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Recent trends in the treatment of rhinosinusitis and postoperative care


MASSEGUR H.
Hospital Sant Pau. Barcelona

Current Vision of Rhinosinusitis
and recent progress in advanced sinonasal endoscopic surgery
Medical forum. Valencia, March 2007

Keywords of Current Vision of Rhinosinusitis 2007 - PDF


LECTURES

After a relatively invasive operation (as may be the case of nasal polyposis surgery) in which it has been possible to preserve normal tissue in the operated area, a typical regeneration process begins consisting of the formation of scabs in the nasal cavity, the appearance of oedema and the development of granulation tissue.

During this regeneration process, hyperplastic changes are documented in the epithelium, with severe disruption of mucociliary flow, generation of epithelial lesions that break the continuity of the mucous membrane, and appearance of oedema and exudate. Both functional and morphological changes occur. The functional changes basically consist of decreased mucociliary activity, changes in the periciliary area, and changes in the secretion’s rheological characteristics.

The morphological changes consist of an increase in the goblet cells with respect to the percentage of ciliated cells, a transformation of seromucous glands into mucous glands, and degeneration and loss of cilia. The airway tissue heals in all directions, irrespective of irrigation, lymph flow or mucociliary movement. Apart from these general features, regeneration after an operation in the nasal region is an individual process which may be slower or faster depending on systemic or local factors.

Chronologically, the regeneration process starts with the growth of bone from the base of the wound (during the first week), ending approximately two months later. Postoperative mucociliary flow has a variable pattern: there are normal areas, there may be halts due to mucus stasis, there may be recirculation or even reverse flow.

Talking about the regeneration process after surgery, Dr. Massegur added that “the connective tissue arises from the endosteum, becoming lined with an immature, fairly non-functional epithelium.” He further stated that “macroscopic cure is not the same as functional cure and improvement of the mucous membrane does not imply restoration of the mucociliary flow.”

The appearance of secondary inflammation after the surgical aggression disrupts mucociliary flow, gland formation is incomplete and delayed, a higher density of mucous glands is detected with reduced secretion quality; these changes persist after macroscopic improvement has been observed.

Likewise, it has been seen that the inflammatory disease persists and adversely affects the healing process. It is also known that the appearance of local infections will also have negative effects on healing and the process will be less favourable in allergic patients, smokers and patients presenting with an ASA syndrome.

There are critical areas where postoperative healing is usually more problematic, such as the middle concha (especially in the head and at the entrance of the meatal cleft) and in the frontal recess. The meatotomy triggers a significant disruption of mucociliary flow in the maxillary sinus.


POSTOPERATIVE CARE

While preoperative and intraoperative measures are important, observance of a series of basic recommendations during the postoperative period will guarantee success of surgery in most cases and rapid, effective recovery of the patient.

As the speaker said, “the postoperative period starts during the operation itself, as the postoperative healing process will be optimised if a series of measures are taken into account during the operation (use of cutting clamp or microdebrider, preserve the healthy mucosa, choose a suitable tamponading material and use it for the optimum time, leave silastic to prevent synechiae).”

The fact is that there is currently no general consensus on what should be done after polyposis or rhinosinusitis surgery to improve the outcome. There is even doubt as to whether wound care should be daily for the first 10 days, whether it is preferable to perform it twice a week or whether it should be weekly. Neither is there agreement concerning the frequency of inspections until a complete cure is obtained. In this case, the scientific literature is highly divergent.

Macroscopic cure is not the same as functional cure and improvement of the mucous membrane does not imply restoration of the mucociliary flow.

As regards the drugs or products that could be indicated in the postoperative period, Dr. Massegur highlighted the benefits obtained from the administration of topical corticoids (which act more on the underlying disease than on the healing process), nasal irrigations (particularly hypertonic irrigations) and creams or gels (not ointments). Clinical evidence has also been appearing for phytotherapy, which consistently indicates the benefits that can be obtained from using certain natural products in the recovery process.

Some of the world’s foremost experts in this field have established certain basic recommendations about what should be done during the postoperative period. In 1991, Professor Stammberger recommended Merocel® + beclometasone solution (1-2 days), antibiotic + corticoid ointment (it has since been shown that, far from bringing benefits, this measure is associated with significant risks); he also said that during the first three days of the postoperative period, suction should be applied, removing clots and secretions, with non-routine saline solution irrigations, monitoring the results after 1 week and 4-6 weeks (6 weeks being the time required for reepithelialisation to occur).

In 2000, Professor Hosemann published more up-to-date and aggressive recommendations. He advised mechanical cleaning, administration of topical steroids, use of inhalations and irrigations, use of gels, creams or saline solutions, extirpation of scabs and bone fragments, elimination of synechiae, suction of all cavities or repositioning of the middle concha. This author was particularly concerned about removing scabs, as large scabs may obstruct ventilation and drainage and, therefore, significantly increase the risk of secondary mucositis; to do this, he proposes using the microdebrider.

On the other hand, hand-operated nasal suction would be ruled out. According to Hosemann, surgical wound care will depend on the patient’s progress (patients may have bloody, sticky mucus, scabs covering the surface, oedematous mucosa or a rapid normalization). This expert provides an approximate calendar for the healing process: appearance of scabs after 10 days, obstructive lymph oedema after 30 days, mesenchymal reaction after 3 months, and healing from the 3rd month onwards.

