A Comparison of Two Botulinum Type A Toxin Preparations for the Treatment of Glabellar Lines: Double-Blind, Randomized, Pilot Study

BACKGROUND: Botulinum toxins have been proven effective for reducing facial lines. There are two commercial types of botulinum toxin type A available in many countries but no published comparison studies. OBJECTIVE: To compare the efficacy and tolerability of Botox Cosmetic and Dysport 50 U in the treatment of glabellar lines (using 20 U of Botox Cosmetic, which is the dose approved by the US Food and Drug Administration for the treatment of glabellar lines, and 50 U of Dysport, which has been reported to be the optimal dose for this formulation). STUDY DESIGN: Parallel-group double-blind pilot study. Evaluation by observing physician, photographic, and patient evaluations. CONCLUSION: Botox 20 U provided better and more prolonged efficacy than Dysport 50 U in the treatment of glabellar lines.     

Comparison of Botulinum Toxin Types A And B: A Bilateral and Double-Blind Randomized Evaluation in the Treatment of Canthal Rhytides

BACKGROUND: The obligate bacterium Clostridium botulinum produces exotoxins (A, B, C-1, C-2, D, E, F, G) that are serologically and antigenically distinct. All serotypes have similar neurotoxic properties resulting in flaccid muscle paralysis. Types A and B are commercially available and are used widely for the reduction of dynamic facial rhytides. Although extensive information is known about type A, type B has recently become available; however, there is a limited clinical familiarity. Some of the remaining unknown distinctions between the two subtypes are the extent of toxin diffusion from the site of injection, the onset of action, the dose equivalency, and the duration of effect. OBJECTIVE: The purpose of this preliminary double-blind study was to compare the duration of muscle paralysis and rhytid reduction of botulinum toxin types A and B. Additional relevant information was obtained, all of which can be useful in toxin selection. METHOD: Ten women, ages 28 through 60, voluntarily consented to undergo a double-blind trial and were randomly assigned to have botulinum toxin type A injected into one set of lateral canthal rhytides and toxin type B into the contralateral periocular region. Based on dose-ranging investigations performed in patients with cervical dystonia, participants received treatment at the lowest reported effective ratio of 1:50 (1 U of toxin type A to 50 U of toxin type B). Three injections of 5 U of type A (total 15 U) and three injections of 250 U of undiluted type B (total 750 U) were injected into the lateral fibers of the orbicularis oculi muscle. RESULTS: Patients were evaluated at 7, 30, 60, and 90 days. Findings were compared by the treating physician, patient self-assessment, and photographic images. CONCLUSION: All patients noted rapid and satisfactory reduction in the rhytides in both periocular areas. However, upon unblinding of the solutions at the same volumes with a 1:50 ratio, type B toxin was found to be associated with slightly more discomfort upon injection, quicker onset of action, a sensation of "tightness" of the treated area, and a briefer duration of muscle paralysis.     

Minimal effective dose of dysport and botox in a rat model of neurogenic detrusor overactivity

Background

Two botulinum toxins A have been evaluated for the treatment of refractory neurogenic detrusor overactivity (NDO) in humans: Dysport (abobotulinumtoxinA) and Botox (onabotulinumtoxinA). However, these two distinct commercialized products have different potency units and are not interchangeable.

Objective

Assessment of the dose response and determination of minimal effective dose (MED) for Dysport and Botox in spinal cord–injured (SCI) rats with NDO.

Design, setting, and participants

Female, adult, Sprague-Dawley rats (n = 98) underwent T8-T9 spinal cord transection. Nineteen days after spinal cord injury, rats received intradetrusor injections (25 μl injected, eight sites) of vehicle (V); Dysport 2, 5, 7.5, 10, and 12.5 U; and Botox 0.8, 2, 5, 7.5, and 10 U. Two days after injection, continuous cystometry was performed in conscious rats.

Measurements

Voiding contractions (VC) were assessed by duration of VC, intercontraction interval, voided volume, maximal pressure, pressure threshold change, and intravesical baseline pressure (BP), while nonvoiding contractions (NVC) were evaluated by amplitude, frequency, and volume threshold to elicit NVC. MEDs for Dysport and Botox were determined by analysis of variance step-down trend test.

