| Objection:To evaluate the clinical efficacy and safety of applying leech earthworm activating blood stasis capsule for alternative anticoagulation after digital replantation. Methods :1) the 100 patients that meet the conditions is selected from Affiliated Chinese Hospital of Lu Zhou Medical College of Hand Surgery from June 2014 to December 2014, the 100 case were randomly divided into two group:The cases had been postoperatively given with anti-infective treatment, anti-spasmodic treatment combined only oral administration Leech earthworm activating blood stasis capsule in the Study Group(group A);The other cases had been postoperatively given with conventional treatment(three anti-treatment) in Control Group(group B); For to reduce bias results, the two groups were operated by the same operation group,using the same or similar surgical reimplantation. 2)Collecting to compare two group demographic data, collecting to compare clinical outcome measures of two groups(including wound healing type, finger swelling time, the number of days of hospitalization, finger temperature, wound bleeding, injured finger elastic, capillary refill time, finger color) in postoperative two weeks, comparing two groups of preoperative and postoperative blood inflammatory response indicators colleted(includingwhite blood cell count, C-reactive protein, procalcitonin),comparing two groups of preoperative and postoperative coagulation data colleted, comparing two groups of preoperative and postoperative hemorheological parameters colleted, comparing two groups of adverse drug reactions, after postoperative 3 month, comparing two groups of functional rehabilitation, that is to study safety and effectiveness of Leech earthworm activating blood stasis capsule. 3)All data were processed using SPSS18.0.0 software, Defining that P<0.05 was considered statistically significant. Results:(1) There are 50 cases of 68 fingers in the Study Group(Group A), the patients in Group A consisted of 30 male patients(60%) and 20 female patients(40%) with an average age of 37.96±11 years old(range 20 to 60), injured finger and finger amputation plane: the proximal part of thumb amputated 6 cases(8.82%), the distal part of thumb amputated 14 cases(20.59%), the proximal part of forefinger amputated 6 cases(8.82%), the middle part of forefinger amputated 6 cases(8.82%), the distal part of forefinger amputated 7 cases(10.29%), the proximal part of the middle finger amputated 2 cases(2.94%), the middle part of middle finger amputated 5 cases(7.35%), the distal part of middle finger amputated 3 cases(4.41%), the proximal part of ring finger amputated 4 cases(5.88%), the middle part of ring finger amputated 1 cases(1.47%), the distal part of ring finger amputated 2 case(2.94%),the proximal part of little finger amputated 6 cases(8.82%), themiddle part of little finger amputated 5 cases(7.35%), the distal part of little finger amputated one cases(1.47%).(2) There are 50 cases of 56 fingers in Control Group(group B). Patients in Group B consisted of 28 male patients(56%) and 22 female patients(44%) with an average age of aged 36.6±9.8 years old(range,18 to 58), injured finger and finger amputation plane: the proximal part of thumb amputated 7 cases(10.45%), the distal part of thumb amputated 11 cases(16.42%),the proximal part of forefinger amputated 3 cases(4.48%), the middle part of forefinger amputated 8 cases(11.94%), the distal part of forefinger amputated 10 cases(14.93%), the proximal part of the middle finger amputated 2 cases(2.99%), the mid section of middle finger amputated 3 cases(4.48%), the distal part of middle finger amputated 6 cases(8.96%), the proximal part of ring finger amputated 3 cases(4.48%), the middle part of ring finger amputated 1 cases(1.49%), the distal part of ring finger amputated 2 cases(2.99%),the proximal segment of little finger amputated 4 cases(5.97%), the middle section of little finger amputated 6 cases(8.96%),the distal part of little finger amputated 1 cases(1.49%).(3) Baseline demographic characteristics and injured situation of the two groups have no statistically significant difference.(4)There are 2 fingers of vascular crisis(Incidence of 2.94%) and 1 finger of replantation necrosis(necrosis rate 1.5%,the survival rate 98.5%)in group A. There are 9 fingers of vascular crisis(Incidence of 13.4%) and 8fingers of replantation necrosis(Necrosis rate11.9%) the survival rate 88.1% in group B. The incidence of vascular crisis and finger replantation survival rate is significant difference between two groups(P=0.026,0.036).(5) Group A and group B have no statistically significant difference of coagulation before treatment( P>0.05), in Study Group and Control Group there is no statistically significant difference of coagulation after treatment( P>0.05).