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Objective: To perfect the theory system of minimally invasive treatment for osteonecrosis of the femoral head (ONFH) with β tricalcium phosphate (β-TCP) bioceramic system and evaluate the effectiveness. Methods: Eighteen New Zealand white rabbits aged 7-8 months were used to establish an animal model to verify the vascularization of porous β-TCP bioceramic rods. Micro-CT based three-dimensional reconstruction and fluorescence imaging were used to display the new blood vessels at 4, 8, and 12 weeks after operation. The inserting depth, number and diameter of vessels in the encapsulated area were analyzed. Nine pig femoral specimens were randomly divided into 3 groups ( n=3): group A was normal femur; group B had cavity (core decompression channel+spherical bone defect in femoral head); in group C, mixed bioceramic granules were implanted to fill the defect in femoral head, and porous β-TCP bioceramic rod was implanted into decompression channel. The stiffness and yield load of specimens were analyzed by biomechanical test. A multicenter retrospective study was conducted to analyze 200 patients (232 hips) with femoral head necrosis treated with bioceramic system in 7 hospitals in China between January 2012 and July 2018. There were 145 males and 55 females, with an average age of 42 years (range, 17-76 years). According to the Association Research Circulation Osseous (ARCO) stage, 150 hips were in stage Ⅱ and 82 hips in stage Ⅲ. Postoperative imaging assessment was carried out regularly, and hip function was evaluated by Harris score. The effectiveness of ARCO stage Ⅱ and Ⅲ was also compared. Results: Animal experiments showed that blood vessels could grow into the encapsulated area and penetrate it at 12 weeks. The inserting depth, number and diameter of blood vessels in the encapsulated area gradually increased, and there was significant difference between different time points ( P<0.05). Biomechanical tests showed that the stiffness and yield load of specimens in groups B and C were significantly lower than those in group A, while the yield load in group B were significantly lower than that in group C ( P<0.05). The stiffness in group C was restored to 41.52%±3.96% in group A, and the yield load was restored to 46.14%±7.85%. Clinical study showed that 200 patients were followed up 6-73 months, with an average of 22.7 months. At last follow-up, 12 patients (16 hips) underwent total hip arthroplasty, and the hip survival rate was 93.10%. According to the imaging evaluation, 184 hips (79.31%) were stable and 48 (20.69%) were worse. Harris score (79.3±17.3) was significantly higher than that before operation (57.3±12.0) ( t=18.600, P=0.000). The excellent rate of hip function was 64.22% (149/232). The survival rate of hip joint, imaging score and Harris score of patients in ARCO stage Ⅱ were better than those in ARCO stage Ⅲ ( P<0.05). Conclusion: β-TCP bioceramic system can guide the abundant blood supply of greater trochanter and femoral neck to the femoral head to promote repair; it can partly restore the mechanical properties of the femoral head and neck in the early stage, providing a new minimally invasive hip-preserving method for patients with ONFH, especially for those in early stage.
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OBJECTIVE: To evaluate the efficacy and safety of motherwort(herba leonuri)injection in the treatment of fetal membrane retention after vaginal delivery.METHODS: The prospective study was designed as a multicenter,open,randomized,controlled research from December 2017 to October 2018.A total of 244 women who achieved fullterm vaginal delivery were enrolled from 7 tertiary hospitals in China.Sixteen people were lost to follow-up(7 in the experimental group and 9 in the control group).All cases were randomly divided into group of motherwort(experimental group)and group of basic treatment(control group).Full Analysis Set(FAS)and Per ProtocolSet(PPS)were used for statistical analysis.The results of main validity indicators were the same.Therefore,only the results of PPS set analysis were reported in detail.PPS set included 109 cases in control group and 114 cases in experimental group.Control group were administered by oxytocin 20 U and cephalosporinⅡintravenous injection daily for3 days after birth;experimental group were administered by motherwort 20 mg intramuscular injection per 12 hours for 5 consecutive days on the basis of basic treatment.Both groups of patients were given oral herb medicine Chan-fu-kang or Chan-fu-an Granules after discharge for 7 consecutive days.The following clinical parameters were collected and analyzed for evaluation of the efficacy and safety of motherwort injection in the treatment of retained fetal membrane after vaginal delivery.The main effectiveness indicators were maternal lochia,uterine volume change,and discharge of retained fetal membrane;the secondary effectiveness indicators were the maternal infection-related factors and infections,the incidence of secondary postpartum hemorrhage,postpartum body temperature changes,and the use of other hemostatic drugs.Safety indicators were laboratory tests(blood routine,electrocardiogram),adverse reactions/events,which were used to evaluate the safety and efficacy of motherwort injection in the treatment of retained fetal membrane after vaginal delivery.RESULTS:(1)Lochia:the duration of bloody lochia was significantly shorter in the experiment group than in the control group([(5.12±1.83)d]vs.(6.27±2.07)d,P=0.000);rate of termination of bloody lochia within 5 days was significantly higher in the experiment group than in the control group(64.91% vs. 35.78%,P=0.000).(2)Comparison of uterine volume:the reduction of uterus volume in the experiment group was significantly greater than that in the control group(Z=-2.27,P8.0 mg/L or PCT>0.5 ng/L was defined as infection,the infection rate of the experiment group after 5 days of treatment was significantly lower than that of the control group(P0.05).No other hemostatic drugs were used in the two groups,and no secondary postpartum hemorrhage occurred.(6)There were no adverse reactions reported in both groups,and no abnormal blood routine indicators or electrocardiogram appeared.CONCLUSION: The application of motherwort injection combined with the basic treatment after the vaginal delivery can significantly shorten the duration of bloody lochia,promote uterine involution,increase the discharge rate of retained fetal membrane,and reduce the rate of uterine curettage.