Results and limitations

MEDs for Dysport and Botox were 10 U and 7.5 U, respectively. Regarding VC, only BP significantly decreased after 10 U Dysport and 7.5 U Botox compared to V (from 3.7 ± 0.6 to 1.5 ± 0.1 and 1.4 ± 0.3 mm Hg, respectively; p < 0.01 and p < 0.001, respectively). Dysport (10 U) and Botox (7.5 U) significantly inhibited NVC by decreasing their amplitude (from 7.4 ± 1.1 to 5.8 ± 0.5 and 5.4 ± 0.6 mm Hg, respectively; p < 0.05); frequency (from 2.2 ± 0.4 to 1.5 ± 0.2 and 1.3 ± 0.3 NVC per minute, respectively; p < 0.01); and increasing volume threshold to elicit NVC (from 29.8 ± 3.7 to 47.6 ± 6.9 and 47.7 ± 6.3%, respectively; p < 0.05 and p < 0.001, respectively).

Conclusions

This is the first preclinical dose-ranging study with Dysport and Botox under standardized conditions showing similar inhibiting effects on NDO, albeit at different MEDs. It highlights the importance of distinguishing each preparation for predicted outcomes and doses to be used. Further studies in patients with NDO are warranted to confirm these experimental results.     

Effects of botulinum toxin A on the contractile function of dog prostate

OBJECTIVES: To study effects of botulinum toxin A (BoNT/A) on prostate contractile function in dogs. METHODS: One hundred units (N=6) or 200 units (N=5) BoNT/A was injected into dog prostate. Sham control group (N=7) received normal saline injections. Before and 1 mo after injection, prostate urethral pressure response to electrostimulation and intravenous (IV) norepinephrine was measured. Contractile responses of prostate strips were tested in tissue bath. Structural changes were evaluated with conventional histology and smoothelin immunohistochemistry. RESULTS: Injection of normal saline and 100 units BoNT/A did not significantly change prostate urethral pressure response to IV norepinephrine and electrostimulation. However, injection of 200 units BoNT/A significantly reduced prostate urethral pressure response to IV norepinephrine and electrostimulation. Contractile responses of prostate strips to potassium chloride, electrostimulation, and phenylephrine did not differ between sham control and 100U groups. In the 200U group, however, all responses were less than those of sham controls. Control and BoNT/A groups exhibited nitric oxide-related relaxation in prostate strips precontracted by phenylephrine. Injection of 100 units BoNT/A induced mild atrophy of prostate gland; injection of 200 units BoNT/A induced more pronounced atrophic changes in prostate gland and vacuoles formation in smooth muscle cells of stromal tissue. CONCLUSIONS: Injecting BoNT/A into dog prostate reduces contractile function while maintaining relaxation response of the prostate. These effects make BoNT/A a viable option in managing prostate-related symptoms. However, large, randomized clinical studies to determine long-term effects and safety of BoNT/A application in human prostates are required.     

Electromotive drug administration of lidocaine to anesthetize the bladder before botulinum-A toxin injections into the detrusor

STUDY DESIGN: Prospective, open label, cross-over-designed clinical study. OBJECTIVE: To evaluate the effectiveness of an instillation of lidocaine into the bladder with versus without electromotive drug administration (EMDA) to anesthetize the bladder before botulinum-A toxin injections. SETTING: Neurourology, Swiss Paraplegic Center, Balgrist University Hospital, Zurich, Switzerland. METHODS: In all, 28 patients with severe neurogenic detrusor overactivity but preserved bladder sensibility were treated with botulinum-A toxin injections into the detrusor muscle. A measure of 300 u of botulinum-A toxin (Botox) was injected at 30 sites sparing the trigone. Prior to the injection, the bladder was anesthesized with conventional lidocaine instillation in a group of 10 patients and with lidocaine instillation enhanced by EMDA in 28 patients. The patients scored the injection pain on a 10-point rating scale. Pain rating scores with versus without EMDA enhancement of the lidocaine instillation were analyzed and the costs of the EMDA procedure were compared to general/spinal anesthesia. RESULTS: The mean pain score of the 10 patients who underwent the injections of Botox after conventional lidocaine instillation was 4.0 (SD 1.6). Following EMDA enhanced lidocaine instillation slight even or no pain occurred during the injections of Botox, and the mean pain score was 0.5 (SD 0.2). Compared to spinal or general anesthesia, the local anesthesia saved around 15% of the costs. CONCLUSIONS: EMDA enhanced instillation of lidocaine enables a sufficient anesthesia of the bladder wall that ensures a painless application of the botulinum-A toxin injections into the detrusor muscle. This method may avoid general or spinal anesthesia in patients with preserved bladder sensibility. It ensures considerable cost reduction, avoids anesthesia-related risks and complications and enables the procedure on an outpatient basis.     