(6) Except postoperative fifth and twelfth day, hemorheology indicators of two groups was no statistically significant difference preoperatively, this same result occurs at the postoperative first hour and the postoperative first day.(7)The general clinic Situation(including injured finger elastic, capillary refill time, finger color) of the study group generally score at postoperative third day and postoperative sixth day is better than the Control Group, the general clinic Situation of the two groups was statistically different(P=0.033,0.001).(8)Study Group(Group A) 65 fingers of Ⅰ type wound healing(95.59%), 57 fingers ofⅠ type wound healing in the Control Group(Group B)(85.07%), there was statistical difference between two groups(P=0.038).(9)57 finger of Study Group have 6 days of finger swelling time,that accounted for 83.82%. In the Control Group, 35 fingers have 6 days of six days finger swelling time, that accounted for 52.24%, difference of the two groups is statistically significant(P = 0.000).(10)the average days of Study Group in hospital stay is 12 days,an average of 14 days in the Control Group, there was statistically significant difference in the two groups(P=0.000).( 11) After postoperative treatment, the mean limb temperature of Study Group is higher than the mean limb temperature of the Control Group, The difference from two groups is statistically significant(P=0.000).(12)Group A and Group B have no statistically significant difference of mean white blood cell count before treatment, at the postoperative sixth day mean white blood cell count in the Study Group is less than number of the Control Group, the difference in two groups is statistically significant(P=0.000); Group A and Group B have no statistically significant difference of C-reactive protein quantitative before treatment. At the postoperative sixth day C-reactive protein quantitative of Study Group was lower than the Control Group’s, the difference in two groups is statistically significant(P=0.000). Group A and Group B have no statistically significant difference of procalcitonin quantitative. At the postoperative third day the postoperative procalcitonin quantitative of Study Group was lower than the Control Group, The difference of two groups was statistically significant(P=0.000).(13)Adverse drug reactions(gastrointestinal side effects, upper gastrointestinal bleeding, allergy): there are no cases in Study Group, there are 6 cases in the Control Group, The difference between two groups is statistically significant(P=0.026).(14)wound bleeding : there are no cases in Study Group, thereare 2 fingers of two cases in the Control Group, The difference of two groups is not statistically significant(P=0.244).(15) Functional rehabilitation: there are 64 function excellent fingers in Study Group, there are 50 function excellent fingers in the Control Group, The difference in two groups was statistically significant(P=0.040). Conclusion:1 It has better efficiency that the conventional anti-infective treatment and anti-spasmodic treatment combined only oral administration Leech earthworm activating blood stasis capsule compared to the traditional three anti therapy:①the therapy can improve the survival rate of finger replantation surgery, significantly improve hemorheological parameters of finger replantation patients, improve microcirculation of patients after replantation, it have superior efficacy for preventing vascular crisis and reducing finger necrosis. ②the therapy improve patient clinical outcome measures in general, including wound healing time, finger swelling time, the hospitalization days, finger temperature, wound bleeding, injured finger elastic, capillary refill time, finger color,all of the datas are better than the Control Group. ③ Study Group inflammation is lighter than the Control Group, no postoperative infection occurs. ④It more improve coagulation of finger replantation patients, comparing to conventional drugs.⑤ After postoperative 3 month the functional recovery of the Study Group is more excellent than the Control Group’s. 2 Study group’s therapy compared to the traditionalthree anti-treatment is more economical, safe and controllabe,and low side effects is less, etc.① It reduces drug injection pain and vascular crisis from pain;② Study has shown that leech earthworm activating blood stasis capsule has no oral significant gastrointestinal reactions, no abnormal wound bleeding; no coagulation abnormalities for using leech earthworm activating blood stasis capsule, and it have better controllability. ③ It is low anticoagulant cost and a better economy. Patient of hand injury have condition of blood block and vein damaged. leech earthworm activating blood stasis capsule have the above advantages, Really leech earthworm activating blood stasis capsule is good medicine for patient of hand injury. |
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