have statistics significance(P＜0.05).All the syndrome except fever and loss of appetite reduce than before the intervention.The differents have statistics significance(P＜0.05).The aidi injection group has a lower infection and shorter infect duration than the other group.The differents haven' t statistics significance(P＞0.05).All the patient' s liver function change smaller one week,one month,three month after the intervention than before the intervention.ALT,AST,TBIL,DBIL,GGT,TBA are smaller one week,one month,three month after the intervention than before the intervention.The differents have statistics significance(P＜0.05).KPS increase one week,one month after the intervention.The differents have statistics significance(P＜0.05).The patient' s liver function such as ALT,AST,TBIL,DBIL,GGT,TBA change smaller in the treatment group one week,one month,three month,six month after the intervention than before the intervention,one week after the intervention change smaller obviously.TBIL,DBIL in the treatment group are smaller one week,one month,three month,six month after the intervention than before the intervention.There are obviously smaller one week,one month,six month after the intervention than before the intervention.The differents have statistics significance(P＜0.05).The liver function change smaller in the antitheses group one week,one month,three month after the intervention than before the intervention.TBIL,DBIL in the antitheses group are smaller one week,one month after the intervention than before the intervention.The differents have statistics significance(P＜0.05).But ALT,AST,TBIL,DBIL,ALP increase six month after the intervention than before the intervention.It remind that the jaundice in the antitheses group recur six month after the intervention.ALT,AST,TBIL,DBIL,GGT,TBA,ALP in the treatment group are smaller than that of the antitheses group six month after the intervention.AST,TBIL,DBIL in the treatment group are seriously smaller than that of the antitheses group. The differents haven' t statistics significance(P＞0.05).KPS increace one week,one month after the intervention than before the intervention in the two groups.KPS in the treatment group increace seriously one week,one month after the intervention than before the intervention.The differents have statistics significance(P＜0.05).KPS in the antitheses group increace seriously one week after the intervention than before the intervention.The differents have statistics significance(P＜0.05).KPS in the treatment group is more than that of the antitheses group one week,one month after the intervention.The differents have statistics significance(P＜0.05).CEA in the treatment group is seriously smaller than that of the antitheses group six month after the intervention.The differents have statistics significance(P＜0.05).The counts without jaundice in the treatment group are more than that of the antitheses group when the patient die or the last correspondence.The differents have statistics significance(P＜0.05).The median survival time of the treatment group is 456 days.The median survival time of the antitheses group is 330 days.The median survival time of the treatment group is longer than that of the antitheses group.The differents have statistics significance(P＜0.05). The median survival time of the pancreatic cancer IS the longest in the treatment group,it' s 690 days.And the shortest is the carcinoma of gallbladder,.it' s 60 days.The differents in different carcinoma type haven' t statistics significance(P＞0.05).The median survival time of the carcinoma of bile duct IS the longest in the antitheses group,it' s 330 days.And the shortest is the pancreatic cancer,.it' s 165 days.The differents in different carcinoma type haven' t statistics significance in the antitheses group(P＞0.05).ALT,AST in the treatment group change smaller after the intervention than before the intervention.WBC,BUN,Crea in the treatment group after the intervention haven' t differents than that before the intervention.The differents in different carcinoma type haven' t statistics significance(P＞0.05).ConclusionThe Intervention has seriously effect to the TCM zhenghou' s in the malignant obstructive jaundice.Before the Intervention there are Benxu and Biaoshi syndromes,and the Biaoshi syndromes are major.After the Intervention Benxu syndromes are noticeable.Aidi injection can reduce the infect rate of the malignant obstructive jaundice.PTCD combined with Billary stent can get rid of the obstruction,recover the physiologic drainage of the bile, improve the liver function.PTCD combined with Billary stent have precise effection in the treatment of the malignant obstructive jaundice.It' s feasible to apply the I-125 seeds in the bile duct with home-made catheter. I-125 seeds in the bile duct can inhibit the grouth of the tumor tissue,extend the time of the stent keep smooth,,improve the liver function,extend the survival time of the patients.