Success of repeat detrusor injections of botulinum a toxin in patients with severe neurogenic detrusor overactivity and incontinence

OBJECTIVES: Detrusor injections with botulinum toxin type A are an effective treatment for neurogenic detrusor overactivity, lasting for 9-12 months. When the patients develop botulinum resistance, subsequent injections might be less effective. Repeat injections in patients with severe neurogenic detrusor overactivity and incontinence were studied. METHODS: Patients received Botox (300 UI) or Dysport (750 UI) injections. Clinical variables: satisfaction, anticholinergics use, mean and maximum bladder capacity, continence volume. Cystometric parameters: compliance, cystometric capacity, reflex volume. Statistics: Anova, chi2-tests; t-tests and paired t-tests (p=0.05). RESULTS: Forty-three men and 23 women (mean age 38.3 years; mean duration of lesion 9.2 years) were included. The interval between subsequent injections (on average 9-11 months) did not change significantly (p=0.5594). The satisfaction was high and anticholinergics use decreased substantially (p=0.0000). Significant improvements were found in clinical parameters and in cystometric capacity, for compliance only at the second treatment. The incidence of reflex contractions was significantly reduced. Four patients had transient adverse events after Dysport. CONCLUSIONS: Repeat injections with botulinum toxin type A are as effective as the first one. The cause for repeat treatment is relapse of overactive bladder symptoms.     

Treatment of chronic plantar fasciitis with botulinum toxin A--an open pilot study on 25 patients with a 14-week-follow-up

AIM: The conservative and operative treatments of plantar fasciitis tend to be tedious. Unsatisfactory results are common in chronic cases. This study was performed in order to test the hypothesis that the analgesic and anti-inflammatory effect of a single injection of Botulinum toxin A (BoNT A) induces a significant reduction of symptoms. METHOD: 25 patients were included and followed-up for 14 weeks. Prior to injection, all of them had undergone at least two trials of conservative treatment. To determine the optimal treatment dose, 6 patients were injected subfascially with 100 units BoNT A (Dysport), another 6 with 200 units BoNT A. As result of this pre-trial, another 13 patients were treated with the higher dose. The patients documented maximum pain and continuous pain on a visual analogue scale. The strength of the lower leg and foot muscles was clinically assessed. RESULTS: A significant reduction of maximum and continuous pain was seen 2 weeks after injection in the group of 19 patients treated with 200 units BoNT A and persisted until the end of the follow-up. Adverse effects such as weakness of the muscles or systemic reactions have not been observed. CONCLUSION: This pilot study shows the efficacy of a single application of 200 units BoNT A as a treatment option for chronic plantar fasciitis.     

Effects of Botox® and Neuronox® on muscle force generation in mice

The current study determined the dose–response relationship for inhibition of muscle force of two commercially available botulinum neurotoxin type‐A (BoNTA) preparations (Botox® and Neuronox®) in a murine model and characterized the time course of recovery from the toxin‐induced muscle paralysis. The effect of freezing reconstituted toxin on toxin potency was also determined. The gastrocnemius muscles in male CD‐1 mice were injected with either saline or BoNTA (0.3–3.0 U/kg), and muscle force generation was examined following stimulation of the tibial nerve (single twitch and 15–200 Hz tetany). Botox and Neuronox produced nearly equivalent decrements in muscle force (30%–90%) at 4 days after toxin injection. At 28 days after injection (1 U/kg), muscle force had recovered from the effects of both toxin preparations. Maintaining reconstituted toxin at ?80°C for up to 5 months did not result in significant loss of toxin activity. The results of this study suggest that Botox and Neuronox produce equivalent responses in a murine model, and, in contrast to other models, muscle recovery is rapid with doses of toxin that produce less than maximal decrements in muscle force. © 2007 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 25:1658–1664, 2007     

Botulinum toxin type B: a new therapy for axillary hyperhidrosis.

