鱼皮胶原蛋白-壳聚糖复合海藻酸盐水凝胶敷料对烧烫伤创面的促愈合作用

本文以海藻酸钠为原料,复配壳聚糖、鱼皮胶原蛋白,通过Ca2+离子交联制备成海藻酸盐水凝胶敷料。测试了该敷料的物理机械性能及其对大白兔浅Ⅱ度烧烫伤创面的促愈合作用。结果表明：鱼皮胶原蛋白-壳聚糖复合海藻酸盐水凝胶的含水量≥80%,具有良好的吸湿保湿和机械性能,是一种理想的伤口创面敷料;对浅Ⅱ度烧烫伤的愈合周期远远少于医用纱布、市售聚氨酯水凝胶敷料,且能消除伤口炎症,抑制瘢痕的生成,在伤口护理方面有着良好的前景和应用方向。     

An alternative approach to wound healing field; new composite films from natural polymers for mupirocin dermal delivery

In this study, novel adhesive films were prepared for Mupirocin dermal delivery. Natural polymers as chitosan, sodium alginate and carbopol were used for films development to evaluate possible interactions and drug release properties. Solvent evaporation method was used for films preparation. Preliminary studies involved FT-IR spectroscopy and Scanning Electron Microscopy to specify interactions and morphology. Thickness, tensile strength and water uptake in phosphate buffer saline were evaluated whereas in vitro release studies were also performed. In vitro drug release studies demonstrated that mupirocin release was improved. Ex vivo bioadhesion and permeation studies using Balb-c mice were performed to check the suitability of the films. Antimicrobial ability was evaluated by agar well diffusion tests. Finally, excisional wound model applied to test the wound healing effect and evaluated macroscopic and histopathologically. One formulation was found more effective compared to the market product for wound healing at Balb-c mice.     

Novel multifunctional platforms for potential treatment of cutaneous wounds: Development and in vitro characterization

An original formulative/manufacturing approach for the development of a multi-composite wound dressing able to control the release of a water soluble API (lidocaine HCl) for several days was evaluated. The prepared multi-composite wound dressing is a microstructured spongy matrix, which embeds solid lipid microparticles (SLMs). The matrices were obtained by freeze drying of polyelectrolyte complexes made up two biopolymers: three different chitosan to alginate weight ratios (1:1, 3:1 and 1:3) were studied. The drug-loaded matrices were investigated as regards water uptake ability, swelling, drug loading, morphology and release profiles. SLMs were prepared at two different drug loadings (5% and 25%, w/w) by the spray congealing technology and were then incorporated in the spongy matrices. The characterization of the SLMs evidenced their spherical shape, mean dimensions lower than 20 μm, controlled release and the modification of the drug crystalline state. Comparing the release profiles of the SLMs-loaded sponges, the matrices with 1:3 chitosan/alginate ratio displayed a sustained release profile with the lower burst effect. Then hyaluronan and cysteine were embedded into the matrix to enhance the wound healing properties of the dressing. The final multi-composite platform was able to promote the growth of fibroblasts maintaining its prolonged release characteristic.     

藻酸盐敷料治疗顽固性窦道伤口的疗效观察

目的探讨藻酸盐敷料治疗顽固性窦道伤口的疗效。方法将32例顽固性窦道伤口患者根据随机分为观察组和实验组,各16例,观察组使用传统碘仿敷料条填充治疗,实验组使用藻酸盐敷料填充条治疗,两组从愈合时间、疼痛和治疗费用方面比较治疗效果。结果实验组藻酸盐敷料较观察组碘仿敷料可明显提高治愈率,在伤口愈合时间28天之内实验组有12例,而观察组仅6例。实验组较观察组可有效地减轻换药时的疼痛程度,实验组0、1、2、3级疼痛者分别为2、14、0、0例,而观察组分别为1、2、13、0例。实验组患者平均医疗费用为356元,而观察组为468元。经统计学分析,差异均有统计学意义（P〈0．05）。结论藻酸盐敷料治疗顽固性窦道伤口不仅可缩短治愈时间,减轻患者疼痛,同时还能减少患者的费用,具有临床应用价值。     

