| Objective Develop an absorbable bone wax based on Pluronic and prove its nontoxic through the animal experiment; Use composites from absorbable bone wax and Yunnan baiyao into the bone wounds bleeding in order to research its efficacy and safety.Method Mixed the amount of solid Pluronic F88and solid Pluronic P85according to the proportion of1to9, and heated、dissoluted、packed、cooled, sterilized, got an absorbable (Pluronics copolymer, like wax) bone wax; Injected leach liquor of absorbable bone wax and normal saline into the mice abdominal cavity respectively by the celiac shots. At the different point-in-time, observed general condition (activity, appetite, breathe, abdominal stimulating signs, failure, cyanosis and death); Made modes of rats cranial parietal defect:divided54health SD rats (any male and female, weight250g±50g) into the experimental group, the control group and blank group, each group included18rats. Via ether anesthesia, fixed rats, disinfected rats forehead, and paved sterile sheet. Cut the skin along the rats parietal midline, separated soft tissue and periosteum. Drilled two holes for1cm distance with electric drills(3mm in diameter,2mm deep); Implanted absorbable bone wax into rats skull defect, at the same time set Aixikang bone wax group and blank control group, Implanted Aixikang bone wax into rats skull defect from Aixikang bone wax group, blank control group rats were not implanted any material. After2w.4w、8w detected blood routine (WBC. RBC. PLT. HGB. LY. NE), blood biochemical of liver and kidney (ALT. AST. UREA. CR. UA) through femoral artery bloodletting. After blood collection, executed rats, cut off the cranial parietal, removed liver and kidney, and made the tissue slice. Observed inflammation of implant area of skull defects organization generally. Under a microscope, observed morphological changes of the rats liver and kidney. Evaluated inflamemation of implant area around the skull defect; Preliminary observation of clinical application:(1). preparation of absorbable bone wax and yunnan baiyao compound:heated the absorbable bone wax, and made it melt into liquid, Mixed the amount of Yunnan baiyao according to the proportion of1to2, stired and mixed them, under normaltemperature cooled them into soft solid.(2),Clinical application:Selected orthopaedic surgery cases from the175th hospital of PIL (Thoracolumbar fractures,2011-02to2012-02), a total of42cases, including26male cases,16female cases). The average age is16to61years old. Divided patients into two groups randomly(Absorbable bone wax and yunnan baiyao compound group and Aixikang bone wax group), each group included21cases. When patients had bone haemorrhage symptom, the doctor daubed absorbable bone wax and yunnan baiyao compound group or Aixikang bone wax. Observed hemostatic effect after the first, the second daubs, intraoperative blood loss, intraoperative blood transfusion and the healing conditon of incision operation area postoperatively, evaluated the curative effect.Result After injecting leach liquor of absorbable bone wax into the abdominal cavity of12small mices, all the mices breathing rhythms were well-balanced, none of the mices were found expiratory dyspnea, diarrhea, abdominal stimulation, weight reduction and death at24h、48h、72h after surgery; At2w、4w after surgery, absorbable bone wax group and Aixikang bone wax group were statistically significant (P<0.05) as blood routine index (WBC、RBC、PLT、HGB、LY、NE) by single factor analysis of variance. At8w after surgery absorbable bone wax group and blank control group were not statistically significant (P>0.05) as blood routine index. At2w,4w,8w after surgery, each group were statistically significant (P<0.05) as blood biochemical index (ALT、AST). UREA、CR、UA index were not statistically significant (P>0.05); At2w after surgery, the liver and kidney organization structure were not changed, the bone defect of cranial parietal were a few inflammatory cells under a microscope. At4w,8w after surgery, liver, kidney, and bone defect were not significantly change and had no inflammatory cells; Comparison of significant efficiency of composites from absorbable bone wax and Yunnan baiyao group(30cases) and Aixikang bone wax group (30cases) after the first, the second daubs:the former is better than the latter; Significant efficiency of daubs for many times (including the first, the sesond times):the former is better than the latter; We found that using composites from absorbable bone wax and Yunnan baiyao into bone bleeding wound was effecter than Aixikang bone wax after the first, the second daubs, that is significant difference (P<0.05). The two groups were compared to blood loss and intraoperative blood transfusion:the former is significantly less than the latter; After using composites from absorbable bone wax and Yunnan baiyao into bone bleeding wound,18cases were not abnormal reaction,2cases were serie grade Ⅰ healing. A little colorless or light yellow secretions were found in operation area. And in rare cases,1cases were poor healing, local tissue intensity decreased, healing delayed, the incisions were grade Ⅱ healing. But none of operation districts were infectd after using composites from absorbable bone wax and Yun-nan baiyao.Conclusion Absorbable bone wax is a safe, nontoxic hemostatic material, which can be used for bone wound bleeding; Composites from absorbable bone wax and Yunnan baiyao were used in bone bleeding wound, its hemostatics is rapid, and its adhesion is good, it do not influence on healing of operation area, and it is a safe and reliable hemostatic materials of compound Chinese medicine-organic compounds. |
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