Primary axillary hyperhidrosis is a disorder affecting mainly adolescents with significant adverse effects on quality of life. No ideal treatment exists, although recent data has demonstrated Botulinum toxin type A (Botox) as a treatment option. However, antibody formation may lead to loss of clinical benefit over time. Botulinum toxin type B (Neurobloc) has recently been introduced and may induce less immunogenic response. OBJECTIVE: To investigate the efficacy of Neurobloc for axillary hyperhidrosis. METHOD: Thirteen patients (22 axillae) were recruited to the study. The hyperhidrotic area was defined using the iodine-starch test then measured and photographed. 5000 MU of Neurobloc was administered subdermally. Patients were reviewed at 4, 8 and 12 weeks to assess outcome objectively (hyperhidrotic area measurements and photographs) and subjectively (sweat production and patient satisfaction). RESULTS: There was a significant reduction in hyperhidrotic area at follow-up compared to baseline. Mean percentage reduction in hyperhidrotic area was 84, 87 and 81% at 4, 8 and 12 weeks (p=0.001, paired t test). Patient satisfaction was 100% throughout. Subjective mean percentage reduction in sweat production was 98, 96 and 90 at 4, 8 and 12 weeks. Side effects were minimal. CONCLUSION: Neurobloc is an effective treatment for axillary hyperhidrosis.     

Warm and Neutral Tumescent Anesthetic Solutions Are Essential Factors for a Less Painful Injection

BACKGROUND: Tumescent local anesthesia is widely used in dermatologic surgery. Minimizing pain associated with injections is crucial to successful surgical procedures. OBJECTIVE: This study investigates the pain associated with warm and room temperatures in neutralized or nonneutralized tumescent anesthetic solutions injection. METHODS: Thirty-six patients with axilla osmidrosis who underwent local anesthesia for surgery were randomly assigned to three groups. Group A received warm neutral (40 degrees C) and room-temperature neutral (22 degrees C) tumescent injections to each axillary region. Group B received warm neutral (pH 7.35) and warm nonneutral (pH 4.78) tumescent injections on each side of axilla. Group C received warm nonneutral and room-temperature nonneutral tumescent injections on each side of axilla. Pain associated with infiltration of anesthesia was rated on a visual analog scale (VAS). RESULTS: A statistically significant decrease (p < .001) in pain sensation was reported on the warm, neutral injection side (mean rating, 32.7 mm) compared with the room-temperature, neutral injection side (mean rating, 53.3 mm). Patient-reported pain intensity was significantly lower on the side that received warm, neutral tumescent anesthesia (mean rating, 26.8 mm) than on the side receiving warm, nonneutral tumescent anesthesia (mean rating, 44.9 mm; p < .001). The difference in VAS scores between warm neutral (mean rating, 23.9 mm) and room-temperature nonneutral (mean rating, 61.2 mm) was statistically significant (p < .001). CONCLUSION: The warm, neutral tumescent anesthetic preparation effectively suppressed patient pain during dermatologic surgical procedures.     

Evaluating Effects of Preservative-Containing Saline Solution on Pain Perception During Botulinum Toxin Type-A Injections at Different Locations: A Prospective, Single-Blinded, Randomized Controlled Trial

Pain is a side effect of botulinum toxin type-A (BTX-A) injections. The efficiency of the preservative-containing saline solution used as the “dilution solution” for controlling the pain felt during multiple injections in different areas has been investigated by a prospective, randomized, single-blinded, controlled study. A total of 93 patients were divided into three groups for the study. All the patients were given BTX-A. Of these 93 patients, 60 received injections in the upper face, 15 in the neck, and 18 in the axillary regions. The visual analog scale (VAS), a single-dimension pain intensity rating scale, was used to evaluate pain perception. The average VAS values for pain sensation experienced by the groups were 1.2 of 10 points for the upper face area in the experimental group (n = 60) and 4.5 point for the control group. In the neck region (n = 15), the respective scores were 0.6 in the experimental group and 3.9 in the control group. Finally, in the axillary region (n = 18), the respective values were 0.9 and 5.1. The authors conclude that the preservative-containing saline solution significantly decreased pain perception during BTX-A injections (p = 0.000).     

