Objective To evaluate the clinical effectiveness and safety of compound loratadine capsule in the treatment of allergic rhinitis. Methods A multi-center randomized single blind controlled trial (by using a random number table generated random sequence and the sequence was concealed by sealed envelopes) was designed. Two hundred and forty outpatients with allergic rhinitis who met the inclusion and exclusion criteria were randomized to the treatment group (n=120 with compound loratadine capsule, 1 capsule q 24 h) or the control group (n=120 with loratadine tablet, 1 tablet q 12 h). All patients were given standard therapy. Results ① At the end of the treatment, in the compound loratadine group, 101 patients completed the study, and 19 patients withdrew. In the loratadine group, 103 patients completed the study, 17 patients withdrew. According to intention-to-treat analysis (ITT), the improvement rates of the treatment and control groups were 89.17% (107/120) and 88.33% (106/120) respectively. No significant difference was seen between the two groups (rank sum test, u=-1.8348, P＞0.05). According to per-protocol analysis (PP), the improvement rates of the treatment and control groups were 96.04% (97/101) and 91.26% (94/103) respectively. No significant difference was seen between the two groups (rank sum test, u=-1.625 7, P＞0.05). ② Adverse events were slight to moderate.The adverse event rates were 22.5% (27/120) and 21.67% (26/120) in the treatment and control groups respectively. No significant difference was seen between the two groups ( χ2 test, P＞0.05). Conclusion Compound loratadine capsule is effective and safe for allergic rhinitis.
To develop the chitosan /polyethylene glycols succinate (CH/PEG-SA) mitomycin C (MMC) film drug del ivery system and its release effect in vitro. Methods MMC loading in composite films was determined using a UV-visible spectrophotometer. Freeze-dried films (90 mg) were immersed in 1 mL PBS buffer (pH 7.4). The concentrations ofMMC releasing in vitro were calculated refer to the standard curve of relationship between the concentrations of MMC and the value of UV-visible spectrophotometer. The curve of the concentrations of MMC releasing from the films in vitro was drawn at different time. The relationship between the films, structure and the drug releasing was revealed. Results The films showed swell ing without brittleness. The equation of Linear Regression was y=0.593x3– 2.563x2 +25.944x – 0.236 (R2=1.000). The film had a good drug del ivery capabil ity. The samples weighing 20 mg were soaked into the l iquid of PBS, the releasing concentrations of MMC were 14.961 6 μg/mL at 12 days, 14.482 4 μg/mL at 18 days and 11.409 2 μg/mL at 32 days, which was higher than ID50 of MMC (10.471 3 μg/L) to fibroblast. Then MMC was released at a low concentration. The releasing concentrations of MMC was 0.179 3 μg/ mL at 60 days until being del ivered completely. Conclusion The flexibil ity is enhanced , and the mechanical function is improved, so that there is better nature of membrane. The initial burst is avoided more effectively, and the drug releasing would be maintained for a certain time.
Objective To introduce a method to repair soft tissue defect in different regions and different areas of hand in one procedure. Methods From May 2002 to May 2005, anterolateral femoral flap or lobulated anterolateral femoralflap(forming irregular anterolateral femoral flap) was designed into different shapes to repair multiple soft tissue defect in different regions in hand, whichwas used clinically in 27 cases. Among 27 cases, there were 16 males and 11 females; the locations were left hand in 9 , right hand in 16 and left foot in 2; including 5 penetrating injury, 9 hotpressing injury, 2 soft tissue defection of instep and planta by milled injury, 6 gearing injury and 5 carding machine injury. All the cases complicated by exposure of tendons, bones or joints. Defect was repaired with H-shape flaps in 5 cases of penetrating palm injuries; with Y-shape or K-shape flaps in 11 cases of dorsals or combined with fingers of hand with skin defect; with shape flaps in 3 cases of dorsals combined with sides of palms or the first web of hands with skin defect and in 2 cases of skin defects of dorsals combinedwith palms of feet;with h-shape flaps in 6 cases of skin defects of dorsal or palms combined with disconnected skin defect of fingers. The sizes of main flaps ranged from 6.5 cm×4.8 cm to 17.0 cm×12.0 cm, the sizes of lobulate flaps ranged from 3.5 cm×2.8 cm to 7.5 cm×4.5 cm. Results Allflaps survived without vascular crisis after operation. Except the fascia flapall recipient sites healed by first intention. The follow-up period ranged from 3 months to 1 year, all cases had satisfactory appearance, the texture of flaps was soft. Except 2 cases of penetrating injury, 3 cases of hotpressing injuryand1 case of carding machine injury whose function was not satisfactory, theremaining cases achieved the function of snap and pinch. More than 1 year after operation, the sense of pain and touch recovered. There was no functional impairment at the donor sites although scar hyperplasia was formed in some cases.Conclusion The application of irregular anterolateral femoralflap is an optimal choice for complex skin defect of hand.
