The Efficacy And Safety Study Of Caffeic Acid Tablet In Combination With High Does Dexamethasone In The Treatment Of ITP

BackgroundPrimary immune thrombocytopenia(ITP)is one kind of common hemorrhagic diseases,accounting for about 33%of hemorrhagic disease.The main manifestations of ITP include spontaneous bleeding of skin and mucous membrane,or even life-threatening intracranial hemorrhage.Laboratory examinations of ITP show decreased periphery platelet counts,reduced platelet lifespan with normal or slightly increased megakaryocytes in bone marrow.The main mechanism of ITP is loss of immune tolerance,and thus leading to increased platelet destruction and decreased platelet release through maturation of megakaryocytes.High-does dexamethasone(40 mg/d*4 days,2 weeks for one cycle)is commonly used as a first-line treatment for ITP.However,long-term remission rate in patients under high-dose dexamethasone treatment is low.Caffeic acid's functions are known as antioxidant,increasing WBC counts,anti-inflammation,increasing platelet counts and hemostasis.One of our multi-center clinical research found that caffeic acid can significantly increase the platelet count of ITP patients and may be a potential therapeutic method for ITP treatment.The pathogenetic mechanisms of ITP are diversities,and monotherapy still has shortcome and risk.Research objectivesTo evaluate the efficiency and safety of caffeic acid tablet in combination with high-doe dexamethasone in the treatment of patients with newly diagnosed ITP.Research methodsA total of 60 patients were enrolled in this retrospective study with 34 patients in group A and 26 patients in group B.All patients enrolled were newly diagnosed with ITP in Qilu hospital Shandong University.Patients in group A were treated with high-dose dexamethasone for 1 or 2 cycles,and oral administration caffeic acid(0.9g/d,tid)for 12 weeks.Patients in group B only received dexamethasone for 1 or 2 cycles.The overall response rate(OR),complete response rate(CR),platelet accounts(day 7,day 14,day 21,day 28,months 2,months 3,months 4,months 5,months 6),bleeding scores,the time to response(TTR)and adverse effects were collected.Gender,age,initial platelet number and other basic conditions of patients enrolled were also taken into account.Result(1)In group A,the median age of patients was 45(18?69)years old,the sex ratio(male/female)was 8/26 and initial platelet counts was 4.5(0?27)×109/L.In group B,the median age of patients was 49.5(27?67)years old,the gender ratio(male/female)was 9/17 and platelet counts before treatment was 7(0?28)×109/L.There was no significant difference in sex ratio(P=0.87),age(P=0.35)or initial platelet counts(P=0.54)between two groups.(2)After 28 days of treatment,the overall response rate(OR)of group A was 79.4%(27/34),the complete response rate(CR)was 58.8%(20/34);and in group B the overall response rate(OR)was 57.7%(15/26),the complete response rate(CR)was50%(13/26),There was no significant difference in OR(P=0.069)or CR(P=0.496).(3)After treatment,there was no significant difference in platelet counts and it' s elevation between two groups.Blood routine examination was done in day 7,day 14,day 21,day 28,months 2,months 3,months 4,months 5,months 6(platelet counts P=0.84,0.21,0.90,0.75,0.62,0.23,0.46,0.56,0.52,respectively;platelet counts elevation P=0.90,0.19,0.86,0.81,0.79,0.18,0.18,0.33,0.32,respectively).(4)The reduction of bleeding scores in group A was remarkably higher than group B(P = 0.019),meaning obvious improvement of bleeding symptoms in group A compared to group B was found.(5)There was no significant difference in the time to response[4.5(1?22)vs.6(2?57)days]between two groups.(6)The adverse effects were mild both in group A and group B,and could usually be resolved spontaneously without drug withdrawal.ConclusionThe overall response rate(OR)of caffeic acid combined with high dose dexamethasone in the treatment of newly diagnosed ITP was 79.4%,which means that combined drugs has good curative effect,but the difference was not significant.Caffeic acid combined with high doses dexamethasone could significantly alleviate the bleeding symptoms of patients than high doses of dexamethasone monotherapy did.The platelet counts at each time point was not significantly different between two groups.There was no significant difference on time to response between two groups.Compared to high dose dexamethasone monotherapy,caffeic acid with high dose dexamethasone was well tolerated without multiplied adverse effects.