Botulinum Toxin Type B for Dynamic Glabellar Rhytides Refractory to Botulinum Toxin Type A

BACKGROUND: Botulinum toxin type B (BTX-B; Myobloc) has recently been introduced for the treatment of dynamic rhytides. This serotype is structurally similar to botulinum toxin type A (BTX-A; Botox) and appears to produce equivalent muscular paralysis. Because of the fact that some patients may become resistant to the effects of BTX-A with its continued use or may require large doses of type A to exert adequate muscular paralysis, the use of BTX-B may prove beneficial in these cases. OBJECTIVE: To determine the effect of BTX-B on glabellar rhytides refractory or showing decreased clinical effect to treatment with BTX-A. METHODS: Twenty females (mean age, 43 years) with vertical glabellar rhytides showing decreased or negligible clinical effect to BTX-A were treated with intramuscular injections of BTX-B. Five standardized intramuscular sites (procerus, inferomedial corrugator muscles, superior middle corrugator muscles) received a total dose of 2,500 U. Patients were evaluated at pretreatment and 48 to 72 hours, 1 week, and 2 and 4 months after injection. RESULTS: All glabellar rhytides improved after treatment with BTX-B injections. Peak clinical effect was noted 1 month after treatment, with 50% of peak effect evident at the 2-month follow-up. Near complete dissolution of effect was seen at 4 months after treatment. Side effects were transient and were limited to moderate injectional pain and rare bruising and frontal brow tightness. CONCLUSIONS: BTX-B is an effective treatment modality for glabellar rhytides refractory or exhibiting decreased clinical effect to BTX-A. The duration of effect using the 2,500 U dosing schedule described herein was shorter than that typically achieved after equivalent BTX-A injection.     

Bladder botulinum toxin A injection can benefit patients with radiation and chemical cystitis

OBJECTIVE

To investigate the potential utility of botulinum toxin A (BoNT‐A) bladder injections in patients with radiation cystitis and bacillus Calmette‐Guérin (BCG)‐induced chemical cystitis.

PATIENTS AND METHODS

In all, six patients with refractory radiation cystitis were treated with 200 U bladder BoNT‐A injections and two patients with refractory cystitis after intravesical BCG therapy were treated with 100 U bladder BoNT‐A injections. All the patients were refractory to anticholinergic agents. Under sedation or local anaesthesia, BoNT‐A was injected through a cystoscope into 20 sites submucosally in the trigone and floor of the bladder.

RESULTS

There were no side‐effects or retention after BoNT‐A injection. In five of the six patients with radiation cystitis there was a moderate to significant improvement; the mean (sd ) bladder capacity increased from 105 (25) mL to 250 (35) mL and the urinary frequency decreased from 14 (2) to 11 (1) episodes per day. In the two patients with BCG cystitis both reported significant symptomatic improvement; the mean (sd ) bladder capacity increased from 110 (23) to 230 (23) mL, the urinary frequency decreased from 16 (1) to 12 (1) episodes per day, and using a 10‐point visual analogue pain scoring system, the perceived pain score decreased from 8 to 2. Microscopically, the bladder tissue at 1 month after BCG injection showed marked acute and chronic inflammation with eosinophilic infiltration and focal granulomatous formation. At 2 months after BoNT‐A injection, there was only a mild degree of chronic inflammation with few eosinophils.

CONCLUSION

These preliminary results suggest that BoNT‐A injected into the bladder is a promising treatment for patients with refractory radiation and BCG cystitis.     