Novel neomycin sulfate-loaded hydrogel dressing with enhanced physical dressing properties and wound-curing effect

To develop a novel neomycin sulfate-loaded hydrogel dressing (HD), numerous neomycin sulfate-loaded HDs were prepared with various amounts of polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP) and sodium alginate (SA) using freeze-thawing technique, and their physical dressing properties, drug release, in vivo wound curing and histopathology in diabetic-induced rats were assessed. SA had a positive effect on a swelling capacity, but a negative effect on the physical dressing properties and drug release of HD. However, PVP did the opposite. In particular, the neomycin sulfate-loaded HD composed of drug, PVA, PVP and SA at the weight ratio of 1/10/0.8/0.8 had excellent swelling and bioadhesive capacity, good elasticity and fast drug release. Moreover, this HD gave more improved wound curing effect compared to the commercial product, ensured the disappearance of granulation tissue and recovered the wound tissue to normal. Therefore, this novel neomycin sulfate-loaded HD could be an effective pharmaceutical product for the treatment of wounds.     

A comparison of the efficacy of the alginate preparation, Gaviscon Advance, with placebo in the treatment of gastro-oesophageal reflux disease

The aim of this study was to compare the efficacy of the sodium alginate preparation, Gaviscon Advance, with placebo in the relief of symptoms of reflux oesophagitis. This was a randomised, double-blind, parallel-group, multicentre study conducted at 13 GP centres in the UK. Patients aged between 18 and 70 years, who had experienced symptoms of reflux oesophagitis within the previous 24 h, and on two other occasions within the previous week, were recruited into the study. Patients were evaluated at baseline, and then reassessed after two and four weeks of treatment with sodium alginate or placebo, for symptoms of reflux oesophagitis in the previous 24 h. Patients were required to fill out a diary card twice daily, from which frequency and severity of symptoms were assessed, and the percentage of symptom-free days and nights calculated. Of the 100 patients recruited into the study, 98 received medication (safety population; placebo, n = 50; sodium alginate, n = 48) and 94 were eligible for inclusion in the intention-to-treat (ITT) population (placebo, n = 48; sodium alginate, n = 46). For this population, sodium alginate was assessed as significantly superior by both investigators and patients at week two (p < 0.001 and p = 0.004, respectively) and at week four (p = 0.001 and p < 0.001, respectively). Significantly more patients in the safety population on placebo withdrew from the study (40%) compared with sodium alginate (21%; p = 0.04), due primarily to lack of effect and adverse events. The sodium alginate preparation demonstrated a superior efficacy compared with placebo, which was achieved in a more acceptable volume of medication than a previous standard preparation, Liquid Gaviscon. The reduced dosage volume of the 'new' preparation (Gaviscon Advance) may be expected to improve patient compliance, and thereby increase treatment efficacy.     

Comparison of 1% and 2% lidocaine hydrochloride used as single local anesthetic: effect on postoperative pain course after oral soft tissue surgery.

It is known that some local anesthetics may cause pain when the initial local anesthetic effect disappears. The aim of this trial was to compare the postoperative pain intensities after infiltration of plain lidocaine 1% and 2% used in gingivectomies. The trial was done as a controlled, randomized, double-blind, parallel group study involving 117 patients with mean age 48 years (range 29-71 years) allocated to two treatment groups. There was no statistically significant difference between the mean postoperative pain courses of lidocaine 1% and 2% after gingivectomies during an 11-h observation period. A numerical difference was seen from 7 to 11 h in favor of lidocaine 1%. There were more patients experiencing no pain, but more patients reporting higher pain scores in the lidocaine 2% group than in the lidocaine 1% group. These differences were not statistically significant. It can be concluded that there is apparently no difference between lidocaine 1% and 2% with respect to postoperative pain experience when using gingivectomy as a pain model.     