For his part, Professor Bernal insists that wound treatment should be performed 3-5 times for the first 15 days, 1-2 twice a week during the first month, and then once a week until fully healed. He also recommends postoperative use of irrigation and topical medication.

Recently, the EP3OS consensus has enabled the evidence level or recommendation grade to be established for the main products used in the postoperative care of nasal polyposis and rhinosinusitis. In the case of nasal polyposis, only the topical steroids have a recommendation grade A, with an evidence level Ib, based on a comparative study with polypectomy; however, a later study gave recommendation grade D for the topical steroids.

Also, the evidence level and recommendation grade for the other drugs or products routinely used in the postoperative care of nasal polyposis (oral and topical antibiotics, oral steroids, nasal irrigations, decongestion) are low, which “shows the lack of really useful resources that are backed by clinical data in such cases,” Dr. Massegur assured.

The evidence level and recommendation grade for the most commonly used products in the postoperative treatment of chronic rhinosinusitis also show a certain weakness for the treatments of choice. Either there are no data or the evidence levels are inconsistent, with very low recommendation grades. Only the topical steroids seem to have an acceptable evidence level (Ib), although the recommendation grade is D (they may be useful in the immediate postoperative period but not as a long-term therapy).


CYCLAMEN EXTRACT

Given the lack of consistency of the clinical evidence and the absence of a truly effective, well-tolerated treatment, it becomes particularly interesting to assess new therapies that may help improve the postoperative management of patients receiving surgery for a nasal polyposis or rhinosinusitis.

With Nasodren®, we achieve a physiological drainage, that is, during administration the mucociliary clearing processes are activated.

In this context, and as Dr. Humbert Massegur stressed, “a new plant extract-based treatment is particularly attractive. Nasodren® (cyclamen extract) is a natural active product that induces a reflex secretion.” The copious secretion facilitates an intense natural cleansing of the paranasal sinuses. In short, as the speaker highlighted, “with this plant extract preparation, we achieve a physiological drainage, that is, during administration the mucociliary clearing processes are activated.”

After intranasal administration of the product, the saponins it contains concentrate on the mucosal surface due to its surfactant properties and produce an osmotic effect on the mucous membranes in the lower portion of the nasal cavity.

Shortly after administration, the patient may feel a mild or moderate smarting sensation and irritation in the nose. There may be repeated sneezing. In the meantime, an intense reflex secretion begins a few minutes after administration of the product and may continue for a couple of hours.

This rapid secretion quickly dehydrates the mucosa, reducing the tissue oedema and mucosal inflammation and opening the osteomeatal complex. The secretion causes an intense physiological drainage of the paranasal sinuses, giving effective results in terms of therapeutic intent.

On the basis of his personal observations and experience, Dr. Massegur confirmed the usefulness, efficacy and safety of this preparation. His personal experience in postoperative care is based primarily on 28 patients who underwent ethmoidectomies for polyposis. Fourteen patients received only saline solution irrigations while the other 14 received the intranasal administration of cyclamen extract in addition to the irrigations.

One spray was administered into each nostril, once a day. The treatment was started on the third day after withdrawing Merocel®. Among the most salient findings, Dr. Massegur stated that “the patients treated with cyclamen extract experience a significant improvement in the evolution of the cavities after the sixth day of the postoperative period (third day of treatment).

Only one case of frontal pain caused by frontal sinusitis, requiring discontinuation of the treatment, has been documented.”

significant improvement in the evolution of the cavities

The endoscopic images of the nasal passages shown by this specialist, corresponding to a patient with sinonasal polyposis and superinfection, show how abundant mucus from the maxillary sinus appears only a few minutes after administration of this product. In the patients treated with Nasodren®, the maxillary sinus is clear after 48 hours, due to the product’s self-cleansing effect. By the 4th day after starting treatment, recovery of the affected area is obvious. By the 6th day, there is a clear decrease in the mucosal oedema (when normally this happens after 10-12 days); this effect could be due to use of this preparation.

significant improvement in the evolution of the cavities after the postoperative period


KEY POINTS ABOUT NASODREN®

Treatment can be started on the day after surgery or when the tamponade is removed, because, in Dr. Massegur’s opinion, there is no risk of bleeding.

The reason for using Nasodren® only once a day is basically because it induces a very strong expression of mucoid cells. Consequently, readministering after 12 hours would not provide any significantly greater benefit than that obtained by administering every 24 hours.

This treatment can be continued without problems for more than a week. “Since it causes no significant adverse effects, it can be used for up to 10-15 days,” the speaker said.

For what postoperative patients can its use be recommended? According to Dr. Humbert Massegur, “this preparation may be useful in all patients who require postoperative care, provided that there is healthy mucosa. Its effect would be very limited in those cases where the entire mucous membrane has been removed.”

The main contraindication for this product is that it should not be used in patients with obstruction.

This treatment, as the speaker explained, “can be repeated as often as is wished”, and can be stopped when the patient requests (minimum 7-10 days).

Summing up the main advantages offered by administration of this product in the postoperative care of patients undergoing surgery for nasal polyposis or rhinosinusitis, Dr. Massegur highlighted that “it will be very useful in clearing the surgical cavity, it will reduce the need for aggressive postsurgical wound treatments, the time between treatments of the surgical area will be longer, it will facilitate self-cleansing, it will possibly speed up the reepithelialisation process, and will enable topical corticoids to be applied earlier.”



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Hartington Pharma owns Nasodren® for sinusitis treatment