| ObjectiveTo evaluate the clinical curative effect and advantages of Shuganhuayutang combined with hydroxyurea in high-risk patients with essential thrombocythemia(ET),and to provide the basis for further prospective study of this treatment of high-risk ET.MethodsRetrospective investigation of medical records of ET patients from department of Hematology in Guangdong Hospital of Traditional Chinese Medicine from January 2010 to December 2016.First of all,the first clinic visit data of all the ET patients were collected,and the differences in sex constitution,age,clinical symptoms(vasomotor symptoms)and Traditional Chinese Medicine(TCM)syndrome(stagnation of liver qi,blood stasis)scores between the high-risk group and the non high-risk group were compared.Secondly,according to the research criteria,the high-risk patients with ET who in treatment of Shuganhuayutang combined with hydroxyurea for more than 3 months were screened.The changes of blood routine and the improvement of clinical symptoms were recorded during the treatment.To evaluate the TCM syndrome efficacy of Shuganhuayutang,after 1-month treatment,we compared the TCM syndrome(stagnation of liver qi,blood stasis)score before and after treatment of the high-risk patients with ET whose platelet count decreased less than 20%(according to ET standard of Western medicine efficacy is invalid).To evaluate the clinical efficacy of Shuganhuayutang combined with hydroxyurea in high-risk patients with ET,after 3-month treatment we compared the platelet count,clinical symptoms,TCM syndrome score before and after treatment.Finally,according to the presence of JAK2V617F gene mutations,the high-risk patients with ET after 3-month treatment were divided into JAK2V617F gene mutation positive group and JAK2V617F gene mutation negative group.To make sure that the two groups of patients were comparable,we compared baseline data(gender,age,platelet count,hydroxyurea dose)between the two groups before treatment,and compared the efficacy of two groups according to response evaluation criteria after 3-month treatment with Shuganhuayutang combined with hydroxyurea.Results1.There were 209 patients with ET,males:females=1:1.58,with an average age of 47.25±18.60 years old.122 cases of non high-risk group,males:females=1:1.49,the average age of 36.86±11.75 years old,vasomotor symptoms scores 1.16±2.04,stagnation of liver qi syndrome scores 1.92±2.99,blood stasis syndrome scores 1.28±1.75;87 cases of high-risk group,males:females=1:1.72,the average age of 61.83 ±16.55 years old,vasomotor symptoms scores 1.29±2.09,stagnation of liver qi syndrome scores 2.55±3.26,blood stasis syndrome scores 1.17±1.74.The difference between high risk group and non high risk group in gender,clinical symptoms,TCM syndrome scores were not statistically significant(P>0.05);in terms of age,high-risk patients were older than non high risk group,the difference was statistically significant(P<0.05).2.There were 49 high-risk ET patients in treatment of Shuganhuayutang combined with hydroxyurea more than 3 months,the average age of 62.45±17.03 years old,the mean platelet count before treatment 906.29±270.69×109/L.Distribution of high risk factors:35 patients older than 60 years old,10 patients with history of thrombosis,12 patients with platelet count greater than 1500×109/L.3.After 1-month treatment of Shuganhuayutang combined with hydroxyurea,there were 10 high-risk patients with ET whose platelet count decreased less than 20%(according to ET standard of Western medicine efficacy is invalid).Before the treatment,stagnation of liver qi syndrome scores 6.00±2.65,blood stasis syndrome scores 3.50±1.41;after 1-month treatment,stagnation of liver qi syndrome scores 2.44 ±2.40,blood stasis syndrome scores 1.75±1.28.The TCM syndrome scores after 1-month treatment were lower than before,the difference were statistically significant(P<0.05),the total effective rate were 77.78%,62.50%,suggested that Shuganhuayutang could improve the TCM syndromes of high-risk patients with ET.4.After 3-month treatment of Shuganhuayutang combined with hydroxyurea,49 high-risk patient’ mean platelet count was 506.98±188.45×109/L.The platelet count after 3-month treatment were lower than before,and the difference was statistically significant(P<0.05),suggesting that Shuganhuayutang combined with hydroxyurea can effectively reduce the number of platelets in high-risk patients with ET.The clinical efficacy after 3-month treatment:28 cases effective,16 cases partially effective,5 cases ineffective,the total effective rate was 89.80%.The score of clinical symptoms(vasomotor symptoms)score and TCM syndrome(stagnation of liver qi,blood stasis)after 3-month treatment were lower than before,and the difference was statistically significant(P<0.05).The total effective rate was 82.14%,87.50%,58.62%,prompting that Shuganhuayutang combined with hydroxyurea had good curative effect for high-risk patients with ET,and could improve the clinical symptoms and TCM syndrome of patients.5.After 3-month treatment of Shuganhuayutang combined with hydroxyurea,according to the detection of JAK2V617F gene mutation,38 high-risk patientswith ET were divided into JAK2V617F gene negative group and JAK2V617F gene positive group.There were 21 patients without JAK2V617F gene mutation,males:females=l:1.33,with an average age of 63.43±17.65 years old,hydroxyurea dose 0.77±0.32g/d,the mean platelet count before treatment 889.76±331.33 X 109/L;17 patients with JAK2V617F gene mutation,males:females=1:1.43,with an average age of 64.18±14.04 years old,hydroxyurea dose 0.81±0.37g/d,the mean platelet count before treatment 927.41±277.75X 109/L.The difference between the two groups in gender,mean age,hydroxyurea dose,mean platelet count before treatment were not statistically significant(P>0.05).The two groups have balanced comparability.After the treatment,JAK2V617F gene negative group with the mean platelet count 494.10±202.42X 109/L,the total effective rate of Western medicine,vasomotor symptoms scores,stagnation of liver qi and blood stasis syndrome scores were 80.95%,80.00%,90.00%and 50.00%;JAK2V617F gene positive group with the mean platelet count 479.71±171.45 X 109/L,the total effective rate of Western medicine,vasomotor symptoms scores,stagnation of liver qi and blood stasis syndrome scores were 94.12%,75.00%,76.92%and 77.78%.Compared two groups with platelet count,clinical symptoms(vasomotor symptoms),TCM syndrome(stagnation of liver qi,blood stasis)scores,the difference were not statistically significant(P>0.05),suggested that Shuganhuayutang combined with hydroxyurea have similar curative effect on JAK2V617F gene mutation positive and negative in high-risk patients with ET.ConclusionThere was no significant difference in clinical symptoms in high-risk and non high risk ET patients,suggested that Shuganhuayutang could treat all ET patients.It was necessary that Shuganhuayutang combined with hydroxyurea in high-risk patients for thrombosis.Shuganhuayutang combined with hydroxyurea can effectively reduce the platelet count in high-risk patients with ET,and have better clinical curative effect,and relieve the vasomotor symptoms,stagnation of liver qi and spleen deficiency syndrome,blood stasis syndrome.Shuganhuayutang may play a major role in combination therapy for curative effect of TCM syndrome.The treatment had similar curative effect on JAK2V617F gene mutation positive and negative in high-risk patients with ET. |
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