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Objective: To observe the therapeutic effect and safety of Yaotongning Capsule in the treatment of lumbar hyperplasia. Methods: A random, double-blind, placebo controlled, multicenter clinical research method was used. The lumbar hyperplasia patients (144 cases) were selected, divided into Yaotongning Capsule group (treatment group) with 72 cases, 72 cases completed; and placebo group (control group) with 72 cases, 70 cases completed. The treatment lasted for 2 weeks. After treatment, the symptom of traditional Chinese medicine and pain relief situation were observed in the two groups. Results: The curative effects of Yaotongning Capsule in the treatment of lumbar hyperplasia disease (cold-dampness stagnation syndrome) were as follows: The control rate in treatment group was 41.5%, and that in the control group was 0.0%, superiority test (P<0.001) was established. Pain relief: the relieve rate in treatment group was 86.1%, and that in the control group was reduced to 45.7%, there was significant difference between the groups (P<0.001). Conclusion: Yaotongning Capsule in the treatment of lumbar hyperplasia (cold-dampness stagnation syndrome) has obviously curative effect, and can effectively reduce the pain caused by lumbar hyperplasia.
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Objective: To observe the clinical efficacy and safety of Yaotongning Capsule in acute lumbar muscle fiber inflammation (cold damp stagnation syndrome). Methods: A randomized, double-blind, placebo controlled multicenter and clinical trial was performed. The 144 patients were randomly divided into two groups, 72 cases in the treatment group treated with Yaotongning Capsule and 72 cases in the control group treated with placebo, 14 d as a course of treatment. Results: After one course of treatment, there was significant difference in the curative rate between treatment group and control group. According to FAS analysis, the ratio of control/effective cases and total cases (effective rate) in the treatment group was higher than that in the control group (P < 0.001). According to PPS analysis, the effective rate of the treatment group was obviously higher than that of the control group (P < 0.001). The pain relief of FAS and PPS in the treatment group also surpasses that in the control group (P < 0.001). And the differences both had statistical significance. Among 144 patients, the adverse events were found in three cases with the incidence of 2.10%. All of the adverse events were found in the control group and there were no remarkable adverse event and side effect in the treatment group. The incidence rate of adverse event in the treatment group was similar to that in the control group (P = 0.245). Conclusion: Yaotongning Capsule for lumbar muscle fiber inflammation has reliable efficacy, safety, and less incident of adverse effects.
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A total of 1,000 female patients aged between 18-45 years with menstrual irregularities and those willing to give informed consent were included in this multicentric, post marketing surveillance study. At the initial visit, a detailed medical history, symptomatic evaluation and gynecological evaluation was carried out in all the patients. Out of the 1,000 patients, 372 had dysmenorrhea, 388 had menorrhagia and 240 patients had oligomenorrhea. Each patient was administered Evecare Syrup at a dose of 15 ml, twice-daily for a period of three months. Statistical analysis was carried out using GraphPad Prism, Version 4.03. In 372 patients suffering from dysmenorrhea, 14 had slight abdominal pain and 358 of them had total absence of symptoms at the end of treatment. In patients with menorrhagia, significant reduction was observed in the mean score of duration of menstruation, quantity of blood loss, blood flow loss and character of blood flow changed from clot to flow after treatment with Evecare Syrup. At the end of three months of treatment, 238 patients had normal menstruation, normal duration and flow in oligomenorrhea. No clinically significant adverse drug reactions were reported except for one patient, who had symptoms of nausea; one patient had symptoms of gaseous distension at third month of treatment and it did not require additional treatment or drug withdrawal. The results of the present study showing clinical benefit of Evecare Syrup appear promising in the management of menstrual irregularities.