Efficacy of topical ketorolac tromethamine 0.4% for control of pain or discomfort associated with cataract surgery

SUMMARY

Objective: To evaluate the efficacy of ketorolac 0.4% ophthalmic solution for control of pain and discomfort associated with cataract surgery.

Methods: This was a single-center, double-masked, randomized, fellow-eye placebo-controlled clinical study of 25 patients (mean age 72?years; 76% female) requiring bilateral cataract surgery. Patients received either ketorolac tromethamine 0.4% ophthalmic solution (Acular LS*) or placebo, 1 drop QID for 3?days prior to and 1?day following phacoemulsification and intraocular lens implantation on their first eye, and the other treatment for surgery on the second, fellow eye 1?week–4?weeks later. The physician rated patient cooperation and ocular pain or discomfort during surgery, and patients rated ocular pain or discomfort immediately and 24?h after surgery.

Results: Patients reported significantly less ocular pain during the 24?h following surgery when treated with ketorolac 0.4% than with placebo (?p = 0.02). Ocular pain was reported for only a single ketorolac 0.4%-treated eye (4%) during that period, compared with 39% of placebo-treated eyes (?p = 0.004). No significant differences between eyes treated with ketorolac 0.4% and placebo were observed in patient cooperation, and ocular pain or discomfort during or immediately after surgery. No adverse events occurred during the study.

Limitations: Evaluation of pain is subjective, and the severity of pain experienced in the control, vehicle-treated eyes was low.

Conclusions: The reduction in pain associated with cataract surgery afforded by ophthalmic ketorolac 0.4%, together with its favorable safety profile, make it an important tool to help surgeons meet the high expectations of today's cataract and refractive surgery patients.     

1例输液港植入术后囊袋切口脂肪液化并血栓形成的护理

目的 探讨股静脉输液港植入术后囊袋切口脂肪液化及下肢静脉血栓形成的护理效果.方法 对1例因股静脉置入输液港后发生囊袋切口脂肪液化并血栓形成的肺癌患者,通过正确进行伤口评估、囊袋切口运用了湿性愈合及减痛换药的护理;同时动态观察右下肢静脉血栓及时进行下腔静脉滤网置入术的处理.结果 患者输液港囊袋伤口愈合良好,输液港拔出后未发生血栓脱落.结论 正确进行伤口评估,湿性愈合及减痛换药理论,使用适宜的敷料,进行有效的伤口护理,可减轻患者的痛苦,促进伤口愈合,有效防止并发症.     

Multifunctional Medicated Lyophilised Wafer Dressing for Effective Chronic Wound Healing

Wafers combining weight ratios of Polyox with carrageenan (75/25) or sodium alginate (50/50) containing streptomycin and diclofenac were prepared to improve chronic wound healing. Gels were freeze-dried using a lyophilisation cycle incorporating an annealing step. Wafers were characterised for morphology, mechanical and in vitro functional (swelling, adhesion, drug release in the presence of simulated wound fluid) characteristics. Both blank (BLK) and drug-loaded (DL) wafers were soft, flexible, elegant in appearance and non-brittle in nature. Annealing helped to improve porous nature of wafers but was affected by the addition of drugs. Mechanical characterisation demonstrated that the wafers were strong enough to withstand normal stresses but also flexible to prevent damage to newly formed skin tissue. Differences in swelling, adhesion and drug release characteristics could be attributed to differences in pore size and sodium sulphate formed because of the salt forms of the two drugs. BLK wafers showed relatively higher swelling and adhesion than DL wafers with the latter showing controlled release of streptomycin and diclofenac. The optimised dressing has the potential to reduce bacterial infection and can also help to reduce swelling and pain associated with injury due to the anti-inflammatory action of diclofenac and help to achieve more rapid wound healing. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 103:1720-1733, 2014     

Development of polyvinyl alcohol-sodium alginate gel-matrix-based wound dressing system containing nitrofurazone