Further experience with Botox injection for tracheoesophageal speech failure

BACKGROUND: Some patients fail to acquire tracheoesophageal (TE) speech after laryngectomy because of pharyngeal constrictor hypertonicity. Botox injection relieves hypertonicity, but there are little objective data regarding outcomes, duration of effect, and reinjection rates. METHODS: Hypertonicity was identified by means of insufflation testing and confirmed videofluoroscopically in 23 unsuccessful TE speakers. Each patient received an EMG-guided Botox injection. Additional injections were offered if the first injection failed to produce fluent speech. RESULTS: Overall, 20 of 23 patients (87%) achieved fluent TE speech production after Botox injections; 5 after additional injections. Two patients declined further intervention, and 1 failed to achieve fluent TE speech production even after 3 Botox injections. The longest sustained effect was 37 months, the shortest was 5 months for 1 patient who required reinjection of Botox to maintain her TE speech production. CONCLUSIONS: Botox injection relieves constrictor hypertonicity in selected cases of TE speech failure with little need for reinjection to maintain long-term speech success.     

A lack of antinociceptive or antiinflammatory effect of botulinum toxin A in an inflammatory human pain model

Several in vitro and in vivo investigations have shown that botulinum toxin A (BoNT/A) can inhibit the release of substance P and excitatory amino acids. Recently, a marked antinociceptive effect of BoNT/A and inhibition of glutamate release was observed in an animal pain model with inflammatory sensitization. In the present study, we tested the antiinflammatory and antihyperalgetic effect of BoNT/A in a well-characterized human inflammatory pain model. Using a randomized, double-blind, paired study design, we compared the effects of 100 mouse units of BoNT/A versus pure saline. Thermal and mechanical pain testings and superficial skin blood flow measurements were performed at baseline, at 48 h (in normal skin), and at 72 h (in inflamed skin) thereafter. Ultraviolet B irradiation resulted in a local inflammation with significant primary and secondary hyperalgesia. However, despite the evidence of efficacy on sudomotor function, BoNT/A had no effect on pain measures in either normal or inflamed skin. Signs of inflammation and primary and secondary hyperalgesia were found to be unaffected by BoNT. We have confirmed that BoNT/A has no direct effect on acute, noninflammatory pain. Furthermore, despite highly promising data from animal research, we have not observed antiinflammatory or antinociceptive effects of BoNT/A in human inflammatory pain.     

Comparison of intravesical botulinum toxin type A injections plus hydrodistention with hydrodistention alone for the treatment of refractory interstitial cystitis/painful bladder syndrome

OBJECTIVE

To compare the clinical effectiveness of botulinum toxin type A (BoNT‐A) injections followed by hydrodistention (HD) with HD alone in patients with interstitial cystitis/painful bladder syndrome (IC/PBS).

PATIENTS AND METHODS

A prospective, randomized study was performed in a urological referral centre. In all, 67 patients with IC/PBS who had failed conventional treatments were enrolled. Of these, 44 patients received suburothelial injection with 200 U (15) or 100 U (29) of BoNT‐A followed by cystoscopic HD 2 weeks later (BoNT‐A groups). The control group (23 patients) received the identical HD procedure with no BoNT‐A injection. All patients remained on baseline medications of pentosan polysulphate throughout the study. Bladder pain visual analogue scale (VAS), O’Leary‐Sant symptom and problem indexes, functional bladder capacity (FBC) and urodynamic variables were measured at baseline and after treatment. Global response assessment was used to evaluate successful treatment response.

RESULTS

The IC/PBS symptom score significantly decreased in all three groups, but VAS reduction, FBC and cystometric bladder capacity increases were significant only in the BoNT‐A groups at 3 months. Of the 44 patients in the BoNT‐A group 31 (71%) had a successful result at 6 months. A successful result at 12 and 24 months was reported in 24 (55%) and 13 (30%) patients in BoNT‐A group, respectively, compared with only six (26%) and four (17%) in the control group (P = 0.002).

CONCLUSION

Intravesical injections of BoNT‐A followed by HD produced significantly better clinical results than HD alone in patients with IC/PBS.     