In order to solve the difficult problems of repair and reconstruction for severe deep burns with compound tissue defects of upper limb, 26 cases were treated with transplantation of compound tissue flap, vascularized by anastomosis of blood vessel or by vascular pedicle. Several kinds of reparative and reconstructive procedure could be performed simultaneously. Not only the tissue defect was repaired, but also the upper limb function was reconstructed in one stage operation. Owing to the presence of abundant vascular supply from the vascularized compound tissue and primarily closing the wounds, the anti-infection potency was high, then it was suitable for such conditions as fresh severe deep burn with infection and compound tissue defects. As a result, this technique provided the best chance to save upper limb from amputation. The duration required for treatment could be markedly shortened. All the cases successed. The long-term functional recovery was satisfactory. This method provided the possibility to solve effectively the difficult problem dealing with the severe deep burns with compound tissue defects of upper limb.
Objective To investigate the current situation of randomized controlled trials (RCTs) on compound salvia pellet (CSP) for angina pectoris and assess whether there is adequate evidence for clinical practice. Methods We collected all the published clinical studies on CSP for angina pectoris from 1994 to December 2005, and assessed each included report using the Jadad scale, the revised CONSORT statement and other self-edited items. Results We finally identified 115 RCTs. Among which, 1 scored 3 points, 6 scored 2 points, 106 scored 1 points and 2 socred 0 points. No RCT performed allocation concealment according to the CONSORT criteria, only 4 RCTs (3.5%) described the generation of the randomization sequence, among which 2 were quasi-randomized. No RCT provided randomization implementation,1 RCT (0.9%) carried out placebo control, 1 RCT (0.9%) reported endpoint, 9 RCTs (7.8%) adopted single blinding, 4 RCTs (3.5%) reported double blinding, 11 RCTs (9.6%) calculated statistical values, 2 RCTs (1.7%) provided the record of follow-up, 1 RCT (0.9%) reported negative outcome, 25 RCTs (21.8%) described adverse events, no RCT described how the sample size was estimated, and how an intent-to-treat (ITT) analysis and correlation analysis were reported, 1 RCT (0.9%) was multi-center, no RCT completed ethical approval and informed consent, 27 RCTs (23.5%) described syndrome type of TCM. Conclusion Currently, the methodology and reporting of studies on CSP for angina pectoris are not good enough to provide reliable evidence for clinical practice.
Objective To summarize the therapeutic experiences of abdominal wall bulge repair with compound patch intraperitoneal placement. Methods From October 2005 to October 2008, intraperitoneal onlay mesh with compound patch applied in 7 patients with abdominal wall bulge, whose clinical data were analyzed retrospectively. Results All the procedures were performed successfully, including 5 open operation and 2 laparoscopic repair. The mean operation time was 85 min (ranged 68 to 130 min). After operation, 1 seroma formation and 1 hemorrhage in the thoracic cavity developed and were cured with the conservative therapy. Mean postoperative hospital stay was 9.5 d (ranged 8 to 16 d). There was no recurrence, infection, or prolonged pain during 1－4 years follow-up. Conclusion Abdominal wall bulge is caused by the weakness of abdominal wall muscle, and the intraperitoneal onlay mesh repair with compound patch is an appropriate therapy.
OBJECTIVE: To investigate the effect of compound pattern of ceramic bovine bone (CBB) and hydrogel(HG) on attachment, proliferation and differentiation of bone marrow stromal cell (MSC), and to find out the best way of constructing tissue engineered bone. METHODS: CBB, HG and MSC was compounded in different patterns and sequences to form CBB/HG/MSC (group A), HG/MSC/CBB (group B), CBB/MSC/HA (group C) and CBB/MSC (control group). Attachment and morphology of MSC were observed by scanning electronic microscope; the proliferation of MSC was evaluated by cell count; alkaline phosphatase(ALP) activity was examined by histochemistry and type I collagen synthesis was examined by immunohistochemistry staining 5 and 10 days later. RESULTS: In group A, MSC spread better, and ALP activity of group A was significantly higher than that of group B and control group(P lt; 0.01); but there was no significant difference between group A and group C(P gt; 0.05). There was no significant difference in type I collagen synthesis between four groups on the 5th day; but mean gray scale of type I collagen in group B was significantly higher than that in the other groups on the 10th day(P lt; 0.01). CONCLUSION: Different compound patterns of CBB, HG and MSC affect attachment, proliferation, differentiation of MSC. The compound pattern of CBB/HG/MSC is better than the others.
Objective
To study the influence of calcium acetate tablets combined with compound alpha-keto acid on calcium and phosphorus metabolism in maintenance hemodialysis (MHD) patients.
Methods
A total of 112 MHD patients with hyperphosphatemia treated between May 2014 and May 2015 were included in this study. Based on random number table method, they were divided into calcium acetate group (n=37), compound alpha-keto acid group (n=36) and combined drug use group (n=39). All the patients were given a low protein diet. Twelve weeks after treatment, we compared the calcium and phosphorus metabolic indexes, nutrition indicator levels and adverse reactions within and across the three groups.
