| Objectives:1. To evaluate the effectiveness of Yunnan Baiyao capsules taken orally by the fracture patients.2. To evaluate the safety of Yannan Baiyao capsules taken orally by the fracture patients.Methods:Compared with the placeboes through randomizing double-blind, comparisons, multicenter clinical trials, we have treated 70 effective cases in two sub-centers of People's Hospital of Sichuan Province and the First Orthopedist Hospital of Chengdu so as to evaluate the effectiveness and safety of Yunnan Baiyao capsules with regard to fracture healing. According to therapeutic regimens, we have established two groups, the experimental group and the control group. The experimental group:After surgery, the patients took Yunnan Baiyao capsules in the morning of the first day and didn't cease until the end of the fourth week; then they took the placeboes-a kind of lacuna starch capsules-two capsules a time and four time a day for two weeks. The control group:After surgery, the patients took the placeboes from the first day's morning, two capsules a time and four times a day until the end of the sixth week. The effectiveness indexes, that is, the indexes of primary curative effects:in accordance with the X-ray irradiation taken on the day of surgery, two days as well as six weeks after surgery, the therapeutic indexes can be figured out in order to evaluate the effectiveness of accelerating fracture healing. Safety evaluation indexes:i. vital signs; ii. laboratory examinations:blood routine, liver function, renal function and coagulation function; iii, poor incoming part, in line with the former indexes, the safety can be evaluated.Results:1. Case distributions and general results74 patients are chosen in this study. There are 34 patients in experimental group,36 cases are completed, one case is lost to follow and one excluded; there are 36 patients in control group,34 cases are completed, two cases are lost to follow. The ages, sexes, case resources and surgical procedures of the two groups are not statistically significant (P>0.05).2. Analysis of effectiveness (the curative effects of fracture healing)There are ten patients are cured,19 patients'conditions are excellent and seven patients'conditions are improved in the experimental group; there are seven patients are cured,13 patients'conditions are excellent and 14 patients'conditions are improved. The rates of curative effects of fracture healing by closed reduction with internal fixation and open reduction with internal fixation are not statistically significant (P>0.05). The rates of curative effects between patients grouped closed reduction and those grouped open reduction are not statistical significance (P>0.05).3. Analysis of safetyAfter treatment, the laboratory parameters of the patients have been manifested'normal before treatment, abnormal after treatment'. The phenomena may be caused by infection or drug combination on account of fracture. A poor incoming part appeared in the control group. The analyzed reason may be the combination of open reduction and postoperative analgesia pump. The incidence rates of poor incoming part between the two groups are not statistically different (P>0.05).Conclusion:It is effective and safe that the fracture patients are healed through Yunnan Baiyao capsules.
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