A型肉毒毒素对小型猪肌皮瓣扩张的影响

目的 探讨A型肉毒毒素对小型猪扩张肌皮瓣的组织学影响.方法 小型猪7只,在左、右两侧腰肋部对称区域分别作面积为10 cm×6 cm的文身区,将A型肉毒毒素96 U随机注射于一侧文身区皮肌层,每点注射4 U(0.1 ml),注射间距2 cm(肉毒毒素组),另一侧注射等量生理盐水,作为对照.3 d后于两侧腰肋部对称部位分别植入200 ml扩张器1枚.完成扩张后,在两组扩张肌皮瓣对应部位取材进行HE及Masson染色,观察扩张肌皮瓣组织结构变化,对比两侧扩张肌皮瓣的厚度及组织学改变.结果 肉毒毒素组肌层、包膜层、真皮层平均厚度分别为(275.74±28.93)μm、(468.03±34.28)μm、(1990.79±102.10)μm,生理盐水组分别为(409.13±44.63)μm、(626.55±44.05)μm、(2508.44±70.71)μm,肉毒毒素组各指标明显低于生理盐水组,两组比较差异均有统计学意义(P＜0.01).Masson染色显示肉毒毒素组扩张器包膜胶原平均灰度为185.38±9.56,明显高于生理盐水组的120.77±10.31,两组比较差异有统计学意义(P＜0.01).光镜下HE染色显示肉毒毒素组肌肉明显萎缩,肌纤维横截面面积减少,生理盐水组皮肌肌纤维大致正常;电镜下见肉毒毒素组肌细胞明暗带模糊,Z线弯曲,生理盐水组皮肌肌细胞明暗带排列整齐,Z线清晰.结论 使用A型肉毒毒素辅助肌皮瓣扩张,可使肌肉萎缩,肌皮瓣变薄,包膜中胶原纤维含量减少.

Abstract：

Objective To investigate the histologic effect of botulinum toxin type A (Botox A )injection on myocutaneous flap expansion in minipigs model. Methods Seven minipigs were included in this study. Two symmetric tatoo area, 10 cm× 6 cm in size, were seclected on the bilateral flank of the pigs. The Botox A was injected into one tatoo area randomly, 4 U every point, 2 cm apart, with a total dose of 96 U. The same dose of sterile normal saline (0.9%) was injected in the same fashion on the opposite side as control. 3 days after injection , two 200 ml expanders were inserted beneath the cutaneous muscle at the tatto area. After complete expansion of 200 ml, the specimens were drawn from both groups symmetrically and were stained by means of HE and Masson. The histologic changes of myocutaneous flap were compared. Thickness of each layer in myocutaneous flap was measured in histological section. Results The thickness of cutaneous muscle, capsule, dermis were ( 275.74 ± 28.93 ) μm、 (468.03 ± 34.28 )μm 、(1990.79 ± 102.10) μm in Botox group, and (409.13 ± 44.63) μm、(626.55 ±44.05) μm、( 2508.44 ± 70.71 ) μm in saline group, respectively, show a significant difference between the two groups (P ＜0.01 ). The Masson stained slice showed that collagen average gray of capsule in Botox group was 185.38 ±9.56, which was significantly higher than that in the saline group( 120.77 ± 10.31, P ＜0.01 ).Light microscope ( HE stained sections ) showed that muscle in Botox group was significantly atrophy and cross-section of muscle fiber decreased. The muscle fiber in saline group was generally normal. It was observed through transmission electron microscope that the light and dark band of muscle cell became fuzzy and the Z line bending in Botox group. The light and dark band in saline group arranged neatly, the Z line was clear. Conclusions Application of Botox A in myocutaneous flap expansion can make the muscle atrophy and reduce the content of collagen in capsule layer, makeing the myocutaneous flap thinner which is suitable for reconstruction in face and neck.     