Polyvinyl alcohol (PVA)/sodium alginate (SA) hydrogel matrix-based wound dressing systems containing nitrofurazone (NFZ), a topical anti-infective drug, were developed using freeze-thawing method. Aqueous solutions of nitrofurazone and PVA/SA mixtures in different weight ratios were mixed homogeneously, placed in petri dishes, freezed at -20 degrees C for 18h and thawed at room temperature for 6h, for three consecutive cycles, and evaluated for swelling ratio, tensile strength, elongation and thermal stability of the hydrogel. Furthermore, the drug release from this nitrofurazone-loaded hydrogel, in vitro protein adsorption test and in vivo wound healing observations in rats were performed. Increased SA concentration decreased the gelation%, maximum strength and break elongation, but it resulted into an increment in the swelling ability, elasticity and thermal stability of hydrogel film. However, SA had insignificant effect on the release of nitrofurazone. The amounts of proteins adsorbed on hydrogel were increased with increasing sodium alginate ratio, indicating the reduced blood compatibility. In vivo experiments showed that this hydrogel improved the healing rate of artificial wounds in rats. Thus, PVA/SA hydrogel matrix based wound dressing systems containing nitrofurazone could be a novel approach in wound care.     

Efficacy of topical ketorolac tromethamine 0.4% for control of pain or discomfort associated with cataract surgery

OBJECTIVE: To evaluate the efficacy of ketorolac 0.4% ophthalmic solution for control of pain and discomfort associated with cataract surgery. METHODS: This was a single-center, double-masked, randomized, fellow-eye placebo-controlled clinical study of 25 patients (mean age 72 years; 76% female) requiring bilateral cataract surgery. Patients received either ketorolac tromethamine 0.4% ophthalmic solution (Acular LS *) or placebo, 1 drop QID for 3 days prior to and 1 day following phacoemulsification and intraocular lens implantation on their first eye, and the other treatment for surgery on the second, fellow eye 1 week-4 weeks later. The physician rated patient cooperation and ocular pain or discomfort during surgery, and patients rated ocular pain or discomfort immediately and 24 h after surgery. RESULTS: Patients reported significantly less ocular pain during the 24 h following surgery when treated with ketorolac 0.4% than with placebo (p = 0.02). Ocular pain was reported for only a single ketorolac 0.4%-treated eye (4%) during that period, compared with 39% of placebo-treated eyes (p = 0.004). No significant differences between eyes treated with ketorolac 0.4% and placebo were observed in patient cooperation, and ocular pain or discomfort during or immediately after surgery. No adverse events occurred during the study. LIMITATIONS: Evaluation of pain is subjective, and the severity of pain experienced in the control, vehicle-treated eyes was low. CONCLUSIONS: The reduction in pain associated with cataract surgery afforded by ophthalmic ketorolac 0.4%, together with its favorable safety profile, make it an important tool to help surgeons meet the high expectations of today's cataract and refractive surgery patients.     

A Comparison of the Efficacy of the Alginate Preparation,Gaviscon Advance,with Placebo in the Treatment of Gastro-Oesophageal Reflux Disease