Results
Before treatment, there was no significant difference among the three groups in terms of serum calcium, phosphorus, calcium-phosphorus product, and parathyroid hormone (PTH) level (P>0.05). After treatment, the combined drug use group had significantly lower levels of serum phosphorus, calcium-phosphorus product and PTH than the other two groups (P<0.05). Before treatment, the levels of creatinine, serum total protein and albumin were not significantly different among the three groups (P>0.05). After treatment, the serum total protein and albumin level in the combined drug use group were significantly higher than those in the other two groups (P<0.01). Three was no significant difference among the three groups in terms of adverse reactions (P>0.05).
Conclusions
For MHD patients with hyperphosphatemia, the combined use of calcium acetate tablets and compound alpha-keto acid is better than the use of single drugs, which can effectively improve patients’ symptoms and reduce the level of serum phosphorus with high security. It is worthy of clinical recommendation.
Objective Dexamethasone (DXM) can regulate the balance of neutrophil and cytokine and enhance the ischemia-reperfusion tolerance of the skin flap; amlodipine besylate (AB) can selectively expand the peripheral blood vesselsand rel ieve the vascular smooth muscle spasm. To investigate the percutaneous penetration abil ity of DXM/AB compound gel and evaluate its effect on survival of ischemic skin flap. Methods Sodium carboxymethylcellulose was used to make blank gel, which was mixed in DXM, AB, azone (AZ), and progylene glycol (PG) respectively to make the compound gel containing 0.3%DXM/0.5%AB only (group D), the compound gel containing 3%AZ/2%PG, 3%AZ, and 2%PG (groups A, B, and C), the 0.3%DXM gel containing 3%AZ/2%PG (group E), the 0.5%AB gel containing 3%AZ/2%PG (group F). The accumulative penetration of DXM and AB in compound gel, 0.3%DXM gel, 0.5%AB gel through excised rat skin and its penetration within flap tissue were investigated by ultraviolet spectrophotometry. Fifty SD rats were selected to make 100 mm × 10 mm random flap at the back, and were randomly divided into 5 groups according to different gels which were used to treat flaps (n=10): compound gel group (group A1), 0.3%DXM gel group (group B1), 0.5%AB gel group (group C1), blank gel group (group D1), and peritoneal injection of DXM (5 mg/kg) and AB (2 mg/kg) (group E1). The survival area of ischemic random skin flap was measured on the 7th day by planimetry. Twenty-four SD rats were selected to make 100 mm × 10 mm random flap at the back, and were randomly divided into 2 groups (n=12). The accumulative penetration of DXM and AB within skin flap were also detected at 2 and 6 hours after appl ication of 2 g of compound gel containing 3%AZ/2%PG (group A2) and peritoneal injection AB (2 mg/kg) / DXM (5 mg/kg) (group B2). Results The accumulative penetration of DXM and AB in compound gel were increased in time-dependent manner (P lt; 0.05), and it was the highest in group A, and was significantly higher than that in group B and group C (P lt; 0.01), but there was no significant difference when compared with group E or group F (P gt; 0.05). The accumulative penetration of DXM and AB in groups A, B, and C were significant higher than that in group D (P lt; 0.05). After 7 days, the survival area of flaps in groups A1, B1, C1, D1, and E1 were (695.0 ± 4.6), (439.3 ± 7.1), (477.5 ± 14.5), (215.2 ± 3.8), and (569.4 ± 9.7) mm2, respectively; group A1 was significantly higher than other groups (P lt; 0.05). After 2 and 6 hours, the quantities of DXM and AB in skin flap of group A2 were significantly higher than that of group B2 (P lt; 0.05). Conclusion In 0.3%DXM/0.5%AB compound gel, DXM and AB might penetrate into skin tissue, which could significantly increase the survivalarea of ischemic skin flap.
Objective To evaluate the effect of nano-hydroxyapatit
e collagen (nHAC) bone and marrow mesenchymal stem cells (MSCs) on the treatment
of rabbit osteonecrosis of the femoral head (ONFH) defect. Methods
From June to October 2004, animal models of ONFH defect were established i
n 45 New Zealand rabbits. They were divided into 3 groups randomly:In group A,
as the control group, defect was not filled with any implants; In group B with
nHAC; In group C with nHAC+MSC. Imaging and histological observation were made
4, 8, 12 weeks after operation. Results group C had a better o
steogenesis ability than group B and group A. group B had a better osteogenesis
ability than group A. Obvious new bones and osteogenesis were observed in group
C 4 weeks after operation. The defect areas in group C were almost repaired 12
weeks after operation. Conclusion nHAC has a better effect of o
steoconduction and it is a superior material for repairing bone defect of ONFH a
nd of great value in treating ONFH when compounded with MSCs.