Botulinum toxin A (Botox) intradetrusor injections in adults with neurogenic detrusor overactivity/neurogenic overactive bladder: a systematic literature review

OBJECTIVES: This systematic literature review discusses the efficacy and safety of botulinum toxin type A (Botox) intradetrusor injections in adults with neurogenic detrusor overactivity (NDO) and urinary incontinence or overactive bladder symptoms of neurogenic origin (NOAB). METHODS: A MEDLINE and EMBASE search for clinical studies with botulinum toxin A injected into the detrusor of adults with NDO was performed. For several efficacy and safety variables data were extracted by one person and independently quality-controlled by another person. Extracted data were reviewed to propose recommendations for use in clinical practice based on level of evidence and expert opinion. RESULTS: A total of 18 articles evaluating the efficacy or safety of Botox in patients with NDO and incontinence/NOAB resistant to antimuscarinic therapy, with or without clean intermittent self-catheterisation (CIC), were selected. The amount of Botox injected was mostly 300 U, usually as 30 injections of 10 U/ml in the bladder (excluding the trigone) under cystoscopic guidance and with different types of anaesthesia. Most of the studies reported a significant improvement in clinical (approximately 40-80% of patients became completely dry between CICs) as well as urodynamic (in most studies mean maximum detrusor pressure was reduced to < or =40 cm H(2)O) variables and in the patients' quality of life, without major adverse events. CONCLUSIONS: Botox injections into the detrusor provide a clinically significant improvement in adults with NDO and incontinence/NOAB refractory to antimuscarinics. It seems to be very well tolerated. However, more adequately powered, well-designed, randomised, controlled studies evaluating the optimal dose, number and location of injections, impact on antimuscarinic regimen and CIC use, duration of effect, and when to perform repeat injections are warranted.     

Dissolving methohexital in a lipid emulsion reduces pain associated with intravenous injection.

Pain often accompanies intravenous injection of 1% methohexital. The aim of the present study was to test whether pain on injection could be reduced by dissolving methohexital in a lipid emulsion (study A) and whether this would affect anesthetic potency (study B). In study A, 24 healthy volunteers, 36 +/- 1 yr (mean +/- SE), were given 1 ml 1% methohexital in saline, 1 ml 1% methohexital in lipid emulsion, and 5 ml 0.1% methohexital in saline in random order. The injections were given in a small vein in the forearm at 5-min intervals. One minute after each injection, the subject was asked to assess the injection pain on a visual analog scale (0-100 mm). The pain score (median [range]) was 44.5 (0-77) after 1% methohexital in saline, 0.5 (0-26) after 1% methohexital in a lipid emulsion, and 1.0 (0-26) after 0.1% methohexital in saline. The pain score for 1% methohexital in saline was significantly greater than those for the other two solutions (P less than 0.001 for each comparison). In study B, 42 patients, 41 +/- 3 yr, were given 1% methohexital in lipid emulsion (n = 22) or 1% methohexital in saline (n = 20). A bolus of either solution was administered over 10 s, and the patient was considered asleep if there was no gross movement or response to verbal command 40-70 s after injection.(ABSTRACT TRUNCATED AT 250 WORDS)     

Pain on injection from propofol may be avoided by changing its formulation

Background: After using propofol for a decade, pain on injection had been considered routine by patients and medical personnel. When given propofol from a different manufacturer, patients did not complain. Two preparations of propofol were compared. Methods: A comparative, double‐blind, randomized study was conducted in 22 adult patients undergoing pain relief procedures; they received sedation by an intravenous injection of 1.7 mg/kg of propofol and then were treated with paravertebral injections. Pain on injection was assessed by verbal complaint, movement of the extremity, of the whole body and recollection of pain at induction, when discharged. Propofol from Baxter Laboratories, mixed with either 5 ml of 2% lidocaine or 5 ml of NaCl 0.9%, was compared with propofol Laboratorios Gray, which was similarly mixed. Injections were randomly administered four times, blindly, to each of 22 patients. Statistical analysis was conducted using the analysis of variance method. Results: A total of 352 propofol injections were given. Each of the four propofol solutions was administered 88 times; of patients receiving Baxter propofol+saline, 74 (84%) had pain; when mixed with 2% lidocaine 45 (50.2%) complained. After propofol Gray with NaCl 0.9% was given, two patients (2.2%) experienced pain. Propofol Gray with 2% lidocaine produced no pain. None of the latter group remembered having pain, whereas, those given propofol Baxter 54 (61.3%) and 26 (29.5%) remembered experiencing pain at injection. Pain on injection was prevented and statistically reduced (<0.01) with the propofol from Laboratorios Gray. Conclusions: By changing the formulation (size of molecules and their dispersion) of propofol, pain on injection was avoided.