Summary

The aim of this study was to compare the efficacy of the sodium alginate preparation, Gaviscon Advance, with placebo in the relief of symptoms of reflux oesophagitis. This was a randomised, double-blind, parallel-group, multicentre study conducted at 13 GP centres in the UK. Patients aged between 18 and 70 years, who had experienced symptoms of reflux oesophagitis within the previous 24?h, and on two other occasions within the. previous week, were recruited into the study. Patients were evaluated at baseline, and then reassessed after two and four weeks of treatment with sodium alginate or placebo, for symptoms of reflux oesophagitis in the previous 24?h. Patients were required to fill out a diary card twice daily, from which frequency and severity of symptoms were assessed, and the percentage of symptom-free days and nights calculated. Of the 100 patients recruited into the study, 98 received medication (safety population; placebo, n = 50; sodium alginate, n = 48) and 94 were eligible for inclusion in the intention-to-treat (ITT) population (placebo, n = 48; sodium alginate, n = 46). For this population, sodium alginate was assessed as significantly superior by both investigators and patients at week two (p < 0.001 and p = 0.004, respectively) and at week four (p = 0.001 and p < 0.001, respectively). Significantly more patients in the safety population on placebo withdrew from the study (40%) compared with sodium alginate (21%;p = 0.04), due primarily to lack of effect and adverse events. The sodium alginate preparation demonstrated a superior efficacy compared with placebo, which was achieved in a more acceptable volume of medication than a previous standard preparation, Liquid Gaviscon. The reduced dosage volume of the ‘new’ preparation (Gaviscon Advance) may be expected to improve patient compliance, and thereby increase treatment efficacy.     

A double-blind study of the efficacy of topical ketorolac tromethamine gel in the treatment of ankle sprain, in comparison to placebo and etofenamate

In a double-blind, placebo-controlled study the efficacy and safety of topical ketorolac tromethamine were assessed in the reduction of inflammation and pain due to ankle sprain. Ketorolac 2% gel was compared with etofenamate and placebo (ketorolac vehicle) in a 15-day study. Patients attended for visits on days 1 (admission), 2, 3, 4, 8, and 15 of the study. Measurements of efficacy were ankle volume, pain measured on visual analogue scales (VAS) and verbal rating of pain. Safety was assessed by volunteered adverse events and vital signs. A total of 37 patients was admitted to the study of whom 13 received ketorolac, 12 placebo, and 12 etofenamate. One patient receiving ketorolac was lost to follow-up on day 15 owing to an unrelated accident. The remaining 36 patients completed the study. Ketorolac was significantly better than placebo in reducing the volume of the injured ankle based on the maximum, the area under the curve, and the day 15 percentage changes in ankle volume. Results for etofenamate were similar to those for ketorolac for all three variables and there were no significant differences between the active treatments. Reductions in VAS pain at rest were more marked in the ketorolac group than either of the other groups at all visits. On day 4 the differences between ketorolac and each of the other groups were statistically significant. Reductions in VAS pain on movement were also greatest for the ketorolac group at all visits. The differences between ketorolac and each of the other groups achieved statistical significance on days 4 and 8, but were marginal in terms of significance on day 2.(ABSTRACT TRUNCATED AT 250 WORDS)     

A double-blind study with placebo control of intramuscular ketorolac tromethamine in the treatment of cancer pain

The analgesic efficacy of ketorolac tromethamine was compared to placebo in 126 patients suffering moderate or severe chronic pain due to cancer in a double-blind parallel randomized study. Ketorolac was administered intramuscularly in doses of 10, 30 or 90 mg. Pain intensity and pain relief were assessed for 6 hours by scoring standard verbal scales and an overall assessment of the medication was given by the patients and the observer on completion of the study. Each dose of ketorolac was statistically superior to placebo for the sum of pain intensity difference (SPID) but no difference was seen between the three ketorolac regimens. When the ketorolac groups are combined, there was a significantly better pain relief as compared to placebo. The global evaluation scores were also statistically superior in the ketorolac groups combined than in the placebo group. A total of 15 patients reported minor adverse events, 10 being after ketorolac doses. This study shows that single intramuscular doses of ketorolac of 10 mg and above are effective in the relief of cancer pain, and are associated with a low incidence of side-effects.     

藻酸钙盐及多爱肤敷料治疗Ⅲ度、Ⅳ度压疮的临床评价

目的观察藻酸钙盐、多爱肤敷料治疗Ⅲ度、Ⅳ度压疮的效果。方法将41例Ⅲ度、Ⅳ度压疮患者根据入院时间随机分成2组,观察组21例予藻酸盐及多爱肤敷料治疗,对照组20例子常规换药。结果两组在创面愈合时间、愈合率、护理工作量、治疗费用方面有显著性差异（P〈0．01）,观察组愈合时间短,疗效高,没有增加费用。结论藻酸盐、多爱肤敷料治疗Ⅲ度、Ⅳ度压疮是目前理想方法之一。     

Local anesthetic lidocaine-encapsulated polymyxin–chitosan nanoparticles delivery for wound healing: in vitro and in vivo tissue regeneration

In relieving local pains, lidocaine, one of ester-type local anesthetics, has been used. To develop the lidocaine membranes of enhanced local anesthetic effects, we have designed to establish the composition of wound dressings based on lidocaine chloride (LCH) (anesthetic drug)-loaded chitosan (CS)/polymyxin B sulfate (PMB). The LCH membranes (LCH-CS/PMB) was fabricated by the LCH oxide solutions within the CS/PMB matrix. The influences of different experimental limitations on CS/PMB membrane formations were examined. The double membrane particle sizes were evaluated by scanning electron microscopy (HR-SEM). Additionally, antibacterial efficacy was developed for gram-positive and negative microorganisms. Moreover, we examined in vivo healing of skin wounds formed in mouse models over 16 days. In contrast to the untreated wounds, rapid healing was perceived in the LCH-CS/PMB-treated wound with less damaging. These findings indicate that LCH-CS/PMB-based bandaging materials could be a potential innovative biomaterial for tissue repair and regeneration for wound healing applications in an animal model.     

Development of polyurethane foam dressing containing silver and asiaticoside for healing of dermal wound

 Polyurethane foam dressings for dermal wounds were formulated with natural polyols in order to improve the foam characteristics and the release of 2 active agents, silver and asiaticoside (AS) as an antimicrobial agent and an herbal wound healing agent, respectively. The foam was instantly formed by interaction of polyols and diisocyanate. Hydroxypropyl methylcellulose, chitosan and sodium alginate were individually mixed with the main polyols, polypropylene glycol, in the formulation while the active components were impregnated into the obtained foam dressing sheets. Although the type and amount of the natural polyols slightly affected the pore size, water sorption-desorption profile and compression strength of the obtained foam sheets, a prominent effect was found in the release of both active components. Among natural polyols formulations, foam sheets with alginate showed the highest silver and AS release. Non-cytotoxicity of these foam sheets to human fibroblast cells was confirmed. Antimicrobial testing on four bacteria strains showed that 1 mg/cm2 silver in formulations with 6% of natural polyols and without natural polyols had sufficient content of the silver release with comparable inhibition zone and significantly larger zone than other formulations. In pig study, the foam dressing with 6% alginate, 1 mg/cm2 silver and 5% AS could improve wound healing in both the percentage of the wound closure and histological parameters of the dermal wound without any dermatologic reactions. In conclusion, this innovative foam dressing had potential to be a good candidate for wound treatment.     

A multiple-dose comparison of ketorolac tromethamine with diflunisal and placebo in postmeniscectomy pain

The efficacy of oral ketorolac 5 mg and 10 mg taken qid was compared in a randomized double-blind study with that of oral diflunisal 500 mg bid (interleaved with placebo twice daily) and of placebo, in 120 patients suffering at least moderate pain following meniscectomy. The trial comprised two phases: (1) an acute phase (the first postoperative day) and (2) a chronic phase (days 2-5 postoperatively). Acutely, pain was assessed before drug administration, and then 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, and 9.0 hours after the first dose. The second of the four daily doses was administered at four hours after the first dose. During the chronic phase, pain was assessed using visual analogue scales at 8 AM and 4 PM daily. The acute phase results show that all the active treatments were statistically significantly superior to placebo but were not distinguished from each other. Over the chronic phase, ketorolac 5 mg and placebo showed similar results, with diflunisal showing the least pain relief and ketorolac 10 mg the most. All the active treatments showed a low incidence of side effects and, in an overall evaluation, no one treatment was distinguishable. Ketorolac would seem to be an acceptable therapy for acute postoperative pain.